Development of Models To Predict Medication Non-Adherence Based o

University of Iowa
Iowa Research Online

Theses and Dissertations
2008
Development of models to predict medication

non-adherence based on a new typology
Elizabeth Jisha Unni
University of Iowa
Copyright 2008 Elizabeth Jisha Unni
This dissertation is available at Iowa Research Online: http://ir.uiowa.edu/etd/10
Recommended Citation
Unni, Elizabeth Jisha. "Development of models to predict medication non-adherence based on a new typology." PhD (Doctor of
Philosophy) thesis, University of Iowa, 2008.
http://ir.uiowa.edu/etd/10.
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Part of the Pharmacy and Pharmaceutical Sciences Commons

DEVELOPMENT OF MODELS TO PREDICT MEDICATION NON-ADHERENCE
BASED ON A NEW TYPOLOGY
by
An Abstract
Of a thesis submitted in partial fulfillment

of the requirements for the Doctor of
Philosophy degree in Pharmacy
in the Graduate College of
The University of Iowa
May 2008
Thesis Supervisor: Associate Professor Karen B. Farris

1
ABSTRACT
Medication non-adherence, the extent to which a persons behavior does not
coincide with medical or health advice, is a serious public health issue.
Objectives: 1) Develop a new typology of medication non-adherence, 2) Develop
models to predict different types of non-adherence based on Andersen Behavioral Model
(ABM) and Leventhals Common Sense Model (CSM), and 3) Test the models across
two different medications used in treating disease conditions with varying
symptomatology.
Methodology: A new typology of medication non-adherence was developed
through literature review of the frequently reported reasons for non-adherence based on
the possibility of a cognitive process intervention directed towards patients and the
mutability of interventions. The typology was analyzed qualitatively and quantitatively.
A new self-reported scale to measure non-adherence was developed from the frequently
reported reasons and compared to the Morisky scale. The conceptual models developed
using ABM and CSM were tested using regression techniques to identify significant
predictors of non-adherence.
Results: Qualitative analysis supported the typology from the literature review,
yet the quantitative exploratory factor analysis did not support it. Instead, four types of
non-adherence each for cholesterol lowering (non-adherence due to managing issues,
multiple medication issues, belief issues with medications, forgetfulness due to busy
schedule) and asthma maintenance medications (non-adherence due to managing and
availability issues, beliefs and convenience issues, cost issues, forgetfulness due to busy
schedule) were identified. Predisposing factors such as concern beliefs in medications,

2
enabling factors such as self efficacy, and need factors such as self health and illness
perceptions, and severity of disease were significant predictors of medication non-
adherence. The Reasons scale had moderate levels of agreement with the Morisky scale
based on kappa coefficients.
Conclusion: No one typology of medication non-adherence fit cholesterol
lowering and asthma maintenance medications, and the typology was driven by type of
disease condition and reasons for non-adherence. The Reasons scale measured and
categorized non-adherence better than the Morisky scale. Adding CSM to ABM
facilitated in identifying predictors of medication non-adherence.
Abstract Approved: ____________________________________

Thesis Supervisor
____________________________________
Title and Department
____________________________________
Date
DEVELOPMENT OF MODELS TO PREDICT MEDICATION NON-ADHERENCE
BASED ON A NEW TYPOLOGY
by
A thesis submitted in partial fulfillment

of the requirements for the Doctor of
Philosophy degree in Pharmacy
in the Graduate College of
May 2008
Thesis Supervisor: Associate Professor Karen B Farris

Copyright by
ELIZABETH JISHA UNNI
2008
All Rights Reserved

Graduate College
Iowa City, Iowa
CERTIFICATE OF APPROVAL
_______________________
PH.D. THESIS
_______________
This is to certify that the Ph.D. thesis of
has been approved by the Examining Committee

for the thesis requirement for the Doctor of Philosophy
degree in Pharmacy at the May 2008 graduation.
Thesis Committee: ___________________________________

Karen B Farris, Thesis Supervisor
___________________________________
John M Brooks
___________________________________
Elizabeth A Chrischilles
___________________________________
William Doucette
___________________________________
Yong-Chan Kim
___________________________________
Bernard Sorofman
To Sudhir Unni, my husband
ii
ACKNOWLEDGMENTS
I would like to sincerely thank my thesis advisor, Dr. Karen B. Farris for her
guidance, direction and understanding during my time in graduate school. Her insightful
comments and constructive criticisms have helped me immensely during the various
stages of this dissertation project. Dr. Farriss mentorship was so profound; that she
encouraged me not only in my daily work as a graduate student, but also to think
independently and progress as a researcher.
Special thanks to the other members of my graduate committee, Dr John
Brooks, Dr Elizabeth Chrischilles, Dr William Doucette, Dr Yong-Chan Kim, and Dr
Bernard Sorofman who were always available with their time to work with me on the
dissertation and have also offered valuable advice during my graduate program.
Sincere thanks to Lisa Haskins of Harris Interactive Inc. who was instrumental
in ensuring that my dissertation saw the light of the day despite various challenges
encountered during the data collection. I would also like to thank Rebecca Hahn for her
valuable inputs during the development of the survey instrument.
My appreciation goes to all my colleagues in the Pharmaceutical
Socioeconomics department as well as College of Pharmacy for their friendship and
support during my time in the program.
. I thank my parents, John and Aleyamma, and my brothers, Joby and Tom for
their faith in me and constant source of love and strength. I would also like to thank my
husbands family for their support, encouragement and enthusiasm. Finally and most
importantly, I would like to thank my husband, Sudhir Unni. His support,
encouragement, patience, and unwavering love made me complete this dissertation.
iii
ABSTRACT
Medication non-adherence, the extent to which a persons behavior does not
coincide with medical or health advice, is a serious public health issue.
Objectives: 1) Develop a new typology of medication non-adherence, 2) Develop
models to predict different types of non-adherence based on Andersen Behavioral Model
(ABM) and Leventhals Common Sense Model (CSM), and 3) Test the models across
two different medications used in treating disease conditions with varying
symptomatology.
Methodology: A new typology of medication non-adherence was developed
through literature review of the frequently reported reasons for non-adherence based on
the possibility of a cognitive process intervention directed towards patients and the
mutability of interventions. The typology was analyzed qualitatively and quantitatively.
A new self-reported scale to measure non-adherence was developed from the frequently
reported reasons and compared to the Morisky scale. The conceptual models developed
using ABM and CSM were tested using regression techniques to identify significant
predictors of non-adherence.
Results: Qualitative analysis supported the typology from the literature review,
yet the quantitative exploratory factor analysis did not support it. Instead, four types of
non-adherence each for cholesterol lowering (non-adherence due to managing issues,
multiple medication issues, belief issues with medications, forgetfulness due to busy
schedule) and asthma maintenance medications (non-adherence due to managing and
availability issues, beliefs and convenience issues, cost issues, forgetfulness due to busy
schedule) were identified. Predisposing factors such as concern beliefs in medications,
iv
enabling factors such as self efficacy, and need factors such as self health and illness
perceptions, and severity of disease were significant predictors of medication non-
adherence. The Reasons scale had moderate levels of agreement with the Morisky scale
based on kappa coefficients.
Conclusion: No one typology of medication non-adherence fit cholesterol
lowering and asthma maintenance medications, and the typology was driven by type of
disease condition and reasons for non-adherence. The Reasons scale measured and
categorized non-adherence better than the Morisky scale. Adding CSM to ABM
facilitated in identifying predictors of medication non-adherence.
v
TABLE OF CONTENTS
LIST OF TABLES........................................................................................................... viii
LIST OF FIGURES ........................................................................................................... xi
CHAPTER
1 INTRODUCTION ...............................................................................................1
Objectives of the study .....................................................................................8

Significance of the study ..................................................................................9
2 LITERATURE REVIEW ..................................................................................10

Prevalence and general impact of medication non-adherence........................11
Theoretical models to predict medication non-adherence ..............................15
Predictors of medication non-adherence ........................................................19
Interventions to improve medication adherence.............................................24
Typology of medication non-adherence .........................................................27
Measurement of medication adherence ..........................................................29
Summary of the literature review ...................................................................33
3 RESEARCH METHODOLOGY.......................................................................44
Aims of the study............................................................................................44

Study design....................................................................................................44
Developing the new typology of medication non-adherence .........................47
Developing the conceptual model ..................................................................51
Developing models to predict two classes of non-adherence.........................62
Measures of the study .....................................................................................70
Analysis ..........................................................................................................90
4 RESULTS ........................................................................................................114
Demographics of the respondents.................................................................114
Aim1 .............................................................................................................115
Aim 2 ............................................................................................................122
Sub analysis of aim 2....................................................................................127
Aim 3 ............................................................................................................129
5 DISCUSSION ..................................................................................................178
Key findings from the results .......................................................................178

Limitations of the study ................................................................................198
Future directions for the research .................................................................200
Conclusions...................................................................................................201
APPENDIX A: SURVEY INSTRUMENT .....................................................................203
APPENDIX B: IRB APPROVAL ...................................................................................233
vi
APPENDIX C: CORRELATIONS IN CHOLESTEROL LOWERING
MEDICATIONS ..............................................................................................................234
APPENDIX D: CORRELATIONS IN ASTHMA MAINTENANCE

MEDICATIONS ..............................................................................................................240
REFERENCES ................................................................................................................246
vii
LIST OF TABLES
Table
2.1: Summary of the literature reviews focused on medication adherence (2000-

2007) .........................................................................................................................36
3.1: Frequently reported reasons for non-adherence......................................................102
3.2: Classification of medication non-adherence from the frequently reported

reasons of non-adherence based on the mutability .................................................103
3.3: Model constructs and associated variables included in the model of

medication non-adherence ......................................................................................104
3.4: Expected significant variables in each separate model...........................................105
3.5: Reasons scale to measure medication non-adherence developed from the

frequently reported reasons of medication non-adherence .....................................106
3.6: Independent variables in the six models .................................................................107
4.1: Sample sizes............................................................................................................130
4.2: Demographic characteristics of the study sample...................................................131
4.3: Distribution of responses across the Reasons scale for cholesterol lowering
medications .............................................................................................................133
4.4: Distribution of responses across the Morisky scale for cholesterol lowering
medications .............................................................................................................134
4.5: Distribution of responses across the objective measure of medication non-

adherence for cholesterol lowering medications ....................................................135
4.6: Distribution of responses across the Reasons scale for asthma medications..........136
4.7: Distribution of responses across the Morisky scale for asthma medications .........137
4.8: Distribution of responses across the objective measure of medication non-

adherence for asthma maintenance medications.....................................................138
4.9: Classification of medication non-adherence based on literature reviewa for

cholesterol lowering and asthma maintenance medications ...................................139
4.10: Domains identified in cholesterol lowering medication non-adherence from

the qualitative analysis............................................................................................140
4.11: Domains identified in asthma maintenance medication non-adherence from

the qualitative analysis............................................................................................141
viii
4.12: Confirmatory factor analysis of Reasons scale for cholesterol lowering
medicationsa ............................................................................................................142
4.13: Confirmatory factor analysis of Reasons scale for asthma medicationsa ...............143
4.14: Exploratory factor analysis of 15 items of Reasons scale for cholesterol

lowering medicationsa .............................................................................................144
4.15: Reliability estimates of the dependent variables for cholesterol lowering

medications .............................................................................................................145
4.16: Exploratory factor analysis of 15 items of Reasons scale of asthma

maintenance medicationsa .......................................................................................146
4.17: Reliability estimates of the dependent variables for asthma medications ..............147
4.18: Dependent variables for cholesterol lowering and asthma maintenance

medications .............................................................................................................148
4.19: Reliability statistics of the scales used in the regression analyses..........................149
4.20: Summary of regression models predicting medication non-adherence in

cholesterol lowering and asthma medications ........................................................150
4.21: Regression model predicting medication non-adherence due to managing

issues in cholesterol lowering medications.............................................................152
4.22: Regression Model predicting medication non-adherence due to multiple

medication issues in cholesterol lowering medications..........................................154
4.23: Regression Model predicting medication non-adherence due to belief issues

in cholesterol lowering medicationsa ......................................................................156
4.24: Logistic regression model predicting medication non-adherence due to

forgetting due to busy schedule in cholesterol lowering medicationsa ...................158
4.25: Regression Model predicting medication non-adherence due to managing and

availability issues in asthma medicationsa ..............................................................160
4.26: Regression Model predicting medication non-adherence due to belief and
convenience issues in asthma medicationsa ............................................................162
4.27: Regression Model predicting medication non-adherence due to cost issues in
asthma medicationsa................................................................................................164
4.28: Logistic regression model predicting medication non-adherence due to

forgetting due to busy schedule in asthma medicationsa ........................................166
4.29: Comparison between Morisky scale and Reasons scale in cholesterol

lowering medications in identifying adherents and non-adherents ........................168
4.30: Comparison between Morisky scale and Reasons scale in asthma medications
in identifying adherents and non-adherents ............................................................168
ix
4.31: Comparison between Morisky scale and non-adherence quantification item
for cholesterol lowering medications in identifying adherents and non-
adherents .................................................................................................................169
4.32: Comparison between Reasons scale and non-adherence quantification item

adherents .................................................................................................................169
4.33: Comparison between Morisky scale and non-adherence quantification item

for asthma medications in identifying adherents and non-adherents......................170
4.34: Comparison between Reasons scale and non-adherence quantification item

for asthma medications in identifying adherents and non-adherents......................170
4.35: Comparing the forgot item across Morisky scale and Reasons scale in
cholesterol lowering medications in identifying forgetfulness as the reason for
non-adherence.........................................................................................................171
4.36: Comparing the forgot item across Morisky scale and Reasons scale in
asthma medications in identifying forgetfulness as the reason for non-
adherence ................................................................................................................172
4.37: Comparing the forgot item across Morisky scale and Quantification item in
non-adherence.........................................................................................................173
4.38: Comparing the forgot item across Reasons scale and Quantification item in
non-adherence.........................................................................................................174
4.39: Comparing the forgot item across Morisky scale and Quantification item in
adherence ................................................................................................................175
4.40: Comparing the forgot item across Reasons scale and Quantification item in
adherence ................................................................................................................176
4.41: Summary of the comparisons between scales in cholesterol lowering and

asthma maintenance medications............................................................................177
x
LIST OF FIGURES
Figure
3.1: Andersens Behavioral Model ..................................................................................97
3.2: Common Sense Model..............................................................................................98
3.3: Conceptual Model in Medication Non-adherence ....................................................99
3.4: Life Style Modification Needed Model ..................................................................100
3.5: Belief Modifications Needed Model.......................................................................101
xi
1
CHAPTER 1
INTRODUCTION
Medication adherence is defined as the extent to which patients take drugs as
prescribed by their health care providers (Osterberg and Blaschke 2005). Often, terms
such as compliance and concordance are used in its place. Medication non-adherence, the
extent to which a persons behavior does not coincide with medical or health advice, is a
public health issue estimated to cost $100 billion and contributing to nearly 125,000
deaths each year in the United States (Vermeire, Hearnshaw et al. 2001).
Studies have shown that the prevalence of medication non-adherence varies from
8 to 71% and is the cause for 10% of hospital admissions and 23% of admissions to
nursing homes (Donovan 1995; Vermeire, Hearnshaw et al. 2001). Bond and Hussar
reported non-adherence between 13% and 93%, with an average rate of 40% and it
encompassed all ages and ethnic groups (Bond and Hussar 1991; Salzman 1995;
Gladman 1997). The non-adherence rate with medications for acute disease conditions
ranges from 23 to 40%, while that with long term or chronic medications ranges from 6
to 67% (Haynes, Taylor et al. 1979). The prevalence of medication non-adherence as well
as the cost associated with it is immense; it is important to understand the causes for non-
adherence.
Current literature reviews show more than 10,000 studies on medication non-
adherence and over 200 variables as predictors of non-adherence (Stockwell and Schulz
1992; Donovan 1995; Vermeire, Hearnshaw et al. 2001). Vermeire in 2001 and Vik in
2004 conducted extensive literature reviews of medication adherence and identified
important predictors of medication non-adherence across the numerous studies
(Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004). These predictors were
examined so that groups of individuals could be targeted and/or interventions could be
designed. Some of the key variables identified in these reviews were patient
2
demographics such as age and education, cost of medications, cognitive disabilities, and
fear of side effects or dependence on medications; disease characteristics including
features of a disease, having psychiatric disorders like depression and anxiety, absence of
symptoms, time between taking drug and having an effect; therapeutic regimen
characteristics such as regimen complexity, treatment duration, number of medications,
and frequency of dosing; and style of interaction with physicians including the duration,
frequency, and quality of communication between the patient and physician (Vermeire,
Hearnshaw et al. 2001; Vik, Maxwell et al. 2004). Psychosocial variables such as
patients illness perceptions, beliefs in medications, attitudes towards medications,
reasoning made based on the pros and cons of taking medications, constraints of
everyday life, and experiences were also identified as significant predictors of medication
non-adherence (Leventhal, 1992; Horne 2003(Donovan and Blake 1992; Horne and
Weinman 1999).
At the same time that the predictors for non-adherence were being identified,
research was also conducted to determine the various ways to reduce non-adherence, and
a variety of intervention strategies to decrease non-adherence were developed. The
interventions used either alone or in combination to reduce medication non-adherence
include providing more instructions for patients, increasing communication and
counseling between patient and health care provider, increasing the convenience of care
provided, involving patients more in their care, providing reminders, and reinforcement
or rewards (McDonald, Garg et al. 2002). In 2003, Petersons meta-analytic review of
interventions to improve adherence reported an improvement of only 4 to 11% (Peterson,
Takiya et al. 2003). McDonald et al concluded that though the current intervention
programs led to improved adherence and treatment success, the interventions were
usually complex, labor-intensive, and not predictably effective (McDonald, Garg et al.
2002). In addition, van Eijken et als systematic literature review of interventions
demonstrated that multifaceted and tailored interventions were more effective in

3
improving medication adherence than single and generalized interventions (van Eijken,
Tsang et al. 2003). In order to provide multifaceted and tailored interventions, we need to
better understand the various types of non-adherence, predictors for each type of non-
adherence, and ways to decrease each type of non-adherence.
Measures have been developed to identify and quantify non-adherence and these
measures include both direct methods such as biological assay and indirect methods such
as patient interviews, diaries, self reporting questions, pill counts, pharmacy records,
prescription claims, clinical outcomes, and electronic monitoring (Vermeire, Hearnshaw
et al. 2001; Vik, Maxwell et al. 2004). Though biological methods are accurate in
determining non-adherence by measuring the concentration of drug in body fluids, they
are intrusive, expensive and impractical in a non-research setting (Vermeire, Hearnshaw
et al. 2001; Vik, Maxwell et al. 2004). The indirect methods of measuring non-adherence
are more frequently reported in the literature and include measures such as pill counts,
pharmacy records, and prescription claims. Though they can quantify non-adherence,
they cannot identify various types of non-adherence and hence cannot be used for
developing interventions (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004).
Self reported measures of non-adherence, though they may underestimate non-adherence
can provide the reasons for non-adherence and hence can be used in defining different
types of non-adherence (Haynes, Taylor et al. 1980). A quarter of all medication non-
adherence studies use self reported measures of non-adherence and the most commonly
used self reported measure is the Morisky scale (Morisky, Green et al. 1986; DiMatteo
2004).
The Morisky scale measures non-adherence using four items and identifies the
two main types of non-adherence (Morisky, Green et al. 1986). The first two items
measure unintentional non-adherence (occurs when patients wishes to adhere to
medications, but is prevented from taking medications due to some reason) and is based
on forgetfulness and carelessness in taking medications. The remaining two items

4
measure intentional non-adherence (occurs when patients deliberately do not take their
medications) and is based on stopping medications when feeling better or worse.
However, the literature indicates several other important reasons why individuals are
non-adherent to medications, in addition to these four reasons. Important other reasons
include, for example, concern about long term effects of medications, fear of side effects,
cost of medications, and unclear about proper administration of medication (Vik,
Maxwell et al. 2004). Thus, for example, an individual who might be non-adherent due to
fear of side effects or concern about the long term effects of medications will be adherent
using the Morisky scale. Subsequently, this individual will not receive any intervention.
However, if more reasons for non-adherence were included in the measure of non-
adherence, we are likely to be able to identify, quantify, and ameliorate non-adherence in
a greater extent.
Types of medication non-adherence behavior are defined by considering the
reasons individuals are non-adherent. As mentioned earlier, the two main types of
medication non-adherence identified and commonly used are intentional and
unintentional non-adherence (Barber, Parsons et al. 2004). Based on the widely used self-
reported adherence behavior scale by Morisky, this classification considers forgetfulness
and carelessness in taking medications as unintentional non-adherence, and skipping or
missing doses when feeling better or worse as intentional non-adherence, and this
approach has been used in previous studies and (Morisky, Green et al. 1986; Horne 1999;
Horne and Weinman 1999; Wroe 2002; De Smet, Erickson et al. 2006). Though the
intentional-unintentional typology is simple and straightforward, it does not capture all
the diverse facets of medication non-adherence and include the other important reasons
for non-adherence. Thus, the typology of non-adherence as simply intentional and
unintentional is lacking, and it is important to develop a new typology of medication non-
adherence. If we can classify non-adherence based on the underlying reasons, i.e., on

5
more than four reasons as in the Morisky scale, then we can develop appropriate
interventions to reduce each type of non-adherence.
The intentional-unintentional typology, while not widely used, began the process
to consider non-adherence as different types. However, this typology also appears to be
inaccurate based on advances in medication adherence research. Recent studies suggested
a belief component in forgetfulness, which accounts for approximately 30% of non-
adherence (Conrad 1985; Ley 1988; Vik, Maxwell et al. 2004). Foley et al (2006)
demonstrated that beliefs in medications are a major component of forgetfulness in the
consumption of cholesterol lowering medications (Foley and Hansen 2006). In addition, a
pilot study for understanding medication beliefs in older adults confirmed that high
concern beliefs in medications as identified by Horne et al using the Beliefs in
Medications Questionnaire (My medicines are a mystery to me, Having to take medicines
worries me, My medicines disrupt my life,) were significant predictors of forgetting to
take medications (John and Farris 2006). If forgetfulness has a belief component, then it
is not unintentional non-adherence as suggested by the earlier studies (Morisky, Green et
al. 1986; Barber, Parsons et al. 2004).
Recall that interventions to date have not been very successful in improving
medication adherence (McDonald, Garg et al. 2002; Peterson, Takiya et al. 2003; van
Eijken, Tsang et al. 2003). This assertion is supported by the fact that the majority of
studies examining medication non-adherence have considered it as a single entity and
have not differentiated types of non-adherence such as intentional and unintentional non-
adherence or the reasons underlying each type (Murray, Morrow et al. 2004; Brown,
Battista et al. 2005; Chia, Schlenk et al. 2006; Elliott, Ross-Degnan et al. 2007).Studies
have grouped people with varying reasons for non-adherence in one approach or model
and used single or combination intervention strategies (Grant, Devita et al. 2003;
Krueger, Felkey et al. 2003; Lee, Grace et al. 2006; Kripalani, Yao et al. 2007). However,
studies by Donovan (1992), Wore (2002), and Lehane (2006) demonstrated the need to
6
separate the different types of non-adherence to understand them better and to develop
intervention strategies to improve adherence. According to Donovan, patient reasoning
based on the pros and cons of taking medications is the principal reason for intentional
non-adherence, and this cognitive process is different for patients who are unintentionally
non-adherent (Donovan and Blake 1992). This view was also supported by Wroe in her
study of non-adherence with asthma medications, who emphasized the importance of
studying intentional and unintentional non-adherence as separate entities to assess the
beliefs of non-adherent individuals (Wroe 2002). She concluded that while decision
balance based on the pros and cons of taking medications predicted intentional non-
adherence, it was less associated with unintentional non-adherence. Lehane and
McCarthy also argued how both intentional and unintentional non-adherence accounted
for considerable variance in explaining medication non-adherence in their theoretical
discussion (Lehane and McCarthy 2006). They proposed the need to consider the two
types of non-adherence simultaneously while developing intervention strategies to
improve adherence.
Logically, different interventions are needed for non-adherence arising from
different reasons. The intervention needed for a patient who is non-adherent due to
thinking that medications are not needed will be different from another patient who is
being non-adherent due to the complexity of the regimen. If we need to develop tailored
interventions based on the types of non-adherence, which in turn is based on the reasons
of non-adherence, we also need to understand the variables that predict each different
type of non-adherence. In other words, theoretical models to predict each class of non-
adherence are needed.
In addition to understanding the various types of non-adherence and the
corresponding intervention strategies, it is also important to know whether non-adherence
varies by different types of medications. The majority of studies on medication non-
adherence have looked at one medication at a time or all medications combined (Eisen,
7
Miller et al. 1990; Boulet 1998; Cline, Bjorck-Linne et al. 1999; Brook, van Hout et al.
2006; Barclay, Hinkin et al. 2007). In these studies, the patient is often considered the
unit of analysis, thus avoiding the possibility that a patient while being adherent with one
medication can be non-adherent with another medication. It is logical to believe that the
underlying reasons for non-adherence in a patient taking medications for asthma may be
different from that of a patient taking statins for high levels of cholesterol. It may be that
reasons for non-adherence found in other studies such as beliefs in medications, treatment
satisfaction, communication between physician and patient vary by medication, and a
focus on one medication at a time seems necessary. Only one study has concomitantly
looked at medication non-adherence across two medications, for COPD and diabetes
(Krigsman, Nilsson et al. 2007). The study reported that the refill adherence pattern were
different for both medications, but failed to provide any reasons for the difference in non-
adherence pattern between medications.
This study will focus on maintenance medications for asthma and medications
used to lower high levels of cholesterol, as these are two commonly used medications
(Cherry, Woodwell et al. 2007). In addition, these two medications are used for two
different types of diseases conditions, namely, symptomatic and asymptomatic. High
levels of cholesterol do not lead to specific symptoms and hence can be considered as an
asymptomatic disease (Expert Panel on Detection Evaluation and Treatment of High
Blood Cholesterol in Adults 2001). Whereas, asthma is a symptomatic disease with
several symptoms such as shortness of breath, tightness in chest, and wheezing (National
Heart Lung and Blood Institute). Symptoms are important in considering medication non-
adherence as they are somatic information that patients may consider in evaluating the
need for a medication, their beliefs in that medication and the interpretation of the effects
of the medication and these are important predictors of medication non-adherence
(Leventhal, Diefenbach et al. 1992; Horne and Weinman 1999). Because of the presence
8
of symptoms in one condition versus another, patients having high levels of cholesterol
may have different reasons for being non-adherent compared to patients with asthma.
Objectives of the study
To continue fruitful research in medication non-adherence, three primary research
gaps are evident. First, the current classification of non-adherence as intentional and
unintentional with only four reasons of non-adherence is insufficient. Second, the
predictors of different types of non-adherence are not known. Third, the predictors of
medication non-adherence may vary across medications that are used to treat different
disease conditions.
The three specific aims of this study can be summarized as follows:
Aim 1: Develop a new typology of non-adherence which distinguishes the various types
of non-adherence based on the reasons underlying non-adherence, so that it will be more
approachable to develop matched intervention strategies.
Aim 2: Develop models to predict different types of non-adherence.
Aim 3: Test the developed models across two different medications used in treating
disease conditions with varying symptomatology.
Based on the above aims, we can summarize the research questions for the study as
follows:
Research question 1: What are the different types of non-adherence based
on the reasons underlying them?
Research question 2: What are the variables predicting each types of non-
adherence?
Research question 3: Does the model predicting different types of non-
adherence vary across disease conditions such as asthma which is a
symptomatic condition and high levels of cholesterol which is an
asymptomatic condition?
9
Significance of the study
This study will develop a new typology of medication non-adherence and identify
the predictors for each type of non-adherence across two medications. One of the
expected outcomes from this study is better understanding of the underlying reasons for
medication non-adherence and the typology of medication non-adherence based on these
reasons. A major drawback in the medication adherence literature today is the absence of
a gold standard for measuring medication adherence including self reported adherence
(Vik, Maxwell et al. 2004). The most widely used scale in measuring self reported
adherence is the Morisky scale (Vik, Maxwell et al. 2004). Though it is a well validated
scale, it is limited to just four reasons of non-adherence (forgetting, careless, stopping
medications when feeling better or worse). Studies have identified numerous other
significant reasons of non-adherence and Morisky scale fails to capture them. This study
will be significant in making an effort to develop a new self-reported measure and
typology of medication non-adherence based on the frequently reported reasons.
This study will also identify the predictors of each type of medication non-
adherence based on a theoretical approach. This will enable healthcare professionals to
develop efficient intervention strategies to improve adherence and thus decrease the
health care costs. The study will also inform medication adherence researchers as to
whether medication non-adherence is based on different reasons for non-adherence for
medications used to treat different conditions, i.e., symptomatic versus asymptomatic. If
the typology of medication non-adherence and the predictors of each type of non-
adherence vary based on the medication, this will be a new direction in the medication
non-adherence research and it may explain the low success rates with interventions to
reduce medication non-adherence.

10
CHAPTER 2
LITERATURE REVIEW
This chapter provides an overview about the various aspects of medication non-
adherence including the prevalence and general impact of non-adherence, theories
developed to predict non-adherence, predictors of non-adherence, interventions
developed to reduce non-adherence, typology of non-adherence, and measures developed
to identify and quantify medication non-adherence. Literature on medication adherence is
available from the 1970s. Compliance in healthcare by Haynes and Taylor in 1979 is
considered a significant beginning in the medication adherence literature. Over the next
three decades, several studies were done to identify the predictors of non-adherence,
develop theoretical models to predict non-adherence, develop interventions to improve
medication adherence, and develop methods to measure medication non-adherence.
The search strategy for conducting the literature review is explained below. The
search was conducted on medication adherence studies published after the 1990s and
literature reviews on medication adherence since 2000. The search was conducted only
on studies published in English. The key search words were medication adherence,
medication non-adherence, medication compliance, prevalence, rate, cost, predictors,
interventions, classifications, and measures and these words were used either single or in
combination. Both qualitative and quantitative studies on medication adherence were
included from the search. The resource that was mainly used for identifying journal
articles on medication adherence was Pubmed. In addition, other resources like
government publications, government websites, and World Health Organization reports
were also used. The search engine Google Scholar was also used to identify literature. A
summary of the major literature reviews of medication adherence from 2000 is presented
in Table 2.1.
11
Prevalence and general impact of medication non-
adherence
Medication non-adherence is the extent to which a patient does not act in
accordance with the prescribed interval and dose and dosing regime. It is an important
health care problem, experienced by as many as 50% of individuals and contributing to
$100 billion health care costs annually (Sullivan, Kreling et al. 1990; Vermeire,
Hearnshaw et al. 2001; Cleemput, Kesteloot et al. 2002; Wroe 2002; Haynes, McDonald
et al. 2003). The prevalence of medication non-adherence is 8 to 71% and is the cause for
10% of hospital admissions and 23% of admissions to nursing homes (Donovan 1995;
Vermeire, Hearnshaw et al. 2001). Prevalence of medication non-adherence as reported
by Bond and Hussar (1991) ranges from 13 to 93%, with an average rate of 40% and it
encompassed all ages and ethnic groups. A meta-analysis by DiMatteo reported the
average non-adherence rate as 24.8% (DiMatteo 2004). The non-adherence rate with
medications for acute disease conditions ranged from 23 to 40%, while that with long
term or chronic medications ranged from 6 to 67% (Haynes, Taylor et al. 1979). It has
been estimated that 43% of the general population, 55% of the elderly, and 54% of
children and teenagers are non-adherent (Gladman 1997). The rate of medication non-
adherence in elderly population as determined by Salzman (1995) was between 40 and
75% (Salzman 1995). The medication adherence rate was generally higher among
medical professionals, 77% for short term medications and 84% for long term
medications (Corda, Burke et al. 2000). As evidenced from these studies, different
researchers have estimated different medication non-adherence rates ranging from 8% to
93%. This wide variation in non-adherence rate can be due to several reasons such as
absence of a single operationalization of the term medication non-adherence, and
variation of non-adherence rate with different medications and different populations.
Consequently, it is important to develop a standardized operationalization of non-

12
adherence and to quantify whether non-adherence varies with medications and
populations.
When medication non-adherence exists, serious consequences can arise including
poorer health, additional health care costs and loss of independent living. Medication
non-adherence has been linked to poorer outcomes, in that individuals with high
medication adherence have 20% better outcomes than individuals with low medication
adherence (DiMatteo, Giordani et al. 2002). In addition to reducing treatment benefits,
medication non-adherence is also associated with poor prognosis (Irvine, Baker et al.
1999). The negative outcomes associated with all medication errors, of which inability to
administer medications and non-adherence is one component, include admission to
hospitals and long term care institutions, increased physician visits and, in some cases,
death (Dennehy, Kishi et al. 1996; Gray, Mahoney et al. 1999; White, Arakelian et al.
1999). While non-adherence was the cause for 8% of admissions to emergency rooms
(63% of it being intentional non-adherence), it attributed to 11% of admissions to acute
care hospitals (Col, Fanale et al. 1990; Malhotra, Karan et al. 2001). For patients aged 75
years and older, non-adherence has led to 26% of hospital admissions (Chan, Nickalson
et al. 2001). Thus, medication non-adherence remains an important issue and
understanding the complex predictors of medication non-adherence is imperative
(Bharucha, Pandav et al. 2004; Ellenbecker, Frazier et al. 2004).
Non-adherence with statins and asthma medications
In this study, medications for two specific disease conditions medications to
lower high levels of cholesterol and maintenance medications for asthma were selected.
Statistics from Centers for Disease Control and Prevention (CDC) showed that in 2005,
an estimated 106.9 million US adults have total blood cholesterol levels of 200 mg/dL
and higher, which is above desirable levels. Of these, 37.7 million have levels of 240
mg/dL or higher, which is considered high risk (Centers for Disease Control and
13
Prevention). Studies on statins, a class of medications to lower cholesterol and other
lipids, have demonstrated that between 25 and 70% of patients were non-adherent with
statins (Furmaga 1993; Bruckert, Simonetta et al. 1999). Insull reported the
discontinuation rate of statins as 12 to 45% at the end of one year of treatment in various
studies using data from HMOs (Insull 1997). For statins, Rudd (1994) identified 30 to
40% of patients as partially adherent (defined as 20 to 79% adherence) and 5 to 10% as
non-adherent (defined as less than 20% adherence). In an elderly population, adherence
with statin therapy was 40% after 2 years and only 25% were taking at least 80% of the
prescribed doses after 5 years (Benner, Glynn et al. 2002; Jackevicius, Mamdani et al.
2002). Studies have shown that fewer daily doses, fewer number of medications, and less
severe side effects increase adherence with statins (Insull 1997; Kiortisis, Giral et al.
2000; Kim, Sunwoo et al. 2002). In addition, patients knowledge of the disease and
attitudes towards cholesterol lowering treatments also predicted adherence to statins.
Senior et al (2004) demonstrated that elderly people, those with no formal education,
having a personal history of cardiovascular diseases, and those with a lower cholesterol
level were more adherent with statins. Patients perceptions such as lower perceived risk
of cholesterol or myocardial infarction, perceived frequent side effects, perceived
efficacy of the treatment, perceived greater control over family cholesterolemia, and
perceiving genes and cholesterol to be important determinants of a heart attack predicted
adherence with statins (Kiortisis, Giral et al. 2000; Senior, Marteau et al. 2004; Mann,
Allegrante et al. 2007). Medication beliefs such as concern about potential harm from
statins have also been identified as a reason for non-adherence (Mann, Allegrante et al.
2007).
The prevalence of self reported asthma as reported by CDC among US adults in
2002 was 7.5% or 16 million (Centers for Disease Control and Prevention 2004). The
non-adherence rate with maintenance asthma medications such as metered dose inhalers
was found to be 50% (Coutts, Gibson et al. 1992; Gibson, Ferguson et al. 1995). A study
14
conducted in UK to determine the patient adherence to anti inflammatory therapy as
controller medication in asthma noted the under use of inhaled corticosteroids in 55% of
study days (Coutts, Gibson et al. 1992). Horne et al demonstrated that patients
perception of asthma as an acute condition, symptom experiences, negative beliefs about
medications in general, and concerns about long term adverse effects of asthma
medications predicted non-adherence with maintenance inhaled corticosteroid
medications (Boulet 1998; Horne and Weinman 2002; Horne 2006). Ulrik et al identified
lack of perceived asthma symptoms as the major cause for non-adherence with asthma
maintenance medications (Ulrik, Backer et al. 2006). Other reasons identified by Ulrik
(2006) and colleagues for non-adherence to asthma medications included running out of
prescription, not liking the use of medication, concomitant treatment with multiple
medications, fear of adverse effects, and unwillingness to accept the reality of a chronic
disease. According to De Smet et al (2006), increased adherence to asthma maintenance
medications was associated with stronger beliefs in the benefits of the treatment, greater
perceived severity of the disease, increased duration of the disease, and more instructors
to educate about metered dose inhalers. Another significant predictor of non-adherence
with asthma maintenance medications is the medication concern beliefs such as
medications disrupting life and fear of being dependent on the medications and perceived
side effects (Horne, 2002; Horne, 1999; Boulet 1998; Gamble 2006). While some studies
showed that illness perceptions about the potential serious consequences of asthma
attacks predicted adherence with asthma maintenance medications (Horne 2002), few
other studies showed that adherence was linked to symptom experience and absence of
symptoms lowered the necessity need for medications (Main 2004; Ulrik 2006 ). Another
observation that was made was that those individuals with higher participation in their
treatment tended to discontinue medications when feeling better or worse compared to
those with passive participation in their treatment (Schneider 2007). Other significant
predictors noted were complexity of the treatment regimen including dosing frequency
15
and number of drugs, knowledge regarding the correct use of medications, necessity
beliefs in medications such as the belief that their health and future depends on medicines
and they would be very ill without their medicines, disease severity, and locus of control,
which is a persons perceived control over his/her behavior (Rau 2005, Menckeberg,
2007; Holgate 2006). Socioeconomic variables have produced conflicting results in
predicting non-adherence (Rau 2005).
Both statins and asthma medications have high non-adherence rates and as
evidenced from these studies, these rates are different for both medications. While the
non-adherence rate with statins varies from 10 to 70%, the non-adherence rate with
asthma maintenance medications ranged around 50%. In addition, the predictors of non-
adherence were also different for each medication. For example, while the major
predictor of statin non-adherence was concern beliefs about the potential harm caused by
these medications, the major predictor for asthma maintenance medications was the lack
of perceived symptoms. If type of medications or populations is not important in non-
adherence, then similar non-adherence rates and predictors for both medications should
be evident. With varying non-adherence rates and predictors for these different
medications, it is important to focus on this potentially important discrepancy.
Theoretical models to predict medication non-adherence
Various theoretical models have been used to predict medication non-adherence.
The theories used in explaining medication non-adherence were classified by Leventhal
and his colleagues as 1) biomedical, 2) behavioral learning, 3) communicative, 4)
cognitive, and 5) self regulative (Leventhal and Cameron 1987; Horne and Weinman
1998; World Health Organisation 2003; Munro, Lewin et al. 2007).
The biomedical theory assumes the patient to be a passive recipient of health care
and the focus is on patient characteristics such as age and gender (Leventhal and
Cameron 1987). While diseases are traced to biomedical causes such as bacteria or
16
viruses, treatment is focused on the patient's body. The limitation of this theory is that it
does not take into account the other factors that influence medication adherence,
including, illness perceptions of patients, psychosocial factors and socioeconomic
environment (Munro, Lewin et al. 2007). The behavioral learning theories such as
Banduras Social Learning Theory incorporate the principle of antecedents (both internal
such as thoughts of patients and external such as environmental cues) and consequences
(such as punishment or rewards for a behavior) as a mechanism for influencing
medication adherence (Leventhal and Cameron 1987). In this theory, adherence is
considered as a behavior which can be learned. The theory lacks focus on the less
conscious influences on behavior which are not linked to immediate rewards such as past
behavior and habits (Munro, Lewin et al. 2007). The communicative theories highlight
the importance of the communication skills of the health care providers to develop
rapport with the patients (Leventhal and Cameron 1987). According to this perspective,
an equal relationship between the patient and physician can improve adherence.
However, it still does not guarantee changes in the adherence behavior of the patient as it
ignores the attitudes and personality characteristics of the patient.
The cognitive theories are widely used in studying medication adherence and are
based on the assumption that attitudes and beliefs along with expectancies of outcomes
are the major determinants of health behavior such as medication adherence (Gebhardt
and Maes 2001). These theories assume that if patients are provided with the logical
understanding of the benefits and risks of taking medications, they will be better adherent
with the medications. The major theories in this classification are Health Belief Model,
Protection Motivation Theory, Social Cognitive Theory, and Theory of Planned Behavior
(Bandura and Simon 1977; Becker and Maiman 1979; Ajzen and Fishbein 1980; Rogers
and Prentice-Dunn 1997).
Health Belief Model considers medication adherence as a rational appraisal of the
balance between the barriers to and benefits to action (Munro, Lewin et al. 2007). While
17
the perceived seriousness and susceptibility to a disease constitutes perceived threat;
perceived barriers and perceived benefits influence the perceived effectiveness of
medication adherence. Becker notes that high perceived threat, low barriers, and high
perceived benefits promote healthy behavior (Becker and Maiman 1979). The model also
adds cues to action which can be either internal such as symptom perceptions or external
such as health communication (Rosenstock, Strecher et al. 1988). In addition, the model
also added self efficacy as a construct to explain the need to feel competent to be
medically adherent (Rosenstock, Strecher et al. 1988). The major limitations of the model
are its failure to take into account the influence of social relationships and the inability to
address behavioral coping skills (World Health Organisation 2003). In addition, a meta
analysis of the model demonstrated that the model was capable of predicting only 10% of
the variance in the behavior (Harrison, Mullen et al. 1992).
Protection Motivation Theory utilizes an individuals fear to create behavior
changes (Rogers 1975). Three components of fear including the magnitude of harm,
probability of the events occurrence, and efficacy of the protective responses are used in
this model to explain medication adherence. The advantage of this model is that it
explicitly uses the cost benefit analysis of the existing and recommended behavior to
predict the likelihood of change (Gebhardt and Maes 2001). The disadvantage of the
model is that the various environmental and cognitive variables other than fear are not
considered in the model (Rogers 1975). A meta analysis examining this theory found
only moderate effects on behavior (Floyd, Prentice-Dunn et al. 2000).
Social Cognitive Theory developed by Bandura proposes a reciprocal
determinism between the individual, environment, and behavior (Glanz, Rimer et al.
2002). According to this theory, behavior change happens if people perceive that they
have control over the outcome, there are few external barriers, and individuals have
confidence in their ability to execute the behavior (Armitage and Conner 2000). In other
words, the behavior is a function of knowledge of health risks and benefits, beliefs
18
regarding personal efficacy, expected outcomes, and perceived barriers and facilitators
(Bandura 2004).
According to the Theory of Planned Behavior, intention to be adherent with
medications is influenced by attitudes towards the behavior, subjective norms, and
perceived behavioral control (Ajzen and Fishbein 1980). Behavioral intention is
considered as the strongest predictor for the behavior. While attitudes comprise both
positive and negative beliefs as well as the evaluation of outcomes of the behavior,
subjective norms include the perceived expectations of significant others and the
individuals motivation to comply with their expectations. Perceived control is a function
of the perceived ease or difficulty in performing a behavior. However, this theory is
based on the assumption that individuals behave rationally and thus does not consider the
impacts of affective beliefs in medication adherence (Mullen, Hersey et al. 1987).
The self regulatory theory conceptualizes medication adherence to be based on
patients cognitive factors and planning. The theory proposes that medication adherence
is a function of the patients subjective experience of the health threats, which in turn will
guide the various coping strategies such as being adherent with medications (Leventhal,
Diefenbach et al. 1992). In this theory, the assumption is made that people are active, self
regulating problem solvers. The dynamics between illness representations and coping
strategies are influenced by other factors such as personality, psychosocial factors,
cultural context, and environmental perceptions (Edgar and Skinner 2003).
As can be noted, no single theory can explain medication non-adherence
adequately. Each theory has its own advantages and disadvantages. A conceptual
framework developed by combining aspects from the above theories and presented in
Chapter 3 may provide a better understanding of medication non-adherence.

19
Predictors of medication non-adherence
Studies on medication adherence in the past three decades have identified several
predictors of non-adherence. Vermeire et al in 2001 and Vik et al in 2004 provided the
most comprehensive literature reviews on medication adherence. Vik and colleagues
(2004) noted the absence of a single systematic descriptor of a non-adherent patient,
thereby requiring a range of variables to describe individuals who are non-adherent to
their medications. The major predictors of medication non-adherence can be grouped as
1) sociodemographic factors, 2) economic factors, 3) disease factors 4) treatment factors,
and 5) psychosocial factors.
The association between sociodemographic factors and medication non-adherence
is not clearly established since the studies provided inconsistent results (Balkrishnan
1998; Morrison and Wertheimer 2004). Though age was not a direct predictor of non-
adherence, medication non-adherence among the elderly population was above 50%
(Stewart and Caranasos 1989; Vik, Maxwell et al. 2004). Several factors including
number of medications, cognitive impairment, and polypharmacy have been considered
as reasons for this phenomenon. Other sociodemographic variables such as gender,
marital status, occupation, and living arrangements were also poor predictors of
medication non-adherence (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004).
However, age and gender were better predictors of medication non-adherence among
pediatric patients compared to adults; whereas income and socioeconomic status were
better predictors in adults than in pediatric patients (DiMatteo 2004). Race has been
found to be a significant predictor of medication adherence (Balkrishnan 1998). White
race was more associated with medication adherence compared to blacks. African
Americans have been reported to be non-adherent due to several reasons such as
medication beliefs, low literacy, lack of trust in physicians, and poor access to health care
(Vlasnik, Aliotta et al. 2005). According to Park et al, a busy life style and middle age
were good predictors of non-adherence (Park, Hertzog et al. 1999).

20
The economic factors studied were cost of medications and health insurance. Cost
of medications was a significant predictor of non-adherence and was estimated to occur
in one fourth of the elderly (Osterberg and Blaschke 2005; Safran, Neuman et al. 2005;
Hutchison, Jones et al. 2006). The rate of medication non-adherence due to cost among
elderly Medicare beneficiaries was 12.6% and that among non-elderly disabled enrollees
was 29.4% (Hutchison, Jones et al. 2006; Soumerai, Pierre-Jacques et al. 2006). Access
to medications can also influence medication adherence. A study of Medicaid patients
showed that restricting the access to medications to three paid prescriptions per month
caused a drop of 30% in the number of prescriptions filled (Soumerai, Avorn et al. 1987).
The authors also noted that the highest drop was for ineffective drugs and the category
of patients who were most affected were elderly, female, and disabled patients.
Disease factors such as cognitive impairment, increased comorbidity, poor quality
of life, and impaired activities of daily living have inconsistent associations with non-
adherence, while there is a strong evidence for the association between depression and
non-adherence (DiMatteo 2004; Morrison and Wertheimer 2004; Vik, Maxwell et al.
2004; Osterberg and Blaschke 2005). A study that assessed the relationship between
adherence and the presence of depression and anxiety concluded that the odds of a
depressed patient being non-adherent were three times greater than those of a non-
depressed patient (Morrison and Wertheimer 2004). However, the study did not find any
relation between adherence and anxiety. On the other hand, Haynes et al suggested the
relationship between adherence and anxiety (Haynes, Taylor et al. 1979). The association
between adherence and severity of disease was not obvious since various studies
provided conflicting results (Morrison and Wertheimer 2004).
Treatment factors such as complexities of regimen as well as an increased number
of daily doses were strong predictors of medication non-adherence. Use of polypharmacy
and having multiple prescribing physicians have negative associations with medication
adherence (Vik, Maxwell et al. 2004). Being unclear about the proper administration of
21
the drug was found to be a frequently reported reason for non-adherence and can be due
to the complexity of the regimen as well as poor communication between the patient and
physician (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004; Osterberg and
Blaschke 2005). Studies have shown that the quality, duration, and frequency of
interaction between the physicians and patients predict adherence (Vermeire, Hearnshaw
et al. 2001; Morrison and Wertheimer 2004; Osterberg and Blaschke 2005). Prescription
from a specialist led to greater adherence than when the prescription was by a general
practitioner (Lau, Beuning et al. 1996). The non-adherence rate was higher with new
medications compared to existing medications(Barber, Parsons et al. 2004). Intelligent
non-adherence or being non-adherent on a rational basis to avoid adverse effects was
another reason for non-adherence (Weintraub 1980). Weintraub (1980) noted that elderly
patients were intentionally non-adherent if the dose was excessive or if therapy was
inconvenient and would still achieve optimal therapeutic outcome. In addition, patients
unresolved concerns about diagnosis, absence of symptoms, and time between taking the
drug and its effect were considerable predictors of medication non-adherence (Vermeire,
Hearnshaw et al. 2001; Morrison and Wertheimer 2004; Osterberg and Blaschke 2005).
Another group of significant predictors of medication non-adherence is
psychosocial factors such as beliefs in medications and illness perceptions. Beliefs in
medications have been identified as a significant predictor for non-adherence by Horne
and colleagues (Horne and Weinman 1999). Several studies were conducted to establish
the belief component in non-adherence, especially intentional non-adherence (Donovan
1995; Wroe 2002; Brown, Battista et al. 2005; Atkins and Fallowfield 2006). The two
major domains of beliefs in medications as identified by Horne et al are necessity beliefs
(perceived role of medication in protecting against deterioration of the present and future
health status of the patient) and concern beliefs (perceived potential for the medication to
cause problems for the patient such as developing dependency on the medications)
(Horne and Weinman 1999). Donovan suggested that patients make a rational decision
22
about being non-adherent with their medications which may appear irrational to the
health care provider (Donovan and Blake 1992). This decision was made after carrying
out a cost benefit analysis of the treatment based on the patients perceptions of the
treatment and the personal and social circumstances within which they live (Pound,
Britten et al. 2005). The lay evaluation of the medication included evaluating whether the
regimen will fit their daily schedules, weighing the undesirable effects of the medication
to decide whether it is worth continuing, stopping the medicine to see what happens,
obtaining information about medicines from others, and using objective indicators such
as blood pressure monitoring and subjective indicators such as feeling good or bad
(Pound, Britten et al. 2005).
According to Conrad, patients choose to be non-adherent as a way of coping with
illness (Conrad 1985). Pound and colleagues (2005) demonstrated that the identity of the
illness and the patients acceptance of the illness play a major role in being adherent with
medications. Leventhal et al attributed patients perceptions of illness as reasons for
medication non-adherence (Leventhal, Diefenbach et al. 1992; Diefenbach and Leventhal
1996; Morrison and Wertheimer 2004). According to Leventhal, these illness perceptions
were created based on prior health and illness experiences, previous social
communication and cultural knowledge of the illness, and communication from perceived
significant others and authoritative sources such as physicians or parents (Leventhal,
Diefenbach et al. 1992; Hagger and Orbell 2003). A study of medication adherence in
renal dialysis patients showed that the personality trait conscientiousness (will to achieve
or dependability or self control) was a predictor of medication adherence (Christensen
and Smith 1995). Patients knowledge, ideas and experiences, lay evaluation of
medicines, as well as constraints of every day lives were important in determining
adherence to medications (Vermeire, Hearnshaw et al. 2001; Pound, Britten et al. 2005).
Vermeire (2001) also noted the influence of social factors including positive attitude by
others in the community that increases adherence.

23
Self efficacy, self regulation, and locus of control are other psychosocial variables
that were significant in predicting medication non-adherence. OLeary (1985) has
identified self efficacy as a significant cognitive factor affecting several health behaviors
including medication adherence. Various other studies have also demonstrated that self
efficacy is an important predictor of medication adherence in chronic illnesses (OLeary
1985; Tobin, Wigal et al. 1987; Lorig, Chastain et al. 1989; Horan, Kim et al. 1998;
Ogedegbea, Mancuso et al. 2003). According to Kanfer and Goldstein (1986), regulation
of health behaviors including medication adherence is determined by the patients
motivation to be healthy, perceived control over one's health, and perceived support of
health-promoting behaviors from significant others (Kanfer 1986). Atkins et al (2006) in
his study of non-adherence in breast cancer women showed patients who were
intentionally non-adherent had lower health locus of control and considered themselves
to have significantly less influence over their own health (Atkins and Fallowfield 2006).
In summary, Pound (2005) explained the various reasons why patients modify
regimens including minimizing medication intake, minimizing adverse effects and
addiction, making it fit their daily schedule, decreasing costs, and replacing medicines
with nonpharmacologic treatments. The most frequently reported reasons for non-
adherence as reported by Vik et al (2004) were adverse effects, forgetting,
asymptomatic/thinking the drug is not needed/feeling well without medication,
prescription running out, drug is ineffective, taking too many drugs, unclear about proper
administration, difficulty in swallowing, problems opening containers, and stopping drug
to see whether it is still needed. As evidenced, numerous factors particularly those related
to costs of medications, specific disease or functional conditions, characteristics of the
medication regimen, and psychosocial issues such as perceived necessity of medications,
confidence to take medications as prescribed and acceptance of illness/diagnosis are
important in predicting medication non-adherence. Demographic variables were much
less helpful in identifying medication non-adherence.

24
Interventions to improve medication adherence
With high rates and many reasons for medication non-adherence, it is imperative
to have a better understanding about and management of medication adherence. Several
interventions either alone or in combination have been applied to improve medication
adherence. These include providing more instructions for patients through oral and
written information, increased communication and counseling using automated telephone
and computer assisted patient monitoring and counseling, increasing the convenience of
care including simplified dosage and provision of service at the work site, involving
patients more in their care such as self monitoring of blood pressure or blood glucose
level, reminders including special pill packaging and dose dispensing units, and
reinforcement or rewards including partial payment of blood pressure monitoring
equipment (Haynes, McKibbon et al. 1996; Vermeire, Hearnshaw et al. 2001; McDonald,
Garg et al. 2002). Interventions based on overcoming patient barriers such as memory,
dexterity, and vision by using pill boxes, calendars, blister packs, etc were also discussed
in the literature (Vermeire, Hearnshaw et al. 2001; Morrison and Wertheimer 2004; Vik,
Maxwell et al. 2004). Donovan advocated using the patient-physician relationship to
improve adherence including physicians friendliness and approachability, enhancing
patient centeredness, improving physicians communication skills, and encouraging
physicians and patients to work together (Donovan 1995). Osterberg (2005) promoted a
similar intervention of patient education, improving dosing schedules, shorter waiting
times with physicians to avoid missed appointments, and improved communication
between physicians and patients. Alliance between patients, physicians, pharmacists, and
other health care providers were also considered as a way to enhance adherence (Morris
and Schulz 1992).
A systematic literature review of interventions to improve medication adherence
in elderly population noted that majority of the interventions considered the patient to be
a passive recipient while designing interventions (Higgins and Regan 2004). In

25
addition, Higgins et al (2006) commented that the interventions have not dealt with
intentional non-adherence where the patient actively chose not to take medications and
that none of the intervention designs aimed at eliciting patients attitude towards
medications as a mediator of adherence.
Kripalani et al in their review of interventions classified them into informational
interventions consisting of counseling and behavioral interventions made of dosage
simplifications, repeated assessment of medication use, specialized packaging, and
cognitive behavior therapy (Kripalani, Yao et al. 2007). While only 50% of the
informational interventions were effective, none of the behavioral interventions
significantly affected adherence or clinical outcomes. According to Kripalani (2007), the
most effective intervention was simplifying dose demands. Haynes et al classified
interventions based on the duration of treatment as short term and long term treatments
(Haynes, Yao et al. 2005). While five of the nine studies in short term treatment
improved adherence, only 26 of the 58 studies in long term treatment improved
adherence. In addition, while 80% of the studies in short term treatment improved clinical
outcome, only 69% of the studies in long term treatment improved clinical outcome.
The literature reviews which determined the effectiveness of reminder packaging
for improving medication adherence to long term medications produced conflicting
results. Heneghans results demonstrated that reminder packing which is a simple method
for improving adherence increased pill taking by only 11% (Heneghan, Glasziou et al.
2006). On the other hand, Lee et al reported a significant increase in adherence from
61.2% to 96.9% using an intervention consisting of pharmacist counseling and reminder
medication packaging (Lee, Grace et al. 2006). However, it should be noted that in this
study, the participants had a mean age of 78 years and were taking an average of 9
medications for chronic diseases, which makes generalization of the study uncertain. In
addition, the intervention included pharmacist counseling in addition to reminder
packaging.
26
Haynes et al in their systematic literature review of interventions to enhance
medication adherence has summarized the complexity and labor intensiveness of
interventions for long term medications (Haynes, McKibbon et al. 1996; McDonald, Garg
et al. 2002; Haynes, Yao et al. 2005). Both Haynes (2005) and McDonald (2002) in their
review summarized all the unconfounded randomized controlled trials (n = 57) where
both adherence and treatment effects were measured. They pointed out the difficulty in
using such interventions in non-research settings, especially taking into consideration the
cost containment and staff reduction in various practice settings. In addition, they also
commented that even the most effective interventions were not able to make large
improvements in adherence or treatment outcomes. A meta-analysis of trials of
interventions to improve medication adherence revealed that there was only an increase
of 4 to 11% in adherence and the study concluded that there was no single strategy that
appeared to be the best (Peterson, Takiya et al. 2003). Multifaceted and tailored
interventions were found to be better and effective in community dwelling older adults
compared to single and generalized interventions (van Eijken, Tsang et al. 2003). Weekly
or monthly appointments that consisted of counseling, monitoring, and education were
effective according to a systematic review of interventions used by community
pharmacists to improve medication adherence to chronic medications (Van Wjik, Klungel
et al. 2005).
As can be seen from the literature, in spite of the vast amount of research in the
area of developing interventions to improve medication adherence, the success rate with
interventions is still low. Reviews suggest that the current methods of improving
adherence with chronic medications are complex and not very effective (Higgins and
Regan 2004; Haynes, Yao et al. 2005; Van Wjik, Klungel et al. 2005). Researchers have
continuously mentioned the importance of providing multifaceted and tailored
interventions to reduce medication non-adherence (Haynes, McKibbon et al. 1996;
McDonald, Garg et al. 2002; Haynes, McDonald et al. 2003; Van Wjik, Klungel et al.
27
2005). Development of tailored interventions to reduce non-adherence requries a refined
and intervention-oriented typology of non-adherence, and understanding the predictors
for each type of non-adherence.
Typology of medication non-adherence
The majority of studies examining medication non-adherence has usually
considered it as a single entity both while identifying the predictors as well as while
developing interventions to improve medication adherence (Murray, Morrow et al. 2004;
Brown, Battista et al. 2005; Chia, Schlenk et al. 2006; Elliott, Ross-Degnan et al. 2007).
However, there have been typologies made in medication non-adherence.
The two main types of non-adherence identified presently are intentional and
unintentional medication non-adherence (Morisky, Green et al. 1986; Horne and
Weinman 1999; Wroe 2002; Lowry, Dudley et al. 2005; Atkins and Fallowfield 2006;
Lehane and McCarthy 2006). Intentional non-adherence happens when people have
issues with motivation to take medications or the way they perceive medications (Barber,
Parsons et al. 2004). Here, the patient undertakes a reasoned decision making process
with regard to following or disregarding medical advice (Playle and Keeley 1998; Lowry,
Dudley et al. 2005). Adverse effects and lack of perceived need for the medication were
the frequently reported reasons for intentional non-adherence (Vik, Maxwell et al. 2004).
The three factors causing intentional non-adherence as reported by Elwyn et al were lack
of information about the pros and cons of taking treatment, when the benefits of the
treatment are less clear and not immediate, and difficulty of patients to adjust to the role
of someone who has to take drugs (Elwyn, Edwards et al. 2003). Lowe et al demonstrated
that medication non-adherence in elderly population was mainly intentional and that an
elderly person decides to be non-adherent after weighing the perceived costs and benefits
of taking a medication and that non-adherence was not always due to confusion resulting
from old age (Lowe and Raynor 2000). Unintentional medication non-adherence occurs
28
when patient wishes to adhere to medications, but is prevented from it probably due to
forgetfulness or difficulty in taking the medication in the current form (Barber, Parsons et
al. 2004). Forgetting, unavailability of medication due to prescription running out, and
being unclear about the proper administration of the drug were the frequently reported
reasons for unintentional non-adherence (Vik, Maxwell et al. 2004). However, recent
research has demonstrated a belief component in forgetfulness. Foley et al (2006) in a
study of cholesterol lowering medications identified beliefs in medications as a
significant predictor of forgetfulness. Another study in older adults identified concern
beliefs in medications as a significant predictor of forgetfulness and carelessness in
taking medications (John and Farris 2006).
Singh and Kansra (2006) in their study of adherence with asthma medications in
children have classified non-adherence as 1) erratic non-adherence due to forgetfulness
and busy lifestyle, 2) unwitting non-adherence due to failure in understanding the
complete specifics or necessity of therapy, and 3) intelligent non-adherence where the
patient intentionally decides not to take medications (Singh and Kansra 2006). In other
words, unintentional non-adherence was sub classified as erratic and unwitting non-
adherence. The remedial strategy that was offered by Singh et al (2006) for erratic non-
adherence was regimen simplification along with cues and memory aids.
Another typology of non-adherence was made by La Greca et al (2003) based on
self reporting of adherence and drug levels. They classified participants as 1) genuinely
adherent those who report excellent adherence and have acceptable drug levels, 2)
deniers/medically complicated those who report excellent adherence and have
concerning drug levels, 3) at risk those who report non-adherence and have acceptable
drug levels, and 4) genuinely non-adherent - those who report non-adherence and have
concerning drug levels (La Greca and Bearman 2003).
Non-adherence has also been classified as primary and secondary non-adherence.
Primary non-adherence occurs when the patient fails to redeem the prescribed medication
29
and secondary non-adherence happens when the patient fails to take the medication as
prescribed (Wamala, Merlo et al. 2007). Socioeconomic disadvantage was considered as
the reason for primary non-adherence (Wamala, Merlo et al. 2007). Rudd (1994) in his
study classified individuals as 1) adherent taking medications more than 80% of the
time, 2) partially non-adherent taking medications 20-79% of the time, and 3) non-
adherent taking medications less than 20% of the time (Rudd 1994).
As evidenced from these typologies of non-adherence, only two typologies have
classified medication non-adherence based on the reasons of non-adherence. However,
these two typologies have focused only on few reasons of non-adherence. Intentional-
unintentional typology focuses only on the forgetting, carelessness, and stopping
medications when feeling better or worse reasons. Singh and Kansras (2006) typology
uses only forgetfulness, busy lifestyle, communication failure between the patient and
physician, and purposefully not taking medications reasons. However, the literature
indicates several other important reasons why individuals are non-adherent to
medications and these typologies fail to capture these other reasons of non-adherence. In
addition, most of these classifications consider forgetfulness as unintentional non-
adherence and suggest providing cue based interventions to reduce non-adherence.
However, research has demonstrated a belief component in forgetfulness, thus making
these typologies inaccurate. As well, the literature on interventions to improve adherence
suggests the need to have tailored interventions, which in turn require a typology based
on the reasons of non-adherence so that appropriate interventions can be developed. If
more reasons for non-adherence were included in the new typology of medication non-
adherence, that will enable health care providers to develop more tailored interventions.
Measurement of medication adherence
Vik et al in their review of measures of medication adherence concluded that
although several measures are available, accurate measurement continues to be

30
problematic (Vik, Maxwell et al. 2004). Thus, there is no single measure of patient
adherence to medications that is the gold standard (Vermeire, Hearnshaw et al. 2001;
Higgins and Regan 2004; Vik, Maxwell et al. 2004; Osterberg and Blaschke 2005). There
are both direct and indirect methods of measuring medication adherence. The direct
method includes biological assay where a metabolite or marker is detected in a body fluid
like blood or urine. Though this is an accurate measure of the concentration of drug in
body fluids, it is intrusive, expensive, and impractical in a non-research setting. In
addition, this method does not provide information about the type of non-adherence
(intentional or unintentional), and it does not take into account the pharmacokinetic
factors of the drug (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004). The
indirect methods of measuring medication adherence are more frequently reported in the
literature and include patient interviews, diaries, self reporting questions, pill counts,
pharmacy records, prescription claims, clinical outcomes, and electronic monitoring.
Patient interviews, diaries, and self reporting questions are all self reporting
methods and are prone to underestimation of non-adherence and this underestimation is
estimated to be approximately 20% (Haynes, Taylor et al. 1980). DiMatteo indicates that
self reporting has been used in 25.5% of the studies that measured non-adherence
(DiMatteo 2004). A comparison between self reporting measures and pill count showed
that while there is a good agreement between the two methods among self reported non-
adherers, there is considerable discrepancy between the two measures among self
reported adherers (Haynes, Taylor et al. 1979). Patients for social desirability reasons, by
forgetting instances of non-adherence, or not knowing they are being non-adherent may
report to be adherent, when in fact, they are non-adherent (Ley 1988; DiMatteo 2004).
Though self reporting measures do not provide an accurate measure of when and how
patients take their medications, it still provides a relative understanding of the patient on
the adherence dimension and is inexpensive (Horne and Weinman 1999). Haynes et al
(1979) suggest that self reporting measures are good measures when the objective of the
31
study is to just identify non-adherers. Importantly, self-reporting is the only method to
determine the reason/s why individuals are exhibiting this behavor.
The most widely used self reporting measures of non-adherence are Morisky
scale, Medication Adherence Scale (MAS), and Reported Adherence to Medication
(RAM) scale. All these scales are based on the classification of non-adherence as
intentional and unintentional and have only items relating to forgetfulness and
carelessness in taking medications and stopping medications when feeling better or
worse. The Morisky scale, the most widely used scale for measuring self reported non-
adherence behavior, measures it using four reasons and identifies the two main types of
non-adherence (Morisky, Green et al. 1986). The first two items measure unintentional
non-adherence and use the reasons forgetfulness and carelessness in taking medications.
The remaining two items measure intentional non-adherence and use the reasons stopping
medications when feeling better or worse. Though Morisky scale is a well validated
scale, it only takes into consideration four reasons of non-adherence. However, the
literature indicates several other important reasons why individuals are non-adherent to
medications, in addition to these four reasons. Important other reasons include, for
example, concern about long term effects of medications, fear of side effects, cost of
medications, and unclear about proper administration of medication (Vik, Maxwell et al.
2004). Thus, for example, an individual who might be non-adherent due to fear of side
effects or concern about the long term effects of medications will be adherent using the
Morisky scale. However, if more reasons for non-adherence were included in the measure
of non-adherence, we are likely to be able to identify, quantify, and ameliorate non-
adherence in a greater extent.
The other self reported scales to measure medication non-adherence are
Medication Adherence Scale (MAS) and Reported Adherence to Medication (RAM). The
Medication Adherence Scale is quite close to the Morisky scale in that it uses the same
reasons for non-adherence, except that the time frame used is 3 months instead of
32
ever in the Morisky scale. In addition, MAS also asks whether the patients have taken
more or less than the prescribed dosing (Brooks, Richards et al. 1994). The RAM scale,
which is adapted from the Morisky scale, measures non-adherence using two reasons of
non-adherence - forgetfulness in taking medications and altering dose to suit the patients
needs. While the first two items measure the agreement to these reasons using a 5 point
Likert scale, the last two items measure the frequency of these two reasons (Horne,
Weinman et al. 1999) .
Pharmacy records and prescription claims can be used to estimate non-adherence
and they are often readily available and will provide an economical approach in
estimating adherence (Vik, Maxwell et al. 2004). These are the frequently used methods
for measuring medication non-adherence (DiMatteo 2004; Morrison and Wertheimer
2004; Van Wjik, Klungel et al. 2005; Kripalani, Yao et al. 2007). The disadvantage in
this method is the reliability and validity of the estimate which depends on the
completeness and accuracy of the data in the records (Vermeire, Hearnshaw et al. 2001;
Vik, Maxwell et al. 2004). In addition, we cannot determine whether the patients actually
consumed the medications or not and we cannot classify non-adherence. Besides, these
objective measures, though they will quantify non-adherence, will not be able to provide
the reasons for non-adherence and hence it is difficult to plan intervention strategies.
Pill count, while providing an objective assessment of adherence, often
overestimate adherence (Haynes, Taylor et al. 1979; Vik, Maxwell et al. 2004). The
denominator for calculating pill count adherence is based on the dispensed date. Research
has suggested that patients may refill medications before the current supply runs out and
thus this can result in erroneous estimates of non-adherence. In addition, this method will
not provide information about the type of non-adherence and again it does not give any
indication about the actual consumption of the medication (Vik, Maxwell et al. 2004).
The use of medication event monitoring system (MEMS), in addition to estimating the
number of tablets missed, will also enable the health care provider to understand the
33
frequency and time of opening of medication bottle (Vermeire, Hearnshaw et al. 2001;
Vik, Maxwell et al. 2004). In spite of this benefit, it still has the disadvantages of not
being able to know about the actual consumption of the medication and being expensive.
Clinical outcomes are a reasonable measure of adherence, though not the best
method. The clinical outcomes when observed in a patient may be the result of a
combination of factors including other medications, medical care received,
socioeconomic and cultural factors (Haynes, Taylor et al. 1979). In addition, it is not
practical to collect this data in a non clinical setting.
In summary, there is no gold standard for measuring medication non-adherence.
The measures used by the researchers depend on the objectives of the study. For example,
while pill counts and pharmacy records quantify non-adherence, self reported measures
are more apt for identifying the reasons for non-adherence. In addition, the three common
self-reported measures in the literature use only four reasons to assess medication non-
adherence.
Summary of the literature review
One of the first studies on adherence by Haynes and Sackett was done in 1975
and over the last three decades, more than 10,000 studies and over 200 variables were
studied as predictors of non-adherence (Haynes, Taylor et al. 1979; Stockwell and Schulz
1992; Donovan 1995; Vermeire, Hearnshaw et al. 2001). Researchers have identified
several key predictors of non-adherence and developed numerous interventions to reduce
non-adherence. Despite this work, we are still faced with several issues including a wide
range of non-adherence rates, low success rates with interventions and contradictory
results with predictor variables of non-adherence.
A significant gap in the literature on medication non-adherence is the lack of a
specific operational definition of medication non-adherence (Morrison and Wertheimer
2004). The studies which had a definition for medication non-adherence varied in their
34
definitions (Morrison and Wertheimer 2004; Vik, Maxwell et al. 2004). While some
studies used a single measurement method, other studies employed a variety of
measurements. The Morisky scale, the most commonly used scale for measuring self
reported medication non-adherence behavior, is based on the intentional-unintentional
classification of non-adherence, which is the commonly used typology of non-adherence.
Using Morisky, forgetfulness and carelessness in taking medications is considered as
unintentional non-adherence and stopping medications when feeling better or worse is
considered as intentional non-adherence. Yet, research has identified several other
significant reasons for medication non-adherence. In addition, forgetfulness is considered
as unintentional non-adherence, however recent studies have identified belief in
medications as a predictor of forgetfulness. Consequently, the unintentional-intentional
typology is lacking, and including more reasons in a new self-reported measure of
medication non-adherence may contribute to a broader and improved definition.
Another gap is that the majority of studies have predicted non-adherence as a
single entity. However, as evidenced from the literature reviews on interventions to
improve non-adherence, multifaceted and tailored interventions are needed to improve
adherence. This suggests that research is needed to identify significant predictors for
types of non-adherence.
Finally, wide variance in the non-adherence rates across medications and
populations exists. The variance may arise due to definitional issues as well as true
variation from different reasons of medication non-adherence to different medications
and among different populations. Clearly, the literature indicates that one definition and
one intervention strategy do not work.
The literature suggests the need for a standard definition of medication non-
adherence, a new typology or classification of non-adherence; and the need for
developing a new measure of non-adherence, especially self reported medication non-
adherence. In addition, identifying predictors for types of non-adherence may ultimately

35
improve intervention effectiveness, and determining how non-adherence varies across
medications is also needed. Since medication non-adherence is a major health care
problem, more research is needed to better understand medication non-adherence so that
appropriate intervention strategies can be developed to decrease non-adherence and its
associated healthcare costs.

36
Table 2.1: Summary of the literature reviews focused on medication adherence (2000-
2007)
Vermeire Focus of the Comprehensive review of medication adherence articles

(Vermeire, study from 1975 to 1999
Hearnshaw et
al. 2001)
Predictors Almost 200 different predictors
Identified predictors - Psychiatric disorders, disability, side
effects, regimen complexity, poor communication between
patient and health care provider, doctor patient relationship,
patients unresolved concerns, absence of symptoms, time
between taking the drug and its effect, patients beliefs
about medications, knowledge, attitudes, constraints of
everyday life, attitude by others in the society
Interventions Improving doctor-patient relationship, communication
effectiveness of doctors, organizers and reminders such as
calendars and special containers, education strategies such
as good verbal communication and one to one counseling,
eliciting patients beliefs, improving patient comprehension,
recall, and motivation
Measures Lack of development of a gold standard of measurement
Direct measures - assays - Can be the most accurate, but is
intrusive
Indirect measures interviews, dairies, pill counts,
therapeutic outcome, prescription filling dates
Recent measures medication event monitoring system
There are advantages and disadvantages with each method.
Other Extent of poor adherence is 30 to 50%
Vik Focus of the Comprehensive literature review on the measurement,
(Vik, Maxwell study correlates, and health outcomes of medication adherence
et al. 2004) among community dwelling adults from 1966 to 2002
37
Table 2.1 - Continued
Predictors Sociodemographic variables generally not influencing

adherence
Health variables such as depression, cognitive impairment,
comorbidity, poor quality of life, impaired activities of daily
living, type of indications, vision problems, poor perceived
health status inconsistent results
Drug and prescriber related variables number of
medications, regimen complexity, duration of treatment,
type of drug, knowledge, self administering, problems
opening containers, multiple physicians, multiple
pharmacies, specialist prescribing, number of recent
physician visits, provider relationship and communication,
patient satisfaction mixed results
Frequently reported reasons for non-adherence adverse
effects, forgetting, asymptomatic, think drug is not needed,
feeling well without medication, prescription running out,
drug is ineffective, taking too many drugs, unclear about
proper administration, difficulty in swallowing, problems
opening containers, and stopping drug to see whether it is
still needed
Interventions Based on overcoming patient barriers such as memory,
dexterity, vision- calendar charts, blister packs, pill boxes
with digital alarms, etc
Based on enhancing patient care provider interactions using
pharmacists and nurses.
Measures No generally accepted gold standard for measuring
adherence
Direct measures biological assays - Intrusive, costly, and
impractical; cannot differentiate the patterns of non-
adherence
Other measures pill counts (though economical can cause
over estimation); medication event monitoring system
(provides information on the appropriateness of dosing
schedule but is costly); pharmacy records and prescription
claims (economical and readily available but validity and
reliability depends on the completeness of data);
Interviews and self reported measures - Interviews bias the
estimates by overestimating adherence, but self reported
measures provide a reasonably accurate assessment of
adherence
38
Other Estimates of drug adherence ranged from 43.7% to 100%

Wide range explained via different methodologies and
operational definitions for measuring adherence, difference
in populations and study settings
Needs more focus on examining health outcomes along with
adherence
DiMatteo Focus of the To retrieve and compile average adherence rates in all
(DiMatteo study empirical studies from 1948 to 1998
2004)
Predictors Age and gender were better predictors of medication
adherence among pediatric patients compared to adults,
education predicted adherence in chronic illnesses better
than adherence in acute illnesses, income and
socioeconomic status were better predictors of adherence in
adults than pediatric patients
Other reasons were patient self determination, depression,
lack of social support, patients misunderstanding,
forgetting, or choosing not to follow the recommendations
Interventions Not applicable
Measures Frequently used methods were medical record (28.2%), self
report (25.5%), pill count (25%)
Best measure of medication adherence was still
questionable
Self reports direct, simple, and inexpensive, but limited by
memory
Pill counts and tests such as urine tests good but not sure
whether patients actually took the medications as prescribed
or consumed it just before the test to appear adherent
Physician reports might be biased by unawareness of
patient behavior and accuracy of data
Other Over 569 studies, adherence ranged from 4.6% to 100%,
with a median of 76% and a mean of 75.2%.
The average adherence rate before 1980 was 62.6%, but the
rate after 1980 was 76.3% (p<0.001)
Larger studies report lower adherence compared to smaller
studies (p = 0.007)
Across 17 disease conditions, the average adherence rate
ranged from 65.5% in sleep disorders to 88.3% in HIV
disease.
39
Morrison Focus of the To compile and critique quantitative reviews of studies on

(Morrison and study adherence and to summarize the current knowledge of
Wertheimer adherence
2004)
Predictors Demographic, socioeconomic variables, and severity of
disease were not associated with adherence
Psychiatric diagnosis, type of drug, regimen complexity,
daily dose frequency, side effects, patients perceptions of
their illness, patient provider relationship, social support,
access to medications, and institutions providing service
were all associated with adherence
Interventions Reminder packaging, mailed reminders, and positive
reinforcements can improve adherence
Patient education was not associated with adherence
Effectiveness of patient counseling was mixed This might
be due to the heterogeneity in the type of interventions
Measures Most studies used variety of measurement methods
including electronic monitoring, prescription filling, and
continuation in clinical studies
Other Not applicable
Pound Focus of the Synthesis of qualitative studies of lay experiences of
(Pound, Britten study medicine taking from 1992 to 2001
et al. 2005)
40
Predictors Lay evaluation of medicines trying out the medicine to

weigh up its costs and benefits was very common;
evaluation of adverse effects; evaluating whether the
regimen will fit their daily schedules; weighing the
undesirable effects of treatment to decide whether it was
worth continuing it; stopping the medicine to see what
happens; obtaining information about medicines from
others; using objective indicators such as blood pressure
monitor and subjective methods such as feeling good or
bad; women were more skeptical about the drugs; most of
the time the evaluation was done in terms of its immediate
impact on their lives; fear of dependency
Medicines and identity those who did not accept their
illness felt that medicine did not help; stigma of taking
medicines in public especially for illnesses such as
schizophrenia
Ways people take their medicines Imposed compliance
when patients are forced to take medicines by relatives and
health professionals; modifying regimen to minimize intake;
modifying regimen to decrease adverse effects and
addiction; modifying regimen to make it fit their daily
schedule; modifying regimen to decrease the costs; taking
drug only when feeling sick; replacing medicines with
nonpharmacological treatments; changing doctors to change
drug regimen to avoid confrontation with the previous
doctors
Interventions Not applicable
Measures Not applicable
Osterberg Focus of the A general review article on medication adherence
(Osterberg and study
Blaschke
2005)
Predictors Major predictors of poor adherence - Presence of
psychological problems such as depression, cognitive
impairment, asymptomatic disease, inadequate follow up or
discharge planning, side effects, lack of belief in the
treatment, lack of insight into the illness,, poor provider
patient relationship, presence of barriers to care or
medications such as restricted formulary, missed
appointments, complexity of treatment, and cost of
medication
41
Interventions Four categories Patient education; improving dosing

schedules including simplifying regimen and reminders to
take medications; shorter waiting times to meet physicians
to avoid missing appointments and to have convenient and
effective follow up visits; and improved communication
between physicians and patients.
Measures No consensual statement as to what constitutes adequate
adherence
Direct methods objective measure, but expensive and can
cause white coat adherence
Indirect methods self report, pill counts, prescription
refills, clinical responses, electronic monitoring, patient
diaries - have both advantages and disadvantages
Other One sixth of patients have perfect adherence; one sixth
come close to perfect adherence, but with some timing
irregularity; one sixth miss an occasional single days dose
and have some timing inconsistency; one sixth take drug
holidays three to four times a year; one sixth have drug
holidays every month; and one sixth take few or no doses
while giving the impression of good adherence
Kripalan Focus of the To summarize, categorize, and estimate the effect size of
(Kripalani, study interventions to improve medication adherence using
Yao et al. randomized controlled trials published between Jan 1967
2007) and Sep 2004
Predictors Not applicable
Interventions Informational interventions consisted of counseling lasting
from single sessions of one hour to several sessions over
hours. Six of 12 studies increased adherence
Behavioral interventions consisted of dosage
simplifications, repeated assessment of medication use,
specialized packaging, and cognitive behavior therapy
None of these interventions significantly affected adherence
or clinical outcomes
Combined interventions used informational and behavioral
interventions along with social support strategies Five of
13 showed improvements in adherence
The most effective intervention according to this review
was simplifying dose demands
Measures Most studies reported a single measure of adherence. The
measures varied from self reports to refill rates, pill counts,
and electronic monitoring
42

Haynes Focus of the To summarize the results of the review of randomized
(Haynes, Yao study controlled trials of interventions to enhance medication
et al. 2005) adherence up to September 2004
Interventions Short term treatments Five of the nine studies improved
adherence and four of them had improved clinical
outcomes.
Long term treatments 26 of the 58 interventions improved
medication adherence, but only 18 interventions resulted in
improvement in clinical outcomes.
Almost all the interventions were complex and labor
intensive including combinations of several interventions
Even the most effective interventions did not lead to large
improvements in adherence or clinical outcomes
Several studies lacked power to detect clinically important
effects
Measures Not applicable
Higgins Focus of the To systematically review interventions to improve
(Higgins and study medication adherence in older people between 1966 and
Regan 2004) 2002
Interventions Effective interventions were complex
Interventions with single discrete strategies did not produce
sufficiently good results and positive effects were only
found with combinations of approaches
Results were mixed and the statistical significance of the
clinical effects were small
Studies were not sufficiently rigorous enough with respect
to randomization, blind raters, power, specified patient
samples, intention to treat analyses, outcome measurements,
and clearly defined objectives.
None of the interventions directly tackled the issue of
intentional non-adherence
Measures Lack of consensus as to how medication adherence should
be measured
43

Van Wjik Focus of the To systematically review the impact of community
(Van Wjik, study pharmacist interventions to improve patient adherence to
Klungel et al. chronic medications between 1966 and 2003
2005)
Interventions The common interventions were providing education and
counseling, and monitoring of medicine taking
Eight of 18 studies showed significant improvements in
adherence and five of these were RCT
The interventions that showed an effect were weekly or
monthly appointments that consisted of counseling,
monitoring, and education
Current methods of improving adherence with chronic
medications are complex and not very effective
Measures Most of the studies used self report or pill counts, followed
by pharmacy records
Other Heterogeneity between studies makes it difficult to draw a
general conclusion about interventions
Most of the studies did not report a power calculation
44
CHAPTER 3
RESEARCH METHODOLOGY
This chapter will explain in detail the methodology that was used in this study.
The first two sections of the chapter explain the aims of the study and the study design
including the study subjects and data collection methods. The third section of the chapter
describes the development of the new typology of medication non-adherence based on
the literature review, development of the conceptual model, and development of the
models to predict the classes of non-adherence. The fourth section explains the measures
that were used to collect data and the final section depicts the analyses that were done.
Aims of the study
The three specific aims of the study were to:
Develop a new typology of medication non-adherence which will distinguish the
various types of non-adherence based on the reasons underlying non-adherence
Develop models to predict different types of non-adherence.
Test the developed models across two different medications used in treating
disease conditions with varying symptomatology cholesterol lowering
medications and asthma maintenance medications.
Study design
A cross sectional survey was used for this study. Data were collected using both
quantitative and qualitative methods using an internet based survey administered by
Harris Interactive. The qualitative method was used to address Aim 1 and the quantitative
methods were used to address all the three aims. Harris Interactive (HI) maintains a panel
of individuals who have opted to be invited to participate in online surveys. The study
population was adult US individuals who were members of the HI panel. Since this study
focused on individuals who have high levels of cholesterol and asthma, HI included
45
individuals who were either taking cholesterol lowering medications such as statins or
asthma maintenance medications in the sample population. The lipid lowering
medications were defined as those medications that lower blood cholesterol levels by
inhibiting HMG-CoA reductase. The most commonly used lipid lowering medications
are statins and include brands such as Lipitor, Crestor, Zocor, Mevacor, and
Lescol. The asthma maintenance medications were defined as those that are used
everyday to help prevent asthma attacks and include brands such as Aerobid,
Pulmicort, Flovent, and Singulair. The other common type of asthma medications are
rescue inhalers which are often used during asthma attacks. In this study, the intention
was to understand the adherence pattern of individuals on maintenance medications and
hence the study was confined only to asthma maintenance medications. The inclusion
criteria for participants in the study were 1) 18 years of age or older, 2) members of HI
panel, 3) taking either cholesterol lowering medications or asthma maintenance
medications, and 4) internet users.
The study sample was a convenience sample selected from the HI panel based on
the above inclusion criteria. Using a random sampling method to select the study sample
would have been beneficial in generalizing the study results. However, since this study
was considered a step towards developing and testing models of new classes of non-
adherence, it was decided that it was more important to have a large sample size, even if
that meant forgoing the generalizability of the study (Eysenbach and Wyatt 2002;
Schonlau 2004). The next phase of this research program can be focused on the
generalizability of the study results. Since the survey was done using internet, selection
bias is an important drawback, and efforts were made to match the respondents with
telephone survey (random digit dialing) respondents using weights such as age, race,
ethnicity, education, religion, and income (Schonlau, Van Soest et al. 2004). This
procedure helped in reducing the selection bias to some extent by matching the internet
46
sample with a sample selected using random digit dialing. However, these measures still
do not guarantee the generalizability of the study.
The sample size for conducting the quantitative analysis was 1000 subjects; 500
subjects using cholesterol lowering medications and the remaining 500 on asthma
maintenance medications. The sample size calculation was based on two assumptions.
First, since we were using a convenience sample, our intention was to maximize
responses from as many subjects as possible. Second, we used multiple regression
analysis to test the models developed in the study and overall, we had 27 independent
variables. According to Tabachnick and Fidell, a rule of thumb for testing regression
coefficients is to have a sample size where the case: independent variables ratio is 15: 1
to make meaningful interpretations in regression analysis, and the ideal ratio is 20:1
(Tabachnick and Fidell 2001). This summed to 405 completed responses for making a
meaningful interpretation of the regression results. Thus, a sample size of 500 subjects
for each disease condition was considered adequate to satisfy the above two assumptions.
The sample size for the qualitative analysis was 50 subjects, 25 subjects using
cholesterol lowering medications and 25 subjects on asthma maintenance medications.
When deciding on the sample size for qualitative analysis, the focus was to attain
saturation in the responses (Marshall and Rossman 1995). Based on previous research on
medication adherence using qualitative methods, it was determined that 25 subjects in
each disease condition would be sufficient to attain saturation in responses. Pound
reviewed 37 qualitative studies of medication adherence, and the number of subjects
varied from 6 to 82. Out of the 34 studies having information about the participants, one
study had a sample size less than 10, 5 studies had a sample size between 10 and 20
subjects, 10 studies had between 20 and 30 subjects, 7 studies had between 30 and 40
subjects, 4 studies had between 40 and 50 subjects, and 7 studies with more than 50
subjects. As can be seen, most (29%) of the studies had participants ranging from 20 to
30 participants (Pound, Britten et al. 2005).

47
The data collection was performed using two internet survey instruments
(Appendix 1). One instrument was for respondents who were on cholesterol lowering
medications and the other was for those who were on asthma maintenance medications.
Both the instruments had 115 items each and were tested for face validity using a
convenience sample of participants at the University of Iowa and Harris Interactive. The
data collected was entered using the data analysis software SPSS version 14. The study
was approved by the Institutional Review Board of the University of Iowa (Appendix B).
Developing the new typology of medication non-adherence
The first aim of this study was conducted in three steps. In the first step, a new
typology of medication non-adherence was created using an extensive literature search.
In the second step, the types of medication non-adherence created in the first step were
confirmed using qualitative analysis. In the third step, quantitative methods were used to
substantiate the types developed by the first two steps.
The new typology of medication non-adherence was developed based on the
underlying reasons for non-adherence to enable health care providers to develop targeted
interventions in the future to reduce medication non-adherence. The reasons for non-
adherence behavior were identified from existing literature since these were a
culmination of information regarding medication non-adherence. Vik et al in a literature
review of medication adherence from 1996 to 2002 identified the ten most frequently
reported reasons for non-adherence as adverse effects, forgetting, asymptomatic/thinking
that the drug is not needed/feeling well without medication, running out of prescription,
drug is ineffective, taking too many drugs, unclear about proper administration, difficulty
in swallowing, problems opening containers, and stopping drug to see whether it is still
needed (Table 3.1) (Vik, Maxwell et al. 2004). Based on our review of literature, we
identified five other frequently reported reasons for non-adherence and these were added
to the list of frequently reported reasons for non-adherence. Other significant reasons for
48
non-adherence found in literature included cost of medications, concern about long term
effects of medication, embarrassment in taking medications in a public place, and
inconvenience in taking medications as prescribed (Horne and Weinman 1999; Sirey,
Bruce et al. 2001; Svensson and Kjellgren 2003; Piette, Heisler et al. 2004; Soumerai,
Pierre-Jacques et al. 2006). The frequently reported reasons for medication non-
adherence listed in Table 3.1 were classified.
The literature on interventions to improve medication adherence has pointed to
the need for developing tailored interventions. Hence, the decision was made to develop
the typology of non-adherence based on possible interventions and how mutable the
reasons for non-adherence are for possible interventions. While Kripalani (2007)
classified interventions as informational (educational), and behavioral (cognitive therapy,
dosage simplifications); Higgins (2004) classified them as external cognitive support
(mechanics of medication delivery) and education strategies. Haynes (2005) and
McDonald (2002) studied interventions based on disease conditions and the duration of
treatment.
The classification of reasons as shown in Table 3.2 was based on the mutability or
changeability of reasons in terms of potential responsiveness to a cognitive intervention
as well as the focus of the cognitive intervention. For this study, a cognitive intervention
was considered as any intervention that was based on modifying the everyday thoughts
and behaviors of patients. For example, an individual who considers the medication to be
ineffective may gain knowledge or have a belief or attitude change from an intervention
that will aim at positively influencing his/her beliefs about medications. Hence,
considering the medication to be ineffective can be considered as a reason with high
mutability for a cognitive intervention focused on belief issues. Similarly, an individual
who frequently complains about forgetting to take medications can be provided a
cognitive intervention focused on lifestyle modification to change his/her everyday
behavior and make taking medication a priority. On the other hand, if non-adherence is
49
due to the cost of medication, a cognitive intervention aimed at the patient will be
unsuccessful in reducing non-adherence. Thus, the reason cost of medication (s) was
considered to have a low level of mutability for a cognitive intervention for the patient.
The classification was based on the mutability of the reasons and the focus of cognitive
intervention (beliefs or lifestyle modification) to facilitate the development of tailored
interventions to decrease non-adherence. Andersen raised the importance of mutability in
promoting access to health care service utilization and this same concept applies to health
care related behaviors such as medication taking (Andersen 1995).
For those reasons that were categorized under the class reasons with low
mutability for a cognitive process intervention for the patient, the intervention has to be
provided by the physician, a health care provider, family member, or a friend. It is
possible to educate patients to report to health care providers any type of difficulty in
taking the medication as prescribed. The provider can then provide the necessary
intervention. For example, if a patient finds it difficult to swallow the medications, he/she
could be trained to talk with the pharmacist to help break the drug instead of
discontinuing the medication. In other words, for all these reasons, it may not be right to
hold the patient accountable for being non-adherent because the reasons seem out of their
control. Hence, towards the classification of medication non-adherence, these reasons
were categorized as those with low mutability for a cognitive process intervention
focused toward patients.
In the class reasons with medium to high mutability for a cognitive process
intervention where lifestyle modifications are needed, cognitive interventions can affect
the everyday behavior of patients and thus reduce medication non-adherence. These are
the patients who can be convinced to make taking medications a priority and therefore
lifestyle modifications are needed to accomplish that goal. If the patient has to take too
many medications, he/she needs to make lifestyle modifications to take each one in the
prescribed manner. The inconvenience in taking medications as well as the social stigma
50
attached to taking them in a public place points to the need of a lifestyle modification
intervention so that taking medications becomes a part of the daily routine. Those
individuals who forget to take medications or ran out of prescriptions due to a busy
schedule can be provided with cue based interventions which will help them to make
lifestyle modifications and thus taking the medications can become a high priority in
daily life.
It should be noted that the reasons forgetting due to busy schedule and
prescription running out due to busy schedule were classified under lifestyle
modifications needed. Currently, in the literature, forgetting is usually considered as
unintentional non-adherence and cue-based interventions are provided to reduce non-
adherence (Morisky, Green et al. 1986; Horne 1999). However, recent studies suggested
a belief component in forgetfulness. Foley et al (2006) demonstrated that beliefs are a
major component of forgetfulness in consumption of cholesterol lowering medications
(Foley and Hansen 2006). In addition, a pilot study for understanding medication beliefs
in older adults confirmed that high concern beliefs are significant predictors of
forgetting to take medications (John and Farris 2006). Thus it was decided to separate
forgetting due to busy schedule and forgetting due to issues in health beliefs.
Subsequently, the items forgetting and prescription running out were reworded as
forgetting due to busy schedule and prescription running out due to busy schedule to
force people who forgot to take medications but were not busy to choose another reason
for non-adherence rather than forgetting.
In the class reasons with medium to high mutability for a cognitive process
intervention where belief modifications are needed, cognitive process intervention can
influence the patients beliefs. In all the reasons in this class, the patient is non-adherent
to medications either due to low necessity beliefs in medications, high concern beliefs
regarding the medications, and concerns with illness beliefs. The intervention for these
patients should be aimed at changing their beliefs. For example, if a patient has concerns
51
with respect to the long term effects of medications, interventions can be developed to
help him/her better understand the medications.
For this study, two types of medication non-adherence were of interest, namely,
1) lifestyle reasons and 2) medication belief reasons. These two types of medication non-
adherence were the focus because the interventions can be directed at the patient level,
the patient has control over these issues and a cognitive intervention may be helpful.
Developing the conceptual model
The second aim of the study was to develop a conceptual model to predict
medication non-adherence in cholesterol lowering and asthma maintenance medications.
Once the typology of non-adherence was developed from aim 1, in aim2, theoretical
models were developed and tested to predict at least two different types of non-
adherence. The types of non-adherence as well as the models for predicting each type of
non-adherence were developed separately for both cholesterol lowering and asthma
maintenance medications. The respective models for each type of medications were to be
compared to determine if the predictors were equivalent.
The social cognitive models that involve the identification of beliefs and
cognitions underlying an individuals behavior have been widely used in studying
medication adherence (Hughes 2004). Some of the models used include Health Belief
Model, Health Locus of Control, Self-efficacy Theory, Theory of Reasoned Action, and
Theory of Planned Behavior. As evidenced from the literature review, no single theory
can explain medication non-adherence adequately (World Health Organisation 2003).
Each theory has its own advantages and disadvantages. In addition, studies have
identified more than 200 predictors of medication non-adherence. Hence, the decision
was made to use a conceptual model that will summarize the sociodemographic,
economic, disease, treatment, and psychosocial variables that predict non-adherence.
Andersens Behavioral Model and Leventhals Common Sense Model (Andersen, 1995;
52
Leventhal, 1992) were used to develop a comprehensive model that encapsulated the
significant variables that predict medication non-adherence. The first part of this section
will present background information about both theories and the second section will
discuss the model that was tested in aim 2 of this study.
Andersens behavioral model
Andersons Behavioral Model was originally developed to explain health services
use and had a family-level focus (Andersen 1995). The model was later adapted to
predict the use of health care services at an individual level. The model (Figure 3.1)
classifies individual predictors of health service use into three categories, namely,
predisposing factors, enabling resources, and need factors. Predisposing factors are
defined as those factors that shape attitudes towards health care use. These include
demographics (age, gender), social factors (education, occupation, and ethnicity), and
health beliefs of patients (attitudes, values, and knowledge). Enabling resources refer to
resources that promote or inhibit the health care utilization. These include personal
factors (income and health insurance), and community factors (social support). The need
factors represent the individual's illness or impairment that necessitates the use of health
care services. These include perceived need (perceptions of illness) and evaluated need
(professional judgment about health status of patient). Although the model was originally
developed to predict service use, it can also be used to predict medication adherence
(Andersen 1995; Murray, Morrow et al. 2004; De Smet, Erickson et al. 2006). The
original model as depicted in Figure 3.1 was developed in the 1960s and underwent
modifications since then. In the 1970s, Aday et al (1974) modified the model and
included health care system (policy, resources, and organization) as a construct to
explain the use of health care services (Aday and Andersen 1974). In addition, the model
included consumer satisfaction as an outcome of health services. In the 1980s and 90s,
the model included external environment (physical, political, and economic components)
53
as a primary determinant of health behavior (Evans and Stoddart 1990). The model also
incorporated personal health practices such as self care and diet to predict health
behavior.
Andersen stresses the importance of the mutability of the model components to
promote access to health services (Andersen 1995). The same concept can be used in the
medication adherence model to organize non-adherence based on the mutability of the
underlying reasons causing non-adherence. This in turn will help in developing tailored
interventions to decrease non-adherence. In other words, the interventions to improve
medication adherence can be confined to those types of non-adherence where the
underlying reason for non-adherence is subject to change. Demographics such as age and
gender have low mutability since they cannot be altered. Other reasons for non-adherence
such as health beliefs or beliefs in medications have moderate to high mutability as they
may be changed using interventions such as health education. Consequently, when non-
adherence is due to taking too many drugs, the level of mutability is high for an
intervention such as specialized packaging to increase adherence. If the patient is non-
adherent due to insufficient knowledge about medications or miscommunication between
the physician and patient, the level of mutability is high and interventions can be targeted
towards the physicians for the latter. Being non-adherent due to the cost of medications
may be beyond the control of the patient and the level of mutability is low for a cognitive
intervention.
Andersen Behavioral Model has been used in a wide range of research. The main
utilization of the model was in identifying the various predisposing, enabling, and need
factors that lead to health care utilization. The major use of the model was in studying the
utilization of various health care services including mental health service, outpatient
service, alcohol treatment, home health care service, and occupational therapy service in
diverse populations such as African Americans, elderly people, individuals with and
without insurance, Mexicans, Medicare beneficiaries, HIV individuals, homeless, and

54
veterans (Bazargan, Bazargan et al. 1998; Smith and Kirking 1999; Gelberg, Andersen et
al. 2000; Finlayson and DalMonte 2002; Henton 2002; Smith 2003; Gaskin, Briesacher et
al. 2006; Austin, Andersen et al. 2008; Elhai, Grubaugh et al. 2008). Other studies
included identifying the characteristics associated with the use of private and public
websites as sources of health care information; nonprescription and alternative
medication use; factors leading to inappropriate drug use in rural community dwelling
older adults, factors that predispose women aged 50 and older to seek mammography;
and physician utilization (Andersen and Tewfik 1985; Miller and Champion 1996;
Dobalian, Tsao et al. 2004; Blalock, Byrd et al. 2005; Miller and West 2007; Wu,
Pilowsky et al. 2007).
The use of this model to understand medication adherence has been limited. The
Andersen Behavioral Model was used by Murray et al (2004) to develop a conceptual
model in adherence research in older adults (Murray, Morrow et al. 2004). In this study,
Murray et al developed the model based on the relationship between environmental
factors (patients home and community composition, health care system, and medication
use system), patient characteristics (which include the predisposing, enabling, and need
factors from the Andersen Behavioral Model), and medication adherence to predict the
patient outcomes. De Smet et al (2006) used Andersens Behavioral Model to examine
self-reported adherence in asthma patients and concluded that adherence with asthma
medications was moderately related to predisposing factors such as health beliefs,
enabling characteristics including number of metered dose inhaler instructors, and need
factors such as perceived severity of the disease (De Smet, Erickson et al. 2006).
Leventhals common sense model
The Common Sense Model of self regulation (Figure 3.2) outlines how
individuals cognitively and emotionally process symptoms, illnesses and treatments
(Leventhal, Diefenbach et al. 1992; Diefenbach and Leventhal 1996). According to

55
Leventhal, coping procedures and illness-related perceptions facilitate the formation of
self regulatory systems in patients to manage their chronic conditions. The Common
Sense Model identifies both the cognitive and affective factors involved in the processing
of information made by patients regarding their diseases or illnesses. Accordingly,
individuals make mental representations of their illness based on the information
available to them in terms of 1) identity, which refers to disease label and the individuals
ideas about the somatic representation of the disease, 2) timeline, the expected timeframe
of the disease, 3) causation, the cause for the disease, 4) perceived controllability, the
personal control the patient has on the illness, and 5) consequences, anticipated
repercussions of the illness (Leventhal, Diefenbach et al. 1992; Diefenbach and
Leventhal 1996). At the emotional level, the health related stimuli can cause emotional
responses such as depression, anxiety, or fear (Aguilar 1997; Cameron, Booth et al.
2005). The information can be from previous social communication and cultural
knowledge of the illness, an external social environment such as perceived significant
others or authoritative sources such as a doctor or parent, or their current experience with
the illness. These representations from illness and emotions can lead to various coping
strategies including taking medications or avoidance. The individual after taking some
kind of coping action will evaluate the progress of coping actions and compare it with the
expected outcomes and the mental representations of illness; and coping strategies must
match for the individual to continue the coping strategies.
The Common Sense Model has been widely used in the research to identify the
perceptions of illness among patients in various chronic diseases such as cardiac
problems, musculoskeletal problems, stroke, kidney disease, schizophrenia, etc (Zerwic,
King et al. 1997; Fortune, Smith et al. 2005; Fowler and Baas 2006; Hill, Dziedzic et al.
2007; Zerwic, Young Hwang et al. 2007). All these studies were carried out to identify
the significant illness perceptions of individuals so that specific coping mechanisms can
be introduced to enhance the overall well being of the patient. In a study which
56
determined the beliefs of hypercholesterolemia patients in medication adherence, three
illness cognitions, namely, consequences, symptoms, and timeline were significant in
predicting non-adherence (Brewer, Chapman et al. 2002). This model was also used by
Meyer et al (1985) to determine the illness cognitions in hypertensive patients and found
a positive relationship between illness cognitions such as identity and levels of
medication adherence (Meyer, Leventhal et al. 1985).
Conceptual model to explain medication non-adherence
The conceptual model to explain medication non-adherence used in this study was
a comprehensive model that was developed based on the Andersen Behavioral Model and
Leventhals Common Sense Model (Figure 3.3). Andersens Behavioral Model can be
used to explain medication adherence at an individual level and the Common Sense
Model can be used to explain the individual mental representations made by individuals
regarding illnesses. Combined together, this conceptual model can explain medication
non-adherence.
The components of the conceptual model as explained by Andersen Behavioral
Model (ABM) and Leventhals Common Sense Model (CSM) are explained below.
Research on medication non-adherence has identified several significant variables that
predict medication non-adherence. These variables were used to explain each of the
constructs in the model. The ABM was modified based on the literature review to suit
medication adherence as the health care service.
Predisposing factors
The predisposing factors in the original ABM were demographics, social
structure, and health beliefs. Age and gender were significant predictors in explaining
medication adherence (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004).
Hence, the demographics in the conceptual model were age and gender. The social
factors included in the original model were education and race and all these variables
57
were significant predictors of medication adherence (Vermeire, Hearnshaw et al. 2001)
and were included in the conceptual model.
The health belief factor in ABM included beliefs, attitude, and knowledge in
medications (Andersen 1995) and these variables were included in the conceptual model.
Beliefs in medications is a significant predictor of medication adherence across various
chronic diseases (Donovan 1995; Balkrishnan 1998; Horne and Weinman 1999; Horne
and Weinman 2002; Iihara, Tsukamoto et al. 2004; Brown, Battista et al. 2005; Byrne,
Walsh et al. 2005; Foley and Hansen 2006; Phatak and Thomas 2006). The two major
domains of beliefs in medications as identified by Horne et al are necessity beliefs
(perceived role of medication in protecting the health of the patient) and concern beliefs
(perceived potential for the medication to cause problems for the patient such as
developing dependency on the medications) (Horne and Weinman 1999). Patients
knowledge of medications is important in determining adherence to medications
(Vermeire, Hearnshaw et al. 2001). In addition, the reasoning made by patients based on
the pros and cons of taking medications were added to the health beliefs since this was an
important predictor of medication adherence (Donovan 1995; Horne 1999; Wroe 2002).
A positive necessity concern differential indicated that the patient perceived the benefits
of taking medications larger than the costs of taking medications.
In addition to these three factors in the original model, two additional factors were
added, namely, disease characteristics (psychological disorders such as depression and
anxiety) and treatment characteristics (complexity of regimen, convenience of dosing,
duration of treatment, and side effects) to explain predisposing factors. The disease
characteristics were added due to two reasons. Andersen in a later article that was
reviewing the revisions to his model suggested the addition of disease characteristics
such as mental dysfunction and cognitive impairment to predisposing factors (Andersen
1995). In addition, research has suggested that depression and anxiety are associated
58
with medication adherence (Haynes, Taylor et al. 1979; DiMatteo 2004; Morrison and
Wertheimer 2004; Siegel, Lopez et al. 2007).
In the original Andersen Behavioral Model, treatment characteristics did not have
a role in explaining the use of health care services. However, in medication adherence,
treatment characteristics such as complexity of regimen, convenience of dosing, duration
of treatment, and side effects predict medication adherence and since they were
exogenous variables in this model they were added as predisposing factors (Vermeire,
Hearnshaw et al. 2001; Vik, Maxwell et al. 2004). In effect, the predisposing factors in
ABM can be considered as those variables that shape attitudes towards medication use.
It should be noted that, in this study, the aim was to predict medication non-
adherence to chronic medications such as cholesterol lowering medications and asthma
maintenance medications. It was assumed that the patient had been on these medications
for some time. If the medication was new or if the patient did not have any previous
experience with these medications, all the predisposing factors described in this model
may not apply. Demographics, social structure, and disease characteristics will remain the
same. While the treatment characteristics such as side effects and duration of treatment
may not be applicable; complexity of regimen and convenience of dosing may still be
influential at least to some extent. Medication beliefs of patients including necessity and
concern beliefs will be significant, because these are beliefs that patient may develop
from vicarious learning. However, the beliefs as such, may be different. The medication
beliefs such as my medicines disrupt my life and my health, at present, depends on my
medicines may not be significant when the medication is new. However, the belief
having to take medicines worries me and my health in the future will depend on my
medicines may be significant even when the medication is new because the patient
might have developed this belief from other sources like family and friends.
59
Enabling resources
The enabling resources in the original ABM represented personal and community
factors that should be present for the health care service use to take place. The personal
variables were income, health insurance, regular source of care, and travel and waiting
times. Income and health insurance have been identified as significant predictors of
medication adherence and thus were included in the model (Soumerai, Avorn et al. 1987;
Piette, Heisler et al. 2004; Soumerai, Pierre-Jacques et al. 2006). However, in comparison
with health care service utilization that is obtained from physicians or health care
institutions, medication adherence includes a component of self management behavior. In
addition, the 1980s modified ABM included personal health practices such as self care to
explain health behavior (Evans and Stoddart 1990). Hence, self variables including self
efficacy, self regulation, and internal locus of control were also used to explain the
personal factor. Various studies have demonstrated that self efficacy is an important
predictor of medication adherence in chronic illnesses (OLeary 1985; Tobin, Wigal et al.
1987; Lorig, Chastain et al. 1989; Horan, Kim et al. 1998; Ogedegbea, Mancuso et al.
2003). According to Kanfer and Goldstein (1986), regulation of health behaviors
including medication adherence is determined by the patients motivation to be healthy,
perceived control over one's health, and perceived support of health-promoting behaviors
from significant others (Kanfer 1986). Atkins et al (2006) in his study of non-adherence
in breast cancer women showed patients who were intentionally non-adherent had lower
health locus of control and considered themselves to have significantly less influence
over their own health (Atkins and Fallowfield 2006). These self variables will enable
individuals to make taking medications a part of their daily routine such as remembering
to refill prescriptions before running out and taking medications when traveling or busy.
It will also enable them to take responsibility of their health and depending on themselves
to keep their illnesses in control. Hence, these self variables were added in the model. As
a result, in the conceptual model, there were two personal variables access variables
60
(income and health insurance) and self variables (self efficacy, self regulation, and
internal locus of control).
The community factor in the original ABM comprised social relationships. This
variable was added in the conceptual model since it was a significant predictor of
medication adherence. Studies have shown that the absence of social support can increase
the rate of non-adherence in chronic illnesses (Levy 1983; Kelly, Zyzanski et al. 1991). A
major predicting factor that explained the rehospitalization of elderly adults with heart
failure was medication non-adherence, which in turn was caused by the absence of strong
social support (Happ, Naylor et al. 1997). Another study to determine the adherence to
prescribed therapy in outpatient chronic hemodialysis patients identified family and
social support as predictors of adherence (Laidlaw, Beeken et al. 1999). Social support
has been identified as an important factor in improving adherence in several mental
illnesses as well as HIV infections (Brook, van Hout et al. 2006; Simoni, Frick et al.
2006).
Attitude of others to illness was also added in the community factor since illness
representations were supported by an individuals social network such as spouses
preexisting attitude towards illness (Kanfer 1986; Leventhal, Diefenbach et al. 1992).
Vermeire (2001) also notes the influence of social factors including positive attitude by
others in the community that increases adherence.
Need factors
The need factors in the original ABM were perceived need and evaluated need.
Both these variables were included in the conceptual model. Andersen (1995) considered
these constructs as the prime determinants of the use of health care services. Perceived
need in ABM explains how people view their own general health and functional state,
and how they experience symptoms of pain, illness, and worries about their health, and
how important is the problem to them so that they seek medical help. The perceived need
61
in this conceptual model was explained based on the illness cognitions as explained by
the Common Sense Model. The patients experience of symptoms of illness is guided by
cognitive factors such as illness beliefs (Diefenbach and Leventhal 1996; Hagger and
Orbell 2003). These illness beliefs can be represented using an individuals idea about the
illness, expected duration of the illness, personal control over the illness, causes of the
illness, and consequences of the illness (Moss-Morris and et al 2002; Ross, Walker et al.
2004). Patients determine whether the treatment is in accordance with their perceptions
about illness and decide whether or not to be adherent to the medications. This decision is
also influenced by other factors such as appraisal of symptom relief.
Evaluated need represented professional judgment about peoples health status
and their need for medical care (Andersen 1995). In the conceptual model, the evaluated
need was based on the severity of the disease as assessed by the physician.
Health outcomes
The modification to the ABM in the 1980s included health outcomes as a factor.
The model suggests the prediction of health outcomes such as consumer satisfaction from
health care service utilization. It also includes feedback loops showing that health
outcomes in turn affect predisposing factors, perceived need for services, and health care
service utilization. Treatment satisfaction can be considered as a health outcome for
medication adherence, which in turn can affect predisposing factors, perceived need, and
medication adherence. Thus, in the conceptual model, we added health outcomes as a
factor and it included the variable treatment satisfaction.
Table 3.3 provides a summary of the variables that will measure each of the
constructs in the model. Though this comprehensive conceptual model helps us to
understand the basic mechanisms of medication adherence, it still bundles all types of
non-adherence into a single concept, without making distinctions between different types
of non-adherence.
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Developing models to predict two classes of non-adherence
In aim 2, the general conceptual model developed above was used to predict two
classes of non-adherence including 1) non-adherence due to need for lifestyle
modifications, and 2) non-adherence due to need for medication beliefs modifications.
These two classes were selected because they have medium to high levels of mutability in
terms of potential responsiveness to a cognitive intervention for the patient. This in turn
would allow the health care providers to develop tailored interventions for both these
classes of non-adherence once their predictors are identified.
All the variables in the conceptual model were measured for each of the
developed models. Nonetheless, the variables that would significantly predict each model
were expected to vary. The possibility that there could be changes in the reasons that
underlie each class of non-adherence was noted.
Model 1: Non-adherence due to need for lifestyle
modifications
According to the literature review, the major reasons for non-adherence that were
included in this model were forgetting to take medications during a busy schedule due to
a low priority, running out of prescriptions during a busy schedule due to a low priority,
taking too many medications, inconvenience in taking medications as prescribed, and the
embarrassment taking medications in public.
Using the general model, the constructs and variables that were expected to be
important in predicting this model were 1) predisposing factors demographics (age,
gender), social structure (education, race), health beliefs (knowledge of medications),
disease characteristics (depression, anxiety), treatment characteristics (convenience of
dosing, complexity of regimen, duration of treatment, side effects), 2) enabling factors
personal (income, health insurance, self efficacy, self regulation, locus of control),
community (social support), and 3) health outcomes (treatment satisfaction) (Figure 3.4).
63
Significant variables in model 1
Demographic & social structure characteristics
Age, gender, education, and race are significant predictors of medication
adherence (Balkrishnan 1998; Park, Hertzog et al. 1999; Vermeire, Hearnshaw et al.
2001; Vik, Maxwell et al. 2004). Though not directly predicting non-adherence due to
need for life style modifications, these variables were included in the model as control
variables.
Disease characteristics
Research has suggested that depression and anxiety are associated with
medication adherence (Haynes, Taylor et al. 1979; DiMatteo 2004; Morrison and
Wertheimer 2004; Siegel, Lopez et al. 2007). These variables like sociodemographic
characteristics do not directly predict non-adherence due to need for life style
modifications. However, these variables were included in the model as control variables.
Treatment characteristics
Complexity of regimen, convenience of dosing, duration of treatment, and
treatment side effects are significant predictors of medication adherence (Haynes, Wang
et al. 1987; Vermeire, Hearnshaw et al. 2001; DiMatteo 2004; Vik, Maxwell et al. 2004).
Bartlett demonstrated that life style modification will be needed when the number of
drugs and dosing frequency increases along with dietary restrictions (Bartlett 2002).
According to Wenger at al, lifestyle fit is an important predictor of medication
adherence for HIV medications which has a complex regimen, longer duration of
treatment, and side effects (Wenger, Gifford et al. January 31February 4, 1999). In their
study, adherence rate was 67% if medication fit extremely well into a patients
lifestyle, 50% if the fit was somewhat well, and 32% if the fit was not at all well.
With fewer medications to be taken daily and convenient dosing, it will be easier for
64
individuals to integrate medication taking behavior into their daily routine, thus
improving adherence. Similarly, as the side effects of the medications increase, the
perceptions of illness may increase tending to make individuals non-adherent.
Health beliefs
Knowledge of medications is a significant predictor of medication adherence
(Vermeire, Hearnshaw et al. 2001). Lack of knowledge in medications might be a factor
that stops patients from considering taking medications a priority (Vlasnik, Aliotta et al.
2005). If patients have sufficient knowledge about the long term benefits of medications,
they may be more likely to make lifestyle changes to accommodate the medications.
Personal factors
Access variables including income and health insurance are significant predictors
of medication adherence (Soumerai, Avorn et al. 1987; Piette, Heisler et al. 2004;
Soumerai, Pierre-Jacques et al. 2006). These variables, though not directly predicting
non-adherence due to need for life style modifications, were included in the model as
control variables.
Self variables such as self efficacy, self regulation, and locus of control are
significant factors that influence the lifestyle modifications that are needed for being
adherent to medications. Various studies have demonstrated self efficacy, self regulation,
and locus of control as important predictors of medication adherence in chronic illnesses
(OLeary 1985; Kanfer 1986; Tobin, Wigal et al. 1987; Lorig, Chastain et al. 1989;
Horan, Kim et al. 1998; Ogedegbea, Mancuso et al. 2003; Atkins and Fallowfield 2006).
Self variables reflect an individuals ability to consider how and make taking medications
part of their daily routine as well as how they perceive their responsibility of their health.
65
Community factors
Social support was added in this model. Patients diagnosed with chronic illnesses
need life style adjustments including modifications in diet and activities, and adherence
to medication regimens. Family and social support are two factors that enable patients to
achieve these goals (Happ, Naylor et al. 1997; Laidlaw, Beeken et al. 1999; Brook, van
Hout et al. 2006; Simoni, Frick et al. 2006). Individuals with social support will have
tangible aid/support via someone to remind them to take medications or obtain the
prescriptions from the pharmacy when they are sick, thus improving adherence.
Health outcomes
Satisfaction with treatment has been identified as a significant predictor of
medication adherence (Albrecht and Hoogstraten 1998; Atkinson, Kumar et al. 2005). If
patients are satisfied with the treatment they receive, they may make lifestyle
modifications to be adherent.
Variables not significant in Model 1
Beliefs in medications and both need factors were expected to be non-significant
predictors of medication non-adherence due to need for lifestyle modifications. This class
of medication non-adherence includes reasons that need a change in lifestyle and not a
change in beliefs. Hence, medication beliefs were not expected to be a significant
predictor. The need factors were also not a significant predictor because it was assumed
that individuals in this class had high levels of need for health care use and what they
called for was a change in lifestyle to accommodate medications in their daily routine.
Model 2: Non-adherence due to need for beliefs
modifications
The major reasons for non-adherence that were included in this model were side
effects/fear of side effects, thinking the drug is not needed, feeling well without
66
medications, thinking that the drug is ineffective, stopping drug to see whether it is still
needed, and having concerns about the long term effects of the medications.
From the general model, the constructs and variables that predicted this model
were 1) predisposing factors demographics (age, gender), social structure (education,
race), health beliefs (necessity beliefs in medications, concern beliefs in medications,
necessity concern differential, knowledge of medications), disease characteristics
(depression, anxiety), 2) enabling factors personal (income, health insurance), and
community (attitude by others towards disease), 3) need factors perceived need
(perceptions about own health, concerns about own health, perceptions of illness,
appraisal of coping procedures), and evaluated need (severity of disease), and 4) health
outcomes (treatment satisfaction) (Figure 3.5).
Significant variables in model 2
Demographic & social structure characteristics
Age, gender, education, and race are significant predictors of medication
adherence (Balkrishnan 1998; Park, Hertzog et al. 1999; Vermeire, Hearnshaw et al.
2001; Vik, Maxwell et al. 2004). These variables even when not directly predicting non-
adherence due to need for beliefs modifications were still included in the model as
control variables.
Research has suggested that depression and anxiety are associated with
medication adherence (Haynes, Taylor et al. 1979; DiMatteo 2004; Morrison and
Wertheimer 2004; Siegel, Lopez et al. 2007). These variables were similar to
sociodemographic characteristics and do not directly predict non-adherence due to need
for belief modifications. However, these variables were included in the model as control
variables.
67
Health beliefs
Beliefs in medications are a significant predictor of medication adherence across
various chronic diseases and was included in the model (Donovan 1995; Balkrishnan
1998; Horne and Weinman 1999; Horne and Weinman 2002; Iihara, Tsukamoto et al.
2004; Brown, Battista et al. 2005; Byrne, Walsh et al. 2005; Foley and Hansen 2006;
Phatak and Thomas 2006). The two major domains of beliefs in medications as identified
by Horne et al are necessity beliefs and concern beliefs (Horne and Weinman 1999). The
reasons for medication non-adherence in this class of non-adherence have issues with
beliefs in medications. As the necessity beliefs in medications increase, individuals are
convinced that the medications will enable them to have an improved quality of life and
this will lead to improved adherence to medications. Conversely, individuals with high
concern beliefs in medications, consider medications to be doing more harm than good to
their health, thus being non-adherent.
The reasoning made by patients based on the pros and cons of taking medication
was included in this model since it was an important predictor of medication adherence
(Donovan 1995). A positive necessity concern differential indicated that the patient
perceived the benefits of taking medications larger than the costs of taking medications.
The reasoning made in this manner was based on medication beliefs and thus affects
medication non-adherence.
Patients knowledge of medications is important in determining adherence to
medications (Vermeire, Hearnshaw et al. 2001). Knowledge in medications can affect the
beliefs in medications and can be an indirect predictor of medication non-adherence.
Educational interventions to improve medication adherence aim in improving the
patients knowledge about medications so that they have less concerns and high necessity
beliefs about their medications (McDonald, Garg et al. 2002; Haynes, Yao et al. 2005;
Kripalani, Yao et al. 2007). If patients have sufficient knowledge about the long term
68
benefits of medications, they may be more likely to make lifestyle changes to
accommodate the medications.
Personal factors
Access variables including income and health insurance are significant predictors
of medication adherence (Soumerai, Avorn et al. 1987; Piette, Heisler et al. 2004;
Soumerai, Pierre-Jacques et al. 2006). These variables, though not directly predicting
non-adherence due to belief modifications need, were included in the model as control
variables. Individuals with sufficient income and health insurance will have fewer
concerns regarding the cost issues of medications, an important reason for non-
adherence.
Community factors
Vermeire (2001) notes the influence of social factors including positive attitude
by others in the community increasing adherence. The illness representations by patients
are supported by social network such as spouses or significant others preexisting
attitude towards illness (Leventhal, Diefenbach et al. 1992). The attitudes of significant
others or an authoritative source like a physician can be the source of the illness beliefs of
patients.
Perceived need
Patients perceptions and concerns about their own health can have an effect upon
medication adherence through perceived need (Williams, Rodin et al. 1998). Patients who
are satisfied with their health and who have few concerns about their health may have a
low perceived need to be adherent with medications compared to patients with poor
perception of own health and high levels of concerns about health. Similarly, medication
adherence is also guided by patients illness beliefs. Patients who score high on the
various dimensions of illness beliefs including timeline and consequences of illness

69
might have a high level of perceived need (Diefenbach and Leventhal 1996; Moss-Morris
and et al 2002; Hagger and Orbell 2003; Ross, Walker et al. 2004). Patients determine
whether the treatment is in accordance with their perceptions about illnesses and decide
whether or not to be adherent with the medications. This decision is influenced by factors
such as appraisal of symptom relief.
Evaluated need
The severity of the disease as assessed by the physician can influence the patients
decision to be adherent with the medications. For example, a patient with high levels of
cholesterol, if advised by his physician about the same, may have a change in his/her
beliefs in illness and may become adherent with medications.
Health outcome
Satisfaction with treatment has been identified as a significant predictor of
medication adherence (Albrecht and Hoogstraten 1998; Atkinson, Kumar et al. 2005). If
the patients are satisfied with the treatment they receive, it might provide feedback, thus
changing their beliefs in medications and expectations from treatment, thus reducing non-
adherence due to need for belief modifications.
Variables not significant in model 2
The variables not significant in the medication non-adherence due to need
for belief modifications were treatment characteristics and self variables. Treatment
characteristics such as complexity and convenience of dosing do not contribute to beliefs
in medications or illnesses and hence were not expected to be significant predictors in the
model. Self variables were believed to be significant only when non-adherence is due to a
busy schedule or having too many drugs and they were not expected to have any
relationship with beliefs.

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Comparison between the two models
Table 3.4 provides a summary of the expected independent variables that may be
significant in predicting each model. While self variables such as self efficacy, self
regulation, and locus of control may be significant in non-adherence due to lifestyle
modification needs; perceived and evaluated need of treatment may predict non-
adherence due to need for belief modification.
Measures of the study
Qualitative analysis measures
The qualitative analysis was carried out on 50 subjects, 25 subjects with
high levels of cholesterol and the remaining 25 who had asthma. Data were collected
using the open ended question In the past week, did you always take the medication as
prescribed by the physician? If not, what was the change from the prescription? Why did
you change the way of taking medication?
Quantitative analysis measures
All variables in Table 3.3 were measured in this study along with medication non-
adherence. This section explains the items and scales that were used to measure each of
the variables.
Medication non-adherence
Medication non-adherence was measured using two different scales. Medication
non-adherence is usually measured by self reported measures such as the Morisky scale
or Reported Adherence to Medication scale in survey research (Morisky, Green et al.
1986; Horne and Weinman 1999; Wroe 2002). These scales can identify medication non-
adherence and can classify between adherents and non-adherents as well as between
intentional and unintentional non-adherents. However, since this study was focused on
developing a new typology for medication non-adherence based on the frequently

71
reported reasons for non-adherence, these reasons were used to identify non-adherence,
in addition to the Morisky scale. The Morisky scale, though a validated scale in
measuring non-adherence, considers forgetfulness and carelessness in taking medications
as unintentional non-adherence. However, as mentioned before, research has
demonstrated that beliefs are an important predictor of forgetfulness and we concluded
that a new typology of non-adherence was needed based upon the reasons. Therefore, the
reasons for non-adherence were used to identify non-adherence.
The self reported Morisky scale was adapted from validated questionnaires and
has been validated by comparing reported adherence with pill count (Morisky, Green et
al. 1986; Horne and Weinman 1999; Wroe 2002). In addition, the scale also had
predictive validity with blood pressure control (Morisky, Green et al. 1986). Morisky
scale has four items that measure non-adherence that has occurred within a specified time
frame (Morisky, Green et al. 1986). The original Morisky scale was a dichotomous scale,
but was later modified to be anchored on a 5 point Likert scale ranging from 1 to 5, 1
being never and 5 being always (Brooks, Richards et al. 1994; Erickson, Coombs et al.
2001). This will allow estimating the frequency of the occurrence of non-adherence in
addition to just classifying respondents as adherents and non-adherents (Horne 1999;
Wroe 2002). The first two questions refer to unintentional non-adherence (forgetfulness
and carelessness) and the remaining two refer to intentional non-adherence (stopping
medications when feeling better or worse). The reliability of the scale was estimated to be
0.86 (Erickson, Coombs et al. 2001).

Response options: never = 1; rarely = 2; sometimes = 3; often = 4; always = 5
Do you ever forget to take your medications?
Are you careless at times about taking your medications?
When you feel better, do you sometimes stop taking your
medications?
Sometimes, if you feel worse when you take your medications, do
you stop taking them?
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The scores were averaged and ranged from 1 to 5. A score of 1 indicated perfect
adherence and any score higher than 1 and less than 5 indicated less than perfect
adherence or non-adherence. In this study, those who answered never or rarely to all the
four items were considered as adherents to their medications.
Medication non-adherence was also measured using the frequently reported
reasons for medication non-adherence, further referred as Reasons Scale (Table 3.5).
Subjects were asked to indicate how often they have been non-adherent with their
medications for each of the reasons mentioned above using a 5 point Likert scale ranging
from none of the time to all of the time (1= none of the time and 5=all of the time). This
was a technique developed from Wroe where she asked the respondents to state all the
reasons for non-adherence and write a number by each of the reasons indicating how
relevant that reason was to the subject (Wroe 2002). In this study, the subjects were
provided with the most frequently reported reasons for non-adherence and were asked to
indicate how often they have been non-adherent due to that reason.
Based on the current understanding from the literature on medication adherence,
these reasons were grouped to different types, though the typology was to be verified
using aim 1. Items 6 to 10 measured non-adherence due to need for lifestyle
modifications (referred further on as lifestyle non-adherence). The scores were summed
for all the 5 items and the total score ranged from 5 to 25. Higher scores were indicators
of non-adherent due to need for lifestyle modifications. Items 11 to 15 measured non-
adherence due to need for belief modifications (referred further on as belief non-
adherence). The scores were summed for all the 5 items and the total score ranged from 5
to 25. Higher scores were indicators of non-adherence due to need for belief
modifications. In the Reasons scale, those who answered none of the time or a little of the
time to all the fifteen items were considered as adherents for the comparison analyses
with Morisky scale and objective measure of medication non-adherence.

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Demographic variables & social structure
Age and gender were measured as the demographic variables. The social structure
variables were education and race. In addition to testing the association between these
variables and medication adherence, these variables also acted as the control variables.
Variables Measurement Scale items Scale characteristics
scale
Age Self reported What year were you Continuous
born?
Gender Self reported What is your sex? Categorical
1 = male; 2 = Female
Education Self reported What is the highest level Categorical
of education that you 1 = elementary/ some high school; 2 =
have attained? (Check graduated high school; 3 = associates
only one) degree; 4 = some technical school or
college; 5 = graduated 4 year college;
6 = some graduate school; 7 = masters,
Ph.D. or professional degree
Race Self reported What describes your Categorical
race? 1 = White; 2 = Black;
3 = Hispanic; 4 = Other
The variables that were measured for the construct disease characteristics were
psychiatric disorders including depression and anxiety, as they were associated with non-
adherence (Vermeire, Hearnshaw et al. 2001; Vik, Maxwell et al. 2004). Specific
instruments have been developed to screen individuals with depression and anxiety
(Beck, Ward et al. 1961; Beck and Steer 1990; Antony, Bieling et al. 1998; Parker, Hilton
et al. 2002). Screening instruments are used to measure the characteristic attitudes and
symptoms of depression and anxiety as well as to identify those who are depressed. Since
this study was focused on medication adherence, we only needed to understand the
association of depression and anxiety with medication adherence. Therefore single items
asking whether subjects were currently prescribed any medication for depression or
anxiety was used. Medication adherence studies that use pharmacy records to identify
74
depression and anxiety have often used marker drugs of depression and anxiety to
identify those diagnoses (Siegel, Lopez et al. 2007). We followed the same logic and
asked the subjects to self report if they have been prescribed medications for depression
and anxiety.
Are you currently prescribed any medications for depression? Yes No
Are you currently prescribed any medications for anxiety? Yes No
The treatment characteristics that were measured included convenience of dosing,
complexity of regimen, duration of treatment, and treatment side effects.
Convenience of dosing
This variable was measured using the convenience domain of Treatment
Satisfaction Questionnaire for Medications (TSQM) (Atkinson, Sinha et al. 2004;
Atkinson, Kumar et al. 2005). The Treatment Satisfaction Questionnaire for Medications
consists of 14 items and the scale was tested across eight disease conditions including
arthritis, asthma, depression, diabetes, high cholesterol, hypertension, migraine, and
psoriasis. The items in TSQM were developed from a thorough review of the scientific
literature as well as from patient focus groups. The scale comprises four domains
including convenience, satisfaction, side effects, and effectiveness. The convenience
domain has 3 items and has a Cronbachs alpha of 0.87. The first two items are anchored
on a 7 point Likert scale ranging from 1 (extremely difficult) to 7 (extremely easy). The
third item in this scale is anchored on a 7 point Likert scale ranging from 1 (extremely
inconvenient) to 7 (extremely convenient). The scores can range from 0 to 100. TSQM
scale scores are computed by adding the item scores. The lowest possible score is then
subtracted from this total score and then divided by the greatest possible score minus the
lowest possible score. This will provide a transformed score between 0 and 1, which is
then multiplied by 100, thus having the final score ranging from 0 to 100.
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Other studies have developed scales to measure the complexity of the regimen
which also includes a convenience domain. However, these scales do not have
psychometric properties for the convenience items (Kelley 1988; George, Phun et al.
2004). Another scale that has been developed to measure the satisfaction with dosing is
the Treatment Satisfaction Scale for Benign Prostatic Hyperplasia (Hareendran and
Abraham 2005). Though this scale has good reliability and validity, these psychometric
properties were determined for one specific disease. In comparison, TSQM was
developed for medications in general and was tested across eight illnesses.
Response options: Item 1 and Item 2: extremely difficult to extremely easy; Item 3: extremely
inconvenient to extremely convenient
1. How easy or difficult is it to use the medication in the current form?
2. How easy or difficult is it to plan when you will use the medication each time?
3. How convenient or inconvenient is it to take the medications as instructed?
Complexity of regimen
This variable was measured using a single item which described the total number
of medications taken on a daily basis. Typically, more medications are indicators of more
complex regimen. One of the identified predictors of non-adherence was the total number
of medications taken on a daily basis (Conrad 1985; Bartlett 2002). Hence, the total
number of drugs taken daily could be considered as a proxy for measuring the regimen
complexity (Muir, Sanders et al. 2001; Phatak and Thomas 2006). Few scales have been
developed to measure the index of the regimen complexity (Kelley 1988; George, Phun
et al. 2004). The medication regimen complexity index developed by George et al has a
correlation of 0.9 with the number of medications. This allows us to use the total number
of medications for measuring regimen complexity.

What is the total number of medications you are taking on a daily basis? Continuous
variable
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Duration of treatment
This variable was measured using a single item by asking the subject how long
they have been taking the medication in months. This was a direct question and did not
need a scale to measure it.

How long you have been taking medications for high levels of cholesterol? Continuous
variable
How long you have been taking the asthma medications? Continuous
variable
Side effects of medication
This variable was measured using the side effects domain of Treatment
Atkinson, Kumar et al. 2005). The side effects domain of the scale has 5 items and has a
Cronbachs alpha of 0.87. The first item is a categorical item asking the subjects whether
they have experienced any side effects as a result of taking the medication. The second
item on the scale is anchored on a 5 point Likert scale ranging from 1 (extremely
bothersome) to 5 (not at all bothersome). The remaining three items on the scale are
anchored on a 5 point Likert scale ranging from 1 (a great deal) to 5 (not at all). The scale
scores ranged from 0 to 100, with individuals reporting no to item 1 as having 0 and the
remaining items summed and rescored on a 0-100 scale as described in the convenience
items.
Response options:
Item 1: Yes/No
Item 2: 5 point Likert scale of Extremely bothersome to not at all bothersome
Item 3, Item 4, & Item 5: 5 point Likert scale of a great deal to not at all
As a result of taking this medication, do you currently experience any side effects at all?
How bothersome are the side effects of the medication you take to treat your condition?
To what extent do the side effects interfere with your physical health and ability to function?
To what extent do the side effects interfere with your mental health?
To what degree have medication side effects affected your overall satisfaction with the
medications?
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Health beliefs
The health beliefs to be measured included beliefs in medications, knowledge
about medications, and patient reasoning based on the pros and cons of taking
medications.
Beliefs in medications
This variable was measured using beliefs in medications questionnaire (BMQ)
developed by Horne et al (Horne, Weinman et al. 1999). BMQ has been tested across
four types of chronic patients including asthmatic, cardiac, renal and oncology patients.
In addition, the scale has a good internal consistency of 0.78. BMQ is used in several
studies where relationship between medication adherence and medication beliefs has
been elicited (Horne, Clatworthy et al. 2001; Brown, Battista et al. 2005; Neame and
Hammond 2005; Sud, Kline-Rogers et al. 2005; Phatak and Thomas 2006).
BMQ includes two domains of medication beliefs, namely, necessity beliefs and
concern beliefs in medications. While necessity beliefs in medications explain the
perceived role of medication in protecting the health of the patient, concern beliefs in
medications explain the perceived potential for the medication to cause problems for the
patient such as developing dependency on the medications. The necessity beliefs domain
(internal consistency of 0.86) includes five items that ask the patients about the necessity
of taking prescribed medications, while the concern beliefs domain (internal consistency
of 0.65) has five items that ask patients about their concerns regarding the potential
consequences of taking the prescribed medications (Horne, Weinman et al. 1999). Both
beliefs are measured on a 5 point Likert scale ranging from 1 (strongly disagree) to 5
(strongly agree). The total score for the necessity and concern scales range from 5 to 25
with higher scores indicating stronger beliefs.

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Response options:
strongly agree = 5; agree = 4; uncertain = 3; disagree = 2; strongly disagree = 1
Necessity Beliefs
My health, at present, depends on my medicines
My life would be impossible without my medicines
My health in the future will depends on my medicines
My medicines protect me from becoming worse
Without my medicines, I will be very ill
Concern Beliefs
Having to take medicines worries me
I sometimes worry about long-term effects of my medicines
My medicines are a mystery to me
My medicines disrupt my life
I sometimes worry about becoming too dependent on my medicines
Knowledge about medications
This variable was measured using the 5th item in the Modified Morisky Scale
(Vlasnik, Aliotta et al. 2005) and was based on a dichotomous response to the question
Do you know the long term benefit of taking your medicines as told to you by your
doctor or pharmacist? This item provided a subjective understanding of the patients
knowledge about medications. Studies focused on understanding the knowledge of
patients about medications usually use interviews (German, Klein et al. 1982; Cline,
Bjorck-Linne et al. 1999; Okuno, Yanagi et al. 1999). The patients are often asked to
bring in their medications and are asked various questions to determine their knowledge
about medications including its use, administration, and side effects. However, since this
study had a survey research design, we could not conduct interviews with patients and
instead used the 5th item of the Modified Morisky scale.

79
Reasoning based on the pros and cons of taking
medications
The reasoning based on the pros and cons of taking medications was calculated
using the Beliefs in Medications Questionnaire (Horne and Weinman 1999; Wroe 2002).
This scale has two belief domains necessity beliefs and concern beliefs. A necessity
concern differential was calculated as the difference between necessity and concern
scores and ranged from -20 to + 20. The necessity concern differential could be perceived
as the cost-benefit analysis in which the patients perceptions of cost (concern beliefs)
were weighed against their perceptions of benefit (necessity beliefs). If the necessity
concern differential was positive, the patient perceived that the benefits of medications
outweighed the costs and vice versa (Horne and Weinman 1999; Wroe 2002). This
differential could be considered as the reasoning by the patients based on the pros and
cons of taking medications. This is a technique developed by Horne and Weinman and
there are no other scales available to measure patients reasoning based on the pros and
cons of taking medications.
Personal enabling factors
Income and health insurance were measured as access variables; while self
efficacy, self regulation, and internal locus of control were measured as self variables in
personal enabling factors. In addition to testing the association between these variables
and medication adherence, the access variables also served as the control variables.
Variables Measurement Scale characteristics Scale characteristics
scale
Income Self reported What is your best estimate of the Categorical
total income in the past 12 months? 1 = < $35,000; 2 = $35,000
- $49,999; 3 = $50,000 -
$74,999; 4 = $75,000 to
$99,999; 5 = $100,000
Insurance Self reported Do you have medical insurance or Categorical
a co-pay program that covers some 1 = Yes; 0 = No
or all of the cost of your
prescription medications? Yes/No
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Self efficacy
This variable was measured using the Medication Adherence Self Efficacy Scale
(MASES) (Ogedegbea, Mancuso et al. 2003). The scale is comprised of 26 items and has
a Cronbachs alpha coefficient of 0.95. The items for this scale were developed using
patient interviews which explored patients experiences and challenges in taking their
medications as prescribed. The scale is anchored on a 3 point Likert scale ranging from 1
(not at all sure) to 3 (very sure). The total score on the scale ranges from 26 to 78. Higher
scores indicate higher self efficacy in managing medications. The items in the scale
reflect multiple barriers and facilitators of adherence as identified by patients and thus
measures situation-specific efficacy beliefs.
Several other self efficacy scales have been developed for measuring self efficacy
in managing various situations such as arthritis, osteoporosis, exercise, and cardiac
problems (Lorig, Chastain et al. 1989; Schwarzer and Jerusalem 1995; Horan, Kim et al.
1998; Sullivan, Andrea et al. 1998; Resnick and Jenkins 2000). However, none of these
scales measure self efficacy in medication adherence.

Please rate how sure you are that you can take your medication all of the time as prescribed in the
following situations.
1 = Not at all sure; 2 = Some what sure; 3 = Very sure
When you are busy at home
When you are at work
When there is no one to remind you
When you worry about taking them for the rest of your life
When they cause some side effects
When they cost a lot of money
When you come home late from work
When you do not have symptoms
When you are with family members
When you are in a public place
When you are afraid of becoming dependent on them
When you are afraid they may affect your sexual performance
When the time to take them is between your meals
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When you feel you do not need them

When you are traveling
When you take them more than once a day
If they sometimes make you tired
If they sometimes may you feel dizzy
When you have other medications to take
When you feel well
If they make you want to urinate while away from home
Please rate how sure you are that you can always carry out the following tasks
1 = Not at all sure; 2 = Some what sure; 3 = Very sure
Get refills for your medications before you run out
Fill your prescriptions whatever they cost
Make taking your medications part of your routine
Always remember to take your asthma medications
Take your medications for the rest of your life
Self regulation
This variable was measured using the modified version of Treatment Self
Regulation Questionnaire for taking medications for diabetes (TSRQ). This instrument
was developed from an assessment approach by Ryan and Connell (Ryan and Connell
1989). The TSRQ concerns why people engage in some healthy behavior, enter treatment
for a medical condition, try to change an unhealthy behavior, follow a treatment regimen,
or engage in some other health-relevant behavior. The TSRQ has been used in several
studies including controlling glucose level in diabetes, and weight loss (Williams, Grow
et al. 1996; Williams, Freedman et al. 1998).
TSRQ has two subscales, namely autonomous regulation and controlled
regulation. The scale has 8 items and is anchored on a 7 point Likert scale ranging from 1
(not at all true) to 7 (very true). The scale has three items that measure autonomous
regulation and five items that measure controlled regulation. The subscale scores are
calculated by averaging the items on the scale and the scores can range from 1 to 7. Both
the subscales of the scale have high levels of internal consistency. The autonomous
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regulation subscale has an internal consistency ranging from 0.84 to 0.86 whereas the
controlled regulation subscale has an internal consistency ranging from 0.70 to 0.75.
Response options 1 2 3 4 5 6 7
Not at all Somewhat true Very true
true
I take my medications because
Other people would be mad at me if I didn't
I find it a personal challenge to do so
I personally believe that controlling my disease will
improve my health
I would feel guilty if I didn't do what my doctor said.
I want my doctor to think I'm a good patient.
I would feel bad about myself if I didn't.
It's exciting to try to keep my disease under control
I don't want other people to be disappointed in me.
Self regulation of medication adherence battery (SRMAAB) also measures self
regulation in medication adherence (Tucker, Petersen et al. 2001). However, this scale
does not have any reported psychometric properties.
Internal Locus of Control
This variable was measured using the internal locus of control domain of the
Multidimensional Health Locus of Control Form C (Wallston, Stein et al. 1994). The
scale has 6 items and has an internal consistency of 0.87 in a sample of diabetic patients
and 0.85 in a sample of cancer patients (Wallston, Stein et al. 1994). The scale is
anchored on a 6 point Likert scale ranging from 1 (strongly disagree) to 6 (strongly
agree). The total score of the scale is calculated by summing the score of the items.
Higher scores represent higher internal health locus of control. The health locus of
control scale introduced by Wallston in 1976 is the most widely used scale measuring
health locus of control in health services research (Williams, Rodin et al. 1998;
McDonald-Miszczak, S et al. 2000; Voils, Steffens et al. 2005; Atkins and Fallowfield
2006; George and Shalansky 2007).

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Response options: strongly agree = 6; moderately agree = 5; slightly agree = 4; slightly disagree =
3; moderately disagree = 2; strongly disagree = 1
If my condition worsens, it is my own behavior which determines how soon I will feel better
again.
I am directly responsible for my condition getting better or worse.
Whatever goes wrong with my condition is my own fault.
The main thing which affects my condition is what I myself do.
I deserve the credit when my condition improves and the blame when it gets worse.
If my condition takes a turn for the worse, it is because I have not been taking proper care of
myself.
Community enabling factors
The variables that were measured in this construct were social support and
attitude by others towards illness
Social Support
This variable was measured using the Tangible domain of the Medical Outcomes
Study Social Support Survey (Sherbourne and Stewart 1991; Servellen and Lombardi
2005). The tangible domain of the scale has 4 items and has a Cronbachs alpha of 0.92.
In addition, this domain correlated very well (0.72 to 0.87) with the social support scale.
The scale is anchored on a 5 point Likert scale ranging from 1 (none of the time) to 5 (all
of the time). The score of the tangible domain of the social support is the average score of
the four items and higher scores represent better social support. Studies suggest the use of
only the tangible domain of social support in medication adherence (Branin 2001).
Other scales on social support do not measure the tangible support offered, but
rather measure the source of support and the quality of support (Power, Koopman et al.
2003; Naar-King, Templin et al. 2006). Duke Social Support Index measures social
support and has an instrumental support domain (George, Blazer et al. 1989). However,
this scale does not have psychometric properties reported for its instrumental support
domain.
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People sometimes look to others for companionship, assistance, or other types of support. How
often are the following supports available to you if you need it? Circle one number on each line.
1 = None of the time; 2 = A little of the time; 3 = Some of the time; 4 = Most of the time; 5 = All
the time
Someone to help you if you were confined to bed
Someone to take you to the doctor if you needed it
Someone to prepare your meals if you were unable to do it yourself
Someone to help with daily chores if you were sick
Attitude by others towards disease
This variable was measured using a self reported measure. The subjects were
asked to report the three most important people in their lives who helped them with their
medications. The subjects were then asked to rate how important were these significant
others opinion for them on a 3 point Likert scale ranging from not at all important to
very important. The total score is calculated by summing the three scores and it ranges
from 3 to 9. Higher scores represented more importance given by the subject to the
attitude by others towards the disease. This was a technique developed by Fishbein in the
Theory of Reasoned Action to measure the estimate of the social pressure to perform or
not perform the target behavior(Fishbein and Ajzen 1975). This will measure the attitude
by others who may be in some way important to the person thus influencing their beliefs.
Perceived need factors
Perceptions & concerns about own health
These variables were measured using self reported measures. Perceptions
about own health was measured using two items which were anchored on 5 point Likert
scales. The concerns about own health was measured using a single item. The total score
is calculated by summing the scores of the individual items. These measures have been
used in previous studies (Eriksson, Undn et al. 2001; Fayers and Sprangers 2002; John
and Farris 2006)

85
Which of the following best describes your current overall health?

Poor Fair Good Very good Excellent
Thinking about your own health, how would you say that it compares to other peoples health of
your own age?
Much worse than Somewhat worse About the same as Somewhat better Much better than
others than others others than others others
How concerned are you about your own personal health?
Not at all Somewhat Concerned Very concerned Extremely
concerned concerned concerned
Perceptions about illness
This variable was measured using the Brief Illness Perception Questionnaire
(Broadbent, Petrie et al. 2006). This scale was tested over six illness groups including
myocardial infarction, renal disease, asthma, type 2 diabetes, minor illnesses such as
headache, allergies, and colds, and patients with chest pain undergoing stress exercise
testing prior to diagnosis to define its psychometric properties. The scale has nine items
and was developed from the Revised Illness Perception Questionnaire which had over 80
items (Moss-Morris and et al 2002). The first eight items are anchored on a scale ranging
from 0 to 10. The final item in the scale measures the causal illness representation. This
item is measured using an open ended question which asks the subjects to list the three
most important causal factors in their illness. The test retest reliability of the various
concepts in the scale was in an acceptable range of 0.48 to 0.7 (Broadbent, Petrie et al.
2006). The validity of the scale was confirmed by comparing it with Illness Perception
Questionnaire Revised and The Knowledge, Attitude, and Self Efficacy Asthma
Questionnaire.
The Illness Perception Questionnaire was developed based on the Common Sense
Model developed by Leventhal et al (Leventhal, Diefenbach et al. 1992). The instrument
incorporates all the five components of the common sense model including identity,
cause, controllability, timeline, and consequences. Since the model being tested in this
study is based on the common sense model by Leventhal, this will be the best scale to
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measure it. The items personal control over illness, treatment control of illness, and
understanding illness was reverse scored and the scores of all items were summed, and
higher scores represented more threatening illness perceptions. In this study, we used the
eight items of the scale which represents the identity, timeline, controllability, and
consequences dimensions of the illness perceptions. The ninth item is an open ended
question that asks respondents their perceptions about the causes of the illness and it was
excluded from this study.

For the following questions, please circle the number that best corresponds to your views:
How much does your illness affect your life?
0 1 2 3 4 5 6 7 8 9 10
No affect at all Severely affects my life
How long do you think your illness will continue?
0 1 2 3 4 5 6 7 8 9 10
A very short time Forever
How much control do you feel you have over your illness?
0 1 2 3 4 5 6 7 8 9 10
Absolutely no control Extreme amount of control
How much do you think your treatment can help your illness?
0 1 2 3 4 5 6 7 8 9 10
Not at all Extremely helpful
How concerned are you about your illness?
0 1 2 3 4 5 6 7 8 9 10
Not at all concerned Extremely concerned
How well do you feel you understand your illness?
0 1 2 3 4 5 6 7 8 9 10
Dont understand at all Understand very clearly
How much does your illness affect you emotionally? (e.g. does it make you angry, scared,
upset or depressed?
0 1 2 3 4 5 6 7 8 9 10
No at all affected emotionally Extremely affected emotionally
Appraisal of coping procedures
This variable was measured using the effectiveness domain of Treatment
Satisfaction Questionnaire for Medications (TSQM). The scale has 3 items and is
87
anchored on a 7 point Likert scale ranging from extremely dissatisfied (1) to extremely
satisfied (3). The scale scores ranged from 0 to 100, with the items summed and rescored
on a 0-100 scale as described in the convenience items. According to the Common Sense
Model, individuals will decide and engage in a particular coping procedure using their
perceptions of illness. They then evaluate the coping procedures to determine whether the
behavior has to be continued (Hagger and Orbell 2003). In medication adherence, taking
medications is considered as a coping procedure by the patients. The evaluation of these
coping procedures can be considered as the patients perceived effectiveness of the
medications. Subsequently, if the patients perceive the medications to be effective, they
may be more likely to be adherent than when the patients perceive the medications to be
ineffective.
Response options: extremely satisfied = 7; very satisfied = 6; satisfied = 5; uncertain = 4;
dissatisfied = 3; very dissatisfied = 2; extremely dissatisfied = 1
1. How satisfied or dissatisfied are you with the ability of the medication to prevent or
treat your condition?
2. How satisfied or dissatisfied are you with the way the medication relieves your symptoms?
3. How satisfied or dissatisfied are you with the amount of time it takes the medication to start
working?
Evaluated need factors
Severity of illness
The cholesterol level was measured by asking the subjects to self report their
recent total cholesterol level. The severity of cholesterol levels was measured using the
Third Report of the National Cholesterol Education Program (Expert Panel on Detection
Evaluation and Treatment of High Blood Cholesterol in Adults 2001). Accordingly, less
than 200 mg/dL of cholesterol is considered to be desirable level, between 200 and 239
mg/dL is borderline high and more than 240 mg/dL is considered as high levels of
cholesterol.
88
The asthma severity was measured using the Asthma Control Test (ACT)
(Nathan, Sorkness et al. 2004). The scale has five items and has an internal consistency of
0.84. The items are measured on 5 point Likert scales. The ACT score was calculated as
the sum of the individual scores and ranged from 5 to 25. Scores less than or equal to 15
was considered as uncontrolled asthma and scores greater than 15 was considered as
controlled asthma.This scale was developed to create a simple method for quantifying
asthma control by both patients and physicians. Though there are other instruments
available, they are difficult to score and need input from health care professionals
(Juniper, O'Byrne et al. 1999; Boulet, Boulet et al. 2002).

How severe is your asthma? Very Severe Moderate Mild Very mild
severe
In the past 4 weeks, how much All of the Most of Some of the A little of None of the
of the time did your asthma keep time the time time the time time
you from getting as much done
at work, school or at home?
During the past 4 weeks, how More than Once a day 3 to 6 times Once or Not at all
often have you had shortness of once a day a week twice a
breath? week
During the past 4 weeks, how 4 or more 2 or 3 Once a Once or Not at all
often did your asthma symptoms nights a nights a week twice
(wheezing, coughing, shortness week week
of breath, chest tightness or
pain) wake you up at night or
earlier than usual in the
morning?
During the past 4 weeks, how 3 or more 1 or 2 2 or 3 times Once a Not at all
often have you used your rescue times per times per per week week or
inhaler or nebulizer medication day day less
(such as albuterol)?
How would you rate your Not Poorly Somewhat Well Completely
asthma control during the past 4 controlled controlled controlled controlled controlled
weeks? at all
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Health outcomes
This variable was measured using the overall satisfaction domain of Treatment
Atkinson, Kumar et al. 2005). The overall satisfaction domain has three items and has a
Cronbachs alpha of 0.85. The first item in the scale is anchored on a 5 point Likert scale
ranging from 1 (not at all confident) to 5 (extremely confident); the second item on a 5
point Likert scale ranging from 1 (not at all certain) to 5 (extremely certain); and the third
item on a 7 point Likert scale ranging from 1 (extremely dissatisfied) to 7 (extremely
satisfied). The scale scores ranged from 0 to 100, with the items summed and rescored on
a 0-100 scale as described in the convenience items.

Response options:
Item 1: 5 point Likert scale from not at all confident to extremely confident
Item 2: 5 point Likert scale from not at all certain to extremely certain
Item 3: 7 point Likert scale from extremely dissatisfied to extremely satisfied
Overall, how confident are you that taking this medication is a good thing for you?
How certain are you that the good things about your medication outweigh the bad things?
Taking all things into account, how satisfied or dissatisfied are you with this medication?
Other control measures
Cost of medications
This variable was measured using a single item by asking subjects to indicate
their average out of pocket cost each month for buying prescription medications. This
was a direct question and did not need a scale to measure it.
Self rated memory
This variable was measured using a single item by asking the subjects to rate their
memory on a 5 point Likert scale ranging from excellent to poor. No other items were
used to measure this variable.

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Objective measure of medication non-adherence
Medication non-adherence was objectively measured by asking the
respondents how much they missed their medications in the past week prior to the survey
due to forgetfulness and due to purposeful missing.

In the past week, on how many days did you forget to take your 0 1 day 2 days or
medication? day more
In the past week, on how many days did you not take your 0 1 day or
medication on purpose? day more
Respondents who answered 2 days or more were considered as non-adherents due
to forgetfulness. Respondents who answered 1 day or more were considered as non-
adherents due to purposeful missing. In purposeful missing of medicaitons, individuals
have probably weighed the pros and cons of taking medications and have made up their
mind to be non-adherent. Hence, even one day of not taking medications was considered
as non-adherence. However, in the case of forgetfulness, there is a possibility that
individuals can genuinely forget to take medications once in a while and they cannot be
considered as non-adherents. However, if they start forgetting to take medications more
than a day in a week, we need to consider that as non-adherence and need to provide
interventions, either cue based or belief based.
Analysis
Aim 1
The first aim of the study was to develop a new typology of medication
non-adherence based on the frequently reported reasons for non-adherence. This aim was
achieved using a literature review. The classification of medication non-adherence
developed from the literature review was confirmed first using a qualitative analysis and
then using a quantitative analysis.
The qualitative analysis software, Qualrus was used in analyzing the data. The
technique used in qualitative analysis was content analysis. Content analysis is a
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technique used to summarize the content of a text by systematically identifying the
structure of a text using an a priori theory (Neuendorf 2002). For example, the frequency
of the most used key words can be used to identify the structure. The data was organized
by transcribing the data into various reasons as given by the subjects. This was followed
by identifying salient themes, recurring ideas or languages, and patterns that linked the
reasons together. This was done by identifying the key words as was evident from the a
priori classification of non-adherence in Table 3.2 such as forget or side effects. All the
reasons provided with these key words were grouped separately. As categories and
patterns became apparent, these classes were then mapped back to the a priori typology.
A colleague was asked to read through the data analysis report to confirm the logic of
flow of patterns and justifications in the theme development. The categories that were
developed using the above technique were considered as the types of medication non-
adherence.
The quantitative analysis was done using a confirmatory factor analysis of the
reasons for medication non-adherence as explained in Table 3.2. The confirmatory factor
analysis (CFA) is a technique used to determine if the number of factors and the loadings
of measured variables on them conform to what is expected on the basis of pre-
established theory. The a priori assumption is that each factor is associated with a
specified subset of indicator variables. MPLUS was used to conduct the CFA. The fit of
the model with the data, that is, the loading of each measured variable on the preset
concept in the model, was determined using the goodness of fit indices such as chi square
statistics, comparative fit index (CFI), Tucker Lewis Index (TLI), root mean square error
of approximation (RMSEA), and standardized root mean residual (SRMR). For the
model to have a good fit with the data, the chi square statistic should be insignificant. A
significant chi square statistic can be due to poor fit of the model or the size of the
sample. CFI and TLI values close to 1 and RMSEA and SRMR values less than or equal
to 0.05 indicate that the fit of the model is good. If the model fit indices were good, the
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classification of medication non-adherence based on the literature review would be
accepted as the non-adherence typology.
The new typology of non-adherence developed from the reasons of non-adherence
was based on literature review. Hence, there was a possibility that the CFA model might
not fit the data. In such a situation, an exploratory factor analysis to identify the
underlying factor structure of the Reasons scale was used. A common factor analysis on
the frequently reported reasons for non-adherence was carried out using SPSS version
12. The common factor analysis with principal axis factoring extraction and varimax
rotation was used to detect the underlying factors which were then considered as the
various classes of non-adherence based on the underlying reasons.
While confirmatory factor analysis is the deductive approach in model building,
exploratory factor analysis (EFA) is the inductive approach. Exploratory factor analysis,
in addition to identifying the common factors that underlie a set of responses, will also
determine the strength of relationship between each factor and each observed variable. In
EFA, common factor analysis would be used as compared to principal components
analysis because the former was generally preferred for the purposes of identifying
underlying latent variables, while the latter was used for data reduction. While principal
component analysis assumes all measurement errors to be random, the common factor
analysis assumes that the measurement error consists of a systematic and unique
component. This systematic component of measurement error may reflect the common
variance due to factors which are not measured directly, known as latent variables.
Rotation of the axes causes the factor loadings of each variable to be more clearly
differentiated by factor. Varimax rotation was used because it is the most commonly used
rotation and it maximizes the variance of the loadings and will produce orthogonal
rotations. The number of factors to be retained was determined using the Kaiser criteria
by dropping all components with eigenvalues under 1.0. Each eigenvalue represents the
amount of variance that has been captured by one component. In other words, any
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component that accounted for less variance than a single variable would be dropped. The
reliability of the extracted factors would be computed and Cronbachs alpha would be
used to determine the internal consistency of the factors.
Aim 2
The second aim of the study was to test the conceptual models developed using
the medication non-adherence classification for cholesterol lowering and asthma
maintenance medications. Aim 2 analysis had an original analysis plan that was proposed
based on the classification of non-adherence as lifestyle non-adherence and beliefs non-
adherence. These non-adherence classifications were to be used as the dependent
variables to test the conceptual models. However, the results from the first aim did not
classify non-adherence as proposed. The classes of non-adherence developed from Aim 1
were different and accordingly the dependent variables in the models to be tested had to
be changed. All the other analyses remained the same.
Descriptive analyses were carried out to determine the mean, standard deviation,
and frequency of each variable. The reliability of each scale was estimated and
Cronbachs alpha criteria were used to establish internal consistency. The scale was
considered to have a good internal consistency if the Cronbachs alpha was 0.70 or
greater (Nunnally and Bernstein 1994). Correlation tests were conducted to explore
relationships among variables. Table 3.6 describes how each variable was coded to be
used in the analysis.
Regression analyses were conducted to test the models using SPSS version 12.
Multiple regression analysis is a statistical technique used to examine the proportion of
variance in a dependent variable as explained by a set of independent variables and to
establish the relative predictive importance of the independent variables by comparing
beta weights. There were three models each for cholesterol lowering medications and
asthma maintenance medications. The dependent variables for each model were derived
94
from the exploratory factor analysis of the frequently reported reasons of non-adherence.
Logistic regression was used when the dependent variable was nominal.
Table 3.6 explains the direction of the expected relationship of each independent
variable to the dependent variable. The regression model to be tested was as follows:
Non-adherence = 0 + 1age + 2gender + 3education + 4race + 5income +
6health insurance + 7depression + 8anxiety + 9convenience + 10complexity +
11duration + 12side effects + 13necessity beliefs + 14concern beliefs + 15reasoning +
16 knowledge + 17self efficacy + 18self regulation + 19locus of control + 20social
network + 21attitude by others + 22health perceptions + 23concern perceptions +

24illness perceptions + 25appraisal of coping procedures + 26severity of illness +
27treatment satisfaction
The assumptions of the multiple regression analyses were examined to verify that
all the assumptions were met. Multicollinearity was tested using the variance inflation
factor (VIF). Higher values of VIF indicate high multicollinearity and instability of the
regression coefficients. The fit of the models were tested using the F statistics, which
tests the significance of the whole model. If prob (F) < 0.05, then the model was
considered significantly better than would be expected by chance and the null hypothesis
of no linear relationship between the dependent variable and independent variables was
rejected. The R2 value and regression coefficient values of the models were estimated. R2
is the percent of the variance in the dependent explained uniquely or jointly by the
independents. The higher the value of R2, greater is the fit of the model. The regression
coefficient is the average amount the dependent variable changes when the independent
variable changes one unit and other independent variables are held constant. The
unstandardized regression coefficients were used since they are used for actually making
a prediction, using the independent variables as they were measured. However, the
standardized regression coefficients were used to compare the strength of different
independent variables measured in different ways.

95
Sub analysis: Comparing reasons scale and Morisky scale
An analysis was conducted to estimate the agreement between the Morisky scale
and the Reasons scale introduced in this study. The objective measure of medication non-
adherence was also compared with Morisky scale and Reasons scale. The forgetfulness
domain in all three measures was compared to estimate the agreement between them.
Kappa coefficient was used to estimate the proportion of times respondents agreed to be
adherent or non-adherent by chance alone in the scales. The Kappa coefficient lies
typically on a scale between 0 and 1, where the former indicates complete disagreement
and the latter indicates complete agreement. A Kappa value of 0.01 to 0.2 will be
considered as slight agreement, 0.21 to 0.4 as fair agreement, 0.41 to 0.6 as moderate
agreement, 0.61 to 0.8 as substantial agreement and 0.81 to 0.99 as almost perfect
agreement(Cohen 1960).
Aim 3
Data was collected for both cholesterol lowering and asthma maintenance
medications. The data collected and analyzed was to be compared between the two
groups of medications to determine if the predictive power of independent variables in
both the models were equivalent. The following sections explain the original analysis
plan for comparing the groups. However, since the results from Aim 1 and 2 were
different than expected, this analysis was not conducted.
For Aim 1 (classifying medication non-adherence), the principal components
analysis of the reasons for medication non-adherence as explained in Table 3.2 was
carried out for each medication separately. The factors that were derived from the two
types of medications were to be compared using comparison measures method (Levine
1977). Root mean square (RMS) as well as coefficient of congruence (CC) would also be
calculated. RMS is the root mean square of the average squared differences of the
loadings of the variables on each of the two factors and the value varies from 0 to 2. A
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value of 0 indicates perfect match between samples of both the pattern and the magnitude
of factors in the two samples. An RMS of 2 indicates all loadings are at unity but differ in
sign between the two samples. CC is the sum of the products of the paired loadings
divided by the square root of the product of the two sums of squared loadings. CC
measures both pattern and magnitude similarities between samples and the value can
range from +1 to -1. A value of +1 indicates perfect match and -1 indicates a perfect
inverse agreement.
For Aim 2 (predicting the two typologies of medication non-adherence), Chow
test would have been used to test whether the coefficients estimated over one group of the
data were equal to the coefficients estimated over another group. The two models for
cholesterol lowering medications and asthma maintenance medications were tested
separately as conducted in aim 2. For aim 3, dummy variables would have been created
to indicate from which group (statins or asthma medications) each case came from by
coding statins as 1 and asthma medications as 0. The regression model would have been
expanded to include interaction terms, which were the multiplication products of each
independent variable by the dummy variable. The data from the two groups would have
been combined to form one dataset, by adding the dummy variable. A regression analysis
would have been carried out with lifestyle non-adherence as the dependent variable in
Model 1 and belief non-adherence as the dependent variable in Model 2. All the
independent variables along with the interaction terms would have been added in the
analysis. F test would have been used to test the null hypothesis that the regression
coefficients for the two groups (statins or asthma medications) are equal. The significant
interactions in the model would allow us to conclude that there was a significant
difference in the predictive power of that particular independent variable between the two
models in the analysis.

97
Figure 3.1: Andersens Behavioral Model
PRESDISPOSING ENABLING NEED USE OF
CHARACTERISTICS RESOURCES FACTORS HEALTH SERVICES
Demographic Personal/Family Perceived
Social Structure Community Evaluated
Health Beliefs
98
Figure 3.2: Common Sense Model
Representation of
illness Coping Appraisal
Stimuli
Representation of
illness Coping Appraisal
99
Figure 3.3: Conceptual Model in Medication Non-adherence
Common Sense
Model
Predisposing
Factors Enabling Factors Need Factors
Demographics and
Social Structure Personal Perceived Need
Health Beliefs Community Evaluated Need
Disease
Characteristics
Treatment Medication Non-

Characteristics Health Outcomes adherence
100
Figure 3.4: Life Style Modification Needed Model
Predisposing
Demographics (Age, Personal (Income,

Gender) and Social Health Insurance,
Structure (Education, Self-efficacy, Self
Race) Regulation, Internal
Locus of Control)
Health Beliefs
(Knowledge of Community
Medications) (Social Support)
Disease
Characteristics
(Depression, Anxiety)
Treatment
Characteristics
(Regimen Complexity,
Convenience of Lifestyle
Dosing, Side effects, Health Outcomes Modification
Duration of (Treatment Needed Medication
Treatment) Satisfaction) Non-adherence
101
Figure 3.5: Belief Modifications Needed Model
Predisposing
Demographics (Age, Personal (Income, Perceived Need

Gender) and Social Health Insurance) (Health Perceptions,
Structure (Education, Concerns about
Race) Health, Illness
Community Perceptions,
Health Beliefs (Attitude by Appraisal)
(Necessity Beliefs in Others towards
Medications, Concern Disease)
Evaluated Need
Beliefs in
Medications,
Necessity Concern
Differential,
Knowledge in
Medications)
Disease Health Outcomes Belief Modification

Characteristics (Treatment Needed Medication
(Depression, Anxiety) Satisfaction) Non-adherence
102
Table 3.1: Frequently reported reasons for non-adherence
1 Adverse effects/Fear of adverse effects

2 Forgetting
3 Asymptomatic, think medication (s) is (are) not needed, feel well without medication (s)
4 Prescription ran out

5 Medication (s) not available
6 Medication (s) is (are) ineffective
7 Taking too many medication (s)
8 Unclear about proper administration
9 Difficulty swallowing
10 Problem opening containers
11 Stop medication (s) to see whether it is still needed
12 Concern about long term effects of medication (s)/dependency on medication (s)
13 Embarrassment in taking medications (e.g. you are with friends, you are in a public place,
etc)
14 Inconvenience in taking medication (s) as prescribed (e.g. you are away from home, the
medication (s) makes you urinate more frequently, etc)
15 Cost of medication (s)
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Table 3.2: Classification of medication non-adherence from the frequently reported

reasons of non-adherence based on the mutability
Reasons with low mutability for a cognitive process intervention for the patient
Difficulty swallowing medications

Problems opening containers
Medication (s) not available in the pharmacy
Cost of medication (s)
Unclear about proper administration of medication (s)
Reasons with medium to high mutability for a cognitive process intervention for the
patient - Lifestyle modifications are needed
Forgetting due to busy schedule
Prescription running out due to busy schedule
Taking too many medication (s)
Inconvenience in taking medication (s) as prescribed
Embarrassment in taking medication (s) in a public place
patient - Belief modifications are needed
Asymptomatic, think medication (s) is (are) not needed, feel well without medication (s)
Stop medication (s) to see whether it is still needed
Adverse effects/fear of adverse effects
Medication (s) is (are) ineffective
Concern about long term effects of medication (s) and/or dependency on medication (s)
104
Table 3.3: Model constructs and associated variables included in the model of medication
non-adherence
Constructs Variable
Predisposing factors
Demographics Age
Gender
Social structure Education
Race
Disease characteristics Psychiatric disorders (depression & anxiety)
Treatment characteristics Convenience of dosing
Side effects
Health beliefs Beliefs in medications
Knowledge about medications
Reasoning based on pros & cons of taking meds
Enabling Factors
Personal
Access variables Income
Health insurance
Self variables Self efficacy
Self regulation
Locus of control
Community Social network
Attitude by others towards disease
Need factors
Perceived need
How people view their own general health Perception about own health
Concern about own health
How people view their symptoms of illness Perceptions about illness
Evaluated need Severity of illness
Health Outcomes
Consumer satisfaction Treatment satisfaction
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Table 3.4: Expected significant variables in each separate model
Model 1 Model 2
(Lifestyle modifications needed) (Medication belief modifications)
Demographics Age Age
Gender Gender
Social structure Education Education
Race Race
Disease Psychiatric disorders (depression Psychiatric disorders (depression &
characteristics & anxiety) anxiety)
Treatment Frequency of dosing
characteristics
Side effects of treatment
Health beliefs Necessity beliefs in medications
Concern beliefs in medications
Reasoning based on the pros and
cons of taking medications
Knowledge about medications Knowledge about medications
Personal
Income Income
Health insurance Health insurance
Self efficacy
Self regulation
Locus of control
Community Social network Attitude by significant others
towards taking medicine
Perceived need Perceptions about health
Concerns about own health
Perceptions about illness
Evaluated need Severity of illness
Health outcome Treatment satisfaction Treatment satisfaction
106
Table 3.5: Reasons scale to measure medication non-adherence developed from the
frequently reported reasons of medication non-adherence
If you have ever missed taking your medication (s), please indicate how often you have
missed taking your medication due to the various reasons listed below.
(1 = none of the time; 2 = a little of the time; 3 = some of the time; 4 = most of the time;
and 5 = all of the time)
1 Medication not available in the pharmacy
2 Difficulty swallowing medications
3 Problems opening containers
4 Cost of medications
5 Unclear about proper administration of medication
6 Forgetting due to busy schedule
7 Prescription ran out due to busy schedule

8 Taking too many medications
9 Inconvenience in taking medications as prescribed (e.g. you are away from home, the
medication makes you urinate more frequently, etc)
10 Embarrassment in taking medications (e.g. you are with friends, you are in a public place,
etc)
11 Medication is ineffective
12 Side effects or fear of side effects
13 Think medication is not needed because you are not showing any indications of the disease
or you feel well without medication
14 Stop medication to see whether it is still needed
15 Concern about long term effects of medications or dependency on medications
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Table 3.6: Independent variables in the six models
Construct Variables Initial coding Recoding Comments Direction of

relationship
Demographics Age Continuous Unknown
Gender 1 = Male 1 = Male Unknown
2 = Female 0 = Female
Education 1 = elementary or Elementary Unknown
some high school or some
2 = Associates high school
degree was the
compa-rison
3 = graduated
group &
high school
dummy
4 = some variables
technical school was created
or college
5 = graduated 4
year college
6 = masters,
Ph.D. or
professional
degree
Race 1 = White The Unknown
2 = Black comparison
group was
3 = Hispanic
white &
4 = Other dummy
variables
were created
Disease Psychiatric 1 = Yes 1 = Yes Positive
characteristics disorders 0 = No 0 = No
(depression
& anxiety)
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Table 3.6. Continued.

relationship
Treatment Convenience 3 items ([Sum of Higher Negative
characteristics of dosing Item 1: 7 point item 1 to 3) score,
Likert scale from 3]divided greater is
Extremely diffi- by 18) *100 the
cult to Extremely convenience
easy in dosing
Item 2: 7 point
Likert scale from
Extremely diffi-
cult to Extremely
easy
Item 3: 7 point
Likert scale from
Extremely incon-
venient to
Extremely
convenient
Complexity Continuous Continuous Higher Positive
of regimen Number of number of
medications taken medications,
daily more
complex is
the regimen
Duration of Continuous Continuous Negative
treatment Number of
months
Side effects 5 items ([Sum of Higher Positive
Item 1: Yes/No items 2 to 5) score, more
4]divided difficult are
Item 2: 5 point
by 16 *100 the side
Likert scale of
effects
Extremely
bothersome to
not at all
bothersome
Item 3, Item 4, &
Item 5: 5 point
Likert scale of a
great deal to not at
all
109
Table 3.6.Continued.

relationship
Personal Income 1 = < $35,000 Less than Unknown
2 = $35,000 - $35000 will
$49,999 be the
comparison
3 = $50,000 to
group and
$74,999
dummy
4 = $75,000 to variables
$99,999 will be
5 = > $100,000 created
Health 1 = Yes 1 = Yes Negative
insurance 0 = No 0 = No
Self 23 items Mean of all Higher Negative
efficacy 3 point Likert 23 items mean score,
scale of Not at all larger the
sure to very sure self
efficiency
of the
subject
Self 8 items Mean of the Higher Negative
regulation 2 subscales two score, larger
autonomous subscales the self
regulations with 3 regulation
items and of the
controlled subject
regulation with 5
items
7 point Likert
scale of Not at all
true to very true
Internal 6 items Sum of the Higher Negative
locus of 6 point Likert items scores,
control scale ranging greater the
from strongly locus of
disagree to control
strongly agree
Community Social 4 items Mean of the Higher Negative
network 5 point Likert 4 items mean score,
scale of none of larger the
the time to all of social
the time support
110

relationship
Attitude by Three most Mean of the Higher Negative
significant important combined scores,
others significant others scores more
towards 3 point Likert important is
medications scale from not at their
all important to attitude to
very important the subject
Health beliefs Necessity 5 items Mean of the Higher Negative
beliefs 5 point Likert 5 item score,
towards scale of strongly scores greater the
medications disagree to necessity
strongly agree beliefs
Concern 5 items Mean of the Higher Positive
beliefs 5 point Likert 5 item score,
towards scale of strongly scores greater the
medications disagree to concern
strongly agree beliefs
Reasoning Necessity beliefs Ranges from Positive Negative

based on - Concern beliefs -20 to +20 score means
pros & cons pros are
of taking outweighing
medications the cons of
taking
medications
and vice
versa
Knowledge 1 = Yes 1 = Yes Negative
about 0 = No 0 = No
medications
Perceived Perceptions 2 items Mean of the Higher Positive

need about own 5 point Likert 2 items scores,
health scale better health
perceptions
about self
Concerns 1 item Higher Negative
about own 5 point Likert scores,
health scale more
concerns
about own
health
111

relationship
Perceptions 8 items Mean of the Higher Negative
about 10 point Likert scores scores,
illness scale ranging stronger the
from 0 to 10 threatening
illness
perceptions
Appraisal 3 items ([Sum of Higher Negative
Item 1: 7 point items 1 to 3) score, better
Likert scale of 3]divided the
Extremely by 18) * 100 effectiveness
dissatisfied to of the
extremely treatment
satisfied
Item 2: 7 point
Likert scale of
Extremely
dissatisfied to
extremely
satisfied
Item 3: 7 point
Likert scale of
Extremely
dissatisfied to
extremely
satisfied
112

relationship
Evaluated Severity of Cholesterol Cholesterol Negative
need illness < 200 mg/dL Less than
-Desirable 200mg/dL
200 to and between
239mg/dL - 200 and
Borderline 239mg/dL
high will be
> 240mg/dL - considered
High as controlled
levels of
cholesterol
Asthma Control
More than
Test
240mg/dL
5 items was
Item 1: 5 point considered
Likert scale from as
all of the time to uncontrolled
none of the time levels of
Item 2: 5 point cholesterol
Likert scale from
more than once a
day to not at all
Asthma
Item 3: 5 point control test
Likert scale
Sum of all
ranging from 4 or
the five
more nights a
items. Score
week to not at all
ranges from
Item 4: 5 point 5 to 25.
Likert scale from
Scores
3 or more times
greater than
per day to not at
15 = 1
all
(controlled
Item 5: 5 point levels of
Likert scale from asthma).
not controlled at
Scores less
all to completely
than or equal
controlled
to 15 = 0
(uncontrolled
levels of
asthma)
113

relationship
Health Treatment 3 items Recode item Higher Negative
outcomes satisfaction Item 1: 5 point 3: (Item 3 score,
Likert scale of 1)*5/6 greater is
not at all ([Sum of the
confident to item 1 to 3) satisfaction
extremely 3]divided with the
confident by 12) * 100 treatment
Item 2: 5 point
Likert scale of
not at all certain
to extremely
certain
Item 3: 7 point
Likert scale of
extremely
dissatisfied to
extremely
satisfied
114
CHAPTER 4
RESULTS
This chapter will present the results obtained from the analysis. The first section
of the chapter will present the demographics of the respondents and the second to fourth
sections will present the results from the three study objectives. The tables for all the
results are presented at the end of the chapter.
Demographics of the respondents
Harris Interactive collected the data for this study from a convenience sample of
subjects who opted to be in the survey. The survey was send to 7378 Harris Interactive
online panel enrollees between 4th and 17th December, 2007 to determine whether they
were interested in participating in the study and met the inclusion criteria, and the
response rate was 31%. Out of the 2287 responses received, only 840 completed
responses were qualified to be in the study based on the inclusion criteria. There were
420 completed responses for cholesterol lowering medications and 399 for asthma
maintenance medications The total completed responses is more than the number of
individuals combined on cholesterol lowering and asthma maintenance medications
because there were a few individuals who were on both medications and answered both
surveys (Table 4.1).
In the sample with individuals on cholesterol lowering medications, the mean age
was 59.4 and more than half the sample was males (54.35). Approximately, half the
sample (49%) had at least a college degree and 47% had an annual income more than
$50,000. The majority of the sample was white (85.5%), married (58.1%), and had health
insurance (94.5%) (Table 4.2).
In the sample with individuals on asthma maintenance medications, the mean age
was 48.71 and the majority of the sample was female (61.4%). Approximately 39% had
an education level of at least college degree, 37% had an income more than $50,000, and
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91% had health insurance. About half the sample (50.9%) was married and 81% were
white (Table 4.2).
Tables 4.3 to 4.8 provide an overview of the responses for non-adherence items
across the Reasons scale, the Morisky scale, and the objective measure of non-adherence
for cholesterol lowering and asthma maintenance medications. As can be seen, non-
adherence rates as well as intentional non-adherence rates were higher for asthma
maintenance medications compared to the cholesterol lowering medications in both
Morisky scale and objective emasure. Reasons scale was able to identify various other
significant reasons for non-adherence such as cost of medications, ran out of prescription,
and concerns about long term effects of medications for both cholesterol lowering and
asthma maintenance medications.
Aim1
The first aim of the study was to create a new typology of medication non-
adherence. This aim was achieved through an extensive literature review and a qualitative
and quantitative analysis to confirm the typology developed from the literature.
Classification of medication non-adherence from the
literature review
The most frequently reported reasons for medication non-adherence were
identified from the literature and were used for developing a new typology of medication
non-adherence (Table 4.3). The literature on interventions to improve medication
adherence has pointed to the need of developing tailored interventions. Hence, the new
typology of non-adherence was developed based on possible interventions and how
mutable the reasons for non-adherence are for possible interventions. The classification
of reasons as shown in Table 4.3 was based on the mutability or changeability of reasons
in terms of potential responsiveness to a cognitive intervention. A detailed version of the
methodology of classification is in Chapter 3.

116
Qualitative analysis to confirm the medication non-
adherence classification based on the literature review
A qualitative analysis was done to validate the typology of medication non-
adherence made from the literature review. Twenty five respondents who indicated that
they did not take their cholesterol lowering medication as prescribed by their physician
and another twenty five who indicated that they did not take their asthma maintenance
medication as prescribed by their physician were asked the open ended question Why
did you take your medication differently than prescribed? Please list all your reasons
below. The reasons listed by these 50 respondents were analyzed qualitatively to
develop the medication non-adherence typology. A quality check on the qualitative
analysis was done by a colleague who is well versed with qualitative analysis. Any
discrepancy was resolved through discussion.
Cholesterol lowering medications
In cholesterol lowering medications, there were 21 different responses to the open
ended question and six salient themes were identified from these responses. Based on the
key from actual respondents, the themes identified were 1) forgetfulness, 2) forgetfulness
due to other activities, 3) fear of side effects, 4) cost of medications, 5) not able to take
the medications as prescribed due to conflict with dosing schedule/instructions and daily
routine, and 6) dont feel it is necessary to take the medications as prescribed (Table 4.4).
The key words recognized in these 21 responses were forgot, side effects, cost, busy,
and need. Based on these identified key words, six themes were developed. For
example, reasons that had the key word forgot were considered as one theme. Those
reasons with the key word forgot due to with an explanation for forgetfulness were
considered as a separate theme. These two themes were separated because recent studies
suggested that respondents may be providing forgetfulness as the reason for non-
adherence for social desirable reasons (Atkins and Fallowfield 2006). In this situation,
117
those respondents with an explanation for forgetfulness were considered as those who
genuinely forgot to take medications. The respondents who just said forgot may or may
not be non-adherent due to forgetfulness. The next step was to map these six themes to
the a priori classification so that these six themes were consistent with the three classes of
medication non-adherence from the literature review. The theme cost was consistent
with reasons with low mutability for a cognitive process intervention for the patient as
explained in Chapter 3. The themes forgetting, forgetting due to other activities, and did
not take medications due to conflict of the daily routine with the dosing
schedule/instructions were considered as reasons with medium to high levels of
mutability for a cognitive process intervention for the patient for a lifestyle modification.
The themes fear of side effects, and not feeling it necessary to take medications as
prescribed were considered as reasons with medium to high levels of mutability for a
cognitive process intervention for the patient for belief modification.
Asthma medications
From the twenty five different responses to the open ended question, four salient
themes were identified. Based on respondent actual words, the themes were 1)
forgetfulness, 2) forgetting due to other activities, 3) cost of medications, and 4) think the
drug is not needed (Table 4.5). The key words recognized in these 25 responses were
forgot, side effects, and need. Based on these identified key words, four themes were
developed. For example, all the reasons that had the key word forgot was considered as
one theme. Those reasons with the key word cost was considered as another theme.
These themes in turn were classified based on the mutability of the reasons to be
consistent with the non-adherence classification from the literature review. Cost was
considered as a reason with low mutability for a cognitive process intervention for the
patient. Forgetting and forgetting due to other activities were considered as reasons
with medium to high levels of mutability for a cognitive process intervention for the
118
patient for a lifestyle modification, and think the drug is not needed was a reason with
medium to high levels of mutability for a cognitive process intervention for the patient
for belief modification.
The results from the qualitative analysis thus substantiated the non-adherence
classification created based on the literature review. However, only few reasons for
medication non-adherence implied in the literature review were stated in the qualitative
analysis. So, it can be assumed that the reasons that were provided are the key reasons
when non-adherent with cholesterol lowering and asthma medications.
Quantitative analysis to confirm the medication non-
adherence classification based on the literature review
A confirmatory factor analysis (CFA) was done to validate the a priori
classification of medication non-adherence made from the literature review using the data
collected. The 15 frequently reported reasons of non-adherence identified from the
literature was used to develop a new 15 item scale, known as the Reasons scale, to
measure the frequency of medication non-adherence behavior. The Reasons scale
measured the frequency of medication non-adherence on a five point frequency scale
ranging from none of the time to all of the time. According to the a priori classification,
these 15 reasons were classified into three types and consequently, we expected the data
to load on three factors as specified in the non-adherence classification from literature
review (Table 4.3).
MPLUS was used to conduct the CFA and was carried out for both cholesterol
lowering (Table 4.6) and asthma maintenance (Table 4.7) medications. Neither CFA fit
the data based on the fit indices. The p-value was statistically significant (p = 0.000) in
both the models, which is an indication of the poor fit of the model. In addition, though
the CFI and TLI values were greater than 0.9, they were still lower than 1.0 which is the
ideal fit. Additionally, the RMSEA and SRMR values were larger than 0.05, and for a
119
good model fit, these values should be less than 0.05. Each of the estimated parameters
has an estimate to standard error ratio greater than 1.96, indicating that each factor
loading is statistically significant. In addition, the R squared values of the indicators in
the type reasons with low mutability for an intervention and type reasons with medium to
high mutability for a belief modification intervention illustrates that a large amount of
variance in these factors are explained by these indicator variables in both medications.
However, the goodness of fit indices were poor and we concluded that the CFA did not
confirm the medication non-adherence classification derived from the literature review
and qualitative analysis. Using results from the first CFA models, minor changes were
explored to determine if the fit indices improved, but they did not.
Exploratory factor analysis to identify the underlying
structure of Reasons scale
While CFA is the deductive approach in model building, exploratory
factor analysis (EFA) is the inductive approach. The fit of the model was poor with the
CFA, and an EFA was conducted to identify the underlying structure of the Reasons
scale. The EFA was done using SPSS version 12.
The exploratory factor analysis with 15 items in the Reasons scale extracted five
factors (Table 4.14). The first factor with four items had factor loadings ranging from
0.458 to 0.775 and had a Cronbachs alpha of 0.752. The second factor with 3 items had
factor loadings ranging from 0.452 to 0.754 and had a Cronbachs alpha of 0.616. The
third factor had 3 items and the factor loadings ranged from 0.624 to 0.643 and had a
Cronbachs alpha of 0.728. The fourth factor only had two items loaded on it with factor
loadings 0.499 and 0.640 and had a poor Cronbachs alpha of 0.290. The fifth factor also
had only 2 items loaded on it with the factor loadings 0.590 and 0.616 and the
Cronbachs alpha was also low at 0.488. The item medication is ineffective had a factor
120
loading of only 0.365 and did not load strongly on any factor. Hence, it was decided not
to include this item for the present study. Similarly, the fourth and fifth factors had only
two items each and the internal consistency of the factors were also poor. As a result, it
was decided not to include those two factors in the typology domain of cholesterol
lowering medications non-adherence. However, realizing the fact that forgetfulness due
to busy schedule is an important reason for non-adherence in cholesterol lowering
medications (12% of respondents indicated forgetting due to busy schedule as the reason
for non-adherence), this item was retained as a type of non-adherence with a single item
in the typology domains. The reliability statistics of the factors are explained in Table
4.15.
The first extracted factor managing issues had 4 items. These items reflected
the physical limitations that prevent individuals from taking medications as prescribed
and the embarrassment in taking medications in a public place. The second factor was
named multiple medication issues and had three items reflecting the issues when
individuals had to take too many medications such as concern about their long term
effects and costs of medications. Belief issues with medications was the third extracted
factor with three items. These items reflected the fear of side effects and whether
medications are needed.
Asthma maintenance medications
The exploratory factor analysis of the 15 items in the Reasons scale for asthma
maintenance medications extracted three factors (Table 4.16). The first factor had six
items loaded on it, with factor loadings ranging from 0.563 to 0.904 and had a
Cronbachs alpha of 0.881. The second factor also had six items loaded on it with factor
loadings ranging from 0.499 to 0.736 and had a Cronbachs alpha of 0.817. The third
factor only had two items loaded on it. The loadings were above 0.6 and the Cronabchs
alpha was also in the acceptable range of 0.654. All three factors were included in the
121
typology domains of asthma maintenance medications non-adherence. The item, Forgot
due to busy schedule had a factor loading of only 0.280 and did not load well on any
factors. However, 29% of the respondents on asthma maintenance medications indicated
forgetting due to busy schedule as the reason for non-adherence. Subsequently, this item
was retained as a non-adherence type with a single item. The reliability statistics of the
factors are explained in Table 4.17.
The first factor managing and availability issues had six items and reflected the
physical and emotional issues that prevent individuals from taking medications as
prescribed, and the unavailability of medications. The second extracted factor with six
items was named beliefs and convenience issues. These items reflected the number of
medications to be consumed, fear associated with taking medications, and whether the
medications are needed. The third factor cost issues had two items which reflected the
cost as well as the possibilities of running out of prescriptions.
As evidenced from the quantitative analysis, the classification of medication non-
adherence is notably different from the a priori classification. In addition, contrary to the
expected result, the classification was different for cholesterol lowering medications and
asthma medications. Thus, dependent variables for subsequent analyses were redefined
(Table 4.18). The dependent variables for cholesterol lowering medications were 1)
managing issues, 2) multiple medication issues, and 3) belief issues with medications.
The dependent variables for asthma maintenance medications were 1) managing and
availability issues, 2) beliefs and convenience issues, and 3) cost issues. Forgetfulness, as
a single item, was included for both medications.
Summary of Aim 1 results
The objective of aim 1 was to develop a new typology of medication non-
adherence for cholesterol lowering and asthma maintenance medications based on
literature review, qualitative analysis, and quantitative analysis. The new typology was
122
developed from the literature review based on the frequently reported reasons for
medication non-adherence. Three types of medication non-adherence were identified and
were supported by the qualitative analysis. The confirmatory factor analysis did not
support the qualitative findings. As well, the quantitative analysis using an exploratory
factor analysis created a new typology of medication non-adherence which was different
from the a priori classification. In addition, in contrast to the expected results, the
typology developed was different for cholesterol lowering and asthma maintenance
medications. Subsequently, the types of medication non-adherence which will serve as
the dependent variables for the remaining analyses were redefined for cholesterol
lowering and asthma maintenance medications.
Aim 2
The second aim of the study was to develop models to predict different types of
non-adherence. Given the results in Aim 1, for aim two, four types of non-adherence with
cholesterol lowering medications and four types of non-adherence with asthma
maintenance medications were predicted. Multiple regression analyses using SPSS
version 12 were used to predict all types of medication non-adherence with cholesterol
lowering and asthma maintenance medications, excluding forgetfulness domain in both
medications. Since this domain had only a single item in both medications, logistic
regression using SPSS version 12 was used to predict non-adherence due to
forgetfulness in both cholesterol lowering and asthma maintenance medications.
Reliability estimates of the scales used as independent
variables
The independent variables used in the analyses are explained in Table 3.6 of
Chapter 3. The reliability statistics of all the scales used in the regression analyses were
estimated (Table 4.19). All the scales and subscales had an acceptable Cronbachs alpha,
though it was low for autonomous self regulation (0.434 for cholesterol lowering
123
medications and 0.477 for asthma medications). The reliability estimate of the self
efficacy scale with 23 items was high for both cholesterol lowering (0.954) and asthma
maintenance (0.958) medications and the scale had 23 items. A factor analysis was done
on the scale to confirm whether all 23 items loaded on one factor. All items were forced
on one factor and the factor loadings ranged from 0.4 to 0.8, and it was self efficacy as
one construct.
The final model can be written as follows:
Non-adherence = 0 + 1age + 2gender + 3education + 4race + 5income +
6health insurance + 7depression + 8anxiety + 9convenience + 10complexity +

11duration + 12side effects + 13necessity beliefs + 14concern beliefs + 15reasoning +
16 knowledge + 17self efficacy + 18self regulation + 19locus of control + 20social
network + 21attitude by others + 22health perceptions + 23concern perceptions +
24illness perceptions + 25appraisal of coping procedures + 26severity of illness +
27treatment satisfaction
Regression analyses
All eight models of the regression analyses were significant and the summary of
the results obtained from the regressions are presented in Table 4.20.
The first model (Table 4.21) with non-adherence due to managing issues as the
dependent variable was significant (F = 2.966 and p-value = 0.000). The significant
predictors were self efficacy, cost of medications, and income less than $50,000. An
increase in self efficacy decreased non-adherence; whereas an increase in cost increased
non-adherence. Income less than $50,000 had decreased non-adherence compared to an
income less than $35,000. For every one unit change in self efficacy, there was a 0.088
unit decrease in non-adherence due to managing issues.

124
The second model (Table 4.22) with non-adherence due to multiple medication
issues as the dependent variable was significant with an F statistic of 4.964 and p-value of
0.000. The significant predictors were being male, necessity and concern beliefs in
medications, self efficacy, social support, illness perceptions, and cost of medications.
While an increase in self efficacy and social support decreased non-adherence; an
increase in the concern beliefs in medications and cost of the medications increased non-
adherence as anticipated. However, an increase in the illness threat perceptions and
necessity beliefs in medications increased non-adherence in contrast to the anticipated
results.
The third model with belief issues in medications was significant with an F
statistic of 3.191 and p-value of 0.000 (Table 4.23). The significant predictors were
income more than $100,000, treatment side effects, self efficacy, autonomous self
regulation, medication concern beliefs, and treatment satisfaction. All the predictions
were in the anticipated directions except for autonomous self regulation. As self efficacy
and treatment satisfaction increased, there was a decrease in medication non-adherence.
As treatment side effects and concern beliefs in medications increased, non-adherence
also increased. However, as autonomous self regulation increased, there was an increase
in non-adherence. The relationship between income and non-adherence was in the
positive direction. An income level more than $100,000 led to non-adherence compared
to an income less than $35,000.
The logistic regression model with forgot due to busy schedule as the dependent
variable had significant predictors including being male, regimen complexity, self
efficacy, self health perceptions, and necessity beliefs as the significant predictors (Table
4.24). As anticipated, an increase in self efficacy and regimen complexity decreased non-
adherence due to forgetting; while an increase in self health perceptions increased non-
adherence. However, in contrast to the expectations, an increase in necessity beliefs
increased non-adherence.
125
The first model in asthma maintenance medications with non-adherence due to
managing and availability issues as the dependent variable was significant (F = 3.648 and
p-value = 0.000) (Table 4.25). The significant predictors were age, medication concern
beliefs, self efficacy, severity of asthma, attitude of others towards disease, and cost of
medications. While an increase in self efficacy and concern beliefs in medications
decreased non-adherence, an increase in severity of disease and more importance given to
significant others attitudes towards disease increased non-adherence. That means, for
every one unit increase in self efficacy, there was a 0.106 unit decrease in medication
non-adherence. As age increased, non-adherence decreased.
The second model (Table 4.26) with beliefs and convenience issues as the
dependent variable was significant with an F statistic of 6.689 and p-value of 0.000. The
significant variables were gender, treatment convenience, concern beliefs in medications,
self efficacy, attitude by others towards disease, self health perceptions, and treatment
satisfaction. All predictions were in the expected direction except for attitude by others
towards the disease. An increase in treatment convenience, self efficacy, and treatment
satisfaction decreased non-adherence. An increase in the concern beliefs in medications
and self health perceptions increased non-adherence. Being male decreased non-
adherence.
The third model with cost issues as the dependent variable was also significant (F
= 4.422 and p-value = 0.000) (Table 4:27). The significant predictors were age, health
insurance, self efficacy, illness perceptions, and cost of medications. While cost
escalations increased non-adherence, having a health insurance and increased self
efficacy decreased non-adherence. However, in contrast to the expectations, increase in
threatening illness perceptions increased non-adherence. Increase in age led to a decrease
in non-adherence.
126
In the logistic regression model where forgot due to busy schedule was the
dependent variable, the significant predictors were belonging to any race other than
white, black or Hispanic, income more than $100,000 compared to income less than
$35,000, having an education of Masters or PhD compared to high school or less than
high school, self efficacy, autonomous self regulation, and knowledge of medications
(Table 4.28). As expected, increases in self efficacy, autonomous self regulation, and
having knowledge of medications decreased non-adherence due to forgetting. An
increase in income increased non-adherence due to forgetting compared to having an
income less than $35,000. Belonging to any race other than white, black or Hispanic and
having higher education decreased non-adherence due to forgetting compared to whites.
Summary of Aim 2 results
The objective of Aim 2 was to test the developed models for medication non-
adherence for cholesterol lowering and asthma maintenance medications. Four models
each were tested for cholesterol lowering and asthma maintenance medications. In
cholesterol lowering medications with managing issues as the dependent variable, the
significant predictors were self efficacy, cost, and income less than $50,000. In the model
with multiple medication issues as the dependent variable, the significant predictors were
necessity and concern beliefs in medications, self efficacy, social support, illness
perceptions, cost of medications, and gender. In the model with medication belief issues
as the dependent variable, the significant predictors were treatment side effects,
autonomous self regulation, concern beliefs in medications, self efficacy, treatment
satisfaction, and income more than $100,000. The significant predictors for forgetfulness
model were gender, regimen complexity, necessity beliefs in medications, self efficacy,
and self health perceptions.
In asthma maintenance medications with managing and availability issues as the
dependent variable, the significant predictors were age, concern beliefs in medications,
127
self efficacy, attitude by others towards disease, severity of disease, and cost of
medications. The models with beliefs and convenience issues as the dependent variable
had gender, treatment convenience, concern beliefs in medications, self efficacy, attitude
by others towards disease, self health perceptions, and treatment satisfaction as the
significant predictors. The model with cost issues as the dependent variable had age, self
efficacy, health insurance, illness perceptions, and cost of medications as the significant
predictors. The significant predictors of forgetfulness model were income more than
$100,000, any race other than black or Hispanic, knowledge in medications, self efficacy,
and autonomous self regulation.
Sub analysis of aim 2
The second aim of the study had a sub analysis which compared the Morisky
scale and the Reasons scale. Morisky scale is a 4 item scale that measures medication
non-adherence based on the four reasons of non-adherence, namely, forgetfulness,
carelessness, and stopping medications when feeling better or worse. Reasons scale
measures the frequency of medication non-adherence due to the most frequently reported
fifteen reasons of non-adherence. The adherents and non-adherents in Morisky scale were
compared to the same identified by Reasons scale for cholesterol lowering and asthma
medications. If the respondents answered never or rarely for all the four items in
Morisky scale, they were considered as adherents according to Morisky scale. Similarly,
if the respondents answered none of the time or a little of the time for all the fifteen
items in Reasons scale, they were considered as adherents according to Reasons scale. In
cholesterol lowering medications, the agreement between both the scales in identifying
adherents and non-adherents as measured by kappa coefficient was 0.381 (Table 4.29),
and in asthma medications was 0.545 (Table 4.30). While the agreement was moderate in
asthma medications, it was low for cholesterol lowering medications.

128
To objectively measure medication non-adherence, the respondents were asked to
quantify their non-adherence by answering In the past week, on how many days did you
forget to take your cholesterol-lowering/asthma medication? and In the past week, on
how many days did you not take your cholesterol-lowering/asthma medication on
purpose? In non-adherence due to forgetfulness, if they missed medication for more than
a day, they were considered as non-adherents. However in purposeful non-adherence,
they were considered as non-adherents if they missed their dose even for a day. The
adherents and non-adherents identified from these questions were compared with those
identified by Morisky scale and Reasons scale. The agreement (kappa coefficient)
between this objective measure and Morisky scale in cholesterol lowering medications
was 0.285 (Table 4.31) and with the Reasons scale was 0.337 (Table 4.32). In asthma
medications, the agreement of this objective measure with Morisky scale was 0.387
(Table 4.33) and with Reasons scale was 0.270 (Table 4.34).
A comparison was also made between the domain Forgetting in Morisky scale
and Forgot due to busy schedule in Reasons scale. This was the most direct comparison
between both the scales since it was comparing the same domain across both the scales.
Morisky scale and Reasons scale had moderate agreement in identifying forgetfulness as
the reason for non-adherence in both cholesterol lowering (0.495) and asthma
medications (0.481) (Tables 4.35 and 4.36). In addition, the forgetting domain in
Morisky and Reasons scales were compared to the Forgetting item in the non-
adherence objective measure. In cholesterol lowering medications, the agreement of the
objective measure with Morisky scale was 0.305 and with the Reasons scale was 0.245
(Tables 4.37 and 4.38). In asthma medications, the agreement of the objective measure
with Morisky scale was 0.429 and with the Reasons scale was 0.307 (Tables 4.39 and
4.40).
A summary of all the comparisons are presented in Table 4.41.

129
Aim 3
The third aim of the study was to compare the developed model across cholesterol
lowering and asthma medications. Towards this, we proposed comparing the factors
extracted from the Reasons scale and the model regression coefficients across cholesterol
lowering and asthma medications. However, as evidenced from the results, there was
considerable difference between the extracted factors or classes of medication non-
adherence for the two different medications. The Reasons scale for cholesterol lowering
medications extracted four classes, yet extracted only three classes for asthma
medications. In addition, the reasons of non-adherence that loaded to both the classes
were different. As a result, no comparison of non-adherence classification across the
medications can be done.
To compare the regression models, the regression coefficients for both the
medications were to be compared and the medication non-adherence classes from Aim 1
were to be used as the dependent variables for the regression models. Since the classes
were different for each medication, the dependent variables were also different for each
medication. Hence Chows test cannot be used to compare the regression coefficients
across the medications.

130
Table 4.1: Sample sizes
Sample size
Number of potential respondents to whom the survey was sent 7378
Total respondents (both who qualified and disqualified for the survey) 2287
Response rate 31%a
Respondents who admitted that they have high levels of cholesterol 574
Respondents who have cholesterol, and are on cholesterol lowering 497
medications
Respondents who have cholesterol, but are not taking any medications to 77
control the cholesterol
Number of qualified completed responses for cholesterol lowering 420
medications
Respondents who admitted that they have asthma 442
Respondents who have asthma, and are on maintenance asthma 431
medications
Respondents who have asthma, but are not taking any medications to 11
control asthma
Number of qualified completed responses for asthma maintenance 399
medications
Total sample size for the study (number of qualified completed responses) 840b
a
Response rate based on all the responses (both qualified and unqualified responses)
b
Total responses is more than the number of individuals combined on cholesterol lowering and
asthma maintenance medications because there were few individuals who were both on
cholesterol lowering and asthma maintenance medications and answered both surveys
131
Table 4.2: Demographic characteristics of the study sample
Total responses Sample on Sample on asthma

(N = 840)a cholesterol maintenance
lowering medications
medications (N = (N = 399 )
420)
Variable Mean SD Mean SD Mean SD
Age 53.8 14.20 59.41 11.52 48.71 14.33
Average monthly cost of 107.18 309.44 105.50 273.57 118.84 347.65
prescription medications
Total number of medications 5.14 3.95 5.59 3.87 5.48 4.35
taken on a daily basis
Duration on cholesterol lowering NA 33.37 51.01 NA
medications
Duration on asthma maintenance NA NA 33.63 67.31
medications
Frequency (%) Frequency (%) Frequency (%)
Gender
Male 398 (47.4) 228 (54.3) 154 (38.6)
Female 442 (52.6) 192 (45.7) 245 (61.4)
Education
Elementary or some high school 10 (1.2) 2 (0.5) 7 (1.8)
Associates degree 100 (11.9) 37 (8.8) 59 (14.8)
Graduated high school 131 (15.6) 61 (14.5) 70 (17.5)
Some technical school or college 224 (26.7) 113 (26.9) 106 (26.6)
Graduated 4 years of college 164 (19.5) 89 (21.2) 74 (18.5)
Some graduate school, but no 61 (7.3) 30 (7.1) 24 (6.0)
degree
Masters, PhD, or professional 150 (17.9) 88 (21.0) 59 (14.8)
college
Martial Status
Single, never married 159 (18.9) 47 (11.2) 96 (24.1)
Married 447 (53.2) 244 (58.1) 203 (50.9)
Living with partner 40 (4.8) 21 (5.0) 19 (4.8)
Married but living separate 17 (2.0) 5 (1.2) 10 (2.5)
Divorced 124 (14.8) 66 (15.7) 57 (14.3)
Widowed 53 (6.3) 37 (8.8) 14 (3.5)
132
Total responses Sample on Sample on asthma

(N = 840)a cholesterol maintenance
lowering medications
medications (N = (N = 399 )
420)
Frequency (%) Frequency (%) Frequency (%)
Race
White 694 (82.6) 359 (85.5) 323 (81.0)
Black 69 (8.2) 28 (6.6) 38 (9.6)
Hispanic 33 (3.9) 16 (3.8) 15 (3.8)
Other (Asian or Pacific 23 (0.27) 7 (1.7) 16 (4.1)
islander/Alaskan or Native
American/Mixed race/Other race)
Income
Less than $35, 000 243 (29.0) 84 (20.0) 152 (38.0)
$35,000 - $49,999 124 (14.8) 67 (16.0) 55 (13.8)
$50,000 - $74,999 153 (18.2) 80 (19.0) 72 (18.0)
$75,000 - $99,999 89 (10.6) 46 (11.0) 37 (9.3)
$100,000 or more 108 (12.9) 70 (16.8) 40 (10.0)
Health Insurance
Yes 765 (91.1) 397 (94.5) 361 (90.5)
No 69 (8.2) 20 (4.8) 36 (9.0)
Has depression 191 (22.7) 80 (19.0) 122 (30.6)
Has anxiety 115 (13.7) 50 (11.9) 72 (18.0)
a
Total responses is more than the number of individuals combined on cholesterol lowering and
asthma maintenance medications because there were few individuals who were both on
cholesterol lowering and asthma maintenance medications and answered both surveys
133
Table 4.3: Distribution of responses across the Reasons scale for cholesterol lowering
medications
Cholesterol lowering None of A little of Some of Most of All of

medications Reasons the time the time the time the time the time
scale (%) (%) (%) (%) (%)
Side effects/Fear of side 93.6 3.1 1.7 0.7 1.0
Medication is not needed 94.8 3.1 1.7 0.5 0
Ran out of prescription 76.4 16.9 3.1 2.1 1.4
Medication not available in 96.0 3.8 0.2 0 0
the pharmacy
Medication is ineffective 96.4 2.4 0.7 0.2 0.2
Taking too many 92.6 2.9 2.4 1.4 0.7
medications
Unclear about proper 97.6 1.7 0.7 0 0
administration
Difficulty swallowing 97.1 1.7 0.7 0.5 0
Problems opening 98.1 1.2 0.2 0.2 0.2
containers
Stop medication to see 95.2 2.6 2.1 0 0
whether it is still needed
Inconvenience in taking 90.5 6.4 1.9 0.7 0.5
medications in prescribed
way
Embarrassment in taking 97.4 2.1 0.5 0 0
medications
Cost of medications 82.6 6.9 4.5 2.4 3.6
Concern about long term 88.1 5.7 2.6 2.4 1.2
effects of medication
Forget due to busy 65.5 22.9 4.3 3.8 3.6
schedule
134
Table 4.4: Distribution of responses across the Morisky scale for cholesterol lowering
medications
Cholesterol lowering Never Rarely Sometimes Often Always

medications Morisky scale (%) (%) (%) (%) (%)
Forgetfulness 40.5 46.4 11.9 1.2 0
Carelessness 64.0 25.7 8.3 1.9 0
Stopping meds when feeling 88.3 8.6 2.9 0 0.2
better
Stopping meds when feeling 73.6 14.0 9.5 1.2 1.7
worse
135
Table 4.5: Distribution of responses across the objective measure of medication non-
adherence for cholesterol lowering medications
Cholesterol lowering medications Objective Forgetfulness Purposeful

0 days 83.8 91.9
1 day 11.7 8.1
2 days or more 4.5
136
Table 4.6: Distribution of responses across the Reasons scale for asthma medications
Asthma medications None of A little of Some of Most of All of

Reasons scale the time the time the time the time the time
(%) (%) (%) (%) (%)
Side effects/Fear of side 81.0 6.0 9.0 2.3 1.8
Medication is not needed 57.4 13.0 15.3 10.3 4.0
Ran out of prescription 58.1 21.8 14.8 3.0 2.3
Medication not available in 86.7 7.3 5.3 0.5 0.3
the pharmacy
Medication is ineffective 85.2 7.0 7.3 0.5 0
Taking too many 79.4 8.8 2.8 0 2.0
medications
Unclear about proper 91.5 4.0 4.3 0.3 0
administration
Difficulty swallowing 91.5 4.0 4.0 0 0.5
Problems opening 88.7 3.8 6.5 0.5 0.5
containers
Stop medication to see 75.7 11.0 11.0 1.5 0.8
Inconvenience in taking 75.4 12.3 9.8 1.8 0.8
medications in prescribed
way
Embarrassment in taking 87.0 5.5 6.8 0.5 0.3
medications
Cost of medications 61.9 10.0 14.5 6.8 6.8
Concern about long term 73.2 7.8 13.3 1.8 4.0
Forget due to busy schedule 47.9 23.6 14.3 9.5 4.8
137
Table 4.7: Distribution of responses across the Morisky scale for asthma medications
Asthma medications Morisky Never Rarely Sometimes Often Always

scale (%) (%) (%) (%) (%)
Forgetfulness 27.6 35.3 28.6 7.8 0.8
Carelessness 42.9 30.8 20.3 5.0 1.0
better
worse
138
Table 4.8: Distribution of responses across the objective measure of medication non-
adherence for asthma maintenance medications
Asthma maintenance medications Objective Forgetfulness Purposeful

0 days 66.9 81.7
1 day 17.0 18.3
2 days or more 16.0
139
Table 4.9: Classification of medication non-adherence based on literature reviewa for

cholesterol lowering and asthma maintenance medications
Frequently reported reasons Difficulty swallowing medications
Medication not available in the pharmacy
Cost of medication
Unclear about proper administration of medication
patient
Lifestyle modifications are needed
Forgetting due to busy schedule
Prescription running out due to busy schedule
Taking too many medications
Inconvenience in taking medication as prescribed
Embarrassment in taking medication
Belief modifications are needed
Think medication is not needed
Medication is ineffective
Side effects/fear of side effects
Stop medication to see whether it is still needed
Concern about long term effects of medication
a
The classification was done based on the fifteen frequently reported reasons for medication non-
adherence identified from the literature
140
Table 4.10: Domains identified in cholesterol lowering medication non-adherence from

the qualitative analysis
Domain Reasons in the domain a

Cost of medications Cost
patient Lifestyle modification
Forgetfulness Forgot (4)b
Forgot to take
Forgetting due to other activities Traveling, and forgot 1 night
Because I was out of town and didn't have it with me
Was tired and forgot it
I just plain forgot and was focused on going to bed
I forgot to take them with me when I went out
Occasionally am not home to take it
I had laid it down on the dresser to get my NSAID for the
night and apparently forgot to pick it up to take, it was
dark in my room when I did it
Remembered, but decided not to Missed the time & couldn't take w/food
take it due to conflict with
dosing schedule/instructions
At time for taking (before going to sleep), not having
avoided food intake for several hours prior
patient Belief modification
Fear of side effects I am fearful of its affect on my liver
I am afraid of side effect
Because of the side effects
Dont feel it is necessary to take Since it is a daily dosage, I didn't feel that missing one or
medications as prescribed two days would hurt significantly - Why?...because I
found research data on the web that generally indicated
that missing a day or so, would not be very problematic
I forgot to take my meds until late in the
evening...decided not to take them that day
a
20 reasons stated by the respondents in response to the open ended question. One reason was
excluded since it was not a reason (it was an inadvertent mistake)
b
Number of times this reason was noted in the original responses
141
Table 4.11: Domains identified in asthma maintenance medication non-adherence from

the qualitative analysis
Domain Reasons in the domain a

Cost of I don't have prescription coverage with my health insurance and Flovent is
medications very expensive. My asthma seems to be under control with Singular.
I didn't feel I needed it, and wanted to save it for a time I would really
need it, due to financial reasons
Forgetfulness Forgot to take the dose
Forgetfulness
Forgot (6)b
Forgot, absent minded
Forgot to take it
Forgetting due to Forgot what time it was and realized late that I had missed the dose
other activities
Busy and forgot
I got busy at home and was not sure if I took them in am or not
Sometimes forgot to take, at time when there was a change to the normal
routine
I forgot to take it or my prescription runs out and I forget to fill it right
away
Fell asleep early, went straight to bed
Think the drug is No symptoms, didn't need to take it
not needed
I feel I should only take when necessary. My doctor prescribed daily
Smptoms seldomly flare up
Ddn't need it
When Im not having symptoms or Im late for work I sometimes forget.
I felt okay and was not thinking about it and did not take the medicine
Usually don't need it so sometimes forget it
a
Exhaustive list of all reasons stated by the respondents in response to the open ended question
b
Number of times this reason was noted in the original responses
142
Table 4.12: Confirmatory factor analysis of Reasons scale for cholesterol lowering
medicationsa
Unstandardized Estimate/Std Standardized R-

coefficients Error coefficients squared
Unclear about proper 1.000 0.000 0.919 0.845
administration
Difficulty swallowing 0.967 15.939 0.889 0.791
medications
Problem opening 1.034 14.468 0.951 0.904
containers
Medication not available 0.788 8.490 0.725 0.525
in the pharmacy
Cost of medications 0.868 13.489 0.798 0.636
Forgot due to busy 1.000 0.000 0.484 0.234
schedule
Ran out of prescription 0.973 6.860 0.470 0.221
due to busy schedule
Taking too many 1.923 9.515 0.930 0.865
medications
Inconvenience in taking 1.442 9.116 0.698 0.487
meds as prescribed
Social stigma 1.848 8.667 0.894 0.799
Medication is not needed 1.000 0.000 0.808 0.652
Medication is ineffective 1.139 12.945 0.920 0.846
Stop medication to see 0.894 8.804 0.722 0.521
Concern about the long 1.116 14.657 0.901 0.812
term effects of
medications
Side effects/Fear of side 0.970 13.694 0.783 0.613
effects
a
Fit statistic include Chi square value = 84.294; Df = 25; p-value = 0.000; CFI = 0.951; TLI =
0.93; RMSEA = 0.075; SRMR = 0.075
143
Table 4.13: Confirmatory factor analysis of Reasons scale for asthma medicationsa
Unstandardized Estimate/Std Standardized R-

coefficients Error coefficients squared
Medication not available 1.000 0.000 0.827 0.684
in the pharmacy
Unclear about proper 1.198 25.136 0.991 0.982
administration
Difficulty swallowing 1.141 21.334 0.944 0.891
medications
Problem opening 0.996 17.768 0.824 0.679
containers
Cost of medications 0.869 15.194 0.719 0.516
Ran out of prescription 1.000 0.000 0.457 0.416
due to busy schedule
Taking too many 1.411 10.203 0.645 0.639
medications
Inconvenience in taking 1.749 10.138 0.800 0.601
meds as prescribed
Social stigma 1.695 10.918 0.775 0.717
Forgot due to busy 1.852 9.775 0.847 0.209
schedule
Side effects/Fear of side 1.000 0.000 0.866 0.750
effects
Medication is not needed 0.738 17.409 0.639 0.409
Medication is ineffective 0.990 22.276 0.858 0.736
Stop medication to see 0.893 24.456 0.774 0.599
Concern about the long 0.984 24.850 0.853 0.727
term effects of
medications
a
Fit statistic include Chi square value = 187.399; Df = 37; p-value = 0.000; CFI = 0.947; TLI =
0.977; RMSEA = 0.101; SRMR = 0.079
144
Table 4.14: Exploratory factor analysis of 15 items of Reasons scale for cholesterol
lowering medicationsa
Factor 3 Factor 4 Factor 5

Factor 1 Factor 2 (Multiple (Availab- (Forgetful
(Managin (Belief medicatio ility -ness
g issues) b issues) b n issues) b issues) b issues) b
Problems opening containers .775
Embarrassment taking
.731
medications
Difficulty swallowing .593
Unclear about proper
.458
administration
Medication is not needed .754
Stop medication to see
.622
Side effects/Fear of side
.452
effects
Medication is ineffectivec .321 .365 .301 .226 .026
Taking too many medications .643
Concern about long term
.632
Cost of medications .624
Medication not available in
.640
the pharmacy
Ran out of prescription .499
Forget due to busy schedule .616
Inconvenience in taking
.590
medications in prescribed way
a
Fit statistic include Kaiser-Meyer-Olkin Measure of sampling adequacy = 0.768; Bartletts test
of sphericity had a p-value of 0.000
b
The names provided to the extracted factors based on the characteristics of the loaded items
c
This item was not included in any domain and not predicted since the factor loading was low
145
Table 4.15: Reliability estimates of the dependent variables for cholesterol lowering
medications
Dependent Variables Mean Item SD Cronbachs alpha

Managing issues 4.14a 0.758 0.752
Problems opening containers 1.03 0.283
Embarrassment taking medications 1.03 0.199
Difficulty swallowing medications 1.05 0.294
Unclear about proper administration 1.03 0.211
Multiple medication issues 3.75a 1.849 0.728
Concern about long term effects of medications 1.23 0.718
Taking too many medications 1.15 0.588
Cost of medications 1.37 0.948
Belief issues with medications 3.27a 0.959 0.616
Medication is not needed 1.08 0.367
Stop medication to see whether it is still needed 1.07 0.328
Side effects/Fear of side effects 1.12 0.547
Availability issuesb 2.40a 0.863 0.290
Medication not available in the pharmacy 1.04 0.214
Ran out of prescription due to busy schedule 1.35 0.769
b a
Forgetfulness and convenience issues 2.71 1.29 0.488
Forgot due to busy schedule 1.57 0.995
Inconvenience in taking meds as prescribed 1.14 0.511
a
Scale statistics
b
These domains were removed from the non-adherence typology domains due to the low
Cronbachs alpha
146
Table 4.16: Exploratory factor analysis of 15 items of Reasons scale of asthma

maintenance medicationsa
Itemsb Factor 1 (Managing Factor 2 (Beliefs & Factor 3 (Cost

& availability convenience issues) b issues) b
issues)b
Unclear about proper 0.904
administration
Difficulty swallowing 0.840
medications
Medication not available 0.630
in the pharmacy
Problems opening 0.621
containers
Embarrassment taking 0.584
medications
Medication is ineffective 0.563
Concern about long term 0.736

effects of medications
Side effects/ fear of side 0.664

effects
Taking too many 0.597
medications
Stop medication to see 0.525
Inconvenience in taking 0.519
medications as prescribed
Medication is not needed 0.499
Ran out of prescriptions 0.660

Cost of medications 0.620
Forgot due to busy 0.124 0.280 0.175
schedule
a
Fit statistic include Kaiser-Meyer-Olkin Measure of sampling adequacy = 0.889; Bartletts test
of sphericity had a p-value of 0.000
b
The names provided to the extracted factors based on the characteristics of the loaded items
147
Table 4.17: Reliability estimates of the dependent variables for asthma medications
Dependent Variables Mean Item SD Cronbachs alpha

Managing and availability issues 7.13a 2.680 0.881
Unclear about proper administration 1.13 0.465
Difficulty swallowing medications 1.14 0.512
Medication not available in the pharmacy 1.20 0.573
Problems opening containers 1.20 0.619
Embarrassment taking medications 1.22 0.605
Medication is ineffective 1.23 0.595
Belief and convenience issues 9.06 a 4.137 0.817
Concern about long term effects of medications 1.56 1.050
Side effects/Fear of side effects 1.38 0.874
Taking too many medications 1.41 0.908
Stop medication to see whether it is still needed 1.41 0.802
Inconvenience in taking medications as prescribed 1.40 0.795
Medication is not needed 1.90 1.222
a
Cost issues 3.56 1.962 0.654
Ran out of prescription due to busy schedule 1.69 0.981
Cost of medications 1.86 1.277
a
Scale statistics
148
Table 4.18: Dependent variables for cholesterol lowering and asthma maintenance
medications

Managing issues Problems opening containers
Embarrassment taking medications
Unclear about proper administration
Multiple medication issues Concern about long term effects of medications
Cost of medications
Belief issues with medications Medication is not needed
Side effects/Fear of side effects
Forgetfulness due to busy schedule
Asthma medications
Managing and availability issues Unclear about proper administration
Medication not available in the pharmacy
Embarrassment taking medications
Medication is ineffective
Beliefs and convenience issues Concern about long term effects of medications
Side effects/ fear of side effects
Inconvenience in taking medications as prescribed
Medication is not needed
Cost issues Ran out of prescriptions
Cost of medications
Forgetfulness due to busy schedule
149
Table 4.19: Reliability statistics of the scales used in the regression analyses
Cholesterol lowering Asthma maintenance medications

medications (n = 399)
(n = 420)
Constructs (# of Range Mean Cronbac Range Mean Cronbac
items) SD hs alpha SD hs alpha
Dosing convenience 0-100 88.41 0.859 0-100 80.23 0.857
(3) 14.41 17.89
Side effects (4) 0-100 63.90 0.856 0-100 66.52 0.854
21.20 21.26
Appraisal of coping 0-100 72.80 0.959 0-100 70.68 0.939
procedures (3) 20.20 19.71
Treatment 0-100 73.92 0.908 0-100 70.85 0.873
satisfaction (3) 21.21 21.12
Necessity beliefs in 5-25 3.39 0.832 5-25 3.61 0.867
medications (5) 0.80 0.87
Concern beliefs in 5-25 2.35 0.805 5-25 2.60 0.795
medications (5) 0.81 0.87
Self efficacy (23) 0.954 0.958
Self regulation 7-21 4.09 0.434 7-21 3.90 0.477
Autonomous (3) 1.22 1.28
Self regulation 7-35 3.01 0.835 7-35 2.83 0.873
Control (5) 1.53 1.66
Illness perceptions 0-80 3.23 0.643 0-80 4.37 0.764
(8) 1.31 1.56
Locus of control - 6-36 25.95 0.843 6-36 23.22 0.843
Internal (6)a 6.01 6.52
Social support (4) a 4-16 3.52 0.967 4-16 3.50 0.967
1.44 1.30
a
These items were asked based on the patient and was not medication related. Hence the same
reliability statistics for both cholesterol lowering and asthma maintenance medications
150
Table 4.20: Summary of regression models predicting medication non-adherence in

cholesterol lowering and asthma medications
Source Dependent Significant independent Direction of Agreement

variable variables relationship with the
in the tested hypothesized
models direction of
relationship
Cholesterol lowering medications non-adherence
Table Non-adherence Self efficacy Negative Agree
4.21 due to Cost of medications Positive Agree
managing issues Income less than $50,000 Negative Not predicted
Table Non-adherence Gender Negative Not predicted
4.22 due to Necessity beliefs in meds Positive Disagree
multiple Concern beliefs in meds Positive Agree
medication issues
Self efficacy Negative Agree
Social support Negative Agree
Illness perceptions Positive Disagree
Cost of medications Positive Agree
Table Non-adherence Income more than $100,000 Positive Not predicted
4.23 due to Side effects Positive Agree
medication belief Concern beliefs in meds Positive Agree
issues
Autonomous self regulation Positive Disagree
Treatment satisfaction Negative Agree
4.24 due to Regimen complexity Negative Agree
forgefulness
Necessity beliefs in meds Positive Disagree
Self health perceptions Positive Agree
Asthma medications non-adherence
Table Non-adherence Age Negative Not predicted
4.25 due to Self efficacy Negative Agree
managing and Concern beliefs in meds Positive Agree
availability issues
Attitude by others to disease Positive Disagree
Severity of the disease Positive Disagree
151
Source Dependent Significant independent Direction of Agreement

variable variables relationship with the
in the tested hypothesized
models direction of
relationship
4.26 due to Treatment convenience Negative Agree
beliefs and Concern beliefs in meds Positive Agree
convenience
issues
Attitude by others to disease Positive Disagree
Self health perceptions Positive Agree
Treatment satisfaction Negative Agree
Table Non-adherence Age Negative Not predicted
4.27 due to Having health insurance Negative Agree
cost issues Self efficacy Negative Agree
Illness perceptions Positive Disagree
Table Non-adherence Income more than $100,000 Positive Not predicted
4.28 due to Education Masters or PhD Negative Not predicted
forgetfulness
Race Any other than Black Negative Not predicted
or Hispanic
Knowledge of meds Negative Agree
Autonomous self regulation Negative Agree
152
Table 4.21: Regression model predicting medication non-adherence due to managing

issues in cholesterol lowering medications
Dependent Variable Non-adherence due B Std. Error Beta Sigb

to managing issues
Constant 1.267 .200 .000
Predisposing Factors
Demographics
Age .000 .001 -.013 .807
Gender (1=female) -.018 .020 -.048 .358
Social structurec
Associates Degree .041 .135 .061 .762
Graduated high school .047 .133 .088 .723
Some college, but no degree .063 .133 .147 .636
Graduated college .076 .133 .164 .566
Some graduate school .015 .136 .020 .914
Masters, PhD, etc .027 .133 .058 .840
Black -.001 .036 -.001 .983
Hispanic .003 .048 .003 .954
Other .061 .070 .042 .377
Depression -.004 .015 -.015 .799
Anxiety .021 .016 .074 .181
Convenience -.001 .001 -.091 .152
Complexity .002 .003 .041 .521
Duration .000 .000 -.031 .534
Side effects .000 .000 .004 .938
Medication beliefs
Necessity beliefs .023 .014 .096 .111
Concern beliefs .019 .015 .080 .205
Knowledge of medications -.005 .026 -.010 .846
Enabling Factors
Access variablesd
Income less than $50,000 -.063 .027 -.122 .022
153

to managing issues
Income less than $75,000 -.025 .026 -.052 .338
Income less than $100,000 -.013 .032 -.021 .696
Income more than $100,000 -.032 .029 -.063 .265
Having health insurance (1=yes) -.019 .042 -.022 .653
Self variables
Self efficacy -.088 .029 -.189 .002
Autonomous self regulation -.003 .010 -.017 .777
Controlled self regulation .005 .007 .041 .477
Internal locus of control -.002 .002 -.079 .110
Community
Social network .007 .007 .050 .333
Attitude by others towards illness -.005 .010 -.024 .625
Need Factors
Perceived need
Self Health perceptions .017 .013 .083 .192
Concern perceptions of own health -.005 .010 -.029 .586
Illness perceptions .004 .010 .027 .668
Treatment effectiveness .000 .001 -.006 .913
Evaluated need
Disease severity (1 = controlled) -.046 .035 -.068 .184
Health Outcomes
Treatment satisfaction .000 .001 -.009 .894
Control Variables
Monthly prescription out of pocket cost .000 .000 .299 .000
Self rated memory -.007 .010 -.037 .493
a
Fit statistic include R squared = 0.234; F statistic = 2.966; p-value = 0.000
b
Numbers in bold are significant predictors at 0.05 level of significance
c
The comparison variable was high school or less than high school for education and white for
race
d
The comparison variable was income less than $35,000
154
Table 4.22: Regression Model predicting medication non-adherence due to multiple

medication issues in cholesterol lowering medications

to multiple medication issues
Constant 1.513 .604 .013
Demographics
Age .003 .003 .050 .302
Gender (1=female) -.119 .060 -.096 .048
Social structurec
Masters, PhD, etc -.028 .403 -.018 .946
Black .178 .109 .072 .103
Hispanic -.070 .145 -.022 .629
Other .024 .210 .005 .909
Depression -.059 .046 -.069 .198
Anxiety .039 .047 .042 .411
Convenience -.003 .003 -.067 .258
Complexity -.004 .009 -.024 .686
Duration .000 .000 .022 .640
Side effects .000 .001 .000 .991
Medication beliefs
Knowledge of medications .006 .078 .004 .935
Enabling Factors
Access variablesd
Income less than $50,000 -.040 .083 -.024 .630
155
Dependent Variable Non-adherence B Std. Error Beta Sigb

due to multiple medication issues
Income less than $75,000 -.065 .080 -.042 .414
Income less than $100,000 -.016 .097 -.008 .871
Income more than $100,000 .000 .087 .000 .997
Having health insurance (1=yes) .047 .126 .017 .709
Self variables
Self efficacy -.394 .087 -.259 .000
Controlled self regulation -.020 .022 -.049 .360
Internal locus of control .001 .005 .005 .911
Community
Social network -.041 .021 -.096 .048
Attitude by others towards illness .022 .030 .033 .470
Need Factors
Perceived need
Concern perceptions of own health .013 .030 .022 .660
Treatment effectiveness .000 .002 -.011 .843
Evaluated need
Disease severity (1 = controlled) .049 .105 .022 .644
Health Outcomes
Treatment satisfaction -.001 .002 -.033 .602
Control Variables
a
b
c
race
d
156
Table 4.23: Regression Model predicting medication non-adherence due to belief issues
in cholesterol lowering medicationsa

to belief issues
Constant 1.176 .334 .000
Demographics
Age -.003 .001 -.095 .065
Gender (1=female) -.041 .033 -.064 .213
Social structurec
Some graduate school -.030 .227 -.024 .896
Masters, PhD, etc .033 .223 .041 .884
Black .040 .060 .031 .511
Hispanic .026 .080 .016 .742
Other -.107 .116 -.043 .359
Depression -.037 .025 -.082 .151
Anxiety .000 .026 .000 .997
Convenience -.001 .001 -.034 .588
Complexity -.006 .005 -.069 .273
Duration .000 .000 -.001 .991
Side effects .001 .001 .098 .042
Medication beliefs
Knowledge of medications .009 .043 .010 .834
Enabling Factors
Access variablesd
Income less than $50,000 -.006 .046 -.006 .903
157
Dependent Variable Non-adherence due

to belief issues B Std. Error Beta Sigb
Income less than $75,000 -.016 .044 -.020 .714
Income less than $100,000 .091 .054 .089 .090
Income more than $100,000 .105 .048 .122 .031
Having health insurance (1=yes) .079 .070 .055 .259
Self variables
Self efficacy -.094 .048 -.120 .050
Autonomous self regulation .043 .016 .165 .007
Controlled self regulation -.019 .012 -.093 .103
Community
Social network .010 .011 .047 .360
Need Factors
Perceived need
Illness perceptions -.002 .016 -.006 .920
Treatment effectiveness -.001 .001 -.044 .450
Evaluated need
Health Outcomes
Control Variables
Self rated memory .022 .016 .072 .182
a
b
c
The comparison variable was high school or less than high school for education and white for race
d
158
Table 4.24: Logistic regression model predicting medication non-adherence due to

forgetting due to busy schedule in cholesterol lowering medicationsa
Dependent Variable Non-adherence B Std. Error Sigc Odds

due to forgetting due to busy scheduleb Ratio
Constant 3.623 3.784 .338 37.457
Demographics
Age -.042 .026 .112 .959
Gender (1=female) -1.106 .563 .049 .331
Social structured
Associates Degree -.122 1.039 .906 .885
Some college, but no degree -.787 .988 .426 .455
Graduated college -1.185 .945 .210 .306
Some graduate school -.636 1.258 .613 .529
Masters, PhD, etc .265 .945 .780 1.303
Black -.886 1.155 .443 .412
Hispanic -.162 1.147 .888 .851
Other -18.817 13758.813 .999 .000
Depression -.037 .829 .965 .964
Anxiety -1.013 .763 .184 .363
Convenience -.021 .021 .335 .980
Complexity -.333 .148 .025 .717
Duration .007 .005 .127 1.007
Side effects .001 .011 .927 1.001
Medication beliefs
Necessity beliefs .863 .431 .045 2.370
Concern beliefs -.127 .419 .761 .880
Knowledge of medications .077 .833 .926 1.081
Enabling Factors
Access variablese
Income less than $50,000 .065 .783 .934 1.067
Income less than $75,000 -.123 .776 .874 .884
159
Dependent Variable Non-adherence B Std. Error Sigc Odds Ratio

due to forgetting due to busy scheduleb
Income less than $100,000 .896 .867 .302 2.450
Income more than $100,000 -.588 .941 .532 .555
Having health insurance (1=yes) 2.461 1.444 .088 11.712
Self variables
Self efficacy -3.741 .801 .000 .024
Autonomous self regulation -.234 .289 .418 .791
Controlled self regulation .277 .210 .187 1.319
Internal locus of control .011 .044 .803 1.011
Community
Social network .033 .194 .865 1.033
Attitude by others towards illness .080 .270 .766 1.084
Need Factors
Perceived need
Self Health perceptions .960 .397 .016 2.611
Concern perceptions of own health .490 .279 .079 1.632
Illness perceptions -.328 .321 .308 .721
Treatment effectiveness .014 .018 .436 1.014
Evaluated need
Disease severity (1 = controlled) 1.503 .781 .054 4.497
Health Outcomes
Treatment satisfaction .008 .017 .622 1.008
Control Variables
Monthly prescription out of pocket .004 .002 .036 1.004
cost
Self rated memory .002 .306 .994 1.002
a
Fit statistics; Cox & Snell R squared = 0.257; Chi-square = 100.861; p-value = 0.000
b
Dependent variable was adherent and non-adherent due to forget due to busy schedule
c
d
Comparison variable was high school/ less than high school (education) and white (race)
e
160
Table 4.25: Regression Model predicting medication non-adherence due to managing and
availability issues in asthma medicationsa
Dependent Variable Non-adherence due to

managing and availability issues B Std. Error Beta Sigb
Constant 1.921 .320 .000
Demographics
Age -.004 .002 -.120 .027
Gender (1=female) .013 .045 .014 .776
Social structurec
Associates Degree -.234 .176 -.186 .184
Graduated high school -.144 .171 -.122 .401
Some college, but no degree -.253 .170 -.249 .138
Graduated college -.191 .172 -.167 .270
Some graduate school -.196 .186 -.105 .293
Masters, PhD, etc -.227 .178 -.182 .201
Black .086 .073 .057 .240
Hispanic .048 .109 .020 .662
Other -.129 .109 -.057 .234
Depression -.010 .018 -.028 .563
Anxiety .014 .019 .036 .466
Convenience -.003 .002 -.111 .091
Complexity .003 .006 .026 .665
Duration .000 .000 -.039 .426
Side effects .000 .001 .016 .750
Medication beliefs
Necessity beliefs -.017 .030 -.032 .586
Enabling Factors
Access variablesd
Income less than $50,000 -.049 .063 -.038 .436
Income less than $75,000 -.016 .059 -.014 .787
161
Dependent Variable Non-adherence due to

managing and availability issues B Std. Error Beta Sigb
Income less than $100,000 .033 .078 .021 .668
Income more than $100,000 .034 .078 .023 .662
Self variables
Self efficacy -.106 .049 -.120 .032
Community
Social network -.001 .018 -.003 .949
Need Factors
Perceived need
Illness perceptions -.002 .021 -.007 .928
Treatment effectiveness -.001 .002 -.066 .342
Evaluated need
Health Outcomes
Treatment satisfaction .000 .002 -.001 .993
Control Variables
a
b
c
race
d
162
Table 4.26: Regression Model predicting medication non-adherence due to belief and
convenience issues in asthma medicationsa
Dependent Variable Non-adherence

due to belief and convenience issues B Std. Error Beta Sigb
Constant 2.245 .446 .000
Demographics
Age -.002 .002 -.035 .468
Gender (1=female) -.138 .062 -.097 .027
Social structurec
Masters, PhD, etc .080 .247 .041 .748
Black .043 .101 .018 .670
Hispanic -.044 .152 -.012 .772
Other .140 .151 .040 .353
Depression -.024 .025 -.042 .338
Anxiety .016 .026 .027 .539
Convenience -.006 .002 -.165 .005
Complexity .001 .009 .004 .944
Duration .000 .000 -.048 .276
Side effects .000 .001 .005 .910
Medication beliefs
Enabling Factors
Access variablesd
Income less than $50,000 -.022 .088 -.011 .800
Income less than $75,000 .078 .081 .044 .338
163

due to belief and convenience issues B Std. Error Beta Sigb
Income less than $100,000 .104 .108 .043 .337
Income more than $100,000 .020 .108 .009 .852
Self variables
Self efficacy -.333 .069 -.244 .000
Community
Social network -.001 .025 -.001 .980
Need Factors
Perceived need
Treatment effectiveness .004 .002 .106 .091
Evaluated need
Health Outcomes
Control Variables
a
b
c
race
d
164
Table 4.27: Regression Model predicting medication non-adherence due to cost issues in
asthma medicationsa

to cost issues
Constant 1.017 .229 .000
Demographics
Age -.004 .001 -.152 .004
Gender (1=female) -.057 .032 -.085 .074
Social structurec
Masters, PhD, etc .065 .127 .071 .608
Black .020 .052 .018 .702
Hispanic .054 .078 .032 .487
Other -.084 .077 -.050 .280
Depression -.020 .013 -.075 .113
Anxiety .007 .013 .026 .581
Convenience .000 .001 .006 .924
Complexity .002 .004 .021 .712
Duration .000 .000 .008 .875
Side effects .001 .001 .061 .201
Medication beliefs
Enabling Factors
Access variablesd
Income less than $50,000 .023 .045 .025 .604
165

to cost issues
Income less than $75,000 .030 .042 .036 .471
Income less than $100,000 .005 .055 .004 .932
Income more than $100,000 .067 .055 .061 .231
Self variables
Self efficacy -.199 .035 -.306 .000
Internal locus of control .000 .003 -.003 .952
Community
Social network -.008 .013 -.032 .529
Attitude by others towards illness -.018 .017 -.055 .278
Need Factors
Perceived need
Treatment effectiveness .000 .001 .025 .715
Evaluated need
Health Outcomes
Control Variables
a
Fit statistic include R squared = 0.328; F-statistic = 4.422; p-value = 0.000
b
c
race
d
166
Table 4.28: Logistic regression model predicting medication non-adherence due to

forgetting due to busy schedule in asthma medicationsa
Dependent Variable Non-adherence B Std. Error Sigc Odds Ratio

due to forgetting due to busy
scheduleb
Constant 4.910 2.302 .033 135.675
Demographics
Age -.026 .013 .049 .975
Gender (1=female) -.422 .330 .201 .656
Social structured
Associates Degree -.137 .546 .802 .872
Some college, but no degree -.374 .491 .447 .688
Graduated college .083 .506 .870 1.086
Some graduate school .368 .699 .599 1.445
Masters, PhD, etc -1.280 .611 .036 .278
Black -.081 .556 .884 .922
Hispanic .140 .745 .851 1.150
Other -3.044 1.053 .004 .048
Depression .487 .400 .223 1.627
Anxiety -.354 .459 .440 .702
Convenience -.005 .013 .683 .995
Complexity -.030 .050 .542 .970
Duration -.002 .002 .490 .998
Side effects -.003 .006 .593 .997
Medication beliefs
Necessity beliefs .286 .235 .222 1.331
Concern beliefs .329 .247 .184 1.389
Knowledge of medications -.933 .368 .011 .393
Enabling Factors
Access variablese
Income less than $50,000 .425 .467 .362 1.530
Income less than $75,000 .552 .441 .211 1.736
167

due to forgetting due to busy scheduleb B Std. Error Sigc Odds Ratio
Income less than $100,000 .970 .560 .083 2.637
Income more than $100,000 2.165 .583 .000 8.714
Having health insurance (1=yes) 1.209 .718 .092 3.351
Self variables
Self efficacy -2.624 .419 .000 .072
Autonomous self regulation -.464 .174 .008 .629
Controlled self regulation .226 .127 .075 1.253
Internal locus of control .011 .027 .684 1.011
Community
Social network -.040 .131 .760 .961
Attitude by others towards illness .050 .177 .778 1.051
Need Factors
Perceived need
Self Health perceptions -.052 .239 .829 .950
Concern perceptions of own health .178 .172 .300 1.195
Illness perceptions -.005 .166 .976 .995
Treatment effectiveness .002 .012 .841 1.002
Evaluated need
Disease severity (1 = controlled) -.158 .406 .697 .854
Health Outcomes
Treatment satisfaction .010 .013 .414 1.010
Control Variables
Monthly prescription out of pocket
.000 .000 .594 1.000
cost
Self rated memory .111 .150 .457 1.118
a
Fit statistics; Cox & Snell R squared = 0.311; Chi-square = 126.278; p-value = 0.000
b
Dependent variable was adherent and non-adherent due to forget due to busy schedule
c
d
The comparison variable was high school or less than high school (education) and white (race)
e
168
Table 4.29: Comparison between Morisky scale and Reasons scale in cholesterol
lowering medications in identifying adherents and non-adherents
CHOLESTEROL Reasons scale Total

Non-
Adherentb adherent
Morisky Adherenta 263 51 314
scale
Non-adherent 48 58 106
Total 311 109 420
Kappa coefficient = 0.381

a
Adherents in Morisky scale Answered never or rarely to all the 4 items in the Morisky scale
b
Adherents in Reasons scale Answered none of the time or a little of the time to all the fifteen
items in the Reasons scale
Table 4.30: Comparison between Morisky scale and Reasons scale in asthma medications
in identifying adherents and non-adherents
ASTHMA Reasons scale Total

Non-
Adherentb adherent
scale
Total 161 238 399

a
b
169
Table 4.31: Comparison between Morisky scale and non-adherence quantification item
adherents
CHOLESTEROL Quantification item Total

Non-
Adherentb adherent
scale
Total 377 43 420

a
b
Adherents in objective measure Answered to zero days in purposefully not taking medications
and less than or equal to one day in forgetting to take medications
Table 4.32: Comparison between Reasons scale and non-adherence quantification item
adherents
CHOLESTEROL Quantification item Total

Non-
Adherentb adherent
Reasons Adherenta 301 10 311
scale
Total 377 43 420

a
b
170
Table 4.33: Comparison between Morisky scale and non-adherence quantification item
for asthma medications in identifying adherents and non-adherents
ASTHMA Quantification item Total

Non-
Adherentb adherent
scale
Total 294 105 399

a
b
Table 4.34: Comparison between Reasons scale and non-adherence quantification item
for asthma medications in identifying adherents and non-adherents
ASTHMA Quantification item Total

Non-
Adherentb adherent
Reasons Adherenta 148 13 161
scale
Total 294 105 399

a
b
171
Table 4.35: Comparing the forgot item across Morisky scale and Reasons scale in
non-adherence
Forgot due to busy

schedule Reasons
CHOLESTEROL scale Total
Non-
adherent
b
Adherent
Do you ever Adherent
forget to 345 20 365
take your
medication? Non-
Morisky adherenta
scale 26 29 55
Total 371 49 420

a
Forgetfulness in Morisky scale Answered sometime or often or always to the forgetfulness
item in the Morisky scale
b
Forgetfulness in Reasons scale Answered some of the time or most of the time or all of the
time for the forgetfulness item in the Reasons scale
172
Table 4.36: Comparing the forgot item across Morisky scale and Reasons scale in
adherence
Forgot due to busy

schedule Reasons
ASTHMA scale Total
Non-
adherent
b
Adherent
Do you ever Adherent
forget to 222 29 251
take your
medication?
Morisky Non-
scale adherenta 63 85 148
Total 285 114 399

a
b
173
Table 4.37: Comparing the forgot item across Morisky scale and Quantification item in
non-adherence
Do you ever forget to

take your medication?
CHOLESTEROL Morisky scale Total
Non-
Adherent adherenta
Forgot Adherent
Quantification 359 42 401
item
Non-adherentb 6 13 19
Total 365 55 420

a
b
Forgetfulness in objective measure Answered one day or more in forgetting to take
medications in the week prior to answering the survey
174
Table 4.38: Comparing the forgot item across Reasons scale and Quantification item in
non-adherence
Forgot due to busy

schedule Reasons
CHOLESTEROL scale Total
Non-
Adherent adherenta
Forgot Adherent
item
Non-
9 10 19
adherentb
Total 371 49 420

a
b
175
Table 4.39: Comparing the forgot item across Morisky scale and Quantification item in
adherence
Do you ever forget to

take your medication?
ASTHMA Morisky scale Total
Non-
Adherent adherenta
Forgot Adherent
item
Non-
5 59 64
adherentb
Total 251 148 399

a
b
176
Table 4.40: Comparing the forgot item across Reasons scale and Quantification item in
adherence
Forgot due to busy

schedule Reasons
ASTHMA scale Total
Non-
Adherent adherenta
Forgot Adherent 261 74 335
Quantification
item Non-
24 40 64
adherentb
Total 285 114 399

a
b
177
Table 4.41: Summary of the comparisons between scales in cholesterol lowering and
asthma maintenance medications
Source Variable Scales Kappa

Cholesterol
Table 23 Adherents and Non-adherents Morisky scalea vs. Reasons scaleb 0.381
a c
Table 25 Adherents and Non-adherents Morisky scale vs. Objective measure 0.285
Table 26 Adherents and Non-adherents Reasons scaleb vs. Objective measurec 0.337
d e
Table 29 Forgetfulness Morisky scale vs. Reasons scale 0.495
Table 30 Forgetfulness Morisky scaled vs. Objective measuref 0.305
e f
Table 31 Forgetfulness Reasons scale vs. Objective measure 0.245
Asthma
Table 24 Adherents and Non-adherents Morisky scalea vs. Reasons scaleb 0.545
Table 27 Adherents and Non-adherents Morisky scalea vs. Objective measurec 0.387
Table 28 Adherents and Non-adherents Reasons scaleb vs. Objective measurec 0.270
Table 32 Forgetfulness Morisky scaled vs. Reasons scalee 0.481
d f
Table 33 Forgetfulness Morisky scale vs. Objective measure 0.429
Table 34 Forgetfulness Reasons scalee vs. Objective measuref 0.307
a
b
c
d
e
f
Forgetfulness in objective measure Answered one day or more in forgetting to take medications
in the week prior to answering the survey
178
CHAPTER 5
DISCUSSION
This chapter will discuss the implications of this study in medication adherence
research. The first three sections of this chapter will discuss the three main findings from
this study. This includes the development of a new typology of medication non-
adherence, development of a new measure for medication non-adherence, and
development of a theory driven model to predict non-adherence in cholesterol lowering
and asthma maintenance medications. The fourth and fifth sections of this chapter will
discuss the limitations of this study and the future research directions.
Key findings from the results
Development of a new typology of medication non-
adherence
The development of a new typology of medication non-adherence which can be
used for developing interventions to decrease medication non-adherence was one of the
most important findings from this study. The study was able to identify four types of
medication non-adherence each for cholesterol lowering and asthma maintenance
medications. The new typology developed was based on fifteen frequently reported
reasons of non-adherence identified from literature. As mentioned in the literature
review, the majority of the studies have considered medication non-adherence as a single
entity without differentiating them into types of non-adherence (Murray, Morrow et al.
2004; Brown, Battista et al. 2005; Chia, Schlenk et al. 2006; Elliott, Ross-Degnan et al.
2007). Even when a distinction was made between the types of non-adherence, the
commonly used classification was intentional (forgetting and carelessness in taking
medications) and unintentional (stopping medications when feeling better or worse) non-
adherence (Barber, Parsons et al. 2004). Though this classification is also based on the
179
reasons for non-adherence, it has used only four reasons of non-adherence. A few other
classifications of medication non-adherence developed such as erratic, unwitting, and
intelligent non-adherences, also used similar reasons as in intentional and unintentional
non-adherence. Hence, a new typology was developed which includes the frequently
reported reasons of medication non-adherence and was successful in identifying the
various underlying dimensions of medication non-adherence for two common disease
conditions. Consequently, this will enable a better and precise identification of non-
adherence.
While developing the new typology of medication non-adherence, another key
finding was that there was no one medication non-adherence classification that fit both
medications. The study revealed that the typology of non-adherence was considerably
different for cholesterol lowering and asthma medications. As indicated in the research
gaps for this study, most of the previous studies considered non-adherence with all
medications for a patient as similar, thereby avoiding the possibility that a person while
being adherent with one medication can be non-adherent with another medication. A
recent study which investigated the non-adherence patterns of 56 individuals who were
concomitantly prescribed diabetes medications and medications for chronic obstructive
pulmonary disease showed that there was no agreement regarding the refill adherence
pattern for both the drugs (Krigsman 2007). This study on cholesterol lowering and
asthma maintenance medications had similar results and showed that the domains of
medication non-adherence were different for both medications. In addition, the
independent variables that predicted each domain of non-adherence were different. Since
different typologies of non-adherence were developed for the two different medications,
it can be wisely assumed that while an individual is adherent with one medication, he/she
can be non-adherent with another medication. In addition, they can be non-adherent with
different medications due to different reasons. This is especially important for individuals
who are on multiple medications. For example, an individual who is on both cholesterol
180
lowering and asthma medications may be non-adherent with cholesterol medications due
to treatment side effects and may be non-adherent with asthma medications due to issues
with self efficacy. Subsequently, health care providers have to account for the fact that
medication non-adherence is driven by a combination of people and characteristics of the
disease condition when providing interventions to reduce non-adherence.
The types of medication non-adherence developed from this study are different
from the predefined classes based on the literature review. Based on literature review, the
frequently reported reasons for medication non-adherence were classified as reasons with
low levels of mutability, reasons with medium to high levels of mutability for lifestyle
modifications, and reasons with medium to high levels of mutability for belief
modifications. In addition, we anticipated the classification to be the same for a
preventive health condition (cholesterol lowering medications) and a chronic health
condition (asthma maintenance medications). This a priori classification was based on
matching the reasons for non-adherence with a potentially possible intervention and the
mutability of those interventions. The possible interventions were clearly delineated as
lifestyle modifications and belief modifications. However, when these reasons were
quantitatively analyzed using an exploratory factor analysis to identify the underlying
dimensions of the reasons, there was a combination of interventions needed in each class.
For example, the multiple medications issue in cholesterol lowering medications had both
too many medications as well as concerns about long term effects of medications.
Also, in asthma medications, the reasons medication is ineffective, and medication is
not needed which were considered a priori as belief issues emerged in two different
types of non-adherence. The initial understanding from the new typology is that there is
no clear-cut classification of reasons for non-adherence as lifestyle modifications and
belief modifications and instead, most people who are non-adherent may require an
interconnected combination of lifestyle and beliefs modifications/ interventions. With

181
further use of Reasons scale in other medications and other populations, we may be able
to identify the logic behind this new typology.
The four types of medication non-adherence developed for cholesterol lowering
medications are non-adherence due to managing issues, non-adherence due to multiple
medication issues, non-adherence due to beliefs in medications issues and non-adherence
due to forgetfulness. The first type of non-adherence deals with practical issues such as
opening containers or understanding physician instructions and emotional issues such as
embarrassment in taking medications in public. The second type of non-adherence deals
with the issues when the individual has to take too many medications such as concerns
about their long term effects and their cost. The third type of non-adherence deals with
the issues of beliefs in medications including side effects and necessity beliefs. These
three types of non-adherence in cholesterol lowering medications separated the various
reasons for non-adherence in a rational way. The fourth type of non-adherence was the
forgetfulness domain with the single item forgot due to busy schedule.
In asthma maintenance medications, the four types of non-adherence were non-
adherence due to managing and availability issues, non-adherence due to beliefs and
convenience issues, non-adherence due to cost issues and non-adherence due to
forgetfulness. Unlike the typology for cholesterol lowering medications, the asthma
medications non-adherence typology was not clear-cut. Except for the forgetfulness
domain, the various types of non-adherence seemed to combine different reasons for non-
adherence. The first type combined both the practical issues of taking medications and
the availability issues. In the second type, beliefs in medications issues such as fear of
side effects and necessity beliefs were combined with convenience issues such as
regimen complexity and conflict of dosing schedule with daily schedule. The third type
of non-adherence dealt with cost of medications and running out of prescriptions.
Probably, in asthma medications, the reasons for non-adherence have more implicit
common elements than the cholesterol lowering medications.

182
In six types of non-adherence discussed above (except forgetfulness in both
medications), non-adherence was intentional. Under all circumstances, the individuals on
these medications knew they were not taking the medications as prescribed by their
physician and had made a purposeful decision about their medication taking behavior.
Either they have weighed the pros and cons of taking medications and decided not to take
it (such as cost of medications), or they have not made taking medications a priority in
their life (such as running out of prescriptions) (Donovan and Blake 1992). However,
classifying non-adherence as intentional and unintentional and providing interventions
mainly for intentional non-adherence might not be the best way to deal with non-
adherence. Instead, classifying them based on the mutability of the reasons might be a
better way to tackle it for cholesterol-lower medications.
One of the most frequently reported reason for non-adherence, forgetting, was
included as a single-item type of non-adherence in both cholesterol lowering and asthma
maintenance medications. The item forgot due to busy schedule in the Reasons scale
had a poor loading with the extracted factors in the exploratory factor analysis and also
did not have strong bivariate correlations with any other items in the scale. These
findings suggest that forgot due to busy schedule is a class by itself leading to non-
adherence. Or, there might be other reasons like concern beliefs in medications masking
forgetfulness.
Another important finding while developing the new typology of medication non-
adherence is the definition of each type of medication non-adherence. Since the typology
was developed based on the reasons for non-adherence, effective intervention strategies
can be developed to reduce non-adherence. Research on interventions to reduce
medication non-adherence has shown that though various interventions are available, the
success rates with those interventions are generally low(Peterson, Takiya et al. 2003).
One of the reasons assumed for these low success rates is the lack of a proper
classification of medication non-adherence. Rather than dividing non-adherence as

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intentional and unintentional, the new typology of non-adherence accounted for other
domains of non-adherence such as cost, availability, convenience, and medication beliefs
which can be used for developing appropriate intervention strategies. While the
classification of non-adherence as intentional and unintentional was useful in quantifying
and predicting medication non-adherence, the new typology will be beneficial in
developing intervention plans to reduce medication non-adherence.
Cholesterol lowering and asthma maintenance medications were chosen in this
study to represent medications for asymptomatic conditions and symptomatic conditions
respectively. However, this does not necessarily mean that the typology developed from
this study can be extrapolated to other drugs which are used in asymptomatic and
symptomatic conditions. Further studies must be conducted on more medications before
making such a conclusion. In addition, it is also necessary to conduct additional studies to
determine the reliability of each of these types of medication non-adherence. It is only
then we can use the developed typology in a realistic practice setting to identify and
measure non-adherence.
To conclude, this study was able to develop a new typology of medication non-
adherence based on the frequently reported reasons for non-adherence, thus enabling
healthcare providers to develop appropriate matching intervention strategies. Further
research on medication non-adherence has to consider non-adherence as multiple entities
and not as a single entity. In addition, we were also able to understand that medication
non-adherence is driven by an interaction between the individual and the type of
medication or disease condition.
Development of a new measure of medication non-
adherence
The study was able to develop a new scale for measuring medication non-
adherence based on the frequently reported reasons for medication non-adherence known
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as the Reasons scale. The most commonly used subjective measures of non-adherence are
Morisky scale, Medication Adherence Scale (MAS), and Reported Adherence to
Medication (RAM) scale. All these scales are based on the classification of non-
adherence as intentional and unintentional and had only items relating to forgetfulness
and carelessness in taking medications and stopping medications when feeling better or
worse. Since medication non-adherence is a multifaceted issue, a measure with only these
reasons of non-adherence is not sufficient. For example, an individual who is non-
adherent with medications due to the cost of the medications or fear of side effects will be
adherent based on the Morisky scale, MAS and RAM scale. Subsequently, the non-
adherent patient will be considered as an adherent one and will not receive any
interventional action from a health care provider. The objective measures which quantify
medication non-adherence such as prescription refill records will not be able to provide
the reasons for non-adherence and hence it is difficult to plan intervention strategies. The
Reasons scale developed in this study is an important step in developing a new measure
for measuring self-reported medication non-adherence. Based on an extensive literature
review, the study used the fifteen most frequently reported reasons of non-adherence in
developing the Reasons scale. The Reasons scale can be used by health care providers to
measure non-adherence as well as to identify the domain of non-adherence such as
managing issues, multiple medications issues, medication beliefs issues, and cost issues
which will allow interventions to be targeted.
The Reasons scale with fifteen reasons for non-adherence will be able to measure
and categorize non-adherence better than the currently used scales such as Morisky scale
or MAS or RAM scale. However, the Reasons scale is a newly developed scale and needs
further research and refining to improve the reliability and validity of the scale. The items
in the scale, generated from the literature review, captured all the critical elements of the
domains of non-adherence, and the reliability of the scale measured by Cronbachs alpha
was strong. To improve the reliability of the scale and the scale domains, two items from
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the Reasons scale had to be discarded for cholesterol lowering medications and forgot
due to busy schedule was used as a single item in both medications. This leads one to
consider further refinements are needed for the Reasons scale.
The comparison analyses of the Reasons scale with the Morisky scale and the
objective measure of non-adherence have shown that the Reasons scale performed quite
well in comparison with those measures. The comparison analyses in this study shows
that the agreement between the Reasons scale and the Morisky scale for identifying
medication non-adherence was low for cholesterol lowering medications, but was
moderate for asthma medications. However, in both medications, the Reasons scale
identified more non-adherents than Morisky scale (51 versus 48 in cholesterol lowering
medications and 54 versus 35 in asthma medications). It should be noted that the
agreement between the two scales was measured using a kappa coefficient. Though the
Kappa coefficient will provide the agreement between the two scales, it cannot determine
the source of discrepancy or establish the better scale. Logically, since both the scales are
measuring non-adherence based on the reasons for non-adherence, it is possible to
assume that the Reasons scale with fifteen frequently reported reasons for non-adherence
can identify non-adherence better than the Morisky scale with only four reasons of non-
adherence.
Non-adherence with cholesterol lowering and asthma medications was also
measured using an objective measure. In both medications, the agreement between the
Morisky scale and the objective measure and between the Reasons scale and objective
measure were poor. Nevertheless, in both medications, the Reasons scale identified more
non-adherents than the objective measure. In addition, the Reasons scale also identified
more forgetfulness responses than the objective measure in both medications.
The agreement between these two scales in identifying forgetfulness as the reason
for non-adherence was moderate for both cholesterol lowering and asthma medications.
In this situation, the Morisky scale was able to identify more forgetful responses than the
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Reasons scale. This might be because the Morisky scale had only 4 items and the focus is
on forgetfulness; whereas in the Reasons scale, there are fifteen reasons, and
forgetfulness was the last item in the scale. In addition, the Morisky scale measured
forgetfulness, while Reasons scale measured forgetfulness due to busy schedule.
While refining the scale, the positioning of this item in the scale as well as the wording
has to be reconsidered.
The distribution of responses across the Morisky scale and the Reasons scale
shows that the Reasons scale was able to identify other important reasons for non-
adherence such as cost of medications, ran out of prescriptions, and concern about the
long term effects of medications in cholesterol lowering medications. For asthma
medications, inconvenience in taking medications as prescribed, ran out of prescription,
taking too many medications, cost of medications, and concern about long term effects of
medications were identified. Consequently, it can be assumed that the Reasons scale was
able to identify more domains of medication non-adherence compared to the Morisky
scale.
The results showed that there was a group of individuals who reported adherence
with the Reasons scale and non-adherence with the Morisky scale. This is quite
interesting, taking into consideration the fact that the Reasons scale includes more
reasons than the Morisky scale. In addition, the Reasons scale covers all the domains in
the Morisky scale except for carelessness in taking medications. However, the
distribution of responses in Morisky scale shows that approximately 10% of non-
adherents in cholesterol lowering medications and 26% in asthma maintenance
medications have attributed carelessness as the reason for non-adherence. This lack of
carelessness in the Reasons scale may account for the discrepancy. The qualitative
analysis part of this study did not imply any non-adherence reasons comparable to
carelessness. While developing the Reasons scale, this issue was considered and hence
the use of the words forgot due to busy schedule rather than just forgot addes another
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dimension to non-adherence. It can be argued that since the Morisky scale did not have a
good comprehensive list of non-adherence reasons, individuals who were non-adherent
due to other reasons, such as running out of prescription or stopping medications to see if
it is still needed, might have selected carelessness as the reason for non-adherence.
Nevertheless, this is an issue to be considered while refining the Reasons scale.
The major advantage of the Morisky scale with only four items is its brevity. In
addition, the classification of non-adherence from the Morisky scale as intentional and
unintentional is simple and straightforward. In comparison, the Reasons scale with fifteen
items is longer and will add to the survey burden. However, the Reasons scale will be
able to identify more reasons for non-adherence, and thus will assist in developing
additional and diverse interventions to reduce non-adherence.
A question that can arise from this study is the use of Medication Adherence Self
Efficacy Scale (MASES) in measuring non-adherence. MASES with 23 items was used
to measure self efficacy. The items in the scale reflected multiple barriers of adherence in
specific situations such as when busy at home or when in a public place. Though this
scale can capture various situations leading to non-adherence, this scale cannot be
compared to the Reasons scale for measuring non-adherence. The Reasons scale is
measuring the reasons underlying non-adherence and the MASES is measuring ones
confidence to be adherent. While related, non-adherence behavior and self-efficacy are
different concepts. As well, the Reasons scale in addition to measuring barriers leading to
non-adherence such as problems opening containers, also measures various beliefs
leading to non-adherence such as stopping medications to see if it is still needed. The
MASES does not address the latter.
To conclude, the study was able to develop a new subjective measure of
medication non-adherence based on the frequently reported reasons of non-adherence
which is able to quantify medication non-adherence finer than the commonly used
Morisky scale.
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Development of theory driven models to predict medication
non-adherence
The study was able to develop theory driven models to predict non-
adherence in both cholesterol lowering and asthma maintenance medications. Having a
strong theoretical background allows for better incorporation of the model into research
practice since it may be integrated into previous research and it may be more influential
in developing interventions (Brazil, Ozer et al. 2005). Theory based models specify the
relationships between variables and the direction of those relationships. Knowing the
mechanism of relationship between variables may allow us to extend the studies on non-
adherence either to predict non-adherence or develop interventions to reduce non-
adherence to other settings such as other medications or other populations. For example,
in this study, when the predictor variables are different for different medications, theory
can be used to explain the rationale. Similarly, the success or failure of an intervention
program to reduce non-adherence can be attributed back to the theoretical model. In this
study, a combination of Andersens Behavioral Model and Leventhals Common Sense
Model was used. The concepts in these models including predisposing factors (social
structure, treatment characteristics), enabling factors (access variables, self variables),
and need factors (perceived need, and evaluated need) were significant predictors of
medication non-adherence in both cholesterol lowering and asthma maintenance
medications.
A major uniqueness of this study is the definition of the dependent variables in
these models. Using the Reasons scale, non-adherence was identified and categorized,
and these classes were used as the dependent variables in each of the models. As a result,
the significant predictors in each model relates to a particular class of non-adherence.
Though earlier models predicted non-adherence, it was not possible to establish to which
group of non-adherents those models defined. Vik and her colleagues (2004) noted the
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absence of a single systematic descriptor of a non-adherent patient and this study has
succeeded to some extent in describing the characteristics of each class of non-adherence.
A second advantage of the model development in this study is the use of both
Andersens Behavioral Model and Leventhals Common Sense Model; Leventhals
Common Sense Model to further explain the concept of perceived need in the Andersen
Behavioral Model. Andersen, in his original model, explained perceived need as how
people view their own general health and functional state, and how they experience
symptoms of pain, illness, and worries about their health, and how important the problem
is to them so that they seek medical help. Leventhal explains how individuals cognitively
and emotionally process symptoms, illnesses and treatments. When this combined model
was used in the study, illness perceptions as explained by Common Sense Model was a
significant perceived need factor of medication non-adherence.
While developing the models to predict medication non-adherence based on the
literature review, hypotheses were made as to which variables would be significant
predictors of each type of medication non-adherence (Table 3.4). Though it is not
possible to make a direct comparison between the models developed from the a priori
classification and the classification from the quantitative analysis, it is still possible to
evaluate the predictors of non-adherence. In the predisposing factors, concern beliefs was
a significant predictor in medication non-adherence due to multiple medication issues and
belief issues in cholesterol lowering medications; and non-adherence due to managing
and availability issues and beliefs and convenience issues in asthma maintenance
medications. Though the a priori theory argued that concern beliefs are significant only in
interventions requiring belief based modifications, the results from this study has
demonstrated that concern beliefs in medications are also significant when non-adherence
is due to availability, convenience, and managing multiple medictions where a life style
modification may be needed.

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In the a priori classification, the expectation was that the self enabling factors
such as self efficacy would be a significant predictor for lifestyle non-adherence.
However, in this study, the enabling factor, self efficacy was identified as a significant
predictor in all types of non-adherence in both cholesterol lowering and asthma
maintenance medications. Though, self efficacy has been identified and studied as a
significant predictor for non-adherence with medications for HIV, its role in predicting
non-adherence has not been exploited in most of the other chronic medications (Siegel,
Karus et al. 2000; Heckman, Catz et al. 2004; Wilson, Doxanakis et al. 2004; Remien,
Bastos et al. 2007). The results from this study support the importance of considering self
efficacy as an important criterion while developing interventions to reduce non-adherence
in both cholesterol lowering and asthma maintenance medications.
Need factors were expected to be significant only in non-adherence where life
style interventions were needed and the results were expected to be same for both
cholesterol lowering and asthma maintenance medications. However, the results from this
study showed that need factors, both perceived and evaluated, were more significant in
explaining non-adherence to asthma maintenance medications (which are used for
treating symptomatic or chronic health condition) compared to cholesterol lowering
medications (used for treating an asymptomatic or preventive condition).
Retrospectively, it can be argued that predictors such as severity of disease, self health
perceptions, and illness perceptions are more pertinent for a symptomatic disease
condition. For an individual with an asymptomatic condition such as elevated levels of
cholesterol, perceived need factors such as threatening perceptions of illness or evaluated
need factors such as severity of disease may not be as relevant as that of an asthma
patient while deciding to be adherent or non-adherent.
A few predictors of non-adherence in both cholesterol lowering and asthma
maintenance medications, such as necessity beliefs in medications, illness perceptions,
self regulation, attitude by others towards disease, and severity of disease turned out to be
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in a direction opposite to the anticipated direction in the a priori model. Necessity beliefs
in medication was expected to have a negative association with non-adherence. That is,
as the necessity beliefs in medication increase, there was expected to be a decrease in
non-adherence. However, the results from the study proved otherwise. Necessity beliefs
in medications were a significant predictor of non-adherence due to multiple medication
issues in cholesterol lowering medications, a type of non-adherence in which, concern
beliefs in medications was also significant. It might then be possible that the necessity
beliefs in medications were masked by an equivalent or higher concern belief in
medications. An increase in threatening perceptions of illness and secerity of disease
were expected to decrease non-adherence. However, the results from the study were in
opposite direction. Both the disease conditions studied were chronic conditions and from
the patients view point, in spite of the use of medications, if the disease severity and
illness perceptions were still high, they may as well be non-aderent based on the pros and
cons of taking medications for a long period of time. In fact, a study by Horne and
Weinman (2002) also resulted in a negative correlation between medication adherence
and higher perceived illness consequences. Consequently, an increase in illness threat
perceptions may contribute to an increase in the concern beliefs leading to non-
adherence.
An increase in self regulation was expected to decrease non-adherence. The logic
was that self regulation will determine a patients motivation to be healthy, perceived
control over health, and perceived support of health-promoting behaviors from significant
others, thus making the patient adherent with medications (Kanfer 1986). However, using
the same logic, it can be argued that individuals with high levels of self regulation have a
strong need to control their health behaviors, and hence may decide to be non-
adhedications to control their health and life. In fact, Schneider et al (2007) has
demonstrated that patients with high levels of involvement in their treatment, while
exhibiting motivation for self-management, also have lower medication adherence.

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Schneider et al (2007) argued that this may be due to a continuous internal negotiation
process to accept the potentially lifelong demands of the disease (Schneider, Wensing et
al. 2007).
Attitude by others towards disease was also expected to have a negative
association with non-adherence, based on the thought that the more importance given to
significant others attitudes the better will be adherence. However, in asthma
maintenance medications, where this predictor was significant in non-adherence due to
managing and availability issues and beliefs and convenience issues, an increase in
attitude by others towards disease increased non-adherence. Probably, individuals with
asthma, a symptomatic condition, may be receiving a negative attitude by others towards
disease, and since they are giving importance to these attitudes, they may be more non-
adherent.
Previous studies have noted treatment convenience, side effects, perception of
side effects, perception about the treatment effectiveness, concern beliefs about the
medications, and incompatibility with the daily routine as predictors of non-adherence
with cholesterol lowering medications (Insull 1997; Kiortsis 2000; McGinnis 2007; Mann
2007). Research has also identified illness perceptions including lower perceived risk and
consequences and symptom experiences as predictors of medication non-adherence
(Senior 2004; Brewer 2002). However, in all these previous studies, as noted before, the
prediction was either for non-adherence in general or for intentional and unintentional
non-adherence. In contrast, this study predicted the three classes of non-adherence as
identified by the Reasons scale.
In non-adherence due to managing issues, self efficacy, the enabling self variable,
significantly predicted non-adherence as did the cost of medications and income less than
$50, 000. Non-adherents in this category have reported mainly physical and few
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emotional difficulties in taking medications as prescribed. Based on the a priori
classification, this group of individuals is similar to the type that needs lifestyle
modifications rather than belief modifications. An important predictor in the lifestyle
modifications was enabling self variables, including self efficacy. Subsequently, as
expected in the hypothesized relationships, self efficacy was a significant predictor in this
class of non-adherence and an increase in self efficacy decreased medication non-
adherence.
For non-adherence due to multiple medications issues, predisposing, enabling,
and need factors were significant predictors. The significant predictors of non-adherence
in this class were gender, predisposing factors such necessity and concern beliefs in
medications, enabling factors such as self efficacy and social support, need factors such
as illness perceptions, and cost of medications. These are the non-adherents that have too
many medications and they are concerned about the cost of these medications as well as
the long term effects of medications. Subsequently, for these individuals, an increase in
cost translated to low rates of non-adherence. This type of non-adherence is an example
that needs both lifestyle and belief modifications. As hypothesized, an increase in self
efficacy and social support which are enabling factors, led to an increase in medication
adherence. The rational is that when there are multiple medications to be managed, self
enabling variables such as self efficacy and community enabling variables such as social
support help in improving adherence. Thus they may benefit from a lifestyle modification
versus belief modification. On the other hand, as the number of medications to be taken
on a daily basis increases, the predisposing factor, concerns about the long term effects of
these medications also increases. Hence as hypothesized, concern beliefs in medications
and non-adherence had a positive relationship. However, necessity beliefs in medications
and illness perceptions predicted this type of non-adherence in a direction opposite to the
anticipated direction. Belief based interventions will be needed to improve adherence for
these reasons in this type of non-adherence. In summary, non-adherence due to multiple

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medications issues in cholesterol lowering medications needs both lifestyle and belief
interventions to reduce non-adherence.
In non-adherents with issues of beliefs in medications, only predisposing and
enabling factors were significant predictors. The significant predictors were predisposing
factors such as treatment side effects and concern beliefs in medications, enabling factors
such as self efficacy and self regulation, health outcomes such as treatment satisfaction,
and income more than $100,000. As expected, an increase in treatment side effects and
concern beliefs in medications increased non-adherence; while an increase in the self
efficacy and treatment satisfaction decreased non-adherence. This class of non-adherence
also needs both lifestyle and belief modifications to reduce non-adherence.
In non-adherence due to forgetting due to busy schedule, regimen complexity, a
predisposing factor, and self efficacy, an enabling factor, had negative relationships with
non-adherence. No need factors were significant. The negative relationships were in the
expected direction since these are the individuals who reported forgetfulness in taking
medications due to busy schedule. Subsequently, a simple regimen and increased self
efficacy can decrease non-adherence. In addition, individuals with better self health
perceptions were also non-adherent with their medications. Since high levels of
cholesterol is an asymptomatic condition, individuals who are feeling good health, may
decide to be non-adherent to avoid becoming dependent on medications. However, the
relationship between necessity beliefs, a predisposing factor, and non-adherence was not
in the expected direction. Increase in the necessity beliefs in medications was expected to
decrease non-adherence. Taking into consideration the fact that individuals with varying
reasoning use forgetfulness as a reason to explain their non-adherence(Atkins and
Fallowfield 2006), this finding points to the importance of in depth study of forgetfulness
as a reason for non-adherence.
In conclusion, self efficacy, an enabling factor was significant in predicting
medication non-adherence in all four types of non-adherence in cholesterol lowering

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medications. Among the predisposing factors, concern beliefs in medications
significantly predicted non-adherence due to multiple medications and non-adherence
due to belief issues with medications. Need factor was significant only in non-adherence
due to multiple medication issues.
In previous studies regarding non-adherence with asthma maintenance
medications, the most significant predictors of non-adherence were fear of side effects,
perceived side effects, low necessity and high concern beliefs in medications, and high
illness perceptions (Horne 2002; Main 2004; Ulrik 2006). Other predictors included
regimen complexity such as dosing frequency and number of medications, knowledge
about medications, locus of control, and severity of disease (Rau 2005, Menckeberg,
2007; Holgate 2006).
The predictors of non-adherence from this study are comparable to the previous
studies. In addition, self efficacy was a significant predictor of non-adherence in all four
types of non-adherence with asthma medications in this study. Considering the fact that
non-adherence with asthma maintenance medications is due to variables such as regimen
complexity, severity of disease, and fear of side effects, self efficacy is an important
enabling self variable which can be used by health care providers as a platform to
develop intervention strategies.
For non-adherents with managing and availability issues, age, concern beliefs in
medications, self efficacy, disease severity, attitude by others towards diseases, and cost
of medications were significant predictors. Since this type of non-adherence deals with
issues related to managing and procuring medications, enabling factors such as self
efficacy and low cost of medications will assist in improving medication adherence and
need life style modifications. Concern beliefs in medications, a predisposing factor, was a
significant predictor in this type of non-adherence and this finding was unexpected,
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although the relationship between concern beliefs and non-adherence was in an expected
direction. This is a type of non-adherence where lifestyle modifications were expected.
However, concern beliefs in medications along with disease severity and attitude by
others towards disease point to belief modifications also. This echoes the earlier comment
that there is no clear cut distinction between the reasons of non-adherence and the type of
possible interventions.
For non-adherents with belief and convenience issues, predisposing factors such
as treatment convenience and concern beliefs in medications, enabling factor such as self
efficacy and attitude by others towards disease, need factors such as self health
perceptions, and health outcomes such as treatment satisfaction were all significant
predictors. These are the individuals who have belief issues in their medications (such as
medication is not needed and stop medications to see whether it is still needed) and
convenience issues (such as inconvenience in taking medications as prescribed).
Subsequently, as expected, as treatment convenience, treatment satisfaction, and self
efficacy increases, medication non-adherence decreases. On the other hand, as concern
beliefs in medications and self health perceptions increases, non-adherence also increases
as expected. Individuals with better perceptions about own health status were non-
adherent, probably due to low perceived need for medications. Again, in this type of non-
adherence, both lifestyle and belief modifications are needed to reduce non-adherence.
For non-adherents with cost issues and running out of prescriptions, the
significant predictors were age, cost of medications, health insurance, self efficacy, and
illness perceptions. As hypothesized, a decrease in the cost of medications and having a
health insurance (enabling factor) decreased non-adherence. Self efficacy had an inverse
relationship with non-adherence and this enabling factor is needed for those individuals
who reported that they run out of prescriptions due to a busy schedule. As explained
before, an increase in the need factor, illness threat perceptions, increased non-adherence.
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In non-adherence due to forgetting, the significant predictors were predisposing
factors such as having a Masters level of education compared to high school education,
any race other white, black, or Hispanic, and knowledge of medication, enabling factors
such as self efficacy , self regulation, income more than $100,000 and health insurance.
No need factors were significant. The predisposing factors such as knowledge in
medications and high levels of education predicted non-adherence due to forgetting due
to a busy schedule in the expected direction. The better the knowledge and education an
individual has about his/her medications, more are the chances that the individual will
make efforts to integrate medication taking into their daily routine. As expected, an
increase in self efficacy and self regulation decreased non-adherence, probably because,
these predictors enable the individuals to remember taking medications as prescribed in
various situations such as being busy or traveling. Though income was considered as an
enabling factor in improving medication adherence, an income level more than $100,000
had a positive relation with non-adherence. This can be explained based on the fact that
non-adherence is due to forgetting due to busy schedule and usually those with high
levels of income have busy schedules and thus chances of forgetting to take medications
also increase. Though the direction of relationship between health insurance and non-
adherence was in the expected negative direction, it was interesting that health insurance
was a predictor of non-adherence due to forgetting. Possibly, those with no health
insurance do not want to admit it as a reason for non-adherence and instead put forward
forgetting as the reason. Similarly, an increasing age is usually associated with
forgetting. However, in asthma medications non-adherence due to forgetting, an
increasing age was associated with better adherence. This can be attributed to two
reasons. One, forgetting was worded as forget due to busy schedule, thereby forcing
people who do not have a busy schedule to pick another reason for non-adherence. Or,
more probably, forgetting as a reason for non-adherence is simply not forgetting and that
is being used as a reason for social desirability (Atkins and Fallowfield 2006).
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In conclusion, while enabling factors such as self efficacy predicted all four types
of non-adherence, predisposing factors such as concern beliefs in medications predicted
non-adherence due to managing and availability issues and non-adherence due to beliefs
and convenience issues. Among need factors, while evaluated need predicted non-
adherence due to managing and availability issues, perceived need predicted non-
adherence due to beliefs and convenience issues and cost issues.
To conclude, the models developed based on the new typology of non-adherence
were able to predict non-adherence using the predisposing, enabling, and need factors of
Andersens Behavioral Model and illness perceptions of Leventhals Common Sense
Model. While concern beliefs in medications, a predisposing factor, predicted non-
adherence in two types of non-adherence in both cholesterol lowering and asthma
maintenance medications; an enabling factor, self efficacy, was significant in all types of
non-adherence for both medications. Similarly, while need factors were significant in
three types of asthma maintenance medications excluding forgetfulness, it was significant
only in multiple medication issues in cholesterol lowering medications.
Limitations of the study
1. Generalizability of the study: The study was conducted using an internet survey
with a convenience sample. As a result, we cannot generalize the results from this study
to the general population. The survey was administered to a panel of individuals with
Harris Interactive who have opted to be invited to participate in online surveys. The main
reason to choose a convenience sample was to have a large sample size. Since this study
was considered as a step towards developing a new typology of medication non-
adherence and testing models of non-adherence, it was more important to have a large
sample size, even if we forego the generalizability of the study. Testing the
generalizability of the results from this study can be the next phase in this research.
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The mode of survey administration was through the internet. This poses some
amount of selection in the sample. Internet World Stats reports that only 72% of
American citizens are regular users of internet (Internet World Stats 2007). A report from
the National Telecommunications and Informations Administration of the US
Department of Commerce indicates that the internet users in US are predominantly white
or Asian American aged 18 to 50 years, with higher incomes and higher levels of
education and employed (National Telecommunications and Informations Administration
2002). Consequently, the results from this study do not represent the general population.
However, administering an internet survey also provides some advantages such as a
dynamic interaction between respondent and questionnaire(Dillman 1999). Internet
surveys make it easy to provide extensive and difficult skip patterns and pop up
instructions for individual questions. Consequently, considering this study as the first step
in developing a new typology of non-adherence and models to predict non-adherence, the
next phase of this research should use random sampling of the general population to
improve generalizability.
2. Use of a new scale in measuring medication non-adherence: This study used the
Reasons scale which is a newly constructed scale to measure medication non-adherence.
Though the reliability of the scale domains was reasonable, it still needs refining to be
used as a validated scale. A comparison of the Reasons scale with the Morisky scale, the
commonly used scale to measure medication non-adherence, showed that the Reasons
scale was able to identify more non-adherents compared to adherents.
3. Focus only on cholesterol lowering and asthma medications: The study focused
only on cholesterol lowering and asthma maintenance medications which were used as
representatives for asymptomatic and symptomatic diseases, respectively. Subsequently,
the results from this study cannot be generalized to other diseases. However, as can be
seen from the results, the domains of non-adherence as well as the reasons contributing to
200
each domain of non-adherence were different for each medication, and justify studying
medications separately. Nevertheless, more studies are needed on other medications.
4. Exclusion of primary non-adherents in the study: The study excluded individuals
who admitted that they were diagnosed with high levels of cholesterol and asthma, but
were not taking any medications for the same. Hence, the definition of non-adherence in
this study does not include primary non-adherents. However, the logic is that these
individuals may have totally different reasons for non-adherence since they were not even
taking any medications for their condition. These individuals may not be accepting the
fact that they have the condition or they may be managing the condition using diet
changes or alternative treatments. The primary aim of this study was to understand
secondary non-adherence or the reasons why individuals miss medications at times.
Future directions for the research
Further research should be directed in refining the Reasons scale. The Reasons
scale with fifteen frequently reported reasons for medication non-adherence has a high
potential for identifying and categorizing non-adherence. However, it is a new scale and
the reliability and validity of the scale needs to be further established. To improve the
quality of the scale, a think aloud process can be used. This will help in detecting the
cognitive and design issues associated with the scale.
Once the Reasons scale is refined, the next phase in the research is to repeat the
study in cholesterol lowering and asthma maintenance medications. This will help in
confirming the typology of medication non-adherence developed from this study. The
non-adherence models developed from this study should be used to predict the various
types of medication non-adherence. The third phase of the future research should be to
test the scale across various medications and various populations. This will help in
developing classes of non-adherence for each type of medication. The Anderseon-
Leventhal model combination can be used to predict the various classes of non-adherence
201
so developed. The identified significant predisposing, enabling, and need factors can be
used for developing appropriate intervention strategies to decrease non-adherence.
Conclusions
The study was aimed at developing a new typology of medication non-adherence
based on the frequently reported reasons of non-adherence, developing models to identify
the significant predictors of non-adherence based on the new typology, and understanding
how medication non-adherence varies across chronic medications such as cholesterol
lowering medications and asthma maintenance medications. A new scale to measure non-
adherence, known as the Reasons scale was developed from the frequently reported
reasons and it performed well when compared to Morisky.
The typology of medication non-adherence developed based on the literature
review was not substantiated by the exploratory factor analysis. Four types of non-
adherence were developed each for cholesterol lowering and asthma maintenance
medications, yet the typologies were different. This finding suggests that no one
classification of medication non-adherence fits all medications and the typology is likely
to be driven by a combination of people and reasons. The Reasons scale for measuring
medication non-adherence was able to quantify and categorize non-adherence using more
reasons than the commonly used the Morisky scale. The Reasons scale had moderate
levels of agreement with the Morisky scale based on the kappa coefficient.
The Andersen-Leventhal combined model was significant in predicting
medication non-adherence in both cholesterol lowering and asthma maintenance
medications. While self efficacy predicted all the types of non-adherence in both
medications and concern beliefs in medications predicted two types of non-adhernece in
each medication, need factors were significant predictors of non-adherence in three types
of asthma maintenance medications excluding forgetfulness. Adding Leventhals

202
Common Sense Model to Andersens Behavioral Model facilitated in identifying the
perceived need factors of medication non-adherence.

203
APPENDIX A: SURVEY INSTRUMENT
SECTION 400: SAMPLE PRELOAD AND SCREENING QUESTIONS
[PROGRAMMER NOTE: PLEASE COORDINATE WITH THE SAMPLE PROGRAMMER ABOUT THE
PROCESSING OF ANY PRELOADED VARIABLES INDICATED IN THIS SECTION.]
BASE: ALL RESPONDENTS

Q75 PRELOAD SAMPLE SUPPLIER (QV7)
1 HPOL

Q350 PRELOAD SAMPLE SUPPLIER (QV8)
1 General HPOL
2 CIP Asthma
3 CIP High Cholesterol
4 CIP Both Asthma and High Cholesterol
5 Other Sample Source

Q101 [GENDER/AGE PLACEMENT QUESTION]
[PN: GET CODE 1.]
1 GENDER/AGE AS FIRST ITEMS

2 GENDER/AGE FOLLOWING SCREENER ITEMS
3 GENDER/AGE IN DEMOGRAPHIC SECTION

Q109 [HIDDEN QUESTION FOR COUNTRY OF RESIDENCE POSITION.]
[PN: GET CODE 1]
1 PRESENT Q110 (COUNTRY OF RESIDENCE BEFORE DEMOGRAPHIC SECTION)

2 PRESENT Q166 (COUNTRY OF RESIDENCE IN DEMOGRAPHIC SECTION)

Q410 Sometimes, a person may reside in one country, but he/she is a citizen of another country. Of what
country are you a citizen? If you hold citizenship in more than one country, please indicate the country
you consider your primary country of citizenship.
[STANDARD CITIZENSHIP LIST: CODES 10, 14, 15, 24, 33, 42, 47, 48, 55, 60, 66, 75,
76, 85, 89, 112, 114, 116, 122, 123, 125, 126, 148, 157, 168, 171, 177, 179, 187, 189, 190, 193,
196, 204, 208, 214, 215, 223, 224, 226, 243, 244, 259, 261, 262, 263, 264, 265, 267, 286, 996,
994.]
[STANDARD PLACEMENT: U.S. (CODE 244) AT TOP, CODES 265, 259, 261, 262,
263, 264, 996, 994 AT BOTTOM IN THAT ORDER, WITH REMAINING CODES ALPHABETIZED.]

Q1400 Which of the following best describes your current overall health?
[PROGRAMMER: RESULTS LABEL: Percent indicating their current overall health is best described by the
following]
1 Poor
2 Fair
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3 Good
4 Very good
5 Excellent

Q1405 How concerned are you about your own personal health?
[PROGRAMMER: RESULTS LABEL Degree of concern about own personal health]
1 Not at all concerned

2 Somewhat concerned
3 Concerned
4 Very concerned
5 Extremely concerned

Q1410 Thinking about your own health, how would you say that it compares to other peoples health?
[PROGRAMMER NOTE: RESULTS LABEL: Percent indicating how they rate their health status compared
to other people]
1 Much worse than others

2 Somewhat worse than others
3 About the same as others
4 Somewhat better than others
5 Much better than others

Q1415 Have you heard of any of the following items in the media recently? Please select all that apply.
[PROGRAMMER NOTE: INSTANT RESULTS LABEL Percentage indicating hearing of current events in
the media]
[MULTIPLE RESPONSE]
1 Changes in local hospital structures

2 Advances in medical technology
3 New medications/treatment therapies available
9 None of these E
[IF US RESIDENT/CITIZEN 18+ (Q110/244 AND Q410/244 AND Q105/18+), CONTINUE TO

Q435. ALL OTHERS JUMP TO Q465.]
BASE: ALL US RESIDENTS/CITIZENS 18+ (Q110/244 AND Q410/244 AND Q105/18+)

Q435 Have you ever been told by a doctor that you have any of the following? Please select all that apply.
[MULTIPLE RESPONSE. ALPHABETIZE LIST.]
1 Asthma
2 High cholesterol
3 Diabetes
4 GERD
5 Depression
6 Anxiety
7 Chronic pain
8 High blood pressure
9 Insomnia
10 Thyroid disease
11 Other ANCHOR
12 None of these ANCHOR,
205
13 Decline to answer ANCHOR, E
[IF HAS BEEN DIAGNOSED WITH ASTHMA (Q435/1), CONTINUE TO Q440. IF HAS BEEN
DIAGNOSED WITH HIGH CHOLESTEROL (Q435/2), JUMP TO Q450 ALL OTHERS JUMP TO Q465.]
BASE: HAS ASTHMA (Q435/1)

Q440 Do you still have asthma?
1 Yes
2 No
3 Decline to answer
[IF YES (Q440/1) ASK Q445, OTHERWISE JUMP TO PN BEFORE Q450]
BASE: STILL HAS ASTHMA (Q440/1)

Q445 Which of the following medications, if any, are you currently taking to treat your asthma? Please
select all that apply.
[MULTIPLE RESPONSE]
[ALPHA SORT]
1 Short acting beta agonists/Rescue inhalers (example: Albuterol, Foradil)

2 Maintenance (controller/preventative) inhalers (example: Serevent, Flovent, Advair)
3 Oral medications (example: Singulair)
4 Other ANCHOR
97 None E; ANCHOR
[PN: IF TAKING MEDICATION (Q445/1-4) ASK Q1445, IF NONE (Q445/97) ASK Q447]
BASE: NOT TAKING MED FOR ASTHMA (Q445/97)

Q447 You indicated that you are not taking a medication to treat your asthma. Please explain why in the
text box below.
[MANDATORY TEXT BOX]
[PN: IF TAKING MED (Q445/1-4) ASK Q1445, ALL OTHERS JUMP TO PN BEFORE Q450]
BASE: TAKING MEDICATION FOR ASTHMA (Q445/1-4)

Q1445 How long have you been taking medication (s) for your asthma? If you just started taking a
medication within the last month, please enter a 1 in the months slot. Please note, if you currently are
using more than one medication in a category to treat your asthma, please think about the medication you
have been using the longest.
[LIST ONLY CODES SELECTED AT Q445/1-4]
Q1446 Q1447
[RANGE: 0-99] [RANGE: 0-11]
Years Months
1 Short acting beta agonists/Rescue inhalers I_I_I I_I_I

2 Maintenance (controller/preventative) inhalersI_I_I I_I_I
3 Oral medications I_I_I I_I_I
4 Other I_I_I I_I_I
[PN: IF Q1446 = 00, Q1447 MUST = AT LEAST 01]
BASE: TAKING MEDICATION FOR ASTHMA (Q445/1-4)

Q442 Please indicate which of the following prescription medication (s), you are currently taking to
treat your asthma. Please also include medications that you have taken in the
past six months, but do not need right now. Please select all that apply.
[ALPHA SORT]
[MULTIPLE RESPONSE]
206
1 Advair
2 Albuterol, also known as Proventil or Ventolin/HFA
3 Atrovent
4 Combivent
5 Flovent/HFA
6 Pulmicort
7 Serevent
8 Singulair
9 Spiriva
10 Asmanex
11 Accolate
12 Foradil
13 Qvar
14 DuoNeb
15 Azmacort
97 Other medication E; ANCHOR
[PN: IF HAS HIGH CHOLESTEROL (Q435/2) ASK 450, ALL OTHERS JUMP TO PN BEFORE Q455]
BASE: HAS HIGH CHOLESTEROL (Q435/2)

Q450 You indicated that you have high cholesterol. Which of the following prescription medications, if
any, are you currently taking to lower your cholesterol? Please select all that apply.
[MULTIPLE RESPONSE]
[ALPHA SORT]
1 Crestor
2 Lescol
3 Lipitor
4 Mevacor
5 Pravachol
6 Zocor
7 Caduet
8 Vytorin
9 Zetia
10 Other Q451 [MANDATORY TEXT BOX IF Q450/10 IS SELECTED] ANCHOR
11 None ANCHOR, E
[PN: IF TAKING MEDICATION (Q450/1-10) ASK Q1450, IF NOT TAKING MEDICATION (Q450/11) ASK
Q452. ALL OTHERS JUMP TO PN BEFORE Q455]
BASE: NOT TAKING MED FOR HIGH CHOLESTEROL (Q450/11)

Q452 You indicated that you are not taking a prescription medication to treat your high cholesterol.
Please explain why in the text box below.
[PN: JUMP TO PN BEFORE Q455.]
BASE: TAKING MEDICATION FOR HIGH CHOLESTEROL (Q450/1-10)

Q1450 How long have you been taking medication (s) to lower your cholesterol? If you just started taking
a medication within the last month, please enter a 1 in the months slot.
Q1451
[PN: INSERT ONLY THOSE MEDICATIONS CHOSEN AT Q450/1-10]
[RANGE: 0-99] [RANGE: 0-11]

207
Years Months
1 Crestor |_|_| |_|_|

2 Lescol |_|_| |_|_|
3 Lipitor |_|_| |_|_|
4 Mevacor |_|_| |_|_|
5 Pravachol |_|_| |_|_|
6 Zocor |_|_| |_|_|
7 Caduet |_|_| |_|_|
8 Vytorin |_|_| |_|_|
9 Zetia |_|_| |_|_|
10 Other |_|_| |_|_|
[PN: IF HAS HIGH CHOLESTEROL OR STILL HAS ASTHMA (Q435/2 OR Q440/1) ASK Q455, ALL
OTHERS JUMP TO PN BEFORE Q465]
[PN: IF YEARS = 00, MONTHS MUST = AT LEAST 01]
BASE: HAS HIGH CHOLESTEROL OR STILL HAS ASTHMA (Q435/2 OR Q440/1))

Q455 Are you currently prescribed any medications for depression?
1 Yes
2 No
3 Not sure
4 Decline to answer
BASE: HIGH CHOLESTEROL OR STILL HAS ASTHMA (Q435/2 OR Q440/1))

Q460 Are you currently prescribed any medications for anxiety?
1 Yes
2 No
3 Not sure
4 Decline to answer

Q465 [HIDDEN QUALIFICATION QUESTION]
RESPONDENT IS QUALIFIED IF:
18+ (Q105/18+)
US RESIDENT (Q110/244)
US CITIZEN (Q410/244)
HAS HIGH CHOLESTEROL (Q435/2) OR STILL HAS ASTHMA (Q440/1)
GET CODE 1 IF HAS HIGH CHOLESTEROL AND IS TAKING MEDICATION (Q435/2 AND
Q450/ANY 1-10)
GET CODE 2 IF HAS HIGH CHOLESTEROL AND IS NOT TAKING MED (Q435/2 AND Q450/11)
GET CODE 3 IF HAS ASTHMA AND IS TAKING MAINTENANCE MEDICATION (Q440/1 AND
Q445/2-3)
GET CODE 4 IF HAS ASTHMA AND IS NOT TAKING MAINTENANCE MED (Q440/1 AND
Q445/1, 4 & 97)
ALL OTHERS GET CODE 5 (NOT QUALIFIED)
[MULTIPLE RESPONSE MAY QUALIFY FOR HIGH CHOLESTEROL AND ASTHMA PATHS]
1 MEDICATED HIGH CHOLESTEROL PATIENT QUOTA=350

2 NON-MEDICATED HIGH CHOLESTEROL PATIENT QUOTA=25
3 MEDICATED ASTHMA PATIENT QUOTA=350
4 NON-MEDICATED ASTHMA PATIENT QUOTA=25
5 NOT QUALIFIED
[PROGRAMMER: NON-QUALIFIED RESPONDENTS (Q465/5) JUMP TO Q99.]

208
BASE: ASTHMA OR HIGH CHOLESTEROL PATIENT (Q465/1-4)

Q372 [GET ALL OPEN QUALIFYING QUOTA CELLS FROM Q465]
1 MEDICATED HIGH CHOLESTEROL PATIENT

2 NON-MEDICATED HIGH CHOLESTEROL PATIENT
3 MEDICATED ASTHMA PATIENT
4 NON-MEDICATED ASTHMA PATIENT
97 ALL QUOTA CELLS MET
[PROGRAMMER: QUOTA MET RESPONDENTS (Q372/97) JUMP TO Q99.]
BASE: QUOTA OPEN RESPONDENTS (Q372/1-4)

Q474 HIDDEN QUESTION FOR PATH ASSIGNMENT
[PROGRAMMER: IF QUALIFIES FOR ASTHMA PATH ONLY (Q372/3 OR 4 ONLY) , GET CODE 1.]
[PROGRAMMER: IF QUALIFIES FOR CHOLESTEROL PATH ONLY (Q372/1 OR 2 ONLY), GET CODE 2.]
[PROGRAMMER: IF RESPONDENT QUALIFIES FOR BOTH CHOLESTEROL AND ASTHMA PATHS

(Q372/1 OR 2) AND (Q372/3 OR 4), GET CODE 3. RESPONDENT WILL GET OPT-IN QUESTION AND
IF YES, RANDOM ASSIGNMENT WILL DETERMINE WHICH PATH THE RESPONDENT GETS FIRST
(ASTHMA OR CHOLESTEROL). IF NO, RANDOM ASSIGNMENT WILL DETERMINE WHICH PATH
RESPONDENT TAKES.]
1 QUALIFIES FOR ASTHMA PATH ONLY [JUMP TO Q475]

2 QUALIFIES FOR CHOLESTEROL PATH ONLY [JUMP TO Q475]
3 QUALIFIES FOR ASTHMA AND CHOLESTEROL PATHS [ASK Q1420]
BASE: QUALIFIES FOR SECOND PATH (Q474/3)

Q1420 Based on your responses, we are very interested in asking you some additional questions that will
take about 20 more minutes to complete. In exchange for your participation, well give you 100 more
HIpoints. Would you like to complete the additional questions and receive a total of 200 HIpoints, or would
you like to finish the current survey for 100 HIpoints?
1 Yes, Id like to complete the longer survey for 200 HIpoints.

2 No, Id like to finish the current survey for 100 HIpoints.
If you wish to take the longer survey for more HIpoints but are unable to continue at this
time, please be sure to advance to the next screen before hitting the "Resume Later" button. This will ensure
that you will be awarded the correct amount of HIpoint/s upon survey completion.

Q475 Assignment
[PROGRAMMER NOTE: IF RESPONDENT IS Q1420/2 RANDOMLY ASSIGN TO CODE 1 OR 2]
1 Asthma Path Only (Q474/1)

2 Cholesterol Path Only (Q474/2)
3 Both Asthma and Cholesterol Paths (Q1420/1)

Q480 Final Quota Groups
1 MEDICATED HIGH CHOLESTEROL PATIENT (GET CODE 1 FROM Q372 IF Q475/2,3)

2 NON-MEDICATED HIGH CHOLESTEROL PATIENT (GET CODE 2 FROM Q372 IF
Q475/2,3)
3 MEDICATED ASTHMA PATIENT (GET CODE 3 FROM Q372 IF Q475/1,3)
4 NON-MEDICATED ASTHMA PATIENT (GET CODE 4 FROM Q372 IF Q475/1,3)

Q99 SCREENER QUALIFICATION IDENTIFICATION QUESTION (DOES NOT APPEAR ON
SCREEN)
209
1 SCREENER QUALIFIED RESPONDENTS, QUOTA OPEN (Q480/1-4)

2
3 SCREENER QUALIFIED RESPONDENTS, QUOTA CLOSED (Q372/97)
4
5
6 NOT SCREENER QUALIFIED (ALL OTHERS)
BASE: HPOL RESPONDENTS (Q75/1&2)

Q77 HIPOINTS VALUE (DOES NOT APPEAR ON SCREEN)
[PROGRAMMER NOTE: GET 77/3 FOR RESPONDENTS WHO QUALIFIED FOR BOTH PATHS AND
AGREED TO TAKE SECOND PATH (Q475/3 AND Q1420/1).]
[PROGRAMMER NOTE: GET Q77/2 FOR RESPONDENTS WHO QUALIFIED FOR ONE PATH (Q475/1
OR 2) OR WHO QUALIFIED FOR BOTH PATHS BUT DECLINED SECOND PATH (Q475/3 AND
Q1420/2).]
[PROGRAMMER NOTE: GET Q77/1 FOR ALL OTHER RESPONDENTS.]
1 30 [JUMP TO WEIGHTING]
2 100 [IF Q475/1, JUMP TO ASTHMA PATH. IF Q475/2, JUMP TO CHOLESTEROL
PATH. IF Q475/3 AND Q1420/2, JUMP TO RANDOMLY ASSIGNED SOLE PATH.]]
3 200 [JUMP TO RANDOMLY ASSIGNED FIRST PATH]
SECTION 500: ASTHMA PATH
[PN: IF Q375/2, JUMP TO Q500]
[PROGRAMMER NOTE: DISABLE BACK BUTTON ON THIS SCREEN ONLY.]
BASE: ALL QUALIFIED RESPONDENTS

Q1000
[PN : PLEASE DISPLAY THIS ALL ON ONE SCREEN]
INFORMED CONSENT DOCUMENT
Project Title: DEVELOPMENT OF MODELS TO PREDICT MEDICATION NON-ADHERENCE

BASED ON A NEW TYPOLOGY OF MEDICATION ADHERENCE
Research Team: Elizabeth John, BS, MBA

Karen Farris, PHD
This consent form describes the research study to help you decide if you want to participate. This form
provides important information about what you will be asked to do during the study, about the risks and
benefits of the study, and about your rights as a research subject.
If you have any questions about or do not understand something in this form, you should ask
the research team for more information.
You should discuss your participation with anyone you choose such as family or friends.
Do not agree to participate in this study unless the research team has answered your
questions and you decide that you want to be part of this study.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We are inviting you to participate in this research study because you indicated that
you are taking medications either for asthma or high levels of cholesterol.
210
The purpose of this research study is to understand the reasons why individuals do no take asthma
medications or medications for high levels of cholesterol as prescribed by their physician. Understanding this
will help us to develop strategies to improve the medication taking behavior of individuals.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 750 people will take part in this study conducted by investigators at the University of Iowa
HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement will last for 25 to 30 minutes
WHAT WILL HAPPEN DURING THIS STUDY?
During the study, you will be asked to answer an online survey regarding your medication taking behavior.
You are free to skip any question that you prefer not to answer, All your answers will be confidential. If at
any point during the survey, you do not want to continue, you are free to discontinue the survey. If during the
survey, you want to pause, you can stop taking the survey and can return to it later.
WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. In addition to these,
there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.
WHAT ARE THE BENEFITS OF THIS STUDY?
You will not benefit from being in this study. However, we hope that, in the future, other people might benefit
from this study because based on your answers we will be able to develop better strategies to improve the
medication taking behavior of individuals
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being in this research study.
WHO IS FUNDING THIS STUDY?
The University and the research team are receiving no payments from other agencies, organizations, or
companies to conduct this research study.
WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study confidential to the extent permitted by law. However, it
is possible that other people such as those indicated below may become aware of your participation in this
study and may inspect and copy records pertaining to this research. Some of these records could contain
information that personally identifies you.
federal government regulatory agencies,
auditing departments of the University of Iowa, and
the University of Iowa Institutional Review Board (a committee that reviews and approves research
studies)
To help protect your confidentiality, we will have a unique identifier for your data and the data will be stored
in the office of the principal investigator. The computer in which the data will be stored can be accessed only
using the password. Any hard copy data will be stored in the locked cabinets in the office of principal
investigator. The database will have access only by the members of the research team to maintain the
211
confidentiality of the responses. If we write a report or article about this study or share the study data set
with others, we will do so in such a way that you cannot be directly identified.
IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary. You may choose not to take part at all. If you
decide to be in this study, you may stop participating at any time. If you decide not to be in this study, or if
you stop participating at any time, you wont be penalized or lose any benefits for which you otherwise
qualify.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself, please
contact: Elizabeth John at 813-514-7961 or Dr. Karen Farris at 319-384-4516.
If you have questions, concerns, or complaints about your rights as a research subject or about research
related injury, please contact the Human Subjects Office, 340 College of Medicine Administration Building,
The University of Iowa, Iowa City, Iowa, 52242, (319) 335-6564, or e-mail irb@uiowa.edu. General
information about being a research subject can be found by clicking Info for Public on the Human Subjects
Office web site, http://research.uiowa.edu/hso. To offer input about your experiences as a research subject
or to speak to someone other than the research staff, call the Human Subjects Office at the number above.
This Informed Consent Document is not a contract. It is a written explanation of what will happen during the
study if you decide to participate. You are not waiving any legal rights by agreeing to this Informed Consent
Document. When you agree to this Informed Consent Document, it indicates that this research study has
been explained to you, that your questions have been answered, and that you agree to take part in this
study.
[PN : IF ASTHMA PATH (Q475/1) OR ASTHMA/CHOLESTEROL PATH PLUS YES TO OPT-IN

QUESTION (Q475/1,2 AND Q1420/1) ASK Q500, ALL OTHERS JUMP TO PN BEFORE Q600]
BASE: ASTHMA PATH (Q475/1 OR 3)

Q500 This next section will ask numerous questions related to your experience with asthma.
(RESEARCHER NOTE : ASTHMA CONTROL TEST IS Q1555-Q1575)

Q1555 In the past 4 weeks, how much of the time did your asthma
keep you from getting as much done at work, school or at home?
[PN: DISPLAY SCALE HORIZONTALLY WITH RESPONSE CHOICES BELOW RADIO BUTTONS.]
1 All of the time

2 Most of the time
3 Some of the time
4 A little of the time
5 None of the time

Q1560 During the past 4 weeks, how often have you had shortness of breath?
1 More than once a day

2 Once a day
3 3 to 6 times a week
4 Once or twice a week
212
5 Not at all

Q1565 During the past 4 weeks, how often did your asthma symptoms
(wheezing, coughing, shortness of breath, chest tightness or pain) wake you up at night or earlier than usual
in the morning?
1 4 or more nights a week

2 2 or 3 nights a week
3 Once a week
4 Once or twice
5 Not at all

Q1570 During the past 4 weeks, how often have you used your rescue inhaler or nebulizer
medication (such as albuterol)?
1 3 or more times per day

2 1 or 2 times per day
3 2 or 3 times per week
4 Once a week or less
5 Not at all

Q1575 How would you rate your asthma control during the past 4
weeks?
1 Not controlled at all

2 Poorly controlled
3 Somewhat controlled
4 Well controlled
5 Completely controlled
[PN: IF CURRENTLY TAKING MAINTENANCE MEDS FOR ASTHMA (Q445/2-3) ASK Q510, ALL
BASE : ASTHMA PATH (Q475/1 OR 3)

Q1577 HIDDEN QUESTION TO CALCULATE ACT SCORE.
SUM THE NUMERIC VALUE FOR EACH ANSWER GIVEN FROM Q1555-Q1575 AND INSERT THAT
NUMBER BELOW.
[RANGE: 5-25]
|_|_| ACT SCORE
BASE: CURRENTLY TAKING MAINTENANCE MEDS FOR ASTHMA (Q445/2-3)

Q510 This next section will ask more questions related to your experience with asthma and prescription
asthma medications. With questions related to medication (s), please think only about asthma maintenance
medication (s) (i.e., those medications that you use every day to control your asthma).
(RESEARCHER NOTE: Q515/516 IS THE MORISKY SELF REPORTED MEASURE OF ADHERENCE)

Q515 In the past month, thinking of the medications prescribed to you
by your doctor (s) for your asthma, please answer the following questions.
213
Q516 1 2 3 4 5
Never Rarely Sometimes Often Always
1 Do you ever forget to take your medications?

2 Are you careless at times about taking your medications?
3 When you feel better, do you stop taking your medications?
4 If you feel worse when you take your medications, do you stop taking them?
(RESEARCHER NOTE: Q520/521 IS HORNES BELIEFS ABOUT MEDICATION QUESTIONNAIRE)

Q520 We would like to ask you about your personal views about medicines prescribed for you for your
asthma. These are statements other people have made about their medicines.
Please indicate the extent to which you agree or disagree with them by selecting the appropriate box. There
are no right or wrong answers. We are interested in your personal views.
Q521
1 2 3 4 5
Strongly Disagree Uncertain Agree Strongly
disagree agree
1 My health, at present, depends on my medicines.

2 Having to take medicines worries me.
3 My life would be impossible without my medicines.
4 Without my medicines, I would be very ill.
5 I sometimes worry about long-term effects of my medicines.
6 My medicines are a mystery to me.
7 My health in the future will depend on my medicines.
8 My medicines disrupt my life.
9 I sometimes worry about becoming too dependent on my medicines.
10 My medicines protect me from becoming worse.
(RESEARCHER NOTE: TREATMENT SATISFACTION QUESTIONNAIRE FOR MEDICATION (TSQM) IS

Q1505-1554)

Q1505 How satisfied or dissatisfied are you with?
Q1506 1 2 3 4 5
6 7
Extremely Very Dissatisfied Somewhat Satisfied
Very Extremely
dissatisfied dissatisfied satisfied
satisfied satisfied
1 The ability of the medication to prevent or treat your condition

2 The way the medication relieves your symptoms
3 The amount of time it takes the medication to start working

Q1510 As a result of taking this medication, do you experience any side effects at all?
1 Yes
2 No
[PN: IF EXPERIENCE SIDE EFFECTS (Q1510/1) ASK Q1515, ALL OTHERS JUMP TO Q1535]
BASE: EXPERIENCE SIDE EFFECTS (Q1510/1)

Q1515 How bothersome are the side effects of the medication you take to treat your condition?
214
1 Extremely bothersome
2 Very bothersome
3 Somewhat bothersome
4 A little bothersome
5 Not at all bothersome

Q1520 To what extent do the side effects interfere with your physical health and ability to function (i.e.,
strength, energy levels, etc.)?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all

Q1525 To what extent do the side effects interfere with your mental health (i.e., ability to think clearly, stay
awake, etc.)?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all

Q1530 To what degree have medication side effects affected your overall satisfaction with the medicine?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all

Q1535 How easy or difficult is it to use the medication in its current form?
1 Extremely difficult
2 Very difficult
3 Difficult
4 Somewhat easy
5 Easy
6 Very easy
7 Extremely easy

Q1540 How easy or difficult is it to plan when you will use the medication each time?
2 Very difficult
3 Difficult
4 Somewhat easy
5 Easy
6 Very easy
7 Extremely easy

Q1545 How convenient or inconvenient is it to take the medication as instructed?
215
1 Extremely inconvenient
2 Very inconvenient
3 Inconvenient
4 Somewhat convenient
5 Convenient
6 Very convenient
7 Extremely convenient

Q1550 Overall, how confident are you that taking this medication is a good thing for you?
1 Not at all confident

2 A little confident
3 Somewhat confident
4 Very confident
5 Extremely confident

Q1552 How certain are you that the good things about your medication outweigh the bad things?
1 Not at all certain

2 A little certain
3 Somewhat certain
4 Very certain
5 Extremely certain

Q1554 Taking all things into account, how satisfied or dissatisfied are you with this medication?
1 Extremely dissatisfied
2 Very dissatisfied
3 Dissatisfied
4 Somewhat satisfied
5 Satisfied
6 Very satisfied
7 Extremely satisfied
RESEARCHER NOTE: UI REASONS SCALE FOR NON-ADHERENCE (Q1590 Q563)

Q1590 Do you know the long term benefit of taking your asthma medication as
told to you by your doctor or pharmacist?
1 Yes
2 No

Q530 In the past 4 weeks, did you always take your asthma
medication as prescribed by the physician?
1 Always
2 Usually
3 Seldom
4 Never
[PN: IF LESS THAN ALWAYS (Q530/2-4) SEE PN BEFORE Q535, ALL OTHERS JUMP TO Q562]
[PN: RANDOMLY ASSIGN 25 RESPONDENTS TO SEE Q535 AND Q540]
BASE: DID NOT TAKE MEDS AS PRESCRIBED [TWENTY-FIVE RESPONDENTS] (Q530/2-4)

Q881 Random Selection
216
1 Selected
2 Not Selected
3 Not Selected
4 Not Selected
5 Not Selected

Q883 Check Quotas if Q881=1
1 Quota Met
2 Quota Not Met
3 Error

Q884 Selection Status
1 Selected (if Q883=2 or 3)

2 Not selected (default)
[PN: If Q884=1, then ask 535 and Q540]
BASE: DID NOT TAKE MEDS AS PRESCRIBED [TWENTY-FIVE RESPONDENTS] (Q884/1)

Q535 You mentioned that you did not take your asthma medication as
prescribed by your physician. What was the change from the prescription?
[LARGE MANDATORY TEXT BOX]
BASE: DID NOT TAKE MEDS AS PRESCRIBED [ALL RESPONDENTS] (Q530/2-4)

Q536 You mentioned that you did not take your asthma medication as
prescribed by your physician. Using the list below, what was the change from the prescription? Please
select all that apply[INSERT IF Q535 IS ASKED , including those you may have
mentioned in the previous question].
[RANDOMIZE]
[MULTIPLE RESPONSE]
1 Did not take the dose

2 Took less than the prescribed dose
3 Took more than the prescribed dose
4 Took medication at the wrong time
5 Other ANCHOR Q537 [INSERT MANDATORY TEXT BOX FOR
RESPONDENTS CHOOSING Q536/5]

Q540 Why did you take your medication differently than prescribed? Please list all your reasons below.

Q562 If you have ever missed taking your asthmamedication (s), please
indicate how often you have missed taking your asthmamedication due to the
various reasons listed below.
Q563
1 2 3 4 5
None of the time A little of the time Some of the time Most of the time All of the time
[PN: PLEASE DISPLAY SCALE AT TOP, BOTTOM, AND AFTER CODE 8 IN THE GRID.]
217
1 Side effects/Fear of side effects

2 Medication is not needed because you are not showing any indications of the disease or you
feel well without medication
3 Ran out of prescription
11 Inconvenience in taking medications in prescribed way (e.g., you are away from home, the
medication makes you urinate more frequently, etc.)
12 Social stigma (e.g., you are with friends, you are in a public place, etc.)
14 Concern about long term effects of medication
15 Forget due to busy schedule
(RESEARCHER NOTE: MEDICATION ADHERENCE SELF EFFICACY SCALE IS Q565/566-Q1580/1581)

Q565 Situations come up that make it difficult for people to take their medications as prescribed by their
doctors. Below is a list of such situations. We want to know your opinion about taking your asthma medications under each of them. Please indicate your response by checking the
box that most closely represents your opinion. There are no right or wrong answers.

For each of the situations listed below, please rate how sure you are that you can take your asthma medication all of the time.
Q566 1 2 3
Not at all sure Somewhat sure Very sure
1 When you are busy at home

2 When you are at work
3 When there is no one to remind you
4 When you worry about taking them for the rest of your life
5 When they cause some side effects
6 When they cost a lot of money
7 When you come home late from work
8 When you do not have symptoms
9 When you are with family members
10 When you are in a public place
11 When you are afraid of becoming dependent on them
12 When the time to take them is between your meals
13 When you feel you do not need them
14 When you are traveling
15 When you take them more than once a day
16 If they sometimes make you tired
17 When you have other medications to take
18 When you feel well

Q1580 Please rate how sure you are that you can carry out the following tasks <fontcolor=blue>all of the
time.
Q1581 1 2 3
1 Get refills for your medications before you run out

2 Make taking your medications part of your routine
3 Fill your prescriptions whatever they cost
4 Always remember to take your asthma medications
218
5 Take your asthma medications for the rest of your life

RESEARCHER NOTE: SELF REGULATION SCALE (Q570 Q571)

Q570 There are a variety of reasons why patients take their medications. Please consider the following
behaviors and indicate how true each of these reasons is for you.
Q571
1 2 3 4 5 6 7
Not at Somewhat Very
all true true true
1 Other people would be mad at me if I didnt.

2 I find it a personal challenge to do so.
3 I personally believe that controlling my asthma will improve my health.
4 I would feel guilty if I didnt do what my doctor said.
5 I want my doctor to think Im a good patient.
6 I would feel bad about myself if I didnt.
7 Its exciting to try to keep my disease under control.
8 I dont want other people to be disappointed in me.
[DISPLAY Q800 AND Q805 ON SAME SCREEN]
(RESEARCHER NOTE: ILLNESS PERCEPTION QUESTIONNAIRE IS Q800-Q835)
[PN: FOR Q800-Q835 PLEASE DISPLAY THE RESPONSE CHOICES AS 0 THROUGH 10 ON THE
SCREEN.]
[PN: IF ASTHMA PATH (Q475/1 OR 3), ASK Q800. ALL OTHERS JUMP TO PN BEFORE Q840]

Q800 Thinking about your asthma, please answer the following questions:

1 2 3 4 5 6 7 8 9 10 11

Q805 How long do you think your illness will continue?
1 2 3 4 5 6 7 8 9 10 11
A very Forever
short time
BASE: ASTHMA PATH (Q475/1 OR 3))

Q810 Again, thinking about your asthma, please answer the following
questions:

1 2 3 4 5 6 7 8 9 10 11

Q815 How much do you think your treatment can help your illness?
1 2 3 4 5 6 7 8 9 10 11
219
Not at all Extremely helpful

questions:

How much do you experience symptoms from your illness?
1 2 3 4 5 6 7 8 9 10 11
No symptoms at all Many severe symptoms

Q825 How concerned are you about your illness?
1 2 3 4 5 6 7 8 9 10 11

questions:

1 2 3 4 5 6 7 8 9 10 11

Q835 How much does your illness affect you emotionally (e.g., does it make you angry, scared,
upset or depressed)?
1 2 3 4 5 6 7 8 9 10 11
Not at all affected emotionally Extremely affected emotionally
[PN: IF CURRENTLY TAKING MAINTENANCE MEDS FOR ASTHMA (Q445/2-3), ASK Q840. ALL
RESEARCHER NOTE: MEDICATION NON-ADHERENCE OBJECTIVE MEASURES (Q840 Q842)

Q840 In the past week, on how many days did you forget to take your asthma
medication?
1. 0 days
2. 1 day
3. 2 days or more

Q842 In the past week, on how many days did you not take your asthma
medication on purpose?
1. 0 days,
2. 1 day or more
220
SECTION 600: CHOLESTEROL PATH
[PN : IF CHOLESTEROL PATH ONLY (Q475/2) OR ASTHMA/CHOLESTEROL PATH PLUS YES TO

OPT-IN QUESTION (Q475/3) ASK Q600, ALL OTHERS JUMP TO PN BEFORE Q700]
BASE: CHOLESTEROL PATH (Q475/2 OR 3)

Q600 This next section will ask numerous questions related to your experience with high cholesterol and any prescription cholesterol lowering
medications you may be taking.

What is your recent measure of total cholesterol level?
1 Less than 200 mg/dL

2 200 to 239 mg/dL
3 240 mg/dL or more
4 Not sure
[PN: IFCURRENTLY TAKING MEDS FOR CHOLESTEROL (Q450/1-10) ASK Q605, ALL OTHERS JUMP
TO PN BEFORE Q695]
(RESEARCHER NOTE: Q515/516 IS THE MORISKY SELF REPORTED MEASURE OF ADHERENCE)
BASE: CURRENTLY TAKING MEDS FOR CHOLESTEROL (Q450/1-10)

Q605 In the past month, thinking of the medications prescribed to you
by your doctor (s) for your cholesterol, please answer the following questions.
Q606
1 2 3 4 5
Never Rarely Sometimes Often Always
1 Do you ever forget to take your medications?

2 Are you careless at times about taking your medications?
3 When you feel better, do you stop taking your medications?
4 If you feel worse when you take your medications, do you stop taking them?
(RESEARCHER NOTE: Q610/611 IS HORNES BELIEFS ABOUT MEDICATION QUESTIONNAIRE)

Q610 We would like to ask you about your personal views about medicines prescribed for you for your
cholesterol. These are statements other people have made about their
medicines. Please indicate the extent to which you agree or disagree with them by selecting the appropriate
box. There are no right or wrong answers. We are interested in your personal views.
Q611
1 2 3 4 5
Strongly Disagree Uncertain Agree Strongly
disagree agree
1 My health, at present, depends on my medicines.

2 Having to take medicines worries me.
3 My life would be impossible without my medicines.
4 Without my medicines, I would be very ill.
5 I sometimes worry about long-term effects of my medicines.
6 My medicines are a mystery to me.
7 My health in the future will depend on my medicines.
8 My medicines disrupt my life.
9 I sometimes worry about becoming too dependent on my medicines .
10 My medicines protect me from becoming worse.

221
(RESEARCHER NOTE: TREATMENT SATISFACTION QUESTIONNAIRE FOR MEDICATION (TSQM) IS

Q615-1655)

Q615 How satisfied or dissatisfied are you with?
Q616
1 2 3 4 5 6 7
Extremely Very Dissatisfied Somewhat Satisfied Very Extremely
Dissatisfied dissatisfied satisfied satisfied satisfied
1 The ability of the medication to prevent or treat your condition

2 The way the medication relieves your symptoms
3 The amount of time it takes the medication to start working

Q1660 As a result of taking this medication, do you experience any side effects at all?
1 Yes
2 No
[PN: IF EXPERIENCE SIDE EFFECTS (Q1660/1) ASK Q1665, ALL OTHERS JUMP TO Q1685]

Q1665 How bothersome are the side effects of the medication you take to treat your condition?
1 Extremely bothersome
2 Very bothersome
3 Somewhat bothersome
4 A little bothersome
5 Not at all bothersome

Q1670 To what extent do the side effects interfere with your physical health and ability to function (i.e.,
strength, energy levels, etc.)?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all

Q1675 To what extent do the side effects interfere with your mental health (i.e., ability to think clearly, stay
awake, etc.)?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all

Q1680 To what degree have medication side effects affected your overall satisfaction with the medicine?
1 A great deal
2 Quite a bit
3 Somewhat
4 Minimally
5 Not at all
222

Q1685 How easy or difficult is it to use the medication in its current form?
2 Very difficult
3 Difficult
4 Somewhat easy
5 Easy
6 Very easy
7 Extremely easy

Q1690 How easy or difficult is it to plan when you will use the medication each time?
2 Very difficult
3 Difficult
4 Somewhat easy
5 Easy
6 Very easy
7 Extremely easy

Q1695 How convenient or inconvenient is it to take the medication as instructed?
1 Extremely inconvenient
2 Very inconvenient
3 Inconvenient
4 Somewhat convenient
5 Convenient
6 Very convenient
7 Extremely convenient

Q1701 Overall, how confident are you that taking this medication is a good thing for you?
1 Not at all confident

2 A little confident
3 Somewhat confident
4 Very confident
5 Extremely confident

Q1702 How certain are you that the good things about your medication outweigh the bad things?
1 Not at all certain

2 A little certain
3 Somewhat certain
4 Very certain
5 Extremely certain

Q1655 Taking all things into account, how satisfied or dissatisfied are you with this medication?
1 Extremely dissatisfied
2 Very dissatisfied
3 Dissatisfied
4 Somewhat satisfied
5 Satisfied
6 Very satisfied
7 Extremely satisfied
223

Q620 Do you know the long term benefit of taking your cholesterol-lowering 
medication as told to you by your doctor or pharmacist?
1 Yes
2 No
RESEARCHER NOTE: UI REASONS SCALE FOR NON-ADHERENCE (Q625 Q648)

Q625 In the past 4 weeks, did you always take your cholesterol-lowering
 medication as prescribed by the physician?
1 Always
2 Usually
3 Seldom
4 Never
[PN: IF NOT ALWAYS (Q625/2-4) GO TO PN BEFORE Q630, ALL OTHERS JUMP TO Q647]
[PN: RANDOMLY ASSIGN 25 RESPONDENTS TO SEE Q630 AND Q1635]

Q885 Random Selection
1 Selected
2 Not Selected
3 Not Selected
4 Not Selected
5 Not Selected

Q887 Check Quotas if Q885=1
1 Quota Met
2 Quota Not Met
3 Error

Q888 Selection Status
1 Selected (if Q887=2 or 3)

2 Not selected (default)
[PN: If Q888=1, then ask Q630 and Q1635]

Q630 You mentioned that you did not take your cholesterol-lowering 
medication as prescribed by your physician. What was the change from the prescription?
[LARGE MANDATORY TEXT BOX]
BASE: DID NOT TAKE MEDS AS PRESCRIBED [ALL RESPONDENTS] (Q625/2-4)

Q631 You mentioned that you did not take your cholesterol-lowering 
medication as prescribed by your physician. Using the list below, what was the change from the
prescription? Please select all that apply[INSERT , including those you may have
mentioned in the previous question if Q630 IS ASKED].
[MULTIPLE RESPONSE]
[RANDOMIZE]
224
1 Did not take the dose

2 Took less than the prescribed dose
3 Took more than the prescribed dose
4 Took medication at the wrong time
5 Other ANCHOR Q632 [INSERT MANDATORY TEXT BOX FOR
RESPONDENTS CHOOSING Q631/5]

Q1635 Why did you take your medication differently than prescribed? Please list all your reasons below.

Q647 If you have ever missed taking your cholesterol-lowering medication
(s), please indicate how often you have missed taking your cholesterol-lowering 
medication due to the various reasons listed below.
Q648
1 2 3 4 5
None of the time A little of the time Some of the time Most of the time All of the time
1 Side effects/Fear of side effects

2 Medication is not needed because you are not showing any indications of the disease or you
feel well without medication
3 Ran out of prescription
11 Inconvenience in taking medications in prescribed way (e.g., you are away from home, the
medication makes you urinate more frequently, etc.)
12 Social stigma (e.g., you are with friends, you are in a public place, etc.)
14 Concern about long term effects of medication
15 Forget due to busy schedule
[PN: IF CURRENTLY TAKING MEDS FOR CHOLESTEROL (Q450/1-10) ASK Q650, ALL OTHERS JUMP
TO PN BEFORE Q695]
(RESEARCHER NOTE: MEDICAITON ADHERENCE SELF EFFICACY SCALE IS Q650/651-Q1650/1651)

Q650 Situations come up that make it difficult for people to take their medications as prescribed by their
doctors. Below is a list of such situations. We want to know your opinion about taking your
<font=fuchsia>cholesterol-lowering medications under each of them. Please indicate your response
by checking the box that most closely represents your opinion. There are no right or wrong
answers.

For each of the situations listed below, please rate how sure you are that you can take your
<font=fuchsia>cholesterol-lowering medication all of the time.
Q651 1 2 3
1 When you are busy at home

2 When you are at work
3 When there is no one to remind you
225
4 When you worry about taking them for the rest of your life
5 When they cause some side effects
6 When they cost a lot of money
7 When you come home late from work
8 When you do not have symptoms
9 When you are with family members
10 When you are in a public place
11 When you are afraid of becoming dependent on them
12 When the time to take them is between your meals

13 When you feel you do not need them
14 When you are traveling
15 When you take them more than once a day
16 If they sometimes make you tired
17 When you have other medications to take
18 When you feel well

Q1650 Please rate how sure you are that you can carry out the following tasks <fontcolor=blue>all of the
time.
Q1651 1 2 3
1 Get refills for your medications before you run out

2 Fill your prescriptions whatever they cost
3 Make taking your medications part of your routine
4 Always remember to take your cholesterol-lowering medications
5 Take your cholesterol-lowering medications for the rest of your life
RESEARCHER NOTE: SELF REGULATION SCALE (Q655 Q666)

Q655 There are a variety of reasons why patients take their medications. Please consider the following
behaviors and indicate how true each of these reasons is for you.
Q656
1 2 3 4 5 6 7
Not at Somewhat Very
all true true true
1 Other people would be mad at me if I didnt.

2 I find it a personal challenge to do so.
3 I personally believe that controlling my cholesterol will improve my health.
4 I would feel guilty if I didnt do what my doctor said.
5 I want my doctor to think Im a good patient.
6 I would feel bad about myself if I didnt.
7 Its exciting to try to keep my disease under control.
8 I dont want other people to be disappointed in me.
(RESEARCHER NOTE: ILLNESS PERCEPTION QUESTIONNAIRE IS Q695-Q1630)
[PN: FOR Q695-Q1630 PLEASE DISPLAY THE RESPONSE CHOICES AS 0 THROUGH 10 ON THE
SCREEN.]
[PN: IF CHOLESTEROL PATH (Q475/2 OR 3), ASK Q695. ALL OTHERS JUMP TO PN BEFORE Q1640]

226
Q695 Thinking about your high cholesterol, please answer the following
questions:
1 2 3 4 5 6 7 8 9 10 11
BASE: CHOLESTEROL PATH (Q475/2 OR 3))

Q1601 How long do you think your illness will continue?
1 2 3 4 5 6 7 8 9 10 11
A very Forever
short time

Q1602 Again, thinking about your high cholesterol, please answer the following
questions:
1 2 3 4 5 6 7 8 9 10 11

Q1610 How much do you think your treatment can help your illness?
1 2 3 4 5 6 7 8 9 10 11
Not at all helpful Extremely helpful

questions:
How much do you experience symptoms from your illness?
1 2 3 4 5 6 7 8 9 10 11
No symptoms at all Many severe symptoms

Q1620 How concerned are you about your illness?
1 2 3 4 5 6 7 8 9 10 11

questions:
1 2 3 4 5 6 7 8 9 10 11

Q1630 How much does your illness affect you emotionally (e.g., does it make you angry, scared,
upset or depressed)?
1 2 3 4 5 6 7 8 9 10 11
Not at all affected emotionally Extremely affected emotionally
227
[PN: IF CURRENTLY TAKING MEDS FOR CHOLESTEROL, ASK Q1640. ALL OTHERS JUMP TO PN
BEFORE Q1950]
RESEARCHER NOTE: MEDICATION NON-ADHERENCE OBJECTIVE MEASURES (Q1640 Q1645)

Q1640 In the past week, on how many days did you forget to take your cholesterol
lowering medication?
1. 0 days
2. 1 day
3. 2 days or more

Q1645 In the past week, on how many days did you not take your cholesterol
lowering medication on purpose?
1. 0 days
2. 1 day or more
SECTION 700: ADHERENCE
[PN : IF ASTHMA PATH (Q475/1) OR CHOLESTEROL PATH (Q475/2) OR BOTH (Q1420/1) ASK Q700,
ALL OTHERS JUMP TO SECTION 800]
(RESEARCHER NOTE: SOCIAL SUPPORT SURVEY IS Q700/701)

Q700 People sometimes look to others for companionship, assistance, or other types of support. How
often is each of the following kinds of supports available to you if you need it? Select one response on each
line.
Q701 1 2 3 4 5
None of the A little of the Some of the Most of the All of the
time time time time time
1 Someone to help you if you were confined to bed

2 Someone to take you to the doctor if you needed it
3 Someone to prepare your meals if you were unable to do it yourself
4 Someone to help with daily chores if you were sick

Q705 Who are the most important individuals in helping you with taking medications as directed? Please
choose up to three.
[MULTIPLE RESPONSE]
[RANDOMIZE]
[RESPONDENT MAY CHOOSE UP TO THREE RESPONSES]
1 Spouse
2 Children
3 Parent
4 Grandparent
5 Other family member
6 Friend
7 Doctor
8 Nurse
9 Paid caregiver
10 Grandchild
228
11 Pharmacist
12 Other non-family member ANCHOR
13 No one else helps me take my medication. ANCHOR E
14 I am not taking any medications
[PN: IF SOMEONE ELSE HELPS (Q705/1-12) ASK Q710, ALL OTHERS JUMP TO Q715]
BASE: SOMEONE ELSE HELPS (Q705/1-12)

Q710 How important are each of these individuals opinion to you?
Q711 1 2 3
Not at all important Somewhat important Very important
[DISPLAY CHOICES SELECTED AT Q705 IN SAME ORDER]
1 Spouse
2 Children
3 Parent
4 Grandparent
5 Other family member
6 Friend
7 Doctor
8 Nurse
9 Paid caregiver
10 Grandchild
11 Pharmacist
12 Other non-family member ANCHOR

Q715 What is the total number of medications you are taking on a daily basis? Your best estimate will
do.
[RANGE: 0-999]
I_I_I_I medication (s)

Q716 Thinking about the prescription medication (s) you currently take, how much in total do you pay out-of-
pocket per month for your prescription medication (s)? Please enter 9999 if you are not taking any
prescription medications. If you buy your prescriptions in three month increments, please average how
much you spend per month.
[RANGE: 0-9999]
$|_|_|_|_| per month
(RESEARCHER NOTE: MULTIDIMENSIONAL HEALTH LOCUS OF CONTROL IS Q720)

Q720 Each item below is a belief statement about your medical condition with which you may agree or
disagree. For each item please indicate the extent to which you agree or disagree with that statement. This
is a measure of your personal beliefs; obviously, there are no right or wrong answers.
Q721
1 2 3 4 5 6
Strongly Moderately Slightly Slightly Moderately Strongly
disagree disagree disagree agree agree agree
1 If my condition worsens, it is my own behavior which determines how soon I will feel better
again.
2 As to my condition, what will be will be.
229
3 If I see my doctor regularly, I am less likely to have problems with my condition.

4 Most things that affect my condition happen to me by chance.
5 Whenever my condition worsens, I should consult a medically trained professional.
6 I am directly responsible for my condition getting better or worse.
7 Other people play a big role in whether my condition improves, stays the same, or gets worse.
8 Whatever goes wrong with my condition is my own fault.
9 Luck plays a big part in determining how my condition improves.
10 In order for my condition to improve, it is up to other people to see that the right things happen.
11 Whatever improvement occurs with my condition is largely a matter of good fortune.
12 The main thing which affects my condition is what I myself do.
13 I deserve the credit when my condition improves and the blame when it gets worse.
14 Following doctor's orders to the letter is the best way to keep my condition from getting any
worse.
15 If my condition worsens, it's a matter of fate.
16 If I am lucky, my condition will get better.
17 If my condition takes a turn for the worse, it is because I have not been taking proper care of
myself.
18 The type of help I receive from other people determines how soon my condition improves.

Q725 How would you rate your memory at the present time? Would you say it is excellent, very good, good,
fair or poor?
1. Excellent,
2. Very good
3. Good
4. Fair
5. Poor
6. Uncertain
7. Decline to answer

Q730 In the past year, have you had any side effects, unwanted reactions, or other health problems from
medications you were taking?
1 Yes
2 No
3 Not sure
4 I am not taking any medications.
[PN: IF SIDE EFFECTS (Q730/1) ASK Q735, ALL OTHERS JUMP TO PN BEFORE Q845]]
BASE: SIDE EFFECTS (Q730/1)

Q735 Thinking about the most severe of the reactions you experienced from
medications you were taking in the past year, what did you do in response?
Q736 1 2
Yes No
1 Did you cut down or stop taking the drug on your own?
2 Did you talk to a doctor about this reaction?
3 Did you visit a doctors office or emergency room mostly because of this reaction?
4 Did your doctor ask you to cut down or stop taking the medication because of this
reaction?
5 Did you take another medication or treatment to treat this reaction?
6 Were you admitted to a hospital overnight mostly because of this reaction?
230
SECTION 800: WEBOGRAPHIC QUESTIONS
[PN: ALL US RESPONDENTS AGE 18 AND OVER (110/244 & 105 >=18) GO TO Q800. OTHERS GO TO
Q112.]
[PN: IF NOT QUALIFIED (Q77/1) DISABLE BACK BUTTON ON THIS SCREEN ONLY]
[PROGRAMMER NOTE: PLEASE DISPLAY Q800 AND Q805 ON ONE SCREEN]
BASE: ALL US RESPONDENTS 18+

Q845 [IF Q77/1, DISPLAY: Next we have a few more general questions for you.]
Some people feel that the people in Washington, D.C. are out of touch with the rest of the
country. Do you feel this is the case?
1 Yes
2 No

Q850 Some people also feel that they are left out of things going on around them. Do you feel
this is the case?
1 Yes
2 No

Q855 In the last month have you?
1 Yes
2 No
[RANDOMIZE]
1 Read a book
2 Traveled
3 Participated in a team or individual sport
BASE: ALL US RESPONDENTS AGE 18+

Q856 [PROGRAMMER: PLEASE COMPUTE ONE BEHIND-THE-SCENES SINGLE-PUNCH QUESTION
FOR EACH ITEM IN THE GRID QUESTION ABOVE. GET CODE 1 IF THE RESPONSE FOR Q811 WAS
YES (1); ELSE GET CODE 2.]
...........................THIS HOLDS FIRST RESPONSE FOR READ A BOOK Q856/1

1 Yes
2 No
........................................... Q857 HOLDS RESPONSE FOR TRAVELED Q856/2

1 Yes
2 No
Q858 HOLDS RESPONSE FOR PARTICIPATED IN A TEAM OR INDIVIDUAL SPORT Q856/3

1 Yes
2 No
[PROGRAMMER NOTE: PLEASE DISPLAY Q820 AND Q825 ON ONE SCREEN]

Q860 Do you own an investment account that is specifically designed to provide for your
retirement, or not?
231
1 Yes
2 No

Q865 Some people say that there is too much information being generated these days,
considering all the TV news shows, magazines, newspapers, and computer information
services. Others say that they like having so much information available. Do you feel
overloaded with information or do you like having so much information available?
1 Feel overloaded
2 Like having information available

Q870 Do you have medical insurance or a co-pay program that covers some or all of the cost of
your prescription medications?
1 Yes
2 No
3 Dont know

Q875 Please enter your height in feet and inches. If you decline to answer, please enter 99 in
each textbox.
[RANGE: 1-12 FOR FEET AND 0-12 FOR INCHES]
I_I_I feet I_I_I inches

Q880 Please enter your weight in pounds. If you decline to answer, please enter 9999 in the
box below.
[RANGE: 0-9999]
I_I_I_I_I pounds
SECTION 100: DEMOGRAPHICS

Q112 [HIDDEN QUESTION - MANDATORY QUESTION SELECTION.]
[MULTIPLE RESPONSE]
[PROGRAMMER: DESELECT CODE 18.]
[PROGRAMMER NOTE: IF 18 OR OLDER OR AGE UNKNOWN (Q106/3-13,99) PICK

CODES 3,6,7,9,10,12,13,14,15,16,17,19,20,21,22,24. IF 17 OR YOUNGER (Q106/1,2) PICK
CODES 3,6,7,9,10,12,13,17,19,20,21,22,24.]
[PN: JUMPFILL CODE 09 WITH RESPONSE FROM Q410]
03 PRESENT SOLE EMAIL USER (Q199)

06 PRESENT COUNTRY OF RESIDENCE (Q110/Q166)
07 PRESENT CONFIRMATION SCREEN (Q150)
09 PRESENT CITIZENSHIP (Q170)
10 PRESENT INTERNET CONNECTION (Q190)
12 PRESENT INTERNET USAGE (Q194/Q195/Q196)
13 PRESENT EDUCATION (Q214 OR Q216)
14 PRESENT MULTI-EMPLOYMENT (Q210)
232
15 PRESENT RELATIVE INCOME (Q230)

16 PRESENT INCOME (Q232)
17 PRESENT STATE/TERRITORY/PROVINCE (Q172)
18 PRESENT PRIMARY LANGUAGE (Q182)
19 PRESENT ZIP CODE (Q178)
20 PRESENT POSTAL CODE (Q180)
21 PRESENT RACE (Q236-Q244)
22 PRESENT SURVEY EVALUATION (Q288-Q294)
24 PRESENT SWEEPSTAKES (Q252-Q262)

Q114 [HIDDEN QUESTION - OPTIONAL QUESTION SELECTION.]
[PROGRAMMER NOTE: GET CODE 5, 6, 7, 8, 10. DO NOT SELECT QUESTIONS FOR
PRESENTATION UNLESS INDICATED BY PROJECT RESEARCH STAFF.]
[MULTIPLE RESPONSE]
01 PRESENT READING COMPREHENSION (Q184)

02 PRESENT READING FLUENCY [CAN SELECT ONLY IF Q114/01.] (Q186)
04 PRESENT SURVEY LOCATION (Q200)
05 PRESENT MARITAL STATUS (Q202)
06 PRESENT ADULTS IN HOUSEHOLD (Q204)
07 PRESENT CHILDREN IN HOUSEHOLD (Q206)
08 PRESENT AGE OF CHILDREN [CAN SELECT ONLY IF Q114/07.] (Q208/Q209)
09 PRESENT SINGLE EMPLOYMENT (Q212)
10 PRESENT INDUSTRY (Q226)
11 PRESENT PROFESSION (Q228)
12 PRESENT INVESTABLE ASSETS (Q234)
13 PRESENT SEXUAL ORIENTATION (Q246/Q248)
15 PRESENT SCHOOL LOCATION (Q220)
16 PRESENT MOTHERS EDUCATION (Q222)
17 PRESENT FATHERS EDUCATION (Q224)
18 PRESENT DIRECT INCENTIVE (Q264-Q275)
19 PRESENT OPT-IN FOR NON-HPOL (Q278-Q284)
20 DO NOT PRESENT ANY OPTIONAL DEMOGRAPHIC ITEMS E

Q60 STATUS OF RESPONDENT (DOES NOT APPEAR ON SCREEN)
1 QUALIFIED RESPONDENTS, QUOTA OPEN (Q99/1)

2 PARTIALLY QUALIFIED, QUOTA OPEN
3 QUALIFIED RESPONDENTS, QUOTA CLOSED (Q99/3)
4 PARTIALLY QUALIFIED RESPONDENTS, QUOTA CLOSED
5 OVERALL QUOTA CLOSED
6 NOT QUALIFIED (Q99/6)
233
APPENDIX B: IRB APPROVAL
IRB ID #: 200708721
To: Elizabeth John
From: IRB-01 DHHS Registration # IRB00000099,
Univ of Iowa, DHHS Federalwide Assurance # FWA00003007
Re: DEVELOPMENT OF MODELS TO PREDICT MEDICATION NON-ADHERENCE BASED ON A NEW

TYPOLOGY OF MEDICATION ADHERENCE
Protocol Number:
Protocol Version:
Protocol Date:
Amendment Number/Date (s):
Approval Date: 11/07/07
Next IRB Approval
Due Before: 09/01/08

Type of Application: Type of Application Review: Approved for Populations:
New Project Full Board: Children

Continuing Review Meeting Date: Prisoners
Modification Expedited Pregnant Women, Fetuses,
Neonates
Exempt
Source of Support:
Investigational New Drug/Biologic Name:

Investigational New Drug/Biologic Number:
Name of Sponsor who holds IND:
Investigational Device Name:

Investigational Device Number:
Sponsor who holds IDE:
This approval has been electronically signed by IRB Chair:
Martha Jones, CIP, MA
11/07/07 1829
APPENDIX C: CORRELATIONS IN CHOLESTEROL LOWERING MEDICATIONS
Educa- Depress- Cost of Marital Compl-

Age Gender tion Race Income Insurance ion Anxiety meds status exity
Age 1
Gender 0.054 1
Education 0.082* 0.152** 1
Race -0.142** -0.070 0.032 1
Income 0.053 0.242** 0.283** -0.032 1
Insurance 0.164** 0.038 0.051 -0.079** 0.129* 1
Depression -0.004 -0.193 -0.055 0.003 -0.006 0.008 1
Anxiety 0.040 -0.138** 0.020 -0.036 0.047 0.058 0.400** 1
Cost of
0.050 -0.029 -0.028 0.028 -0.018 -0.030 0.151** 0.130** 1
meds
Marital
0.257** -0.106** -0.053 -0.052 -0.054 0.076* 0.062 0.023 0.110** 1
Status
Complexity 0.233** -0.099** -0.056** -0.009 -0.145** 0.125** 0.367** 0.269** 0.176** 0.126** 1
*Correlation is significant at the 0.05 level (2-tailed); **Correlation is significant at the 0.01 level (2-tailed).
234
Treatment
Social Locus of Treatment Treatment Treatment Treatment Cholesterol
Attitude side
support control effectiveness convenience satisfaction duration severity
effects
Social
1
support
Attitude 0.237** 1
Locus of
0.060 0.036 1
control
Treatment
0.157** 0.018 0.159** 1
effectiveness
Treatment
-0.013 -0.263 -0.028 0.299* 1
side effects
Treatment
0.161** -0.120* -0.033 0.437** 0.317* 1
convenience
Treatment
0.097* 0.002 0.119* 0.537** 0.561** 0.484** 1
satisfaction
Treatment
0.007 -0.002 0.061 0.028** 0.106 0.063 0.148** 1
duration
Cholesterol
-0.112* 0.011 0.001 -0.238 -0.671** -0.092 -0.266** -0.088 1
severity
* Correlation is significant at the 0.05 level (2-tailed); ** Correlation is significant at the 0.01 level (2-tailed).
235
Necessity Autonomous Control Self Self Self
Necessity Concern Illness Concern
concern self self efficacy efficacy efficacy Knowledge
beliefs beliefs perceptions perceptions
differential regulation regulation 1 2 3
Necessity
1
beliefs
Concern
0.085 1
beliefs
Necessity
-
concern 0.669** 1
0.684**
differential
Illness
0.200** 0.485** -0.216** 1
perceptions
Autonomous
self 0.359** -0.079 0.322** -0.041 1
regulation
Control self
0.300** 0.106* 0.140** 0.109* 0.534** 1
regulation
Self efficacy -
0.098* 0.341** -0.329** 0.111* -0.008 1
1 0.361**
Self efficacy -
0.102* 0.346** -0.309** 0.175** 0.068 0.693** 1
2 0.364**
Self efficacy -
0.002 0.295** -0.302** 0.176** 0.017 0.606** 0.538** 1
3 0.394**
Concern
0.289** 0.168** 0.086 0.307** 0.117* 0.119* -0.090 -0.109 -0.099* 1
perceptions
Knowledge - - -
-0.021 0.174** -0.145** 0.151** -0.090 -0.007 0.071 1
0.161** 0.146** 0.230**
236
Social -
0.094** -0.008 0.007 0.001 0.167** 0.098** -0.070* 0.012 -0.055 -0.026
support 0.098**
Attitude -0.053 0.109** -0.022 0.120** 0.061 0.048 -0.032 0.003 0.047 -0.045 0.044
Locus of
0.167** 0.020 -0.041 -0.005 0.005 0.061 -0.054 -0.042 -0.055 0.080* -0.051
control
Treatment
0.098* -0.051 0.001 -0.018 0.134** 0.093 -0.032 0.039 -0.091 -0.001 0.008
effectiveness
Treatment
0.252 -0.121 0.125 -0.227 -0.214 -0.084 -0.479** -0.254 -0.227 0.240 -0.321*
side effects
Treatment -
0.131** -0.107* 0.041 -0.060 0.145** 0.062 -0.010 0.054 -0.017 0.005
convenience 0.168**
Treatment -
0.135** -0.066 0.014 -0.094 0.180** 0.009 -0.053 0.022 -0.008 -0.002
satisfaction 0.127**
Treatment
0.349 0.120** 0.062 -0.078 0.112 0.109** 0.063 0.020 0.024 0.126 0.240
duration
Cholesterol
-0.132 -0.047 -0.037 -0.021 -0.038 -0.026 0.036 0.026 0.092 -0.012 -0.059
severity
237
Necessity
0.069 -0.196** -0.056 -0.023 -0.052 0.010 0.187** 0.090 0.051 0.044 0.423**
beliefs
Concern
-0.226** -0.015 -0.040 0.075 -0.211** 0.058 0.124* 0.122* 0.066 0.015 0.167**
beliefs
Necessity
concern 0.219** -0.123* -0.011 -0.074 0.122* -0.011 0.044 -0.038 -0.012 0.021 0.185**
differential
Illness
-0.200** 0.043 -0.105* 0.105* -0.148** -0.041 0.105* -0.055 0.097* 0.094* 0.256**
perceptions
Autonomous
self 0.179** -0.028 -0.014 0.105* -0.020 -0.030 -0.080 0.002 0.009 -0.030 0.109*
regulation
Control self
0.076 0.070 -0.066 0.051 -0.030 -0.005 -0.028 0.066 -0.048 -0.049 0.119*
regulation
Self efficacy
0.211** -0.036 -0.006 -0.140** 0.166** 0.072 -0.052 -0.062 -0.110* 0.100* 0.061
1
Self efficacy
0.274** -0.014 -0.008 -0.097 0.146** 0.103* -0.056 0.031 -0.048 0.094 0.030
2
Self efficacy
0.205** 0.088 0.026 -0.128** 0.275** 0.075 -0.087 -0.077 -0.098* 0.030 -0.062
3
Concern
-0.008 -0.058 -0.053 0.092** -0.135** 0.020 0.126** 0.105** 0.092** 0.001 0.227**
perceptions
Knowledge -0.034 -0.129** -0.075 0.105 -0.170** -0.069 0.060 0.072 0.100* 0.035 0.078
238
Locus
Social Treatment Treatment Treatment Treatment Treatment Cholesterol
Attitude of
support effectiveness side effects convenience satisfaction duration severity
control
Necessity
0.065 0.098* 0.059 0.169** 0.054 0.067 0.176** 0.068 -0.121*
beliefs
Concern
-0.216** 0.070 0.018 -0.303** -0.462** -0.384** -0.506** -0.155** 0.191**
beliefs
Necessity
concern 0.209** 0.019 0.030 0.349** 0.400** 0.336** 0.507** 0.165** -0.231**
differential
Illness
-0.213** 0.092* -0.105* -0.320** -0.478** -0.345** -0.313** 0.069 0.189**
perceptions
Autonomous
0.076 0.134** 0.192** 0.280** 0.188 0.113* 0.293** 0.032 -0.116*
self regulation
Control self
0.078 0.154** 0.164** 0.111* -0.134 -0.070 0.112* 0.005 -0.020
regulation
Self efficacy 1 0.252** -0.065 0.027 0.288** 0.264 0.523** 0.401** 0.028 -0.148**
Self efficacy 2 0.231** -0.028 0.033 0.312** 0.331* 0.456** 0.416** 0.024 -0.183**
Self efficacy 3 0.249** 0.026 0.047 0.268** 0.280 0.343** 0.428** 0.045 -0.186**
Concern
-0.018 0.078* -0.054 0.024 -0.280 0.021 0.028 -0.008 0.056
perceptions
Knowledge -0.072 0.010 -0.039 -0.097* 0.053 -0.107* -0.144** 0.084 -0.039
239
APPENDIX D: CORRELATIONS IN ASTHMA MAINTENANCE MEDICATIONS

Age 1
Gender 0.054 1
Education 0.082* 0.152** 1
Race -0.142** -0.070 0.032 1
Income 0.053 0.242** 0.283** -0.032 1
Insurance 0.164** 0.038 0.051 -0.079** 0.129* 1
Depression -0.004 -0.193 -0.055 0.003 -0.006 0.008 1
Anxiety 0.040 -0.138** 0.020 -0.036 0.047 0.058 0.400** 1
Cost of
0.050 -0.029 -0.028 0.028 -0.018 -0.030 0.151** 0.130** 1
meds
Marital
0.257** -0.106** -0.053 -0.052 -0.054 0.076* 0.062 0.023 0.110** 1
Status
Complexity 0.233** -0.099** -0.056** -0.009 -0.145** 0.125** 0.367** 0.269** 0.176** 0.126** 1
240
Cost of Marital Regimen
Age Gender Education Race Income Insurance Depression Anxiety
meds status complexity
Social
.094** -.005 .007 .001 .167** .109** -.030 -.014 -.098** -.055 -.026
support
Attitude by
-.053 .088* -.022 .120** .061 .031 -.001 -.041 .047 -.045 .044
others
Internal
locus of .167** .017 -.041 -.005 .005 .061 -.011 .015 -.055 .080* -.051
control
Concern
-.008 -.057 -.053 .092** -.135** .018 .049 .022 .092** .001 .227**
perceptions
Illness
.060 -.002 -.119* -.082 -.188** .026 .095* .069 .174** .046 .217**
perceptions
Knowledge -.066 -.042 -.163** .040 .014 .019 .025 -.005 .049 .026 -.072
Treatment
-.141** -.101** -.057 .092** -.043 .018 .021 -.042 -.023 -.074* .062
duration
Disease
.070 -.093 -.136** -.041 -.212** .051 .102* .099* .113* .058 .329**
severity
241
Regimen
Educatio Depressi Cost of Marital
Age Gender Race Income Insurance Anxiety complexi
n on meds status
ty
Treatment
.089 -.015 .078 -.046 .158** .119* -.055 .023 -.129** .021 -.079
effectiveness
Treatment side
.178 -.274** -.075 -.147 .155 .113 -.170 -.005 -.111 .128 -.107
effects
Treatment
.114* -.059 .043 -.061 .084 .060 -.061 .073 -.127* .033 -.077
convenience
Treatment
.049 -.092 .080 -.039 .151** .089 -.054 .004 -.161** .030 -.058
satisfaction
Necessity
.245** -.045 -.057 -.114* -.060 .107* .095 .030 -.014 .079 .246**
beliefs
Concern beliefs -.121* .003 -.091 .021 -.085 .024 .016 .041 .022 .022 .051
Necessity
concern .278** -.036 .026 -.102* .019 .063 .060 -.009 -.027 .043 .148**
differential
Autonomous
.158** -.012 -.169** -.032 -.106* .049 .039 -.002 .002 .062 .105*
self regulation
Control self
-.006 .019 -.203** .084 -.192** -.019 .037 -.070 .042 .040 .119*
regulation
Self efficacy 1 .108* -.003 -.016 -.118* .066 .003 -.020 .045 -.032 .054 .023
Self efficacy 2 .150** -.001 .053 -.128* .026 .004 -.001 .044 -.108* .046 .007
Self efficacy 3 .228** .029 .018 -.111* .084 .054 -.011 .051 -.105* .089 .053
242
Social Attitude by Internal locus of Concern Illness Treatment Disease
Knowledge
support others control perceptions perceptions duration severity
Social support 1
Attitude by others .237** 1
Internal locus of
.060 .036 1
control
Concern
-.018 .078* -.054 1
perceptions
Illness
-.180** .076 -.147** .299** 1
perceptions
Knowledge -.110* -.025 -.195** -.029 .209** 1
Treatment
.003 .085* -.083* .038 .064 -.002 1
duration
Disease severity -.112* .070 -.079 .179** .584** .109* .094 1
243
Treatment Autono- Control Self Self Self
Treatment Treatment Treatment Necessity Concern
side NCD mous self self efficacy efficacy efficacy
effectiveness convenience satisfaction beliefs beliefs
effects regulation regulation 1 2 3
Treatment
1
effectiveness
Treatment
.409** 1
side effects
Treatment
.502** .359** 1
convenience
Treatment
.683** .516** .628** 1
satisfaction
Necessity
.168** -.100 .143** .184** 1
beliefs
Concern
-.299** -.432** -.291** -.499** .133** 1
beliefs
NCD .355** .266** .329** .519** .658** -.659** 1
Autonomous
self .245** -.082 .155** .260** .399** .050 .265** 1
regulation
Control self
.001 -.217* -.125* .010 .247** .229** .014 .505** 1
regulation
Self efficacy
.318** .287** .403** .342** .286** -.225** .387** .235** .057 1
1
Self efficacy
.341** .265** .442** .314** .214** -.190** .307** .172** -.010 .802** 1
2
Self efficacy
.340** .240* .358** .314** .228** -.250** .363** .196** .030 .733** .784** 1
3
244
Attitude Internal locus Concern Illness Treatment Disease
Social support Knowledge
by others of control perceptions perceptions duration severity
Treatment
.194** .037 .223** -.098* -.508** -.205** .118* -.384**
effectiveness
Treatment side
.070 -.280** .027 -.141 -.504** -.083 .032 -.409**
effects
Treatment
.199** -.101* .076 -.057 -.419** -.086 .016 -.264**
convenience
Treatment
.186** -.044 .173** -.105* -.500** -.248** .059 -.308**
satisfaction
Necessity
.018 -.043 .091 .150** .216** -.118* .190** .184**
beliefs
Concern
-.180** .146** .033 .166** .434** .133** .006 .234**
beliefs
Necessity
concern .150** -.143** .044 -.012 -.166** -.191** .141** -.038
differential
Autonomous
.044 .118* .297** .194** .021 -.182** .089 .047
self regulation
Control self
.045 .270** .163** .238** .244** -.055 .109* .173**
regulation
Self efficacy 1 .202** -.076 -.019 -.020 -.193** -.184** .061 -.088
Self efficacy 2 .165** -.066 .037 -.042 -.222** -.181** .094 -.104*
Self efficacy 3 .220** -.056 .018 -.010 -.226** -.180** .094 -.086
245
246
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Development of models to predict medication

Copyright 2008 Elizabeth Jisha Unni

This dissertation is available at Iowa Research Online: http://ir.uiowa.edu/etd/10

Follow this and additional works at: http://ir.uiowa.edu/etd

Part of the Pharmacy and Pharmaceutical Sciences Commons

BASED ON A NEW TYPOLOGY

Of a thesis submitted in partial fulfillment

Thesis Supervisor: Associate Professor Karen B. Farris

Medication non-adherence, the extent to which a persons behavior does not

coincide with medical or health advice, is a serious public health issue.

Objectives: 1) Develop a new typology of medication non-adherence, 2) Develop

models to predict different types of non-adherence based on Andersen Behavioral Model

two different medications used in treating disease conditions with varying

Methodology: A new typology of medication non-adherence was developed

mutability of interventions. The typology was analyzed qualitatively and quantitatively.

non-adherence each for cholesterol lowering (non-adherence due to managing issues,

schedule) and asthma maintenance medications (non-adherence due to managing and

schedule) were identified. Predisposing factors such as concern beliefs in medications,

perceptions, and severity of disease were significant predictors of medication non-

based on kappa coefficients.

Conclusion: No one typology of medication non-adherence fit cholesterol

facilitated in identifying predictors of medication non-adherence.

Abstract Approved: ____________________________________

BASED ON A NEW TYPOLOGY

A thesis submitted in partial fulfillment

Thesis Supervisor: Associate Professor Karen B Farris

ELIZABETH JISHA UNNI

All Rights Reserved

This is to certify that the Ph.D. thesis of

Elizabeth Jisha Unni

has been approved by the Examining Committee

Thesis Committee: ___________________________________

independently and progress as a researcher.

Special thanks to the other members of my graduate committee, Dr John

Brooks, Dr Elizabeth Chrischilles, Dr William Doucette, Dr Yong-Chan Kim, and Dr

valuable inputs during the development of the survey instrument.

My appreciation goes to all my colleagues in the Pharmaceutical

Socioeconomics department as well as College of Pharmacy for their friendship and

support during my time in the program.

importantly, I would like to thank my husband, Sudhir Unni. His support,

encouragement, patience, and unwavering love made me complete this dissertation.

Medication non-adherence, the extent to which a persons behavior does not

coincide with medical or health advice, is a serious public health issue.

Objectives: 1) Develop a new typology of medication non-adherence, 2) Develop

models to predict different types of non-adherence based on Andersen Behavioral Model

two different medications used in treating disease conditions with varying

Methodology: A new typology of medication non-adherence was developed

mutability of interventions. The typology was analyzed qualitatively and quantitatively.

non-adherence each for cholesterol lowering (non-adherence due to managing issues,

schedule) and asthma maintenance medications (non-adherence due to managing and

schedule) were identified. Predisposing factors such as concern beliefs in medications,

perceptions, and severity of disease were significant predictors of medication non-

based on kappa coefficients.

Conclusion: No one typology of medication non-adherence fit cholesterol

facilitated in identifying predictors of medication non-adherence.

LIST OF TABLES........................................................................................................... viii

LIST OF FIGURES ........................................................................................................... xi

Objectives of the study .....................................................................................8

2 LITERATURE REVIEW ..................................................................................10

Aims of the study............................................................................................44

Key findings from the results .......................................................................178