JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 67, NO.

5, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION AND ISSN 0735-1097/$36.00
THE AMERICAN HEART ASSOCIATION, INC. http://dx.doi.org/10.1016/j.jacc.2015.02.003
PUBLISHED BY ELSEVIER

FOCUSED UPDATE

2015 ACC/AHA Focused Update

of Secondary Prevention
Lipid Performance Measures
A Report of the American College of Cardiology/American Heart Association
Task Force on Performance Measures

Endorsed by the American Academy of Family Physicians, American Association of Cardiovascular and
Pulmonary Rehabilitation, American Geriatrics Society, American Society of Health-System
Pharmacists, Association of Black Cardiologists, Inc., Preventive Cardiovascular Nurses Association,
Society for Cardiovascular Angiography and Interventions, Society for Cardiovascular Magnetic
Resonance, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery,
Society of Cardiovascular Computed Tomography, Society of Interventional Radiology,
and Society of Thoracic Surgeons.

Writing Joseph P. Drozda, JR, MD, FACC, Chair Harlan M. Krumholz, MD, SM, FACC
Committee Brahmajee K. Nallamothu, MD, FACC
Members T. Bruce Ferguson, JR, MD, FACC, FAHA Jeffrey W. Olin, DO, FACC, FAHA, MSVM
Hani Jneid, MD, FACC, FAHA, FSCAI Henry H. Ting, MD, MBA, FACC, FAHA

ACC/AHA Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair P. Michael Ho, MD, PHD, FACC, FAHA
Task Force on Sean O’Brien, PHD
Performance Nancy M. Albert, PHD, CCNS, CCRN, CCA, FAHA Andrea M. Russo, MD, FACC
Measures Paul S. Chan, MD, MSc, FACC Randal J. Thomas, MD, FACC, FAHA
Lesley H. Curtis, PHD Henry H. Ting, MD, MBA, FACC, FAHA
T. Bruce Ferguson, JR, MD, FACC, FAHA Paul D. Varosy, MD, FACC
Gregg C. Fonarow, MD, FACC, FAHA

This document was approved by the American College of Cardiology Board of Trustees in November, 2014 and the American Heart Association Science
Advisory and Coordinating Committee in October, 2014.
The American College of Cardiology requests that this document be cited as follows: Drozda JP Jr, Ferguson TB Jr, Jneid H, Krumholz HM, Nallamothu
BK, Olin JW, Ting HH. 2015 ACC/AHA focused update of secondary prevention lipid performance measures: a report of the American College of Car-
diology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol 2016;67:558–87.
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JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
TABLE OF CONTENTS
PREAMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 559
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560
1.1. Rationale for Update . . . . . . . . . . . . . . . . . . . . . . . . 560
1.2. Structure and Membership of the
Writing Committee . . . . . . . . . . . . . . . . . . . . . . . . . 560
1.3. Disclosure of Relationships With Industry
and Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . 560
2. METHODOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561
2.1. Target Population and Care Period . . . . . . . . . . . . 561
2.2. Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . 561
2.3. Definition and Selection of Measures . . . . . . . . . . 561
3. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY
PREVENTION LIPID PERFORMANCE MEASURES . . . . . 561
3.1. Gaps in Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561
3.2. Broader Denominator (ASCVD)—
Unique to This PM Set . . . . . . . . . . . . . . . . . . . . . . 562
4. GENERAL DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . 564
4.1. Patient-Centered PMs and SDM . . . . . . . . . . . . . . 564
4.2. “Prescribed” Versus “Offered” . . . . . . . . . . . . . . . 565
4.3. Prescription Versus Adherence . . . . . . . . . . . . . . . 565
4.4. Exceptions and Exclusions . . . . . . . . . . . . . . . . . . 567
4.5. Method of Reporting . . . . . . . . . . . . . . . . . . . . . . . 568
4.6. Limitations and Unintended Consequences . . . . . 569
5. FUTURE DIRECTIONS . . . . . . . . . . . . . . . . . . . . . . . . . 569
5.1. Improved Information Systems for
Capturing Clinical Data . . . . . . . . . . . . . . . . . . . . . . 569
5.2. Measures of SDM and Shared Accountability . . . . 569
5.3. Conclusion and Summary . . . . . . . . . . . . . . . . . . . 570
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 570
APPENDIX A
2015 ACC/AHA Focused Update of Secondary
Prevention Lipid Performance Measures:
Performance Measure Set . . . . . . . . . . . . . . . . . . . . . . . 572
APPENDIX B
Author Relationships With Industry and Other Entities
(Relevant) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 582
Drozda et al. 559
Focused Update of Secondary Prevention Lipid Performance Measures
APPENDIX C
Peer Reviewer Relationships With Industry and
Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583
APPENDIX D
2015 ACC/AHA Focused Update of Secondary
Prevention Lipid Performance Measures:
Summary Analysis Table . . . . . . . . . . . . . . . . . . . . . . . . 587
PREAMBLE
American College of Cardiology (ACC)/American Heart
Association (AHA) performance measures can serve as
vehicles to accelerate appropriate translation of scientific
evidence into clinical practice. Performance measures
cover a subset of the most important recommended care
practices and are considered appropriate for public
reporting or use in pay for performance programs. Other
measures of care that are not considered appropriate for
public reporting or payment modification may be used as
quality or test metrics for internal quality improvement.
As defined by the ACC/AHA, quality metrics are those
measures that have been developed to support self-
assessment and quality improvement at the provider,
hospital, and/or healthcare system level. These metrics
may not meet all specifications of formal performance
measures (1). In certain cases, an ACC/AHA performance
measure writing committee may identify particular mea-
sures as quality metrics for the purposes of pilot testing
with the potential of later promotion to performance
measurement. Specific criteria for performance measures
have been published (2,3) by the ACC/AHA and include an
important gap in care and a clear path to improve care.
Recently, value was added as an exclusion criterion (4),
where a care practice deemed to be of poor value by an
ACC/AHA guideline would not be considered as a perfor-
mance measure. The ACC/AHA Task Force on Perfor-
mance Measures has historically focused on process of
care measures under the control of individual providers.
However, writing committees may also create structural
or outcome measures when they meet the ACC/AHA
performance measurement criteria.
A goal of the ACC/AHA Task Force on Performance
Measures is to rapidly create or update a performance
measure when there are changes to a relevant ACC/AHA
clinical guideline. Whenever possible, the ACC/AHA
attempt to create relevant performance measures imme-
diately following the publication of a guideline. However,
the ACC/AHA believe that it is important to balance speed
in measure development with a thorough review by
stakeholders, content experts, and other interested
560 Drozda et al. JACC VOL. 67, NO. 5, 2016

Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

parties using a public comment period. The goal is to have
up-to-date and valid measures that can be used by all
interested members of the healthcare system to evaluate
and improve the quality of cardiovascular care.
Paul A. Heidenreich, MD, MS, FACC, FAHA
Chair, ACC/AHA Task Force on Performance Measures
1. INTRODUCTION
The “2015 ACC/AHA Focused Update of Secondary Pre-
vention Lipid Performance Measures” Writing Committee
(the writing committee) was charged with updating the
current lipid performance measures (PMs) based on the
new recommendations in the “2013 ACC/AHA Guideline
on the Treatment of Blood Cholesterol to Reduce Athero-
sclerotic Cardiovascular Risk in Adults” (the Cholesterol
Guideline) (5). In this measure set, the writing committee
presents 5 PMs (Appendix A) 3 of which are intended for
ambulatory settings and 2 for hospital (inpatient) settings.
Four are revisions of lipid management measures
appearing in 4 existing measure sets: “ACCF/AHA/ACR/
SCAI/SIR/SVM/SVN/SVS 2010 Performance Measures for
Adults With Peripheral Artery Disease” (6); “ACC/AHA
2008 Performance Measures for Adults With ST-Elevation
and Non-ST-Elevation Myocardial Infarction” (7); “ACC/
AHA/SCAI/AMA-PCPI/NCQA 2013 Performance Measures
for Adults Undergoing Percutaneous Coronary Interven-
tion” (8); and “ACCF/AHA/AMA-PCPI 2011 Performance
Measures for Adults With Coronary Artery Disease and
Hypertension” (9). These measure sets for percutaneous
coronary intervention (PCI), coronary artery disease
(CAD), peripheral artery disease (PAD), and ST-elevation
myocardial infarction (STEMI)/non ST-elevation myo-
cardial infarction (NSTEMI) are summarized in Table 1.
The fifth measure is new and applies to the population
of patients with clinical atherosclerotic cardiovascular
disease (ASCVD) as defined in the 2013 guideline (5).
1.1. Rationale for the Update
To ensure that ACC/AHA PMs for cardiovascular disease
fulfill their intended purposes, remain relevant, and are
fully aligned with current clinical practice guidelines,
the ACC/AHA Task Force on Performance Measures
(the Task Force) requires a transparent and consistent
process that will allow focused updates to individual
PMs when needed. This may occur when new guideline
recommendations are released, when the Task Force re-
ceives feedback from end users of the measures about
critical implementation problems, or when unintended
adverse consequences associated with implementation
of the measure(s) are detected. The current writing
effort used the Cholesterol Guidelines’ recommendations
(5), which are significantly different from those of the
prior Adult Treatment Panel III guidelines and emphasize
administration of high-intensity statin therapy instead
of achievement of low-density lipoprotein cholesterol
(LDL-C) targets.
1.2. Structure and Membership of the Writing Committee
The members of the writing committee included clini-
cians specializing in interventional cardiology and general
cardiology, as well as persons with expertise in develop-
ment of guidelines and development, implementation,
and testing of PMs. Chairs for each of the previously
published PMs (Table 1) were selected for the current
writing effort.
1.3. Disclosure of Relationships With Industry and Other Entities
The Task Force makes every effort to avoid actual, poten-
tial, or perceived conflicts of interest that could arise as a
result of relationships with industry or other entities
(RWI). Detailed information on the ACC/AHA policy on
RWI can be found online. All members of the writing com-
mittee, as well as those selected to serve as peer reviewers
of this document, were required to disclose all current re-
lationships and those existing within the 12 months before
initiation of this writing effort. ACC/AHA policy also re-
quires that the writing committee co-chairs and at least 50%
of the writing committee have no relevant RWI.
Any writing committee member who develops new
RWI during his or her tenure on the writing committee is

TABLE 1 ACC/AHA Secondary Prevention Lipid PMs to Be Updated

Measure Description

2013 PCI Lipid Performance Measures (8) Percentage of patients $18 y of age for whom PCI is performed and who are prescribed optimal
medical therapy at discharge

2011 CAD Lipid Performance Measures (9) Percentage of patients $18 y of age with a diagnosis of CAD seen within a 12-mo period who have an LDL-C
result <100 mg/dL OR patients who have an LDL-C result $100 mg/dL and have a documented plan of
care to achieve an LDL-C <100mg/dL, including at a minimum the prescription of a statin

2010 PAD Lipid Performance Measures (6) Percentage of patients $18 y of age with PAD who were prescribed a statin and whose LDL-C is <100 mg/dL

2008 STEMI/NSTEMI Lipid Performance Percentage of patients with STEMI/NSTEMI who are $18 y of age with documented LDL-C level in the hospital
Measures (7) record or documented LDL-C testing done during the hospital stay or planned for after discharge

ACC/AHA indicates American College of Cardiology/American Heart Association; CAD, coronary artery disease; LDL-C, low-density lipoprotein cholesterol; NSTEMI,
non ST-elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PM, performance measure; and STEMI, ST-elevation myocardial
infarction.
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
required to notify staff in writing. These statements are
reviewed periodically by the Task Force and members of
the writing committee. Author and peer reviewer RWI
relevant to the document are included in the appendixes
(see Appendix B for relevant writing committee RWI
and Appendix C for relevant peer reviewer RWI). Addi-
tionally, to ensure complete transparency, the writing
committee members’ comprehensive disclosure informa-
tion, including RWI not relevant to the present document,
is available as an online supplement. Disclosure informa-
tion for the Task Force is also available online.
The work of the writing committee was supported
exclusively by the ACC and AHA without commercial
support. Members of the writing committee volunteered
their time for this effort. Meetings of the writing com-
mittee were confidential and attended only by committee
members and staff from the ACC and AHA.
2. METHODOLOGY
The development of PM systems involves identification of
a set of measures targeting a specific patient population
observed over a particular period. To achieve this goal,
the Task Force has outlined a set of mandatory sequential
steps (2). The following sections outline how these steps
were applied by the present writing committee.
2.1. Target Population and Care Period
The target population for the ASCVD PM reflects the
ACC/AHA Cholesterol Guidelines (5) population and
consists of patients ages 18 to 75 years. In the focused
update of the 4 existing lipid PMs, the target population
consists as well of patients ages 18 to 25 years, repre-
senting a change from the age range previously speci-
fied in each measure set. This change was felt to be
necessary in order to maintain consistency with the
Class of Recommendation I, Level of Evidence A re-
commendation in the guidelines for treatment of pa-
tients with clinical ASCVD. Additionally, the writing
committee developed exclusion criteria for the mea-
sures where appropriate in order to further specify the
target population.
2.2. Literature Review
The writing committee used the Cholesterol Guidelines
(5) as a primary source for deriving the measures. The
writing committee also carried out a literature review to
assess contemporary gaps in care.
2.3. Definition and Selection of Measures
The writing committee focused on developing these
measures against the ACC/AHA attributes of PMs. Each
measure was constructed in a way to ensure it was evi-
dence based, desirable in regard to measure selection,
Drozda et al. 561
Focused Update of Secondary Prevention Lipid Performance Measures
feasible to implement, and consistent with accountability
(Table 2). After the peer review and public comment
period, the writing committee reviewed and discussed
the comments and made further refinements in the
measure set. The writing committee evaluated the po-
tential measures against the ACC/AHA attributes of PMs
(Table 2) to reach consensus on which measures should
be advanced for inclusion in the final measure set;
the Summary Analysis Table (Appendix D) captures this
evaluation process. The majority of the writing com-
mittee believed that the 5 measures in the set fulfilled
the PM attributes.
3. 2015 ACC/AHA FOCUSED UPDATE OF
SECONDARY PREVENTION LIPID
PERFORMANCE MEASURES
3.1. Gaps in Care
Each of the original writing committees that developed
the measures revised in this update identified secondary
prevention performance gaps in the patient populations
that were the subjects of their measure sets. There is
evidence that these gaps are ongoing, although the
published studies deal primarily with prescription of
medication.
A study from the REACH (Reduction of Athero-
thrombosis for Continued Health) Registry found that
only 83% of ambulatory patients with known ASCVD
were receiving lipid-lowering agents (11). A prospective
study by Rabus and colleagues of 73 patients with an-
giographically diagnosed CAD found that only 44%
received prescriptions for statins (12). Reports from the
National Cardiovascular Data Registry PINNACLE Reg-
istry of ambulatory patients with CAD revealed that
only 66.5% (103,830 of 156,145) were receiving optimal
medical therapy (OMT), including statins (13), that
77.8% (30,160 of 38,775) were prescribed statins (14),
and that uninsured patients were 6% less likely to
receive lipid-lowering therapy (15). Additionally, the
study by Maddox and colleagues found substantial
variation in prescription patterns by practice site (13,15).
Shah and colleagues reported that, among 292 patients
from Olmstead County, MN, with incident acute myo-
cardial infarction (MI), only 44% were still taking sta-
tins 3 years after their infarction (16). Interestingly, a
study by Borden and colleagues (17) involving patients
in the National Cardiovascular Data Registry CathPCI
Registry failed to show any significant improvement
in the prescription of OMT after PCI following publica-
tion of the results of the Clinical Outcomes Utilizing
Revascularization and Aggressive Drug Evaluation
(COURAGE) study, which had demonstrated no incre-
mental advantage of PCI over OMT on outcomes other
than angina-related quality of life in stable CAD. Among
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Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

TABLE 2 ACC/AHA Task Force on Performance Measures Attributes for PMs

1. Evidence Based

High-impact area that is useful in improving patient outcomes a) For structural measures, the structure should be closely linked to a meaningful process of care
that in turn is linked to a meaningful patient outcome.
b) For process measures, the scientific basis for the measure is well established and the process
should be closely linked to a meaningful patient outcome.
c) For outcome measures, the outcome should be clinically meaningful. If appropriate, PMs based
on outcomes should adjust for relevant clinical characteristics by using appropriate
methodology and high-quality data sources.
2. Measure Selection
Measure definition a) The patient group to whom the measure applies (denominator) and for whom conformance
is achieved is clearly defined and clinically meaningful.
Measure exceptions and exclusions b) Exceptions and exclusions are supported by evidence.
Reliability c) The measure is reproducible across organizations and delivery settings.
Face validity d) The measure appears to assess what it is intended to assess.
Content validity e) The measure captures most meaningful aspects of care.

Construct validity f) The measure correlates well with other measures of the same aspect of care.
3. Measure Feasibility
Reasonable effort and cost a) Data required for the measure can be obtained with reasonable effort and cost.
Reasonable period b) Data required for the measure can be obtained within the period allowed for data collection.
4. Accountability
Actionable a) Those held accountable can affect the care process or outcome.
Unintended consequences avoided b) The likelihood of negative unintended consequences with the measure is low.

Adapted with permission from Normand et al. (10).

ACC/AHA indicates American College of Cardiology/American Heart Association; and PM, performance measure.

all 467,211 patients (173,416 before [37.1%] and 293,795
after [62.9%] the COURAGE trial) who met the study
criteria, the use of OMT at discharge following PCI
before and after the COURAGE trial
(95% confidence interval, 63.3% to 63.7%) and 66.0%
(95% confidence interval, 65.8% to 66.1%), respectively
(p < 0.001).
The extent to which statin treatment is initiated as a
result of a shared decision-making (SDM) process be-
tween patient and clinician has not been systematically
assessed but is likely small. Additionally, there is min-
imal information available about the statin doses being
used in practice, although there are reasons for concern
that many patients are being undertreated. It is com-
mon practice among clinicians to use the smallest dose
of a medication necessary to achieve a therapeutic
target and minimize the chance of adverse effects. Even
PMs such as those revised in this focused update
exclude the requirement for therapy in patients who
have achieved goals. A study of 38,775 patients in
the PINNACLE Registry by Arnold and
revealed findings consistent with undertreatment of
patients with CAD (14). They found that 6,573 (17.0%)
patients were not receiving any lipid-lowering therapy.
Cholesterol levels were available for 3,365 of these pa-
tients, 1,794 (53.3%) of whom had LDL-C levels <100
mg/dL, consistent with clinicians either failing to treat
or discontinuing lipid-lowering therapy when patient
LDL-C levels met the previously recommended thera-
peutic target. In a secondary analysis of the Trans-
lational Research Investigating Underlying Disparities in
was 63.5% Acute Myocardial Infarction Patients’ Health Status
(TRIUMPH) study, only 23% of 4,271 patients discharged
alive following an acute MI were on maximal statin
therapy, with substantial variability across hospitals
(18). Finally, a study in the Get With The Guidelines
Registry of 65,396 patients with acute coronary syn-
dromes (ACS) who were discharged with lipid-lowering
agents found that only 38.3% were discharged with
intensive lipid-lowering therapy (19). An editorial chal-
lenged measure developers to track the use of effective
drug therapy, including dose (20). The current measures
are designed therefore not only to promote the use of
statins as recommended by the Cholesterol Guidelines
(5) but also to emphasize the importance of high-
intensity dosing.
3.2. Broader Denominator (ASCVD)—Unique to This PM Set
colleagues The target population for the ASCVD PM includes women
and men between 18 and 75 years of age who have clinical
ASCVD, which includes the following: ACS, history of MI,
stable or unstable angina, coronary (including PCI) or
other arterial revascularization, stroke, transient ischemic
attack, or PAD. Although this patient population seems
heterogeneous, it encompasses a variety of patients
who all share presumed atherosclerosis (21) as a common
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
pathophysiology. Atherosclerosis is a chronic diffuse
disease involving a myriad of arterial beds with inter-
mittent acute clinical manifestations, predominantly
occurring as a result of superimposed thrombosis, plaque
progression, spasm, embolism, or a combination of the
above. Other pathophysiological processes can contribute
to the creation of stenosis or aneurysms in the arterial
circulation; however, atherosclerosis remains the most
common pathophysiology.
Patients with clinical ASCVD represent 1 of 4 major
groups identified by the writing committee of the
Cholesterol Guidelines (5). For these patients, treatment
with a 3-hydroxy-3-methylglutaryl-coenzyme A reductase
inhibitor, commonly known as a statin, is clearly benefi-
cial. According to the Cholesterol Guidelines (5), patients
with clinical ASCVD were identified by using the inclusion
criteria from randomized clinical trials (RCTs) in second-
ary prevention. In addition, the potential for reduction
of risk for ASCVD with statins in these patients clearly
exceeds the potential for adverse effects (22).
The Cholesterol Treatment Trialists provided
comprehensive assessment of the benefits observed with
statins (23). They undertook meta-analyses of individual
participant data from 26 RCTs and demonstrated reduc-
tion in all-cause mortality, which was largely attributable
to significant reductions in deaths due to CAD and other
cardiac causes (23). The majority of studies in the afore-
mentioned report included patients with known ASCVD.
Of the 26 RCTs included, 5 trials (39,612 subjects, all of
whom had CAD) compared more versus less intensive
statin regimens. The trials demonstrated that more
intensive regimens produced a highly significant 15%
further reduction in major vascular events, driven by re-
ductions in coronary death or nonfatal MI, coronary
revascularization, and ischemic stroke (23). The in-
vestigators also found no significant effects
served on deaths due to cancer or other nonvascular
causes or on cancer incidence, even at low LDL-C
concentrations (23).
The aforementioned report was a meta-analysis of
RCTs (23). Concerns about the quality and quantity of
safety reporting in RCTs have been raised previously,
and many researchers find the reporting of risks in
RCTs to be largely inadequate (24–26). Data from
RCTs should generally be supplemented by evidence
from effectiveness studies to inform best clinical
practice (27).
On extensive examination of clinical studies from the
literature, the current clinical evidence does not support
the notion that titrating lipid therapy to achieve pro-
posed low LDL-C levels is beneficial or safe. Conversely,
compelling evidence supports near-universal empirical
statin therapy for patients at high cardiovascular risk
regardless of their LDL-C levels (28). Thus, many argued
Drozda et al. 563
Focused Update of Secondary Prevention Lipid Performance Measures
to abandon the paradigm of treating patients to LDL-C
targets and instead replace it with a more tailored treat-
ment approach (i.e., personalized care), which aims not
only to improve patient outcomes but also reduce harms
and costs caused by overtreating patients at low risk
(29,30).
For patients with ACS, which includes unstable
angina, NSTEMI, and STEMI, the general period of
assessment is the inpatient hospitalization or related
emergency department visit. For other patients (non-
ACS patients), the PM is intended to assess the care for
patients at the practitioner level in an ambulatory care
setting for the primary purpose of quality improvement.
For these non-ACS patients, the outpatient care period
is defined as the care provided in an outpatient setting
within the time under evaluation, which is usually
12 months.
There are important potential exceptions for routine
initiation of statin treatment. For primary prevention,
the Cholesterol Guidelines expert panel determined that,
a despite the high level of risk for cardiovascular disease
in patients with a higher New York Heart Association
class of heart failure or receiving hemodialysis, the
available evidence suggests that initiation of statin
therapy might not achieve a significant risk reduction
(31–33). In recognizing this, the expert panel made no
recommendations about the initiation or discontinuation
of statins in these populations, allowing for physician
judgment in individual patients (5). Additional excep-
tions and exclusions related to secondary prevention
measures are discussed in a separate section of this
report.
Historically, the Task Force has developed separate
sets of PMs in discrete patient populations, including
patients with STEMI and NSTEMI (7), PAD (6), CAD (9),
ob- and those undergoing PCI (8). These separate seminal
documents, each inclusive of a PM pertaining to statin
therapy in its corresponding population, may generally
be more useful in specialty care quality improvement
programs. Although the writing committee is adhering
to this philosophy in revising the lipid PMs for each of
these 4 specific populations, it is taking a novel
approach in creating a new PM that applies to the
much broader population of patients with ASCVD. This
PM is concordant with the Cholesterol Guidelines (5),
which was based on evidence from RCTs and their
meta-analyses showing risk reduction among the vari-
ety of patients with clinical ASCVD, including those
with ischemic cerebrovascular events. The writing
committee believes that primary care clinicians and
specialists concerned with secondary prevention of
ASCVD will find these new PMs easy to use in the
clinical setting. The 5 updated measure sets are sum-
marized in Table 3.
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Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

TABLE 3 2015 ACC/AHA Focused Update of Secondary Prevention Lipid PMs

PM Description

PAD Percentage of patients 18-75 y of age with PAD who were offered moderate- to high-intensity statin

STEMI/NSTEMI Percentage of patients 18-75 y of age with AMI who were offered moderate- to high-intensity statin at hospital discharge

PCI Percentage of patients 18-75 y of age for whom PCI was performed who were offered optimal medical therapy at discharge

CAD Percentage of patients 18-75 y of age with CAD who were offered moderate- to high-intensity statin

ASCVD Percentage of patients 18-75 y of age with clinical ASCVD who were offered moderate- to high-intensity statin

ACC/AHA indicates American College of Cardiology/American Heart Association; AMI, acute myocardial infarction; ASCVD, atherosclerotic cardiovascular disease; CAD, coronary artery
disease; NSTEMI, non-ST elevation myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PM, performance measure; and STEMI, ST elevation
myocardial infarction.

4. GENERAL DISCUSSION outcomes that matter to patients. A PM that integrates

4.1. Patient-Centered PMs and SDM
The recommendation to initiate statins for secondary
prevention is based on strong evidence in which benefit
far exceeds risk (34). However, better patient outcomes
are realized only if patients agree with, act on, and adhere
to the recommendation for 5 to 10 years. The importance
of clinician-patient discussions about statin therapy is
specifically emphasized in the Cholesterol Guidelines
(5). Among patients who are prescribed statins for sec-
ondary prevention, most initiate treatment, but up to half
discontinue statins at 1 to 2 years’ follow-up (16,35).
Therefore, a PM that represents only the number of pa-
tients prescribed statins in the numerator divided by the
number of patients eligible to receive statins for second-
ary prevention in the denominator is inadequate and
does not reflect quality of care. Rather, a measure that
reflects the proportion of patients who participated in
SDM would promote patient participation in the treat-
ment plan, potentially increasing adherence to guideline-
recommended care and improving patient-centered
outcomes.
SDM: What Is It?
The SDM approach aims to promote a process whereby
patients and clinicians together make a choice about
treatments that incorporates 2 perspectives: 1) clinicians
recommending treatments based on strong evidence in
which benefit exceeds risk, and 2) patients deliberating on
how treatments fit with their preferences, values, and
personal context (36). In this framing, the clinician is the
expert on evidence-based medicine and guidelines, and
the patient is the expert on his or her preferences, values,
and personal context. SDM mitigates the power differen-
tial between these 2 experts and acknowledges that both
perspectives contribute equal weight to decision making.
By incorporating patient preferences, values, and per-
sonal context to decision making, clinicians strengthen
their implementation of evidence-based medicine and
guidelines in a patient-centered manner to improve
patient values, preferences, and personal context with
evidence-based medicine and guidelines is novel and
changes the focus from recommending and prescribing
statins based on strong evidence to promoting choice
by an informed patient whether or not to initiate statins.
SDM: Why Do It?
SDM has often been framed as an approach to curb over-
use of expensive or unnecessary treatments. However,
clinicians and healthcare organizations should bear
the responsibility for curbing overuse, that is, recom-
mending treatments where benefit does not exceed risk.
The rationale for SDM includes patient safety, patient
engagement, patient experience, and ethical principles.
The patient safety reasoning arises from the notion that a
misdiagnosis of a patient’s medical condition leads to
unnecessary and unwanted tests and treatments associ-
ated with harm and cost. Similarly, misdiagnosis of a pa-
tient’s preferences, values, and personal context can lead
to unnecessary and unwanted treatments. The patient
engagement principle poses the question “What would
the patient choose if the patient knew what the clinician
knows?” When patients are offered the opportunity to
participate in SDM, the majority prefer this approach, and
patient satisfaction and experience with care improve
(37). The ethical justification for SDM is based on the
principle of autonomy that patients should be empowered
to make informed decisions about their health.
SDM: How to Do It?
The path forward includes advancing how clinicians
engage patients in decision making, developing tools to
promote and facilitate SDM, and measuring that SDM
occurred (38,39). Clinicians need to embrace the concept
that evidence-based medicine and guidelines alone are
not sufficient to make a recommendation or decision;
rather, the evidence has to be considered from the view-
point of what matters to individual patients. Hence,
the clinical encounter transforms from one where
the clinician strives to convince the patient of the
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
“right answer” to one where the clinician and patient
collaborate, deliberate, and arrive at the “best answer”
that fits patient preferences, values, and context. Decision
aids are one type of tool used during clinical encounters
and have been shown to increase knowledge transfer to
patients about personalized benefit and risk, improve
patient involvement in decision making, and reduce
decisional conflict (40). Decision aids can be implemented
at the point of care to promote SDM, including the choice
of whether or not to initiate a statin for the next
5 to 10 years to lower cardiovascular risk (http://
statindecisionaid.mayoclinic.org). Measuring the occur-
rence of SDM is a developing science, and in the scenario
of clinicians recommending statins for secondary pre-
vention, potential measures to assess if SDM occurred
include: 1) Does the patient know his or her personalized
cardiovascular risk? 2) Was a statin offered to reduce risk?
3) What decision did the patient make about whether or
not to initiate statins?
4.2. “Prescribed” Versus “Offered”
A true measure of SDM would assess the process of
imparting information on statin therapy, including ben-
efits, harms, and alternative approaches, along with
the patient “outcomes” of that discussion. The possible
outcomes of SDM on statin therapy would be that the
1. Patient agrees to initiate statin therapy and gets a
prescription
2. Patient declines to initiate statin therapy
3. Patient is undecided and will continue deliberations
Given the short time frame available for completing
this focused update, it was determined that developing a
measure of SDM that could be implemented inclusive of
its key components was not possible, and the decision
was made to defer this task to the writing committees of
each of the individual PM sets at the times of the next full
revisions. At the same time, the writing committee
determined that it would be important to put forward
measures that more closely approximated SDM than do
measures of prescription only.
Prescription-only measures have the disadvantage that
they assess an action (prescribing medication) that is
completely under a provider’s control but one that can be
performed without any participation by the patient. In
other words, prescription-only measures reflect none of
the patient outcomes of SDM.
The writing committee thought that, at the least, some
indication of the outcome of a patient declining a statin
prescription should be included in the numerator. An
example of reporting such a PM is presented in Figure 1.
The ACC/AHA PM methodology states that if the provider
documents the patient’s refusal of medication, the pa-
tient should be removed from the denominator of the
Drozda et al. 565
Focused Update of Secondary Prevention Lipid Performance Measures
measure as an exception for patient reasons (2). In these
instances, the patient is removed from both numerator
and denominator. This approach does accommodate SDM.
However, the writing committee decided to construct
measures whereby patients with exceptions for patient
reasons would be retained in both numerators and de-
nominators in order to “give credit” for SDM rather than
have these efforts simply disappear from measures
should the patient decline medication. The combination
of “prescribed” and “exception for patient reasons” was
termed “offered” and was considered to be a surrogate
for the patient outcomes of agreement and decline and
to represent an initial step away from the current state
of measuring prescribing toward more comprehensive
and direct measures of SDM. The methodology of
capturing patients with exceptions in the numerator was
actually used in the construction of the prior PAD statin
measure so that patients with LDL-C levels <100 mg/dL
who had medical or personal reasons for not being pre-
scribed a statin were retained in the numerator (6).
Additionally, a strength of using patient exceptions in
this manner is that it does not require capturing any new
data elements for the measures but is simply an alter-
ation of measure construction using the same measure
components.
The writing committee also thought that it was
important for the measures to reflect the Cholesterol
Guidelines’ recommendation that patients with clinical
ASCVD be offered high-intensity statin therapy and
receive moderate-intensity statin when high-intensity
statin therapy is contraindicated according to each
manufacturer’s prescribing information or when charac-
teristics predisposing the patient to statin-associated
adverse effects are present (5). Again, it was determined
that the statin dose should also be subjected to SDM.
As such, patients “offered” high-intensity statin therapy
are included in the numerators and denominators of
the revised measures, as are patients who have docu-
mented medical exceptions (2) for not being offered a
high-intensity statin and who are “offered” a moderate-
intensity statin instead. Patients with medical excep-
tions to moderate-intensity statin therapy are excluded
both from the numerators and denominators. High-
intensity and moderate-intensity statins are defined
according to the dosing tables included in the Cholesterol
Guidelines (5).
4.3. Prescription Versus Adherence
Rethinking Adherence
The writing committee also considered measures of
patient adherence to statin medications but ultimately
concluded that, as with prescription-only measures, such
measures would not be optimal for assessing provider
performance and improving quality of care. Measures of
566 Drozda et al. JACC VOL. 67, NO. 5, 2016

Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

F I G U R E 1 Method for Reporting Secondary Prevention Lipid PMs: Example Using PM for the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults With ST-Elevation and Non–ST-Elevation Myocardial Infarction

Patients with STEMI and NSTEMI (hypothetical sample meeting denominator

criteria) 105

Exceptions:
Patients not prescribed statins for medical reasons (excluded from numerator and
denominator) 3

Exclusions (excluded from numerator and denominator) 2

Patients not prescribed statins for patient reasons (included in numerator and
denominator) 10

Patients prescribed statins 80

Patients not offered statins (not prescribed and with no documented exceptions) 10

Measure calculation (percentage of patients with STEMI and NSTEMI statins):

Numerator (80+10) 90
Denominator (105–5) 100
Performance 90%

Numerator analysis:
Proportion of patients prescribed statins calculation:
Numerator 80
Denominator 100
Proportion prescribed statins 80%

Proportion of patients not prescribed statins for patient reasons:

Numerator 10
Denominator 100
Proportion not prescribed statins for patient reasons 10%

NSTEMI indicates non–ST-elevation myocardial infarction; PM, performance measure; and STEMI, ST-elevation myocardial infarction.

adherence suffer from the same inadequacy as measures
of prescription in that they ignore patient preferences.
Furthermore, adherence is a different process, occurring
after the patient has agreed to a treatment plan as a result
of SDM. Measures of adherence oversimplify complex
human behaviors, and when used in provider incentive
and public reporting programs, put the onus for adher-
ence entirely on the clinician. Additionally, measuring
adherence is quite difficult, particularly when using
clinical data from the electronic health record (EHR).
Several components ultimately determine whether a
patient derives maximum benefit from medications that
decrease cardiovascular event rates. Clinicians must pre-
scribe the medication at an optimal dose and the patient
must take the medication as instructed on a long-term
basis. There is still an opportunity to improve persis-
tence in taking statins among patients with known car-
diovascular disease. This is especially true for patients
with PAD: only 33% were using statins within 3 months of
incident diagnosis, whereas 37% were using statins 18
months after incident diagnosis (41).
Ensuring adherence is not simply a matter of writing a
prescription and advising the patient to take the medi-
cation (42). It has been estimated that at 2 years’ follow-
up, one-half of patients are no longer taking statins (42).
The discontinuation rate is highest in patients with
asymptomatic chronic diseases such as hypertension and
hypercholesterolemia (42). In those who do not discon-
tinue the medication completely, studies have demon-
strated that patients take fewer than 50% of the doses
prescribed (42). Nonadherence to taking medication is an
important public health consideration, affecting health
outcomes and overall healthcare costs (43). The concept
of shared accountability as related to long-term adher-
ence and PMs is important to achieve the ultimate goal
of improved patient outcomes and quality of life. Shared
accountability must include the healthcare team, the
healthcare system, and the patient (44). At the same
time, it remains important that the clinician and patient
have ongoing discussions about statin therapy and the
reasons for less than optimal adherence if such is found
to be the case.
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FEBRUARY 9, 2016:558–87
Intentional and Unintentional Nonadherence
The reasons for the high discontinuation rate and missed
doses are complex and multifactorial and may include
both intentional (45) and unintentional nonadherence
(46):
1. Cost of medication
2. Patient cannot afford the co-pay
3. Unclear label instructions
4. Patient forgetfulness
5. Adverse effects from medication that patient is too
embarrassed to discuss with doctor
6. Patient does not like the idea of having to take
medication
7. Patient does not understand the importance of a given
medication for a condition for which he or she has no
symptoms
8. Patient–practitioner relationship is suboptimal
9. Polypharmacy and complexity of regimen
It is important to understand the concept of “unin-
tentional nonadherence,” which is defined in the Institute
of Medicine report Health Literacy: A Prescription to End
Confusion as “the degree to which individuals have the
capacity to obtain, process, and understand basic health
information and services needed to make appropriate
health decisions (47).” Unintentional nonadherence is
thought to be a passive process on the part of the patient
and may involve a lack of understanding of physical
problems, resulting in an inability to follow treatment
instructions, impaired manual dexterity, poor eyesight, or
forgetfulness. In a recent systematic review and meta-
analysis, it was noted that there is a statistically signifi-
cant relationship between health literacy and medication
adherence; however, the magnitude of effect was small
when compared with other causes of nonadherence, such
as medication beliefs and cost (48). One of the most
important aspects of long-term medication adherence is
to review the medication list; ask about adverse effects,
cost, and adherence; and discuss barriers to adherence at
every office visit (44). Finally, the shared accountability
of all of those involved in the prescription process,
including the patient, is critical to the success or failure of
long-term medication adherence (44).
Medication adherence is dependent on a complex
interrelationship between the disease and demographic
and socioeconomic factors; beliefs of the patient and the
patient’s family and friends; the medication itself; and
the healthcare system (patient care provider interaction,
access to care and care organizations) (49). It is readily
apparent that an individual clinician should not be solely
accountable for a patient’s adherence to medication,
because many factors related to nonadherence are out of
the healthcare provider’s control, although there are
measures the clinician can take to increase the likelihood
Drozda et al. 567
Focused Update of Secondary Prevention Lipid Performance Measures
of adherence. These include the quality of the patient
care provider relationship, SDM, and avoidance of
overly complex and expensive medication regimens.
A Cochrane Database systematic review concluded
that some interventions were nominally effective in the
short term. However, it was found that current methods of
improving adherence for chronic health problems are
mostly complex and not very effective (43). These complex
solutions to adherence included combinations of more
convenient care, information, counseling, reminders, self-
monitoring, reinforcement, family therapy, psychological
therapy, mailed communications, crisis intervention,
manual telephone follow-up, and other forms of addi-
tional supervision or attention (43). Even with the most
effective methods to increase adherence, the magnitude of
effect was quite small. Clearly, much more research is
needed to determine the causes of nonadherence and to
develop patient- and systemwide strategies to reduce the
likelihood that the patient will stop taking medication
shown to have beneficial effects on overall health.
4.4. Exceptions and Exclusions
The detailed description of exceptions is central to the
characterization of the PM for the treatment of blood
cholesterol to reduce the risks of ASCVD in adults with
established disease. In developing exceptions and exclu-
sions for these measures, the writing committee fol-
lowed the ACC/AHA PM development methodology (2,3),
which is concordant with that of the American Medical
Association Physician Consortium for Performance Im-
provement (now PCPI) (50). Notably, measure exceptions
are based predominantly on clinical judgment, individual
patient characteristics, or patient preferences. On the
other hand, exclusions are used in circumstances not
requiring clinical judgment to factor into the decision
making (e.g., patients who died, left against medical
advice, or were discharged to hospice). In accordance
with the ACC/AHA PM development methodology (3),
the writing committee maintains that if a patient has a
potential contraindication but does in fact receive treat-
ment, then that patient should be included in both the
numerator and denominator of the PM. This approach
recognizes that contraindications may be relative and re-
wards clinicians for exerting clinical judgment and suc-
cessfully fulfilling the PM (by offering a medication when
the clinician believes the benefits outweigh the risks).
The writing committee recognizes that there are justifi-
able reasons for patients not receiving a service that
is the subject of a process PM. According to the ACC/AHA
report “New Insights Into the Methodology of Performance
Measurement” (3), exceptions are used in these instances
because the data from these patients should still be
captured for the purposes of internal quality improvement
analyses. Exceptions can be related to medical reasons
568 Drozda et al.
Focused Update of Secondary Prevention Lipid Performance Measures
(e.g., the patient’s allergic history, concern for potential
adverse drug interaction, and intolerance to therapy), pa-
tient reasons (e.g., patient preference, social or religious
reasons, economic reasons), or system reasons (e.g., lack
of available resources, insurance coverage/payer-related
limitation). The writing committee has provided for ex-
ceptions from the denominator for medical reasons only
and does not allow exceptions for system reasons. The
writing committee concluded that the frequency of events
that could be interpreted as system reasons for not offering
a statin would be very low and would not likely have a
material impact on measure results, making it unnecessary
to make provisions for them in measure construction.
(As noted previously, patients with exceptions for pa-
tient reasons are retained in the denominator.) Addition-
ally, the writing committee has chosen to use only
exceptions for most patients with ASCVD but has also
made exclusions for patients with STEMI and NSTEMI
and those undergoing PCI in concordance with the meth-
odology previously used in the PM documents for these
patients (7,8).
The ACC/AHA PM methodology (2,3) advocates that all
patients who receive the treatment (e.g., statin) should be
included in the numerator and denominator of the mea-
sure and that the assessment of the documented contra-
indications to therapy will be undertaken only among the
remaining patients who did not receive it. As previously
noted (7), some contraindications are relative or tempo-
rary or both and may resolve between the time of docu-
mentation and provision of therapy. This approach will
likely help eliminate false exclusions of patients who are
ultimately appropriately treated and further decrease the
burden of data abstraction.
The writing committee endorses the recommendations
in the ACC/AHA PM methodology report (3) that clinicians
document the specific reasons for exclusions and excep-
tions in the patient’s health records for purposes of
optimal patient management, future research, and audit-
readiness; to identify practice patterns and opportunities
for quality improvement; and for accountability purposes.
The sources of data where exclusions and exceptions can
be sought include all administrative data and claims,
prospective flow sheets, and patient health records (both
electronic and hard copy [paper]). The writing committee
maintains that the abstractor may wish to pay close
attention to the clinician’s documentation. In the patient
health record, any of the above care providers must still
link the specific reason reported for the nonuse of statins
for the documentation to count as a reason for not offering
moderate- to high-intensity statin (as an example:
“Patient receiving hemodialysis; no statins needed”).
The writing committee has revised the exceptions and
exclusions for the lipid measures from the prior PM doc-
uments (6–9). Most importantly, it has decided not to
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
exclude patients with a known LDL-C level <100 mg/dL,
as was done specifically in the “ACC/AHA 2008 Per-
formance Measures for Adults with ST-Elevation and
Non-ST-Elevation Myocardial Infarction” (7). This is in
alignment with the Cholesterol Guidelines (5), which do
not recommend an approach of treat-to-cholesterol target
but rather the use of fixed doses of cholesterol-lowering
drugs (specifically statins) to reduce the risk of ASCVD.
This is also concordant with the evidence from RCTs
showing that ASCVD events are reduced by using maxi-
mally tolerated statins in those patients shown to benefit
(23). Notably, statin dosage increases occurred in only a
few RCTs with the intent of maximizing therapy, but
these were not true tests of defining optimal goals for
LDL-C, because not all persons in the statin treatment
groups received drug therapy titrated to achieve a specific
LDL-C, nor were specific treatment targets compared (5).
Denominator Exclusions (Not Included in Numerator or
Denominator)*:
 Patient died
 Patient left against medical advice
 Patient discharged to hospice or for whom a comfort
measures only order is documented
 Patient transferred to another hospital for inpatient care
Denominator Exceptions (Not Included in Numerator or
Denominator):
 Documentation of medical reason(s) for not prescribing
a statin (e.g., allergy, intolerance to statin[s], hepatic
failure, hemodialysis, heart failure, other medical
reasons)
4.5. Method of Reporting
In selecting a methodology for measures that calls for
inclusion of patients in the numerator for 1 of 2 reasons,
that is, patients for whom statins were prescribed and
patients for whom statins were not prescribed for patient
reasons, the writing committee recognizes the need for
more visibility for both components of the numerator.
The writing committee therefore recommends that
reporting of these measures include the proportion of
patients for whom statins were prescribed and the pro-
portion for whom statins were not prescribed due to ex-
ceptions for patient reasons. In this construct, the
percentage of patients offered statins remains the PM for
accountability purposes, whereas reporting the additional
data provides full transparency for the components of
the measure along with information useful to the care
team in understanding their performance (Figure 1).
*Apply specifically to STEMI/NSTEMI and PCI measure sets.
JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
4.6. Limitations and Unintended Consequences
The writing committee recognizes that a different
approach to medication PMs from that used with most
prior such measures is presented in this paper. As such, at
this time conclusions cannot be drawn about the effec-
tiveness of these measures in helping to close the per-
formance gaps described above. Furthermore, as with all
PMs, the potential for unintended consequences exists
for these measures and may be greater because of the
different methodology being used. For instance, when
PMs are used in accountability programs, the risk of
“gaming” by clinicians is always present. Clinicians could,
for example, convince patients not to take high-intensity
statins for fear of adverse effects and still receive “credit”
under the methodology described herein. The method for
reporting these measures described in this paper should
mitigate the potential for gaming, but it remains to be
seen whether or not that will be the case. Although the
writing committee is convinced that these measures will
assist clinicians in improving patient care, careful evalu-
ations of benefits and unintended consequences should
be carried out, particularly when they are used in pay-
for-performance and public reporting programs.
5. FUTURE DIRECTIONS
5.1. Improved Information Systems for Capturing Clinical Data
Measures of provider-patient interaction, including SDM,
require data from clinical sources such as EHRs and clin-
ical registries and cannot be derived from insurance
claims. Unfortunately, challenges remain for imple-
mentation of such measures in clinical data sets. EHRs
have a relatively constrained number of discrete data
fields related to provider-patient encounters that can be
used for calculating measures. In addition, significant
variation in data definitions exists among registries and
EHRs and among instances of ostensibly the same EHR,
making comparisons among providers difficult. Finally,
and of particular importance to measures of SDM, patient-
reported data are rarely captured in EHRs or registries.
Registries have typically obtained discrete data
through the use of case report forms, but completion of
such forms is labor intensive and not a feasible solution in
the nonresearch clinical setting. Checklists and “smart
forms” are often used in EHRs to collect key data ele-
ments for PMs, particularly measures of patient education
and counseling. These techniques have proved to be
less than satisfactory, because checking a box that SDM
has occurred communicates little of what that process
included. Additionally, smart forms require additional
work by the provider during the patient encounter and
are therefore used only sporadically.
As was the case with the original measures on which
they are based, the revised lipid measures were designed
Drozda et al. 569
Focused Update of Secondary Prevention Lipid Performance Measures
with the current reality of clinical information systems in
mind. For truly robust measures of SDM to be feasible,
significant improvements in collecting clinical data will
be required. Efforts to capture data in the course of care,
as opposed to requiring providers to enter data, are being
made by a variety of health information technology
companies and by registries such as the National Cardio-
vascular Data Registry PINNACLE Registry, which em-
ploys a system integration software utility (51) to extract
elements from the EHR that are necessary for measures
calculation. Structured data capture whereby data from
the EHR would be collected as discrete elements has
been recognized by the Office of the National Coordinator
for Health Information Technology as a priority and is
the subject of a major initiative (52). An example of a
“structured format” is a standardized provider office note
that contains discrete fields for key data elements
potentially including those necessary for assessing SDM.
Methods for capturing patient-reported data for com-
parative effectiveness research are also being inves-
tigated, with significant interest in the use of EHR
patient portals for that purpose (53). Patient-reported
data collected in this way would be useful as well in
assessing SDM from the patient’s point of view. Addi-
tionally, integration of EHR-derived data with national
registries would provide a mechanism for implementation
of standard data definitions, enabling valid comparisons
and analyses employing common data models.
5.2. Measures of SDM and Shared Accountability
SDM has been a core concept that the writing committee
has considered in the construction of these PMs for statin
therapy in ASCVD. It is the writing committee’s rationale
for the numerator to include the number of patients
offered a statin as defined. This outcome reflects both
patients who declined a statin as well as those for whom a
prescription was provided. However, measuring whether
or not SDM has occurred during a clinical encounter is a
developing science and pushes the boundaries of the new
field of shared accountability measures. In particular,
determining whether high-quality SDM has been provided
depends on understanding the process. Ideally, this in-
volves the extent to which a patient 1) has obtained
knowledge of the risks and benefits of a decision, and 2)
has demonstrated engagement in the decision-making
process through deliberations that consider the patient’s
preferences, values, and capacity for action and agree-
ment for long-term adherence. Future approaches to
address PMs in this area will require a better under-
standing of both of these issues, perhaps allowing for
addressing situations where patients remain undecided
and continue deliberations with their providers.
In addition to measuring whether a statin was offered
to reduce risk for patients with ASCVD, potential measures
570 Drozda et al.
Focused Update of Secondary Prevention Lipid Performance Measures
to assess the quality of SDM may include: 1) measuring if
the patient knows his or her personalized cardiovascular
risk; 2) assessing whether the patient understands the
available options and their risks and benefits; 3) asking
patients about interactions with their provider; and
4) determining if high-quality decision tools were incor-
porated into the clinical encounter. Future studies in
these areas will need to determine that reliable and
valid PMs may be constructed under this framework of
shared accountability measures that potentially require
surveying the patient about these domains. The exam-
ples listed above also must be broadened to address
additional challenges in measurement of longitudinal
adherence and across multiple care settings (hospital,
outpatient clinic, home), as well as development of PMs
and incentives that also target patients directly rather
than providers alone, because having participated in
SDM and having agreed to take a statin, the patient
assumes responsibility for following through on this
commitment or bringing any concerns back to the pro-
vider. PMs should also measure the performance of other
stakeholders who share accountability for adherence,
including insurance companies, policy makers (benefit
design and care coordination programs), and accountable
care organizations.
5.3. Conclusion and Summary
The writing committee believes that these new PMs
closely support the new ACC/AHA Cholesterol Guidelines,
will assist providers in providing better care to their
patients with improved outcomes, and represent an
advance in medication measures because they promote
SDM and appropriate dosing. At the same time, the
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JACC VOL. 67, NO. 5, 2016
FEBRUARY 9, 2016:558–87
writing committee recognizes that much remains to be
done to develop truly robust measures of SDM as well
as measures of shared accountability for medication
adherence.
STAFF
American College of Cardiology
Patrick T. O’Gara, MD, FACC, President
Shalom Jacobovitz, Chief Executive Officer
William J. Oetgen, MD, MBA, FACC, Executive Vice
President, Science, Education, and Quality
Lara Slattery, MHS, Senior Director, ACC Scientific
Reporting
Jensen S. Chiu, MHA, Team Lead, Quality Measurement
Laura L. Ritzenthaler, PA, MBA, Associate, PINNACLE
Registry
Amelia Scholtz, PhD, Publications Manager, Clinical
Policy and Pathways
Penelope Solis, JD, Associate, Clinical Measurement
American College of Cardiology/American Heart Association
Naira Tahir, MPH, Associate, Clinical Measurement
American Heart Association
Elliott Antman, MD, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FACC, FAHA, Chief Science
and Medical Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice
President, Office of Science Operations
Melanie B. Turner, MPH, Science and Medicine Advisor,
Office of Science Operations
Jody Hundley, Production Manager, Scientific Publications,
Office of Science Operations
5. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 Resonance; the Society of Cardiovascular Computed
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adults: a report of the American College of Cardiology/
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Guidelines. J Am Coll Cardiol. 2014;63(25 pt B):
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2889–934.
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American Heart Association Task Force on Performance
6. Olin JW, Allie DE, Belkin M, et al. ACCF/AHA/ACR/
Measures (Writing Committee to Develop Performance
SCAI/SIR/SVM/SVN/SVS 2010 performance measures
Measures for ST-Elevation and Non-ST-Elevation
for adults with peripheral artery disease: a report of
Myocardial Infarction). Developed in collaboration
the American College of Cardiology Foundation/
with the American Academy of Family Physicians and
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American College of Emergency Physicians. J Am Coll
Measures, the American College of Radiology, the So-
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mittee to Develop Clinical Performance Measures for neous coronary intervention: a report of the American
Peripheral Artery Disease). Developed in collaboration College of Cardiology/American Heart Association Task
with the American Association of Cardiovascular and Force on Performance Measures, the Society for
Pulmonary Rehabilitation; the American Diabetes As- Cardiovascular Angiography and Interventions, the
sociation; the Society for Atherosclerosis Imaging and American Medical Association Convened Physician
Prevention; the Society for Cardiovascular Magnetic Consortium for Performance Improvement, and the
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10. Normand SL, McNeil BJ, Peterson LE, et al. Eliciting
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11. Kumar A, Fonarow GC, Eagle KA, et al. Regional and
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12. Rabus SA, Izzettin FV, Sancar M, et al. Five-year
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14. Arnold SV, Spertus JA, Tang F, et al. Statin use in
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16. Shah ND, Dunlay SM, Ting HH, et al. Long-term
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18. Arnold SV, Kosiborod M, Tang F, et al. Patterns of
statin initiation, intensification, and maximization
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19. Javed U, Deedwania PC, Bhatt DL, et al. Use of
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161:418–24.
20. Roger VL. The quality of quality: is it time for new
tools? Circulation. 2014;129:1270–2.
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24. Ioannidis JP, Lau J. Completeness of safety
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31. Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of
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34. Elwyn G, Dehlendorf C, Epstein RM, et al. Shared
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Med. 2007;167:1076–82.
38. Krumholz HM. The new cholesterol and blood
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Outcomes. 2014;7:360–7.
41. Subherwal S, Patel MR, Kober L, et al. Missed
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extremity peripheral artery disease, underuse remains.
Circulation. 2012;126:1345–54.
42. Haynes RB, Ackloo E, Sahota N, et al. Interventions
for enhancing medication adherence. Cochrane Data-
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costs. Risk Manag Healthc Policy. 2014;7:35–44.
44. Peterson ED, Ho PM, Barton M, et al. ACC/AHA/
AACVPR/AAFP/ANA concepts for clinician patient
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sures. J Am Coll Cardiol. 2014;64:2133–45.
45. Mukhtar O, Weinman J, Jackson SH. Intentional
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cation self-management. J Health Commun. 2013;18
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47. Nielsen-Bohlman L, Panzer AM, Kindig DA. Health
Literacy: A Prescription to End Confusion. Washington,
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48. Zhang NJ, Terry A, McHorney CA. Impact of health
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48:741–51.
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medication adherence: options to consider. Int J Clin
Pharm. 2014;36:55–69.
50. Physician Consortium for Performance Improve-
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KEY WORDS ACC/AHA Performance Measures,
coronary artery disease, health policy and
outcome research, myocardial infarction,
percutaneous coronary intervention, peripheral
arterial disease, shared decision making, statins
572 Drozda et al. JACC VOL. 67, NO. 5, 2016

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APPENDIX A. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE

MEASURES: PERFORMANCE MEASURE SET

1. Updated Performance Measure for the Treatment of Blood Cholesterol to

Reduce Atherosclerotic Cardiovascular Risk in Adults With Peripheral
Artery Disease
3-hydroxy-3-methylglutaryl-coenzyme A Reductase Inhibitor (Statin) Therapy in Patients With PAD
Measure Description: Percentage of patients 18-75 y of age with PAD who were offered moderate- to high-intensity statin.
Numerator: Patients in the denominator who
• Have been offered* high-intensity statin† or
• Have been offered* moderate-intensity statin† and have documentation of a medical reason for not prescribing high-intensity statin
Definitions:
*
A statin is “offered” if it is prescribed or if a patient reason exception is documented.
†Moderate-intensity and high-intensity statin doses are defined in Table 5 of the 2013 ACC/AHA Guideline on the Treatment of Blood
Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (5).
Denominator: Patients 18-75 y of age with PAD* seen in a 12-mo period

Definition:
*PAD is defined as the presence of ≥1 of the following:
• Claudication
• Critical limb ischemia (ischemic rest pain, nonhealing ischemic ulcers, gangrene)
• History of vascular reconstruction, bypass surgery, or percutaneous intervention to the extremities
• Amputation for critical limb ischemia
• Abnormal noninvasive test (e.g., ankle brachial index, ultrasound, magnetic resonance, or computed tomography imaging
demonstrating stenosis in any peripheral artery, i.e., aorta, iliac, femoral, popliteal, tibial, peroneal)
Denominator None
Exclusions:
Denominator Documentation of medical reason(s) for not prescribing a statin (e.g., allergy, intolerance to statin[s], other medical reasons)
Exceptions:
Period of 12 mo
Assessment:
Attribution: Clinician practices caring for patients with PAD
Rationale
This measure was revised based on the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in
Adults (5) and is consistent with the ACC/AHA 3-hydroxy-3-methylglutaryl-coenzyme A Reductase Inhibitor (Statin) Therapy in Patients with Atherosclerotic
Cardiovascular Disease (ASCVD) Performance Measure.
Clinical Recommendation(s)
The following evidence statements are quoted verbatim from the referenced 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults:

“High-intensity statin therapy should be initiated or continued as first-line therapy in women and men ≤75 years of age who have clinical ASCVD*, unless
contraindicated.” (Class I; Level of Evidence: A)

“In individuals with clinical ASCVD * in whom high-intensity statin therapy would otherwise be used, when high-intensity statin therapy is contraindicated† or
when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated.”
(Class I; Level of Evidence: A)

“In individuals with clinical ASCVD* >75 years of age, it is reasonable to evaluate the potential for ASCVD risk-reduction benefits and for adverse effects, drug-
drug interactions and to consider patient preferences, when initiating a moderate- or high-intensity statin. It is reasonable to continue statin therapy in those who
are tolerating it.” (Class IIb; Level of Evidence: A)

Definition:
*Clinical ASCVD includes acute coronary syndromes, a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, and
peripheral arterial disease presumed to be of atherosclerotic origin.

Table 5. High-, Moderate-, and Low-Intensity Statin Therapy (Used in the RCTs Reviewed by the Expert Panel)* (5)
High-Intensity Statin Therapy Moderate-Intensity Statin Therapy Low-Intensity Statin Therapy
Daily dose lowers LDL-C, on average, by Daily dose lowers LDL-C, on average, by Daily dose lowers LDL-C, on average,
approximately ≥50% approximately 30% to <50% by <30%

Continued on the next page

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APPENDIX A. CONTINUED

Atorvastatin (40†)–80 mg Atorvastatin 10 (20) mg Simvastatin 10 mg

Rosuvastatin 20 (40) mg Rosuvastatin (5) 10 mg Pravastatin 10–20 mg
Simvastatin 20–40 mg‡ Lovastatin 20 mg
Pravastatin 40 (80) mg Fluvastatin 20–40 mg
Lovastatin 40 mg Pitavastatin 1 mg
Fluvastatin XL 80 mg
Fluvastatin 40 mg BID
Pitavastatin 2–4 mg

CQ1: What is the evidence for LDL–C and non-HDL–C goals for the secondary prevention of ASCVD?; CQ2: What is the evidence for LDL–C and non-HDL–C
goals for the primary prevention of ASCVD?; and CQ3: For primary and secondary prevention, what is the impact on lipid levels, effectiveness, and safety of
specific cholesterol-modifying drugs used for lipid management in general and in selected subgroups?
Boldface type indicates specific statins and doses that were evaluated in RCTs (16-18,46-48,64-77) included in CQ1, CQ2, and the Cholesterol Treatment
Trialists 2010 meta-analysis included in CQ3 (20). All of these RCTs demonstrated a reduction in major cardiovascular events. Italic type indicates statins and
doses that have been approved by the FDA but were not tested in the RCTs reviewed.
*Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biological basis for a less-than-
average response.
†Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering)
study (47).
‡Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the
increased risk of myopathy, including rhabdomyolysis.
BID indicates twice daily; CQ, critical question; FDA, U.S. Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; and RCTs, randomized
controlled trials.

Method of Reporting
Proportion or percentage of patients meeting the measure during the measurement period
Secondary Measures to Consider for Quality Improvement
A potential measure to consider is the proportion of patients with PAD on statin therapy who have had 1 or more lipid panels during the 12-mo observation
period. This is based on the following recommendation from the ACC/AHA Cholesterol Guideline:
“Adherence to medication and lifestyle, therapeutic response to statin therapy, and safety should be regularly assessed. This should also include a fasting
lipid panel performed within 4 to 12 weeks after initiation or dose adjustment, and every 3 to 12 months thereafter. Other safety measurements should be
measured as clinically indicated.” (Class I; Level of Evidence: A)
ACC/AHA indicates American College of Cardiology/American Heart Association; ASCVD, atherosclerotic cardiovascular disease; HDL-C, high-density
lipoprotein cholesterol; MI, myocardial infarction; PAD, peripheral artery disease; and TIA, transient ischemic attack.
574 Drozda et al. JACC VOL. 67, NO. 5, 2016

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APPENDIX A. CONTINUED

ASCVD

ASCVD

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APPENDIX A. CONTINUED
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APPENDIX A. CONTINUED

ASCVD

ASCVD

ASCVD

Continued on the next page

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APPENDIX A. CONTINUED

Physician performance measures and related data specifications were developed by the
American Medical Association (AMA) convened Physician Consortium for Performance
Improvement® (PCPI®), the American College of Cardiology (ACC), the American Heart
Association (AHA) and the National Committee for Quality Assurance (NCQA) to facilitate
quality improvement activities by physicians. These performance measures are not clinical
guidelines and do not establish a standard of medical care, and have not been tested for all
potential applications. While copyrighted, they can be reproduced and distributed, without
modification, for noncommercial purposes, e.g., use by health care providers in connection with
their practices. Commercial use is defined as the sale, license, or distribution of the
performance measures for commercial gain, or incorporation of the performance measures into
a product or service that is sold, licensed or distributed for commercial gain. Commercial uses of
the measures require a license agreement between the user and the AMA (on behalf of the
PCPI), or the ACC, or the AHA or the NCQA. Neither the AMA, ACC, AHA, NCQA, the PCPI nor
its members shall be responsible for any use of these measures.

THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY
OF ANY KIND.

© 2015 American College of Cardiology Foundation, American Heart Association, Inc.,

American Medical Association and National Committee for Quality Assurance. All Rights
Reserved.

Limited proprietary coding is contained in the measures specifications for convenience. Users of
the proprietary code sets should obtain all necessary licenses from the owners of these code
sets. The AMA, the ACC, the AHA, the NCQA, the PCPI and its members disclaim all liability for
use or accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the
specifications.

CPT® contained in the measures specifications is copyright 2015 American Medical Association.
LOINC® copyright 2004-2015 Regenstrief Institute, Inc. This material contains SNOMED
CLINICAL TERMS (SNOMED CT®) copyright 2004-2015 International Health Terminology
Standards Development Organisation. All Rights Reserved. Use of SNOMED CT® is only
authorized within the United States.
578 Drozda et al. JACC VOL. 67, NO. 5, 2016

Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

APPENDIX A. CONTINUED

ASCVD

ASCVD

ASCVD

Continued on the next page

JACC VOL. 67, NO. 5, 2016 Drozda et al. 579
FEBRUARY 9, 2016:558–87 Focused Update of Secondary Prevention Lipid Performance Measures

APPENDIX A. CONTINUED

Physician performance measures and related data specifications were developed by the
American Medical Association (AMA) convened Physician Consortium for Performance
Improvement® (PCPI®), the American College of Cardiology (ACC), and the American Heart
Association (AHA) to facilitate quality improvement activities by physicians. These performance
measures are not clinical guidelines and do not establish a standard of medical care, and have
not been tested for all potential applications. While copyrighted, they can be reproduced and
distributed, without modification, for noncommercial purposes, e.g., use by health care providers
in connection with their practices. Commercial use is defined as the sale, license, or distribution
of the performance measures for commercial gain, or incorporation of the performance
measures into a product or service that is sold, licensed or distributed for commercial gain.
Commercial uses of the measures require a license agreement between the user and the AMA
(on behalf of the PCPI) or the ACC or the AHA. Neither the AMA, ACC, AHA, the PCPI nor its
members shall be responsible for any use of these measures.

THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY
OF ANY KIND.

© 2015 American College of Cardiology Foundation, American Heart Association, Inc., and
American Medical Association. All Rights Reserved.

Limited proprietary coding is contained in the measure specifications for convenience. Users of
the proprietary code sets should obtain all necessary licenses from the owners of these code
sets. The AMA, the ACC, the AHA, the PCPI and its members disclaim all liability for use or
accuracy of any Current Procedural Terminology (CPT®) or other coding contained in the
specifications.

CPT® contained in the measures specifications is copyright 2015 American Medical Association.
LOINC® copyright 2004-2015 Regenstrief Institute, Inc. This material contains SNOMED
CLINICAL TERMS (SNOMED CT®) copyright 2004-2015 International Health Terminology
Standards Development Organisation. All Rights Reserved. Use of SNOMED CT® is only
authorized within the United States.
580 Drozda et al. JACC VOL. 67, NO. 5, 2016

Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

APPENDIX A. CONTINUED

Continued on the next page

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APPENDIX A. CONTINUED
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Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

APPENDIX B. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT)—

2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE MEASURES

Ownership/ Institutional,
Speakers Partnership/ Personal Organizational, or Expert
Committee Member Employment Consultant Bureau Principal Research Other Financial Benefit Witness

Joseph P. Drozda, Jr Mercy Health Director of None None None None None None
(Chair) Outcomes Research

T. Bruce Ferguson, Jr Brody School of Medicine None None None None None None
at ECU, Department of
Cardiovascular Sciences

Hani Jneid Baylor College of None None None None None None
Medicine—MEDVAMC

Harlan M. Krumholz Yale University School None None None  Johnson &  UnitedHealth* None
of Medicine Johnson*

Brahmajee K. University of Michigan—  Abbott None None None None None

Nallamothu Assistant Professor,  United Health
Internal Medicine,
Division of Cardiology

Jeffrey W. Olin Mt. Sinai School of  Merck None None  AstraZeneca*  AstraZeneca None
Medicine  Novartis

Henry H. Ting New York-Presbyterian None None None None None None
Hospital/Columbia
University Medical Center

This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were
reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily
reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting
stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of
the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table
are modest unless otherwise noted.
According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or
issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing
drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as
a result of the issues/content addressed in the document.
*No financial benefit.
ACC/AHA indicates American College of Cardiology/American Heart Association; ECU, East Carolina University; and MEDVAMC, Michael E. DeBakey Veterans Affairs Medical Center.
JACC VOL. 67, NO. 5, 2016 Drozda et al. 583
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APPENDIX C. PEER REVIEWER RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES—

2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE MEASURES

Institutional,
Ownership/ Organizational, or
Speakers Partnership/ Personal Other Financial Expert
Peer Reviewer Representation Consultant Bureau Principal Research Benefit Witness

Lynne Braun Official Reviewer—AHA None None None None None None

Blair D. Erb, Jr Official Reviewer—ACC None None  Abbott† None None None
Board of Trustees  Amgen†
 Merck

Gregg C. Fonarow Official Reviewer—ACC/  Amgen None None  Novartis† None None
AHA Task Force for  Johnson &
Performance Measures Johnson
 Novartis†
Content Reviewer—  Takeda
ACC/AHA Task Force Pharmaceutical
on Clinical Data
Standards

G.B. John Mancini Official Reviewer—ACC  Amgen None None  Amgen† None None
Board of Governors  Merck
 Pfizer
 Regeneron/
Sanofi-aventis

Robert Shor Official Reviewer None None None None None None
(Alternate)—ACC
Board of Governors

Laith G. Alsayegh Organizational None  Amarin- None None None None

Reviewer—SVM Vascepa

Christie M. Organizational  Aegerion None None  Amarin† None None

Ballantyne Reviewer—NLA  Amarin  Amgen†
 Amgen  Eli Lilly†
 Cerenis  Merck†
 Esperion  Novartis†
Therapeutics  Pfizer†
 Genentech  Regeneron†
 Genzyme  Sanofi-aventis/
 Merck† Synthelabo†
 Novartis
 Omthera
 Pfizer†
 Regeneron
 Resverlogix
 Sanofi-aventis/
Synthelabo

Mary Barton Organizational None None None None None None

Reviewer—NCQA

Vera Bittner Organizational  Amarin None None  Amgen  Foundation of None

Reviewer—AACVPR  AstraZeneca* the National
 Eli Lilly* Lipid
 GlaxoSmithKline† Association*
 Hoffman-La  National Lipid
Roche Association
 Janssen  American Board
Pharmaceuticals† of Clinical
 Pfizer Lipidology*
 Sanofi-aventis*
 Schering Plough*
 University of
Oxford*

Michael Blaha Organizational None None None None None None

Reviewer—SCCT
Konstantinos Organizational None None None None None None
Boudoulas Reviewer—SCAI

Continued on the next page

584 Drozda et al. JACC VOL. 67, NO. 5, 2016

Focused Update of Secondary Prevention Lipid Performance Measures FEBRUARY 9, 2016:558–87

APPENDIX C. CONTINUED

Institutional,
Ownership/ Organizational, or
Speakers Partnership/ Personal Other Financial Expert
Peer Reviewer Representation Consultant Bureau Principal Research Benefit Witness

W. Virgil Brown Organizational  Amgen†  Merck† None None  National Lipid  Defendant,
Reviewer—NLA  AstraZeneca Association* expert in
 Eli Lilly lipid meta-
 Genzyme† bolism,
 GlaxoSmithKline† 2014
 LipoScience  Plaintiff,
 Merck ezetimibe
patent
challenge,
2015-

J. Thomas Cross, Organizational None None None None None None

Jr Reviewer—ACP

Michael Crouch Organizational None None None None None None

Reviewer—AAFP

Andrew Dunn Organizational None None None  Desai None None

Reviewer—ACP Pharmaceuticals*

Daniel Organizational None None None None None None

Edmundowicz Reviewer—SAIP

Mary Ann Organizational None None None None None None

Forciea Reviewer—ACP

Robert A. Organizational None None  Abbvie† None None None

Gluckman Reviewer—ACP  Abbott†
 Bristol-
Myers
Squibb*
 Walgreens†

Richard Hellman Organizational None None None None None None

Reviewer—
AMA-PCPI

Robert H. Hopkins, Organizational None None None None None None

Jr Reviewer—ACP

Matthew K. Ito Organizational  Regeneron None None  Kowa None None

Reviewer—NLA Pharmaceuticals*

Terry A. Jacobson Organizational  Amarin None None  REDUCE IT Trial  National Lipid None
Reviewer—NLA  AstraZeneca Association
 LipoScience
 Merck
 Regeneron/
Sanofi-aventis

Peter Jones Organizational  Atherotech†  Merck None None  Amarin* None

Reviewer—NLA  Merck  Amgen*
 Regeneron/  Regeneron/
Sanofi-aventis Sanofi-aventis*

Parag Joshi Organizational None None None None None None

Reviewer—SCCT

Eve Askanas Kerr Organizational None None None None None None
Reviewer—ACP

Debra Kohlman- Organizational None None None None None None

Trigoboff Reviewer—SVN

Kesavan Kutty Organizational None None None None None None

Reviewer—ACP

Ngoc-Anh Le Organizational  LipoScience None None  AstraZeneca†  Abbott† None

Reviewer —AHA  Merck†

Sei Lee Organizational None None None None None None

Reviewer—AGS

Ana Maria Lopez Organizational None None None None None None
Reviewer—ACP
Catherine MacLean Organizational None None None None  WellPoint, Inc.† None
Reviewer—ACP

Continued on the next page

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APPENDIX C. CONTINUED

Institutional,
Ownership/ Organizational, or
Speakers Partnership/ Personal Other Financial Expert
Peer Reviewer Representation Consultant Bureau Principal Research Benefit Witness

Charles E. Mahan Organizational  Janssen  Bristol-Myers None None None None

Reviewer—ASHP Pharmaceuticals Squibb
 Janssen
Pharmaceuticals†
 Pfizer

Michael McConnell Organizational None None None  GE Healthcare† None None

Reviewer—SCMR  Tiara
Pharmaceuticals†

James McKenney Organizational None None None None None None

Reviewer—NLA

Pamela B. Morris Organizational  Aegerion  Merck None None None None

Reviewer—NLA  AstraZeneca
 Genzyme
 LipoScience

Carol E. Orringer Organizational  Merck None None None  National Lipid None
Reviewer—NLA Association*

Stephen D. Persell Organizational None None None None None None

Reviewer—ACP

Amir Qaseem Organizational None None None None None None

Reviewer—ACP

Robert Ratner Organizational None None None None None None

Reviewer—ADA

Russell Samson Organizational None None None None None None

Reviewer—SVS

Howell Sasser Organizational None None None None None None

Reviewer—ACP

Terrence Organizational None None None None None None

Shaneyfelt Reviewer—ACP

Elaine Tseng Organizational None None None None None None

Reviewer—STS

Geogy Organizational None None None None None None

Vatakencherry Reviewer—SIR

Kaye-Eileen Willard Organizational  Merck None None None None None

Reviewer—NLA

John Doherty Content Reviewer— None None None None None None
ACC/AHA Appropriate
Use Criteria Task
Force

Eric Peterson Content Reviewer—  Genentech None None  Eli Lilly† None None
ACC/AHA/AACVPR/  Janssen  Janssen
AAFP/AMA-PCPI/ Pharmaceuticals Pharmaceuticals†
ANA/ASHP/NCQA  Sanofi-aventis
The Concepts for
Clinician-Patient
Shared Accountability
in Performance
Measures Writing
Committee

Binh An P. Phan Content Reviewer—ACC None None None None  National Lipid None
Prevention Council Association*
Paul Poirier Content Reviewer—AHA  AstraZeneca None None None None None
 Bristol-Myers
Squibb
 Janssen
Pharmaceuticals
 Merck

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APPENDIX C. CONTINUED

Institutional,
Ownership/ Organizational, or
Speakers Partnership/ Personal Other Financial Expert
Peer Reviewer Representation Consultant Bureau Principal Research Benefit Witness

John Spertus Content Reviewer—  Amgen None None  Eli Lilly† None None
ACC/AHA 2008 AMI  Genentech
Performance Measures  Janssen
Writing Committee; Pharmaceuticals
ACC Clinical Quality  Novartis
Steering Committee;  Regeneron*
ACCF/AHA/AMA-PCPI  United Healthcare—
2011 Performance Scientific Advisory
Measures for Adults Board
With CAD and
Hypertension

Neil Stone Content Reviewer—2013 None None None None None None
ACC/AHA Guideline on
the Treatment of
Blood Cholesterol
to Reduce
Atherosclerotic
Cardiovascular Risk
in Adults Writing
Committee

Carl Tommaso Content Reviewer— None None None None None None
ACC/AHA/SCAI/
AMA-PCPI/NCQA
Percutaneous Coronary
Intervention
Performance
Measurement Writing
Committee

Diane Treat- Content Reviewer— None None None None None None
Jacobson ACC/AHA/ACR/SCAI/
SIR/SVM/SVN/SVS
2010 Performance
Measures for Adults
With Peripheral
Artery Disease

This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. It
does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership
of $5% of the voting stock or share of the business entity, or ownership of $$10,000 of the fair market value of the business entity; or if funds received by the person from the
business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition.
Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in
alphabetical order within each category of review.
According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or
issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing
drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as
a result of the issues/content addressed in the document.
*No financial benefit.
†Significant relationship.
AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; AAFP, American Academy of Family Physicians; ACC/AHA, American College of Cardiology/
American Heart Association; ACCF, American College of Cardiology Foundation; ACP, American College of Physicians; ACR, American College of Radiology; ADA, for American Diabetes
Association; AGS, American Geriatrics Society; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; AMI, acute myocardial infarction; ANA,
American Nurses Association; ASHP, American Society of Health-System Pharmacists; NCQA, National Committee for Quality Assurance; NLA, National Lipid Association; SAIP, Society
of Atherosclerosis Imaging and Prevention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society of Cardiovascular Computed Tomography; SCMR; Society for
Cardiovascular Magnetic Resonance; SIR, Society of Interventional Radiology; STS, Society of Thoracic Surgeons; SVM, Society for Vascular Medicine; SVN, Society for Vascular Nursing;
and SVS, Society for Vascular Surgery.
JACC VOL. 67, NO. 5, 2016 Drozda et al. 587
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APPENDIX D. 2015 ACC/AHA FOCUSED UPDATE OF SECONDARY PREVENTION LIPID PERFORMANCE

MEASURES: SUMMARY ANALYSIS TABLE

Completely Partially Fulfills or

Measures Included in the Fulfills Does Not Fulfill
Performance Measure Set Attribute* Attribute* Summary Comments†

3-hydroxy-3-methylglutaryl-coenzyme A
Reductase Inhibitor (Statin) Therapy
in Patients With PAD
1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacement
for the Cholesterol Lowering Medications (Statins) measure
in the ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010
Performance Measures for Adults With Peripheral Artery
Disease (6).

Statin Therapy for Patients With Acute 1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacement
Myocardial Infarction for the Statin Prescribed at Discharge measure in the ACC/AHA
2008 Performance Measures for Adults With ST-Elevation
and Non-ST-Elevation Myocardial Infarction (7).

Postprocedural Optimal Medical Therapy 1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacement
Composite for the Post-Procedural Optimal Medical Therapy Composite
measure in the ACC/AHA/SCAI/AMA–Convened PCPI/NCQA
2013 Performance Measures for Adults Undergoing Percutaneous
Coronary Intervention (8).

3-hydroxy-3-methylglutaryl-coenzyme A 1,2,3,4 Fulfills all attributes The measure was included in the measure set as a replacement
Reductase Inhibitor (Statin) Therapy for the Lipid Control measure in the ACCF/AHA/AMA-PCPI
in Patients With CAD 2011 Performance Measures for Adults With Coronary
Artery Disease and Hypertension (9).

3-hydroxy-3-methylglutaryl-coenzyme A
Reductase Inhibitor (Statin) Therapy in
Patients With Clinical Atherosclerotic
Cardiovascular Disease
1,2,3,4 Fulfills all attributes The measure was included as a stand-alone measure because
of the strong recommendation made for the use of high-intensity
statins in patients with ASCVD found in the 2013 ACC/AHA
Guideline on the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults (5).

*Corresponding numbers are linked to the ACC/AHA Task Force on Performance Measures Attributes for Performance Measures. Numbers indicate the entire attribute.
†Where applicable, the writing committee provided summary comments about why certain measures were or were not included in the final measure set.
ACC indicates American College of Cardiology/American Heart Association; ACCF, American College of Cardiology Foundation; ACR, American College of Radiology; AMA-PCPI,
American Medical Association Physician Consortium for Performance Improvement; ASCVD, atherosclerotic cardiovascular disease; CAD, coronary artery disease; NCQA, National
Committee for Quality Assurance; PAD, peripheral artery disease; SCAI, Society for Cardiovascular Angiography and Interventions; SIR, Society for Interventional Radiology; SVM,
Society for Vascular Medicine; SVN, Society for Vascular Nursing; and SVS, Society for Vascular Surgery.