Understanding Health Sciences Research

Why Do We Do Health Research?

Understand causes and consequences of health and disease Be able to predict, control, and/ or intervene appropriately Apply this understanding to improving health
Of individuals Of communities

Health Sciences Research

Different types of research, build upon each other

BENCH

BEDSIDE

COMMUNITY/ POLICY

Done on lab bench Usually with mice Mechanisms

Deals with people Outpatient care

Research on large communities Behaviors Ex: My plate

The Scientific Method

Systematic Process of discovery Empirical research
The systematic collection of data Data comes from formal observation and/or measurement

Objective and transparent procedures

Free (or nearly) from personal biases and emotions Methods clearly explained and reported Scientists and lay public have access to data and results

Steps of the Scientific Method:

Observe a phenomenon and ask a question Form a hypothesis (is there a causal relationship; what do you think will happen?) Test hypothesis using empirical methods (research study) Analyze data and draw conclusions (statistical analysis) Communicate your results (informed literature publications, lab report) 1.Observe & ask question 2. Form hypothesis 4.Analyze data 5. draw conclusions 6.communicate results 3. Test

1. Observe
1. Observe a phenomenon and/or ask a question 2. Form a hypothesis
An assumption about the nature of an phenomenon Specific and falsifiable prediction

Often takes one of two forms:

A statement about the relationship between 2 or more variables Statement differences between groups

Steps in the Scientific Method

1. Observe a phenomenon and ask a question 2. Form a hypothesis
An assumption about the nature of a phenomenon Specific and falsifiable prediction

2. Hypothesis formation
Hypothesis : An assumption about the nature of a phenomenon A prediction about what will happen A statement that often takes one of two forms:
relationship between two or more variables. differences between groups.

2. Hypothesis formation: Variables

Identify and define variables
Characteristic or property that can be measured or assessed

Need at least TWO variables Chocolate & obesity

2. Hypothesis Formation: Defining Variables

Identify which variable predicts or influences the other
Independent variable-PREDICTOR Dependent variable-OUTCOME
If the independent variable changes, what happened to the dependent variable?

Independent Variable

------------ leads to--------------

Dependent variable

CHOCOLATE

OBESITY

Hypothesis formation: Whats involved

Identify predictor (independent) and outcome (dependent) variables Decide how you will define the variables Quantitative/Numerical - Can be measured Weight - Height - Age - Test Scores CategoricalDescriptive - Characteristics, can be described Sex Race Group membership

2. Hypothesis formation: Defining Variables

Defining variables: Can you measure the variable? Or can you describe it?

Quantitative/Numerical

Categorical/Descriptive

Can be measured
Height Age Weight Test Scores

Characteristic, can be described

-Characteristics can be describe -Sex -Race -Group membership

2. Hypothesis formation
Defining and measuring variables
Operationalization- How variables are measured

In a study examining chocolate and obesity:

How to measure chocolate?
CHOCOLATE INTAKE: self-reported How many times a week did you eat chocolate? Included ALL types of chocolate

How to measure obesity?

Measured by BMI

2. Hypothesis formation: Variable Relationships

Identify the relationship between the variables
Are we interested in how two variables change in response to one another, or how they are related or correlated? What is the relationship between eating chocolate and obesity? How does eating chocolate daily affect percent body fat?
Are we interested in how two groups are different?
What is the difference in body fat between those who eat chocolate and those who never eat chocolate (chocolate lovers vs chocolate haters)

Hypothesis Formation
Identifying the nature of the relationship between two quantitative variables
How does the independent variable affect the dependent variable? If the Independent variable changes, what happens to the dependent variable?

Prediction?

Independent Independent Variable Variable

Dependent Dependent variable variable

Identifying relationships between variables

Positive (direct) Relationship
Both variables move in the same direction As independent variable increase (gets larger), the ddependet variable also increase As the independent variable decrease, so does the dependent varialbe

Identifying relationships between variables

Negative (indirect) Relationship Negative (indirect)-as independent variable DEcreases, the dependent variable Increases

Hypothesis formation: Variable relationships

Examining differences between two groups Independent variable: Chocolate Dependent variable:Obestiy

Independent Variable

Dependent variable

Steps of the Scientific Method

1. Observe a phenomenon and ask a question 2. Form a hypothesis
Identify, define, and predict relationships between variables

3. Test hypothesis (research study)

Observing naturally occurring relationships
Observational or correlational

Manipulating variables to determine cause and effect

Experiment

Testing the hypothesis: The Research Study

How you test your hypothesis depends on what your goal is
Do you want to identify or describe relationships?
OBSERVATIONAL

Do you want to see what happens to one variable when you change another (cause and effect)?
EXPERIMENTAL

The Research Study

How you test your hypothesis depends on what your goal is WHO you test your hypothesis depends on:
What group you are interested in understanding Where you do your recruiting Who decides to sign up to participate Population vs sample
Population: all possible individuals that might be included in your study Sample: The people from your population that chose to participate

The Research Study: Sample

Generalizability- external validity
The ability to generalize to other group

In both observational and experimental research, sample size and characteristics are important Sample size (n)
How many participants in a study

Sample characteristics
Age, sex, socioeconomic status, race/ethnicity, location

Steps in the Scientific Method

1. Observe a phenomenon and ask a question 2. Form a hypothesis 3. Test hypothesis (research study)
Observational research
Variables are NOT changed, only observed and measured

Experimental research
At least one variable is manipulated (changed)

3. Test Hypothesis: Research Studies

Observational research
Variables not changes, only observed and measured

Experimental research
Variables manipulated Population vs. Sample Pop- everyone Sample- those who participate

Observational Research
Uncover, explore, or define relationships between variables Collect quantitative (numerical) data
Measurement of two or more variables

Statistically manipulate or analyze and evaluate data Describe relationships or predict future outcomes

Observational Research
Describe relationships or predict future outcomes
Chocolate consumption in negatively related to BMI

Observational research is correlational Correlation DOES NOT equal causation

Types of Observational Research

Cross-sectional
Examines one or more groups at a single point in time
Measured an exposure and outcome once Rely on interviews, measurements, and surveys

Types of Observational Research

Longitudinal
Examines one or more groups over time
More than one measurement taken What happens to the relation between weight, and/or chocolate consumption over time?

Types of longitudinal research Prospective studies

Recruit subjects and observe them over time Assess baseline characteristics with future characteristics or disease

Retrospective studies
Recruit subjects and compare current characteristics or disease states with past behaviors or exposures

Observational Research: Strengths

Investigate naturally occurring relationships Provide descriptive information Suggest relationships and areas for further study Generally have larger sample size

Observational Research: Weaknesses

Observational studies do not provide proof of causal and effect We observe that thin people eat chocolate more than obese people.. Bur is it the chocolate or something else Do not always indicate directionality Does eating chocolate lead to reduced weight, or does being thin cause you to crave and eat more chocolate?

Experimental Research
Research design that makes it possible to determine cause and effect (causal inference) ALWAYS prospective
Baseline must be established Identify change

Control group and a treatment/experimental group

Control group nothing changes Treatment group receives a treatment

Experimental Research
Controlling for variables
Keep as many factors the same as possible between groups Measure and examine other factors that can influence outcome of dependent variable
Statistically control

Controls for confounding variables

confounding variables
Factors that influence the relationship between the independent and dependent variable

Experimental Research: Reducing bias

Sources of bias
Researcher Participant/Subject

Reducing bias in research

Favoring one outcome or prediction Inaccurate conclusions/interpretations due to prejudice

Randomization
Each individual has an equal chance of receiving the treatment Reduces researcher bias & selection bias Helps make each group equal at the start of a trial

Experimental Research: Reducing Bias

Placebo: a treatment that does nothing (inactive), but modified in a way to be indistinguishable from the real treatment
Placebo effect

Blinding
Hiding or disguising who is getting what treatment
Researchers interacting with participants Participates dont know if they are on the placebo or control Statisticians dont know which group is which (or what the hypothesis is)

Randomization
Each individual has an equal chance of receiving the treatment

Types of Experimental Designs

Gold-standard
Randomized, double-blind, placebo-control trials Strongest study design to assess the effect of an intervention or treatment Participants are randomized No one knows what group is being treated or who is getting the placebo (researchers or participants)

Human interventions (dietary and behavioral) likely to be randomized-control trials

Randomized into control or treatment group

Experimental Research
Experimental study examining the hypothesis: Eating chocolate will cause individuals to lose weight Independent variable? Chocolate Dependent variable? Obesity/BMI Nature of relationship (positive/negative)?

Chocolate Intake

Obesity

Experimental Research
How could we operationalize these variables?

Chocolate Intake

Give participates choc. 3 times a week Measure weight after 12 weeks

Weight

Experimental Research
Eating chocolate will cause individuals to lose weight. How do we set up the study to control for variables and test cause and effect? 1. Begin with 2 groups that are approximately EQUAL at the beginning 2. Only manipulate one variable
Keep all other variables approximately the same
Calorie intake Fat, carb, protein intake Physical activity level Interactions with researchers

How do we know it is chocolate and not another factor?

Steps of the Scientific Method

Observe a phenomenon and ask a question Form a hypothesis (is there a causal relationship; what do you think will happen?) Test hypothesis (research study) Analyze data and draw conclusions (statistical analysis) Communicate your results (informed literature publications, lab report)

Steps of the Scientific Method

Analyze data and draw conclusions
Statistically analyze data Determine the significance of results (p-value <0.05) Significant results suggests a relationship between the variables

DATA

Statistical analysis program

Statistical tests

Statistical Significance (or not)

Data Analysis
Analyze data and draw conclusions
Statistically analyze data

Describe the sample

Number Demographic characteristics Measurements e.g. mean, range, standard deviation

Statistical tests are used to determine the nature of a relationship between 2 variables
Is it a TRUE relationship or is it due to chance
P-value

What is the relationship?

Positve/negative Difference or no difference

Data Analysis: Statistical Significance

Statistical tests are used to determine the nature of a relationship between 2 variables
Is it a TRUE relationship or is it due to chance?

The p-value is often used as a cut-point for statistical significance

Probability value What is the probability that a particular value occurred by chance, assuming there is no relationship?

P<0.05 is standard cut-point this means there is less than a 5% chance the results are by chance

Statistical Significance
p-values come in all forms
0.05 is the cut off Often see 0.01, 0.001, .0000

NOTE: A smaller p-value does not mean a result is more significant or stronger
p <0.001 is just as significant as p <0.05 The chance that this is a random occurrence is smaller Approaching significance is NOT significant
See approaching significance p-values 0.06-0.08

Significance is significance

Data Analysis: T-tests and Group Differences

Examining differences between two groups T-tests (and F-tests) statistical procedures to compare two (or more) group means Statistical difference between two group means yields a pvalue <0.05
Chocolate

CHOCOLATE
MEAN % BF= 30%

MEAN % BF= 25%

Data Analysis: Correlational Coefficient and linear relationships

Linear relationships
as X changes, Y also changes

Numerically quantify the relationship between the dependent (Y-variable) and independent (x-variable)

Data Analysis: Correlational Coefficient

Pearson product-moment correlation (r)
Measure of the strength of a correlation between variables Range: -1 to +1 Positive values=direct relationship
As one variable increases, related variable also increases

Negative value=indirect relationship

As one variable increases, related variable decreases

Steps of the Scientific Method: Drawing Conclusions

Drawing conclusions

CHOCOLATE INTAKE

Body fatness

r= - 0.11 p-value=0.01
What can we conclude about chocolate and body weight?

Error in Research
No research study or researcher is perfect Measurement error
Incorrect use of measurement tools Measurement tools that dont measure what they are meant to measure

Researcher error
Recording results Implementing experimental procedures

Participant error
Memory bias (record incorrectly) Social desirability bias Misunderstanding of the questions

Steps of the Scientific Method

Observe a phenomenon and ask a question Form a hypothesis (is there a causal relationship; what do you think will happen?) Test hypothesis (research study) Analyze data and draw conclusions (statistical analysis) Communicate your results (informed literature publications, lab report)

Steps of the Scientific Method: Communication

Communicate your results
Publish in peer-reviewed journals Present at conferences Write lab reports (in this class)

Communications must be transparent and clear

Communicate purpose, methods, analysis & results Allow for critique and feedback Demonstrate reproducibility

Peer-reviewed Scientific Literature

Peer reviewed (aka refereed)
Submit research articles to journals for publications Expert review and critique research

Provides check on research promoting publication of only quality, systematic, and informative research

Peer-reviewed journals
Specific subject areas Experts on the editorial boards & as reviewers

Peer-reviewed (Informed) Literature

Caveat: All published research is not good research? It is still your responsibility as a good consumer to critically evaluate the evidence to form your own opinion
Methodological weaknesses
Design issues Sources of bias Analytical weaknesses

Data open to interpretation

Using Scientific Research

One study is generally NOT enough evidence to support a particular treatment or course of action at least not as a standard Compile findings from multiple studies of different types
Explain health and diseases Identify effective treatments and interventions

Evidence Based Practice

Applying the best available research results (evidence) when making decisions about health care. Health care professionals who perform evidence-based practice use research evidence along with clinical expertise and patient preferences. Systematic reviews (summaries of health care research results) provide information that aids in the process of evidence-based practice. - Agency for Healthcare Quality Research
http://effectivehealthcare.ahrq.gov/glossary-of-terms/?filterletter=e

Evidence Based Practice

Relies on scientific research studies Based on numerous and varied studies Standards of practice are NOT based on
One study Opinion Value what weve always done

Evidence Pyramid
Systematic Reviews Randomized controlled trials Cohort studies Case-control studies Case series Case reports Ideas, Editorials, Opinions Animal research In vitro (cell) research
Strongest Evidence

Weak Evidence
For more information (if you are interested) http://researchguides.uic.edu/ebm