Design and Analysis of a Research Study Discussion Questions

Students who are participating in the (optional) research activity can use this portal to turn in their research worksheet (Q1-11 on the full worksheet) in order to get data to complete the project.

Research Project: Design and Analysis of a Research Study
Overview: The purpose of this assignment is to use the material you have learned in class to develop a research study
involving a health topic. In this project, you will use your knowledge about research design to propose a study that will
address a key public health issue. You may work in a group or alone. You (and your fellow group members) must pick a
specific exposure and outcome that interests you and develop a research hypothesis. Your group will design an
appropriate study to test your hypothesis using the epidemiologic concepts covered in class. You will then analyze mock
data and evaluate your findings.
Tasks:
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Each week following lecture, you will complete a specific section of this worksheet.
Once the worksheet is complete you will receive an excel worksheet with a mock dataset to analyze.
After analyzing your data you will interpret the data and identify the strengths and limitations of your study.
You will then right a research abstract to describe all of your work.
Deliverables: Upon completion of this assignment, you will turn in:
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The worksheet
A short abstract (no more than 500 words)
Complete the following sections to design your research study. You should be able to complete questions 1-4 after
the experimental research lecture. After each subsequent lecture, you can add the evaluation of the study design we
reviewed. After all study designs have been evaluated, choose the design that would work the best to test your
hypothesis.
1. State your hypothesis
2. Why did you choose this topic (what is its importance or relevance to the field?
3. Study Variables
a. Define your Exposure:
i. What is your exposure of interest?
ii. What is your control group (or second exposure for comparison)?
b. Define your outcome
i. What is the outcome you are interested in studying?
ii. What is your case definition?
c. Other variables of interest?
i. Are there any other variables you think are important to consider? (ex: age, sex/gender, disease
severity, etc…)
4. Evaluate the utility of each of the following study designs in testing your hypothesis?
a. Experimental
i. Would this study design work?
ii. What are the benefits of using an experimental design?
iii. What are the limitations of using an experimental design?
b. Cohort
i. Would this study design work?
ii. Would use a prospective or retrospective design? Why?
iii. What are the benefits of using a cohort design?
iv. What are the limitations of using a cohort design?
c. Case Control
i. Would this study design work?
ii. What are the benefits of using a case-control design?
iii. What are the limitations of using a case-control design?
d. Cross Sectional
i. Would this study design work?
ii. What are the benefits of using a cross sectional design?
iii. What are the limitations of using a cross sectional design?
5. Which of these study designs would you select to conduct your study in the real world?
6. Do you need IRB approval for your study? ___Yes
____No
Why?
7. Do you need a Data Safety Monitoring Board for your study? ___Yes
____No
Why?
8. Define your population:
a. Who will you study?
b. Who will you exclude from you study?
9. Enrollment:
a. How many people will you study?
b. Describe how you will enroll your subjects into your study:
10. Study Design Tools:
a. What tools would you use to strengthen your study (make sure they are appropriate for the study
design you selected):
i. Randomization
ii. Random allocation ((choose this one)
iii. Restriction ((choose this one))
iv. Stratification
v. Matching
vi. Blinding
vii. Double Blinding
b. Describe how you will use the tools selected above:
Congratulations! You have conducted your study. Submit the information above to receive your data. Once you have
data you can proceed to the next page.
11. Results:
a. What calculation will you use to determine the measure of association?
i. Odds Ratio
ii. Prevalence Ratio
iii. Relative Risk ((choose this))
b. Complete the 2×2 table below with a summary of your data:
Outcome
No Outcome
Total
Exposed
Not Exposed
Total
c. Calculate your measure of association (show your work):
12. Conclusions:
a. Interpret your findings:
b. Circle the guidelines for causality that provide evidence that your results is accurate and state why:
i. Temporal Relationship: ______________________________________________________
ii. Strength of Association: _____________________________________________________
iii. Dose-Response Relationship: _________________________________________________
iv. Replication of Findings: ______________________________________________________
v. Biologic Plausability
vi. Consideration of Alternate Explanations: ________________________________________
vii. Cessation of Exposure: _______________________________________________________
viii. Specificity of the Association: __________________________________________________
ix. Consistency with other Knowledge: ______________________________________________
c. List at least 3 limitations that may have effected your study results:
d. What would you change about your study design to improve future research?
13. Draw a flow chart for your study:
Submit completed worksheet with your summary abstract!
Research Design and Analysis Grading Rubric
Hypothesis
(3 pts)
90-100%
Testable Question with a
clear exposure and outcome
Purpose and
Justification
(10 pts)
Provides clear reasons why
this study is important.
Cites other work as
evidence of knowledge in
the topic area.
Define Exposure
Variable (4 pts)
Selected correct variable as
exposure and split into 2
clear and distinct groups for
comparison
Define Outcome
Variable (4 pts)
Selected correct variable as
outcome and used a clear
and objective case
definition or outcome can
only be measured
subjectively.
Correctly names 3 study
designs that could be used
to test the hypothesis and
at least 1 accurate benefit
and limitation for each
study design
Propose 3 study
designs: (10 pts)
70-89%
Testable Question, but
missing exposure or
outcome
Provides some reasons
why this study is
important. May cite
other work as evidence of
knowledge in the topic
area.
Selected correct variable
as exposure and split into
groups for comparison.
Groups may be vague or
less distinct
Selected correct variable
as outcome and used a
clear and objective case
definition.
=2
study designs that could
be used to test the
hypothesis and at least 1
accurate benefit and
limitation for each study
design
Provides justification for
selection of study design
including benefits or
limitations
IRB (2 pts)
Answered correctly and
justifies with applicable
factors
Answer may not be
correct, but justification is
on the right track
DSMB (2 pts)
Answered correctly and
justifies with applicable
factors
Answer may not be
correct, but justification is
on the right track
Correct answer with little
to no justification
Population
Definition (3 pts)
Enrollment (5 pts)
Clear objective enrollment
criteria
Enrollment strategy is
appropriate for study design
and includes who will be
recruited and classification
into exposure/case groups.
Tools (5 pts)
All tools selected are
appropriate for study design
and clear explanation for
use in study is given.
Clear, but incomplete
enrollment criteria
Enrollment strategy is
appropriate for study
design and includes who
will be recruited or
classification into
exposure/case groups.
Most tools selected are
appropriate for study
design and explanation
for use in study is given.
Vague and incomplete
enrollment criteria
Enrollment strategy is
appropriate for study
design but does not
includes who will be
recruited or classification
into exposure/case groups.
At least 1 tool selected are
appropriate for study
design, but explanation for
use in study is vague or not
given.
Did not answer
Did not answer or
selected wrong
answer with no
justification
Did not answer or
selected wrong
answer with no
justification
Did not answer
Did not answer or
enrollment is
inappropriate for
the study design
Did not answer or
selected all
inappropriate tools
or no explanation.
Results (10 pts)
Conclusions
(10 pts)
Causality
(5 pts)
Limitations
(5 pts)
Study Modifications
(5 pts)
Flow Chart
(2 pts)
Partner Evaluation
(8 pts)
Independent Work
Product (5 pts)
Overall Abstract
Evaluation (50 pts)
4-5
Selected the correct
measure of association and
use the formula to calculate
Interpreted the finding in a
full and complete sentence
stating the difference
between groups to
demonstrate an
understanding of the
meaning of the measure of
association.
Correctly identified and
explained evidence of
causality applying it to
outside literature or
concepts
Correctly identified and
explained possible biases or
other limitations
3
Selected the incorrect
measure of association,
but applied that formula
correctly
Interpreted the finding in
a vague or poorly stated
way, but demonstrated
an understanding of the
meaning of the measure
of association.
1-2
Selected the correct
measure, but did not
correctly perform the
calculation
Attempted, but did not
correctly interpret the
findings.
0
Did not answer
Correctly identified, but
vaguely and explained the
evidence causality
Correctly identified, but
did not explain the
evidence of causality
Did not answer
Correctly identified, but
Correctly identified, but
vaguely and explained the did not explain the
possible biases or other
possible biases or other
limitations
limitations
Identifies at least one
Identifies at least one
Identifies at least one
element of the study design element of the study
element of the study
that could be improved and design that could be
design that could be
clearly explains how this
improved and vaguely
improved but does not
change will enhance the
explains how this change
explain how this change
understanding of the
will enhance the
will enhance the
outcome.
understanding of the
understanding of the
outcome.
outcome.
Flow chart shows the
Flow chart shows most of Flow chart shows some of
correct elements of the
the correct elements of
the correct elements of
study design
the study design
the study design
Partner gives score of
Partner gives score of
Partner gives score of no
meaningful contribution
minimal contribution
contribution
Produced a product that
Produced a product that
Produced a product that
shows independent thinking shows some independent shows minimal
and personal perspective
thinking and personal
independent thinking and
perspective, but has
personal perspective
some overlap with
partners in syntax or
wording
• Contains all required
• Missing some sections
• No section labels,
sections with clear labels
disorganized content.
• Missing relevant
(Intro, Methods, Results,
information
• Many misuses of scientific
Discussion)
terms
• Provides too much
• Provides clear, concise, and
information
• Does not abide by word
relevant summary of
count limitations
• At least 95% Information
research
is in the correct section
• Information is in the
correct section
Did not answer
Did not answer
Did not answer
Did not answer
Produced a
product that shows
lack of personal
thought
Did not complete
abstract