1. Preparing for your Research Project
Christopher Kabir, MS
PCOR Coordinator
Department of Research
July 21, 2016

2. Overview
Focus on practical tips to think about before conducting your project:
Generating research questions
Hypothesis Testing
Data Collection
Analysis Consideration
Presentation of Results

3. Garbage in, garbage out

4. Garbage in, garbage out
Solution: Planning takes time and your proposal and IRB application should be viewed as helpful tools to promote good science.
The more you rush, the more likely your project will fall short of meeting your goals

5. Getting Started where are the knowledge gaps?”
Research is an iterative process…
be patient and use a realistic study timeline based on your schedule and needs!
Literature reviews will almost always be your starting point to any research project.
“What’s been done and
where are the knowledge gaps?”

6. Literature Review Take Away
This is the most overlooked step
There is much more to a study publication than the main results
Look for methodologies, the sample population, and limitations
If you see a trend between the studies, this is a sign that you should do a more in-depth lit review (consider a spreadsheet)
A literature review can also be a study and publishable article!
If you see a blatant lack of studies on the subject, this is a sign that this research area is novel

7. Hypothesis Testing
There is a lot of emphasis around hypotheses, because this is the fulcrum of the modern scientific method.
Check your hypothesis quality
Compare it to other similar studies
Ask the experts, your colleagues
Outside the box: Search google, technical papers, clinicaltrials.gov, professional/ advocacy associations, conference abstracts!

8. Hypothesis Testing P What’s the population (exclusion/ inclusion
It’s a thoughtful, evidence-based statement (not a question)
P What’s the population (exclusion/ inclusion
criteria)?
I Is there a treatment or intervention that is of
interest to study in relation to outcomes?
C What groups are being compared?
O What is the outcome measurement?
Does anyone know what PICO is an acronym for?

9. Hypothesis Testing
Use visual diagrams, equations, or table shells to look at your project from different angles -include the largest possible model to be considered and narrow down your questions -check your hypothesis for alignment with your research goal -define your outcomes, predictors, and confounders specifically and use references if possible

10. Hypothesis Testing Assessing its strength
Is it novel, supported by research but not uniformly confirmed?
Will results change current knowledge/ assumptions or medical practice?
Is it feasible to conduct ethically and regarding resources and time dedication?
Is it logical biologically?
Does anyone know what PICO is an acronym for?

11. Hypothesis Testing Simplicity is necessary
To assess the association/ effect of [independent variable] with/on [dependent variable] in [patient population] at [time frame]
Does anyone know what PICO is an acronym for?

12. Sample size
Magnitude of effect- what is the difference in outcome that indicates these two groups are truly different?
How many patients are needed to enroll that will lead to a robust sample and confidence in findings?
What is the statistical difference that will indicate clinical difference?
Look for expert opinion, evidence from a literature review, or other data for an estimate
Does anyone know what PICO is an acronym for?

13. Data Collection
All variables need to be pre-defined in a data dictionary
Collection begins after IRB approval
Variable #
var_name (no more than 9 characters, no punctuation)
Variable definition (units of measurement)
Coded values 1 ID
Study subject ID 2
sex
0="male; 1="female" 3
race
0="white"; 1="black; 2="asian" 4
ethnicity
0="non-hispanic"; 1="hispanic" 5
dia_base
baseline diastolic blood pressure 6
sys_base
baseline systolic blood pressure 7
dia_final
6-month diastolic blood pressure 8
sys_final
6-month systolic blood pressure 9
age
in years
(continuous)

14. Data Collection
Once collection starts, the biggest mistake made is not addressing the errors quickly and adequately!
Collect original data points whenever possible
Use coded values to reduce errors and increase efficiency

15. Analysis Descriptives
Table 1: Patient Characteristics
Necessary for every project, small or big
Continuous variables are described as
Mean/ Standard Deviation (normal distribution)
Categorical variables (e.g., yes/no, race, gender)
Number/ Percent
Table 1: Patient Characteristics (N= )
Demographics
Age
M (SD)
Male
Male number (%)
Race
White
number (%)
Black
Asian
Clinical Characteristics
Vitamin D
Deficient (<xx)
Insufficient (xx-xx)
Normal (>xx)

16. Analysis Inferential Chi-square test for independence
Used to test differences of proportions between two groups
Proportions are used for categorical variables, in which the numeric value has no significance (race, sex)
2x2 table
Disease
No Disease
Exposure/risk
#(%)
No exposure/ risk

17. Analysis Inferential Student’s t-test
Used to test differences of means between two groups
Means are used for continuous variables, in which the numeric value has significance (age, test result, temperature)
2x2 table
Disease
No Disease
Exposure/risk
M(SD)
No exposure/ risk

18. Analysis Take Away The best studies actually use a simple t-test Why?
research uses a strong study design
results are clearly interpretable

19. Planning checklist
Start with the research outline, not the IRB application
Develop your research objective
Conduct your literature review
Fine tune your hypothesis
Establish your team and roles
Write your protocol
Submit application to Protocol Review Committee
Submit application to IRB (use most recent versions available online)

20. Resources
AHC Library
Get an NCBI account to organize and store your references
Compare literature in charts (PICO)

21. Resources Department of Research
Methodology guidance
Resource needs
REDCap, Qualtrics
Statistical support
Sample size estimation
Analysis plan
Variable list

22. Resources
AHC IRB
Use new forms for each new project as forms update frequently:
FORMS NEEDED
HRP-211
HRP-226
HRP-503
HRP-502 (consent form)
IRB Fee Waiver
Data Collection Tool
Learn about the process
Learn about the office

23. If you have questions or need assistance please contact me.
Thank you!
If you have questions or need assistance please contact me.