Post on 30-Dec-2015
Anatomy
•The structure of a research project is set
out in its protocol•Which is helping the investigator to
organize her/his research in a logical, focused, and efficient way
Outline of the Study Protocol•Research questions•Background and significance•Design•Subjects•Variables•Statistical issues
Do fish oil supplements have the same effects on cardiovascular disease as dietary fish?
Research questions
New Questions Arise
Results Interpreted
Data Collected
Question Identified
Hypotheses Formed
Research Plan
Closed-loop conceptualization of the research process (Drew, Hardman, and Hart, 1996)
Descriptive Analytical
Observational
Cross Sectional
Case Series
Case Report
Randomized Clinical Trial
Cohort
Case-Control
Study Design
Experimental
•Analytical study of one patient•Detailed profile of a “ rare” presentation or unusual side effect of drug
Case Report
Example:
•You interview subjects about current and past history of fish intake and correlates results with history of CHD
Disadvantages of a cross sectional study
•Failing to take time•Biases:Selection biasInformation biasConfounding bias
Example:•You examine a group of patients with
CHD and compares them with a group who did not have CHD (the controls), asking about past fish intake
CHD
NoCHD
High fish
intake
Low fish
intake
Example:•The investigator measures fish intake at
baseline and periodically examines subjects at follow-up visits to see if those who eat more fish have fewer coronary heart disease (CHD) events
CHD
NoCHD
High fish
intake
Low fish
intake
Example:
•You randomly assign subjects to receive fish oil supplements or placebo, then follows both treatment groups for several years to observe the incidence of CHD
Randomized designs
•Methods of randomization:– Several choices, from “flipping a coin” to
stratified randomization•Blinding/masking:– Participant, study investigator (and
anybody else involved in follow-up)– Ideally, double-blinded
The Last Slide•Can I do research?
Yes•How?Assemble a research teamAsk a general questionDo a literature searchAsk a good research questionFind a mentor
Conduct your research project