Develop a study plan which addresses each of the research components listed below. Summarize your design in the form of a two-page study protocol. After you've designed your study, create the data collection form (in EpiData or EpiInfo) you'd need for data collection. Create a code book for your data collection form.
(A) Research Question and Study Hypothesis. What problem motivated the study? What question will the study answer? Is the study primarily exploratory ("descriptive"), confirmatory ("hypothesis testing"), or both? What statistical parameter will the study address (e.g., a risk ratio? a mean difference?, etc.)?
(B) Population. Describe the source population of the study? How will the source population be sampled?
(C) Explanatory (Independent) Variable. What is the main study factor ("independent variable", "exposure")? How will it be measured? Is there an active control group? Is the study experimental or nonexperimental? Will blinding be employed?
(D) Outcome (Dependent) Variable. What is the main outcome variable ("dependent variable", "disease") of the study? How will it be measured? Will the outcome be self-reported? How will you ensure the information is unbiased?
(E) Extraneous Variables (Potential Confounders). What extraneous factors will be controlled? How are causal factors interrelated?
(F) Type of Study: Classify your study as experimental, ecological, a cross-sectional field survey, cohort study or case-control study. List ethical concerns.
(G) Analyses: What exploratory and confirmatory statistical analyses are planned?
(H) Sample Size Requirements: List the information you will need to calculate the sample size requirements for your study. Where might you derive such information? Calculate the sample size requirements for the study.
(I) Study Limitations: List sources of bias in your study design. How will you guard against selection bias, information bias, and confounding?