The goal of this assignment is to design and document a modest public health or otherwise biostatistical study. In so doing, you want to demonstrate your understanding of the materials presented in Biostatistics (HS167), Computational Public Health Statistics (HS267), and perhaps Epidemiology (HS161). Your project should be well-focused, including measurements on no more than 5 to 10 variables.
In designing your study, write a protocol that addresses each of the following design components:
(A) Research Question and Hypothesis: What problem motivates the study, and what question is being addressed? What is research and statistical hypotheses do you wish to address? What parameters are being estimated?
(B) Target Population: What person, place, and time factors define the target population? How will this population be sampled?
(C) Explanatory Variable (i.e., the independent variable; the exposure variable in an epidemiologic study): What is the main independent (explanatory) variable in your study? How will this variable be defined and measured? Does the study design include a reference or control group, or will it simply be desriptive.
(D) Outcome Variable (i.e., the dependent variable; the disease variable in an epidemiologic study): How will the study's outcome be defined? Will data be self-reported or independently measured? If self-reported, will findings be confirmed independently?
(E) Extraneous Factors (i.e., potential confounders). Will extraneous factors that might confound your analysis be considered? If so, how will they be dealt with?
(F) Anatomy of the Proposed Study Design: Is the study observational or experimental? If observational, is it cohort, case-control, or cross-sectional? Will the timing of data collection be concurrent, historical, or mixed? Will study subjects be selected based on their exposure-status, disease-status, or neither? If the study is experimental, describe the randomization method you will use, while discussing blinding methods and ethical considerations.
(G) Planned Analyses: Which descriptive and inferential techniques will be used? What summary statistics will be reported? Will graphs be included in your final report? What parameter(s) will be inferred? Will inference be in the form of confidence intervals or hypothesis tests (or both)?
(H) Sample Size Requirements: How many people need to be studied? Complete preliminary sample size requirement calculations, while being explicit about your assumptions.
(I) Study Limitations: Consider possible sources of error. How will you guard against selection bias, information bias, and confounding? List limits to generalizability.
(A) A concise write-up of your study design protocol. The write-up should be double spaced, and need not be more than a couple of pages long. Please label each section of the write-up as above (e.g., A. Research Question and Hypothesis).
(B) Skeletal computer files you will use during your investigation. These should include your questionnaire (QES) file, an empty record (REC) file, and a data documentation (DD) file showing names, types, descriptions, and encodings of planned variables. Please print out a hard copy of your QES file and DD as well as handing in a floppy disk with these files.