Suppose that you have been hired by university student health services to

design a case-control study

to assess the following hypothesis among undergraduate students:

Irregular sleep patterns increase the risk of headaches.Be sure that your design addresses the following elements:

• Refine the study hypothesis so that it is as specific as possible and contains all elements of a “good” hypothesis.
• How will you identify and define the cases?

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  • Are there any exclusion criteria that you would apply?
• How will you sample from the underlying population for your “controls”?
• Who will you select as controls?
• How will you select them?
• How will you define the exposure of interest?
  • How will you collect the information on exposure?
• What other information do you want to know about participants that may be related to the exposure of interest and/or the outcome (potential confounders)? Of these, what will you be able to collect and what will you be unable to collect?
• Which measures of disease frequency and association will you calculate?
• What are the strengths and limitations of your study?
  • Which limitations could be removed by using a different study design?
• What other information would you like to know to design this study?