You have been asked to conduct an observational study to assess whether a drug i

Question

You have been asked to conduct an observational study to assess whether a drug is associated with an increased risk of Stevens Johnson Syndrome (SJS). SJS is an extremely rare disease characterized by flu-like symptoms followed by a painful rash that eventually spreads to and causes the skin to die. The drug is a commonly used medication to treat arthritic associated pain.

4a. Which type of study would you design? Please support your choice with a 1-2 sentence rationale? (5 points)

4b. Describe how you would design the study. For example, how would you select your population and comparison groups, define your exposure/outcome, follow-up time, etc. (10 points)

4c. What is the major limitation with this study design? (3 points)

Explanation / Answer

4a) The type of observational study that can be used to assess wheather a drug is associated with an increased risk of Stevens Johnson Syndrome is cohort study. This is because cohort study is a prospective study which helps us to follow the cases over a period of time.

4b) The cases (cohorts) will be those who received a particular drug (exposure) and the comparison group will be those who did not receive the drug. The cases and the comparion group will be matched for known confounding factors like age, sex and occupation. The two groups will be followed for a period of 4-5 months and observed for the development of Steven Johnson Syndrome (outcome).

4c) The major limitation with this study design is it is time consuming and costly.

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