Question

STUDY QUESTION: Does use of diet drug fen-phen (fenfluramine-phentermine) cause valvular heart disease?

HINT: Valvular heart disease is most objectively identified by echocardiography. A fairly high percentage of persons with valvular heart disease don’t have a detectable heart murmur and thus, would not be identified by physical examination alone. For this study, valvular heart disease will include mitral and aortic regurgitation. These are graded as absent, trace, mild, moderate, and severe. The Food and Drug Administration (FDA) criterion for significant mitral valve regurgitation is moderate or higher; for aortic regurgitation the criterion is mild or higher.

DESIGN 2: CROSS-SECTIONAL STUDY

Briefly describe the layout of a cross-sectional study designed to address the study question. In formulating your description, consider the following points:

1. How will the study participants be selected?

Answer:

2. How will information on the exposure and the outcome be collected (ascertained)?

Answer:

HINT: Since these drugs have been taken off the market, it would not be possible to do a cross-sectional study now. In designing your study, assume that the drugs are still being prescribed.

Answer 1

Layout of the Study:

OBJECTIVE:To assess whether the diet drug fen-phen (fenfluramine-phentermine) causes valvular heart disease in a vulnerable population.

DESIGN:Cross-sectional study.

SETTING: Tertiary teaching hospital

A-1. Selection of study participants :

100 patients with previous exposure to fen-phen who are diagnosed with atleast mild mitral regurgitation or aortic regurgitation after exposure to fenfluramines should be considered and subjected to echocardiography.

A-2. A validated pre-tested questionnaire should be used to collect details of exposure and oucome.

Exposure in this case is..any history of consumption of fen-phen.(these are the vulnerable population)

Outcome is ...Assessment of severity of valvular regurgitation and presence or absence of valve leaflet restriction by subjecting the individuals to serial electrocardiogram.