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 1: ECOLOGIC COMPARISON STUDY

Briefly describe the layout of an ecological comparison study designed to address the study question. In formulating your description, consider the following points:

1. How will exposure and outcome be defined and measured?

Answer:

2. Where might you get information on the exposure and the outcome?

Answer:

Answer 1

1.

Exposure:-

In epidemiology, the term “exposure” can be broadly applied to any factor that may be associated with an outcome of interest. When using observational data sources, researchers often rely on readily available (existing) data elements to identify whether individuals have been exposed to a factor of interest.

Exposure assessment is the process of estimating or measuring the magnitude, frequency and duration of exposure to an agent, along with the number and characteristics of the population exposed. Ideally, it describes the sources, pathways, routes, and the uncertainties in the assessment.

Outcome:-

Outcome measures reflect the impact of the health care service or intervention on the health status of patients. For example: The percentage of patients who died as a result of surgery (surgical mortality rates). The rate of surgical complications or hospital-acquired infections.