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Surveying physicians to determine the minimal important difference: implications for sample-size calculation.

C van Walraven¹, J L Mahon, D Moher

¹Department of Medicine, University of Ottawa and Clinical Epidemiology Unit, Ottawa Hospital - Civic Campus, Canada.

Journal of Clinical Epidemiology

|August 28, 1999

Summary

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Determining the minimal important difference (MID) for clinical trials is complex. Physician surveys reveal that MID values vary significantly, impacting sample size calculations for treatments like propranolol for abdominal aortic aneurysms.

Area of Science:

Clinical Trials
Medical Statistics
Health Outcomes Research

Background:

The minimal important difference (MID) is crucial for determining treatment benefits that warrant clinical recommendation and for sample size calculations in randomized clinical trials.
Current methods for selecting MID values are often arbitrary, potentially affecting trial validity and resource allocation.

Purpose of the Study:

To assess the feasibility of surveying physicians to determine the MID for clinical trial sample-size calculations.
To investigate how different physician specialties, outcome measures, and data presentation methods influence the elicited MID.

Main Methods:

A mail survey was conducted with physicians from family medicine, internal medicine, and vascular surgery.
The survey elicited the MID for propranolol in slowing abdominal aortic aneurysm (AAA) growth, using various outcome measures (growth rate, proportion of patients needing surgery) and data presentation formats (absolute risk reduction, number needed to treat).

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Main Results:

The elicited MID varied significantly based on physician specialty, experience with AAA and propranolol, and the elicitation method employed.
Consequently, sample-size calculations based on these MIDs ranged widely from 116 to 3015 participants.

Conclusions:

Physician surveys can elicit MID values, but results are sensitive to the surveyed population and the methods used for data presentation and opinion elicitation.
Future research on eliciting MID for clinical trial sample-size calculations must carefully consider these factors to ensure reliable and consistent results.