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

Abstract

The minimal important difference (MID) is the smallest benefit of treatment that would result in clinicians recommending it to their patients. The MID is necessary to calculate sample size for randomized clinical trials, but its chosen value is often arbitrary. This study set out to determine the practicability of surveying physicians to elicit the MID for clinical trial sample-size calculation. Using a mail survey, we elicited the MID of different physician specialties (family medicine, internal medicine, vascular surgery) for using propranolol to slow abdominal aortic aneurysm (AAA) growth assuming that propranolol was efficacious in this condition. We used different outcome measures (growth rate or proportion of patients requiring surgery) and different methods of data presentation for the proportion of patients requiring surgery (absolute risk reduction or number needed to treat). The MID varied significantly by physician specialty, experience with AAA and propranolol, and the method used to elicit the MID. Consequently, sample-size calculations using these various MIDs varied from 116 to 3015. Future attempts to elicit the MID need to consider carefully who is surveyed, how data are presented, and how opinions are elicited.