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A survey of physician efficacy requirements to plan clinical trials
Mark Oremus1, Jean-Paul Collet, Jacques Corcos
1Centre for Clinical Epidemiology and Community Studies, S.M.B.D. Jewish General Hospital, Joint Departments of Epidemiology and Biostatistics and Occupational Health, McGill University, Montreal, Canada. mark.oremus@mail.mcgill.ca
Purpose:
Eliciting physician efficacy requirements for utilizing medical treatments can be a useful means of helping plan a clinical trial. Efficacy requirements were studied for female stress urinary incontinence, where an experimental treatment (collagen injection) was compared to the standard therapy (surgery).
Methods:
A self-administered questionnaire was sent to 223 North American urologists, gynecologists, and urogynecologists. An interviewer also administered a similar questionnaire to 20 other clinician-specialists.
Results:
The response rate for the self-administered questionnaire was 48.4% (108/223). All 20 clinician-specialists who were approached for an interview consented. On average, respondents to the self-administered questionnaire indicated they would consider using collagen as the first line treatment if the absolute reduction in efficacy of collagen versus surgery was no larger than 23%. The corresponding result for the interview-questionnaire was 22%. Efficacy was measured as patient satisfaction with treatment. In the opinion of the physicians, surgery would remain the standard therapy if the reduction was greater than 34% (self-administered questionnaire), or 37% (interviewer-administered questionnaire).
Conclusions:
The elicitation of physician efficacy requirements provides an idea of the treatment effect that would be needed for a clinical trial to have an impact on medical practice. These requirements can be used to calculate a relevant sample size.