The risk-of-bias and standards of reporting of published randomized controlled trials of medical education (Med Ed) research

Article type
Authors
Horsley T1, Rabb D1, Campbell C1, Hamstra S2, Cook D3
1Royal College of Physicians and Surgeons of Canada
2AIME University of Ottawa
3MAYO College of Medicine
Abstract
Background: Controlling bias within randomized trials (RCTs) has been empirically shown to reduce errors in estimates of treatment effects. In theory, the RCT is less susceptible to bias than any other research study design. It is this 'susceptibility to bias' that is the focus of this work.

Objectives: We aimed to establish the risk of bias and standard of reporting of RCTs of medical education (Med Ed) research.

Methods: Records were independently assessed until a representative sample (N = 150) was achieved. Publications were evaluated in duplicate using the Cochrane risk of bias (ROB) assessment tool and the CONSORT reporting guideline for RCTs.

Results: Reporting of components of the CONSORT guidelines (including, but not limited to, sample size calculation, blinding, baseline characteristics, and sequence generation) are woefully inadequate. Med Ed RCTs were predominately rated to be of 'unclear’ risk of bias.

Conclusions: The Med Ed discipline should strongly consider using CONSORT for improving reporting of RCTs. A proposal for developing an extension for RCTs of education for consideration by the CONSORT consortium is underway. Considerations for risks of bias should be made when interpreting Med Ed RCTs.