Quality of randomised controlled trials in medical education reported between 2012 and 2013: a systematic review protocol.

Abstract

Research in medical education has increased in volume over the past decades but concerns have been raised regarding the quality of trials conducted within this field. Randomised controlled trials (RCTs) involving educational interventions that are reported in biomedical journals have been criticised for their insufficient conceptual, theoretical framework. RCTs published in journals dedicated to medical education, on the other hand, have been questioned regarding their methodological rigour. The aim of this study is therefore to assess the quality of RCTs of educational interventions reported in 2012 and 2013 in journals dedicated to medical education compared to biomedical journals with respect to objective quality criteria. RCTs published between 1 January 2012 and 31 December 2013 in English are included. The search strategy is developed with the help of experienced librarians to search online databases for key terms. All of the identified RCTs are screened based on their titles and abstracts individually by the authors and then compared in pairs to assess agreement. Data are extracted from the included RCTs by independently scoring each RCT using a data collection form. The data collection form consists of four steps. Step 1 includes confirmation of RCT eligibility; step 2 consists of the CONSORT checklist; step 3 consists of the Medical Education Research Study Quality Instrument framework; step 4 consists of a Medical Education Extension (MEdEx) to the CONSORT checklist. The MEdEx includes the following elements: Description of scientific background, explanation of rationale, quality of research questions and hypotheses, clarity in the description of the use of the intervention and control as well as interpretation of results. This review is the first to systematically examine the quality of RCTs conducted in medical education. We plan to disseminate the results through publications and presentation at relevant conferences. Ethical approval is not sought for this review.