A Medical Educator's Guide to Thinking Critically about Randomised Controlled Trials

Drawing on the statistical and philosophical expertise of its authors, this book is designed to improve understanding and use of randomised controlled trials (RCTs) among medical and other health professionals.

Its primary aims are:

• To provide a comprehensive and honest consideration of the strengths and limitations of RCTs and thus a balanced representation of their role in clinical research;
• Correspondingly, with the support of topical examples, to highlight potential areas of weakness in the design, conduct and statistical reporting of RCTs;

and

• In turn, to inspire and equip educators to train their students to take a more critical approach to individual RCTs as a source of evidence for clinical effectiveness, without skipping the statistical elements.

This book is intended for use primarily by medical educators involved in the teaching of statistics and evidence-based medicine (EBM) to undergraduate medical students and junior doctors. However, each of the chapters serves a wider range of interests, including the practical needs of physicians in interpreting research evidence and the teaching needs of philosophers of medicine who want to more fully appreciate how RCTs work in practice and provide engaging examples for their students.

Rather than compete with the proliferating methodological literature on RCT designs, this book focuses on cultivating a healthy skepticism among developing health professionals in their critical appraisal of their own and published work on RCTs at a fundamental level with a view to safeguarding the healthcare of future patients. It also encourages making better use of RCTs, including through a more informed understanding of the place of subgroup analyses in sound statistical inference.

Medical educators will find a wealth of reasons to encourage their students to think more critically about how the RCT operates in practice as a gold standard while following its development from a primitive form in Lind's 1747 experiment to its distinguished place in contemporary clinical research. Management of the positive predictive value in the statistical analysis of RCT findings is included as an important topic for contemporary medical curricula. In comparing RCTs with non-randomised studies, a search for empirical evidence for the superiority of RCTs is also initiated, pointing to the need for further work to confirm what form this evidence should take.

Each chapter offers key learning points as signposting to support educators in the design of their future learning content.