Getting off the "gold standard": randomized controlled trials and education research.

While useful in some situations, randomization is not the “gold standard” for medical education research. More important is that decisions regarding methodology precede the intervention, that adequate numbers of subjects and iterations are used, that a comparison group is included, and that limitations are addressed in a thoughtful, thorough manner. In addition, the literature demonstrates quite definitively that medical learners will learn whatever we teach and also may supplement any teaching deficits to meet certification requirements.18 Thus, to increase our understanding of effective educational interventions, a new educational intervention should be compared to another effective intervention. Unlike clinical research, a placebo arm is rarely helpful. Comparing the new educational intervention to “usual” practices is productive as long as students are not “cued” to the novelty of the research arm—which may enhance (or negatively bias) their learning—and the usual practices are well described. Whether randomized or nonrandomized, medical education studies must carefully analyze sources of bias—unforeseen confounding variables—to explain the observed results and ensure that subsequent researchers will find these results reproducible. Rather than an obligatory listing of these potential sources of error in the discussion, researchers will enhance existing knowledge through a careful and detailed analysis of sources of bias that may have affected the results.3 Equally important, research designs must include a control group, concurrent if possible, to ensure equal likelihood of exposure to nonintervention events that could bias the results. If educators begin to work together, more collaborative, multi-institutional projects, perhaps akin to “pragmatic trials,”12 may be produced in the future. This is likely to add substantially to our understanding of effective resident education.