Pragmatic clinical trials to advance research in children and adolescents with eating disorders

Abstract

ObjectiveTo discuss the utility of pragmatic clinical trials (PCTs) to help advance research in eating disorders (EDs).MethodsWe describe challenges associated with traditional explanatory research trials and examine PCTs as an alternative, including a review of the PRECIS‐2 tool.ResultsThere are many challenges associated with the design and completion of traditional RCTs within the field of EDs. Pragmatic clinical trials are studies that closely align with conditions available in everyday practice and focus on outcomes that are relevant to patients and clinicians. Results of PCTS maximize applicability and generalizability to clinical settings.DiscussionAvailable therapies established for the treatment of EDs provide remission rates that rarely exceed 50%, implying a need for additional research on new or adjunctive treatments. In addition to a general overview of PCTs, we draw upon published literature and our own experiences involving adjunctive olanzapine for the treatment of children and youth with anorexia nervosa to help highlight challenges associated with randomized controlled trial (RCT) design and implementation, and offer pragmatic suggestions that would allow patients greater choice in treatment trials, while at the same time capturing outcomes that are most likely to advance treatment efforts.ConclusionsPragmatic clinical trials provide alternatives to RCT design that can help bolster research in EDs that aims to explore real‐world effects of interventions.Public SignificanceAvailable therapies established for the treatment of eating disorders (EDs) in children and adolescents provide remission rates that rarely exceed 50%, implying a need for additional research on new or adjunctive treatments. In this article, we discuss the utility of pragmatic trials to help promote research that can help advance knowledge that is relevant to clinical care settings.