Let's get aligned! Developing a core outcome set for clinical trials in eating disorders

ObjectiveOur study aimed to review the outcome measures/assessment instruments used and to assess their heterogeneity/homogeneity in eating disorders (EDs) randomised controlled trials.MethodsAPA PsycInfo, PubMed, and Embase were searched in December 2022 to identify studies published between and inclusive of January 2012 and December 2022. Inclusion/exclusion criteria were: (1) complete articles published in peer-reviewed scientific journals, which were: (2) randomised trials, (3) in a clinical setting (4) with human subjects, (5) with an ICD or DSM diagnosis of Anorexia Nervosa, Binge Eating Disorder, or Bulimia Nervosa. The selected papers also: (6) used one or more standardised instruments designed to measure one or more psychometric characteristics associated with ED as a primary or secondary outcome, as judged by the authors of this systematic review, and (7) were published in English or Danish.ResultsNinety one articles were included, and a total of 196 outcome measures were collected.DiscussionThe diversity of outcome measures in ED trials hampers result comparability and data integration. We suggest creating a core outcome measure set using the Delphi method, including clinician and patient-reported ED assessments, along with relevant comorbidity scales. There is a significant heterogeneity in outcome measures and a need for standardisation. We identified a predominant focus on female participants and white populations in most randomised controlled trials (RCTs) for eating disorders (EDs), raising concerns about the generalisability of findings to diverse demographic groups. We advocate for the development of a comprehensive core outcome sets' (COS) for ED clinical trials, emphasising the minimum inclusion of a clinician-rated clinical ED assessment, a patient self-reported ED assessment, and scales measuring common co-morbidities.