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Objective: Our study aimed to review the outcome measures/assessment instruments used and to assess their heterogeneity/homogeneity in eating disorders (EDs) randomised controlled trials. Methods: APA 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. Results: Ninety one articles were included, and a total of 196 outcome measures were collected. Discussion: The 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. Highlights: 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. [ABSTRACT FROM AUTHOR]

Objective: The relative merits of inpatient or day‐treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non‐inferiority of a stepped‐care day patient treatment (DPT) approach versus inpatient treatment as usual (IP‐TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. Method: Fifteen patients with AN (of 53 approached) participated and were followed‐up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. Results: At baseline, participants in both trial arms rated stepped‐care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). Conclusions: No conclusions can be drawn concerning the effectiveness of IP‐TAU and stepped‐care DPT, but the latter was perceived more positively. Patient‐related, service‐related and systemic factors (COVID‐19) contributed to the trial's failure. Lessons learnt can inform future studies. Highlights: Patient‐related (e.g., treatment preferences) and service‐related (e.g., reduced service capacity) alongside wider systemic (e.g., increased emergency admissions due to COVID‐19) factors seem to have contributed to the failure of the DAISIES trial.Patients and carers identified valued aspects for both inpatient (e.g., weight gain) and day‐patient (e.g., greater link to home environment) treatment settings, but day‐patient treatment was perceived as a more holistic and collaborative approach, and thus as more positive.Although randomised controlled studies investigating intensive treatments for severe anorexia nervosa are important and necessary, alternative study designs should be explored to overcome implementation challenges. [ABSTRACT FROM AUTHOR]

Objective: The DAISIES trial, comparing inpatient and stepped‐care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation. Method: Semi‐structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020‐June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co‐investigators involved with the DAISIES trial. The Non‐Adoption, Abandonment, Scale‐up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. Results: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid‐19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio‐political context (e.g. Covid‐19 closing services). Conclusions: Our findings emphasise the top‐down impact of systemic‐level research implementation challenges. The impact of the Covid‐19 pandemic accentuated pre‐existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research. Highlights: The paper highlights the particular challenges to research implementation that arise within an NHS intensive service context.Applying an implementation science framework to the interpretive themes indicated that challenges to implementation spanned the individual to the systemic level, with the latter posing greater barriers and impacting implementation success in other areas.The results suggest that future research into intensive treatment needs to better accommodate patient preferences and emphasise clinician‐researcher relationships and the alignment of clinical and research teams. [ABSTRACT FROM AUTHOR]