Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial

This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 17/123/03, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1002/erv.3058 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. Funding This publication was funded by the Health Technology Assessment programme as a part of award number 17/123/03. This article reports on one component of the research award A Randomised Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a ‘Stepping into Day Treatment’ Approach versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/17/123/03] DOI https://doi.org/10.1002/erv.3058