Autopsy of a Failed Trial Part 2: Outcomes, Challenges, and Lessons Learnt from the DAISIES Trial

Başak İnce, Matthew Phillips, Zohra Zenasni, James Shearer, Bethan Dalton, Madeleine Irish, Daniela Mercado Beivide, Hannah Webb, Catherine McCombie, Katie Au , Nikola Kern , Sam Clark-Stone , Frances Connan , A. Louise Johnston , Stanimira Lazarova , Ewa Zadeh , Ciarán Newell , Tayeem Pathan , Jackie Wales , Rebecca Cashmore Sandra Marshall , Jon Arcelus , Paul Robinson , Sarah Byford, Sabine Landau, Vanessa Lawrence, Hubertus Himmerich, Janet Treasure, Ulrike Schmidt*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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 learned can inform future studies.
Original languageEnglish
JournalEuropean Eating Disorders Review
Publication statusAccepted/In press - Nov 2023

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