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

TY - JOUR

T1 - Autopsy of a Failed Trial Part 2: Outcomes, Challenges, and Lessons Learnt from the DAISIES Trial

AU - İnce, Başak

AU - Phillips, Matthew

AU - Zenasni, Zohra

AU - Shearer, James

AU - Dalton, Bethan

AU - Irish, Madeleine

AU - Mercado Beivide, Daniela

AU - Webb, Hannah

AU - McCombie, Catherine

AU - Au , Katie

AU - Kern , Nikola

AU - Clark-Stone , Sam

AU - Connan , Frances

AU - Johnston , A. Louise

AU - Lazarova , Stanimira

AU - Zadeh , Ewa

AU - Newell , Ciarán

AU - Pathan , Tayeem

AU - Wales , Jackie

AU - Cashmore , Rebecca

AU - Marshall , Sandra

AU - Arcelus , Jon

AU - Robinson , Paul

AU - Byford, Sarah

AU - Landau, Sabine

AU - Lawrence, Vanessa

AU - Himmerich, Hubertus

AU - Treasure, Janet

AU - Schmidt, Ulrike

PY - 2023/12/18

Y1 - 2023/12/18

N2 - 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.

AB - 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.

U2 - 10.1002/erv.3058

DO - 10.1002/erv.3058

M3 - Article

SN - 1072-4133

VL - 32

SP - 476

EP - 489

JO - European Eating Disorders Review

JF - European Eating Disorders Review

IS - 3

ER -