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

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 journal › Article › peer-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 language	English
Journal	European Eating Disorders Review
Publication status	Accepted/In press - Nov 2023

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İnce, B., Phillips, M., Zenasni, Z., Shearer, J., Dalton, B., Irish, M., Mercado Beivide, D., Webb, H., McCombie, C., Au , K., Kern , N., Clark-Stone , S., Connan , F., Johnston , A. L., Lazarova , S., Zadeh , E., Newell , C., Pathan , T., Wales , J., ... Schmidt, U. (Accepted/In press). Autopsy of a Failed Trial Part 2: Outcomes, Challenges, and Lessons Learnt from the DAISIES Trial. European Eating Disorders Review.

@article{6103be7731a5442d9b6858631d8e53a0,

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

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{\textquoteright}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{\textquoteright} 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{\textquoteright}s failure. Lessons learned can inform future studies.",

author = "Ba{\c s}ak İnce and Matthew Phillips and Zohra Zenasni and James Shearer and Bethan Dalton and Madeleine Irish and {Mercado Beivide}, Daniela and Hannah Webb and Catherine McCombie and Katie Au and Nikola Kern and Sam Clark-Stone and Frances Connan and Johnston, {A. Louise} and Stanimira Lazarova and Ewa Zadeh and Ciar{\'a}n Newell and Tayeem Pathan and Jackie Wales and Rebecca Cashmore and Sandra Marshall and Jon Arcelus and Paul Robinson and Sarah Byford and Sabine Landau and Vanessa Lawrence and Hubertus Himmerich and Janet Treasure and Ulrike Schmidt",

year = "2023",

month = nov,

language = "English",

journal = "European Eating Disorders Review",

issn = "1072-4133",

}

İnce, B , Phillips, M , Zenasni, Z , Shearer, J , Dalton, B , Irish, M , Mercado Beivide, D , Webb, H , McCombie, C, Au , K, Kern , N, Clark-Stone , S, Connan , F, Johnston , AL, Lazarova , S, Zadeh , E, Newell , C, Pathan , T, Wales , J, Cashmore , R, Marshall , S, Arcelus , J, Robinson , P, Byford, S , Landau, S , Lawrence, V , Himmerich, H , Treasure, J & Schmidt, U 2023, 'Autopsy of a Failed Trial Part 2: Outcomes, Challenges, and Lessons Learnt from the DAISIES Trial', European Eating Disorders Review.

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 - 2023/11

Y1 - 2023/11

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.

M3 - Article

SN - 1072-4133

JO - European Eating Disorders Review

JF - European Eating Disorders Review

ER -

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

Abstract

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