Abstract
Background: A substantial proportion of anorexia nervosa (AN) patients require intensive treatments, commonly inpatient (IP) or day patient treatment (DPT). The relative merits of these treatments for adults with AN are unknown. Therefore, a trial investigating the clinical effectiveness, and cost-effectiveness of IP treatment-as-usual (TAU) versus a stepped-care DP approach in adults with AN (DAISIES) was commissioned. This trial terminated prematurely due to poor recruitment, mainly resulting from COVID-19’s impact on service provision.
Objective(s): We describe the rationale, methods, and available outcomes of the DAISIES trial. Reasons behind the trial’s failure and implications for future research are investigated.
Design: A two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness, acceptability and cost-effectiveness of two intensive treatments for adults with severe AN.
Setting: Specialist eating disorder (ED) services in the UK with IP and/or DPT facilities.
Participants: Adults (age 17+) with severe AN (body mass index [BMI] < 16 kg/m2) requiring intensive treatment and (optionally) their carers. Intended sample size: 386.
Interventions: IP-TAU and a stepped care DPT approach (with the option of initial IP treatment for medical stabilisation).
Main outcome measures: The primary outcome was BMI at 12 months post-randomisation. Qualitative interviews conducted during the trial included semi-structured interviews to investigate patients’, families’, and clinicians’ views on treatments.
Results: During the 16-month recruitment period (November 2020 to March 2022), 53 patients were approached. Of these, 15 were enrolled and randomly allocated to the IP-TAU (n=7) or DPT (n=8) treatment arms. All participants were female with a mean (SD) age of 24.8 (9.1) years and a mean (SD) BMI of 14.4 (1.6) kg/m2. Patients’ BMIs had increased similarly in both groups at 12-months. Participants perceived the stepped-care DPT approach to be more acceptable than IP-TAU. Qualitative interviews with patients, carers, and clinicians suggested valued (e.g., multidisciplinary provision of care) and disliked (e.g., perceived overfocus on weight gain) aspects of treatment. Investigation of the reasons behind the trial’s failure revealed strong treatment preferences amongst patients as the most common reason for non-participation, alongside the impact of COVID-19 on service provision.
Limitations: The main trial questions could not be answered due to low participant numbers.
Conclusions: No conclusions can be drawn concerning the clinical and cost-effectiveness of IP-TAU and stepped-care DPT. The DPT approach was perceived more positively by patients and carers. Service-related (e.g., reduced clinician time for research), patient-related (e.g., treatment preferences) and wider systemic factors (e.g. reduced service capacity and patient throughput nationally during COVID-19) seem to have contributed to the failure of the DAISIES trial.
Future work: Despite the trial’s failure, the need to investigate the effectiveness and experience of intensive treatments of adult AN remains. Alternative trial designs incorporating patient preferences, and investigating community-based intensive treatment options have potential to improve acceptability and recruitment.
Objective(s): We describe the rationale, methods, and available outcomes of the DAISIES trial. Reasons behind the trial’s failure and implications for future research are investigated.
Design: A two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness, acceptability and cost-effectiveness of two intensive treatments for adults with severe AN.
Setting: Specialist eating disorder (ED) services in the UK with IP and/or DPT facilities.
Participants: Adults (age 17+) with severe AN (body mass index [BMI] < 16 kg/m2) requiring intensive treatment and (optionally) their carers. Intended sample size: 386.
Interventions: IP-TAU and a stepped care DPT approach (with the option of initial IP treatment for medical stabilisation).
Main outcome measures: The primary outcome was BMI at 12 months post-randomisation. Qualitative interviews conducted during the trial included semi-structured interviews to investigate patients’, families’, and clinicians’ views on treatments.
Results: During the 16-month recruitment period (November 2020 to March 2022), 53 patients were approached. Of these, 15 were enrolled and randomly allocated to the IP-TAU (n=7) or DPT (n=8) treatment arms. All participants were female with a mean (SD) age of 24.8 (9.1) years and a mean (SD) BMI of 14.4 (1.6) kg/m2. Patients’ BMIs had increased similarly in both groups at 12-months. Participants perceived the stepped-care DPT approach to be more acceptable than IP-TAU. Qualitative interviews with patients, carers, and clinicians suggested valued (e.g., multidisciplinary provision of care) and disliked (e.g., perceived overfocus on weight gain) aspects of treatment. Investigation of the reasons behind the trial’s failure revealed strong treatment preferences amongst patients as the most common reason for non-participation, alongside the impact of COVID-19 on service provision.
Limitations: The main trial questions could not be answered due to low participant numbers.
Conclusions: No conclusions can be drawn concerning the clinical and cost-effectiveness of IP-TAU and stepped-care DPT. The DPT approach was perceived more positively by patients and carers. Service-related (e.g., reduced clinician time for research), patient-related (e.g., treatment preferences) and wider systemic factors (e.g. reduced service capacity and patient throughput nationally during COVID-19) seem to have contributed to the failure of the DAISIES trial.
Future work: Despite the trial’s failure, the need to investigate the effectiveness and experience of intensive treatments of adult AN remains. Alternative trial designs incorporating patient preferences, and investigating community-based intensive treatment options have potential to improve acceptability and recruitment.
Original language | English |
---|---|
Journal | Health Technology Assessment |
Publication status | Accepted/In press - 18 Jun 2024 |