{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T21:20:20Z","timestamp":1762809620737,"version":"3.40.5"},"reference-count":113,"publisher":"National Institute for Health and Care Research","issue":"3","license":[{"start":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T00:00:00Z","timestamp":1738368000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>\nA substantial proportion of anorexia nervosa patients require intensive treatments, commonly inpatient or day-patient treatment. The relative merits of these treatments for adults with anorexia nervosa are unknown. Therefore, a trial investigating the clinical effectiveness and cost-effectiveness of inpatient treatment-as-usual versus a stepped-care day-patient approach in adults with anorexia nervosa (DAISIES) was commissioned. This trial terminated prematurely due to poor recruitment, mainly resulting from COVID-19\u2019s impact on service provision.<\/jats:p>\n<\/jats:sec>\nObjective<\/jats:title>\nWe describe the rationale, methods and available outcomes of the DAISIES trial. Reasons behind the trial\u2019s failure and implications for future research are investigated.<\/jats:p>\n<\/jats:sec>\nDesign<\/jats:title>\nA two-arm multicentre open-label parallel-group non-inferiority randomised controlled trial, evaluating the effectiveness, acceptability and cost-effectiveness of two intensive treatments for adults with severe anorexia nervosa.<\/jats:p>\n<\/jats:sec>\nSetting<\/jats:title>\nSpecialist eating-disorder services in the United Kingdom with inpatient and\/or day-patient treatment facilities.<\/jats:p>\n<\/jats:sec>\nParticipants<\/jats:title>\nAdults (age 17\u2005+) with severe anorexia nervosa (body mass index\u2005\u2264\u200516\u2005kg\/m2<\/jats:sup>) requiring intensive treatment and (optionally) their carers. Intended sample size: 386.<\/jats:p>\n<\/jats:sec>\nInterventions<\/jats:title>\nInpatient treatment-as-usual and a stepped-care day-patient treatment approach (with the option of initial inpatient treatment for medical stabilisation).<\/jats:p>\n<\/jats:sec>\nMain outcome measures<\/jats:title>\nThe primary outcome was body mass index at 12 months post randomisation. Qualitative interviews conducted during the trial included semistructured interviews to investigate patients\u2019, families\u2019 and clinicians\u2019 views on treatments.<\/jats:p>\n<\/jats:sec>\nResults<\/jats:title>\nDuring the 16-month recruitment period (November 2020 to March 2022), 53 patients were approached. Of these, 15 were enrolled and randomly allocated to the inpatient treatment-as-usual (n<\/jats:italic>\u2005=\u20057) or day-patient treatment (n<\/jats:italic>\u2005=\u20058) treatment arms. All participants were female with a mean (standard deviation) age of 24.8 (9.1) years and a mean (standard deviation) body mass index of 14.4 (1.6) kg\/m2<\/jats:sup>. Patients\u2019 body mass indexes had increased similarly in both groups at 12 months. Participants perceived the stepped-care day-patient treatment approach to be more acceptable than inpatient treatment-as-usual. Qualitative interviews with patients, carers and clinicians suggested valued (e.g. multidisciplinary provision of care) and disliked (e.g. perceived over-focus on weight gain) aspects of treatment. Investigation of the reasons behind the trial\u2019s failure revealed strong treatment preferences among patients as the most common reason for non-participation, alongside the impact of COVID-19 on service provision.<\/jats:p>\n<\/jats:sec>\nLimitations<\/jats:title>\nThe main trial questions could not be answered due to low participant numbers.<\/jats:p>\n<\/jats:sec>\nConclusions<\/jats:title>\nNo conclusions can be drawn concerning the clinical and cost-effectiveness of inpatient treatment-as-usual or stepped-care day-patient treatment. The day-patient treatment 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.<\/jats:p>\n<\/jats:sec>\nFuture work<\/jats:title>\nDespite the trial\u2019s failure, the need to investigate the effectiveness and experience of intensive treatments of adult anorexia nervosa remains. Alternative trial designs incorporating patient preferences and investigating community-based intensive treatment options have potential to improve acceptability and recruitment.<\/jats:p>\n<\/jats:sec>\nFunding<\/jats:title>\nThis synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 17\/123\/03.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/ftjp6744","type":"journal-article","created":{"date-parts":[[2025,2,13]],"date-time":"2025-02-13T07:23:15Z","timestamp":1739431395000},"page":"4-40","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Stepping into day treatment approach versus inpatient treatment for adults with anorexia nervosa: the DAISIES 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UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0898-1926","authenticated-orcid":true,"given":"Bethan","family":"Dalton","sequence":"additional","affiliation":[{"name":"Centre for Research in Eating and Weight Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King\u2019s College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5561-0939","authenticated-orcid":true,"given":"Madeleine","family":"Irish","sequence":"additional","affiliation":[{"name":"Centre for Research in Eating and Weight Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King\u2019s College London, London, 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