Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.

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 learnt can inform future studies.

Predictors of Positive Treatment Outcome in People With Anorexia Nervosa Treated in a Specialized Inpatient Unit: The Role of Early Response to Treatment.

OBJECTIVE: To investigate factors which predict positive treatment outcome in inpatients with anorexia nervosa (AN), particularly the role of early treatment response. METHOD: 102 patients entering specialist inpatient treatment were assessed for eating disorder history, psychopathology, and motivation to change. Predictive factors assessed were: early treatment response defined as weight increase of at least 0.5-1 kg/week during the first 6 weeks of treatment (n=87), admission body mass index (BMI), onset age, chronicity, motivation to change, diagnosis, and previous hospitalization for AN. Positive treatment outcome was defined as achieving a BMI of 17.5 kg/m(2) within an individual time frame. RESULTS: Logistic regression indicated that patients were 18 times more likely to reach positive treatment outcome if they met the National Institute for Health and Care Excellence weight guidelines within the first 6 weeks of hospitalization. Higher admission BMI was also found to predict positive treatment outcome. DISCUSSION: Higher entry BMI and early weight gain predict positive treatment outcome in individuals receiving specialist AN inpatient treatment. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.

Evaluation of a Motivation and Psycho-Educational Guided Self-Help Intervention for People with Eating Disorders (MOPED).

High dropout rates and poor levels of engagement are well documented for patients with eating disorders. Utilising motivational techniques and providing psycho-education have been suggested as ways to reduce treatment disengagement. This study aimed to evaluate the effect of a newly developed motivational and psycho-educational (MOPED) guided self-help intervention for people with eating disorders on engagement and retention in therapy. Patients who received MOPED pre-treatment (n = 79) were compared with a diagnosis-matched group of patients receiving treatment as usual (TAU; n = 79). The study found that patients receiving MOPED had a higher engagement rate than those within the TAU group. Specifically, patients in the anorexic spectrum were found to present with both higher rates of engagement and completion of therapy when issued with MOPED in comparison with TAU. Self-help packages using motivational style could be a valuable and cost-effective intervention for patients with eating disorders.

Should I ask about eating? Patients' disclosure of eating disorder symptoms and help-seeking behaviour.

OBJECTIVE: To retrospectively explore the first disclosure of eating problems and the impact of disclosure factors on subsequent help-seeking amongst women with eating disorders. METHOD: Seventy-one eating disorder service users were interviewed using the newly developed Eating Disorder Disclosure Interview and the Eating Disorder Examination Questionnaire. RESULTS: Faster access to specialist services was associated with being older at first disclosure and with disclosures that involved either a general practitioner, an individual's partner or mother. Patients' appraisals of 'other-initiated' and 'volunteered' disclosures did not differ, although 'other-initiated' disclosures were younger and accessed help more quickly than those who 'volunteered'. The more positively 'other-initiated' disclosures were appraised, the quicker the subsequent help-seeking. CONCLUSION: The findings indicate that initiating a disclosure might lead to earlier access to treatment for individuals with eating disorders.

The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial.

BACKGROUND: Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. METHODS: 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. DISCUSSION: The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision. TRIAL REGISTRATION: ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.