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.

Guided self-help treatment for children and young people with threshold and subthreshold eating disorders: A pilot study protocol.

BACKGROUND: Prompt access to evidence-based treatment for children and young people with eating disorders is important for outcomes, yet the gap in service provision remains pervasive. Record levels of young people are waiting for eating disorder treatment and access to care is limited. Guided self-help interventions that are brief and require minimal clinician support have the potential to meet the unprecedented demand for treatment quickly and effectively. OBJECTIVE: To examine the feasibility, acceptability and proof of concept of a novel, CBT guided self-help intervention for children and young people with threshold and subthreshold eating disorders. METHODS: A single-arm, proof-of-concept pilot study of the CBT guided self-help intervention will be conducted. Children and young people (aged 11-19) with threshold and subthreshold eating disorders will receive a self-help intervention covering the core components of CBT, supported by 8 weekly guidance sessions delivered remotely. Clinical outcomes (eating-related psychopathology and associated impairment, changes in weight, depression, anxiety, and behavioural difficulties) will be assessed at baseline and post-intervention (12 weeks). Feasibility and acceptability of the intervention will be measured using various outcomes, including adherence to, and engagement with the intervention, rates of recruitment and retention, measure completion and treatment satisfaction. Qualitative data will also be collected for future intervention refinement. DISCUSSION: If the intervention is shown to produce clinical benefits in this pilot study, a fully powered randomised pilot study will be warranted with the ultimate goal of increasing access to psychological treatment for children and young people threshold and subthreshold eating disorders. ADMINISTRATIVE INFORMATION: This study protocol (S1 File) adheres to the guidelines outlined in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for trial protocols [1, 2] which can be found in S1 Checklist. The numbers in parentheses in this protocol correspond to the item numbers in the SPIRIT checklist. The order of items has been modified to group similar items.

The alarms should no longer be ignored: survey of the demand, capacity and provision of adult community eating disorder services in England and Scotland before COVID-19.

AIMS/METHOD: This national pre-pandemic survey compared demand and capacity of adult community eating disorder services (ACEDS) with NHS England (NHSE) commissioning guidance. RESULTS: Thirteen services in England and Scotland responded (covering 10.7 million population). Between 2016-2017 and 2019-2020 mean referral rates increased by 18.8%, from 378 to 449/million population. Only 3.7% of referrals were from child and adolescent eating disorder services (CEDS-CYP), but 46% of patients were aged 18-25 and 54% were aged >25. Most ACEDS had waiting lists and rationed access. Many could not provide full medical monitoring, adapt treatment for comorbidities, offer assertive outreach or provide seamless transitions. For patient volume, the ACEDS workforce budget was 15%, compared with the NHSE workforce calculator recommendations for CEDS-CYP. Parity required £7 million investment/million population for the ACEDS. CLINICAL IMPLICATIONS: This study highlights the severe pressure in ACEDS, which has increased since the COVID-19 pandemic. Substantial investment is required to ensure NHS ACEDS meet national guidance, offer evidence-based treatment, reduce risk and preventable deaths, and achieve parity with CEDS-CYP.

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.

Drug Prescribing in Child and Adolescent Eating Disorder Services.

BACKGROUND: Psychotropic drugs are not recommended for child and adolescent eating disorders, though they are used empirically for symptomatic treatment and co-morbid conditions. Little is known about rates of prescribing or the beneficial and adverse effects. OBJECTIVE: To ascertain rates and outcomes of psychotropic drug prescribing in child and adolescent eating disorder services. METHOD: Retrospective case note study of eating disorder cases (n = 308), seen in one year in seven specialist UK services, covering indications, response to treatment, beneficial and adverse effects. RESULTS: Drugs were prescribed for 27%, (mainly anorexia nervosa), 12% before referral to specialist services. The most commonly prescribed drugs were fluoxetine and olanzapine, but 26 different drugs were used. The most common indications were depression, anxiety and 'pseudo-psychotic' concerns about weight. Drugs were generally well tolerated, but their effectiveness was uncertain. CONCLUSIONS: Non-specialists commonly prescribe psychotropic medication to this vulnerable group without reference to specialist services. Specialists prescribe regularly on empirical grounds, without apparent undue consequences, though these may be under-reported. A prospective clinical trial would further clarify risks and benefits.

Understanding eating disorders.

Eating disorders can be severe and enduring mental illnesses that have serious physical, psychological and social consequences. They can also have a significant effect on the person's friends and family. In this patient group, control of body shape, weight or eating is over-valued and becomes the main or only way of judging self-worth. Eating disorders can be mild and self-limiting, but they commonly run a chronic course unless treatment is successful. Nurses play an important role in early detection, assessment and treatment.

Can collaboration between education and health professionals improve the identification and referral of young people with eating disorders in schools? A pilot study.

In this pilot study, a number of different methods of identifying young people with eating disorders in schools were compared. Pupils aged 16-18 years from 3 schools in the South West of the UK participated (389 boys and 374 girls in total). A self-report questionnaire (EDE-Q) was found to be the most effective method of case identification. However, very few of these cases accepted the offer of help and it was strongly suspected that other cases went undetected despite teacher, parent and school nurse guidance. Implications for future early intervention studies are discussed.