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.

Implementation of an all-age eating disorders service in the National health service in England: The Dorset experience.

This article provides a commentary on the development of an integrated all-age eating disorders service in the Eating disorders service within the NHS in Dorset. Previously separate services existed for those under the age of 18 and those age 18 and over. The change from traditional age based services to the all age service was prompted by the observed problems with transitions for patients, their families and the service such as discontinuities in care, and distress to patients and families. In addition the literature on transitions although limited in eating disorders showed that patient and carer perspectives were mostly negative about transitions. The aim was to create an all-age service working with patients of different ages, through developing the competencies of the team to appropriately meet the needs of the all age population. This paper describes the context and rationale for this change, its implementation using the organisational change policy approach to service transformation, including addressing the concerns of the stakeholders (patients, carers, staff, and mental health service commissioners), as well as observed changes in the service and its development. Since the all-age service started in 2016, new research has become available on both the improvement of the transition experience and the potential advantages of all-age services and relevant aspects are discussed.

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 Role of Aesthetics in Intentions to Use Digital Health Interventions.

Digital interventions are increasingly recognised as cost-effective treatment solutions for a number of health concerns, but adoption and use of these interventions can be low, affecting outcomes. This research sought to identify how individual aesthetic facets and perceived trust may influence perceptions toward and intentions to use an online health intervention by building on the Technology Acceptance Model, where perceived attractiveness, perceived usefulness, perceived ease of use and perceived enjoyment are thought to predict behavioural intentions towards a website. An online questionnaire study assessed perceptions of nine stimuli varying in four aesthetic facets (simplicity, diversity, colour & craftsmanship), utilising a quasi-experimental within-subjects design with a repetition among three different groups: individuals from the general population who were shown stimuli referring to general health (GP-H) (N = 257); individuals experiencing an eating disorder and shown stimuli referring to eating disorders (ED-ED) (N = 109); and individuals from the general population who were shown stimuli referring to eating disorders (GP-ED) (N = 235). Linear mixed models demonstrated that perceptions of simplicity and craftsmanship significantly influenced perceptions of usefulness, ease of use, enjoyment and trust, which in turn influenced behavioural intentions. This study demonstrates that developing the TAM model to add a further construct of perceived trust could be beneficial for digital health intervention developers. In this study, simplicity and craftsmanship were identified as the aesthetic facets with the greatest impact on user perceptions of digital health interventions.

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.

A Web-Based Intervention (MotivATE) to Increase Attendance at an Eating Disorder Service Assessment Appointment: Zelen Randomized Controlled Trial.

BACKGROUND: Early assessment and treatment of eating disorder patients is important for patient outcomes. However, up to a third of people referred for treatment do not access services and 16.4% do not attend their first scheduled assessment appointment. MotivATE is a fully automated, novel, Web-based program intended to increase motivation to change eating disorder behaviors, designed for delivery at the point of invitation to an eating disorder service, with the aim of increasing service attendance. OBJECTIVE: This paper assesses the impact of MotivATE on attendance at assessment when compared with treatment-as-usual. METHODS: A Zelen randomized controlled design was used. All individuals referred to a specialist eating disorder service, Kimmeridge Court in Dorset, UK, over the course of a year (October 24, 2016-October 23, 2017) were randomized to treatment-as-usual only or treatment-as-usual plus an additional letter offering access to MotivATE. Attendance at the initial scheduled assessment appointment was documented. Logistic regression analysis assessed the impact of MotivATE on attendance at assessment. Additional analyses based on levels of engagement with MotivATE were also undertaken. RESULTS: A total of 313 participants took part: 156 (49.8%) were randomized to treatment-as-usual and 157 (50.2%) were randomized to receive the additional offer to access MotivATE. Intention-to-treat analysis between conditions showed no impact of MotivATE on attendance at assessment (odds ratio [OR] 1.35, 95% CI 0.69-2.66, P=.38). Examination of the usage data indicated that only 53 of 157 participants (33.8%) in the MotivATE condition registered with the Web-based intervention. An analysis comparing those that registered with the intervention with those that did not found greater attendance at assessment in those that had registered (OR 9.46, 95% CI 1.22-73.38, P=.03). CONCLUSIONS: Our primary analyses suggest no impact of MotivATE on attendance at the first scheduled assessment appointment, but secondary analyses revealed limited engagement with the program and improved attendance in those who did engage. It is unclear, however, if engagement with the program increased motivation and, in turn, attendance or if more motivated individuals were more likely to access the intervention. Further research is required to facilitate engagement with Web-based interventions and to understand the full value of MotivATE for users. TRIAL REGISTRATION: ClinicalTrials.gov NCT02777944; https://clinicaltrials.gov/ct2/show/NCT02777944 (Archived by WebCite at http://www.webcitation.org/75VDEFZZ4).

Improving motivation to change amongst individuals with eating disorders: A systematic review.

OBJECTIVE: People with eating disorders can have low motivation to change their eating disorder behaviors. Interventions aiming to enhance motivation to change have been increasingly advocated in their treatment. Questions remain regarding the strength of the evidence supporting the effectiveness of interventions that specifically focus on improving motivation. This review explored the evidence for improving motivation to change in eating disorders via clinical interventions. METHOD: Searches of the published and unpublished literature were conducted by searching databases (PubMed, PsychInfo, Web of Science) and trial registries (WHO ICTRP), and by contacting authors. Studies were included if they investigated an intervention for eating disorder patients, included a pre-post outcome measure of motivation to change and were published in English. Risk of bias was also assessed. RESULTS: Forty-two studies were included in the final review. Evidence was found to support the use of interventions to improve motivation to change, though it was unclear whether motivational interventions present a more effective option than approaches that do not exclusively or specifically focus on motivation. However, motivational interventions were identified as being more effective than low intensity treatments. Risk of bias in included studies was generally high. DISCUSSION: Motivation was found to increase across treatments in general, whether or not the focus of the intervention was on enhancing motivation. It is unclear if interventions specifically targeting motivation to change provide additional benefit over and above established treatment approaches.

MotivATE: A Pretreatment Web-Based Program to Improve Attendance at UK Outpatient Services Among Adults With Eating Disorders.

BACKGROUND: In the UK, eating disorders affect upward of 725,000 people per year, and early assessment and treatment are important for patient outcomes. Around a third of adult outpatients in the UK who are referred to specialist eating disorder services do not attend, which could be related to patient factors related to ambivalence, fear, and a lack of confidence about change. This lack of engagement has a negative impact on the quality of life of patients and has implications for service costs. OBJECTIVE: To describe the development of a Web-based program ("MotivATE") designed for delivery at the point of referral to an eating disorder service, with the aim of increasing service attendance. METHODS: We used intervention mapping and a person-based approach to design the MotivATE program and conducted a needs assessment to determine the current impact of service nonattendance on patients (via a review of the qualitative evidence) and services (through a service provision survey to understand current issues in UK services). Following the needs assessment, we followed the five steps of program development outlined by Bartholomew et al (1998): (1) creating a matrix of proximal program objectives; (2) selecting theory-based intervention methods and strategies; (3) designing and organizing the program; (4) specifying adoption and implementation plans; and (5) generating program evaluation plans. RESULTS: The needs assessment identified current nonattendance rates of 10%-32%. We defined the objective of MotivATE as increasing attendance rates at an eating disorder service and considered four key determinants of poor attendance: patient ambivalence about change, low patient self-efficacy, recognition of the need to change, and expectations about assessment. We chose aspects of motivational interviewing, self-determination theory, and the use of patient stories as the most appropriate ways to enable change. Think-aloud piloting with people with lived experience of an eating disorder resulted in positive feedback on the MotivATE program. Participants related well to the stories used. Nonetheless, because of feedback, we further modified the program in line with patients' stage of change and addressed issues with the language used. A consultation with service staff meant that we could make clear implementation plans. Finally, a randomized controlled trial is currently underway to evaluate the MotivATE program. CONCLUSIONS: Using intervention mapping, we have developed a novel pretreatment Web-based program that is acceptable to people with eating disorders. To our knowledge, this is the first such program. The model of development described here could be a useful template for designing further programs for other difficult-to-engage populations.