Sabine Landau

Sabine Landau

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Sabine Landau has a total of 902 co-authors. Here are the top co-authors by number of shared publications:


Latest Publications

  • Open Access

    Olanzapine for young people with anorexia nervosa: a synopsis of the main results from the OPEN open-label feasibility study

    by Ece Sengun Filiz, Dominic Stringer, Vanessa Kellermann, Rachel Rowan Olive, Olena Said, Hiba Mutwalli, Sevgi Bektas, Melahat Nur Akkese, Katie Ireland, Demelza Beishon-Murley, et al.

    Background: In clinical practice, olanzapine is commonly used in young people with anorexia nervosa, although the underpinning evidence-base is limited. However, its efficacy, tolerability, acceptability and adherence rate, and the patients’, carers’ and clinicians’ views of olanzapine treatment are unclear. This synopsis article summarises the methods and results of the OPEN feasibility study, overarching the findings and drawing comprehensive conclusions from a quantitative feasibility outcome paper and two qualitative research papers. Methods: The OPEN study assessed the feasibility of a future randomised controlled trial on olanzapine in young people with anorexia nervosa in an open-label, one-armed feasibility study. In this study, we aimed to include 55 patients with anorexia nervosa or atypical anorexia nervosa aged 12–24 who gained < 2 kg within at least 1 month of treatment as usual. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated recruitment, adherence and attrition rates and mean changes in body weight, body mass index and eating disorder psychopathology. In addition, we explored the views on and experiences with olanzapine treatment within a clinical trial setting using qualitative interviews with young people with anorexia nervosa, their families and clinicians. Results: Fifty-two people were pre-screened, 35 were eligible and 20 participants were recruited and started olanzapine. Of these, 15 continued olanzapine for ≥ 16 weeks. Participants experienced, on average, a decrease in their eating disorder psychopathology, and body weight and body mass index increased during treatment with olanzapine as an adjunct to treatment as usual. Important themes derived from semi-structured qualitative interviews with young people and their parents were: moving away from the illness towards recovery, evaluating information on olanzapine, consent and trust in shared decision-making and the ambivalence around recovery. The main themes expressed by clinicians included: acknowledging the concerns of young people with anorexia nervosa and their families, prioritising person-centred care, the limited service capacity and strict study eligibility criteria. Limitations: The study failed to meet the recruitment target and showed low adherence rates for treatment with olanzapine. Possible reasons for the recruitment difficulties and the low adherence rate include the high clinical workload of eating disorder services during and after the COVID-19 pandemic, the heterogeneity of eating disorder service setup across the country, and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study. Conclusions: A realistic time schedule for site-preparation, recruitment, treatment and follow-up, realistic recruitment targets and easy access to medical and laboratory examinations may improve the success of future feasibility studies and randomised controlled trials in this patient group. Future work: The difficulties in conducting the OPEN study will inform the planning for future pharmacological and non-pharmacological studies in anorexia nervosa. Therefore, we developed a checklist with action points for the planning of pharmacological trials in eating disorders. Furthermore, novel pharmacological options such as typical and atypical psychedelic drugs (e.g. psilocybin and ketamine) might be more acceptable for people with anorexia nervosa as they do not have the side effect of immediate weight gain. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR130780.

  • Open Access

    Open Dialogue compared to usual care for adults experiencing a mental health crisis: A feasibility study for the ODDESSI trial

    by Stephen Pilling, Kirsty James, Katherine Clarke, Thomas Craig, Shaira Hassan, Yasmin Ishaq, Catherine Kinane, James Osborne, Georgie Parker, Russell Razzaque, et al.

    Background: Open Dialogue is a complex mental health intervention which places strong emphasis on working with service users’ social network in conjunction with provision of crisis and community care. It is both an organisational intervention of the mental health team and a clinical intervention at the individual level. This study examines the feasibility of conducting a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Open Dialogue compared to Usual Care in the English National Health Service. Methods: Coterminous GP practice clusters were randomised to Open Dialogue or Usual Care in preparation for a future evaluation trial. The cluster randomisation approach used restricted randomisation to balance intervention groups for catchment area of the community mental health team, GP practice size and deprivation. Out of these clusters, four clusters were selected for inclusion in a pilot study to assess the feasibility of recruitment, retention and outcome measurement. Feasibility parameters were assessed against stop-go criteria to inform progression to the full cluster randomised trial. Future trial outcome measures were collected at baseline and 3-month follow-up including review of medical records to assess the acceptability and ability of obtaining outcome data in a future evaluation trial. Results: We randomised 32 clusters from 9 catchment areas in 6 NHS Trusts to set up a future multicentre study. We screened 362 people who presented to NHS mental health crisis services in the four identified clusters. A total of 174 service users were identified as potentially eligible for the study with 63 assessed as eligible by the research team. The feasibility study aimed to recruit at least 66% of those deemed eligible, at least 80% of participants retained for interview at 3-month follow-up, and at least 85% retained for the suggested primary outcome obtained from medical records at 3 months. All these criteria were met. Conclusions: A full cluster-randomised controlled effectiveness trial of Open Dialogue within the NHS is feasible in terms of cluster randomisation, participant recruitment and retention, outcome collection, and appropriate delivery of care. Key messages regarding feasibility: Whether a cluster randomised controlled trial (cRCT) of OD might be feasibly undertaken within NHS mental health services. Feasibility criteria were met with high levels of recruitment and retention Large numbers of participants need to be pre-screened in order to reach recruitment targets


  • Open Access

    Understanding and reducing intimate partner violence perpetrated by men who misuse substances: the ADVANCE research programme

    by Gail Gilchrist, Sandi Dheensa, Amy Johnson, Juliet Henderson, Polly Radcliffe, Danielle Stephens-Lewis, David Gadd, Beverly Love, Sabine Landau, Laura Potts, et al.

    Background: Despite the higher prevalence of intimate partner violence perpetration by men who misuse substances, the role of substance use in intimate partner violence is unclear. Evidence about what works to reduce intimate partner violence by men who misuse substances is lacking. Objectives: To (1) understand the role of substance use in intimate partner violence perpetration, (2) develop a perpetrator intervention for men in substance use treatment and (3) test the feasibility and (4) effectiveness of delivering the intervention to men receiving substance use treatment. Design: Objective 1: mixed-methods intervention development, including a qualitative meta-ethnography, narrative interviews with 14 men and their female (ex)-partners and a systematic review and meta-analysis of 9 perpetrator intervention trials. Objective 2: the ADVANCE 16-week group perpetrator intervention delivered in person, was developed and adapted for digitally supported remote delivery (ADVANCE-D) during the pandemic. Objective 3: a multicentre feasibility randomised controlled trial of ADVANCE plus substance use treatment as usual compared to treatment as usual only and a multicentre non-randomised controlled feasibility study of ADVANCE-D were conducted. Objective 4: a multicentre effectiveness and cost-effectiveness randomised controlled trial of ADVANCE was planned. Setting and participants: Six community substance use treatment services in England (London, the West Midlands and the Southwest). Adult men receiving substance use treatment who had perpetrated intimate partner violence, their female (ex)-partners and staff delivering/supporting ADVANCE/ADVANCE-D delivery. Interventions: The ADVANCE comprises 2–4 individual sessions and 1- to 2-hour weekly groups. ADVANCE-D includes 1 individual session, 7 fortnightly video groups and 12 website sessions, each followed by a coaching call. Main outcome measures: The feasibility randomised controlled trial and non-randomised feasibility study measured eligibility, consent, recruitment, attendance (men) and follow-up rates and experiences of receiving or delivering ADVANCE/ADVANCE-D. These feasibility studies also assessed whether the following outcomes could be measured in a future effectiveness trial: intimate partner violence perpetration (men)/victimisation (women), substance use (men), self-management (men), and for men and women, mental health, health and social care service use, criminal justice contacts and quality of life. The primary outcome for the effectiveness trial was men’s self-reported intimate partner violence perpetration in the previous 4 months, 12 months post randomisation, using the Abusive Behaviour Inventory. Review methods: Systematic searches of databases identified qualitative studies for the meta-ethnography and (non)-randomised controlled trials for the systematic review. Meta-analyses were conducted where comparable data existed. Study inclusion and data extraction processes were conducted as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: The meta-ethnography and narrative interviews identified the complex interplay between substance use and intimate partner violence perpetration in the context of intoxication, withdrawal, acquiring drugs, impact on relationships and wider dynamics of power, control and psychological vulnerabilities. Little evidence emerged for effective interventions to reduce intimate partner violence for men who misuse substances. Meta-analysis showed that integrated substance use and intimate partner violence perpetrator interventions were non-superior to substance use treatment as usual in reducing intimate partner violence (combined mean difference 0.1, 95% confidence interval 0.37 to 0.57; p = 0.68). One hundred and four men were randomly allocated to receive ADVANCE + substance use treatment as usual ( n = 54) or treatment as usual only ( n = 50), and at 16 weeks post randomisation, 49% (51/104) were followed up. Of (ex)-partners, 26% (27/104) were recruited and 63% (17/27) were followed up. Median rate of intervention session attendance was 28.6% (lower quartile 0 – upper quartile 50). Self-reported intimate partner violence perpetration reduced at follow-up among men allocated to ADVANCE (estimated group difference on Revised Abusive Behaviour Inventory: −1.31, 95% confidence interval −4.06 to 1.43). Progression to a definitive trial was supported, but the trial was suspended due to COVID-19. ADVANCE was adapted for remote digitally supported delivery. Of men screened to participate in the non-randomised controlled feasibility study of ADVANCE-D, 46% (57/125) were eligible and deemed suitable to participate by staff. Forty-five men were recruited, 40 were offered ADVANCE-D and 25 (25/45; 55.6%) were followed up. Of sessions offered, 68% of core sessions, 44% of website practice sessions and 33% of coaching calls were attended/completed. Mean number of sessions attended was 11.4 (standard deviation 9.1). Twenty-one (ex)-partners were recruited, and 11 were (52.4%) followed up. Reductions in intimate partner violence perpetrated or experienced were reported by 8/11 men and 17/25 women, respectively; however, outcomes measured lacked statistical power to show a difference. Limitations: The COVID-19 restrictions precluded undertaking the randomised controlled trial. Conclusions: Delivering ADVANCE and ADVANCE-D to men in substance use treatment services was feasible, acceptable and safe. Promising findings were reported. Definitive trials are needed. Future work: Evaluation and implementation of ADVANCE and ADVANCE-D in other settings and populations will be considered. Trial registration: The trial is registered as ISRCRTN79435190 and ISRCTN66619273. The review was registered in PROSPERO as CRD42107056596. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20009) and is published in full in Programme Grants for Applied Research ; Vol. 13, No. 10. See the NIHR Funding and Awards website for further award information.


  • Open Access

    Intensive Community Care Services for Adolescents with Acute Psychiatric Emergencies: Trial Feasibility Findings from the Pilot Phase of a Multi-centre Randomised Controlled Trial

    by Dennis Ougrin, Thilipan Thaventhiran, Ben Hoi-Ching Wong, Izabela Pilecka, Sabine Landau, Sarah Byford, Petrina Chu, Hassan Jafari, Margaret Heslin, Emma Tassie, et al.

    Background: Adolescents experiencing psychiatric emergencies often require intensive intervention to avoid hospital admission and support their transition into education, employment, or training (EET). Intensive Community Care Services (ICCS) offer a potential alternative to inpatient care. This pilot study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of ICCS compared to treatment as usual (TAU) in reducing time to start or return to EET. Methods: A multi-centre, parallel-group, single-blinded randomised controlled trial (RCT) with an internal pilot phase was conducted across seven NHS Trusts in the UK. Adolescents aged 12–17 experiencing psychiatric emergencies were randomised to ICCS or treatment as usual (TAU). The primary outcome was time to start or return to EET within six months. Secondary outcomes included clinical symptoms, functioning, service satisfaction, service use, and health-related quality of life. Descriptive statistics and hazard ratios were calculated to explore group differences. Feasibility was assessed against pre-specified progression criteria. Results: Thirty-six adolescents were randomised during the internal pilot phase. The recruitment rate did not meet the progression criteria, and continuation to a full evaluation trial was deemed unfeasible. During follow-up, 83.3% (n=30) returned to EET, with a median time to EET of nine days (IQR: 1–49). Median time to EET was shorter in the ICCS group (6 days) compared to TAU (12 days), with a hazard ratio of 1.34 (95% CI: 0.63–2.86). ICCS was associated with improved service satisfaction, clinical symptoms, and functioning. The average cost per participant was higher in the TAU group (£15,155, SD 31,560) compared to ICCS (£7,063, SD 10,605), with minimal differences in quality-adjusted life years (QALYs). Fourteen safety events were reported across both groups. Conclusions: A full evaluation trial was not feasible due to recruitment challenges, primarily arising from limited-service capacity to deliver two treatment pathways concurrently. Despite this, ICCS showed promising trends in clinical and functional outcomes and may offer a viable alternative to inpatient care. Further research is needed to explore the implementation and effectiveness of ICCS in routine practice. Trial registration: ISRCTN, ISRCTN42999542 . Registered 29/04/2020, https://doi.org/10.1186/ISRCTN42999542

  • Open Access

    Digital augmentation of aftercare for patients with anorexia nervosa: the TRIANGLE RCT and economic evaluation

    by Janet Treasure, Katie Rowlands, Valentina Cardi, Suman Ambwani, David McDaid, Jodie Lord, Danielle Clark Bryan, Pamela Macdonald, Eva Bonin, Ulrike Schmidt, et al.

    Background: High-risk patients with complex anorexia nervosa are managed in inpatient/day patient care, but re-admission rates are high, and new treatments are needed. Objective(s): To examine the effectiveness of a digital augmentation of aftercare (ECHOMANTRA). Design: Transition Care In Anorexia Nervosa through Guidance Online from Peer and Carer Expertise was a multicentre, parallel-group, superiority randomised controlled trial. ECHOMANTRA augmented treatment as usual was compared with treatment as usual. Patient–carer dyads were randomised using minimisation on a 1 : 1 ratio into ECHOMANTRA + treatment as usual (ECHOMANTRA) or treatment as usual alone. Setting: Specialised United Kingdom inpatient/day patient sites (n = 31) participated. Participants: Patient–carer dyads were randomised (n = 185 in ECHOMANTRA and n = 186 in treatment as usual). Interventions: The digital ECHOMANTRA intervention included self-management tools (recovery tips videos) for patients and task-sharing materials for carers (skill-sharing video), supplemented with guided group chat sessions. All participants randomised to ECHOMANTRA + treatment as usual had access to the psychoeducational materials and joint patient/carer chat sessions were also offered. Main outcome measures: The primary outcome was patient distress at 12 months. Other outcomes included patient distress at 18 months, and eating disorder symptoms, social and work adjustment, and carer distress and skills at 12 and 18 months. Results: There was no evidence of an intervention effect on the Depression Anxiety Stress Scale-21 outcome for patients (n = 370) at 12 months, estimated effect 0.48, 95% confidence interval −0.20 to 0.23, standardised estimate (0.02, p = 0.87). In the economic analysis, the intervention was dominated by treatment as usual from both a health system and wider societal perspective, as ECHOMANTRA cost more and resulted in fewer quality-adjusted life-years gained. However, the uptake of the interactive component of the intervention (i.e. the facilitated and moderated online groups) was limited, with only 20% of the dyad members attending the pre-set minimal adherence level (i.e. both the patient and carer attending at least four online forum group sessions). The feedback about the intervention was predominantly positive. For example, the group facilitators were rated highly. However, some feedback was that the intervention offered too little, too late, and that a more personalised intervention would be more helpful. Limitations: Participants were diverse (e.g. 20% were being treated under the Mental Health Act), and a large proportion had a range of comorbidities (depression, anxiety, obsessive–compulsive disorder and autistic spectrum disorders), all factors impacting prognosis. Although efforts were made to enhance inclusion, diversity in terms of gender, sexuality and race was limited, and technological barriers and/or lack of a carer may have led to exclusion. The high level of non-adherence to the group support (80% dyads) may have contributed to the non-significant findings. Conclusions: This guided self-management and task-sharing intervention was reviewed positively by some patients and supporters; however, there was no evidence that the intervention improved outcomes over usual aftercare. Future work: Identifying mechanisms to increase engagement such as a more personalised approach to aftercare to address the diverse needs of this patient group are needed. Greater integration between intensive and step-down services with guidance from peer workers providing support may optimise care. Trial registration: This trial is registered as ISRCTN14644379. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/68/09) and is published in full in Health Technology Assessment; Vol. 29, No. 31. See the NIHR Funding and Awards website for further award information.


  • Open Access

    Why is electroconvulsive therapy for depression more effective in older age? A causal mediation analysis

    by Ana Jelovac, Sabine Landau, Petros Beeley, Cathal McCaffrey, Martha Finnegan, Gabriele Gusciute, Emma Whooley, Sarah McDonogh, Sarah Thompson, Anna Igoe, et al.

    Background: Older people with depression exhibit better response to electroconvulsive therapy (ECT). We aimed to measure the total effect of age on ECT response and investigate whether this effect is mediated by psychotic features, psychomotor retardation, psychomotor agitation, age of onset, and episode duration. Methods: We pooled data from four prospective Irish studies where ECT was administered for a major depressive episode (unipolar or bipolar) with baseline score ≥21 on the 24-item Hamilton Depression Rating Scale (HAM-D). The primary outcome was change in HAM-D between baseline and end of treatment. The estimands were total effect of age, estimated using linear regression, and the indirect effects for each putative mediator, estimated using causal mediation analyses. Results: A total of 256 patients (mean age 57.8 [SD = 14.6], 60.2% female) were included. For every additional 10 years of age, HAM-D was estimated to decrease by a further 1.74 points over the ECT period (p < 0.001). Age acted on all putative mediators. Mechanistic theories, whereby a mediator drives treatment response, were confirmed for all putative mediators except age of onset. Consequently, mediation of the effect of age on change in HAM-D could be demonstrated for psychotic features, psychomotor retardation, psychomotor agitation, and episode duration but not for age of onset. Conclusions: A total of 43.1% of the effect of older age on increased ECT response was explained by the mediators. Treatment planning could be improved by preferentially offering ECT to older adults, especially if presenting with psychotic features, greater severity of psychomotor disturbance, and earlier in the episode.


  • Open Access

    Clinicians’ perspectives on supporting individuals with severe anorexia nervosa in specialist eating disorder intensive treatment settings

    by Başak İnce, Matthew D Phillips, Bethan Dalton, Madeleine Irish, Hannah Webb, Daniela Mercado, Catherine McCombie, Zohra Zenasni, James Shearer, Laura Potts, et al.

    This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 17/123/03, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1186/s40337-021-00528-z Background: Admissions to intensive treatment (i.e., inpatient [IP] and/or day patient [DP]) for individuals with severe anorexia nervosa (AN) are common. Growing literature indicates potential risks and benefits of each intensive treatment approach; however, existing research has focused on patient and carer perspectives of these treatments. Also, there is scant empirical evidence available for guiding the parameters of intensive treatments for AN. We therefore explored clinicians’ perspectives and experience of supporting adults with severe AN in intensive settings. Methods: We conducted twenty one semi-structured interviews with clinicians who deliver intensive treatments (i.e., IP and/or DP) for individuals with severe AN across four specialist Eating Disorder Services in the United Kingdom between May 2020 and June 2021. We asked clinicians about their views and experiences of supporting individuals with severe AN in intensive treatment settings and the challenges and opportunities associated with IP and DP treatment. Data were analysed using reflexive thematic analysis supported by NVivo software. Results: Five broad and interrelated themes were identified: (1) Intensive Support; (2) The Severity of Patients’ Illnesses; (3) Hope and Recovery; (4) Which Treatment When; (5) Limited Resources; and (6) Carer Burden. We identified various similarities between the two intensive treatment approaches, including the value of intensive and multidisciplinary support and carer involvement, and the challenge of managing complex and unique needs in resource-limited intensive settings. We also found differences in the relationship of treatment to patients’ home environments, the necessity of patient motivation, and the management of risk. Conclusions: Both intensive treatment settings are valued by clinicians; however, there are unique challenges and opportunities for supporting individuals with severe AN within each. Our findings suggest DP treatment may be used as an alternative to IP treatment for individuals with severe AN. However, clear questions remain over which intensive treatment setting is best suited to which patient when and should be the focus of future research. Funding: This publication was funded by the Health Technology Assessment programme as a part of award number 17/123/03. This article reports on one component of the research award A Randomized Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a “Stepping into Day Treatment Approach” versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/17/123/03] DOI: https://doi.org/10.1186/s40337-021-00528-z

  • Open Access

    Clinicians’ perspectives on supporting individuals with severe anorexia nervosa in specialist eating disorder intensive treatment settings during the COVID-19 pandemic

    by Başak İnce, Matthew D Phillips, Bethan Dalton, Madeleine Irish, Hannah Webb, Daniela Mercado, Catherine McCombie, Zohra Zenasni, James Shearer, Laura Potts, et al.

    This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 17/123/03, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1186/s40337-022-00555-4 Background: The COVID-19 pandemic has significantly affected intensive treatment settings (i.e., inpatient [IP] and day patient [DP]) in specialist eating disorder services. However, the impact on clinicians working in these services is largely unknown. We therefore explored the perspectives of those supporting individuals with severe anorexia nervosa (AN) in intensive treatment settings during the pandemic. Methods: Between May 2020 and June 2021, we interviewed clinicians (n = 21) who delivered IP and/or DP treatment to patients with severe AN in four specialist eating disorder services in the United Kingdom. Data relating to experiences during COVID-19 were analysed using reflexive thematic analysis. Results: We identified six themes: Disruptions to Routine Treatment; Introduction of Virtual Treatment; Separation from Treatment, Others and the World; Impact on Recovery; Impact on Staff; and Pressure on Referral Pathways. COVID-19 posed significant challenges to IP and DP services: forcing closures, operating with restrictions and virtual treatment, and impacting delivery of essential treatment components, referral pathways, clinician wellbeing, risk management, and patient isolation and recovery trajectories. Opportunities arose, in particular in DP services offering virtual support. Conclusions: COVID-19 challenged the continuation of multidisciplinary treatment. The findings underline the necessity for medical, psychological, practical, and nutritional support, as well as carer involvement and fostering social connections to remain at the forefront of intensive treatment for severe AN. They also emphasise the uncertainty surrounding which intensive treatment may be best suited to which patient when, particularly within the context of virtual DP support. Funding: This publication was funded by the Health Technology Assessment programme as a part of award number 17/123/03. This article reports on one component of the research award A Randomized Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a “Stepping into Day Treatment Approach” versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/17/123/03] DOI: https://doi.org/10.1186/s40337-022-00555-4

  • Open Access

    Autopsy of a failed trial part 1: A qualitative investigation of clinician’s views on and experiences of the implementation of the DAISIES trial in UK-based intensive eating disorder services

    by Başak İnce, Matthew D Phillips, Bethan Dalton, Madeleine Irish, Hannah Webb, Daniela Mercado, Catherine McCombie, Zohra Zenasni, James Shearer, Laura Potts, et al.

    This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 17/123/03, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1002/erv.2975 Objective: The DAISIES trial, comparing inpatient and stepped-care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders’ views on and experiences of its implementation. Method: Semi-structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020-June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co-investigators involved with the DAISIES trial. The Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. Results: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid-19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio-political context (e.g. Covid-19 closing services). Conclusions: Our findings emphasise the top-down impact of systemic-level research implementation challenges. The impact of the Covid-19 pandemic accentuated pre-existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research. Funding: This publication was funded by the Health Technology Assessment programme as a part of award number 17/123/03. This article reports on one component of the research award A Randomised Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a ‘Stepping into Day Treatment’ Approach versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/17/123/03] DOI: https://doi.org/10.1002/erv.2975

  • Open Access

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

    by Başak İnce, Matthew D Phillips, Bethan Dalton, Madeleine Irish, Hannah Webb, Daniela Mercado, Catherine McCombie, Zohra Zenasni, James Shearer, Laura Potts, et al.

    This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 17/123/03, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1002/erv.3058 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. Funding: This publication was funded by the Health Technology Assessment programme as a part of award number 17/123/03. This article reports on one component of the research award A Randomised Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a ‘Stepping into Day Treatment’ Approach versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/17/123/03] DOI: https://doi.org/10.1002/erv.3058