Intervention planning for the REDUCE maintenance intervention: a digital intervention to reduce re-ulceration risk among patients with a history of diabetic foot ulcers

Objectives: To develop a comprehensive intervention plan for the REDUCE maintenance intervention to support people who have had diabetic foot ulcers (DFUs) to sustain behaviours that reduce re-ulceration risk. Methods: Theory-, evidence- and person-based approaches to intervention development were used. In phase 1 of intervention planning, evidence was collated from a scoping review of the literature and qualitative interviews with patients who have had DFUs (N=20). This was used to identify the psychosocial needs and challenges of this population, and barriers and facilitators to the intervention’s target behaviours: regular foot checking, rapid self-referral in the event of changes in foot health, graded and regular physical activity, and emotional management. In phase 2, this evidence was combined with expert consultation to develop the intervention plan. Brief ‘guiding principles’ for shaping intervention development were created. ‘Behavioural analysis’ and ‘logic modelling’ were used to map intervention content onto behaviour change theory to comprehensively describe the intervention and its hypothesised mechanisms. Results: Key challenges to the interventions’ target behaviours included patients’ uncertainty regarding when to self-refer, physical limitations affecting foot checking and physical activity, and, for some, difficulties managing negative emotions. Important considerations for the intervention design included a need to increase patients’ confidence in making a self-referral and in using the maintenance intervention, and a need to acknowledge that some intervention content might be relevant to only some patients (emotional management, physical activity). The behavioural analysis identified the following processes hypothesised to facilitate long-term behaviour maintenance including; increasing patients’ skills, self-efficacy, knowledge, positive outcome expectancies, sense of personal control, social support, and physical opportunity. Conclusions: This research provides a transparent description of the intervention planning for the REDUCE maintenance intervention. It provides insights into potential barriers and facilitators to the target behaviours and potentially useful behaviour change techniques to use in clinical practice

Mediators of change in cognitive behavior therapy and interpersonal psychotherapy for eating disorders: A secondary analysis of a transdiagnostic randomized controlled trial.

OBJECTIVE: Understanding the mechanisms of action of psychological treatments is a key first step in refining and developing more effective treatments. The present study examined hypothesized mediators of change of enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED). METHOD: A series of mediation studies were embedded in a randomized controlled trial (RCT) comparing 20 weeks of CBT-E and IPT-ED in a transdiagnostic, non-underweight sample of patients with eating disorders (N = 130) consecutively referred to the service. Three hypothesized mediators of change in CBT-E (regular eating, weighing frequency, and shape checking) and the key hypothesized mediator of IPT-ED (interpersonal problem severity) were studied. RESULTS: The data supported regular eating as being a mediator of the effect of CBT-E on binge-eating frequency. The findings were inconclusive regarding the role of the other putative mediators of the effects of CBT-E; and were similarly inconclusive for interpersonal problem severity as a mediator of the effect of IPT-ED. DISCUSSION: This research highlights the potential benefits of embedding mediation studies within RCTs to better understand how treatments work. The findings supported the role of regular eating in reducing patients' binge-eating frequency. Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them. Key methodological issues to address in future work include the need to capture both behavioral and cognitive processes of change in CBT-E, and identifying key time points for change in IPT-ED

Feasibility of a complex behaviour change intervention in secondary care to safely and substantially reduce antibiotic use

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Supporting families managing childhood eczema:Developing and optimising Eczema Care Online using qualitative research

Background: childhood eczema is often poorly controlled due to under-use of emollients and topical corticosteroids. Parents/carers report practical and psychosocial barriers to managing their child’s eczema, including child resistance. Online interventions could potentially support parents/carers; however, rigorous research developing such interventions has been limited. Aim: to develop an online behavioural intervention to help parents/carers manage and co-manage their child’s eczema. Design and setting: Intervention development using a theory-, evidence- and Person-Based Approach with qualitative research. Methods: a systematic review and qualitative synthesis (32 studies) and interviews with parents/carers (N=30) were used to identify barriers and facilitators to effective eczema management, and a prototype intervention was developed. Think-aloud interviews with parents/carers (N=25) were then used to optimise the intervention to increase its acceptability and feasibility. Results: qualitative research identified that parents/carers had concerns about using emollients and topical corticosteroids; incomplete knowledge and skills around managing eczema; and reluctance to transitioning to co-managing eczema with their child. Think-aloud interviews highlighted that while experienced parents/carers felt they knew how to manage eczema, some information about how to use treatments was still new. Techniques for addressing barriers included: providing a rationale explaining how emollients and topical corticosteroids work; demonstrating how to use treatments; and highlighting that the intervention provided new, up-to-date information. Conclusions: parents/carers need support in effectively managing and co-managing their child’s eczema. The key output of this research is Eczema Care Online (ECO) for Families; an online intervention for parents/carers of children with eczema, which is being evaluated in a randomised trial

Why do hospital prescribers continue antibiotics when it is safe to stop? Results of a choice experiment survey

Background Deciding whether to discontinue antibiotics at early review is a cornerstone of hospital antimicrobial stewardship practice worldwide. In England, this approach is described in government guidance (‘Start Smart then Focus’). However, < 10% of hospital antibiotic prescriptions are discontinued at review, despite evidence that 20–30% could be discontinued safely. We aimed to quantify the relative importance of factors influencing prescriber decision-making at review. Methods We conducted an online choice experiment, a survey method to elicit preferences. Acute/general hospital prescribers in England were asked if they would continue or discontinue antibiotic treatment in 15 hypothetical scenarios. Scenarios were described according to six attributes, including patients’ presenting symptoms and whether discontinuation would conflict with local prescribing guidelines. Respondents’ choices were analysed using conditional logistic regression. Results One hundred respondents completed the survey. Respondents were more likely to continue antibiotics when discontinuation would ‘strongly conflict’ with local guidelines (average marginal effect (AME) on the probability of continuing + 0.194 (p < 0.001)), when presenting symptoms more clearly indicated antibiotics (AME of urinary tract infection symptoms + 0.173 (p < 0.001) versus unclear symptoms) and when patients had severe frailty/comorbidities (AME = + 0.101 (p < 0.001)). Respondents were less likely to continue antibiotics when under no external pressure to continue (AME = − 0.101 (p < 0.001)). Decisions were also influenced by the risks to patient health of continuing/discontinuing antibiotic treatment. Conclusions Guidelines that conflict with antibiotic discontinuation (e.g. pre-specify fixed durations) may discourage safe discontinuation at review. In contrast, guidelines conditional on patient factors/treatment response could help hospital prescribers discontinue antibiotics if diagnostic information suggesting they are no longer needed is available

Eczema Care Online: development and qualitative optimisation of an online behavioural intervention to support self-management in young people with eczema.

OBJECTIVES: To describe the development of Eczema Care Online (ECO), an online behaviour change intervention for young people with eczema (phase I); and explore and optimise the acceptability of ECO among this target group using think-aloud interviews (phase II). METHODS: Theory-based, evidence-based and person-based approaches to intervention development were used. In phase I, a qualitative systematic review and qualitative interviews developed an in-depth understanding of the needs and challenges of young people with eczema. Guiding principles highlighted key intervention design objectives and features to address the needs of this target group to maximise user engagement. Behavioural analysis and logic modelling developed ECO's hypothesised programme theory. In phase II, qualitative think-aloud interviews were carried out with 28 young people with eczema and the intervention was optimised based on their feedback. RESULTS: The final intervention aimed to reduce eczema severity by supporting treatment use (emollients, topical corticosteroids/topical calcineurin inhibitors), management of irritants/triggers, emotional management and reducing scratching. Generally, young people expressed positive views of intervention content and design in think-aloud interviews. Quotes and stories from other young people with eczema and ECO's focus on living with eczema (not just topical treatments) were valuable for normalising eczema. Young people believed ECO addressed knowledge gaps they had from childhood and the safety information about topical corticosteroids was reassuring. Negative feedback was used to modify ECO. CONCLUSIONS: A prototype of the ECO intervention was developed using rigorous and complementary intervention development approaches. Subsequent think-aloud interviews helped optimise the intervention, demonstrated ECO is likely to be acceptable to this target group, and provided support for our guiding principles including key design objectives and features to consider when developing interventions for this population. A randomised controlled trial and process evaluation of the intervention is underway to assess effectiveness and explore user engagement with the intervention's behavioural goals

Cost-effectiveness of two online interventions supporting self-care for eczema for parents/carers and young people

Objective: To estimate the cost-effectiveness of online behavioral interventions (EczemaCareOnline.org.uk) designed to support eczema self-care management for parents/carers and young people from an NHS perspective. Methods: Two within-trial economic evaluations, using regression-based approaches, adjusting for baseline and pre-specified confounder variables, were undertaken alongside two independent, pragmatic, parallel group, unmasked randomized controlled trials, recruiting through primary care. Trial 1 recruited 340 parents/carers of children aged 0–12years and Trial 2 337 young people aged 13–25years with eczema scored ≥ 5 on Patient-Oriented Eczema Measure (POEM). Participants were randomized (1:1) to online intervention plus usual care or usual care alone. Resource use, collected via medical notes review, was valued using published unit costs in UK £Sterling 2021. Quality-of-life was elicited using proxy CHU-9D in Trial 1 and self-report EQ-5D-5L in Trial 2. Results: The intervention was dominant (cost saving and more effective) with a high probability of cost-effectiveness (> 68%) in most analyses. The exception was the complete case cost–utility analysis for Trial 1 (omitting participants with children aged < 2), with adjusted incremental cost savings of -£34.15 (95% CI – 104.54 to 36.24) and incremental QALYs of – 0.003 (95% CI – 0.021 to 0.015) producing an incremental cost per QALY of £12,466. In the secondary combined (Trials 1 and 2) cost-effectiveness analysis, the adjusted incremental cost was -£20.35 (95% CI – 55.41 to 14.70) with incremental success (≥ 2-point change on POEM) of 10.3% (95% CI 2.3–18.1%). Conclusion: The free at point of use online eczema self-management intervention was low cost to run and cost-effective. Trial registration: This trial was registered prospectively with the ISRCTN registry (ISRCTN79282252). URL www.EczemaCareOnline.org.uk

Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers

Introduction Eczema care requires management of triggers and various treatments. We developed two online behavioural interventions to support eczema care called ECO (Eczema Care Online) for young people and ECO for families. This protocol describes two randomised controlled trials aimed to evaluate clinical and cost effectiveness of the two interventions. Methods and analysis Design: Two independent, pragmatic, unmasked, parallel group randomised controlled trials with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from GP practices in England. Participants: young people aged 13-25 years with eczema and parents / carers of children aged 0-12 years with eczema, excluding inactive or very mild eczema (5 or less on Patient-Oriented Eczema Measure (POEM)). Interventions: Participants will be randomised to online intervention plus usual care or to usual eczema care alone. Outcome measures: Primary outcome is eczema severity over 24 weeks measured by POEM. Secondary outcomes include: POEM 4-weekly for 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, health service and treatment use. Process measures include treatment adherence, barriers to adherence, and intervention usage. Our sample sizes of 303 participants per trial are powered to detect a group difference of 2.5 (SD 6.5) in monthly POEM scores over 24 weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up. Cost effectiveness analysis will be from an NHS and personal social service perspective. Qualitative and quantitative process evaluation will help understand mechanisms of action and participant experiences and inform implementation. Ethics and dissemination The study has been approved by South Central Oxford A Research Ethics Committee (19/SC/0351). Recruitment is ongoing, and follow-up will be completed by mid-2022. Findings will be disseminated to participants, the public, dermatology and primary care journals, and policymakers

Mediators of transdiagnostic psychological treatments for eating disorders

Cognitive behaviour therapy and interpersonal psychotherapy are the leading treatments for eating disorders. Little is understood regarding their mechanisms of action. The research described in this thesis investigated the purported mechanisms of action of two transdiagnostic versions of these treatments; enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED). A series of mediation studies were embedded within a randomised controlled trial comparing CBT-E and IPT-ED in a transdiagnostic sample of patients with eating disorders. An analytic strategy using multilevel and structural equation modelling was used to assess for statistical mediation. Three of the key purported mediators of action of CBT-E (regularity of eating, frequency of weighing, and frequency of shape checking) and the key purported mediator of IPT-ED (interpersonal problem severity) were studied. Only regularity of eating demonstrated a strong case for being a mediator of the effect of CBT-E (on frequency of binge eating). The findings were inconclusive regarding other putative mediators of the effect of CBT-E, and for interpersonal problem severity being a mediator of the effect of IPT-ED. Limitations of the research included the non-optimal choice of measures and non-optimal timing of measurements for establishing temporal precedence. Future research should investigate the mediating role of both cognitive (e.g. interpretation of weight) and behavioural processes (e.g. frequency of weighing) in CBT-E, and the role of interpersonal functioning in CBT-E and IPT-ED. Research should use daily, or session by session measurement to better assess the temporal relationship between the purported mediator/s and the outcome/s. Experimental designs comparing dismantled versions of treatment would also help determine the relative effects that different treatment procedures have on treatment outcome/s

Mediators of transdiagnostic psychological treatments for eating disorders

Cognitive behaviour therapy and interpersonal psychotherapy are the leading treatments for eating disorders. Little is understood regarding their mechanisms of action. The research described in this thesis investigated the purported mechanisms of action of two transdiagnostic versions of these treatments; enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED). A series of mediation studies were embedded within a randomised controlled trial comparing CBT-E and IPT-ED in a transdiagnostic sample of patients with eating disorders. An analytic strategy using multilevel and structural equation modelling was used to assess for statistical mediation. Three of the key purported mediators of action of CBT-E (regularity of eating, frequency of weighing, and frequency of shape checking) and the key purported mediator of IPT-ED (interpersonal problem severity) were studied. Only regularity of eating demonstrated a strong case for being a mediator of the effect of CBT-E (on frequency of binge eating). The findings were inconclusive regarding other putative mediators of the effect of CBT-E, and for interpersonal problem severity being a mediator of the effect of IPT-ED. Limitations of the research included the non-optimal choice of measures and non-optimal timing of measurements for establishing temporal precedence. Future research should investigate the mediating role of both cognitive (e.g. interpretation of weight) and behavioural processes (e.g. frequency of weighing) in CBT-E, and the role of interpersonal functioning in CBT-E and IPT-ED. Research should use daily, or session by session measurement to better assess the temporal relationship between the purported mediator/s and the outcome/s. Experimental designs comparing dismantled versions of treatment would also help determine the relative effects that different treatment procedures have on treatment outcome/s