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There is wide regional variation in clinical practice and access to treatment for patients with diabetic foot ulcer (DFU) from countries in Central and Eastern Europe (CEE). A treatment algorithm that reflects current treatment practices while providing a common framework may facilitate best practice in DFU management and improve outcomes across the CEE region. Following a series of regional advisory board meetings with experts from Poland, the Czech Republic, Hungary and Croatia, we present consensus recommendations for the management of DFU and outline the key features of a unified algorithm for dissemination and use as a quick tool in clinical practice in CEE. The algorithm should be accessible to specialists as well as non-specialist clinicians and should incorporate: patient screening; checkpoints for assessment and referral; triggers of treatment change; and strategies for infection control, wound bed preparation and offloading. Among adjunctive treatments in DFU, there is a clear role for topical oxygen therapy, which can be used concomitantly with most existing treatment regimens in hard-to-heal wounds following standard of care. Countries from CEE face a number of challenges in the management of DFU. It is hoped that such an algorithm will help standardise the approach to DFU management and overcome some of these challenges. Ultimately, a regionwide treatment algorithm in CEE has the potential to improve clinical outcomes and save limbs.

There is currently limited research examining self-structure in clinical groups and no current data on the extent to which self-structure is amendable to change following psychological therapy. We address this important gap by examining self-structure in individuals with persecutory delusions using the card sort task, an established paradigm measuring key self-structure indices, including the degree to which self-structure is compartmentalized (characterized by primarily positive or negative attributes, as opposed to a mix of both), and the proportion and importance of negative attributes. In Study 1, individuals with a schizophrenia spectrum diagnosis with current persecutory delusions (clinical group, n = 27) and a healthy control group (n = 47) were compared on self-structure indices. In Study 2 (n = 27), the clinical group also completed the card sort task before and after randomization to either a 12-week mindfulness-based psychological therapy or treatment-as-usual control. In Study 1, self-structure differed significantly between the clinical and control groups. The clinical group had a greater proportion of negative attributes, assigned more importance to negative self-aspects, and had more compartmentalized self-structures compared with controls. In Study 2 there were no associations between delusion severity and self-structure. Large effect sizes for reductions in compartmentalization and proportion of negative attributes across self-aspects were found following mindfulness therapy. The findings highlight key differences in self-structure between individuals with persecutory delusions and healthy controls, and suggest that it might be possible to change self-structure following psychological therapy. These data support the central role of the self in theoretical models of paranoid thinking.

ObjectiveTo test a novel proposition that dispositional forgiveness has the unrecognized benefit of buffering feelings of paranoia following negative interpersonal experiences and interpersonal transgressions.MethodsIn Study 1 (N = 128), we used an experimental paradigm, the Prisoner's Dilemma Game (PDG), to test the premise that an interpersonal transgression increases state paranoia. Study 2 (N = 180) used a longitudinal design to test the central proposition that dispositional forgiveness buffers state paranoia following naturally occurring difficult (vs pleasant) interpersonal events. Study 3 (N = 102) used a novel experimental paradigm to determine the causal effect of manipulating forgiveness on paranoia.ResultsIn Study 1, interpersonal transgressions in the PDG increased paranoia. In Study 2, paranoia was higher following difficult (rather than pleasant) events, and higher levels of dispositional forgiveness moderated the negative effect of difficult events on paranoia. In Study 3, there was a causal effect of forgiveness on (reduced) paranoia.ConclusionsThis is the first evidence that (1) interpersonal transgressions increase paranoia, (2) high dispositional forgiveness moderates the deleterious effect of interpersonal transgression on paranoia, and (3) dispositional forgiveness is causally related to less paranoia.

Background and HypothesisGame theory paradigms, such as the Prisoner’s Dilemma Game (PDG), have been used to study nonclinical paranoia, though research using clinical populations has been scarce. We test our novel theoretical model that schizophrenia leads to competitiveness in interpersonal interactions, and that this link is serially mediated by trait paranoia, state paranoia, and distrust.Study DesignIn this quasi-experimental study, individuals with schizophrenia spectrum diagnoses with current persecutory delusions (n = 46) and a nonclinical control group (n = 43) played the PDG, and completed measures of trait paranoia, state paranoia, and distrust.Study ResultsIndividuals with schizophrenia competed more in the PDG than the control group. Supporting our theoretical model, all direct effects were significant: schizophrenia was associated with higher trait paranoia (H1); trait paranoia predicted state paranoia in the PDG (H2); state paranoia in the PDG predicted distrust of the opponent in the PDG (H3); and distrust predicted competition in the PDG (H4). The hypothesized indirect effect of schizophrenia on competition in the PDG via trait paranoia, state paranoia, and distrust was supported in a serial mediation model (H5).ConclusionsThe findings make clear theoretical and methodological contributions. We provide the first evidence for a theoretical process model by which schizophrenia leads to competitiveness in interpersonal interactions via trait paranoia, state paranoia, and distrust. Game theory paradigms, and the PDG in particular, are important for advancing theory and research on paranoia as it occurs in both clinical and nonclinical populations.

Background: Patients receiving in-centre haemodialysis (ICHD) are highly vulnerable to COVID-19. Objective: We created a quality improvement (QI) project aimed to eliminate outbreaks of COVID-19 in haemodialysis units and evaluated the utility of surveillance rRT-PCR test and SARS-CoV-2 serum antibodies for prompt identification of patients infected with COVID-19. Methods: A multifaceted QI programme including a bundle of infection prevention control (IPC) measures was implemented across 5 ICHD units following the first wave of the pandemic in June 2020. Primary outcomes evaluated before and after QI implementation were incidence of outbreaks and severe COVID-19 illness defined as COVID-19-related death or hospitalization. Secondary outcomes included the proportion of patients identified in the pre-symptomatic/asymptomatic phase on surveillance rRT-PCR screening and the incidence and longevity of SARS-CoV-2 antibody response. Results: Following the implementation of the QI project, there were no further outbreaks. Pre- and post-implementation comparison showed a significant reduction in COVID-19-related mortality and hospitalization (26 vs. 13 events, respectively, p < 0.001). Surveillance rRT-PCR screening identified 39 asymptomatic or pre-symptomatic cases out of a total of 59 rRT-PCR-positive patients (39/59, 66%). SARS-CoV-2 antibody levels were detected in 72/74 (97%) rRT-PCR-positive patients. Amongst rRT-PCR-positive patients diagnosed before August 2020, 96% had detectable antibodies until January 2021 (days from the rRT-PCR test to last antibody testing, 245–280). Conclusions: Systematic implementation of a bundle of IPC measures using QI methodology and surveillance rRT-PCR eliminated outbreaks in HD facilities. Most HD patients mount and sustain antibody response to COVID-19 for over 8 months.

Objective This study explores whether social cognition and social functioning improve after a mindfulness-based social cognition training (SocialMIND). Methods Thirty-eight outpatients with psychosis completed an assessment with social cognition (Eyes Test, Ambiguous Intentions and Hostility Questionnaire [AIHQ], and Hinting Task) and social functioning tasks (Personal and Social Performance [PSP] scale) before and after eight SocialMIND weekly sessions. Mean differences between timepoints were standardized and 95% confidence intervals were obtained with a paired samples t-test. Results The scores of the Eyes Test (95% CI [.43, 3.32], d = .48), the Hostility Bias subscale (AIHQ) (95% CI [-.29, -.01], d = .44), and the self-care difficulties subscale (PSP) (95% CI [-.77, -.09], d = .45) improved after the intervention. Conclusions and Implications for practice: The results of SocialMIND-8 are very promising in terms of developing comprehensive rehabilitation programs. Further trials must address its effectiveness against a control group during longer follow-up periods. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

This consensus document is endorsed by The Queen's Nursing Institute (QNI) and The Queen's Nursing Institute Scotland (QNIS).

ObjectiveEvidence suggests mindfulness may reduce risk factors for disordered eating. However, mechanisms of change in this relationship are unclear. This longitudinal study tested whether emotion regulation mediates the prospective associations between mindfulness and two proximal risk factors for disordered eating: weight and shape concerns, and negative affect.MethodThis study is a secondary analysis of data collected within an eating disorder prevention trial. Adolescent girls (N = 374, Mage = 15.70, SD = 0.77) completed self-report measures of mindfulness, emotion regulation, weight and shape concerns, and negative affect at baseline, 2 months following baseline, and 7 months following baseline. Path analyses were computed to test hypothesized indirect effects using confidence intervals based on 5000 bootstrap samples.ResultsHigher baseline mindfulness predicted lower weight and shape concerns and negative affect at 7 months via a mediator of better emotion regulation at 2 months. This effect remained while controlling for earlier measurements of the mediator and outcome in the model of negative affect but not weight and shape concerns.DiscussionEmotion regulation may be an important mechanism explaining how mindfulness influences negative affect. Efforts should be made to intervene on mindfulness and emotion regulation in prevention and early intervention programmes for eating disorders and other psychiatric conditions.Public SignificanceResearch has shown that mindfulness can help to reduce some of the risk of developing an eating disorder. This study explored whether mindfulness reduces some of this risk by helping people to better manage their emotions. Understanding this process can help us to develop better mindfulness-based strategies to support people who are at risk of developing an eating disorder.

Biodiversity conservation is increasingly recognized as a main challenge for the sustainability agenda. With humans are at the epicentre of the biodiversity crisis, conserving nature requires changes in individual behaviour. This study reveals gaps regarding the incorporation of behaviour change into national biodiversity policy. A total of 1306 policy actions proposed by ten National Biodiversity Strategies and Action Plans (NBSAPs) from all world regions were coded for target actors, target behaviour and responsible agents as well as the policy options, intervention types and behavioural determinants listed in the Behaviour Change Wheel (BCW) framework. Results show that only 12% of the policy actions specified individual behaviours to be targeted, and only 3% of the policy actions were specific about how interventions and policies could enable behaviour change. Policy actions were aimed mostly at increasing people’s capabilities (i.e., providing information) or providing opportunities (i.e., resources), and rarely addressed the motivation of individuals.

Although there is much interest in the development of prosocial behaviour in young children, and many interventions that attempt to cultivate kindness in children, there is a paucity of research exploring children’s lived experiences of kindness and including their voices. In this study, children’s understanding of kindness is approached through qualitative interviews using puppets. Interviews were conducted with 33 children aged 5-6 years in 3 schools in the United Kingdom. Through thematic analysis, 4 themes were developed: (a) doing things for others, (b) relating with others, (c) rules and values, and (d) kindness affects us. These themes are examined in light of current thinking on prosocial and sociomoral development, and several key insights are highlighted, including types of prosocial behaviour, social connection, kindness-by-omission and defending, in-group bias, universal kindness versus personal safety, self-image, and a desire to improve the condition of society. These findings have implications for future research on prosocial development and for the design of kindness-based interventions, as well as providing an ecologically valid method of inquiry for use with young children.

ObjectivesThere is growing evidence for the benefit of mindfulness-based interventions (MBI) for people with psychosis. However, research is yet to evaluate the clinical benefit of delivering MBI groups online. We examine engagement, clinical outcomes, participant experience and therapeutic process of delivering therapy groups online in routine clinical practice.MethodsThe study used an uncontrolled pre-post design to examine engagement, therapeutic benefits (depression, anxiety, beliefs about voices) and group process in a 12-session online mindfulness group for individuals with a schizophrenia spectrum diagnosis with current distressing voices. Qualitative data on participant experience of online group therapy were analysed using Thematic Analysis.Results17/21 participants (81%) completed one of three consecutively run therapy groups. For completers there were significant reductions pre-post in depression, anxiety, beliefs about voices and voice-related negative affect, with medium to large effect sizes. There were individuals showing reliable and clinically significant improvements in each clinical outcome, and none showing reliable or clinically significant deterioriation. Participants’ rankings of the importance of different group therapeutic factors were very similar to those observed in face-to-face mindfulness for psychosis groups. Qualitative analysis of participant feedback identified three themes: ‘experience of online delivery’, ‘therapeutic benefits’ and ‘feeling connected to people in the group’.ConclusionsFindings in relation to therapy engagement, clinical benefits, participant experience and group process offer encouragement that online delivery of mindfulness for psychosis groups may be a useful addition to mental health services for people with distressing voices.

Background: COVID-19 continues to pose a threat to public health. Booster vaccine programmes are critical to achieve population-level immunity. Stage theory models of health behaviour can help our understanding of vaccine decision-making in the context of perceived threats of COVID-19.Purpose: To use the Precaution Adoption Process Model (PAPM) to understand decision-making about the COVID-19 booster vaccine (CBV) in England.Methods: An online, cross-sectional survey informed by the PAPM, the extended Theory of Planned Behaviour and Health Belief Model administered to people over the age of 50 residing in England, UK in October 2021. A multivariate, multinomial logistic regression model was used to examine associations with the different stages of CBV decision-making.Results: Of the total 2,004 participants: 135 (6.7%) were unengaged with the CBV programme; 262 (13.1%) were undecided as to whether to have a CBV; 31 (1.5%) had decided not to have a CBV; 1,415 (70.6%) had decided to have a CBV; and 161 (8.0%) had already had their CBV. Being unengaged was positively associated with beliefs in their immune system to protect against COVID-19, being employed, and low household income; and negatively associated with CBV knowledge, a positive COVID-19 vaccine experience, subjective norms, anticipated regret of not having a CBV, and higher academic qualifications. Being undecided was positively associated with beliefs in their immune system and having previously received the Oxford/AstraZeneca (as opposed to Pfizer/BioNTech) vaccine; and negatively associated with CBV knowledge, positive attitudes regarding CBV, a positive COVID-19 vaccine experience, anticipated regret of not having a CBV, white British ethnicity, and living in East Midlands (vs. London). Conclusions: Public health interventions promoting CBV may improve uptake through tailored messaging directed towards the specific decision stage relating to having a COVID-19 booster.

Objective: To determine the cost-effectiveness/utility of a superabsorbent wound dressing (Zetuvit Plus Silicone) versus the current standard of care (SoC) dressings, from the NHS perspective in England, in patients with moderate-to-high exudating leg ulcers. Method: A model-based economic evaluation was conducted to analyse the cost-effectiveness/utility of a new intervention. We used a microsimulation state-transition model with a time horizon of six months and a cycle length of one week. The model uses a combination of incidence base and risk prediction approach to inform transition probabilities. All clinical efficiency, health-related quality of life (HRQoL), cost and resource use inputs were informed by conducting a systematic review of UK specific literature. Results: Treatment with the superabsorbent dressing leads to a total expected cost per patient for a six month period of £2887, associated with 15.933 expected quality adjusted life weeks and 10.9% healing rate. When treated with SoC, the total expected cost per patient for a six month period is £3109, 15.852 expected quality adjusted life weeks and 8% healing rate. Therefore, the superabsorbent dressing leads to an increase in quality-adjusted life weeks, an increase in healing rate by 2.9% and a cost-saving of £222 per single average patient over six months. Results of several scenario analyses, one-way deterministic sensitivity analysis, and probabilistic sensitivity analysis confirmed the robustness of base-case results. The probabilistic analysis confirmed that, in any combination of variable values, the superabsorbent dressing leads to cost saving results. Conclusion: According to the model prediction, the superabsorbent dressing leads to an increase in health benefits and a decrease in associated costs of treatment.

Objective: The primary objective of this study was to evaluate the fluid management capabilities of a superabsorbent wound dressing (Zetuvit Plus Silicone), with secondary objectives related to parameters that support whether the dressing enables undisturbed healing. Method: This study was an open labelled non-comparative study. Patients included in the study were selected by the clinical investigator(s) according to whether the patient required a dressing for the management of moderately to highly exuding wounds. Results: A total of 50 patients were included in the study. Results related to the primary objective demonstrated that the superabsorbent wound dressing was able to absorb all levels of exudate across the range (low to high). At each assessment time point these results show that in 98% of assessments the superabsorbent dressing was rated as ‘very good’ (91%) or ‘good’ (7%) at exudate management. Secondary objectives relating to wound bed preparation, healing and management of pain were also positive. Additionally, at the end of each patient treatment, the dressing's fluid management capabilities were rated overall as ‘excellent’ (100% of cases). There was little pain associated with the wound or at dressing change throughout the study and its flexibility/conformability allowed for comfort and patient satisfaction aligned with increased quality of life. Additionally, inclusion of a silicone adhesive layer allowed painless and atraumatic removal of the dressing, increasing patient comfort, both during wear and at dressing removal, and supported the description of enabling undisturbed wound healing. Conclusion: The superabsorbent wound dressing achieved the primary objective relating to wound exudate management in all the assessments undertaken in this study. In addition, the silicone interface allowed for undisturbed healing as evidenced by little or no adherence of the dressing to underlying tissue, preventing damage to periwound skin. Overall, the superabsorbent wound dressing with the addition of the silicone interface could offer advantages over other superabsorbent polymer dressings (that might adhere to the wound surface) or silicone wound dressings (that might not have the absorbent properties of this type of dressing).

In March 2020 the president of the British Psychological Society (BPS) reached out to member networks to join forces on a BPS Covid-19 co-ordinating group. Members of this group were tasked to lead different work-streams highlighting psychology’s role during the pandemic. One workstream focused on ‘Behavioural Science and Disease Prevention’. It was clear that understanding behaviour and anticipating public responses to changes in policies, public messaging and guidelines would be key to improving health outcomes. This workstream focused on developing clear guidance to prevent the spread of Covid-19 and identifying psychological evidence to promote best practice in the design of sustainable behavioural interventions. This includes both immediate infection control behaviours aimed at reducing virus transmission, such as hand washing, physical-distancing and self-isolation, and behaviours that may have been influenced during the pandemic, such as physical activity, eating behaviour, substance use and healthcare use, which will have far reaching impacts on future health. This article provides an overview of the core guidance and practical examples of its application in a public health setting.

Background: To reduce carbon emissions, urgent change is needed to high-carbon human behaviours including home energy use. Previous policy failures point to insufficient integration of systemic and behavioural approaches which are too often seen as alternative and incompatible approaches to bring about change. A novel behavioural systems mapping approach was used to inform national policy recommendations for energy-saving retrofit of homes in Wales. Method: Three participatory workshops were held with the independent Welsh residential decarbonisation advisory group (‘the Advisory Group’) to (1) map relationships between actors, behaviours and influences on behaviour within the home retrofit system, (2) provide training in the Behaviour Change Wheel framework (3) use these to develop policy recommendations for interventions. Recommendations were analysed using the COM-B (capability, opportunity, motivation) model of behaviour to assess whether they addressed these factors. Results: Two behavioural systems maps were produced, representing privately rented and owner-occupied housing tenures. The main causal pathways and feedback loops in each map are described. Necessary interventions to achieve national-scale retrofit included: government-led investment, campaigns and awareness-building, financial-sector funding mechanisms, enforcement of regulations, and creating more streamlined and trusted supply chain services. Of 27 final policy recommendations, 6 addressed capability, 24 opportunity, and 12 motivation. Conclusions: Participatory behavioural systems mapping can be used in conjunction with behaviour change frameworks to develop policy recommendations that address the behavioural determinants of complex environmental problems in a systemic way. Research is underway to refine and extend the approach through application to other sustainability challenges and methods of constructing systems maps.

SummaryThere is increasing interest in potential harmful effects of mindfulness-based interventions. In relation to psychosis, inconsistency and shortcomings in how harm is monitored and reported are holding back our understanding. We offer eight recommendations to help build a firmer evidence base on potential harm in mindfulness for psychosis.

Objectives:Psychosis is associated with increased subjective and altered endocrine and autonomic nervous system stress-reactivity. Psychosis patients often experience auditory verbal hallucinations, with negative voice content being particularly associated with distress. The present study developed a voice-simulation paradigm and investigated the effect of simulated voices with neutral and negative content on psychophysiological stress-reactivity, and the effect of mindful voice-appraisals on stress-reactivity.Method:Eighty-four healthy participants completed the Montreal Imaging Stress Task with simultaneous presentation of one of three randomly allocated auditory stimuli conditions: negative voices, neutral voices or non-voice ambient sounds. Subjective stress-levels and mindful voice-appraisals were assessed using questionnaire measures, and cortisol and α-amylase levels were measured using saliva samples.Results:ANOVA revealed a significant effect of condition on subjective stress-levels (p = .002), but not cortisol (p = .63) or α-amylase (p = .73). Post-hoc analyses showed that negative voices increased subjective stress-levels relative to neutral voices (p = .002) and ambient sounds (p = .01), which did not differ from each other (p = .41). Mindful voice-appraisals were associated with less distress across conditions (p = .003), although negative voices were also associated with less mindful appraisals (p Conclusions:Negative voice content, rather than voices or auditory stimuli per se, is linked to greater subjective but not physiological stress-reactivity. Mindful appraisals may partially moderate this effect. These findings highlight the importance of voice content for the impact of voice-hearing, and highlight the potential value of mindfulness training to treat voice distress in psychosis. published

Background: Public health emergencies require rapid responses from experts. Differing viewpoints are common in science, however, “mixed messaging” of varied perspectives can undermine credibility of experts, reduce trust in guidance, and act as a barrier to changing public health behaviours. Collation of a unified voice for effective knowledge creation and translation can be challenging. This work aimed to create a method for rapid psychologically-informed expert guidance during the COVID-19 response. Method: TRICE (Template for Rapid Iterative Consensus of Experts) brings structure, peer-review and consensus to the rapid generation of expert advice. It was developed and trialled with 15 core members of the British Psychological Society COVID-19 Behavioural Science and Disease Prevention Taskforce. Results: Using TRICE, we have produced 18 peer-reviewed COVID-19 guidance documents, based on rapid systematic reviews, co-created by experts in behavioural science and public health, taking 4–156 days to produce, with approximately 18 experts and a median of 7 drafts per output. We provide worked-examples and key considerations, including a shared ethos and theoretical/methodological framework, in this case, the Behaviour Change Wheel and COM-B. Conclusion: TRICE extends existing consensus methodologies and has supported public health collaboration, co-creation of guidance and translation of behavioural science to practice through explicit processes in generating expert advice for public health emergencies.

Obesity is widespread, with serious health consequences, addressing it requires considerable effort at a public health level, incorporating prevention and management along with policies to support implementation. Behavioural weight-management programmes are widely used by public health bodies to address overweight and obesity. Shape-Up is an evidence-based programme combining a structured behavioural intervention (targeting nutrition and physical activity behaviours) within a peer-learning framework. This study was a service-evaluation of Shape-Up, as delivered in Rotherham by a local leisure provider, and included a secondary analysis of data collected in the community by service providers. The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework was used to explore programme effectiveness, implementation, and whom it reached. A total of 141 participants were included. Compared to local demographics, participants were older, at 48.9 (SD 14.47) years, with a lower employment rate (41% employed) and greater proportion female (67% female). Mean BMI was 38.0 (SD 7.54) kg/m2. Mean weight-change between baseline and endpoint (12 weeks, 10 group sessions) was −4.4 (SD 3.38) kg, and degree of weight change was associated with session attendance (F (9, 131) = 6.356, p &lt, 0.0005). There were positive effects on participants’ weight, health-related behaviours, and quality of life. The intervention content (including the focus of nutritional recommendations) and structure were adapted during implementation to better suit national guidelines and local population needs. RE-AIM was found to be a useful framework for evaluating and adapting an existing evidence-based weight management programme in line with local population needs. This could be a more cost-effective approach, compared to developing new programmes, for delivering public health goals relating to obesity, nutrition, and physical activity.

BACKGROUND Diabetic foot ulcers (DFUs) cause significant morbidity and mortality. Faster and more appropriate referral to specialist clinics after symptom onset has been linked to a reduced risk of patients developing severe DFUs. The INTELLIN® diabetes management platform is a novel mHealth application for the management of recently healed DFUs, promoting clinic engagement and expediting self-referral. OBJECTIVE Aims were to determine the acceptability, suitability and usability of the INTELLIN® platform, as assessed by the patients and the clinical team; and to assess the proportion of patients who self-refer for DFU recurrence over 12 months. METHODS Patients from the Salford Royal NHS Foundation Trust attended follow-up visits at Weeks 1, 4, 16, 28, 40 and 52. Time until reulceration was measured through Week 52, whilst the Site, Ischemia, Neuropathy, Bacterial Infection, and Depth (SINBAD) score was assessed at screening and at any instances of DFU recurrence. The proportion of patients who self-referred for recurrence was also assessed, and patients and clinic staff completed questionnaires to assess platform usability. A Markov cost-utility model was used to predict quality-adjusted life-years (QALYs) and costs to calculate an incremental cost effectiveness ratio (ICER) and indicate the level of benefit INTELLIN® would need to deliver in terms of prevention of DFU recurrence to achieve cost-effectiveness. RESULTS One hundred and ninety-seven patients were assessed for eligibility and 15 entered the full analysis set (FAS). Through Week 52, 8/15 FAS patients experienced a recurrence, with a mean (SD) SINBAD score of 2.1 (1.0) and a mean duration of 2.6 days. Mean time from last DFU to recurrence during follow-up was 273.0 days (95% CI 74.0, 484.0). No patients self-referred during the study. Despite the small sample size, initial qualitative data showed high INTELLIN® platform acceptability and usability for patients and clinicians, with high likelihood of recommendation for future use. In this model, the INTELLIN® platform only required a relative reduction in DFU recurrence of 5% compared with standard of care (SoC) to attain an ICER of £20 000 per QALY, suggesting the potential for significant healthcare cost savings upon wider adoption of the INTELLIN® platform. The substantial barriers to enrolment encountered in this study demonstrate the considerable impact of socio-economic factors on mHealth studies, specifically in this study in patients with diabetes. CONCLUSIONS The results of this feasibility and accessibility study combined with a health economics and outcomes research (HEOR) evaluation suggest that the INTELLIN® platform is required to provide only a small reduction in DFU recurrence compared to SoC to be a cost-effective strategy for the prevention of recurrent DFUs. This is a promising result and supports the future development of a comparative study to evaluate effectiveness of the platform in patients with complications due to diabetes.

Background: Intervention Mapping (IM) is a systematic approach for developing theory-based interventions across a variety of contexts and settings. This paper describes the development of a complex intervention designed to reduce the dose of ultraviolet radiation (UVR) reaching the face of adults with Xeroderma Pigmentosum (XP), by improving photoprotection. XP is a genetic condition that without extreme UVR photoprotection, leads to high risk of developing skin cancer. Methods: The IM protocol of 6 steps was applied, involving comprehensive mixed-methods formative research. Key stakeholders (XP clinical staff and Patient and Public Involvement Panel), were instrumental at every step. Behaviour change methods were informed by the IM taxonomy, therapeutic approaches (e.g. ACT, CBT) and coded according to the taxonomy of behaviour change techniques (version 1). Results: We designed a personalised modular intervention to target psychosocial determinants of photoprotective activities that influence the amount of UVR reaching the face. Content was developed to target determinants of motivation to protect and factors preventing the enactment of behaviours. Participants received personalised content addressing determinants/barriers most relevant to them, as well as core ‘behaviour-change’ material, considered important for all (e.g. SMART goals). Core and personalised content was delivered via 7 one-to-one sessions with a trained facilitator using a manual and purpose designed materials: Magazine; text messages; sunscreen application video; goal-setting tools (e.g. UVR dial and face protection guide); activity sheets. Novel features included use of ACT-based values to enhance intrinsic motivation, targeting of emotional barriers to photoprotection, addressing appearance concerns and facilitating habit formation. Conclusion: IM was an effective approach for complex intervention design. The structure (e.g. use of matrices) tethered the intervention tightly to theory and evidence-based approaches. The significant amount of time required needs to be considered and may hinder translation of IM into clinical and non-academic settings.

Aims Self‐management programmes for type 1 diabetes, such as the UK’s Dose Adjustment for Normal Eating (DAFNE), improve short‐term clinical outcomes but difficulties maintaining behavioural changes attenuate long‐term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. Methods A four‐step method was based on the BCW intervention development approach: 1) Identifying self‐management behaviours and barriers/enablers to maintaining them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation‐Behaviour (COM‐B) model. 2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). 3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. 4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co‐designed by stakeholders (diabetologists, psychologists, specialist nurses and dietitians). Results Thirty‐four barriers and five enablers to sustaining self‐management post‐DAFNE, were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. Twenty‐seven BCTs were added, including ‘Habit formation’, ‘Credible source’ and ‘Conserving mental resources’. Fifteen stakeholder‐agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co‐designed components: (1) face‐to‐face group learning course, (2) individual structured follow‐up sessions, (3) technological support, including blood glucose data management. Conclusions This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self‐management behaviours.