Supporting post-pandemic recovery: a qualitative study of the capabilities, opportunities and motivations to deliver oral health behaviour change messages to parents of young children in community settings.

BACKGROUND: The COVID-19 pandemic exacerbated vulnerabilities and inequalities in children's oral health, and treatment activity virtually ceased during periods of lockdown. Primary care dentistry is still in the post-pandemic recovery phase, and it may be some years before normal service is resumed in NHS dentistry. However, opportunities to support the dental workforce through offering some preventative care in outreach settings may exist. This has the additional benefit of potentially reaching children who do not routinely see a dentist. The aim of this research was therefore to explore views around upskilling practitioners working in early years educational and care settings to support families of pre-school aged children to adopt and maintain preventative oral health behaviours. METHODS: Using the Capability, Opportunity and Motivation model of behaviour (COM-B) to structure our data collection and analysis, we conducted semi-structured interviews with 16 practitioners (dental and non-dental) and analysed the data using deductive framework analysis. RESULTS: The data were a good fit with the COM-B model, and further themes were developed within each construct, representing insights from the data. CONCLUSION: Early years practitioners can reach vulnerable children who are not usually brought to see a dentist, and have the capability, opportunity and motivation to support the oral health behaviours of families of children in their care. Further research is needed to identify training needs (oral health and behaviour change knowledge and skills), acceptability to parents, and supporting dental practice teams to work in partnership with early years settings.

The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature.

BACKGROUND: The Online Resource for Recruitment in Clinical triAls (ORRCA) and the Online Resource for Retention in Clinical triAls (ORRCA2) were established to organise and map the literature addressing participant recruitment and retention within clinical research. The two databases are updated on an ongoing basis using separate but parallel systematic reviews. However, recruitment and retention of research participants is widely acknowledged to be interconnected. While interventions aimed at addressing recruitment challenges can impact retention and vice versa, it is not clear how well they are simultaneously considered within methodological research. This study aims to report the recent update of ORRCA and ORRCA2 with a special emphasis on assessing crossover of the databases and how frequently randomised studies of methodological interventions measure the impact on both recruitment and retention outcomes. METHODS: Two parallel systematic reviews were conducted in line with previously reported methods updating ORRCA (recruitment) and ORRCA2 (retention) with publications from 2018 and 2019. Articles were categorised according to their evidence type (randomised evaluation, non-randomised evaluation, application and observation) and against the recruitment and retention domain frameworks. Articles categorised as randomised evaluations were compared to identify studies appearing in both databases. For randomised studies that were only in one database, domain categories were used to assess whether the methodological intervention was likely to impact on the alternate construct. For example, whether a recruitment intervention might also impact retention. RESULTS: In total, 806 of 17,767 articles screened for the recruitment database and 175 of 18,656 articles screened for the retention database were added as result of the update. Of these, 89 articles were classified as 'randomised evaluation', of which 6 were systematic reviews and 83 were randomised evaluations of methodological interventions. Ten of the randomised studies assessed recruitment and retention and were included in both databases. Of the randomised studies only in the recruitment database, 48/55 (87%) assessed the content or format of participant information which could have an impact on retention. Of the randomised studies only in the retention database, 6/18 (33%) assessed monetary incentives, 4/18 (22%) assessed data collection location and methods and 3/18 (17%) assessed non-monetary incentives, all of which could have an impact on recruitment. CONCLUSION: Only a small proportion of randomised studies of methodological interventions assessed the impact on both recruitment and retention despite having a potential impact on both outcomes. Where possible, an integrated approach analysing both constructs should be the new standard for these types of evaluations to ensure that improvements to recruitment are not at the expense of retention and vice versa.

Wellbeing After Stroke (WAterS): Feasibility Testing of a Co-developed Acceptance and Commitment Therapy Intervention to Support Psychological Adjustment After Stroke.

OBJECTIVE: Feasibility test a co-developed intervention based on Acceptance and Commitment Therapy to support psychological adjustment post-stroke, delivered by a workforce with community in-reach. DESIGN: Observational feasibility study utilising patient, carer, public involvement. SETTING: Online. UK. PARTICIPANTS: Stroke survivors with self-reported psychological distress 4 + months post-stroke. INTERVENTIONS: The co-developed Wellbeing After Stroke (WAterS) intervention includes: 9-weekly, structured, online, group sessions for stroke survivors, delivered via a training programme to upskill staff without Acceptance and Commitment Therapy experience, under Clinical Psychology supervision. MAIN MEASURES: Feasibility of recruitment and retention; data quality from candidate measures; safety. Clinical and demographic information at baseline; patient-reported outcome measures (PROMs) via online surveys (baseline, pre- and post-intervention, 3 and 6 months after intervention end) including Mood (hospital anxiety and depression scale (HADS)), Wellbeing (ONS4), Health-Related Quality of Life (EQ5D5L), Psychological Flexibility (AAQ-ABI) and Values-Based Living (VQ). RESULTS: We trained eight staff and recruited 17 stroke survivors with mild-to-moderate cognitive and communication difficulties. 12/17 (71%) joined three intervention groups with 98% attendance and no related adverse events. PROMS data were well-completed. The HADS is a possible future primary outcome (self-reported depression lower on average by 1.3 points: 8.5 pre-group to 7.1 at 3-month follow-up; 95% CI 0.4 to 3.2). CONCLUSION: The WAterS intervention warrants further research evaluation. Staff can be trained and upskilled to deliver. It appears safe and feasible to deliver online to groups, and study recruitment and data collection are feasible. Funding has been secured to further develop the intervention, considering implementation and health equality.

Optimizing the hydraulic performance of a baffled horizontal subsurface flow constructed wetland through computational fluid dynamics modelling.

Baffled constructed wetlands (CWs) offer a promising solution to address low hydraulic efficiency in traditional CWs. However, there is a research gap in the field regarding the optimal length and quantity of baffles, and their comprehensive effects on hydraulic efficiency. This study is the first CFD-based assessment to comprehensively investigate the combined influence of baffle length and the number of baffles on the hydraulic efficiency of CWs. Using OpenFOAM simulations at a laboratory scale, various baffle configurations were examined with lengths ranging from 0.4 m to 0.58 m and baffle numbers varying from 0 to 11. Experimental tracer tests were conducted to validate the simulations. The high correlation coefficient (R2) between the tracer test results and simulations (ranging between 0.84 and 0.93) further underscores the reliability of the findings. Residence time distributions (RTDs) were derived from the temporal evolution of the outlet concentration of a tracer. The results indicate that augmenting the number of baffles under a fixed baffle length has a greater impact on the RTD curves, causing a backward displacement of the peak time. However, when the number of baffles is three or fewer, extending the baffle length does not significantly affect the RTD. When the baffle length is held constant at 0.58 m, there is a 58% enhancement in hydraulic efficiency as the number of baffles increases from 0 to 5. However, when maintaining a constant number of 11 baffles, increasing the baffle length from 0.4 to 0.5 m results in only a 5.5% improvement in hydraulic efficiency. Moreover, a generalized predictive equation for hydraulic efficiency was derived based on the CFD results and dimensional analysis. The study enhances the optimization of constructed wetland design by providing greater understanding of hydrodynamic behavior, leading to improved performance and applicability in practical environmental engineering.

The effectiveness of digital delivery versus group-based face-to-face delivery of the English National Health Service Type 2 Diabetes Prevention Programme: a non-inferiority retrospective cohort comparison study.

BACKGROUND: Face-to-face group-based diabetes prevention programmes have been shown to be effective in many settings. Digital delivery may suit some patients, but research comparing the effectiveness of digital with face-to-face delivery is scarce. The aim was to assess if digital delivery of the English National Health Service Diabetes Prevention Programme (NHS DPP) is non-inferior to group-based face-to-face delivery in terms of weight change, and evaluate factors associated with differential change. METHODS: The study included those recruited to the NHS DPP in 2017-2018. Individual-level data from a face-to-face cohort was compared to two cohorts on a digital pilot who (i) were offered no choice of delivery mode, or (ii) chose digital over face-to-face. Changes in weight at 6 and 12 months were analysed using mixed effects linear regression, having matched participants from the digital pilot to similar participants from face-to-face. RESULTS: Weight change on the digital pilot was non-inferior to face-to-face at both time points: it was similar in the comparison of those with no choice (difference in weight change: -0.284 kg [95% CI: -0.712, 0.144] at 6 months) and greater in digital when participants were offered a choice (-1.165 kg [95% CI: -1.841, -0.489]). Interactions between delivery mode and sex, ethnicity, age and deprivation were observed. CONCLUSIONS: Digital delivery of the NHS DPP achieved weight loss at least as good as face-to-face. Patients who were offered a choice and opted for digital experienced better weight loss, compared to patients offered face-to-face only.

Diabetes prevention at scale: Narrative review of findings and lessons from the DIPLOMA evaluation of the NHS Diabetes Prevention Programme in England.

AIMS: The NHS Diabetes Prevention Programme (NHS DPP) is a large-scale, England-wide behaviour change programme for people at high risk of progressing to type 2 diabetes. We summarise the findings of our six-year DIPLOMA evaluation of its implementation and impact and highlight insights for future programmes. METHODS: Using qualitative interviews, document analysis, observation, surveys and large dataset analysis, eight interlinked work packages considered: equity of access; implementation; service delivery and fidelity; programme outcomes; comparative effectiveness and cost-effectiveness in reducing diabetes incidence; and patient decision making and experience. RESULTS: Delivery of the NHS DPP encountered barriers across many aspects of the programme, and we identified inequalities in terms of the areas, organisations and patient populations most likely to engage with the programme. There was some loss of fidelity at all stages from commissioning to participant understanding. Despite these challenges, there was evidence of significant reductions in diabetes incidence at individual and population levels. The programme was cost-effective even within a short time period. CONCLUSIONS: Despite the challenge of translating research evidence into routine NHS delivery at scale, our findings suggest that an individual-level approach to the prevention of type 2 diabetes in a 'high-risk' population was more effective than usual care. By embedding evaluation with programme delivery and working closely with the NHS DPP team, we provided actionable insights for improving communications with potential participants, supporting primary care referral, honing the delivery model with better provider relationships and more patient choice, increasing understanding of behaviour change techniques, and enriching the educational and health coaching content.

Design and Early Use of the Nationally Implemented Healthier You National Health Service Digital Diabetes Prevention Programme: Mixed Methods Study.

BACKGROUND: The Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them. OBJECTIVE: This study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants' early engagement with the NHS-digital-DPP apps. METHODS: Mixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants' first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically. RESULTS: Data were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement. CONCLUSIONS: Almost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions.

Reflections of patient and public involvement from a commissioned research project evaluating a nationally implemented NHS programme focused on diabetes prevention.

Patient and Public Involvement and Engagement (PPIE) in research is recognised by the National Institute for Health and Care Research as crucial for high quality research with practical benefit for patients and carers. Patient and public contributors can provide both personal knowledge and lived experiences which complement the perspectives of the academic research team. Nevertheless, effective PPIE must be tailored to the nature of the research, such as the size and scope of the research, whether it is researcher-led or independently commissioned, and whether the research aims to design an intervention or evaluate it. For example, commissioned research evaluations have potential limits on how PPIE can feed into the design of the research and the intervention. Such constraints may require re-orientation of PPIE input to other functions, such as supporting wider engagement and dissemination. In this commentary, we use the 'Guidance for Reporting Involvement of Patients and the Public' (GRIPP2) short form to share our own experiences of facilitating PPIE for a large, commissioned research project evaluating the National Health Service Diabetes Prevention Programme; a behavioural intervention for adults in England who are at high risk of developing type 2 diabetes. The programme was already widely implemented in routine practice when the research project and PPIE group were established. This commentary provides us with a unique opportunity to reflect on experiences of being part of a PPIE group in the context of a longer-term evaluation of a national programme, where the scope for involvement in the intervention design was more constrained, compared to PPIE within researcher-led intervention programmes. We reflect on PPIE in the design, analysis and dissemination of the research, including lessons learned for future PPIE work in large-scale commissioned evaluations of national programmes. Important considerations for this type of PPIE work include: ensuring the role of public contributors is clarified from the outset, the complexities of facilitating PPIE over longer project timeframes, and providing adequate support to public contributors and facilitators (including training, resources and flexible timelines) to ensure an inclusive and considerate approach. These findings can inform future PPIE plans for stakeholders involved in commissioned research.

The influence of demographic, health and psychosocial factors on patient uptake of the English NHS diabetes prevention programme.

BACKGROUND: The prevention of type 2 diabetes (T2DM) is a major concern for health services around the world. The English NHS Diabetes Prevention Programme (NHS-DPP) offers a group face-to-face behaviour change intervention, based around exercise and diet, to adults with non-diabetic hyperglycaemia (NDH), referred from primary care. Previous analysis of the first 100,000 referrals revealed just over half of those referred to the NHS-DPP took up a place. This study aimed to identify the demographic, health and psychosocial factors associated with NHS-DPP uptake to help inform the development of interventions to improve uptake and address inequities between population groups. METHODS: Drawing on the Behavioral Model of Health Services Utilization we developed a survey questionnaire to collect data on a wide range of demographic, health and psychosocial factors that might influence uptake of the NHS-DPP. We distributed this questionnaire to a cross-sectional random sample of 597 patients referred to the NHS-DPP across 17 general practices, chosen for variation. Multivariable regression analysis was used to identify factors associated with NHS-DPP uptake. RESULTS: 325 out of 597 questionnaires were completed (54%). Only a third of responders took up the offer of a place. The best performing model for uptake (AUC = 0.78) consisted of four factors: older age; beliefs concerning personal vulnerability to T2DM; self-efficacy for reducing T2DM risk; and the efficacy of the NHS-DPP. After accounting for these, demographic and health-related factors played only a minor role. CONCLUSION: Unlike fixed demographic characteristics, psychosocial perceptions may be amenable to change. NHS-DPP uptake rates may be improved by targeting the beliefs of patients about their risk of developing T2DM, their ability to carry out and sustain behaviours to reduce this risk, and the efficacy of the NHS-DPP in providing the necessary understanding and skills required. The recently introduced digital version of the NHS DPP could help address the even lower uptake amongst younger adults. Such changes could facilitate proportional access from across different demographic strata.

Comparison of weight change between face-to-face and digital delivery of the English National Health service diabetes prevention programme: An exploratory non-inferiority study with imputation of plausible weight outcomes.

Worldwide evidence suggests face-to-face diabetes prevention programmes are effective in preventing and delaying the onset of type 2 diabetes by encouraging behaviour change towards weight loss, healthy eating, and increased exercise. There is an absence of evidence on whether digital delivery is as effective as face-to-face. During 2017-18 patients in England were offered the National Health Service Diabetes Prevention Programme as group-based face-to-face delivery, digital delivery ('digital-only') or a choice between digital and face-to-face ('digital-choice'). The contemporaneous delivery allowed for a robust non-inferiority study, comparing face-to-face with digital only and digital choice cohorts. Changes in weight at 6 months were missing for around half of participants. Here we take a novel approach, estimating the average effect in all 65,741 individuals who enrolled in the programme, by making a range of plausible assumptions about weight change in individuals who did not provide outcome data. The benefit of this approach is that it includes everyone who enrolled in the programme, not restricted to those who completed. We analysed the data using multiple linear regression models. Under all scenarios explored, enrolment in the digital diabetes prevention programme was associated with clinically significant reductions in weight which were at least equivalent to weight loss in the face-to-face programme. Digital services can be just as effective as face-to-face in delivering a population-based approach to the prevention of type 2 diabetes. Imputation of plausible outcomes is a feasible methodological approach, suitable for analysis of routine data in settings where outcomes are missing for non-attenders.

Influences on Patient Uptake of and Engagement With the National Health Service Digital Diabetes Prevention Programme: Qualitative Interview Study.

BACKGROUND: Digital diabetes prevention programs (digital-DPPs) are being implemented as population-based approaches to type 2 diabetes mellitus prevention in several countries to address problems with the uptake of traditional face-to-face diabetes prevention programs. However, assessments of digital-DPPs have largely focused on clinical outcomes and usability among those who have taken them up, whereas crucial information on decision-making about uptake (eg, whether a user downloads and registers on an app) and engagement (eg, the extent of use of an app or its components over time) is limited. Greater understanding of factors that influence uptake and engagement decisions may support large-scale deployments of digital-DPPs in real-world settings. OBJECTIVE: This study aimed to explore the key influences on uptake and engagement decisions of individuals who were offered the National Health Service Healthier You: Digital Diabetes Prevention Programme (NHS-digital-DPP). METHODS: A qualitative interview study was conducted using semistructured interviews. Participants were adults, aged ≥18 years, diagnosed with nondiabetic hyperglycemia, and those who had been offered the NHS-digital-DPP. Recruitment was conducted via 4 providers of the NHS-digital-DPP and 3 primary care practices in England. Interviews were conducted remotely and were guided by a theoretically informed topic guide. Analysis of interviews was conducted using an inductive thematic analysis approach. RESULTS: Interviews were conducted with 32 participants who had either accepted or declined the NHS-digital-DPP. In total, 7 overarching themes were identified as important factors in both decisions to take up and to engage with the NHS-digital-DPP. These were knowledge and understanding, referral process, self-efficacy, self-identity, motivation and support, advantages of digital service, and reflexive monitoring. Perceptions of accessibility and convenience of the NHS-digital-DPP were particularly important for uptake, and barriers in terms of the referral process and health care professionals' engagement were reported. Specific digital features including health coaches and monitoring tools were important for engagement. CONCLUSIONS: This study adds to the literature on factors that influence the uptake of and engagement with digital-DPPs and suggests that digital-DPPs can overcome many barriers to the uptake of face-to-face diabetes prevention programs in supporting lifestyle changes aimed at diabetes prevention.

Referral to the NHS Diabetes Prevention Programme and conversion from nondiabetic hyperglycaemia to type 2 diabetes mellitus in England: A matched cohort analysis.

BACKGROUND: The NHS Diabetes Prevention Programme (NDPP) is a behaviour change programme for adults who are at risk of developing type 2 diabetes mellitus (T2DM): people with raised blood glucose levels, but not in the diabetic range, diagnosed with nondiabetic hyperglycaemia (NDH). We examined the association between referral to the programme and reducing conversion of NDH to T2DM. METHODS AND FINDINGS: Cohort study of patients attending primary care in England using clinical Practice Research Datalink data from 1 April 2016 (NDPP introduction) to 31 March 2020 was used. To minimise confounding, we matched patients referred to the programme in referring practices to patients in nonreferring practices. Patients were matched based on age (≥3 years), sex, and ≥365 days of NDH diagnosis. Random-effects parametric survival models evaluated the intervention, controlling for numerous covariates. Our primary analysis was selected a priori: complete case analysis, 1-to-1 practice matching, up to 5 controls sampled with replacement. Various sensitivity analyses were conducted, including multiple imputation approaches. Analysis was adjusted for age (at index date), sex, time from NDH diagnosis to index date, BMI, HbA1c, total serum cholesterol, systolic blood pressure, diastolic blood pressure, prescription of metformin, smoking status, socioeconomic status, a diagnosis of depression, and comorbidities. A total of 18,470 patients referred to NDPP were matched to 51,331 patients not referred to NDPP in the main analysis. Mean follow-up from referral was 482.0 (SD = 317.3) and 472.4 (SD = 309.1) days, for referred to NDPP and not referred to NDPP, respectively. Baseline characteristics in the 2 groups were similar, except referred to NDPP were more likely to have higher BMI and be ever-smokers. The adjusted HR for referred to NDPP, compared to not referred to NDPP, was 0.80 (95% CI: 0.73 to 0.87) (p < 0.001). The probability of not converting to T2DM at 36 months since referral was 87.3% (95% CI: 86.5% to 88.2%) for referred to NDPP and 84.6% (95% CI: 83.9% to 85.4%) for not referred to NDPP. Associations were broadly consistent in the sensitivity analyses, but often smaller in magnitude. As this is an observational study, we cannot conclusively address causality. Other limitations include the inclusion of controls from the other 3 UK countries, data not allowing the evaluation of the association between attendance (rather than referral) and conversion. CONCLUSIONS: The NDPP was associated with reduced conversion rates from NDH to T2DM. Although we observed smaller associations with risk reduction, compared to what has been observed in RCTs, this is unsurprising since we examined the impact of referral, rather than attendance or completion of the intervention.

A scoping review to identify process and outcome measures used in acceptance and commitment therapy research, with adults with acquired neurological conditions.

BACKGROUND: Acceptance and Commitment Therapy interventions are increasing in use in neurological populations. There is a lack of information on the measures available. PURPOSE: To identify and classify the measures used in Acceptance and Commitment Therapy research studies with adults with acquired neurological conditions. METHODS: PRISMA-ScR guided scoping review. MEDLINE, PsycInfo and CINAHL databases searched (up to date 29/06/2022) with forward and backward searching. All study types included. Extraction of Acceptance and Commitment Therapy process-of-change and health-related outcome measures. Outcomes coded using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy. RESULTS: Three hundred and thirty three papers found on searching. Fifty four studies included and 136 measurement tools extracted. Conditions included multiple sclerosis, traumatic brain injury and stroke. Thirty-eight studies measured processes of change, with 32 measures extracted. The process measure most often used was the Acceptance and Action Questionnaire (n = 21 studies). One hundred and four health-related outcome measures extracted. Measures exploring quality of life, health status, anxiety and depression occurred most frequently, and were used in all included neurological conditions. COMET domains most frequently coded were emotional functioning/well-being (n = 50), physical functioning (n = 32), role functioning (n = 22) and psychiatric (n = 22). CONCLUSIONS: This study provides a resource to support future identification of candidate measures. This could aid development of a Core Outcome Set to support both research and clinical practice. Further research to identify the most appropriate and relevant targets and tools for use in these populations should include expert consensus, patient, carer and public involvement and psychometric examination of measures.

Healthcare workers' perspectives on barriers and facilitators to referral and recruitment to diabetes prevention programmes: a systematic review protocol.

Background: Diabetes is a growing global health problem. International guidelines recommend identification, screening, and referral to behavioural programmes for those at high risk of developing type 2 diabetes. Diabetes prevention programmes (DPPs) can prevent type 2 diabetes in those at high risk, however many eligible participants are not referred to these programmes. Healthcare workers (HCWs) are pivotal to the referral and recruitment processes. This study aims to identify, appraise and synthesise the evidence on barriers and facilitators to referral and recruitment to DPPs from the perspective of HCWs. Methods: A "best fit" framework synthesis method will synthesise qualitative, quantitative, and mixed methods evidence on factors that affect HCWs referral and recruitment to DPPs, with the Theoretical Domains Framework (TDF) as the a priori framework. MEDLINE, EMBASE, CINAHL, PsychINFO, Web of Science and Scopus will be searched for primary studies published in English. Year of publication will be restricted to the last 26 years (1997-2023). Quality will be assessed using the Mixed Methods Appraisal Tool. A mix of deductive coding using the TDF and inductive coding of data that does not fit the TDF will be synthesised into themes representing the whole dataset. The relationships between the final set of themes will be explored to create a new model to understand HCWs' perspectives on referral and recruitment to DPPs. Sensitivity analysis will be carried out on this conceptual model. Confidence in the synthesised findings will be assessed using the GRADE-CERQual approach. One author will screen, extract, appraise the literature while a second author will independently verify a 20% sample at each stage. Discussion: Participation in DPPs is key for programme impact. HCWs typically identify those at risk and refer them to DPPs. Understanding HCWs' perspectives on the barriers and facilitators to referral and recruitment will inform future implementation of DPPs.

Changes in a Digital Type 2 Diabetes Self-management Intervention During National Rollout: Mixed Methods Study of Fidelity.

BACKGROUND: "Healthy Living for People with type 2 Diabetes (HeLP-Diabetes)" was a theory-based digital self-management intervention for people with type 2 diabetes mellitus that encouraged behavior change using behavior change techniques (BCTs) and promoted self-management. HeLP-Diabetes was effective in reducing HbA1c levels in a randomized controlled trial (RCT). National Health Service (NHS) England commissioned a national rollout of HeLP-Diabetes in routine care (now called "Healthy Living"). Healthy Living presents a unique opportunity to examine the fidelity of the national rollout of an intervention originally tested in an RCT. OBJECTIVE: This research aimed to describe the Healthy Living BCT and self-management content and features of intervention delivery, compare the fidelity of Healthy Living with the original HeLP-Diabetes intervention, and explain the reasons for any fidelity drift during national rollout through qualitative interviews. METHODS: Content analysis of Healthy Living was conducted using 3 coding frameworks (objective 1): the BCT Taxonomy v1, a new coding framework for assessing self-management tasks, and the Template for Intervention Description and Replication. The extent to which BCTs and self-management tasks were included in Healthy Living was compared with published descriptions of HeLP-Diabetes (objective 2). Semistructured interviews were conducted with 9 stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout (objective 3). Qualitative data were thematically analyzed using a modified framework approach. RESULTS: The content analysis identified 43 BCTs in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs ("commitment") in the original HeLP-Diabetes intervention. Healthy Living was found to address all areas of self-management (medical, emotional, and role) in line with the original HeLP-Diabetes intervention. However, 2 important changes were identified. First, facilitated access by a health care professional was not implemented; interviews revealed this was because general practices had fewer resources in comparison with the RCT. Second, Healthy Living included an additional structured web-based learning curriculum that was developed by the HeLP-Diabetes team but was not included in the original RCT; interviews revealed that this was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet the multiple digital standards required for implementation in the NHS. CONCLUSIONS: The national rollout of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT to a nationally implemented intervention, mainly because of fewer resources available in practice and the length of time since the RCT. This study highlights the importance of considering implementation throughout all phases of intervention development.

Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the WORKWELL trial due to the impact of the COVID-19 pandemic.

There are high levels of work disability, absenteeism (sick leave) and presenteeism (reduced productivity) amongst people with inflammatory arthritis. WORKWELL is a multi-centre, randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis. The trial tested the effectiveness and cost-effectiveness of the WORKWELL programme compared to the receipt of written self-help information only. Both arms continued to receive usual care. In March 2020, due to the COVID-19 pandemic, the WORKWELL trial paused to recruitment and intervention delivery. To successfully re-start, protocol amendments were rapidly submitted and changes to existing trial procedures were made. The WORKWELL protocol was adapted in response to both the practical issues likely faced by many clinical research studies active across NHS sites during the pandemic and additional trial-specific challenges. A key eligibility criterion for the trial required participants to be in paid work for at least 15 h per week. However, UK national lockdowns led to a substantial proportion of the workforce suddenly being furloughed or unable to work, and many people with arthritis taking immunosuppressive medications were asked to shield themselves. Thus, the number of eligible participants was reduced. Those continuing to work were harder to identify, as hospital clinics moved to remote delivery, and also to then screen, consent and treat, as the hospital research staff and clinical therapists were re-deployed. New recruitment and consent strategies were applied, and where sites had reduced capacity, responsibilities were absorbed by the trial management team. Remote intervention delivery and electronic data capture were also implemented. By rapidly adapting the WORKWELL protocol and procedures, the trial successfully reopened to recruitment in July 2020, only 4 months after the trial pause. We were able to achieve recruitment figures above the pre-COVID target and maintain a high retention rate. In addition, we found many of the protocol changes beneficial, as these streamlined trial procedures, thus improving efficiency. It is likely that many strategies implemented in response to the pandemic may become standard practice in future research within trials of a similar design and methodology.Trial registration: ClinicalTrials.gov NCT03942783 . Retrospectively registered on 08 May 2019. ISRCTN Registry ISRCTN61762297 . Retrospectively registered on 13 May 2019.

Assessing and ensuring fidelity of the nationally implemented English NHS diabetes prevention programme: lessons learned for the implementation of large-scale behaviour change programmes.

Background: Health services interventions are typically more effective in randomised controlled trials than in routine healthcare. One explanation for this 'voltage drop', i.e. reduction in effectiveness, is a reduction in intervention fidelity, i.e. the extent to which a programme is implemented as intended. This article discusses how to optimise intervention fidelity in nationally implemented behaviour change programmes, using as an exemplar the National Health Service Diabetes Prevention Programme (NHS-DPP); a behaviour change intervention for adults in England at increased risk of developing Type 2 diabetes, delivered by four independent provider organisations. We summarise key findings from a thorough fidelity evaluation of the NHS-DPP assessing design (whether programme plans were in accordance with the evidence base), training (of staff to deliver key intervention components), delivery (of key intervention components), receipt (participant understanding of intervention content), and highlight lessons learned for the implementation of other large-scale programmes. Results: NHS-DPP providers delivered the majority of behaviour change content specified in their programme designs. However, a drift in fidelity was apparent at multiple points: from the evidence base, during programme commissioning, and on to providers' programme designs. A lack of clear theoretical rationale for the intervention contents was apparent in design, training, and delivery. Our evaluation suggests that many fidelity issues may have been less prevalent if there was a clear underpinning theory from the outset. Conclusion: We provide recommendations to enhance fidelity of nationally implemented behaviour change programmes. The involvement of a behaviour change specialist in clarifying the theory of change would minimise drift of key intervention content. Further, as loss of fidelity appears notable at the design stage, this should be given particular attention. Based on these recommendations, we describe examples of how we have worked with commissioners of the NHS-DPP to enhance fidelity of the next roll-out of the programme.

'Finishing the race' - a cohort study of weight and blood glucose change among the first 36,000 patients in a large-scale diabetes prevention programme.

BACKGROUND: The NHS Diabetes Prevention Programme for England, "Healthier You", encourages behaviour change regarding healthy eating and physical exercise among people identified to be at high risk of developing type 2 diabetes. The aim of this research was to examine change, and factors associated with change, in measures of HbA1c and weight in participants and completers of the programme between 2016 and 2019. METHODS: Participant-level data collected by programme service providers on referrals prior to March 2018 was analysed. Changes from baseline to both 6 months and completion in HbA1c and weight were examined using mixed effects linear regression, adjusting for patient characteristics, service provider and site. RESULTS: Completers had average improvements in HbA1c of 2.1 mmol/mol [95% CI: - 2.2, - 2.0] (0.19% [95% CI: - 0.20, - 0.18]) and reductions of 3.6 kg [95% CI: - 3.6, - 3.5] in weight, in absolute terms. Variation across the four providers was observed at both time points: two providers had significantly smaller average reductions in HbA1c and one provider had a significantly smaller average reduction in weight compared to the other providers. At both time points, ex- or current smokers had smaller reductions in HbA1c than non-smokers and those from minority ethnic groups lost less weight than White participants. For both outcomes, associations with other factors were small or null and variation across sites remained after adjustment for provider and case mix. CONCLUSIONS: Participants who completed the programme, on average, experienced improvements in weight and HbA1c. There was substantial variation in HbA1c change and smaller variation in weight loss between providers and across different sites. Aside from an association between HbA1c change and smoking, and between weight loss and ethnicity, results were broadly similar regardless of patient characteristics.

Enhancing community weight loss groups in a low socioeconomic status area: Application of the COM-B model and Behaviour Change Wheel.

BACKGROUND: Obesity rates are higher among people of lower socioeconomic status. While numerous health behaviour interventions targeting obesity exist, they are more successful at engaging higher socioeconomic status populations, leaving those in less affluent circumstances with poorer outcomes. This highlights a need for more tailored interventions. The aim of this study was to enhance an existing weight loss course for adults living in low socioeconomic communities. METHODS: The Behaviour Change Wheel approach was followed to design an add-on intervention to an existing local authority-run weight loss group, informed by mixed-methods research and stakeholder engagement. RESULTS: The COM-B analysis of qualitative data revealed that changes were required to psychological capability, physical and social opportunity and reflective motivation to enable dietary goal-setting behaviours. The resulting SMART-C booklet included 6 weeks of dietary goal setting, with weekly behavioural contract and review. CONCLUSION: This paper details the development of the theory- and evidence-informed SMART-C intervention. This is the first report of the Behaviour Change Wheel being used to design an add-on tool to enhance existing weight loss services. The process benefitted from a further checking stage with stakeholders.

COVID-19 and the UK water sector: Exploring organizational responses through a resilience framework.

The unprecedented scale and impact of the COVID-19 pandemic have required organizations to adapt all facets of their operations. The impact on the UK water sector extends beyond engineering and treatment processes, with social, economic and environmental consequences. Semi-structured interviews were conducted with executives from 10 UK water companies to investigate the organizational response to the pandemic, and how their response impacted operational delivery. The Safe and SuRe framework was used to structure interview questions and analysis. Emergent themes of changes to customer behaviour, changes to operational practices and industry collaboration were mapped onto the framework and a ripple effect map developed. Lessons learnt highlight a failure to adequately prepare for the scale of the threat, the success of sector-level collaboration and a need to embrace new ways of working.