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.

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.

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.

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.

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.

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.

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.

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.

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.

'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.

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.

A natural experimental study of improvements along an urban canal: impact on canal usage, physical activity and other wellbeing behaviours.

BACKGROUND: There are few robust natural experimental studies of improving urban green spaces on physical activity and wellbeing. The aim of this controlled natural experimental study was to examine the impact of green space improvements along an urban canal on canal usage, physical activity and two other wellbeing behaviours (social interactions and taking notice of the environment) among adults in Greater Manchester, UK. The intervention included resurfaced footpaths, removal of encroaching vegetation, improved entrances, new benches and signage. METHODS: Two comparison sites were matched to the intervention site using a systematic five-step process, based on eight correlates of physical activity at the neighbourhood (e.g. population density) and site (e.g. lighting) levels. Outcomes were assessed using systematic observations at baseline, and 7, 12 and 24 months post-baseline. The primary outcome was the change in the number of people using the canal path from baseline to 12 months. Other outcomes were changes in physical activity levels (Sedentary, Walking, Vigorous), Connect and Take Notice behaviours. Data were analysed using multilevel mixed-effects negative binomial regression models, comparing outcomes in the intervention group with the matched comparison group, controlling for day, time of day and precipitation. A process evaluation assessed potential displacement of activity from a separate existing canal path using intercept surveys and observations. RESULTS: The total number of people observed using the canal path at the intervention site increased more than the comparison group at 12 months post-baseline (IRR 2.10, 95% CI 1.79-2.48); there were similar observed increases at 7 and 24 months post-baseline. There was some evidence that the intervention brought about increases in walking and vigorous physical activity, social interactions, and people taking notice of the environment. The process evaluation suggested that there was some displacement of activity, but the intervention also encouraged existing users to use the canal more often. CONCLUSIONS: Urban canals are promising settings for interventions to encourage green space usage and potentially increase physical activity and other wellbeing behaviours. Interventions that improve access to green corridors along canals and provide separate routes for different types of physical activities may be particularly effective and warrant further research. STUDY PROTOCOL: Study protocol published in Open Science Framework in July 2018 before the first follow-up data collection finished ( https://osf.io/zcm7v ). Date of registration: 28 June 2018.

Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis.

BACKGROUND: Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. METHODS: A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0-10) at 12 weeks, analysed using linear regression and intention to treat principles. RESULTS: Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: - 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. CONCLUSION: The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. FUNDING: National Institute for Health Research. TRIAL REGISTRATION: ISRCTN, ISRCTN25892131 ; Registered 05/09/2016: retrospectively registered.

The NHS Diabetes Prevention Programme: an observational study of service delivery and patient experience.

BACKGROUND: The NHS Diabetes Prevention Programme (NHS-DPP) is a nine-month, group-based behavioural intervention for adults in England at risk of developing Type 2 diabetes. Four independent providers were commissioned to deliver versions of the NHS-DPP, in line with NHS England specifications. This observational study maps NHS-DPP delivery in routine practice against the NHS specification, and compares service delivery with observed patient experiences. METHODS: Researchers observed service delivery across eight complete NHS-DPP courses (118 sessions, median 14 sessions per course), consenting 455 participants (36 staff, 398 patients, 21 accompanying persons). Key features of NHS-DPP delivery were described using the Template for Intervention Description and Replication (TIDieR) framework. Researchers wrote detailed field notes during each session, including observations of patient experience. Field notes were content analysed; instances of positive and negative experiences were labelled and grouped into categories. Researchers used a novel method of comparing observed patient experiences to variations in programme delivery. RESULTS: Delivery broadly followed NHS England's specification and the plans set out by providers. Deviations included the scheduling and larger group sizes in some sessions. There was variation in the type and format of activities delivered by providers. Positive patient experiences included engagement, satisfaction with the programme, good within-group relationships and reported behavioural changes. Negative experiences included poor scheduling, large groups, and dissatisfaction with the venue. Where more interactive and visual activities were delivered in smaller groups of 10-15 people with good rapport, there were generally more instances of positive patient experiences, and where there were structural issues such as problems with the scheduling of sessions, poor venues and inadequate resources, there tended to be more negative patient experiences. CONCLUSIONS: Addressing issues that we have identified as being linked to negative experiences with the NHS-DPP could increase uptake, reduce patient drop-out and increase the overall effectiveness of the programme. In particular, modifying structural aspects of the NHS-DPP (e.g. reliable session scheduling, reducing group sizes, enough session resources) and increasing interaction appear particularly promising for improving these outcomes.

The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial).

BACKGROUND: Work problems are common in people with inflammatory arthritis. Up to 50% stop work within 10 years due to their condition and up to 67% report presenteeism (i.e. reduced work productivity), even amongst those with low disease activity. Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations. This aims to create a better match between the person's abilities and their job demands. The objectives of the Workwell trial are to test the overall effectiveness and cost-effectiveness of JRVR (WORKWELL) provided by additionally trained National Health Service (NHS) occupational therapists compared to a control group who receive self-help information both in addition to usual care. METHODS: Based on the learning from a feasibility trial (the WORK-IA trial: ISRCTN76777720 ), the WORKWELL trial is a multi-centre, pragmatic, individually-randomised parallel group superiority trial, including economic evaluation, contextual factors analysis and process evaluation. Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18 years or older with work instability will be randomised to one of two groups: a self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care. WORKWELL will be delivered by occupational therapists provided with additional JRVR training from the research team. The primary outcome is presenteeism as measured using the Work Limitations Questionnaire-25. A comprehensive range of secondary outcomes of work, health, contextual factors and health resource use are included. Outcomes are measured at 6- and 12- months (with 12-months as the primary end-point). A multi-perspective within-trial cost-effectiveness analyses will also be conducted. DISCUSSION: This trial will contribute to the evidence base for provision of JRVR to people with inflammatory arthritis. If JRVR is found to be effective in enabling people to keep working, the findings will support decision-making about provision of JRVR by rheumatology teams, therapy services and healthcare commissioners, and providing evidence of the effectiveness of JRVR and the economic impact of its implementation. TRIAL REGISTRATION: Clinical Trials.Gov: NCT03942783 . Registered 08/05/2019 ( https://clinicaltrials.gov/ct2/show/NCT03942783 ); ISRCTN Registry: ISRCTN61762297 . Registered:13/05/2019 ( http://www.isrctn.com/ISRCTN61762297 ). Retrospectively registered.

The effect of commitment-making on weight loss and behaviour change in adults with obesity/overweight; a systematic review.

BACKGROUND: Adherence to weight loss interventions is crucial to successful outcomes, yet little is known about how best to improve it. This suggests a need for developing and improving adherence strategies, such as formal commitments. This review aims to identify the effect of including a commitment device alongside lifestyle interventions on weight loss, and identify the most appropriate delivery mechanisms and target behaviours. METHODS: We searched five databases and hand-searched reference lists for trials of behavioural interventions to achieve weight loss among adults with excess weight or obesity. Interventions incorporating commitment devices were included in a narrative review and meta-analysis where appropriate. Commitment devices with financial incentives were excluded. RESULTS: Of 2675 unique studies, ten met the inclusion criteria. Data from three randomised trials including 409 participants suggests that commitment interventions increases short-term weight loss by a mean of 1.5 kg (95% CI: 0.7, 2.4). Data from two randomised trials including 302 patients suggests that benefits were sustained at 12 months (mean difference 1.7 kg; 95% CI: 0.0, 3.4). Commitment devices appeared most successful when made publicly, and targeting diet rather than physical activity. CONCLUSIONS: Using commitment devices, such as behavioural contracts, as part of a weight loss intervention may be useful in improving weight loss outcomes and dietary changes, at least in the short-term. However, evidence is limited and of variable quality so results must be interpreted with caution. Poor reporting of intervention details may have limited the number of identified studies. More rigorous methodology and longer term follow-ups are required to determine the effectiveness of behavioural contracts given their potential for use in public health interventions.

Referral of patients to diabetes prevention programmes from community campaigns and general practices: mixed-method evaluation using the RE-AIM framework and Normalisation Process Theory.

BACKGROUND: Each year around 5-10% of people with non-diabetic hyperglycaemia will develop type 2 diabetes mellitus. Diabetes prevention is a national and global public health concern. Diabetes Prevention Programmes, which seek to identify at-risk individuals and support entry to health improvement initiatives, recognise that enhanced identification and referral of at-risk individuals is required within primary care and beyond, through community-focused prevention approaches. We report an evaluation of a demonstrator site for the NHS Diabetes Prevention Programme in the UK, which piloted an enhanced Primary Care referral programme (sampling from patients identified as at-risk from general practice databases) and a Community identification programme (sampling from the general population through opportunistic identification in community locations) in an effort to maximise participation in prevention services. METHODS: We used mixed-methods evaluation to assess the impact of the two referral routes on participation in the Diabetes Prevention Programmes in line with the RE-AIM Framework (Reach, Effectiveness, Adoption, Implementation and Maintenance). Individual level patient data was descriptively analysed to assess identifications and eligible referrals made in each route. Semi-structured interviews conducted with referral staff and key stakeholders were analysed using thematic analysis and informed by Normalisation Process Theory. RESULTS: The nurse facilitated primary care referral route provided 88% of all referrals to the telephone DPP, compared to the community referral route which provided 5%, and the proportion joining the programme was higher among primary care referrals (45%) than community referrals (22%), and retention rates were higher (73% compared to 50%). The nurse-facilitated route integrated more easily into existing clinical processes. The community programme was impeded by a lack of collaborative inter-agency working which obscured the intended focus on high-risk populations despite conversion rates (numbers identified at risk who entered prevention programmes) being highest in areas of high deprivation. CONCLUSIONS: The study demonstrates the interaction of components, with effective Adoption and Implementation necessary to support Reach. The NPT analysis demonstrated the importance of consensus around not only the need for such programmes but agreement on how they can be delivered. Future programmes should support inter-agency communication and collaboration, and focus identification efforts on areas of high-risk.