Inter-individual differences in the responses to pain neuroscience education in adults with chronic musculoskeletal pain: A systematic review and meta-analysis of randomised controlled trials.

Pain neuroscience education (PNE) is an approach used in the management of chronic musculoskeletal pain. Previous reviews on PNE and other pain interventions, have focused on mean treatment effects, but in the context of “precision medicine,” any inter-individual differences in treatment response are also important to quantify. If inter-individual differences are present, and predictors identified, PNE could be tailored to certain people for optimizing effectiveness. Such heterogeneity can be quantified using recently formulated approaches for comparing the response variance between the treatment and control groups. Therefore, we conducted a systematic review and meta-analysis on the extracted standard deviations of baseline-to-follow up change to quantify the inter-individual variation in pain, disability and psychosocial outcomes in response to PNE. Electronic databases were searched between January 1, 2002 and June 14, 2018. The review included 5 randomized controlled trials (n = 428) in which disability outcomes were reported. Using a random effects meta-analysis, the pooled SD (95% confidence interval) for control group-adjusted response heterogeneity to PNE was 7.36 units /100 (95% confidence interval = −3.93 to 11.12). The 95% prediction interval for this response heterogeneity SD was wide (−10.20 to 14.57 units /100). The control group-adjusted proportion of “responders” in the population who would be estimated to exceed a clinically important change of 10/100 ranged from 18 to 45%. Therefore, when baseline-to-follow up random variability in disability is taken into account (informed by the control arm), there is currently insufficient evidence for the notion of clinically important inter-individual differences in disability responses to PNE in people with chronic musculoskeletal pain. The protocol was published on PROSPERO (CRD42017068436). Perspective: We bring a novel method to pain science for calculating inter-individual differences in response to a treatment. This is conductedwithin the context of a systematic review and meta-analysis on PNE. We highlight how using erroneous methods for calculating inter-individual differences can drastically change conclusions when compared to appropriate methods.</p

The benefits and challenges of using crowdfunding to facilitate community-led projects in the context of digital civics

Digital technology is increasingly being used to bring citizens and communities together to address local concerns. While a variety of approaches have been developed that allow citizens and communities to improve their local communities, these approaches are often financially unsustainable. In this paper, we describe our exploration of crowdfunding as an alternative approach to funding and sustaining community-led projects in the context of digital civics. Through our analysis of four community-led crowdfunding projects, we explore the merits of crowdfunding in this context, demonstrating that it can a) provide an alternative funding mechanism suitable for financing some community-led projects, b) create a sense of empowerment and ownership, and c) increase community awareness. By reflecting on our experiences, we identify four key challenges to utilising crowdfunding to support community-led projects in the context digital civics. We also provide advice specific to crowdfunding in the context of digital civics, before discussing the role of crowdfunding within digital civics. By addressing these challenges, we will be able to better support community groups crowdfund for the public good

Glucose Lowering through Weight management (GLoW): a randomised controlled trial of the clinical and cost effectiveness of a diabetes education and behavioural weight management programme vs a diabetes education programme in adults with a recent diagnosis of type 2 diabetes

UK standard care for type 2 diabetes is structured diabetes education, with no effects on HbA , small, short-term effects on weight and low uptake. We evaluated whether remotely delivered tailored diabetes education combined with commercial behavioural weight management is cost-effective compared with current standard care in helping people with type 2 diabetes to lower their blood glucose, lose weight, achieve remission and improve cardiovascular risk factors. We conducted a pragmatic, randomised, parallel two-group trial. Participants were adults (≥18 years) with overweight or obesity (BMI≥25 kg/m ) and recently diagnosed with type 2 diabetes (≤3 years), recruited from 159 primary care practices in England. We randomised participants to a tailored diabetes education and behavioural weight management programme (DEW; delivered by Weight Watchers) or to current standard care diabetes education (DE; Diabetes Education and Self Management for Ongoing and Newly Diagnosed [DESMOND] programme), using a computer-generated randomisation sequence in a 1:1 allocation stratified by gender and diabetes duration, unknown to those collecting and analysing the data. Participants could not be blinded due to the nature of the interventions. Participants completed assessments at 0, 6 and 12 months. The primary outcome was 12 month change from baseline in HbA . We also assessed bodyweight, blood pressure, cholesterol (total, HDL, LDL), glucose-lowering medication, behavioural measures (physical activity, food intake), psychosocial measures (eating behaviour, diabetes-related quality of life, wellbeing) and within-trial and modelled lifetime cost effectiveness. We randomised 577 participants (DEW: 289, DE: 288); 398 (69%) completed 12 month follow-up. We found no evidence for an intervention effect on change in HbA from baseline to 12 months (difference: -0.84 [95% CI -2.99, 1.31] mmol/mol, p=0.44) or 6 months (-1.83 [-4.05, 0.40] mmol/mol). We found an intervention effect on weight at 6 (-1.77 [-2.86, -0.67] kg) and 12 months (-1.38 [-2.56, -0.19] kg). Participants in DEW had a higher likelihood of achieving diabetes remission than participants in DE (6 months: RR 2.10 [95% CI 1.03, 4.47]; 12 months: RR 2.53 [1.30, 5.16]). DEW was cost-effective compared with DE in within-trial and lifetime analyses, in the latter generating an incremental cost effectiveness ratio of £2290 per quality-adjusted life year gained. A commercial behavioural weight management programme combined with remote dietary counselling after diagnosis of type 2 diabetes did not improve HbA up to 12 months post intervention in this trial. The intervention could help people achieve weight loss and be cost-effective compared with current standard National Health Service care. ISRCTN 18399564 FUNDING: National Institute for Health and Care Research (NIHR; RP-PG-0216-20010), Medical Research Council (MC_UU_00006/6), NIHR Cambridge Biomedical Research Centre (NIHR203312)

Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial.

There is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention. WRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150. Between Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention. Although the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving. The UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council

An Acceptance-Based Guided Self-Help Program for Weight Loss Maintenance in Adults Who Have Previously Completed a Behavioral Weight Loss Program: The SWiM Feasibility Study

Most weight lost during weight-loss programmes is eventually regained. Interventions based on Acceptance and Commitment Therapy (ACT) demonstrate good evidence for long-term weight loss, but are often costly and difficult to scale up. Guided self-help programmes delivered using technology and non-specialist coaches could increase scalability, but it is unclear whether delivering ACT-based interventions in this way is feasible and acceptable. In this feasibility study, 61 people who recently completed a behavioral weight management intervention (BWMI) for weight management were randomly allocated to SWiM ("Supporting Weight Management": 4-month digital guided self-help ACT-based intervention for weight loss maintenance) or a standard care group (leaflet about maintaining weight loss) using a 2:1 allocation ratio. At baseline and 6 months, participants completed measures of weight, mental health, eating behavior, and other psychosocial variables. Participants completed an intervention evaluation questionnaire. At 3 and 6 months, qualitative interviews were conducted with participants from both trial arms and SWiM coaches. The analysis integrated statistics and thematic analysis, informed by the Medical Research Council (MRC) framework for process evaluations. Since this was a feasibility study, analyses focused on process outcomes instead of interpreting statistical significance. Eighty-eight percent (36/41) of participants allocated to SWiM completed at least the first session and 22 (54%) completed all sessions. At 6 months, mean weight change was -2.2 (+/-6.4 SD) kg in SWiM participants and +2.2 (+/-6.6) kg in standard care participants. Descriptively, eating behavior and mental health scores improved in SWiM participants but not in standard care participants. In interviews, SWiM participants noted that they reinforced their existing knowledge while acquiring new skills and strategies, which were felt to contribute to positive behavioral changes. The SWiM intervention is practical and well-received, and shows promise in supporting weight loss maintenance, though evaluation in a larger trial is needed to assess effectiveness

Acceptability and feasibility of an acceptance and commitment therapy-based guided self-help intervention for weight loss maintenance in adults who have previously completed a behavioural weight loss programme: the SWiM feasibility study protocol.

INTRODUCTION: The cost-effectiveness and long-term health impact of behavioural weight management programmes depends on post-treatment weight-loss maintenance. Growing evidence suggests that interventions using acceptance and commitment therapy (ACT) could improve long-term weight management. We developed an ACT-based, guided self-help intervention to support adults who have recently completed a behavioural weight loss programme. This study will assess the feasibility and acceptability of this type of intervention and findings will inform the development of a full-scale trial. METHODS AND ANALYSIS: This is a pragmatic, randomised, single-blind, parallel group, two-arm, feasibility study with an embedded process evaluation. We will recruit and randomise 60 adults who have recently completed a behavioural weight loss programme to the ACT-based intervention or standard care, using a computer-generated sequence with 2:1 allocation stratified by diabetes status and sex. Baseline and 6-month measurements will be completed using online questionnaires. Qualitative interviews will be conducted with a subsample of participants and coaches about their experiences at 3 (mid-intervention) and 6 (postintervention) months. Feasibility and acceptability of the intervention, and a full-scale trial will be assessed using a number of outcomes, including adherence to, and engagement with the intervention, recruitment and retention rates, proportion of missing data for each outcome measure, participants' experiences of the intervention and study, and coaches' experiences of delivering intervention support. Quantitative and qualitative findings will be integrated and summarised to contribute to the interpretation of the main feasibility evaluation findings. Value of information methods will be used to estimate the decision uncertainty associated with the intervention's cost-effectiveness and determine the value of a definitive trial. ETHICS AND DISSEMINATION: Ethical approval was received from Cambridge South Research Ethics Committee on 15/03/2021 (21/EE/0024). This protocol (V.2) was approved on 19 April 2021. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN12685964.This study was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0216-20010). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care

Acceptability and feasibility of an acceptance and commitment therapy-based guided self-help intervention for weight loss maintenance in adults who have previously completed a behavioural weight loss programme: the SWiM feasibility study protocol.

INTRODUCTION: The cost-effectiveness and long-term health impact of behavioural weight management programmes depends on post-treatment weight-loss maintenance. Growing evidence suggests that interventions using acceptance and commitment therapy (ACT) could improve long-term weight management. We developed an ACT-based, guided self-help intervention to support adults who have recently completed a behavioural weight loss programme. This study will assess the feasibility and acceptability of this type of intervention and findings will inform the development of a full-scale trial. METHODS AND ANALYSIS: This is a pragmatic, randomised, single-blind, parallel group, two-arm, feasibility study with an embedded process evaluation. We will recruit and randomise 60 adults who have recently completed a behavioural weight loss programme to the ACT-based intervention or standard care, using a computer-generated sequence with 2:1 allocation stratified by diabetes status and sex. Baseline and 6-month measurements will be completed using online questionnaires. Qualitative interviews will be conducted with a subsample of participants and coaches about their experiences at 3 (mid-intervention) and 6 (postintervention) months. Feasibility and acceptability of the intervention, and a full-scale trial will be assessed using a number of outcomes, including adherence to, and engagement with the intervention, recruitment and retention rates, proportion of missing data for each outcome measure, participants' experiences of the intervention and study, and coaches' experiences of delivering intervention support. Quantitative and qualitative findings will be integrated and summarised to contribute to the interpretation of the main feasibility evaluation findings. Value of information methods will be used to estimate the decision uncertainty associated with the intervention's cost-effectiveness and determine the value of a definitive trial. ETHICS AND DISSEMINATION: Ethical approval was received from Cambridge South Research Ethics Committee on 15/03/2021 (21/EE/0024). This protocol (V.2) was approved on 19 April 2021. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN12685964.This study was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0216-20010). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care

Acceptability and feasibility of an acceptance and commitment therapy-based guided self-help intervention for weight loss maintenance in adults who have previously completed a behavioural weight loss programme: the SWiM feasibility study protocol

IntroductionThe cost-effectiveness and long-term health impact of behavioural weight management programmes depends on post-treatment weight-loss maintenance. Growing evidence suggests that interventions using acceptance and commitment therapy (ACT) could improve long-term weight management. We developed an ACT-based, guided self-help intervention to support adults who have recently completed a behavioural weight loss programme. This study will assess the feasibility and acceptability of this type of intervention and findings will inform the development of a full-scale trial.Methods and analysisThis is a pragmatic, randomised, single-blind, parallel group, two-arm, feasibility study with an embedded process evaluation. We will recruit and randomise 60 adults who have recently completed a behavioural weight loss programme to the ACT-based intervention or standard care, using a computer-generated sequence with 2:1 allocation stratified by diabetes status and sex. Baseline and 6-month measurements will be completed using online questionnaires. Qualitative interviews will be conducted with a subsample of participants and coaches about their experiences at 3 (mid-intervention) and 6 (postintervention) months. Feasibility and acceptability of the intervention, and a full-scale trial will be assessed using a number of outcomes, including adherence to, and engagement with the intervention, recruitment and retention rates, proportion of missing data for each outcome measure, participants’ experiences of the intervention and study, and coaches’ experiences of delivering intervention support. Quantitative and qualitative findings will be integrated and summarised to contribute to the interpretation of the main feasibility evaluation findings. Value of information methods will be used to estimate the decision uncertainty associated with the intervention’s cost-effectiveness and determine the value of a definitive trial.Ethics and disseminationEthical approval was received from Cambridge South Research Ethics Committee on 15/03/2021 (21/EE/0024). This protocol (V.2) was approved on 19 April 2021. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration numberISRCTN12685964.</jats:sec

Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial

BackgroundThere is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention.MethodsWRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150.FindingsBetween Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention.InterpretationAlthough the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving.FundingThe UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council

Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial.

BACKGROUND: There is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention. METHODS: WRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention. INTERPRETATION: Although the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving. FUNDING: The UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council.Five year follow up of the WRAP trial was funded by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0216-20010). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The WRAP trial was funded by the National Prevention Research Initiative through the Medical Research Council (MRC) grant MR/J000493. WW (formerly Weight Watchers) provided the intervention at no cost via an MRC Industrial Collaboration Award. ALA, SJG, and SJS are supported by the Medical Research Council (MRC) (Grant MC_UU_00006/6). The University of Cambridge has received salary support in respect of SJG from the National Health Service in the East of England through the Clinical Academic Reserve. PA and SAJ are funded by the NIHR Oxford Biomedical Research Centre and NIHR Oxford and Thames Valley Applied Research Collaboration. PA is an NIHR senior investigator