Natalia Hounsome

An evaluation of the effectiveness and cost effectiveness of the National Exercise Referral Scheme in Wales, UK: a randomised controlled trial of a public health policy initiative.

Background The Wales National Exercise Referral Scheme (NERS) is a 16-week programme including motivational interviewing, goal setting and relapse prevention. Method A pragmatic randomised controlled trial with nested economic evaluation of 2160 inactive participants with coronary heart disease risk (CHD, 1559, 72%), mild to moderate depression, anxiety or stress (79, 4%) or both (522, 24%) randomised to receive (1) NERS or (2) normal care and brief written information. Outcome measures at 12 months included the 7-day physical activity recall, the hospital anxiety and depression scale. Results Ordinal regression identified increased physical activity among those randomised to NERS compared with those receiving normal care in all participants (OR 1.19, 95% CI 0.99 to 1.43), and among those referred for CHD only (OR 1.29, 95% CI 1.04 to 1.60). For those referred for mental health reason alone, or in combination with CHD, there were significantly lower levels of anxiety (OR −1.56, 95% CI −2.75 to −0.38) and depression (OR −1.39, 95% CI −2.60 to −0.18), but no effect on physical activity. The base-case incremental cost-effectiveness ratio was £12 111 per quality adjusted life year, falling to £9741 if participants were to contribute £2 per session. Conclusions NERS was effective in increasing physical activity among those referred for CHD risk only. Among mental health referrals, NERS did not influence physical activity but was associated with reduced anxiety and depression. Effects were dependent on adherence. NERS is likely to be cost effective with respect to prevailing payer thresholds. Trial registration Current Controlled Trials ISRCTN47680448.

Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence

Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI). Percutaneous tibial nerve stimulation (PTNS) is a newer, less invasive, treatment. The effectiveness and acceptability of these treatments have not been compared systematically.

Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

Objectives To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees’ well-being and reduce sickness absence. Methods The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence <21 days from human resources. 35 in-depth interviews were undertaken with key informants, managers and employees, and additional observational data collected. Results 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4–49.0 in the control (n=59) and 51.0–49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI −3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers’ and employees’ experiences of it. Conclusions A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. Trial Registration number ISRCTN58661009.

Novel three-day, community-based, nonpharmacological group intervention for chronic musculoskeletal pain (COPERS): a randomised clinical trial

Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference −1.0, intervention versus control, 95% CI −4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (−0.7, 95% CI −1.2 to −0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US

Faecal incontinence intervention study (FINS): self-management booklet information with or without nurse support to improve continence in people with inflammatory bowel disease: study protocol for a randomized controlled trial

214). The cost–utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI −0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e., £188 [US

Opioid prescribing for chronic musculoskeletal pain in UK primary care: results from a cohort analysis of the COPERS trial.

277], 95% CI −£125 [−US

Developing core economic outcome sets for asthma studies: a protocol for a systematic review.

184] to £501 [US

Testing the assertion that ‘local food is best’: the challenges of an evidence-based approach

738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US

EQ-5D as a quality of life measure in people with dementia and their carers: evidence and key issues.

8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. Conclusions While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. Trial registration ISRCTN Registry 24426731

Psychological Morbidity of Farmers and Non-farming Population: Results from a UK Survey

BackgroundInflammatory bowel disease, comprising Crohn’s disease and ulcerative colitis, is a life-long currently incurable illness. It causes bouts of acute intestinal inflammation, in an unpredictable relapsing-remitting course, with bloody diarrhoea and extreme urgency to access a toilet. Faecal incontinence is a devastating social and hygiene problem, impacting heavily on quality of life and ability to work and socialise. Faecal incontinence affects 2–10 % of adults in the general population. People with inflammatory bowel disease have a high risk of incontinence with up to 74 % affected. No previous study has explored conservative interventions for these patients.MethodsThis randomised controlled trial will recruit 186 participants to answer the research question: does implementation of the UK nationally recommended guidance approach to stepwise management of faecal incontinence improve bowel control and quality of life in people with inflammatory bowel disease? We have worked with people with inflammatory bowel disease to translate this guidance into a condition-specific information booklet on managing incontinence. We will randomise participants to receive the booklet, or the booklet plus up to four 30-minute sessions with an inflammatory bowel disease specialist nurse. To be eligible, patients must be in disease remission and report incontinence. The primary outcome measure at 6 months after randomisation is the St Mark’s incontinence score. Other outcomes include quality of life, MY-MOP (generic tool: participants set two goals for intervention, grading goals at baseline and then re-scoring after intervention) and EQ-5D-5 L to enable calculation of quality-adjusted life years. Analysis will be on an intention-to-treat basis. Qualitative interviews will explore participant and health professionals’ views on the interventions.DiscussionFew high-quality studies of conservative interventions in inflammatory bowel disease, and none for faecal incontinence, have been conducted. We have collaborated with patients to design this study. Blinding to this behavioural intervention is not possible, but our self-report outcome measures with a degree of objectivity. There is genuine equipoise between the booklet only and booklet plus nurse arms, and the study will determine if additional support from a nurse is a crucial element in implementing advice.Trial registrationclinitrials.gov.uk: NCT02355834 (Date of registration: 12 December 2014).Protocol version: 4.0. 08.04.15