Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

INTRODUCTION: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation. METHODS AND ANALYSIS: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022. TRIAL REGISTRATION NUMBER: ISRCTN11499185.

Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study.

INTRODUCTION: Over the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care. METHODS AND ANALYSIS: Economic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model's states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention. ETHICS AND DISSEMINATION: Full ethics approval was granted by Yorkshire & The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

Cost-Effectiveness and Value of Information Analysis of Brief Interventions to Promote Physical Activity in Primary Care.

BACKGROUND: Brief interventions (BIs) delivered in primary care have shown potential to increase physical activity levels and may be cost-effective, at least in the short-term, when compared with usual care. Nevertheless, there is limited evidence on their longer term costs and health benefits. OBJECTIVES: To estimate the cost-effectiveness of BIs to promote physical activity in primary care and to guide future research priorities using value of information analysis. METHODS: A decision model was used to compare the cost-effectiveness of three classes of BIs that have been used, or could be used, to promote physical activity in primary care: 1) pedometer interventions, 2) advice/counseling on physical activity, and (3) action planning interventions. Published risk equations and data from the available literature or routine data sources were used to inform model parameters. Uncertainty was investigated with probabilistic sensitivity analysis, and value of information analysis was conducted to estimate the value of undertaking further research. RESULTS: In the base-case, pedometer interventions yielded the highest expected net benefit at a willingness to pay of £20,000 per quality-adjusted life-year. There was, however, a great deal of decision uncertainty: the expected value of perfect information surrounding the decision problem for the National Health Service Health Check population was estimated at £1.85 billion. CONCLUSIONS: Our analysis suggests that the use of pedometer BIs is the most cost-effective strategy to promote physical activity in primary care, and that there is potential value in further research into the cost-effectiveness of brief (i.e., <30 minutes) and very brief (i.e., <5 minutes) pedometer interventions in this setting.

Community health workers can identify and manage possible infections in neonates and young infants: MINI--a model from Nepal.

The mortality rates of infants and children aged less than five years are declining globally and in Nepal but less among neonates. Most deliveries occur at home without skilled attendants, and most neonates may not receive appropriate care through the existing medical systems. So, a community-based pilot programme-Morang Innovative Neonatal Intervention (MINI) programme-was implemented in Morang district of Nepal to see the feasibility of bringing the management of sick neonates closer to home. The objective of this model was to answer the question: "Can a team of female community health volunteers and paid facility-based community health workers (collectively called CHWs) within the existing heath system correctly follow a set of guidelines to identify possible severe bacterial infection in neonates and young infants and successfully deliver their treatment?" In the MINI model, the CHWs followed an algorithm to classify sick young infants with possible severe bacterial infection (PSBI). Female Community Health Volunteers (FCHVS) were trained to visit homes soon after delivery, record the birth, counsel mothers on essential newborn care, and assess the newborns for danger-signs. Infants classified as having PSBI, during this or subsequent contacts, were treated with co-trimoxazole and referred to facility-based CHWs for seven-day treatment with injection gentamicin. Additional supervisory support was provided for quality of care and intensified monitoring. Of 11,457 livebirths recorded during May 2005-April 2007, 1,526 (13.3%) episodes of PSBI were identified in young infants. Assessment of signs by the FCHVs matched that of more highly-trained facility-based CHWs in over 90% of episodes. Treatment was initiated in 90% of the PSBI episodes; 93% completed a full course of gentamicin. Case fatality in those who received treatment with gentamicin was 1.5% [95% confidence interval (CI) 1.0-2.3] compared to 5.3% (95% CI 2.6-9.7) in episodes that did not receive any treatment. Within the existing government health infrastructure, the CHWs can assess and identify possible infections in neonates and young infants and deliver appropriate treatment with antibiotics. This will result in improvement in the likelihood of survival and address one of the main causes of neonatal mortality.