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BackgroundMusculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. ObjectiveThis study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. MethodsThis is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain–related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. ResultsTrial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. ConclusionsThis trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. Trial RegistrationISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. International Registered Report Identifier (IRRID)DERR1-10.2196/17939

Objectives: To explore physiotherapists' experiences and perceived acceptability of delivering a bracing intervention for knee osteoarthritis (OA) in the 'PROvision of braces for Patients with knee OA' (PROP OA) randomised controlled trial. Method: Semi‐structured telephone interviews with consenting physiotherapists who received the PROP OA training programme and delivered the knee bracing intervention (advice, information and exercise instruction plus knee brace matched to patients' clinical and radiographic presentation and with adherence support). Interviews were recorded and transcribed verbatim. Two‐stage analytic framework: inductive thematic analysis preceded mapping to constructs of the Theoretical Framework of Acceptability. Results: Eight physiotherapists were interviewed and six key themes were developed. Perceptions of the training programme were generally positive, but additional formal training and experiential learning consolidated confidence and skills in novel intervention components. Advice, information, and exercise instruction reflected usual physiotherapy care for knee OA. Physiotherapists were confident in delivering the knee brace, but determining the pattern of knee OA to inform brace type selection was challenging. Physiotherapists valued brace adherence enhancing strategies and the follow‐up appointment to facilitate adherence. Perceived impact of the bracing intervention for people with OA was positive. The bracing intervention was perceived as acceptable, although improving self‐efficacy to deliver novel intervention components (e.g., reading x‐rays) would enhance acceptability. Conclusion: The complex knee bracing intervention was broadly perceived as acceptable by physiotherapists. If implemented within clinical practice beyond the trial, physiotherapists might benefit from not only initial training in brace selection but also ongoing support and mentoring to increase self‐efficacy in delivery. [ABSTRACT FROM AUTHOR]

Introduction: Economic evaluation using decision analytical models (DAMs) plays a limited role in shaping healthcare resource optimization and reimbursement decisions in the Middle East. This review aimed to systematically examine economic evaluation studies focusing on DAMs of medicines in the Middle East, defining methodological characteristics and appraising the quality of the identified models. Methods: Six databases were searched (MEDLINE, Embase, EconLit, Web of Science, the Global Health Cost-Effectiveness Analysis Registry, and the Global Index Medicus) from 1998 to September 2023 to identify published DAMs of medicines in the Middle East. Studies meeting the inclusion criteria—full economic evaluations of medicines using a model-based method in the Middle East—were included. Data were extracted and tabulated to include study characteristics and methodological specifications. The results were analyzed narratively. The Philips checklist was used to assess the quality of the studies. Results: Sixty-two DAM studies of medicines were identified from nine Middle Eastern countries, the majority of which (76%) were conducted in Iran, Turkey, and Saudi Arabia. The cost effectiveness of medications for non-communicable diseases was explored in 70 percent of the models. Cost-effectiveness thresholds based on gross domestic product were commonly used. International sources provided data on intervention effectiveness and health outcomes, while national sources were mainly used for the costs of resource use. Most models incorporated an assessment of parameter uncertainty, whereas other types of uncertainty were not explored. Studies from high-income countries were generally of higher quality than those from middle-income countries. Conclusions: The number of published DAMs was low considering the available medicines and disease burden. Key aspects of high quality DAMs regarding model structure, input sources, and uncertainty assessment were not consistently fulfilled. Recommendations for future studies and policies included strengthening existing health economic capacities, establishing country-specific health technology assessment systems, and initiating collaborations to generate national cost and outcome data. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. Methods Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. Results Over 6 months, the mean (s. d.) total health-care (National Health Service and private) costs associated with the low, medium, and high-risk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium- and low-risk subgroups. Conclusions This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs. [ABSTRACT FROM AUTHOR]