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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

Abstract Background There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. Methods This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. Results Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. Conclusions Our results contribute to understanding the economics of low back- related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. Trial registration 13/09/2011 Retrospectively registered; ISRCTN62880786.

Objectives: The Hip Injection Trial (HIT) compared the effectiveness of adding a single ultrasound‐guided intra‐articular injection of either corticosteroid and local anaesthetic or local anaesthetic alone to advice and education among people with hip osteoarthritis (OA). This nested qualitative study explored participants' experiences of living with hip OA and of the trial treatment they received. Method: Semi‐structured telephone interviews were undertaken with a purposeful sample of trial participants after a 2‐month trial follow‐up. Interviewers were blinded to which injection participants had received. Thematic analysis using constant comparison was undertaken prior to knowing the trial results. Results: 34 trial participants were interviewed across all arms. OA causes pain, physical limitations, difficulties at work, lowered mood, and disrupted sleep. Those who received advice and education alone felt that they had not received 'treatment' and described little/no benefit. Participants in both injection groups described marked improvements in pain, physical function, and other aspects of life (e.g., sleep, confidence). The perceived magnitude of benefit appeared greater among those who received the corticosteroid injection; however, the length of benefit varied in both injection groups. There was uncertainty about the longer‐term benefits of injection and repeated injections. Conclusion: Hip OA is highly burdensome. Participants perceived little/no benefit from advice and education alone but reported marked improvements when combined with either injection. However, the magnitude of benefit was greater among those who received corticosteroid. The varying duration of response to injection and uncertainty regarding longer‐term benefits of injection and repeated injections suggests that these areas are important for future research. Trial registration: EudraCT 2014‐003412‐37; ISRCTN50550256. [ABSTRACT FROM AUTHOR]

A human tumor necrosis factor (TNF) binding protein from serum of cancer patients was purified to homogeneity and partially sequenced. Synthetic DNA probes based on amino acid sequence information were used to isolate cDNA clones encoding a receptor for TNF. The TNF receptor (TNF-R) is a 415 amino acid polypeptide with a single membrane-spanning region. The extracellular cysteine-rich domain of the TNF-R is homologous to the nerve growth factor receptor and the B cell activation protein Bp50. Human embryonic kidney cells transfected with a TNF-R expression vector specifically bind both 125I-labeled and biotinylated TNF-alpha. Unlabeled TNF-alpha and TNF-beta were equally effective at displacing the binding of labeled TNF-alpha to TNF-R expressing cells. Northern analysis indicates a single species of mRNA for the TNF-R in a variety of cell types. Therefore, the soluble TNF binding protein found in human serum is probably proteolytically derived from the TNF-R.

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]

Introduction: High quality data on service performance is essential in healthcare to evidence efficacy, efficiency, and value. There remains a paucity of publicly reported data in community and primary care musculoskeletal (MSK) services. There is also a lack of guidance on which metrics MSK services should be collecting and reporting, and how this data could be used to directly improve patient outcomes, experiences, and value. Method: A narrative review of the evidence around benchmarking MSK services was undertaken with a focus on how to develop routine data collection within community/primary care settings, and how to develop benchmarking capabilities for the future, looking towards a national MSK audit. This evidence was triangulated with the findings from recent MSK data studies undertaken by the authors and emerging UK policy and guidance in this area. Recommendations: To enable MSK benchmarking services need to collect consistent, standardised outcomes and, therefore, we have developed a recommendation on a minimum MSK 'core outcome set' of Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) (PROMs: MSK‐HQ, NPRS, WPAI; PREMs: National MSK PREM). In addition, we make recommendations on the use of a standardised evidence‐based method for case‐mix adjustment and outlier identification (using the following baseline demographics and clinical factors; age, sex, ethnicity, pain site, comorbidities, duration of symptoms, previous surgery, previous pain episodes), alongside considerations on how this data should be integrated and reported within NHS systems. Conclusions: Capturing high quality MSK data in a standardised, consistent, and sustainable way is a significant challenge. Policy holders, commissioners, managers, and clinicians need to be realistic with expectations, and take time to explore barriers to implementation including, funding, digital infrastructure/intra‐operability, data sharing/governance, digital literacy, and local/national leadership. Next steps include developing a national MSK audit programme to provide a benchmarking model to support continuous improvements in care quality for patients living with MSK conditions. [ABSTRACT FROM AUTHOR]