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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

Background Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient’s risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care. Objectives In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cut-off scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and cost-effectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4). Setting General practices and linked musculoskeletal services in the West Midlands of England, UK. Participants Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients. Design The programme included the following work packages: work package 1 – a prospective cohort study in 12 practices; work package 2 – an evidence synthesis, consensus group workshops and qualitative studies; work package 3 – a cluster feasibility and pilot trial in eight practices; and work package 4 – a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation. Interventions Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual non-stratified primary care without formal stratification tools. Main outcome measures Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0–10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decision-making regarding patient management. Results Work package 1 – the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with different characteristics and prognoses. Work package 2: 17 treatment options were recommended – four for patients at low risk, 10 for patients at medium risk and 15 for patients at high risk. Work package 3: the feasibility and pilot trial included 524 patients, and the learning led to amendments to several tool items and a reduced set of treatments (14 in total). Work package 4: in the main trial, 1211 patients consented to data collection (534 in stratified care, 677 in usual care). Stratified primary care did not lead to statistically significant differences in the primary patient outcome of pain intensity [stratified care mean 4.4 (standard deviation 2.3) vs. usual care mean 4.6 (standard deviation 2.4); adjusted mean difference –0.16, 95% confidence interval –0.65 to 0.34; p = 0.535]. Where differences were observed, these were largely isolated to patients at high risk of poor outcome (the smallest subgroup), in favour of stratified care. Positive differences were, however, observed in general practitioner clinical decision-making, with increased provision of written self-management information and referrals to physiotherapy, plus reductions in prescription medication. The economic evaluation demonstrated that costs of care were similar across trial arms (£6.85, 95% confidence interval –£107.82 to £121.54 more for stratified care), with incremental quality-adjusted life-years of 0.0041 (95% confidence interval –0.0013 to 0.0094), representing a net quality-adjusted life-year gain. Stratified care was associated with an incremental cost-effectiveness ratio of £1670 per additional quality-adjusted life-year gained. At a willingness-to-pay threshold (λ) of £20,000 per quality-adjusted life-year, the incremental net monetary benefit was £132 and the probability of stratified care being cost-effective was approximately 73%. The very small differences suggest caution in the interpretation of this result. The qualitative findings revealed that general practitioners felt stratified care had a positive role in informing clinical decision-making, helped them to give greater attention to psychosocial issues and take a more functional approach, and facilitated negotiations with patients about treatment options such as imaging. Limitations The randomised controlled trial was not powered to detect differences between stratified and usual care for patients in each risk subgroup (low, medium and high) nor with each different musculoskeletal pain presentation. The stratified care electronic medical record template ‘fired’ only once per patient. Conclusions The Keele STarT MSK Tool is a valid instrument with which to discriminate between, and predict outcomes of, primary care patients with musculoskeletal pain. Although the randomised trial showed no significant benefit in patient-reported outcomes compared with usual care, some aspects of clinical decision-making improved and the approach was cost-effective. Future work The Keele STarT MSK Tool has been shared with over 1000 tool license requestees, leading to other work. Trial data sets have also led to other work, developing personalised prognostic models for back and neck pain patients (the European Union-funded Back-UP project). The challenge remains how to improve outcomes for primary care patients with musculoskeletal pain. Trial registration This trial is registered as ISRCTN15366334. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 4. See the NIHR Journals Library website for further project information. Plain language summary Around 20% of adults consult their general practitioner each year with a musculoskeletal problem. Musculoskeletal problems represent the largest group of long-term conditions for which patients consult their general practitioner. Although many patients have mild symptoms that can be self-managed with support, some have more serious or persistent problems that need treatments such as physiotherapy. Care varies widely because it is not easy to identify who should be supported to self-manage and who needs more treatment. In this programme we adapted and finalised a short questionnaire [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to sort patients consulting their general practitioner with back, neck, shoulder, knee or multisite pain into one of three groups: those at low, medium and high risk of a poor outcome (for example, patients still experiencing high levels of pain or disability at 6-month follow-up). We recommended treatment options that general practitioners could provide, or offer referral to, for each group of patients and gave general practitioners training to use the new approach. We consulted patients, general practitioners and physiotherapists about this new approach and tested whether or not it led to better outcomes for patients and whether or not it was good value for money for the NHS. Results showed that the Keele STarT MSK Tool works well to identify patients at low, medium and high risk of poor outcome. The approach had several positive impacts on general practitioner clinical decision-making and received positive feedback from patients and clinicians. However, matching groups of patients to the available treatments recommended in this programme did not lead to consistently better patient outcomes than those of patients receiving usual care. We found stratified care had greater potential for the group of patients at high risk. The challenge remains to improve primary care treatments in ways that lead to better outcomes for patients with musculoskeletal pain. Scientific summary Background Musculoskeletal pain such as back, neck, shoulder, knee and multisite pain is common and costly in terms of burden on individuals, the NHS and society. For some people these musculoskeletal problems are painful but short-lived; however, for others the painful episode fails to resolve or recurs, impacting their ability to work and leading to extensive NHS and societal costs. Most patients with musculoskeletal problems are managed in primary care, where 20% of the registered practice population will consult their general practitioner (GP) annually with a musculoskeletal problem, accounting for one in six GP consultations. There is limited evidence to guide how best to direct the right patient to the right treatment in ways that improve patient outcomes such as pain and disability, and make the best use of health-care resource. The sheer number of patients makes it inappropriate and unsustainable to offer more intensive and expensive treatments to all. Building on a previously successful model of prognostic stratified care for patients in primary care with low back pain, the aims of this programme were to adapt, finalise and test a prognostic stratified primary care model for a much larger group of patients with the five most common musculoskeletal pain presentations. Objectives The programme addressed the following objectives: •on the tool to subgroup patients into prognostic strata – ◦validate and optimise the predictive performance of the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool ◦determine the tool risk strata cut-off points based on optimal predictive values and suitability for matched treatment options ◦estimate the proportions of patients at low, medium and high risk of poor outcome and describe their characteristics ◦describe current health-care resource use by all patients and in each risk stratum. •on the recommended matched treatment options – ◦summarise current best evidence on available treatments for the five most common musculoskeletal pain presentations in primary care ◦explore patients’ and GPs’ views on the acceptability of prognostic stratified care and the anticipated barriers to and facilitators of its use in clinical practice ◦agree, through expert consensus, the most appropriate matched treatment options that should be recommended for patients in each risk subgroup ◦develop and specify the training and support package to support delivery of stratified primary care. •on the feasibility of a future main cluster randomised controlled trial (RCT) and of delivery of stratified primary care – ◦estimate participant recruitment and follow-up rates for the main cluster RCT ◦examine evidence of selection bias between trial arms and between participants and non-participants ◦assess GP fidelity to the stratified care intervention (use of the stratification tool and matched treatment options) ◦conduct secondary descriptive analyses of GP decision-making and patient outcomes. •on the clinical effectiveness and cost-effectiveness of stratified primary care compared with usual care (usual care) – ◦determine the comparative clinical effectiveness of stratified care versus usual primary care for patient outcomes ◦investigate GP fidelity to delivery of stratified care and the impact on clinical decision-making ◦undertake an economic evaluation of stratified care versus usual care ◦conduct a nested qualitative study to understand how stratified care was perceived and operationalised by clinicians and patients. Methods A series of studies across four work packages was carried out, involving different research methods: •work package 1 – a prospective longitudinal cohort study and interviews with patients and clinicians •work package 2 – an evidence synthesis, qualitative focus groups and interviews, consensus group workshops, and development of an electronic template and training/support package to support GPs to deliver stratified care •work package 3 – a feasibility and pilot RCT with linked qualitative interviews •work package 4 – a main cluster RCT including analyses of general practice medical record data, health economic analyses and qualitative interviews. Results Work package 1 – the Keele Aches and Pains Study (KAPS) A total of 1890 patients responded to the invitation and consented to participate (mean age 58 years, 61% female). Subsequently, 1425 participants returned questionnaires at 2 months’ follow-up (response rate of 75.8%), and 1452 provided data at 6 months’ follow-up (response rate of 78.7%). The amended 10-item Keele STarT MSK Tool has a scale range of 0–12 (0 = lowest risk of poor outcome, 12 = highest risk of poor outcome). The final model fit (R2) and discrimination (c-statistic) in the Keele Aches and Pains Study (KAPS) data set at 6 months’ follow-up was 0.422 and 0.839 for physical function, respectively, and 0.430 and 0.822 for pain intensity, respectively; there was also acceptable performance across the five musculoskeletal pain presentations. In the external validation data set, the final model fit (R2) was 0.224 and discrimination (c-statistic) was 0.725 for pain intensity. The cut-off points determined to provide the best combination of sensitivity, specificity, predictive values and likelihood ratios, in combination with suitability for the recommended matched treatments (identified in work package 2), overall and across pain sites, were 0–4 for low risk, 5–8 for medium risk and 9–12 for high risk. The KAPS cohort participants were classified as 25% at low risk, 42% at medium risk and 33% at high risk of poor outcome. There were clear and consistent differences between risk subgroups on key variables, health-care utilisation and associated costs, confirming the discriminative ability of the Keele STarT MSK Tool. Work package 2 – study to agree matched treatment options and support package for delivery The evidence synthesis showed that primary care patients with musculoskeletal pain can be managed effectively with non-pharmacological treatments such as self-management advice, exercise therapy and psychosocial interventions, and that pharmacological treatments provide, at best, short-term benefits only. The qualitative focus groups and interviews with patients and clinicians identified four key themes (the acceptability of clinical decision-making guided by stratified care, the impact on the therapeutic relationship, embedding a prognostic approach within a biomedical model and practical issues in using stratified care). For GPs and patients to see stratified care as useful, it must add to existing knowledge and skills, not undermine GPs’ clinical autonomy nor disrupt therapeutic rapport. The need for integration into consultations with minimal disruption was highlighted. In the consensus study, the three Nominal Group Technique workshops with multidisciplinary groups of clinicians led to a total of 17 treatment options being recommended. These were summarised and incorporated into a bespoke electronic health record (EHR) template along with the Keele STarT MSK Tool, in order to make delivery of stratified care as easy as possible for GPs, and a training/support package for GPs was developed, ready for use with GPs participating in the feasibility and pilot trial in the next work package. Work package 3 – the Treatment for Aches and Pains Study (TAPS) pilot trial In work package 3’s feasibility and pilot RCT, 524 participants (42% of those invited) consented to provide questionnaire outcome data (stratified care n = 231, usual care n = 293). Anonymised EHR data were available for 1281 patients (529 in stratified care practices and 752 in usual care practices). Although follow-up rates over 6 months were high, the length of time taken to recruit participants (28 weeks) was over twice as long as expected (12 weeks). GP fidelity to use of the stratification tool was only 40% of eligible consultations (compared with a target of at least 50%), and both GPs and patients identified the need for several items in the tool to be amended. However, in those with whom the tool was used, over 80% were recorded as having been matched to a recommended treatment option. Key changes were therefore needed prior to the main trial; thus, this feasibility and pilot trial became an external pilot trial (rather than the originally intended internal pilot trial). There was no evidence of selection bias and, therefore, no changes were made to identification or recruitment procedures for the main trial. Given the learning from this pilot trial, amendments were made to the stratification tool (revision of the language used in four of the tool items) and matched treatment options (a total of 14 were recommended). Work package 4 – the Treatment for Aches and Pains Study (TAPS) main trial In the main cluster RCT in work package 4, 1211 patients from 24 general practices (12 per arm) participated in self-report data collection (534 in stratified care and 677 in usual care); the participants had a mean age of 60 years and 58.9% were female. Mean pain intensity at the point-of-consultation was 6.73 (6.77 in stratified care, 6.70 in usual care). A total of 1178 (97%) participants provided at least one pain intensity response over the 6 months’ follow-up [515 (96%) in stratified care, 663 (98%) in usual care] and 80.9% responded to the follow-up questionnaire at 6 months (77.9% in stratified care, 83.3% in usual care). The main analysis showed no statistically significant differences in pain intensity over 1–6 months comparing stratified care with usual care, with mean values of 4.4 [standard deviation (SD) 2.3] for stratified care and 4.6 (SD 2.4) for usual care [adjusted mean difference –0.16, 95% confidence interval (CI) –0.65 to 0.34; p = 0.535]. Most sensitivity analyses showed no statistically significant between-arm differences, despite showing consistent slightly favourable results for stratified care. Subgroup analyses showed some between-arm mean differences with a greater difference (although statistically non-significant) in patients at high risk versus those at low risk, and between those with shoulder and knee pain compared with those with neck and back pain. There were no statistically significant differences in secondary clinical outcomes at 6 months, except for a significant improvement in shoulder pain and function and higher satisfaction with care in the stratified care arm compared with the usual care arm. The health economic evaluation showed that the costs of care were very similar in the two arms of the trial: mean cost of stratified care was £356.36 (SD £864.01) compared with a mean cost of £343.44 (SD £942.92) for usual care. The adjusted incremental cost of stratified care compared with usual care over the 6 months was £6.85 (95% CI –£107.82 to £121.54), with incremental quality-adjusted life-years (QALYs) of 0.0041 (95% CI –0.0013, 0.0094), representing a net QALY gain. Stratified care was associated with a cost-per-QALY gain of £1670. At a willingness-to-pay threshold (λ) of £20,000 per QALY, the incremental net monetary benefit was £132 and the probability of stratified care being cost-effective was approximately 73%. The anonymised EHR audit data were available for 2494 patients across all 24 practices and demonstrated several important impacts from stratified care on GP treatment decision-making, including increased provision of written information (58% in the stratified care arm vs. 26% in the usual care arm), physiotherapy referral (63.3% in the stratified care arm vs. 9.9% in the usual care arm), and simple over-the-counter analgesics (16.7% in the stratified care arm vs. 6.3% in the usual care arm). Prescribing of short-term courses of strong opioids increased (20.3% in the stratified care arm vs. 1.0% in the usual care arm), but not long-term opioids. GPs in stratified care practices completed the risk-stratification tool in 29.76% (1056/3548) of possible consultations and reported selecting an appropriate risk-matched treatment option in over three-quarters of patients (77.2% low risk, 77.8% medium risk and 76.7% high risk). Patient and public involvement Patient and public involvement and engagement (PPIE) representatives contributed at all stages and to all work packages. In work package 1 they made suggestions on patient-facing materials that improved acceptability and understanding, and gave patient/public perspectives on the draft Keele STarT MSK Tool’s face validity. PPIE representative views influenced the presentation of evidence for the work package 2 consensus study, and aided the choice of patient websites and leaflets recommended for GP use (in matched treatment options). In work package 3, PPIE perspectives improved study design and patient-facing materials. PPIE representatives helped the team understand and interpret feasibility/pilot trial findings (quantitative and qualitative), and influenced main trial plans. PPIE input was valuable in wording and ordering the clinician-completed version of the Keele STarT MSK Tool. In work package 4, PPIE input led to improvements in wording and formatting of study documents, and advised on acceptable methods for GPs seeking patient consent. PPIE views were also important in the interpretation of study findings. Conclusions The Keele STarT MSK Tool is a valid instrument with which to discriminate between, and predict outcomes of, primary care patients with musculoskeletal pain. However, matching groups of patients to the available treatment options recommended in this programme did not lead to consistently better clinical outcomes than those receiving usual care. Although the randomised trial showed no significant benefit in patient-reported outcomes compared to usual care, some aspects of clinical decision-making improved and there was only a marginal increase in cost. Implications for health care The Keele STarT MSK Tool is a valid tool with which to identify patients with different levels of risk of persistent pain. The tool provides additional systematic information about an individual patient’s prognosis that can help clinicians to direct patients to the most appropriate treatments. The approach of using one tool for this wide range of patients has the major benefit of simplicity for clinical practice, removing the complexity that would result from multiple, pain site-specific screening tools. The main trial showed that although matching patients to treatment options based on their risk subgroup did not lead to superior patient-reported outcomes for the overall trial comparison, there were important improvements in some aspects of clinical decision-making about treatments. Costs of risk-based stratified care were similar to usual care, with marginal additional benefits. The main trial results are partly explained by a loss in fidelity in terms of the delivery of stratified care by participating GPs, likely explained by the additional burden of time to deliver stratified care in consultations with patients. The stratified care approach with the EHR template comprising the tool and 14 treatment options may have been too complex to deliver with high fidelity. The challenge remains to improve primary care treatments in ways that lead to better outcomes for patients with musculoskeletal pain. Implications for research Stratified care involves matching subgroups of patients to treatments in ways that improve clinical outcomes, reduce unnecessary or harmful treatments and make better use of health-care resource. This programme demonstrated that it is possible to use one brief (10-item) stratification tool to accurately identify the prognosis of patients with musculoskeletal pain using simple self-report information. This required the GP to ask patients questions and record their responses, adding time to consultations. Future research needs to identify ways to use more routinely collected data about patients with musculoskeletal pain so that prognostic subgroup information can be provided to clinicians in more time-efficient ways. The stratified care EHR template in this programme fired only once per patient, so as not to burden GPs, and although this led to important changes in some aspects of clinical decision-making, patients had an average of 4 to 5 musculoskeletal pain-related consultations over 6 months’ follow-up. There was no electronic reminder of stratified care during these consultations. Therefore, future research that tests ways to continually ‘nudge’ clinical decision-making in the right direction is needed. For most patients with musculoskeletal pain, this will require efforts to reduce medication prescriptions and instead support self-management and ensure access to non-pharmacological treatments. Trial registration This trial is registered as ISRCTN15366334. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 4. See the NIHR Journals Library website for further project information.

Background: Self-harm is a growing problem in young people. GPs are usually the first point of healthcare contact for young people aged 16–25 years, after self-harm. GPs can experience barriers to supporting young people and behaviour change theory can help to understand these, and the influences on, GP behaviour. Aim: To explore the capabilities, opportunities, and motivations (COM-B model of behaviour) of GPs, and their perceived training needs, to help young people aged 16–25 years avoid future self-harm. Design and setting: This was a qualitative study of GPs in England. Method: Semi-structured interviews were conducted with NHS GPs who were purposively sampled. Interviews occurred in 2021. Data were analysed using reflexive thematic analysis and mapped onto the COM-B model domains. The study's patient and public involvement group supported data analysis. Results: Fifteen interviews were completed. Four themes were generated. GPs described mixed capabilities, with many feeling they had the physical and psychological skills to support young people to avoid future self-harm, but some felt doing so was emotionally tiring. GPs identified opportunities to better support young people, such as use of electronic consultation tools, but cited lack of time as a concern. GPs reported motivation to help young people, but this can be influenced by their workload. Unmet training needs around communication, knowledge, and optimising safety were identified. Conclusion: GPs are supported by their practice teams to support young people after self-harm, but a lack of time hinders opportunities to do so. Future effective GP-led interventions may improve GP motivation to support young people after self-harm. [ABSTRACT FROM AUTHOR]

Background: General practitioners (GPs) are key to the frontline assessment and treatment of young people after self‐harm. Young people value GP‐led self‐harm care, but little is known about how GPs manage young people after self‐harm. Aim: This study aimed to understand the approaches of GPs to self‐harm in young people and explore their perspectives on ways they might help young people avoid repeat self‐harm. Methods: We conducted semi‐structured interviews with GPs from the National Health Service in England in 2021. GPs were recruited from four geographically spread clinical research networks and a professional special interest group. Data were analysed using reflexive thematic analysis. The study's patient and public involvement and community of practice groups supported participant recruitment and data analysis. Results: Fifteen interviews were undertaken with a mean age of participants being 41 years and a breadth of experience in practice ranging from 1 to 22 years. Four themes were generated: GPs' understanding of self‐harm; approaches to managing self‐harm; impact of COVID‐19 on consultations about self‐harm; and ways to avoid future self‐harm. Conclusion: Negative attitudes towards self‐harm within clinical settings are well documented, but GPs said they took self‐harm seriously, listened to young people, sought specialist support when concerned and described appropriate ways to help young people avoid self‐harm. GPs felt that relationship‐based care is an important element of self‐harm care but feared remote consultations for self‐harm may impede on this. There is a need for brief GP‐led interventions to reduce repeat self‐harm in young people. Patient and Public Contribution: A study advisory group consisting of young people aged 16–25 years with personal experience of self‐harm and parents and carers of young people who have self‐harmed designed the recruitment poster of this study, informed its topic guide and contributed to its findings. [ABSTRACT FROM AUTHOR]

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]

Background: Patient Reported Outcome Measures (PROMs) evaluate health status from a patient perspective. They can be used to support care at a patient level but also collectively to review quality of care across care providers. Vast amounts of patients with musculoskeletal (MSK) conditions present to General Practice (GP) primary care practitioners each year. Variation in patient outcomes in this setting however has not been reported. Objective: To identify variation in patient outcomes measured using the musculoskeletal health questionnaire (MSK‐HQ) PROM for adults presenting to 20 GP practices in the UK with MSK conditions. Methods: A secondary analysis of the STarT MSK cluster randomised controlled trial dataset. A standardised case‐mix adjustment model, adjusting for condition complexity co‐variates, was used to calculate predicted 6‐month follow‐up MSK‐HQ scores, and used to compare adjusted and un‐adjusted health gain (n = 868). Patient MSK‐HQ change outcomes were aggregated to practice level and boxplots used to display outlier GP practices for un‐adjusted and adjusted outcomes. Results: Substantial variation in patient outcomes was seen across the 20 practices, even after case‐mix adjustment, with mean change in MSK‐HQ scores ranging from 6 to 12 points. Boxplots displaying un‐adjusted outcomes showed one negative GP practice outlier and two positive outliers. However, the boxplots displaying case‐mix adjusted outcomes showed no negative outliers, with two practices remaining as positive outliers, and one practice additionally becoming a positive outlier. Conclusion: This study showed a two‐fold GP practice variation in patient outcomes measured using the MSK‐HQ PROM. To our knowledge it is the first study to demonstrate that (a) a standardised case‐mix adjustment method can be used to fairly compare patient health outcome variation in GP care, and (b) that case‐mix adjustment changes benchmarking findings with regards to provider performance and outlier identification. This has important implications for identifying best practice exemplars and thereby helping to improve the quality of MSK primary care in the future. [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]

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]

Background: Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinicians.Objectives: To test the feasibility of a randomized controlled trial (RCT) of an intervention integrating case-finding and management for osteoarthritis, anxiety, and depression within LTC reviews.Methods: A pilot stepped-wedge RCT across 4 general practices recruited patients aged ≥45 years attending routine LTC reviews. General practice nurses provided usual LTC reviews (control period), then, following training, delivered the ENHANCE LTC review (intervention period). Questionnaires, an ENHANCE EMIS-embedded template and consultation audio-recordings, were used in the evaluation.Results: General practice recruitment and training attendance reached prespecified success criteria. Three hundred and eighteen of 466 (68%) of patients invited responded; however, more patients were recruited during the control period (206 control, 112 intervention). Eighty-two percent and 78% returned their 6-week and 6-month questionnaires, respectively. Integration of the ENHANCE LTC review into routine LTC reviews varied. Case-finding questions were generally used as intended for joint pain, but to a lesser extent for anxiety and depression. Initial management through referrals and signposting were lacking, and advice was more frequently provided for joint pain. The stepped-wedge design meant timing of the training was challenging and yielded differential recruitment.Conclusion: This pilot trial suggests that it is feasible to deliver a fully powered trial in primary care. Areas to optimize include improving the training and reconsidering the stepped-wedge design and the approach to recruitment by targeting those with greatest need.Trial Registration: ISRCTN registry (ISRCTN: 12154418). Date registered: 6 August 15. Date first participant was enrolled: 13 July 2015. https://www.isrctn.com/ISRCTN12154418?q=depression%20schizophrenia&filters=conditionCategory:Not%20Applicable&sort=&offset=5&totalResults=9&page=1&pageSize=20&searchType=basic-search. [ABSTRACT FROM AUTHOR]

Marek's disease (MD) is caused by virulent strains of Gallid alphaherpesvirus type 2 (MD virus serotype 1; MDV 1) and frequently causes a lymphoproliferative disorder in poultry and other galliform birds worldwide. However, within the peafowl (Phasianinae) subfamily, there are only rare confirmed reports of MD. Here we report MD in an Indian peafowl (Pavo cristatus), which clinically presented with hindlimb paraparesis and intraocular swelling of the right eye. Soft, off-white to tan masses within the right eye, sciatic nerves and coelomic cavity were identified at post-mortem examination which effaced the cranial pole of the kidneys and diffusely effaced the testes. Lymphoid neoplasia was identified histologically at all of these sites and there was extensive hepatic lymphoid cell infiltration, which had not been grossly evident. The T-cell origin of the lymphoid cells was confirmed by immunohistochemistry for CD3 antigen. A virulent strain of MDV 1 was detected by real-time polymerase chain reaction in DNA samples extracted from the kidney and testes. As MD is rare in peafowl it should be considered as a differential diagnosis for intraocular and coelomic masses with associated clinical signs. [ABSTRACT FROM AUTHOR]

Background This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. Methods and findings We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged [greater than or equal to]45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged [greater than or equal to]45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). Conclusions In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. Trial registration ISRCTN registry ISRCTN40721988, Author(s): Christian D. Mallen 1,2,*, Barbara I. Nicholl 3, Martyn Lewis 1, Bernadette Bartlam 1, Daniel Green 1, Sue Jowett 1, Jesse Kigozi 1, John Belcher 1, Kris Clarkson 1, [...]

Introduction: Research on levels of physical activity (PA) in those with peripheral joint pain have only focused on single sites, in the knee or hips. This study investigated the levels of PA in adults with single‐site and multisite peripheral joint pain compared to adults with no joint pain. Methods: Analysis of a cross‐sectional population survey mailed to adults aged ≥45 years (n = 28,443) was conducted. Respondents reported any peripheral joint pain in the last 12 months in either the hands, hips, knees or feet; PA levels were self‐reported using the short telephone activity rating scale. The association between PA levels, peripheral joint pain and outcomes of health status (physical and mental component scores, using SF‐12) pain intensity (10‐point scale) and health‐related quality of life (HRQoL) (EQ‐5D) were investigated using analysis of variance and ordinal regressions. Results: Compared to those with no joint pain, all pain groups reported lower levels of PA: joint pain in one site (odds ratio = 0.91, 95% CI: 0.83–0.99); two sites (0.74, 0.67–0.81), three sites (0.65, 0.59–0.72) and four sites (0.47, 0.42–0.53). Across all joint pain groups, levels of PA were associated with pain intensity, physical health status, mental health status and HRQoL. Discussion: Adults with more sites of peripheral joint pain were more likely to report lower levels of PA. Those with more sites of pain and lower levels of PA reported poorer outcomes. Health care providers should be aware that those with multisite joint pain are most likely to have low levels of PA. [ABSTRACT FROM AUTHOR]