The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study.

Background: Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16-25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice. Methods: This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16-25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination. Discussion: Brief GP-led interventions for young people after self-harm are needed to address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible. Registration: ISRCTN (ISRCTN16572400; 28.11.2023).

Self-harm, usually by cutting or overdosing on tablets, affects young people, their families and friends, and society. Young people who self-harm are more likely to self-harm again and suffer from anxiety and depression. The leading cause of death in young people is suicide and over half of young people who die by suicide have previously self-harmed. Self-harm results in around £128 million a year of costs to the NHS. The GP is the most frequently contacted health professional in the NHS for young people who have self-harmed. Therefore, the GP consultation provides a crucial opportunity to intervene early to reduce future self-harm. At present there are no interventions that work for GPs to use with young people who have self-harmed. We thus developed with GPs and patients a new GP-led brief treatment focusing on psychological and social factors for young people 16­25 years after self-harm (called COPING) to be delivered over two appointments. We would now like to test the COPING treatment in general practice to understand whether a future large clinical trial of COPING is doable in the NHS. We will recruit study sites from practices around England and train GPs at sites. We will identify potential participants through three recruitment strategies and all participants will receive the COPING treatment. We will collect follow-up data from young people at two, four, and six months from enrolment, and data will include information about mood, self-harm thoughts, and episodes of self-harm. GPs and participants will be invited for an interview to gain their experiences of COPING. An online survey of GPs in England will gauge interest about engagement in a future trial. This study will assess whether COPING can be evaluated in a large clinical trial in NHS general practice. If feasible and acceptable there is the potential for COPING to substantially benefit patients, GPs, and the NHS.

Exploring General Practitioners' Management of Self-Harm in Young People: A Qualitative Study.

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.

Can clinical presentation predict radiologically confirmed cauda equina syndrome: retrospective case review of 530 cases at a tertiary emergency department.

PURPOSE: Cauda equina syndrome (CES) may have significant individual consequences if diagnostic delays occur. Our aim was to evaluate the presenting subjective and objective features of patients with suspected CES in comparison to those with radiologically confirmed cauda equina compression (CEC).. METHODS: This was a retrospective analysis of all cases presenting with suspected CES to a tertiary emergency care unit over a two-year period. CEC was defined as radiological confirmation of CEC by Consultant Musculoskeletal (MSK) Radiologist report (MSK-CEC) and by measured canal occupancy due to an acute disc extrusion (> 75%)[measured by a Senior Spinal Surgeon (SP-CEC)]. Routine data collection was compared between categories. Chi square, multivariate regression analyses and ROC analysis of multiple predictors was performed. RESULTS: 530 patients were included in this analysis, 60 (11.3%) had MSK-CEC, and 470 had NO- CEC. Only 43/60 (71.7%) had emergent surgery. Those with MSK-CEC and SP-CEC were statistically more likely to present with bilateral leg pain [(MSK-CEC OR 2.6, 95%CI 1.2, 5.8; p = 0.02)(SP-CEC OR 4.7, 95%CI 1.7, 12.8; p = 0.003)]; and absent bilateral ankle reflexes [(MSK-CEC OR 4.3; 95% CI 2.0, 9.6; p < 0.001)(SP CEC OR 2.5; 95%CI 1.0, 6.19; p = 0.05)] on multivariate analysis. The ROC curve analysis acceptable diagnostic utility of having SP-CEC when both are present [Area under the curve 0.72 (95%CI 0.61, 0.83); p < 0.0001]. CONCLUSION: This study suggests that in those presenting with CES symptoms, the presence of both bilateral leg pain and absent ankle reflexes pose an acceptable diagnostic tool to predict a large acute disc herniation on MRI scan..

How can general practitioners help young people avoid future self-harm? a qualitative study.

Background Self-harm is a growing problem in young people. General practitioners (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 barriers, and the influences on GP behaviour. Aim To explore and understand the capabilities, opportunities, and motivations (COM-B) of GPs, and their perceived training needs, to help young people aged 16-25 years avoid future self-harm. Design and setting A qualitative study in NHS general practice in England Method Semi-structured interviews were conducted with GPs and purposive sampling used to aim for a diverse sample. Interviews occurred in 2021. Data were analysed using reflexive thematic analysis and mapped onto COM-B model. The study patient and public involvement and community of practice groups supported data analysis. Results Fifteen interviews were completed (mean duration - 38 minutes). 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 was influenced by their daily workload. Unmet training needs around communication, knowledge, and optimising safety were identified. Conclusion Future GP-led interventions need to improve the capabilities, opportunities, and motivations of GPs to support young people to avoid future self-harm.

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot.

INTRODUCTION AND OBJECTIVES: There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan. METHODS: We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN10761003.

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

OBJECTIVES: Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising advice and education plus a single ultrasound-guided intra-articular hip injection (USGI) of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T) versus BCT alone. METHODS: A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a United Kingdom (UK) National Health Service (NHS) perspective. RESULTS: BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: £-161.6, 95% CI: £-583.95 to £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487, 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists, and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION: Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION: EudraCT: 2014-003412-37 (August 8, 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (July 28, 2015). TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0#citeas. DOI: doi.org/10.1186/s12891-018-2153-0.

Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial.

OBJECTIVES: In low/middle-income countries (LMICs), more than half of patients with first-episode psychosis initially seek treatment from traditional and religious healers as their first care. This contributes to an excessively long duration of untreated psychosis (DUP). There is a need for culturally appropriate interventions to involve traditional and spiritual healers to work collaboratively with primary care practitioners and psychiatrists through task-shifting for early detection, referral and treatment of first episode of psychosis. METHODS: To prevent the consequences of long DUP in adolescents in LMICs, we aim to develop and pilot test a culturally appropriate and context-bespoke intervention. Traditional HEalers working with primary care and mental Health for early interventiOn in Psychosis in young pErsons (THE HOPE) will be developed using ethnographic and qualitative methods with traditional healers and caregivers. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. Ninety-three union councils in district Peshawar, Pakistan will be randomised and allocated using a 1:1 ratio to either intervention arm (THE HOPE) or enhanced treatment as usual and stratified by urban/rural setting. Data on feasibility outcomes will be collected at baseline and follow-up. Patients, carers, clinicians and policymakers will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH210177), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/IG/001005) and National Bioethics Committee Pakistan (ref no. 4-87/NBC-840/22/621). The results of THE HOPE feasibility trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN75347421.

Supported self-management for all with musculoskeletal pain: an inclusive approach to intervention development: the EASIER study.

BACKGROUND: Supported self-management interventions for patients with musculoskeletal (MSK) conditions may not adequately support those with limited health literacy, leading to inequalities in care and variable outcomes. The aim of this study was to develop a model for inclusive supported self-management intervention(s) for MSK pain that take account of health literacy. METHODS: A mixed methods study with four work-packages was conducted: work package 1: secondary analysis of existing data to identify potential targets for intervention; work package 2: evidence synthesis to assess effective components of self-management interventions taking into account health literacy; work package 3: views of community members and healthcare professionals (HCPs) on essential components; work package 4: triangulation of findings and an online modified Delphi approach to reach consensus on key components of a logic model. FINDINGS: Findings identified targets for intervention as self-efficacy, illness perceptions, and pain catastrophizing. A range of intervention components were identified (e.g. information in diverse formats offered at specific times, action planning and visual demonstrations of exercise). Support should be multi-professional using a combination of delivery modes (e.g. remote, face-to-face). CONCLUSIONS: This research has developed a patient-centred model for a multi-disciplinary, multi-modal approach to supported self-management for patients with MSK pain and varying levels of health literacy. The model is evidence-based and acceptable to both patients and HCPs, with potential for significant impact on the management of MSK pain and for improving patient health outcomes. Further work is needed to establish its efficacy.

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial.

QUESTION: How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? DESIGN: This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control. PARTICIPANTS: Two hundred and fifty-five people with chronic low back pain. DATA ANALYSIS: All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE). RESULTS: Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%). CONCLUSION: Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain.

Benchmarking quality of care using patient reported outcome measure data for patients presenting with musculoskeletal conditions in primary care GP practices.

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.

Benchmarking community/primary care musculoskeletal services: A narrative review and recommendation.

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.

Matching the Outcomes to Treatment Targets of Exercise for Low Back Pain: Does it Make a Difference? Results of Secondary Analyses From Individual Patient Data of Randomised Controlled Trials and Pooling of Results Across Trials in Comparative Meta-analysis.

OBJECTIVE: To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD. DESIGN: We conducted exploratory secondary analyses of data. SETTING: Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics). PARTICIPANTS: The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897). INTERVENTION: Exercise compared with no exercise. MAIN OUTCOME MEASURES: The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses. RESULTS: Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.10). CONCLUSIONS: These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes.

Comparison of health-care utilization, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool.

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.

Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.

Background: Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness and cost-effectiveness of point-of-care risk stratification (using Keele's STarT MSK Tool and risk-matched treatments) versus usual care for the five most common musculoskeletal presentations (back, neck, knee, shoulder, and multi-site pain). Methods: In this cluster-randomised, controlled trial in UK primary care with embedded qualitative and health economic studies we recruited patients from 24 general practices in the West Midlands region of England. Eligible patients were those aged 18 years or older whose general practitioner (GP) confirmed a consultation for a musculoskeletal presentation. General practices that consented to participate via a representative of the cluster were randomly assigned (1:1) to intervention or usual care, using stratified block randomisation. Researchers involved in data collection, outcome data entry, and statistical analysis were masked at both the cluster and individual participant level. Participating patients were told the study was examining GP treatment of common aches and pains and were not aware they were in a randomised trial. GPs in practices allocated to the intervention group were supported to deliver risk-based stratified care using a bespoke computer-based template, including the risk-stratification tool, and risk-matched treatment options for patients at low, medium, or high risk of poor disability or pain outcomes. There were 15 risk-matched treatment options. In the usual care group, patients with musculoskeletal pain consulting their GP received treatment as usual, typically including advice and education, medication, referral for investigations or tests, or referral to other services. The primary outcome was time-averaged pain intensity over 6 months. All analyses were done by intention to treat. The trial is registered with ISRCTN, ISRCTN15366334. Results: Between May 1, 2018, and April 30, 2019, 104 GPs from 24 practices (12 per study group) identified 2494 patients with musculoskeletal pain. 1211 (49%) participants consented to questionnaires (534 in the intervention group and 677 in the usual care group), with 1070 (88%) completing the follow-up questionnaire at 6 months. We found no significant difference in time-averaged pain intensity (mean(SD) mean 4·4 [SD 2·3] in the intervention group vs 4·6 [2·5] in the control group; adjusted mean difference -0·16, 95% CI -0·65 to 0·34) or in standardised function score (mean -0·06 [SD 0·94] in the intervention group vs 0·05 [1·04]; adjusted mean difference -0·07, 95% CI -0·22 to 0·08). No serious adverse events or adverse events were reported. Risk stratification received positive patient and clinician feedback. Interpretation: Risk stratification for patients in primary care with common musculoskeletal presentations did not lead to significant improvements in pain or function, although some aspects of GP decision making were affected, and GP and patients had positive experiences. The costs of risk-based stratified care were similar to usual care, and such a strategy only offers marginal changes in cost-effectiveness outcomes. The clinical implications from this trial are largely inconclusive. Funding: National Institute for Health Research.

Marek's Disease in an Indian Peafowl (Pavo cristatus) with Clinical Ocular Disease and Paraparesis.

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.

Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial.

OBJECTIVE: To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis. DESIGN: Pragmatic, three arm, parallel group, single blind, randomised controlled trial. SETTING: Two community musculoskeletal services in England. PARTICIPANTS: 199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine. INTERVENTIONS: BCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received. MAIN OUTCOME MEASURES: The primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months. RESULTS: Mean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference -1.43 (95% confidence interval -2.15 to -0.72), P<0.001; standardised mean difference -0.55 (-0.82 to -0.27). No difference in hip pain intensity over six months was reported between BCT plus ultrasound-triamcinolone-lidocaine compared with BCT plus ultrasound-lidocaine (-0.52 (-1.21 to 0.18)). The presence of ultrasound confirmed synovitis or effusion was associated with a significant interaction effect favouring BCT plus ultrasound-triamcinolone-lidocaine (-1.70 (-3.10 to -0.30)). One participant in the BCT plus ultrasound-triamcinolone-lidocaine group with a bioprosthetic aortic valve died from subacute bacterial endocarditis four months after the intervention, deemed possibly related to the trial treatment. CONCLUSIONS: Ultrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis. TRIAL REGISTRATION: EudraCT 2014-003412-37; ISRCTN50550256.

The relationship between multisite peripheral joint pain and physical activity levels in older adults: A cross-sectional survey.

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.

Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial.

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.

Refinement and validation of a tool for stratifying patients with musculoskeletal pain.

BACKGROUND: Patients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost-effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients. METHODS: Tool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF-36 Physical Component Score [PCS]) and pain intensity were assessed at 2- and 6-month cohort follow-up; pain intensity was measured at 6-month trial follow-up. RESULTS: The tool was refined by replacing (3), adding (3) and removing (2) items, resulting in a 10-item tool. Model fit (R2 ) was 0.422 and 0.430 and discrimination (c statistic) 0.839 and 0.822 for predicting 6-month cohort PCS and pain (respectively). The tool classified 24.9% of cohort participants at low, 41.7% medium and 33.4% high risk, clearly discriminating between subgroups. The tool demonstrated model fit of 0.224 and discrimination 0.73 in trial participants. Multiple imputation confirmed robustness of findings. CONCLUSIONS: The Keele STarT MSK Tool demonstrates good validity and acceptable predictive performance and clearly identifies groups of musculoskeletal pain patients with different characteristics and prognosis. Using prognostic information for stratification and treatment matching may be clinically/cost-effective. SIGNIFICANCE: The paper presents the first musculoskeletal pain prognostic stratification tool specifically for use among all primary care patients with the five most common musculoskeletal pain presentations (back, neck, knee, shoulder or multisite pain). The Keele STarT MSK Tool identifies groups of musculoskeletal pain patients with clearly different characteristics and prognosis. Using this tool for stratification and treatment matching may be clinically and cost-effective.

Treatment targets of exercise for persistent non-specific low back pain: a consensus study.

OBJECTIVES: Despite several hundred previous randomised controlled trials (RCTs), the key treatment targets of exercise for persistent non-specific low back pain (NSLBP) remain unclear. This study aimed to generate consensus about the key treatment targets of exercise interventions for patients with NSLBP. DESIGN: Consensus was generated using modified nominal group technique in two, sequential, workshops. The results of a previous systematic review informed the first, national, workshop idea generation and the results of this workshop informed the second, international, workshop. The authors generated a starting list of 30 treatment targets from the systematic review. A pre-specified consensus threshold of 75% was used in the voting stage. PARTICIPANTS: Workshop participants included people with experience of using exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design and evaluate exercise interventions in RCTs. All participants generated, voted and ranked the treatment targets in each workshop using an online platform. RESULTS: A total of 39 participants contributed to the consensus (15 in the national workshop and 24 in the international workshop), comprising two people with NSLBP, six clinicians and 31 researchers/clinicians. A total of 40 exercise treatment targets were generated, and 25 were retained after voting and ranking. The prioritised targets of exercise for persistent NSLBP were: improving function, improving quality of life, reducing pain, meeting patient-specific goals and reducing fear of movement. CONCLUSIONS: Future RCTs of exercise should specify the targets of their exercise intervention and consider assessing these treatment targets as well as including mediation analyses.