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Background: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack)., Methods: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486., Findings: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care., Interpretation: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice., Funding: National Institute for Health and Care Research Health Technology Assessment (16/111/78)., Competing Interests: Declaration of interests LCR reports an educational grant from Pfizer held by their institute; consulting fees from the Musculoskeletal Association of Chartered Physiotherapists; and meeting support from Eurospine. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Benchmarking musculoskeletal (MSK) services is limited by the need to adjust for differences in patient characteristics/case-mix. Without this providers and services cannot be usefully compared. This paper investigates the predictive ability of case-mix adjustment models in a primary/community care cohort., Objectives: To investigate the predictive ability of two existing MSK case-mix adjustment models and compare to the predictive ability of an evidence informed and statistically informed model., Method: A secondary analysis of the 'Subgrouping for Targeted Treatment in Musculoskeletal Conditions' cluster randomised controlled trial data (n = 1211). Stepwise linear regression models were built and compared using available baseline variables. The MSK-HQ was used as the primary functional status outcome., Results: Two existing models were compared (UK National PROMs Model, US FOTO Model) using available variables. Of these models the modified US FOTO model showed the best predictive ability in this cohort predicting 44% of the variation in MSK-HQ outcome, the modified UK National PROMs model predicted 41%. A newly developed evidence informed model (Keele Model 1) performed no better than the existing models, and a statistically informed model (Keele Model 2) gave only an additional 2% increase in model power compared to the modified US FOTO model., Conclusion: All models showed strong predictive ability. The modified US FOTO model looks to be best suited to the UK primary/community care cohort of the existing models. This model performed so well that we recommend that this model is used in a UK setting moving forwards rather than development of an alternative UK model., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: The Musculoskeletal Health Questionnaire (MSK-HQ) has been developed to measure musculoskeletal health status across musculoskeletal conditions and settings. However, the MSK-HQ needs to be further evaluated across settings and different languages., Objective: The objective of the study was to evaluate and compare measurement properties of the MSK-HQ across Danish (DK) and English (UK) cohorts of patients from primary care physiotherapy services with musculoskeletal pain., Methods: MSK-HQ was translated into Danish according to international guidelines. Measurement invariance was assessed by differential item functioning (DIF) analyses. Test-retest reliability, measurement error, responsiveness and minimal clinically important change (MCIC) were evaluated and compared between DK (n = 153) and UK (n = 166) cohorts., Results: The Danish version demonstrated acceptable face and construct validity. Out of the 14 MSK-HQ items, three items showed DIF for language (pain/stiffness at night, understanding condition and confidence in managing symptoms) and three items showed DIF for pain location (walking, washing/dressing and physical activity levels). Intraclass Correlation Coefficients for test-retest were 0.86 (95% CI 0.81 to 0.91) for DK cohort and 0.77 (95% CI 0.49 to 0.90) for the UK cohort. The systematic measurement error was 1.6 and 3.9 points for the DK and UK cohorts respectively, with random measurement error being 8.6 and 9.9 points. Receiver operating characteristic (ROC) curves of the change scores against patients' own judgment at 12 weeks exceeded 0.70 in both cohorts. Absolute and relative MCIC estimates were 8-10 points and 26% for the DK cohort and 6-8 points and 29% for the UK cohort., Conclusions: The measurement properties of MSK-HQ were acceptable across countries, but seem more suited for group than individual level evaluation. Researchers and clinicians should be aware that some discrepancy exits and should take the observed measurement error into account when evaluating change in scores over time.

Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations., Methods: The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making., Results: GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success"., Conclusions: A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments., Trial Registration: Name of the registry: ISRCTN., Trial Registration Number: 15366334. Date of registration: 06/04/2016.

Background: Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to appropriate early treatment options. The STarT MSK feasibility and pilot cluster randomised controlled trial (RCT) examined the feasibility of a future main trial and of delivering prognostic stratified primary care for patients with musculoskeletal pain. The pilot RCT was conducted in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK development tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. This paper reports on a nested qualitative study exploring the feasibility of delivering stratified care ahead of the main trial., Methods: 'Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n = 10 patients; 10 GPs), prompted by consultation recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Capability, Opportunity and Motivation GPs and patients had to engage with stratified care., Results: Patients reported positive views that stratified care enabled a more 'structured' consultation, and felt tool items were useful in making GPs aware of patients' worries and concerns. However, the closed nature of the tool's items was seen as a barrier to opening up discussion. GPs identified difficulties integrating the tool within consultations (Opportunity), but found this easier as it became more familiar. Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability). Most GPs reported that the matched treatment options aided their clinical decision-making (Motivation), but identified some options that were not available to them (e.g. pain management clinics), and other options that were not included in the matched treatments but which were felt appropriate for some patients (e.g. consider imaging)., Conclusion: This nested qualitative study, using the COM-B model, identified amendments required for the main trial including changes to the Keele STarT MSK tool and matched treatment options, targeting the COM-B model constructs, and these have been implemented in the current main trial., Trial Registration: ISRCTN 15366334.

Background: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. This study aimed to gain consensus from practitioners who work with MSK pain patients, on the most appropriate primary care treatment options for subgroups of patients based on prognostic risk of persistent disabling pain. Agreement was sought on treatment options for the five most common MSK pain presentations: back, neck, knee, shoulder and multisite pain, across three risk subgroups: low, medium and high., Methods: Three consensus group meetings were conducted with multi-disciplinary groups of practitioners (n = 20) using Nominal Group Technique, a systematic approach to building consensus using structured in-person meetings of stakeholders which follows a distinct set of stages., Results: For all five pain presentations, "education and advice" and "simple oral and topical pain medications" were agreed to be appropriate for all subgroups. For patients at low risk, across all five pain presentations "review by primary care practitioner if not improving after 6 weeks" also reached consensus. Treatment options for those at medium risk differed slightly across pain-presentations, but all included: "consider referral to physiotherapy" and "consider referral to MSK-interface-clinic". Treatment options for patients at high risk also varied by pain presentation. Some of the same options were included as for patients at medium risk, and additional options included: "opioids"; "consider referral to expert patient programme" (across all pain presentations); and "consider referral for surgical opinion" (back, knee, neck, shoulder). "Consider referral to rheumatology" was agreed for patients at medium and high risk who have multisite pain., Conclusion: In addressing the current lack of robust evidence on the effectiveness of different treatment options for MSK pain, this study generated consensus from practitioners on the most appropriate primary care treatment options for MSK patients stratified according to prognostic risk. These findings can help inform future clinical decision-making and also influenced the matched treatment options in a trial of stratified primary care for MSK pain patients.

Background: The STarT Back Tool (Subgrouping for Targeted Treatment; SBT) was developed and validated in the United Kingdom for adults with non-specific low back pain (LBP) to provide risk stratification groups. An Arabic version has not yet been developed. Consequently, our objectives were: First, to cross-culturally adapt the SBT for use in Arabic speaking adults (SBT-Ar) with LBP. Second, to assess the face, content and construct validity of SBT-Ar against relevant reference standards., Methods: This was a prospective, cross-sectional study carried out in the outpatient department in a tertiary care hospital. A total of 59 participants (aged 18-60) with LBP able to read Arabic completed the questionnaire. SBT cross-cultural adaptation was performed according to published guidelines. Face and content validity were explored by individual interviews. Construct validity was assessed using pre-hypothesized correlations with relevant reference standards., Results: Following 48 individual interviews the SBT final version was reached and demonstrated face and content validity. The SBT-Ar total score and psychosocial sub-scale had acceptable internal consistency and no redundancy (Cronbach α = 0.7). Moderate Spearman's correlations were found between the SBT-Ar total score and reference standards (Arabic Pain Numeric Rating Scale NRS-Ar r = 0.50 and Arabic Oswestry Disability Index ODI-ar r = 0.51). As expected the SBT-Ar psychosocial subscale had medium to high correlations with the psychosocial reference measures (Arabic Fear-Avoidance Beliefs Questionnaire Physical Activity FABQPA-Ar r = 0.41, Arabic Hospital Anxiety and Depression Scale-Anxiety HADSA-Ar r = 0.58, Arabic Hospital Anxiety and Depression Scale-Depression HADSD-Ar r = 0.45 and Arabic Pain Catastrophizing Scale PCSAr r = 0.69).The SBT-Ar showed no significant floor or ceiling effects., Conclusion: This study culturally adapted and preliminary validated SBT into Arabic., Study Design: Prospective, Cross-sectional., (Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.)

Introduction:: Acetabular cup orientation during total hip arthroplasty (THA) remains a challenge. This is influenced by patient positioning during surgery and the method used to orientate the acetabular cup. The aim of this study was to assess current UK practice for patient positioning and cup orientation, particularly with respect to patient supports and techniques used to achieve target version and inclination., Methods:: A literature review and pilot study were initially conducted to develop the questionnaire, which was completed by British Hip Society members ( n = 183). As the majority of THA surgical procedures within the UK are performed with the patient in lateral decubitus, orthopaedic surgeons who operated with the patient in the supine position were excluded ( n = 18); a further 6% were incomplete and also excluded ( n = 11)., Results:: Of those who operated in lateral decubitus, 76.6% ( n = 118/154) used the posterior approach. Only 31% ( n = 47/154) considered their supports to be completely rigid. More than 35% ( n = 55/154) were unhappy with the supports that they presently use. The most common methods for controlling operative inclination and version were a mechanical alignment guide (MAG; n = 78/154; 50.6%) and the transverse acetabular ligament (TAL; n = 82/154; 53.2%); 31.2% (48/154) used a freehand technique to control operative inclination., Conclusion:: Limited studies have been conducted whereby patient supports have been analysed and key design principles outlined. With 35.7% of the orthopaedic surgeons surveyed having issues with their current supports, a greater awareness of essential characteristics for patient supports is required.

Background: In contrast to postdischarge arthroplasty readmission rates, the unscheduled reattendance burden to primary care is under-reported. Understanding reasons for reattendance would allow for implementation of strategies to reduce this burden. The present study aims to quantify the out-of-hours (OOH) general practitioner and emergency department (ED) service reattendance burden and readmission rate after primary total hip arthroplasty and total knee arthroplasty, with estimation of the associated costs., Methods: This is a prospective consecutive cohort study. A prospective audit of all total hip arthroplasty and total knee arthroplasty patients in 2016 in a single high-volume UK arthroplasty unit was performed. Incidence and reasons for reattendance to OOH and ED service, as well as readmission rates, at both 30 and 90 days following discharge are reported. A multivariate analysis was performed to determine patient characteristics, which results in increased reattendance and readmission rates., Results: A total of 2351 procedures resulted in 374 attendances of OOH service and 665 to ED with a total estimated cost of £190,000 within 90 days. The readmission rate was 6.8%. Risk factors for reattendance and readmission were increasing age and a prolonged length of stay. The use of a 5-day postdischarge phone call and a dedicated Arthroplasty Care Practitioner favors reduced reattendances but not the readmission rate, with the additional benefit of being cost-effective., Conclusion: The postdischarge arthroplasty reattendance burden is associated with significant costs, and strategies to reduce this should be developed. Further research is required to assess the effectiveness and cost-effectiveness of multicomponent strategies to reduce reattendance operating at scale., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ)., Setting: A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics., Participants: Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients)., Outcome Measures: Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test-retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM)., Results: Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be 'highly relevant' and 'easy to understand'. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test-retest reliability was excellent, and convergent validity was strong (correlations 0.81-0.88)., Conclusions: A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test-retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Purpose: The STarT Back Tool (SBT) was recently translated into Danish and its concurrent validity described. This study tested the predictive validity of the Danish SBT., Methods: Danish primary care patients (n = 344) were compared to a UK cohort. SBT subgroup validity for predicting high activity limitation at 3 months' follow-up was assessed using descriptive proportions, relative risks, AUC and odds ratios., Results: The SBT had a statistically similar predictive ability in Danish primary care as in UK primary care. Unadjusted relative risks for poor clinical outcome on activity limitation in the Danish cohort were 2.4 (1.7-3.4) for the medium-risk subgroup and 2.8 (1.8-3.8) for the high-risk subgroup versus 3.1 (2.5-3.9) and 4.5 (3.6-5.6) for the UK cohort. Adjusting for confounders appeared to explain the lower predictive ability of the Danish high-risk group., Conclusions: The Danish SBT distinguished between low- and medium-risk subgroups with a similar predictive ability of the UK SBT. That distinction is useful information for informing patients about their expected prognosis and may help guiding clinicians' choice of treatment. However, cross-cultural differences in the SBT psychosocial subscale may reduce the predictive ability of the high-risk subgroup in Danish primary care.

Objective: UK Indian adults have higher risks of coronary heart disease and type 2 diabetes than Indian and UK European adults. With growing evidence that these diseases originate in early life, we compared cardiometabolic risk markers in Indian, UK Indian and white European children., Methods: Comparisons were based on the Mysore Parthenon Birth Cohort Study (MPBCS), India and the Child Heart Health Study in England (CHASE), which studied 9-10 year-old children (538 Indian, 483 UK Indian, 1375 white European) using similar methods. Analyses adjusted for study differences in age and sex., Results: Compared with Mysore Indians, UK Indians had markedly higher BMI (% difference 21%, 95%CI 18 to 24%), skinfold thickness (% difference 34%, 95%CI 26 to 42%), LDL-cholesterol (mean difference 0.48, 95%CI 0.38 to 0.57 mmol/L), systolic BP (mean difference 10.3, 95% CI 8.9 to 11.8 mmHg) and fasting insulin (% difference 145%, 95%CI 124 to 168%). These differences (similar in both sexes and little affected by adiposity adjustment) were larger than those between UK Indians and white Europeans. Compared with white Europeans, UK Indians had higher skinfold thickness (% difference 6.0%, 95%CI 1.5 to 10.7%), fasting insulin (% difference 31%, 95%CI 22 to 40%), triglyceride (% difference 13%, 95%CI 8 to 18%) and LDL-cholesterol (mean difference 0.12 mmol/L, 95%CI 0.04 to 0.19 mmol/L)., Conclusions: UK Indian children have an adverse cardiometabolic risk profile, especially compared to Indian children. These differences, not simply reflecting greater adiposity, emphasize the need for prevention strategies starting in childhood or earlier.

Objective: To develop and validate a tool that screens for back pain prognostic indicators relevant to initial decision making in primary care., Methods: The setting was UK primary care adults with nonspecific back pain. Constructs that were independent prognostic indicators for persistence were identified from secondary analysis of 2 existing cohorts and published literature. Receiver operating characteristic curve analysis identified single screening questions for relevant constructs. Psychometric properties of the tool, including concurrent and discriminant validity, internal consistency, and repeatability, were assessed within a new development sample (n = 131) and tool score cutoffs were established to enable allocation to 3 subgroups (low, medium, and high risk). Predictive and external validity were evaluated within an independent external sample (n = 500)., Results: The tool included 9 items: referred leg pain, comorbid pain, disability (2 items), bothersomeness, catastrophizing, fear, anxiety, and depression. The latter 5 items were identified as a psychosocial subscale. The tool demonstrated good reliability and validity and was acceptable to patients and clinicians. Patients scoring 0-3 were classified as low risk, and those scoring 4 or 5 on a psychosocial subscale were classified as high risk. The remainder were classified as medium risk., Conclusion: We validated a brief screening tool, which is a promising instrument for identifying subgroups of patients to guide the provision of early secondary prevention in primary care. Further work will establish whether allocation to treatment subgroups using the tool, linked with targeting treatment appropriately, improves patient outcomes.

Objectives: Muscle-thin but adipose ('thin-fat') body composition of south Asian adults contributes to their high risk of type 2 diabetes. Studies in Pune, India showed that this phenotype is present at birth. We aimed to determine if south Indian babies have a 'thin-fat' phenotype and if this persists in childhood., Design: Prospective cohort study., Setting: Holdsworth Memorial Hospital, Mysore, India., Subjects: Children (n = 663) whose mothers were recruited from the antenatal clinics., Methods: Weight, length, head, mid-upper-arm, abdominal circumferences; triceps and subscapular skinfolds were measured at birth, one and four years, and compared with white Caucasian babies born in Southampton, UK (birth), and UK and Dutch growth standards (one and four years)., Results: Mysore babies were lighter (2983 g vs 3472 g; -1.10 SD, CI -1.16, -1.02) and smaller in all body measurements than UK neonates (P < 0.001). The deficit was greatest for mid-upper-arm (-1.07 SD), head (-0.89 SD) and abdominal circumferences (-0.73 SD), and least for length (-0.25 SD) and subscapular skinfold thickness (-0.19 SD). Predictors of skinfold thickness were maternal body mass index (P < 0.001) and socio-economic status (P = 0.05). At four years, subscapular skinfold thickness was larger than UK (+0.18 SD, CI +0.11, +0.25; P < 0.001) and Dutch standards (+0.61 SD, CI +0.51, +0.71; P < 0.001), despite all other body measurements remaining smaller. Predictors of 4-year skinfold thickness were neonatal skinfold thickness (P = 0.001) and maternal insulin concentrations (P = 0.05)., Conclusions: Mysore newborns have a 'thin-fat' phenotype. This may reflect the action of genes and/or the 'maternal environment'. The phenotype persists in childhood, and may be the forerunner of a diabetogenic adult phenotype.