Musculoskeletal Health and Work: Development and Internal-External Cross-Validation of a Model to Predict Risk of Work Absence and Presenteeism in People Seeking Primary Healthcare.

PURPOSE: To develop and validate prediction models for the risk of future work absence and level of presenteeism, in adults seeking primary healthcare with musculoskeletal disorders (MSD). METHODS: Six studies from the West-Midlands/Northwest regions of England, recruiting adults consulting primary care with MSD were included for model development and internal-external cross-validation (IECV). The primary outcome was any work absence within 6 months of their consultation. Secondary outcomes included 6-month presenteeism and 12-month work absence. Ten candidate predictors were included: age; sex; multisite pain; baseline pain score; pain duration; job type; anxiety/depression; comorbidities; absence in the previous 6 months; and baseline presenteeism. RESULTS: For the 6-month absence model, 2179 participants (215 absences) were available across five studies. Calibration was promising, although varied across studies, with a pooled calibration slope of 0.93 (95% CI: 0.41-1.46) on IECV. On average, the model discriminated well between those with work absence within 6 months, and those without (IECV-pooled C-statistic 0.76, 95% CI: 0.66-0.86). The 6-month presenteeism model, while well calibrated on average, showed some individual-level variation in predictive accuracy, and the 12-month absence model was poorly calibrated due to the small available size for model development. CONCLUSIONS: The developed models predict 6-month work absence and presenteeism with reasonable accuracy, on average, in adults consulting with MSD. The model to predict 12-month absence was poorly calibrated and is not yet ready for use in practice. This information may support shared decision-making and targeting occupational health interventions at those with a higher risk of absence or presenteeism in the 6 months following consultation. Further external validation is needed before the models' use can be recommended or their impact on patients can be fully assessed.

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

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).

The SelfSTarT intervention for low back pain patients presenting to first contact physiotherapists: A mixed methods service evaluation.

INTRODUCTION: Globally, back pain is the leading cause of years of disability. In the United Kingdom, over 20 million people live with musculoskeletal (MSK) pain, with low back pain being one of the most common causes. National strategies promote self-management and the use of digital technologies to empower populations. AIMS: To evaluate the uptake and impact of providing the SelfSTart approach (STarT Back and SelfBACK App) when delivered by a First Contact Physiotherapist (FCP) to people presenting with low back pain in primary care. METHODS: Patients presenting with a new episode of low back pain underwent routine assessment and completion of a STarT Back questionnaire. Patients with low/medium scores were offered the SelfBACK App. A control population was provided by the MIDAS-GP study. Patient Experience, outcome measures, healthcare utilisation and retention were captured through the app and clinical systems (EMIS). Interviews with five FCPs explored the experiences of using the SelfSTart approach. RESULTS: SelfSTarT was taken up by almost half (48%) of those to whom it was offered. Compared to MIDAS-GP, users were more likely to be younger, male, in work, and with higher health literacy. SelfSTarT users reported significant improved experiences relating to receiving an agreed care plan and receiving sufficient information. There were no significant differences in treatments offered. FCPs were positive about the app and felt it had value but wanted feedback on patient progress. They recognised that a digital solution would not be suitable for all. CONCLUSION: This approach offers an opportunity to empower and support self-management, using robustly evaluated digital technology.

Exploring the feasibility and acceptance of an optimised physiotherapy approach for lateral elbow tendinopathy: a qualitative investigation within the OPTimisE trial.

OBJECTIVES: To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial. DESIGN: Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change. SETTING: Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service. PARTICIPANTS: 17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators. RESULTS: Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists. CONCLUSIONS: Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation. TRIAL REGISTRATION NUMBER: ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

Validation of the Keele STarT MSK Tool for Patients With Musculoskeletal Pain in United States-based Outpatient Physical Therapy Settings.

The STarT MSK tool was developed to enable risk stratification of patients with common musculoskeletal (MSK) pain conditions and help identify individuals who may require more targeted interventions or closer monitoring in primary care settings, however, its validity in U.S.-based outpatient physical therapy settings has not been investigated. The 10-item Keele STarT MSK risk stratification tool was tested for construct (convergent and discriminant) and predictive validity using a multicenter, prospective cohort study design. Participants (n = 141) receiving physical therapy for MSK pain of the back, neck, shoulder, hip, knee, or multisite regions completed intake questionnaires including the Keele STarT MSK tool, Functional Comorbidity Index (FCI), Optimal Screening for Prediction of Referral and Outcome Review-of-Systems and Optimal Screening for Prediction of Referral and Outcome Yellow Flag tools. Pain intensity, pain interference, and health-related quality of life (Medical Outcomes Study 8-item Short-Form Health Survey (SF-8) physical [PCS] and mental [MCS] component summary scores) were measured at 2- and 6-month follow-up. Participants were classified as STarT MSK tool low (44%), medium (39%), and high (17%) risk. Follow-up rates were 70.2% (2 months) and 49.6% (6 months). For convergent validity, fair relationships were observed between the STarT MSK tool and FCI and SF-8 MCS (r = .35-.37) while moderate-to-good relationships (r = .51-.72) were observed for 7 other clinical measures. For discriminant validity, STarT MSK tool risk-dependent relationships were observed for Optimal Screening for Prediction of Referral and Outcome Review-of-Systems, Optimal Screening for Prediction of Referral and Outcome Yellow Flag, pain interference, and SF-8 PCS (low < medium < high; P < .01) and FCI, pain intensity, and SF-8 MCS (low < medium-or-high; P < .01). For predictive validity, intake STarT MSK tool scores explained additional variability in pain intensity (11.2%, 20.0%), pain interference (7.5%, 14.1%), and SF-8 PCS (8.2%, 12.8%) scores at 2 and 6 months, respectively. This study contributes to the existing literature by providing additional evidence of STarT MSK tool cross-sectional construct validity and longitudinal predictive validity. PERSPECTIVE: This study presents STarT MSK risk stratification tool validity findings from a U.S. outpatient physical therapy sample. The STarT MSK tool has the potential to help physical therapists identify individuals presenting with the most common MSK pain conditions who may require more targeted interventions or closer monitoring.

Development and External Validation of Individualized Prediction Models for Pain Intensity Outcomes in Patients With Neck Pain, Low Back Pain, or Both in Primary Care Settings.

OBJECTIVE: The purpose of this study was to develop and externally validate multivariable prediction models for future pain intensity outcomes to inform targeted interventions for patients with neck or low back pain in primary care settings. METHODS: Model development data were obtained from a group of 679 adults with neck or low back pain who consulted a participating United Kingdom general practice. Predictors included self-report items regarding pain severity and impact from the STarT MSK Tool. Pain intensity at 2 and 6 months was modeled separately for continuous and dichotomized outcomes using linear and logistic regression, respectively. External validation of all models was conducted in a separate group of 586 patients recruited from a similar population with patients' predictor information collected both at point of consultation and 2 to 4 weeks later using self-report questionnaires. Calibration and discrimination of the models were assessed separately using STarT MSK Tool data from both time points to assess differences in predictive performance. RESULTS: Pain intensity and patients reporting their condition would last a long time contributed most to predictions of future pain intensity conditional on other variables. On external validation, models were reasonably well calibrated on average when using tool measurements taken 2 to 4 weeks after consultation (calibration slope = 0.848 [95% CI = 0.767 to 0.928] for 2-month pain intensity score), but performance was poor using point-of-consultation tool data (calibration slope for 2-month pain intensity score of 0.650 [95% CI = 0.549 to 0.750]). CONCLUSION: Model predictive accuracy was good when predictors were measured 2 to 4 weeks after primary care consultation, but poor when measured at the point of consultation. Future research will explore whether additional, nonmodifiable predictors improve point-of-consultation predictive performance. IMPACT: External validation demonstrated that these individualized prediction models were not sufficiently accurate to recommend their use in clinical practice. Further research is required to improve performance through inclusion of additional nonmodifiable risk factors.

Lived experience of people with lateral elbow tendinopathy: a qualitative study from the OPTimisE pilot and feasibility trial.

OBJECTIVES: To explore the lived experience of people with lateral elbow tendinopathy (LET) and its impact on everyday life. DESIGN: Qualitative semi-structured interviews, analysed using thematic analysis. SETTING: Conducted as part of the mixed-methods OPTimisE pilot and feasibility randomised controlled trial of outpatient physiotherapy patients in the UK. PARTICIPANTS: 17 participants with LET, purposively sampled from the trial to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation. RESULTS: Four themes were identified from the participants' responses: (1) cause of onset-typically symptoms were attributed to: sudden changes in activity, repetitive work or compensating for other musculoskeletal conditions; (2) impact on everyday life-which included substantial impacts on quality-of-life, particularly due to pain disturbing sleep and difficulties performing daily tasks (related to work and hobbies) due to pain, although most reported being able to persevere with work; (3) self-help and understanding of the condition-with uncertainty about the appropriateness and potential harm of online advice and confusion from the diagnostic term 'Tennis Elbow' that non-sporting individuals struggled to relate to; (4) healthcare experiences-the treatments received were highly variable and often perceived as ineffectual. CONCLUSIONS: For the first time, the lived experience of people from a range of backgrounds suffering from LET has been explored. Findings suggest that people frequently related the cause to a specific activity. They reported substantial impacts on daily tasks, sleep, work and hobbies. People also reported hesitancy to trust online information without formal healthcare advice, were confused by the common label of 'Tennis Elbow', and perceived the wide array of healthcare treatment options they had received to offer false hope and be largely ineffective. This study provides stimulus for clinicians to consider the advice and treatment provided, and whether the messages conveyed reflect the favourable natural history of the condition. TRIAL REGISTRATION NUMBER: ISRCTN64444585.

The Swedish version of the STarT MSK Tool: cross-cultural adaption, test-retest reliability, and aspects of validity.

BACKGROUND: Musculoskeletal disorders (MSDs) are a common reason for seeking primary health care. The STarT Musculoskeletal (MSK) tool is designed to stratify patients suffering from MSDs to risk groups, based on prognostic factors. AIM: The aim was to translate and cross-culturally adapt the STarT MSK tool in a Swedish primary health care context through testing of reliability and construct validity. METHODS: We included consecutive patients with MSDs seeking primary care (n = 99). The STarT MSK was translated using international recommendations. Construct validity was investigated by correlation analysis (Spearmans Rho) with the following reference instruments: the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ), the EuroQol 5-dimension (EQ-5D) and the Musculoskeletal Health Questionnaire (MSKHQ). Reliability was tested using test-retest (Intra Class Correlation, ICC2.1) (n = 31). Known-groups validity was calculated with a difference of 10% between risk groups based on how the participants had answered. RESULTS: The STarT MSK was successfully translated into Swedish. The participants were grouped into low risk (n = 28), medium risk (n = 60) and high risk (n = 11). The construct validity showed a moderate to high correlation with the ÖMPQ (r = .61), EQ-5D (r = .59) and MSK-HQ (r = .56). All separate items except item 2 and 9 correlated according to predefined hypotheses. Test-retest demonstrated an excellent reliability for the total score (ICC2.1 0.85) (n = 31). The STarT MSK tool was able to differentiate by 10% between the risk groups, based on how the participants had answered. CONCLUSION: The STarT MSK has been successfully translated and adapted into Swedish and shows acceptable measurement properties regarding test-retest reliability and aspects of validity and seems to be able to discriminate between the proposed risk groups. The tool can therefore be useful in a Swedish primary health care context. A future study needs to determine the tools predictive validity and to investigate if stratification to risk groups leads to a faster recovery and to lower health care costs.

SupportPrim-a computerized clinical decision support system for stratified care for patients with musculoskeletal pain complaints in general practice: study protocol for a randomized controlled trial.

BACKGROUND: Musculoskeletal disorders represented 149 million years lived with disability world-wide in 2019 and are the main cause of years lived with disability worldwide. Current treatment recommendations are based on "one-size fits all" principle, which does not take into account the large degree of biopsychosocial heterogeneity in this group of patients. To compensate for this, we developed a stratified care computerized clinical decision support system for general practice based on patient biopsychosocial phenotypes; furthermore, we added personalized treatment recommendations based on specific patient factors to the system. In this study protocol, we describe the randomized controlled trial for evaluating the effectiveness of computerized clinical decision support system for stratified care for patients with common musculoskeletal pain complaints in general practice. The aim of this study is to test the effect of a computerized clinical decision support system for stratified care in general practice on subjective patient outcome variables compared to current care. METHODS: We will perform a cluster-randomized controlled trial with 44 general practitioners including 748 patients seeking their general practitioner due to pain in the neck, back, shoulder, hip, knee, or multisite. The intervention group will use the computerized clinical decision support system, while the control group will provide current care for their patients. The primary outcomes assessed at 3 months are global perceived effect and clinically important improvement in function measured by the Patient-Specific Function Scale (PSFS), while secondary outcomes include change in pain intensity measured by the Numeric Rating Scale (0-10), health-related quality of life (EQ-5D), general musculoskeletal health (MSK-HQ), number of treatments, use of painkillers, sick-leave grading and duration, referral to secondary care, and use of imaging. DISCUSSION: The use of biopsychosocial profile to stratify patients and implement it in a computerized clinical decision support system for general practitioners is a novel method of providing decision support for this patient group. The study aim to recruit patients from May 2022 to March 2023, and the first results from the study will be available late 2023. TRIAL REGISTRATION: The trial is registered in ISRCTN 11th of May 2022: 14,067,965.

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.

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.

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.

Risk-based stratified primary care for common musculoskeletal pain presentations: qualitative findings from the STarT MSK cluster randomised controlled trial.

BACKGROUND: The STarT MSK cluster randomised controlled trial (RCT) investigated the clinical- and cost-effectiveness of risk-based stratified primary care versus usual care for patients with back, neck, shoulder, knee or multi-site pain. Trial quantitative results showed risk-based stratified care was not superior to usual care for patients' clinical outcomes, but the intervention led to some changes in GP clinical decision-making. This paper reports a linked qualitative study exploring how risk-based stratified care was perceived and used in the trial, from the perspectives of clinicians and patients. METHODS: Semi-structured interviews were conducted with 27 patients, and focus groups and interviews with 20 clinicians (GPs and physiotherapists) in the intervention arm of the trial. Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and the COM-B model. MAIN FINDINGS: Risk-based stratified care (subgrouping and matching treatments) was found to have 'coherence' (i.e. made sense) to several clinicians and patients, in that it was well-integrated in practice, and supported clinical decision-making. However, for some GPs stratified care was less 'meaningful', as the risk-stratification tool did not fit with usual ways of consulting and added to already time-pressured consultations. GPs reported giving more patients written information/advice due to easier access to electronic information leaflets through the trial template and were motivated to refer patients to physiotherapy as they believed the trial resulted in faster physiotherapy access (although this was not the case). Patients and clinicians reported that risk-based stratified care influenced conversations in the consultation, prompting greater attention to psychosocial factors, and facilitating negotiation of treatment options. Physiotherapists saw benefits in receiving information about patients' risk subgroup on referral forms. CONCLUSION: These findings provide context for interpreting some of the trial outcomes, particularly in relation to changes in clinical decision-making when risk-based stratified care was used. Findings also indicate potential reasons for lack of GP engagement with risk-based stratified care. Positive outcomes were identified that were not captured in the quantitative data, specifically that risk-based stratified care positively influenced some GP-patient conversations and facilitated negotiation of treatment options. TRIAL REGISTRATION: ISRCTN15366334 (26/04/2016).

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.

Implementing a new physiotherapist-led primary care model for low back pain: a qualitative study of patient and primary care team perspectives.

BACKGROUND: Low back pain (LBP) is one of the most common reasons for primary care visits and is the leading contributor to years lived with disability worldwide. The purpose of this study was to understand the perspectives of patients and primary care team members related to their experiences with a new physiotherapist-led primary care model for LBP. METHODS: We conducted an interpretive description qualitative study. Data were collected using a combination of semi-structured interviews and focus group discussions and analyzed using thematic analysis. Participants included adults (> 18 years of age) with LBP and primary care team members who participated in a physiotherapist-led primary care model for LBP in Kingston, Ontario, Canada. RESULTS: We conducted 18 semi-structured interviews with patients with LBP (10 women; median age of 52) as well as three focus group discussions with a total of 20 primary care team members representing three teams. Four themes (each with sub-themes) were constructed: 1) enhanced primary care delivery for LBP (improved access and engagement in physiotherapy care, improved communication and care integration between the physiotherapist and primary care team, less inappropriate use of healthcare resources); 2) positive patient experiences and perceived outcomes with the new model of care (physiotherapist built therapeutic alliance, physiotherapist provided comprehensive care, improved confidence in managing LBP, decreased impact of pain on daily life); 3) positive primary care team experiences with the new model of care (physiotherapist fit well within the primary care team, physiotherapist provided expertise on LBP for the primary care team, satisfaction in being able to offer a needed service for patients); and 4) challenges implementing the new model of care (challenges with prompt access to physiotherapy care, challenges making the physiotherapist the first contact for LBP, and opportunities to optimize communication between the physiotherapist and primary care team). CONCLUSIONS: A new physiotherapist-led primary care model for LBP was described by patients and primary care team members as contributing to positive experiences and perceived outcomes for patients, primary care team members, and potentially the health system more broadly. Results suggest that this model of care may be a viable approach to support integrated and guideline adherent management of LBP in primary care settings.

Validation of the German version of the STarT-MSK-Tool: A cohort study with patients from physiotherapy clinics.

BACKGROUND: The STarT-MSK-Tool is an adaptation of the well established STarT-Back-Tool, used to risk-stratify patients with a wider range of musculoskeletal presentations. OBJECTIVE: To formally translate and cross-culturally adapt the Keele STarT-MSK risk stratification tool into German (STarT-MSKG) and to establish its reliability and validity. METHODS: A formal, multi-step, forward and backward translation approach was used. To assess validity patients aged ≥18 years, with acute, subacute or chronic musculoskeletal presentations in the lumbar spine, hip, knee, shoulder, or neck were included. The prospective cohort was used with initial data collected electronically at the point-of-consultation. Retest and 6-month follow-up questionnaires were sent by email. Test-retest reliability, construct validity, discriminative ability, predictive ability and floor or ceiling effects were analysed using intraclass correlation coefficient, and comparisons with a reference standard (Orebro-Musculoskeletal-Pain-Questionnaire: OMPQ) using correlations, ROC-curves and regression models. RESULTS: The participants' (n = 287) mean age was 47 (SD = 15.8) years, 51% were female, with 48.8% at low, 43.6% at medium, and 7.7% at high risk. With ICC = 0.75 (95% CI 0.69; 0.81) test-retest-reliability was good. Construct validity was good with correlations for the STarT-MSKG-Tool against the OMPQ-Tool of rs = 0.74 (95% CI 0.68, 0.79). The ability of the tool [comparison OMPQ] to predict 6-month pain and disability was acceptable with AUC = 0.77 (95% CI 0.71, 0.83) [OMPQ = 0.74] and 0.76 (95% CI 0.69, 0.82) [OMPQ = 0.72] respectively. However, the explained variance (linear/logistic regression) for predicting 6-month pain (21% [OMPQ = 17%]/logistic = 29%) and disability (linear = 20%:[OMPQ = 19%]/logistic = 26%), whilst being comparable to the existing OMPQ reference standard, fell short of the a priori target of ≥30%. CONCLUSIONS: The German version of the STarT-MSK-Tool is a valid instrument for use across multiple musculoskeletal conditions and is availabe for use in clinical practice. Comparison with the OMPQ suggests it is a good alternative.

Stratifying workers on sick leave due to musculoskeletal pain: translation, cross-cultural adaptation and construct validity of the Norwegian Keele STarT MSK tool.

OBJECTIVES: Stratified care using prognostic models to estimate the risk profiles of patients has been increasing. A refined version of the popular STarT Back tool, the Keele STarT MSK tool, is a newly developed model for matched treatment across a wide range of musculoskeletal pain presentations. The aim of this study was to translate and culturally adapt the Keele STarT MSK tool into Norwegian, examine its construct validity and assess the representativeness of the included sample. METHODS: The Keele STarT MSK tool was formally translated into Norwegian following a multistep approach of forward and backward translation. A pre-final version was tested in 42 patients. Minor changes were implemented. To assess its construct validity, an online survey was conducted among workers aged 18-67 years who were on sick leave (>4 weeks) due to musculoskeletal disorders. Construct validity was evaluated in terms of convergent and discriminant validity using Pearson's correlation coefficient, and known-group validity by comparing risk subgroups as suggested by the COSMIN checklist. The representativeness of the sample was assessed by comparing demographic and sick leave information of participants to eligible non-participants (n=168,137). RESULTS: A representative sample of 549 workers participated in the validity assessment; 74 participants (13.5%) were categorised as low risk, 314 (57.2%) as medium risk and 161 (29.3%) as high risk. The construct validity was found sufficient, with 90.9% and 75.0% of the pre-defined hypotheses confirmed for convergent and discriminant validity, and known-group validity, respectively. Floor or ceiling effects were not found. CONCLUSIONS: The Keele STarT MSK tool was successfully translated into Norwegian. The construct validity of the tool was acceptable in a representative cohort of workers on sick leave as a result of musculoskeletal pain. However, the analyses raised concerns as to whether one of the questions captures the construct it is intended to measure.

First Contact Practitioners' (FCPs) and General Practitioners' Perceptions Towards FCPs Delivering Vocational Advice to Patients with Musculoskeletal Conditions: A Qualitative Investigation of the Implementation Potential of the I-SWAP Initiative.

Purpose Musculoskeletal (MSK) pain is a common cause of work absence. The recent SWAP (Study of Work And Pain) randomised controlled trial (RCT) found that a brief vocational advice service for primary care patients with MSK pain led to fewer days' work absence and provided good return-on-investment. The I-SWAP (Implementation of the Study of Work And Pain) initiative aimed to deliver an implementation test-bed of the SWAP vocational advice intervention with First Contact Practitioners (FCP). This entailed adapting the SWAP vocational advice training to fit the FCP role. This qualitative investigation explored the implementation potential of FCPs delivering vocational advice for patients with MSK pain. Methods Semi-structured interviews and focus groups were conducted with 10 FCPs and 5 GPs. Data were analysed thematically and findings explored using Normalisation Process Theory (NPT). Results I-SWAP achieved a degree of 'coherence' (i.e. made sense), with both FCPs and GPs feeling FCPs were well-placed to discuss work issues with these patients. However, for many of the FCPs, addressing or modifying psychosocial and occupational barriers to return-to-work was not considered feasible within FCP consultations, and improving physical function was prioritised. Concerns were also raised that employers would not act on FCPs' recommendations regarding return-to-work. Conclusion FCPs appear well-placed to discuss work issues with MSK patients, and signpost/refer to other services; however, because they often only see patients once they are less suited to deliver other aspects of vocational advice. Future research is needed to explore how best to provide vocational advice in primary care settings.

Development of an optimised physiotherapist-led treatment protocol for lateral elbow tendinopathy: a consensus study using an online nominal group technique.

OBJECTIVES: There are a wide range of physiotherapy treatment options for people with lateral elbow tendinopathy (LET); however, previous studies have reported inconsistent approaches to treatment and a lack of evidence demonstrating clinical effectiveness. This study aimed to combine the best available research evidence with stakeholder perspectives to develop key components of an optimised physiotherapist-led treatment protocol for testing in a future randomised controlled trial (RCT). DESIGN: Online consensus groups using nominal group technique (NGT), a systematic approach to building consensus using structured multistage meetings. SETTING: UK National Health Service (NHS). PARTICIPANTS: 10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET. INTERVENTIONS: Two consensus groups were conducted; the first meeting focused on agreeing the types of interventions to be included in the optimised treatment protocol; the second meeting focused on specific details of intervention delivery. Participants were sent an evidence summary of available treatments for LET prior to the first meeting. All treatment options were discussed before anonymous voting and ranking of priority. Consensus for inclusion of each treatment option was set at ≥70% based on OMERACT guidelines. Options with 30%-69% agreement were discussed again, and a second vote was held, allowing for a change of opinion. RESULTS: The optimised physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics. Specific components for each of these interventions were also agreed such as: condition-specific advice, health-promotion advice, exercise types, exercise into 'acceptable' levels of pain, exercise dosage and type of orthoses. Other treatment options including electrotherapy, acupuncture and manual therapy were excluded. CONCLUSION: An optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach. This intervention is now ready for testing in a future pilot/feasibility RCT to contribute much needed evidence about the treatment of LET. TRIAL REGISTRATION NUMBER: This is the pre-cursor to the OPTimisE Pilot and Feasibility Randomised Controlled Trial. Registration: https://www.isrctn.com/ISRCTN64444585.