Patients' and clinicians' perspectives towards primary care consultations for shoulder pain: qualitative findings from the Prognostic and Diagnostic Assessment of the Shoulder (PANDA-S) programme.

BACKGROUND: Clinical management of musculoskeletal shoulder pain can be challenging due to diagnostic uncertainty, variable prognosis and limited evidence for long-term treatment benefits. The UK-based PANDA-S programme (Prognostic And Diagnostic Assessment of the Shoulder) is investigating short and long-term shoulder pain outcomes. This paper reports linked qualitative research exploring patients' and clinicians' views towards primary care consultations for shoulder pain. METHODS: Semi-structured interviews were conducted with 24 patients and 15 primary care clinicians. Twenty-two interviews (11 patients, 11 clinicians) were conducted as matched patient-clinician 'dyads'. Data were analysed thematically. RESULTS: Clinicians reported attempts to involve patients in management decisions; however, there was variation in whether patients preferred treatment choice, or for decisions to be clinician-led. Some patients felt uncertain about the decisions made, due to a lack of discussion about available management options. Many General Practitioners expressed a lack of confidence in diagnosing the underlying cause of shoulder pain. Patients reported either not being given a diagnosis, or receiving different diagnoses from different professionals, resulting in confusion. Whilst clinicians reported routinely discussing prognosis of shoulder pain, patients reported that prognosis was not raised. Patients also expressed concern that their shoulder pain could be caused by serious pathology; however, clinicians felt that this was not a common concern for patients. CONCLUSIONS: Findings showed disparities between patients' and clinicians' views towards shoulder pain consultations, indicating a need for improved patient-clinician communication. Findings will inform the design of an intervention to support treatment and referral decisions for shoulder pain that will be tested in a randomised controlled trial.

A systematic review of the global prevalence and incidence of shoulder pain.

BACKGROUND AND OBJECTIVES: Studies reporting on the population burden of people living with shoulder pain show wide heterogeneity in terms of case definition, study samples, and occurrence. This systematic review aims to summarize evidence pertaining to the prevalence and incidence of shoulder pain, including variability based on sex and geography. We also explored the potential influence of methodological limitations and important sources of heterogeneity (case definition and reference period) on reported estimates of shoulder pain prevalence. DATABASES AND DATA TREATMENT: The study protocol was registered on Prospero under CRD42021243140. We searched EMBASE, CINAHL, Web of Science and Medline from inception to March 2021. Study selection, data extraction and risk of bias assessment was conducted by a team of three researchers. We performed a narrative synthesis of the data, using forest plots to summarize study findings, and stratified data presentation to explore the potential association of risk of bias, case definition, and reference period with estimates of prevalence and incidence of shoulder pain. RESULTS: We obtained data from 61 studies reporting data from high-, middle- and low-income countries. The overall risk of bias was low, with most rated as "low-risk" and no studies rated as "high-risk". The community prevalence of shoulder pain varied widely across the countries included in our review, with a median of 16% (range 0.67 to 55.2%). Longer reference periods were typically associated with higher prevalence estimates. Primary care prevalence ranged from 1.01 to 4.84% (median 2.36%). Estimates were generally higher for women than men and were higher in high-income nations. The incidence of shoulder pain ranged from 7.7 to 62 per 1000 persons per year (median 37.8 per 1000 persons per year). Risk of bias did not clearly explain variability in study findings, but there was considerable variation in study samples, methods used, and a relative absence of data from low-income countries. CONCLUSIONS: Our review demonstrates that a significant proportion of the population across the world will experience shoulder pain daily, yearly, and throughout a lifetime. Regional gaps in evidence and methodological inconsistencies must be addressed in order to establish a more definitive global burden.

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021.

Since the second version of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations were published in 2015, therapeutic options for psoriatic arthritis (PsA) have advanced considerably. This work reviews the literature since the previous recommendations (data published 2013-2020, including conference presentations between 2017 and 2020) and reports high-quality, evidence-based, domain-focused recommendations for medication selection in PsA developed by GRAPPA clinicians and patient research partners. The overarching principles for the management of adults with PsA were updated by consensus. Principles considering biosimilars and tapering of therapy were added, and the research agenda was revised. Literature searches covered treatments for the key domains of PsA: peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis; additional searches were performed for PsA-related conditions (uveitis and inflammatory bowel disease) and comorbidities. Individual subcommittees used a GRADE-informed approach, taking into account the quality of evidence for therapies, to generate recommendations for each of these domains, which were incorporated into an overall schema. Choice of therapy for an individual should ideally address all disease domains active in that patient, supporting shared decision-making. As safety issues often affect potential therapeutic choices, additional consideration was given to relevant comorbidities. These GRAPPA treatment recommendations provide up-to-date, evidence-based guidance on PsA management for clinicians and people with PsA.

Do recommended interventions widen or narrow inequalities in musculoskeletal health? An equity-focussed systematic review of differential effectiveness.

BACKGROUND: It is unclear whether seven interventions recommended by Public Health England for preventing and managing common musculoskeletal conditions reduce or widen health inequalities in adults with musculoskeletal conditions. METHODS: We used citation searches of Web of Science (date of 'parent publication' for each intervention to April 2021) to identify original research articles reporting subgroup or moderator analyses of intervention effects by social stratifiers defined using the PROGRESS-Plus frameworks. Randomized controlled trials, controlled before-after studies, interrupted time series, systematic reviews presenting subgroup/stratified analyses or meta-regressions, individual participant data meta-analyses and modelling studies were eligible. Two reviewers independently assessed the credibility of effect moderation claims using Instrument to assess the Credibility of Effect Moderation Analyses. A narrative approach to synthesis was used (PROSPERO registration number: CRD42019140018). RESULTS: Of 1480 potentially relevant studies, seven eligible analyses of single trials and five meta-analyses were included. Among these, we found eight claims of potential differential effectiveness according to social characteristics, but none that were judged to have high credibility. CONCLUSIONS: In the absence of highly credible evidence of differential effectiveness in different social groups, and given ongoing national implementation, equity concerns may be best served by investing in monitoring and action aimed at ensuring fair access to these interventions.

Long-term clinical and socio-economic outcomes following wrist fracture: a systematic review and meta-analysis.

A comprehensive review of studies shows that patients with wrist fracture, aged over 50 years, experience pain and functional limitation long after fracture. This is associated with increased healthcare costs, and reduced quality of life. Understanding factors that predict poor outcomes is important for future healthcare policy and planning. PURPOSE: To summarise and appraise evidence on the prognosis and long-term clinical and socio-economic outcomes following wrist fracture among adults aged 50 years and over. METHODS: Five databases (MEDLINE, EMBASE, AMED, CINAHL-P and PsycINFO) were comprehensively searched (supplemented by a grey-literature search) from inception till June 2021 for prospective/retrospective cohort studies of patients (≥ 50 years) with a history of wrist fracture and reporting long-term (≥ 6 months) outcomes. Peer study selection, data extraction and risk of bias assessment were conducted. A random effects meta-analysis was used to summarise estimates of pain and function outcomes. RESULTS: 78 studies (n = 688,041 patients) were included. Patients report persistent moderate to severe pain (range: 7.5%-62%) and functional limitations (range: 5.5-78%) up to 12-months or later after wrist fracture. Mean Patient-Rated Wrist Evaluation (PRWE) score for pain and function (9 studies, n = 1759 patients) was 15.23 (95%CI 12.77, 17.69) at 6-months to 13-years follow-up. Mean disabilities of the arm, shoulder and hand (DASH) score (9 studies, n = 1346 patients) was 13.82 (95%CI 12.71, 14.93)( at 6- to 17-months follow-up. A 10-20% increase in healthcare encounters in the first 12-months after fracture was observed. Twelve prognostic factors were associated with poor long-term outcomes. CONCLUSION: Evidence shows that a high proportion of people aged over 50 years with wrist fracture experience pain and functional limitation > 6 months after fracture. This is associated with increased healthcare costs, and reduced quality of life. Exploratory evidence was found for several candidate prognostic factors. Their predictive performance needs to be investigated further. PROSPERO: CRD42018116478.

[Clinical decision-making: from diagnosis to prognosis-oriented approach]. / Klinische besluitvorming.

Traditionally, diagnosis is the basis for clinical decision-making and regarded as the guide to prognosis and treatment. Although some patients may particularly benefit such a diagnosis-oriented approach (e.g., patients with acute pathology for which effective treatment is available), this approach is not suitable or sufficient for others (e.g., patients without a diagnosis, patients with a diagnosis for which no treatment is available, and patients for whom the current treatment is insufficient). Furthermore, other factors than diagnosis or diagnosis-guided treatment are likely to influence an individual's outcome (prognosis), including biological, clinical, and social factors. The authors propose a prognosis-oriented approach as an alternative starting point for medical decision-making: not only ask yourself 'what is the explanation for my patient's complaint?', but also 'which factors contribute to the future outcome of this complaint?' and 'can I address these to benefit my patient's outcome?'.

Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.

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.

Moderators of the effects of therapeutic exercise for people with knee and hip osteoarthritis: A systematic review of sub-group analyses from randomised controlled trials.

Objective: 1) To identify potential moderators of the effect of therapeutic exercise explored in randomised controlled trials (RCTs) of knee and hip osteoarthritis (OA); 2) summarise the extent, strength and quality of evidence reported for moderators. Design: Systematic review (PROSPERO CRD42019148074). Inclusion criteria: a) RCTs with sub-group analyses investigating potential moderator variables; b) participants with knee and/or hip OA; c) therapeutic exercise interventions compared to either no exercise control or alternative exercise intervention(s), and; d) measuring pain or physical function outcomes. Included RCTs' risk of bias and sub-group analysis quality were assessed. Data were extracted on sub-group analyses (methods and potential moderators), outcomes (pain and function) and sub-group findings (associated statistics of potential moderator∗intervention effects). Findings were analysed using narrative synthesis. Results: 14 RCTs were included; 13 knee OA RCTs (n = 2743 participants) explored 23 potential moderators and 1 hip OA RCT (n = 203) explored 6 potential moderators. Sub-group analysis quality was mixed. Knee varus malalignment was the only moderator of therapeutic exercise compared to non-exercise control in 1 RCT (WOMAC-pain adjusted difference 12.7 in the neutral alignment sub-group and 1.8 in the malaligned sub-group, interaction term: p = 0.02). Varus thrust, knee laxity/instability, obesity and cardiac problems all moderated the effect of therapeutic exercise on pain or function compared to different comparison exercise. Conclusions: Therapeutic exercise may be effective for reducing pain in people with knee OA and neutral alignment but not for those with varus malalignment. The exercise moderator literature is limited. More robust evidence is required to inform sub-group exercise selection.

The Development and Content of the Vocational Advice Intervention and Training Package for the Study of Work and Pain (SWAP) Trial (ISRCTN 52269669).

Purpose There are substantial costs associated with sickness absence and struggling at work however existing services in the UK are largely restricted to those absent from work for greater than 6 months. This paper details the development of an early Vocational Advice Intervention (VAI) for adult primary care consulters who were struggling at work or absent due to musculoskeletal pain, and the structure and content of the training and mentoring package developed to equip the Vocational Advisors (VAs) to deliver the VAI, as part of the Study of Work and Pain (SWAP) cluster randomised trial. Methods In order to develop the intervention, we conducted a best-evidence literature review, summarised evidence from developmental studies and consulted with stakeholders. Results A novel early access, brief VAI was developed consisting of case management and stepped care (three steps), using the Psychosocial Flags Framework to identify and overcome obstacles associated with the health-work interface. Four healthcare practitioners were recruited to deliver the VAI; three physiotherapists and one nurse (all vocational advice was actually delivered by the three physiotherapists). They received training in the VA role during a 4-day course, with a refresher day 3 months later, along with monthly group mentoring sessions. Conclusions The process of development was sufficient to develop the VAI and associated training package. The evidence underpinning the VAI was drawn from an international perspective and key components of the VAI have the potential to be applied to other settings or countries, although this has yet to be tested.

Metabolic risk factors and the incidence and progression of radiographic hand osteoarthritis: a population-based cohort study.

OBJECTIVE: To determine whether selected metabolic factors are associated with greater amounts of radiographic hand osteoarthritis (OA) incidence and progression. METHODS: The study identified 706 adults, aged 50-69 years, with hand pain and hand radiographs at baseline, from two population-based cohorts. Metabolic factors (body mass index, hypertension, dyslipidaemia, and diabetes) were ascertained at baseline by direct measurement and medical records. Analyses were undertaken following multiple imputation of missing data, and in complete cases (sensitivity analyses). Multivariable regression models estimated associations between metabolic factors and two measures of radiographic change at 7 years for all participants, individuals free of baseline radiographic OA, and in baseline hand OA subsets. Estimates were adjusted for baseline values and other covariates. RESULTS: The most consistent and strong associations observed were between the presence of diabetes and the amount of radiographic progression in individuals with nodal OA [adjusted mean differences in Kellgren-Lawrence summed score of 4.50 (-0.26, 9.25)], generalized OA [3.27 (-2.89, 9.42)], and erosive OA [3.05 (-13.56, 19.67)]. The remaining associations were generally weak or inconsistent, although numbers were limited for analyses of incident radiographic OA and erosive OA in particular. CONCLUSION: Overall metabolic risk factors were not independently or collectively associated with greater amounts of radiographic hand OA incidence or progression over 7 years, but diabetes was associated with radiographic progression in nodal, and possibly generalized and erosive OA. Diabetes has previously been associated with prevalent but not incident hand OA. Further investigation in hand OA subsets using objective measures accounting for disease duration and control is warranted.

Evidence flowers: An innovative, visual method of presenting "best evidence" summaries to health professional and lay audiences.

BACKGROUND & AIMS: Barriers to dissemination and engagement with evidence pose a threat to implementing evidence-based medicine. Understanding, retention, and recall can be enhanced by visual presentation of information. The aim of this exploratory research was to develop and evaluate the accessibility and acceptability of visual summaries for presenting evidence syntheses with multiple exposures or outcomes to professional and lay audiences. METHODS: "Evidence flowers" were developed as a visual method of presenting data from 4 case scenarios: 2 complex evidence syntheses with multiple outcomes, Cochrane reviews, and clinical guidelines. Petals of evidence flowers were coloured according to the GRADE evidence rating system to display key findings and recommendations from the evidence summaries. Application of evidence flowers was observed during stakeholder workshops. Evaluation and feedback were conducted via questionnaires and informal interviews. RESULTS: Feedback from stakeholders on the evidence flowers collected from workshops, questionnaires, and interviews was encouraging and helpful for refining the design of the flowers. Comments were made on the content and design of the flowers, as well as the usability and potential for displaying different types of evidence. CONCLUSIONS: Evidence flowers are a novel and visually stimulating method for presenting research evidence from evidence syntheses with multiple exposures or outcomes, Cochrane reviews, and clinical guidelines. To promote access and engagement with research evidence, evidence flowers may be used in conjunction with other evidence synthesis products, such as (lay) summaries, evidence inventories, rapid reviews, and clinical guidelines. Additional research on potential adaptations and applications of the evidence flowers may further bridge the gap between research evidence and clinical practice.

Clinical course and prognostic factors across different musculoskeletal pain sites: A secondary analysis of individual patient data from randomised clinical trials.

BACKGROUND: Previous research has identified similar prognostic factors in patients with musculoskeletal (MSK) conditions regardless of pain presentation, generating opportunities for management based on prognosis rather than specific pain presentation. METHODS: Data from seven RCTs (2483 participants) evaluating a range of primary care interventions for different MSK pain conditions were used to investigate the course of symptoms and explore similarities and differences in predictors of outcome. The value of pain site for predicting changes in pain and function was investigated and compared with that of age, gender, social class, pain duration, widespread pain and level of anxiety/depression. RESULTS: Over the initial three months of follow-up, changes in mean pain intensity reflected an improvement, with little change occurring after this period. Participants with knee pain due to osteoarthritis (OA) showed poorer long-term outcome (mean difference in pain reduction at 12 months -1.85, 95% CI -2.12 to -1.57, compared to low back pain). Increasing age, manual work, longer pain duration, widespread pain and increasing anxiety/depression scores were significantly associated with poorer outcome regardless of pain site. Testing of interactions showed some variation between pain sites, particularly for knee OA, where age, manual work and pain duration were most strongly associated with outcome. CONCLUSIONS: Despite some differences in prognostic factors for trial participants with knee OA who were older and had more chronic conditions, similarity of outcome predictors across regional MSK pain sites provides evidence to support targeting of treatment based on prognostic factors rather than site of pain. SIGNIFICANCE: Individual patient data analysis of trials across different regional musculoskeletal pain sites was used to evaluate course and prognostic factors associated with pain and disability. Overall, similarity of outcome predictors across these different pain sites supports targeting of treatment based on prognostic factors rather than pain site alone.

Physiotherapist-led suprascapular nerve blocks for persistent shoulder pain: Evaluation of a new service in the UK.

INTRODUCTION: This service evaluation explored and reported findings from a new physiotherapist-led service offering suprascapular nerve blocks (SSNBs) to patients with persistent shoulder pain. METHODS: We collected data before the SSNB injection and at the 6-weeks and 6-month follow-up from consecutive patients with persistent shoulder pain being treated by physiotherapists or an anaesthetist. Outcomes were patient-reported pain (numerical rating scale [NRS 0 to 10]), patient-specific functional score (PSFS) and health-related quality of life [the EuroQol five dimensions questionnaire (EQ5D-5 L)]. Exploratory analyses compared baseline and follow-up scores within each clinician delivery group (physiotherapists, anaesthetist). RESULTS: Forty patients (mean age 57 years [standard deviation {SD} 12]; 63% female) received an SSNB from a physiotherapist, eight patients (mean age 59 years [SD 11]; female 88%) received an SSNB from an anaesthetist. At the 6-week follow-up, the physiotherapy group showed a mean reduction in pain (on the NRS): 2.2 (95% confidence interval [CI] 1.3 to 3.0) and an improvement in function (on the PSFS): -1.3 (95% CI -1.9 to -0.4). Similar changes were found in those treated by the anaesthetist (pain: 1.3 [95% CI -1.18 to 3.80]; function: -1.4 (95% CI -3.18 to 0.35]). Very small changes, that were not statistically significant, were found in EQ5D-5 L scores. At the 6-month follow-up, the mean reduction in pain (NRS) was maintained at 2.0 (95% CI 0.99 to 2.95) for the physiotherapy group. CONCLUSION: The results provide early, exploratory evidence that patients with persistent shoulder pain treated by physiotherapists using palpation-guided SSNBs achieve clinically important changes in pain and function in the short and medium term.

Brief pain re-assessment provided more accurate prognosis than baseline information for low-back or shoulder pain.

BACKGROUND: Research investigating prognosis in musculoskeletal pain conditions has only been moderately successful in predicting which patients are unlikely to recover. Clinical decision making could potentially be improved by combining information taken at baseline and re-consultation. METHODS: Data from four prospective clinical cohorts of adults presenting to UK and Dutch primary care with low-back or shoulder pain was analysed, assessing long-term disability at 6 or 12 months and including baseline and 4-6 week assessments of pain. Baseline versus short-term assessments of pain, and previously validated multivariable prediction models versus repeat assessment, were compared to assess predictive performance of long-term disability outcome. A hypothetical clinical scenario was explored which made efficient use of both baseline and repeated assessment to identify patients likely to have a poor prognosis and decide on further treatment. RESULTS: Short-term repeat assessment of pain was better than short-term change or baseline score at predicting long-term disability improvement across all cohorts. Short-term repeat assessment of pain was only slightly more predictive of long-term recovery (c-statistics 0.78, 95% CI 0.74 to 0.83 and 0.75, 95% CI 0.69 to 0.82) than a multivariable baseline prognostic model in the two cohorts presenting such a model (c-statistics 0.71, 95% CI 0.67 to 0.76 and 0.72, 95% CI 0.66 to 0.78). Combining optimal prediction at baseline using a multivariable prognostic model with short-term repeat assessment of pain in those with uncertain prognosis in a hypothetical clinical scenario resulted in reduction in the number of patients with an uncertain probability of recovery, thereby reducing the instances where patients may be inappropriately referred or reassured. CONCLUSIONS: Incorporating short-term repeat assessment of pain into prognostic models could potentially optimise the clinical usefulness of prognostic information.

Applying causal mediation methods to clinical trial data: What can we learn about why our interventions (don't) work?

BACKGROUND: Many randomized controlled trials (RCTs) of psychosocial interventions for low back pain (LBP) have been found to have only small effects on disability outcomes. Investigations of the specific mechanisms that may lead to an improvement in outcome have therefore been called for. METHODS: We present an application of the causal inference approach to mediation analysis using the example of a cluster RCT in a primary care population with (sub)acute LBP randomized to either usual GP care (n = 171) or a minimal psychosocial intervention (n = 143). Mediation analysis explored the causal pathway between treatment allocation and disability at 3 months by considering pain catastrophizing, fear-avoidance beliefs, distress and receiving and following advice as potential mediators, all measured at 6 weeks. We have attempted to explain this approach to mediation analysis in a step-by-step manner to help clinical researchers apply this method more easily. RESULTS: In unadjusted mediation analyses, fear-avoidance beliefs were identified as a mediator of treatment on disability, with an indirect effect of -0.30 (95% CI: -0.86, -0.03), although this relationship was found to be non-significant after adjusting for age, gender and baseline scores. This finding supports the trial authors' hypothesis that while fear-avoidance beliefs are important, this intervention may not have targeted them strongly enough to lead to change. CONCLUSION: The use of mediation analysis to identify what factors may be part of the causal pathway between intervention and outcome, regardless of whether the intervention was successful, can provide useful information and insight into how to improve future interventions. SIGNIFICANCE: This study presents a step-by-step approach to mediation analysis using the causal inference framework to investigate why a psychosocial intervention for LBP was unsuccessful. Fear-avoidance beliefs were found to mediate the relationship between treatment and disability, although not when controlling for baseline scores.

Does a modified STarT Back Tool predict outcome with a broader group of musculoskeletal patients than back pain? A secondary analysis of cohort data.

OBJECTIVES: The STarT Back Tool has good predictive performance for non-specific low back pain in primary care. We therefore aimed to investigate whether a modified STarT Back Tool predicted outcome with a broader group of musculoskeletal patients, and assessed the consequences of using existing risk-group cut-points across different pain regions. SETTING: Secondary analysis of prospective data from 2 cohorts: (1) outpatient musculoskeletal physiotherapy services (PhysioDirect trial n=1887) and (2) musculoskeletal primary-secondary care interface services (SAMBA study n=1082). PARTICIPANTS: Patients with back, neck, upper limb, lower limb or multisite pain with a completed modified STarT Back Tool (baseline) and 6-month physical health outcome (Short Form 36 (SF-36)). OUTCOMES: Area under the receiving operator curve (AUCs) tested discriminative abilities of the tool's baseline score for identifying poor 6-month outcome (SF-36 lower tertile Physical Component Score). Risk-group cut-points were tested using sensitivity and specificity for identifying poor outcome using (1) Youden's J statistic and (2) a clinically determined rule that specificity should not fall below 0.7 (false-positive rate <30%). RESULTS: In PhysioDirect and SAMBA, poor 6-month physical health was 18.5% and 28.2%, respectively. Modified STarT Back Tool score AUCs for predicting outcome in back pain were 0.72 and 0.79, neck 0.82 and 0.88, upper limb 0.79 and 0.86, lower limb 0.77 and 0.83, and multisite pain 0.83 and 0.82 in PhysioDirect and SAMBA, respectively. Differences between pain region AUCs were non-significant. Optimal cut-points to discriminate low-risk and medium-risk/high-risk groups depended on pain region and clinical services. CONCLUSIONS: A modified STarT Back Tool similarly predicts 6-month physical health outcome across 5 musculoskeletal pain regions. However, the use of consistent risk-group cut-points was not possible and resulted in poor sensitivity (too many with long-term disability being missed) or specificity (too many with good outcome inaccurately classified as 'at risk') for some pain regions. The draft tool is now being refined and validated within a new programme of research for a broader musculoskeletal population. TRIAL REGISTRATION NUMBER: ISRCTN55666618; Post results.

Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?

PURPOSE: Back pain is a common problem and has significant societal impact. Sickness certification is commonly issued to patients consulting their general practitioner with low back pain. The aim of this study was to investigate the association of certification for low back pain with clinical outcomes and cost consequences. METHODS: A prospective cohort study using linked questionnaire and medical record data from 806 low back pain patients in 8 UK general practices: comparison of 116 (14.4%) who received a sickness certificate versus 690 who did not receive certification. The primary clinical measure was the Roland and Morris Disability Questionnaire (RMDQ). Data on back pain consultation and work absenteeism were used to calculate healthcare and societal costs. RESULTS: Participants issued a sickness certificate had higher back-related disability at baseline consultation and 6-month follow-up [mean difference 3.1 (95% CI 1.8, 4.4) on the RMDQ], indicating worse health status. After fully adjusting for baseline differences, most changes in clinical outcomes at 6 months were not significantly different between study groups. Productivity losses were significantly higher for the certification group, with most absence occurring after the expected end of certification; mean difference in costs due to absenteeism over 6 months was £1,956 (95% CI £941, £3040). CONCLUSIONS: There was no clear evidence of a difference in clinical outcomes between individuals issued a sickness certificate and those not issued a certification for their back pain. With little overall contrast in clinical outcomes, policy makers and care providers may wish to draw on the likely difference in societal costs alongside issues in ethical and moral care in their consideration of patient care for low back pain.

Pain trajectory groups in persons with, or at high risk of, knee osteoarthritis: findings from the Knee Clinical Assessment Study and the Osteoarthritis Initiative.

OBJECTIVE: The authors aimed to characterize distinct trajectories of knee pain in adults who had, or were at high risk of, knee osteoarthritis using data from two population-based cohorts. METHOD: Latent class growth analysis was applied to measures of knee pain severity on activity obtained at 18-month intervals for up to 6 years between 2002 and 2009 from symptomatic participants aged over 50 years in the Knee Clinical Assessment Study (CAS-K) in the United Kingdom. The optimum latent class growth model from CAS-K was then tested for reproducibility in a matched sample of participants from the Osteoarthritis Initiative (OAI) in the United States. RESULTS: A 5-class linear model produced interpretable trajectories in CAS-K with reasonable goodness of fit and which were labelled "Mild, non-progressive" (N = 201, 35%), "Progressive" (N = 162, 28%), "Moderate" (N = 124, 22%) "Improving" (N = 68, 12%), and "Severe, non-improving" (N = 15, 3%). We were able to reproduce "Mild, non-progressive", "Moderate", and "Severe, non-improving" classes in the matched sample of participants from the OAI, however, absence of a "Progressive" class and instability of the "Improving" classes in the OAI was observed. CONCLUSIONS: Our findings strengthen the grounds for moving beyond a simple stereotype of osteoarthritis as "slowly progressive". Mild, non-progressive or improving symptom trajectories, although difficult to reproduce, can nevertheless represent a genuinely favourable prognosis for a sizeable minority.

Pig-to-monkey islet xenotransplantation using multi-transgenic pigs.

The generation of pigs with genetic modifications has significantly advanced the field of xenotransplantation. New genetically engineered pigs were produced on an α1,3-galactosyltransferase gene-knockout background with ubiquitous expression of human CD46, with islet beta cell-specific expression of human tissue factor pathway inhibitor and/or human CD39 and/or porcine CTLA4-lg. Isolated islets from pigs with 3, 4 or 5 genetic modifications were transplanted intraportally into streptozotocin-diabetic, immunosuppressed cynomolgus monkeys (n = 5). Immunosuppression was based on anti-CD154 mAb costimulation blockade. Monitoring included features of early islet destruction, glycemia, exogenous insulin requirement and histopathology of the islets at necropsy. Using these modified pig islets, there was evidence of reduced islet destruction in the first hours after transplantation, compared with two series of historical controls that received identical therapy but were transplanted with islets from pigs with either no or only one genetic modification. Despite encouraging effects on early islet loss, these multi-transgenic islet grafts did not demonstrate consistency in regard to long-term success, with only two of five demonstrating function beyond 5 months.