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Abstract: There have been at least 7 separate randomised controlled trials published between 2011 and 2023 that have examined primary care for nonspecific low back pain informed by the STarT Back approach to stratified care based on risk prediction, compared with care not informed by this approach. The results, across 4 countries, have been contrasting-some demonstrating effectiveness and/or efficiency of this approach, others finding no benefits over comparison interventions. This review considers possible explanations for the differences, particularly whether this is related to poor predictive performance of the STarT Back risk-prediction tool or to variable degrees of success in implementing the whole STarT Back approach (subgrouping and matching treatments to predicted risk of poor outcomes) in different healthcare systems. The review concludes that although there is room for improving and expanding the predictive value of the STarT Back tool, its performance in allocating individuals to their appropriate risk categories cannot alone explain the variation in results of the trials to date. Rather, the learning thus far suggests that challenges in implementing stratified care in clinical practice and in changing professional practice largely explain the contrasting trial results. The review makes recommendations for future research, including greater focus on studying facilitators of implementation of stratified care and developing better treatments for patients with nonspecific low back pain at high risk of poor outcomes., (Copyright © 2024 International Association for the Study of Pain.)

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.)

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., (© 2024 The Authors. Musculoskeletal Care published by John Wiley & Sons Ltd.)

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., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association.)

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., (© 2022. The Author(s).)

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., Competing Interests: The authors have declared that no competing interests exist.

Background and Objective: This systematic review synthesized evidence from European neck and low back pain (NLBP) clinical practice guidelines (CPGs) to identify recommended treatment options for use across Europe., Databases and Data Treatment: Comprehensive searches of thirteen databases were conducted, from 1st January 2013 to 4th May 2020 to identify up-to-date evidence-based European CPGs for primary care management of NLBP, issued by professional bodies/organizations. Data extracted included; aim and target population, methods for development and implementation and treatment recommendations. The AGREE II checklist was used to critically appraise guidelines. Criteria were devised to summarize and synthesize the direction and strength of recommendations across guidelines., Results: Seventeen CPGs (11 low back; 5 neck; 1 both) from eight European countries were identified, of which seven were high quality. For neck pain, there were consistent weak or moderate strength recommendations for: reassurance, advice and education, manual therapy, referral for exercise therapy/programme, oral analgesics and topical medications, plus psychological therapies or multidisciplinary treatment for specific subgroups. Notable recommendation differences between back and neck pain included, i) analgesics for neck pain (not for back pain); ii) options for back pain-specific subgroups-work-based interventions, return to work advice/programmes and surgical interventions (but not for neck pain) and iii) a greater strength of recommendations (generally moderate or strong) for back pain than those for neck pain., Conclusions: This review of European CPGs identified a range of mainly non-pharmacological recommended treatment options for NLBP that have broad consensus for use across Europe., Significance: Consensus regarding evidence-based treatment recommendations for patients with neck and low back pain (NLBP) from recent European clinical practice guidelines identifies a wide range of predominantly non-pharmacological treatment options. This includes options potentially applicable to all patients with NLBP and those applicable to only specific patient subgroups. Future work within our Back-UP research team will transfer these evidence-based treatment options to an accessible clinician decision support tool for first contact clinicians., (© 2020 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC ®.)

Objective: We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance., Design: Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial., Methods: Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically., Results: Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain)., Conclusions: The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention., (© 2019 American Academy of Pain Medicine.)

The Short form of the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-short) and the STarT Back Tool (SBT) have been developed to screen for risk factors for future low back pain (LBP) -related disability and work loss respectively. The aim of this study was to investigate the accordance of the two questionnaires and to evaluate the accumulation of risk factors in the risk groups of both screening tools in a large population-based sample. The study population consisted of 3079 participants of the Northern Finland Birth Cohort 1966 who had reported LBP over the previous 12 months and had SBT and ÖMPSQ-short data. We evaluated the association of depressive and anxiety symptoms (Hopkins symptom check list-25, Generalized anxiety disorder 7 questionnaire, and Beck's Depression Inventory 21), psychological features (Fear-Avoidance Beliefs Questionnaire), lifestyle characteristics (BMI, smoking, alcohol abuse, physical inactivity) and social factors (education level) with the SBT and ÖMPSQ-short risk groups. The high-risk groups of both questionnaires were associated (p < 0.001) with depressive and anxiety symptoms and fear-avoidance beliefs. In addition, adverse lifestyle factors accumulated in the higher risk groups, especially from the ÖMPSQ-short. Agreement between the two questionnaires was moderate for men and fair for women.

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.)

Background: Low back pain affects about 80% of all adults, many of whom consult general practice. Providing management can be challenging, in part due to the scarcity of effective treatment methods. There is broad consensus in international clinical practice guidelines to provide patients with information about the nature of their pain and recommend them to stay active despite discomfort. Delivering this information is time-demanding and challenged by the limited available resources in general practice in many countries. Furthermore, general practice settings are highly variable in size and in their composition of clinical staff members - which presents difficulties, but also opportunities for developing alternative approaches to clinical management. Expanding the patient consultation time by involving clinical staff members (aside from the general practitioner) has been found feasible for other conditions. We propose that this approach is applied for non-specific low back pain. Consequently, we suggest the involvement of clinical staff members as part of a new strategy for managing low back pain in general practice., Main Text: Multifaceted implementation strategies have the potential to effectively enable change in the clinical management of patients with low back pain in general practice if they are based on theory and are tailored to stake holders. Inspired by the Medical Research Council's guidance for complex interventions and the ChiPP (Change in professional performance) statement, we suggest applying the following two policy categories: organizational change (environmental/social planning) and service provision. This will involve attention to environmental restructuring, modelling, enabling, education, training, persuasion, and incentivising of general practices, with an over-arching strategy of involving clinical staff members in the management of low back pain., Conclusion: This is a pre-clinical proposal of a multifaceted strategy to support the delivery of evidence-based treatment for patients with low back pain in general practice. As an original idea, we suggest it would be feasible to involve clinical staff members in the delivery of information and advice to patients, whilst the general practitioner remains responsible for diagnostic decision-making.

Background: The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England., Objective: This trial evaluated the effect of implementing an adaptation of this approach in a US setting., Design: The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls., Participants: Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later., Interventions: The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients' risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training., Main Measures: Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization., Key Results: Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use., Conclusions: A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use., Trial Registration: National Clinical Trial Number NCT02286141.

Background: Low back pain (LBP) is common, however research comparing the effectiveness of different treatments over the last two decades conclude either no or small differences in the average effects of different treatments. One suggestion to explain this is that patients are not all the same and important subgroups exist that might require different treatment approaches. Stratified care for LBP involves identifying subgroups of patients and then delivering appropriate matched treatments. Research has shown that stratified care for LBP in primary care can improve clinical outcomes, reduce costs and increase the efficiency of health-care delivery in the UK. The challenge now is to replicate and evaluate this approach in other countries health care systems and to support services to implement it in routine clinical care., Results: The STarT Back approach to stratified care has been tested in the National Health Service, within the UK, it reduces unnecessary overtreatment in patients who have a good prognosis (those at low risk) yet increases the likelihood of appropriate healthcare and associated improved outcomes for those who are at risk of persistent disabling pain. The approach is cost-effective in the UK healthcare setting and has been recommended in recent guidelines and implemented as part of new LBP clinical pathways of care. This approach has subsequently generated international interest, a replication study is currently underway in Denmark, however, some lessons have already been learnt. There are potential obstacles to implementing stratified care in low-and-middle-income settings and in other high-income settings outside of the UK, however, implementation science literature can inform the development of innovations and efforts to support implementation of stratified care., Conclusions: The STarT Back approach to stratified care for LBP is a promising method to advance practice that has demonstrated clinical and cost effectiveness in the UK. Over time, further evidence for both the effectiveness and the adaptations needed to test and implement the STarT Back stratified care approach in other countries is needed., (Copyright © 2018 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.)

Objectives: Reassurance is an essential part of treatment for low back pain (LBP), but evidence on effective methods to deliver reassurance remains scarce. The interaction between consultation-based reassurance and patients' psychological risk is unknown. Our objective was to investigate the relationship between consultation-based reassurance and clinical outcomes at follow-up, in people with and without psychological risk., Methods: We tested the associations between specific reassurance components (data gathering, relationship building, generic reassurance, and cognitive reassurance), patients' psychological risk (the presence of depression, anxiety, catastrophizing, or fear-avoidance), and postconsultation outcomes including, satisfaction and enablement, disability, pain, and mood at 3-month follow-up., Results: Adjusted linear regression models using data from patients who had recently consulted for LBP in primary care (n=142 in 43 practices) indicated that all reassurance components were strongly associated with increased satisfaction, whereas generic reassurance was significantly associated with postconsultation enablement. Generic reassurance was also associated with lower pain at 3 months, whereas cognitive reassurance was associated with increased pain. A significant interaction was observed between generic reassurance and psychological risk for depression at 3 months: high rates of generic reassurance were associated with lower depression in low-risk patients, but with higher rates of depression for high-risk groups., Discussion: The findings support the hypothesis that different components of reassurance are associated with specific outcomes, and that psychological risk moderates this relationship for depression. Clinicians reassuring behaviors might therefore have the potential to improve outcomes in people with LBP, especially for patients with higher psychological risk profiles.

Background: The STarT-Back-Approach (STarT: Subgroups for Targeted Treatment) was developed in the UK and has demonstrated clinical and cost effectiveness. Based on the results of a brief questionnaire, patients with low back pain are stratified into three treatment groups. Since the organisation of physiotherapy differs between Germany and the UK, the aim of this study is to explore German physiotherapists' views and perceptions about implementing the STarT-Back-Approach., Methods: Three two-hour think-tank workshops with physiotherapists were conducted. Focus groups, using a semi-structured interview guideline, followed a presentation of the STarT-Back-Approach, with discussions audio recorded, transcribed and qualitatively analysed using content analysis., Results: Nineteen physiotherapists participated (15 female, mean age 41.2 (SD 8.6) years). Three main themes emerged, each with multiple subthemes: 1) the intervention (15 subthemes), 2) the healthcare context (26 subthemes) and 3) individual characteristics (8 subthemes). Therapists' perceptions of the extent to which the STarT-Back intervention would require changes to their normal clinical practice varied considerably. They felt that within their current healthcare context, there were significant financial disincentives that would discourage German physiotherapists from providing the STarT-Back treatment pathways, such as the early discharge of low-risk patients with supported self-management materials. They also discussed the need for appropriate standardised graduate and post-graduate skills training for German physiotherapists to treat high-risk patients with a combined physical and psychological approach (e.g., communication skills)., Conclusions: Whilst many German physiotherapists are positive about the STarT-Back-Approach, there are a number of substantial barriers to implementing the matched treatment pathways in Germany. These include financial disincentives within the healthcare system to early discharge of low-risk patients. Therapists also highlighted the need for solutions in respect of scalable physiotherapy training to gain skills in combined physical and psychological approaches.

Objective: To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support., Design and Setting: A three-armed randomised controlled feasibility trial conducted in 12 general practices in England., Participants: Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness., Interventions: The 'SupportBack' internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance., Outcomes: The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up., Results: Primary outcomes: 87 patients with LBP were recruited (target 60-90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%., Conclusions: This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP., Trial Registration Number: ISRCTN31034004; Results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To test whether change in fear-avoidance beliefs was a mediator of the effect of treatment on disability outcome, and to test an analytical approach, latent growth modeling, not often applied to mediation analysis., Methods: Secondary analysis was carried out on a randomized controlled trial designed to compare an intervention addressing fear-avoidance beliefs (n=119) with treatment as usual (n=121) for patients with low back pain, which found the intervention to be effective. Latent growth modelling was used to perform a mediation analysis on the trial data to assess the role of change in fear-avoidance beliefs on disability outcome. The product of coefficients with bias-corrected bootstrapped confidence intervals was used to calculate the mediating effect., Results: A statistically significant mediating effect of fear-avoidance beliefs on the effect of treatment on disability outcome was found (standardized indirect effect -0.35; bias-corrected 95% CI, -0.47 to -0.24). Poor fit of the model to the data suggested that other factors not accounted for in this model are likely to be part of the same mediating pathway., Discussion: Fear-avoidance beliefs were found to mediate the effect of treatment on disability outcome. Measurement of all potential mediator variables in future studies would help to more strongly identify which factors explain observed treatment effects. Latent growth modelling was found to be a useful technique to apply to studies of treatment mediation, suggesting that future studies could use this approach.

Identification of patient characteristics influencing treatment outcomes is a top low back pain (LBP) research priority. Results from the STarT Back trial support the effectiveness of prognostic stratified care for LBP compared with current best care, however, patient characteristics associated with treatment response have not yet been explored. The purpose of this secondary analysis was to identify treatment effect modifiers within the STarT Back trial at 4-month follow-up (n = 688). Treatment response was dichotomized using back-specific physical disability measured using the Roland-Morris Disability Questionnaire (≥7). Candidate modifiers were identified using previous literature and evaluated using logistic regression with statistical interaction terms to provide preliminary evidence of treatment effect modification. Socioeconomic status (SES) was identified as an effect modifier for disability outcomes (odds ratio [OR] = 1.71, P = .028). High SES patients receiving prognostic stratified care were 2.5 times less likely to have a poor outcome compared with low SES patients receiving best current care (OR = .40, P = .006). Education level (OR = 1.33, P = .109) and number of pain medications (OR = .64, P = .140) met our criteria for effect modification with weaker evidence (.20 > P ≥ .05). These findings provide preliminary evidence for SES, education, and number of pain medications as treatment effect modifiers of prognostic stratified care delivered in the STarT Back Trial., Perspective: This analysis provides preliminary exploratory findings about the characteristics of patients who might least likely benefit from targeted treatment using prognostic stratified care for LBP., (Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Background: The STarT Back Screening Tool (SBST) was developed to stratify low back pain patients according to their risk of future physical disability so that prognostic subgroups can receive matched treatments in primary care., Objective: To measure the construct and discriminative validity of the SBST-Brazil questionnaire., Method: A hundred and fifty one patients were recruited to test the construct and discriminative validity comparing the SBST-Brazil to the Brazilian Version of the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ) and Fear-Avoidance Beliefs Questionnaire-Work (FABQ-W) and Physical Activity (FABQ-PA) subscales at baseline. Spearman's rank-order correlation and area under the curve (AUC) derived from receiver operating curves (ROC) for total scores and psychosocial subscale score of the SBST-Brazil were used for construct and discriminant validity analysis, respectively., Results: The SBST-Brazil total and psychosocial subscale scores had good and moderate correlation with ODI (r=0.61; r=0.56, respectively) and good with RMDQ (r=0.70; r=0.64, respectively). Both scores of the SBST-Brazil total and psychosocial subscale correlated weakly and moderately with the FABQ-PA (r=0.28; r=0.34, respectively) and weakly with the FABQ-W (r=0.18; r=0.20, respectively). The discriminant validity with AUCs for the total and psychosocial subscale scores against reference standard ranged from 0.66 for kinesiophobia to 0.88 for disability., Conclusion: The SBST-Brazil showed a moderate to good correlation with the disability tools, but a weak correlation with fear-avoidance beliefs. The results of discriminant validity suggest that SBST-Brazil is able to discriminate low back pain patients with disability and fear-avoidance beliefs., (Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.)

Interventions developed to improve disability outcomes for low back pain (LBP) often show only small effects. Mediation analysis was used to investigate what led to the effectiveness of the STarT Back trial, a large primary care-based trial that treated patients consulting with LBP according to their risk of a poor outcome. The high-risk subgroup, randomized to receive either psychologically-informed physiotherapy (n = 93) or current best care (n = 45), was investigated to explore pain-related distress and pain intensity as potential mediators of the relationship between treatment allocation and change in disability. Structural equation modeling was used to generate latent variables of pain-related distress and pain intensity from measures used to identify patients at high risk (fear-avoidance beliefs, depression, anxiety, and catastrophizing thoughts). Outcome was measured using the Roland-Morris Disability Questionnaire. Change in pain-related distress and pain intensity were found to have a significant mediating effect of .25 (standardized estimate, bootstrapped 95% confidence interval, .09-.39) on the relationship between treatment group allocation and change in disability outcome. This study adds to the evidence base of treatment mediation studies in pain research and the role of distress in influencing disability outcome in those with complex LBP., Perspective: Mediation analysis using structural equation modeling found that change in pain-related distress and pain intensity mediated treatment effect in the STarT Back trial. This type of analysis can be used to gain further insight into how interventions work, and lead to the design of more effective interventions in future., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients' physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting., Methods: Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1-3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines., Discussion: This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system., Trial Registration: NCT02286141. Registered November 5, 2014.

There is reasonably strong evidence that some physical therapy interventions are effective (compared to minimal or no intervention) for patients with low back pain (LBP); however, the effect sizes are typically small. Many clinicians argue that this evidence is at odds with their daily clinical experience. There are several reasons that likely contribute to small effects in clinical trials of LBP and other musculoskeletal conditions. In this Viewpoint, the authors look at which of these reasons are beyond our control as clinicians and simply need to be acknowledged and understood, and which may provide insights into improving the design of future clinical trials of LBP and ultimately delivering better care to our patients. J Orthop Sports Phys Ther 2016;46(5):317-319. doi:10.2519/jospt.2016.0604.

Purpose: The STarT Back Screening Tool (SBST) is a 9-item questionnaire designed for screening low back pain (LBP) patients into three prognostic groups for stratified care. The stratified care approach has proven to be clinically more beneficial and cost-effective than the current best physiotherapy practice. The objective of this study was to translate, culturally adapt and study psychometric properties of the SBST among Finnish LBP patients., Methods: The SBST was translated into Finnish using appropriate translation guidelines. A total of 116 patients were recruited from outpatient clinics. They were asked to fill out two questionnaires within 1-7 days. The first questionnaire set included the SBST, Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) and intensities of back and leg pain (10-cm Visual Analogue Scale). The second questionnaire form included the SBST and a question about persistence of symptoms., Results: Some linguistic and cultural differences emerged during the translation process with item 1 ("spread down my legs"), item 2 ("neck and shoulder pain"), item 6 ("worrying thoughts") and item 9 ("bothersome"). The test-retest reliability of the SBST total score was excellent (intraclass correlation coefficient 0.78) and of the psychosocial subscale good (0.68). Cronbach's alpha for the psychosocial subscale was 0.55. Spearman's correlation coefficient between SBST total score and BDI was 0.38, ODI 0.39, ÖMPSQ 0.45, intensity of leg pain 0.45 and LBP 0.31. Based on analysis of variance, the SBST discriminated low- and medium-risk groups better than medium- and high-risk groups., Conclusions: The Finnish translation of the SBST is linguistically accurate and has been adapted to the Finnish-speaking population. It showed to be a valid and reliable instrument and comparable with the original English version. Therefore, it may be used in clinical work with Finnish LBP patients.

Background: Current research emphasizes the high prevalence and costs of low back pain (LBP). The STarT Back Tool was designed to support primary care decision making for treatment by helping to determine the treatment prognosis of patients with non-specific low back pain. The German version is the STarT-G. The cross-cultural translation of the tool followed a structured and widely accepted process but to date it was only partially validated with a small sample. The aim of the study was to test the psychometric properties construct validity, discriminative ability, internal consistency and test-retest-reliability of the STarT-G and to compare them with values given for the original English version., Methods: A consecutive cohort study with a two-week retest was conducted among patients with non-specific LBP, aged 18 to 60 years, from primary care practices. Questionnaires were collected before the first consultation, and two weeks later by post, using the following reference standards: the Roland and Morris disability questionnaire, the Tampa Scale of Kinesiophobia, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale. Psychometric properties examined included the tool's discriminative abilities, whether the psychosocial subscale was one factor, internal consistency, item redundancy, test-retest reliability and floor and ceiling effects., Results: There were 228 patients recruited with a mean age of 42.2 (SD 11.0) years, and 53 % were female. The areas under the curve (AUC) for discriminative ability ranged from 0.70 (STarT-G Subscale - Pain Catastrophizing Scale; CI95 0.63, 0.78) to 0.77 (STarT-G Total - Composite reference standard, CI95 0.60, 0.94). Factor loadings ranged from 0.49 to 0.74. Cronbach's alpha testing the internal consistency and redundancy for the total/subscale scores were α = 0.52/0.55 respectively. The STarT-G test-retest reliability Kappa values for the total/subscale scores were 0.67/0.68 respectively. No floor or ceiling effects were present., Conclusions: The STarT-G shows acceptable psychometric properties although not in exact agreement with the original English version. The items previously regarded as a psychosocial subscale may be better seen as an index of different individual psychosocial constructs. The relevance of using the tool at the point of consultation should be further examined.

Introduction: Low back pain (LBP) is a prevalent and costly condition. The majority of patients experiencing LBP are managed in primary care, where first-line care recommendations consist of advice to self-manage and remain active. Internet interventions present a potential means of providing patients with tailored self-management advice and evidence-based support for increasing physical activity., Methods/analysis: This protocol describes a single-blind, randomised controlled feasibility trial of an internet intervention developed to support the self-management of LBP in primary care. Patients are being randomised to 1 of 3 groups receiving either usual primary care, usual primary care with the addition of an internet intervention or an internet intervention with physiotherapist telephone support. Patients are followed up at 3 months. Primary outcomes are the feasibility of (1) the trial design/methods, (2) the delivery of the internet intervention and (3) the provision of telephone support by physiotherapists. Secondary outcomes will include exploratory analysis of estimates and variation in clinical outcomes of pain and disability, in order to inform a future main trial., Ethics/dissemination: This feasibility trial has undergone ethical scrutiny and been approved by the National Health Service (NHS) Research Ethics Committee, REC Reference 13/SC/0202. The feasibility findings will be disseminated to the research community through presentations at conferences and publication in peer review journals. Broader dissemination will come following a definitive trial., Trial Registration Number: ISRCTN 31034004., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background and Objective: The STarT Back stratified primary care approach has demonstrated clinical and cost effectiveness in the UK, and is commonly used by General Practitioners (GPs). However, it remains unknown how this approach could be implemented into the German healthcare system. The aim of this study was therefore to explore the views and perceptions of German GPs in respect to using a stratified primary care for low back pain (LBP)., Methods: A 90-minute think-tank workshop was conducted with 14 male and five female GPs, during which the STarT-Back-Screening-Tool (SBST) and related research evidence was presented. This was followed by two focus groups, based on a semi-structured interview guideline to identify potential implementation barriers and opportunities. Discussions were audiotaped, transcribed and coded using a content analysis approach., Results: For the three deductively developed main themes, 15 subthemes emerged: (1) application of the SBST, with the following subthemes: which health profession should administer it, patients known to the GP practice, the reason for the GP consultation, scoring the tool, the tool format, and the anticipated impact on GP practice; (2) psychologically informed physiotherapy, with subthemes including: provision by a physiotherapist, anticipated impact, the skills of physiotherapists, management of patients with severe psychosocial problems, referral and remuneration; (3) the management of low-risk patients, with subthemes including: concern about the appropriate advising health professional, information and media, length of consultation, and local exercise venues., Conclusions: The attitudes of GPs towards stratified primary care for LBP indicated positive support for pilot-testing in Germany. However, there were mixed reactions to the ability of German physiotherapists to manage high-risk patients and handle their complex clinical needs. GPs also mentioned practical difficulties in providing extended advice to low-risk patients, which nevertheless could be addressed by involvement of specifically trained medical assistants.

Background: Although evidence based treatment approaches for acute low back pain are available, the prevention of persistent disabling symptoms remains a challenge. Subgroup targeted treatment using adequate screening tools may be a key component for the development of new treatment concepts and is demonstrating promising early evidence. The Keele STarT Back Screening Tool is a practical instrument, developed to stratify patients with back pain according to their risk of persistent disabling symptoms. The aim of this study was to translate and cross-culturally adapt the STarT tool into German (STarT-G) and to investigate its psychometric properties., Methods: The translation was performed according to internationally accepted guidelines and pretested to assess face validity among patients. Psychometric testing was then performed within a cross-sectional cohort of adult patients attending physiotherapy practices for back pain. Patients completed a booklet containing STarT-G and 5 reference standard questionnaires. Measurement properties of the STarT-G were explored including construct validity, floor and ceiling effects, and discriminative abilities., Results: The pretests (n=25) showed good face validity including strong comprehension and acceptability of the STarT-G with only item 5 (fear avoidance) manifesting some ambiguities. The questionnaires were sent to 74 and completed by 50 patients (68%) of whom mean age was 46 (SD 14.5) years and 52% were male. Spearman's rank correlations for construct validity ranged from 0.35 to 0.56. AUCs for discriminative ability ranged from 0.79 to 0.91. Neither floor nor ceiling effects were observed. There were 28 (57%) participants defined as low risk, 17 (35%) as medium risk, and 4 (8%) as high risk., Conclusion: STarT-G is linguistically valid for German speaking countries. For the selected population, the correlations indicate acceptable validity and AUC showed satisfying discrimination. Data for psychometric properties have to be confirmed in a large scale study with a representative sample.

Study Design: Translation and psychometric testing., Objective: The study aims to investigate the reliability and validity of the Chinese version of the STarT Back Screening Tool (STarT) in Chinese-speaking patients with low back pain (LBP) after translation and cultural adaptation., Summary of Background Data: To date, no previous studies exist on the translation process and validation of the Chinese version of the STarT., Methods: The procedure of translation, which included 6 stages, was performed according to the current recommended guidelines. Psychometric testing included face validity, test-retest reliability, and discriminant validity. A total of 307 patients completed a questionnaire booklet containing the Chinese version of the STarT, Roland-Morris Disability Questionnaire, Coping Strategies Questionnaire, Tampa Scale for Kinesiophobia-17, and Hospital Anxiety and Depression Scale. Seventy-four randomly selected patients were asked to finish the STarT a second time within 24 to 48 hours. The demographic characteristics and outcomes of psychometric testing were compared with the original English cohort., Results: No items of the final version had reported ambiguity after the face validation and no floor or ceiling effects were noted. The intraclass correlation coefficient was 0.933 (95% confidence interval, 0.896-0.957), demonstrating very good reliability. Discriminant validity was established, with area under curve results in the range from 0.751 to 0.893 (95% confidence interval, 0.697-0.930) in the Chinese cohort compared with 0.840 to 0.925 (95% confidence interval, 0.772-0.948) in the original English cohort., Conclusion: The results confirm the successful translation and adaptation of the STarT into Chinese, with appropriate reliability and validity. Therefore, this version can be recommended for clinical and research use for Chinese patients with LBP.

Purpose: We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs., Methods: The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat., Results: The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed., Conclusions: Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended.

Study Design: Observational prospective study., Objective: Our objective was to assess the reliability and validity of the French version of the Keele STarT Back Screening Tool (SBST)., Summary of Background Data: The SBST is a recently validated tool developed to identify subgroups of patients with low back pain (LBP) to guide early secondary prevention in primary care., Methods: Outpatients 18 years or older with LBP, attending a rehabilitation center, a back school, a private physiotherapy unit, or a fitness center were included. Patients were assessed through the SBST, Roland-Morris Disability Questionnaire, Örebro Musculoskeletal Pain Screening Questionnaire, Medical Outcomes Survey Short Form-36 questionnaire, and a pain visual analogue scale. Test-retest reliability was assessed with Kappa score or the intraclass correlation coefficient, internal consistency of the Psychological subscale with the Cronbach α coefficient, construct validity with the Spearman correlation coefficient, and floor and ceiling effects by percentage frequency of lowest or highest possible score achieved by respondents., Results: One hundred eight patients with LBP were included. The test-retest reliability of the SBST total score was excellent with an intraclass correlation coefficient of 0.90 (0.81-0.95). The Cronbach α coefficient was 0.73 showing a good internal consistency for the Psychological subscale. High Spearman correlation coefficients of 0.74 between SBST and Roland-Morris Disability Questionnaire, and 0.74 between the SBST and Örebro Musculoskeletal Pain Screening Questionnaire were observed. As expected, low-to-moderate correlations were observed between the SBST total score and some dissimilar measures of the Short-Form 36. The lowest possible SBST score was observed for 8 patients (7.4%), whereas only 3 patients (2.8%) had the highest possible SBST score., Conclusion: The French version of the SBST is a reliable and valid questionnaire consistent with the original English version. Therefore, this new version may help French-speaking clinicians and scientists to stratify patients with LBP., Level of Evidence: 2.

Stratified care for back pain involves targeting treatment to subgroups of patients based on their key characteristics such as prognostic factors, likely response to treatment and underlying mechanisms. It aims to tailor therapeutic decisions in ways that maximise treatment benefit, reduce harm and increase health-care efficiency by offering the right treatment to the right patient at the right time. From being called the 'Holy Grail' of back pain research over a decade ago, stratified care is becoming the zeitgeist in research and clinical practice. In this chapter, we introduce and evaluate the quality and underpinning evidence for three examples of stratified care for back pain to highlight their general principles, research design issues and clinical practice implications. We include consideration of their merits for implementation in practice. We conclude with a set of remaining, key research questions., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

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.

Back pain is a leading cause of disability. Previous research suggests that modifiable risk factors influence recovery from back pain, and practice guidelines recommend integrating such factors within primary care management. Toward this goal, a brief, multidimensional questionnaire, the STarT Back Tool, was designed to facilitate risk assessment by reducing the need to administer multiple, unidimensional questionnaires. However, aspects of this tool's clinical utility remain unaddressed. For instance, it is unclear whether this tool is responsive to treatment-related changes or whether clinically meaningful information is lost when it replaces multiple risk questionnaires. This study compared the responsiveness of the STarT Back Tool to its corresponding full-length measures, and evaluated its ability to detect clinically meaningful improvement. The study sample included 300 participants that consulted their doctor with disabling back pain. The STarT Back Tool and its reference standard questionnaires (disability, catastrophizing, fear, and depression) were administered at baseline and 4 months later. Regression analyses tested whether, after controlling for its reference standard questionnaires, the STarT Back Tool (independent variable) predicted treatment-related changes in global improvement, pain severity, disability, catastrophizing, fear, and depression (dependent variables). Receiver operating characteristic analyses determined the level of STarT Back change needed for clinically meaningful improvement. STarT Back scores predicted changes in all dependent variables except depression. Reductions in STarT Back scores predicted meaningful improvement on all dependent variables. These findings suggest that the STarT Back Tool, instead of multiple risk questionnaires, can be used to measure recovery from back pain. Implications for future research and clinical practice are discussed., (Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.)

A new randomised controlled trial of intervention in low back pain has been described recently. In this trial, a screening and targeted approach was found to be more effective and cost-effective than current best practice. Nested within the intervention arm were three different interventions targeting patients identified as 'low', 'medium' or 'high' risk dependent on the presence of (mainly) psychosocial risk factors. In this paper, the development and content of the STarT Back trial's 'high-risk' intervention is described. It offers a systematic approach, termed 'psychologically informed practice', to the integration of physical and psychological approaches to treatment for the management of people with low back pain by physiotherapists. The term 'disability' is used to refer to self-reported pain-associated functional limitations, and 'psychological' is used to refer to the beliefs/expectations, emotional responses and behavioural responses associated with low back pain., (Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.)

Background: The IMPaCT Back study (IMplementation to improve Patient Care through Targeted treatment for Back pain) is a quality improvement study which aims to investigate the effects of introducing and supporting a subgrouping for targeted treatment system for patients with low back pain (LBP) in primary care. This paper details the subgrouping for targeted treatment system and the clinical training and mentoring programmes aimed at equipping clinicians to deliver it. THE SUBGROUPING AND TARGETED TREATMENT SYSTEM: This system differs from 'one-size fits all' usual practice as it suggests that first contact health care practitioners should systematically allocate LBP patients to one of the three subgroups according to key modifiable prognostic indicators for chronicity. Patients in each subgroup (those at low, medium or high risk of chronicity) are then managed according to a targeted treatment system of increasing complexity. THE SUBGROUPING TOOLS: Subgrouping tools help guide clinical decision-making about treatment and onward referral. Two subgrouping tools have been used in the IMPaCT Back study, a 9-item version used by participating physiotherapists and a 6-item version used by GPs. The targeted treatments. The targeted treatments include a minimal intervention delivered by GPs (for those patients at low risk of poor outcome) or referral to primary care physiotherapists who can apply physiotherapy approaches to addressing pain and disability (for those at medium risk) and additional cognitive-behavioural approaches to help address psychological and social obstacles to recovery (for those at high risk). THE TRAINING PACKAGES: Building on previous interventions for other pilot studies and randomized trials, we have developed and delivered clinical training and support programmes for GPs and physiotherapists., Discussion: This paper describes in detail the IMPaCT Back study's subgrouping for targeted treatment system and the training and mentoring packages aimed at equipping clinicians to deliver it, within the IMPaCT Back study., Study Registration: ISRCTN55174281.

Study Design: Merged data from two primary care prospective cohort studies., Objective: To compare the clinical course of low back pain (LBP) consulters to primary care with and without self-reported referred leg pain., Summary of Background Data: In patients with LBP, the presence of leg pain/sciatica is considered a poor prognostic indicator, associated with more severe pain, disability, and time off work. However, questions remain about how best to identify sciatica in primary care and whether self-reported referred leg pain provides a distinct classification for primary care., Methods: Data from two large prospective cohort studies of consecutive patients consulting with LBP in 13 general practices were merged. Using self-report data patients were divided into three subgroups: (1) those with LBP alone, (2) LBP with referred pain above the knee (LBP + above-knee), and (3) LBP with referred pain below the knee (LBP + below-knee). Unadjusted and adjusted baseline and 6-month follow-up scores on physical, psychological, and social indicators were compared between the groups using multiple regression analysis., Results: Among 1247 consulters the baseline prevalence of cases with LBP alone was 465 (37%), LBP + above-knee was 308 (25%), and LBP + below-knee was 474 (38%). Baseline severity and 6-month outcomes in the consulters with referred leg pain were significantly worse compared to those with LBP alone across a wide range of clinical characteristics, although differences diminished after adjusting for baseline characteristics., Conclusion: The clinical course for LBP with self-reported referred leg pain is much worse. However, the fact that differences in outcome were not worse after adjustment suggests that baseline differences in severity and duration of back pain, demographic, and psychological characteristics largely explain the poorer outcomes in patients with referred leg pain. Future research needs to establish if similar results are observed among patients with clinically determined sciatica.

Background: Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control)., Methods: 1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406., Findings: 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06-2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25-1·86]), equating to effect sizes of 0·32 (0·19-0·45) and 0·19 (0·04-0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group., Interpretation: The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care., Funding: Arthritis Research UK., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objective: The aim of this study was to translate and culturally adapt the original version of the STarT Back Screening Tool (SBST) to Spanish for different population subgroups., Design: Translation and cultural adaptation of a questionnaire., Setting: Primary care settings., Method: Thirty-eight people distributed by: gender; adults and elderly; and with or without pain. Phases: a) Forward translation (English-Spanish); b) Evaluation of the clarity, the acceptability and the familiarity of the content of the obtained Spanish version by means of cognitive interviews to participants, and c) Translation of the final Spanish version of the questionnaire back into the original language., Results: The participants interviewed indicated that most of the items of the questionnaire were clear and comprehensible, showing greater difficulty in understanding in the dimensions of disability and anxiety. Furthermore, the questionnaire was more difficult to understand by the elderly and patients with a previous non-specific low back pain episode., Conclusion: The Spanish version of the SBST questionnaire was obtained, which was shown to be comprehensible and adapted to the general population in Spain. Due to being short and easy to use, it is a potentially useful tool for use in primary care., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Evidence suggests that psychosocial factors have an influence on the outcome of physical therapy treatment and that the extent of their influence differs considerably among patients. As a consequence, substantial research efforts are focused on developing new clinical tools designed to identify and highlight when psychosocial factors are present at a level relevant to decision making. The conceptual differences in the ways that psychosocial factors influence outcome are described, structured around 3 common research terms: (1) prognostic factors, (2) treatment effect modifiers or moderators, and (3) treatment mediators. Prognostic factors are those characteristics that help estimate a patient's likely outcome irrespective of the chosen management. Treatment effect modifiers or moderators are factors measured at baseline that influence the relationship between a specific intervention and outcome. Treatment mediators are factors that have an intermediary role in the link between treatment and outcome. How these different influences on outcome can be translated into useful and complementary tools that aim to reduce treatment variability in clinical practice is described. One approach is to use prognostic factors to develop screening tools that identify an individual's risk status, typically based on predictive psychosocial factors such as catastophizing and depression. Another approach is to identify specific treatment effect modifiers to derive treatment decision aids or prediction rules to help match a patient's characteristics to the interventions available. A third approach is to use treatment mediators (eg, self-efficacy) to develop monitoring tools to inform the clinician about which aspects of treatment to strengthen.

Low back pain is a common, disabling condition with high personal and economic costs. Despite clinical guidelines, there have not been tangible reductions in the population prevalence of back pain or its serious long-term consequences. One reason for this might be that the 'one-size fits all approach' advocated by many guidelines fails to target treatments at patients who might benefit the most, thus diluting their potential benefits. Identifying subgroups of patients for whom different treatments are superior has been referred to as the 'Holy Grail' of low back pain research. Maximising the potential for targeted interventions is predicated on better understanding of the prognostic factors that are causally related to clinical outcome and identifying which are a) most predictive of outcome and b) most likely to be modifiable. Systematic identification of key obstacles to recovery in primary care back pain patients from high quality epidemiological studies can inform the development of early, targeted interventions. Only then can closer matching of treatments to patient characteristics be a clinical reality. This paper critically reviews progress in subgrouping for targeted treatment for patients with low back pain, identifies the key arguments for and against subgrouping and highlights the attributes of robust approaches in this field., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Objectives: The STarT Back Screening Tool (SBST) is validated to subgroup primary care patients with back pain into risk groups relevant to initial decision-making. However, it remains unclear how the tool's allocation of individuals compares with subjective clinical decision-making. We evaluated agreement between clinicians and the SBST's allocation to risk subgroups, and explored reasons for differences observed., Methods: Twelve primary care back pain patients underwent a video-recorded clinical assessment. The SBST was completed on the same day. Clinical experts (3 general practitioners, 3 physiotherapists, and 3 pain management specialists) individually reviewed the patient videos (4 each), blind to SBST allocation. Their task was to subgroup patients into low, medium, or high-risk groups., Results: Interrater agreement between clinicians was "fair" (κ=0.28), with consistent allocation between experts in 4 of 12 patients. There was observed agreement with the SBST in 17 of 36 cases (47%) and Cohen's weighted κ was 0.22, indicating fair agreement. Two reasons for differences emerged. Clinicians tailor their decisions according to patient expectations and demands for treatment and clinicians use knowledge of difficult life circumstances that may be unrelated back pain., Discussion: Clinicians make inconsistent risk estimations for primary care patients with back pain when using intuition alone, with little agreement with a formal subgrouping tool. Unlike clinicians, the SBST could not make a sophisticated synthesis of patient preferences, expectations, and previous treatment history. Although acknowledging the limitations of back pain subgrouping tools, more research is needed to test whether their use improves consistency in primary care decision-making.

Introduction: Clinicians require brief, practical tools to help identify low back pain (LBP) subgroups requiring early, targeted secondary prevention. The STarT Back Tool (SBT) was recently validated to subgroup LBP patients into early treatment pathways., Aim: To test the SBT's concurrent validity against an existing, popular LBP subgrouping tool, the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ), and to compare the clinical characteristics of subgroups identified by each tool., Methods: Two hundred and forty-four consecutive 'non-specific' LBP consulters at 8 UK GP practices aged 18-59years were invited to complete a questionnaire. Measures included the OMPSQ and SBT, disability, fear, catastrophising, pain intensity, episode duration and demographics. Instruments were compared using Spearman's correlations, tests for subgroup agreement and discriminant analysis of subgroup characteristics according to reference standards., Results: Completed SBT (9-items) and OMPSQ (24-items) data was available for 130/244 patients (53%). The correlation of SBT and OMPSQ scores was 'excellent (rs=0.80). Subgroup characteristics were similar across the low, medium and high subgroups, but, the proportions allocated to 'low', 'medium' and 'high' risk groups were different, with fewer patients in the SBT's high risk group. Both instruments similarly discriminated for reference standards such as disability, catastrophising, fear, comorbid pain and time off work. The OMPSQ was better at discriminating pain intensity, while the SBT was better for discriminating bothersomeness of back pain and referred leg pain., Conclusions: The SBT baseline psychometrics performed similarly to the OMPSQ, but the SBT is shorter and easier to score and is an appropriate alternative for identifying high risk LBP patients in primary care.

Background: Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain., Methods/design: We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8-10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care., Discussion: This paper presents detail on the rationale, design, methods and operational aspects of the trial., Trial Registration: Current Controlled Trials ISRCTN37113406.