Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial.

OBJECTIVES: To investigate whether and to what extent, return to work (RTW) expectancy and workability mediate the effect of two vocational interventions on reducing sickness absence in workers on sick leave from a musculoskeletal condition. METHODS: This is a preplanned mediation analysis of a three-arm parallel randomised controlled trial which included 514 employed working adults with musculoskeletal conditions on sick leave for at least 50% of their contracted work hours for ≥7 weeks. Participants were randomly allocated (1:1:1) to one of three treatment arms; usual case management (UC) (n=174), UC plus motivational interviewing (MI) (n=170) and UC plus a stratified vocational advice intervention (SVAI) (n=170). The primary outcome was the number of sickness absence days over 6 months from randomisation. Hypothesised mediators included RTW expectancy and workability assessed 12 weeks after randomisation. RESULTS: The mediated effect of the MI arm compared with UC on sickness absence days through RTW expectancy was -4.98 days (-8.89 to -1.04), and workability was -3.17 days (-8.55 to 2.32). The mediated effect of the SVAI arm compared with UC on sickness absence days through RTW expectancy was -4.39 days (-7.60 to -1.47), and workability was -3.21 days (-7.90 to 1.50). The mediated effects for workability were not statistically significant. CONCLUSIONS: Our study provides new evidence for the mechanisms of vocational interventions to reduce sickness absence related to sick leave due to musculoskeletal conditions. Changing an individual's expectation that RTW is likely may result in meaningful reductions in sickness absence days. TRIAL REGISTRATION NUMBER: NCT03871712.

Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial.

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders. METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions). RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant. CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs. TRIAL REGISTRATION NUMBER: NCT03871712.

Implementing a Stratified Vocational Advice Intervention for People on Sick Leave with Musculoskeletal Disorders: A Multimethod Process Evaluation.

Purpose To perform a process evaluation of a stratified vocational advice intervention (SVAI), delivered by physiotherapists in primary care, for people on sick leave with musculoskeletal disorders participating in a randomised controlled trial. The research questions concerned how the SVAI was delivered, the content of the SVAI and the physiotherapists' experiences from delivering the SVAI. Methods We used qualitative and quantitative data from 148 intervention logs documenting the follow-up provided to each participant, recordings of 18 intervention sessions and minutes from 20 meetings with the physiotherapists. The log data were analysed with descriptive statistics. A qualitative content analysis was performed of the recordings, and we identified facilitators and barriers for implementation from the minutes. Results Of 170 participants randomised to the SVAI 152 (89%) received the intervention and 148 logs were completed. According to the logs, 131 participants received the correct number of sessions (all by telephone) and 146 action plans were developed. The physiotherapists did not attend any workplace meetings but contacted stakeholders in 37 cases. The main themes from the recorded sessions were: 'symptom burden', 'managing symptoms', 'relations with the workplace' and 'fear of not being able to manage work'. The physiotherapists felt they were able to build rapport with most participants. However, case management was hindered by the restricted number of sessions permitted according to the protocol. Conclusion Overall, the SVAI was delivered in accordance with the protocol and is therefore likely to be implementable in primary care if it is effective in reducing sick leave.

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

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

Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study.

BACKGROUND: Little research exists on the effectiveness of motivational interviewing (MI) on return to work (RTW) in workers on long term sick leave. The objectives of this study protocol is to describe a randomized controlled trial (RCT) with the objectives to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. METHODS: A multi-arm RCT with economic evaluation will be conducted in Norway with recruitment of 450 participants aged 18-67 years on 50-100% sick leave for > 7 weeks due to MSK disorders. Participants will be randomized to either usual case management by the Norwegian Labour and Welfare Administration (NAV) alone, usual case management by NAV plus MI, or usual case management by NAV plus SVAI. Trained caseworkers in NAV will give two MI sessions, and physiotherapists will give 1-4 SVAI sessions depending upon risk of long-term sick leave. The primary outcome is the number of sick leave days from randomization to 6 months follow-up. Secondary outcomes are number of sick leave days at 12 months follow-up, time until sustainable RTW (≥4 weeks of at least 50% of their usual working hours) at 12 months, proportions of participants receiving sick leave benefits during 12 months of follow-up, and MSK symptoms influencing health at 12 months. Cost-utility evaluated by the EuroQoL 5D-5L and cost-benefit analyses will be performed. Fidelity of the interventions will be assessed through audio-recordings of approximately 10% of the intervention sessions. DISCUSSION: The results from this RCT will inform stakeholders involved in supporting RTW due to MSK disorders such as staff within NAV and primary health care. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03871712 registered March 12th 2020.

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

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.

Content and Evaluation of the Benefits of Effective Exercise for Older Adults With Knee Pain Trial Physiotherapist Training Program.

OBJECTIVE: To explore whether participating in the Benefits of Effective Exercise for knee Pain (BEEP) trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain in older adults. DESIGN: Before/after training program evaluation. Physiotherapists were asked to complete a questionnaire before the BEEP trial training program, immediately after, and 12 to 18 months later (postintervention delivery in the BEEP trial). The questionnaire included a case vignette and associated clinical management questions. Questionnaire responses were compared over time and between physiotherapists trained to deliver each intervention within the BEEP trial. SETTING: Primary care. PARTICIPANTS: Physiotherapists (N=53) who completed the BEEP trial training program. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Self-confidence in the diagnosis and management of knee pain in older adults; and intended clinical behavior measured by a case vignette and associated clinical management questions. RESULTS: Fifty-two physiotherapists (98%) returned the pretraining questionnaire, and 44 (85%) and 39 (74%) returned the posttraining and postintervention questionnaires, respectively. Posttraining, self-confidence in managing older adults with knee pain increased, and intended clinical behavior regarding exercise for knee pain in older adults appeared more in line with clinical guidelines. However, not all positive changes were maintained in the longer-term. CONCLUSIONS: Participating in the BEEP trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain, but by 12 to 18 months later, some of these positive changes were lost. This suggests that brief training programs are useful, but additional strategies are likely needed to successfully maintain changes in clinical behavior over time.

Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.

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.

Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.

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.

Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669).

BACKGROUND: Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. METHODS/DESIGN: This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. DISCUSSION: This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52269669.

Implementing change in physiotherapy: professions, contexts and interventions.

PURPOSE: The purpose of this paper is to report findings from qualitative interviews with physiotherapists to demonstrate why even minor changes to clinical work resulting from the introduction of new interventions, are often difficult to implement. The paper seeks to illustrate how some of the obstacles to implementing change were managed by physiotherapists. DESIGN/METHODOLOGY/APPROACH: A total of 32 qualitative interviews with participating physiotherapists were conducted, 12 interviews prior to the introduction of the new system, and 20 afterwards. The interviews were coded and analysed thematically. FINDINGS: The findings reveal a number of perceived limitations of current management of low back pain and identify key themes around convergence with the new approach, such as willingness by physiotherapists to adopt the new approach, the perception of benefits to adopting the new approach, as well as some difficulty in adjusting to it. The authors refer to the positive and negative elements as "soft" and "hard" disruption. The adoption of the new approach is explored with reference to the "situated" dimensions of physiotherapy practice and normalisation process theory. RESEARCH LIMITATIONS/IMPLICATIONS: The study raises the need to conduct future observational research to support the interview findings. ORIGINALITY/VALUE: The study describes the "situated" components of physiotherapy work, which have received limited research attention. The value of the study lies less in its ability to explain specifically why physiotherapists adopted or rejected the new system, but in describing the conditions and consequences of change that might be translated to other professions, contexts and interventions.

Constructing therapeutic support and negotiating competing agendas: A discourse analysis of vocational advice provided to individuals who are absent from work due to ill-health.

Work participation is known to benefit people's overall health and wellbeing, but accessing vocational support during periods of sickness absence to facilitate return-to-work can be challenging for many people. In this study, we explored how vocational advice was delivered by trained vocational support workers (VSWs) to people who had been signed-off from work by their General Practitioner (GP), as part of a feasibility study testing a vocational advice intervention. We investigated the discursive and interactional strategies employed by VSWs and people absent from work, to pursue their joint and respective goals. Theme-oriented discourse analysis was carried out on eight VSW consultations. These consultations were shown to be complex interactions, during which VSWs utilised a range of strategies to provide therapeutic support in discussions about work. These included; signalling empathy with the person's perspective; positively evaluating their personal qualities and prior actions; reflecting individuals' views back to them to show they had been heard and understood; fostering a collaborative approach to action-planning; and attempting to reassure individuals about their return-to-work concerns. Some individuals were reluctant to engage in return-to-work planning, resulting in back-and-forth interactional negotiations between theirs and the VSW's individual goals and agendas. This led to VSWs putting in considerable interactional 'work' to subtly shift the discussion towards return-to-work planning. The discursive strategies we have identified have implications for training health professionals to facilitate work-orientated conversations with their patients, and will also inform training provided to VSWs ahead of a randomised controlled trial.

The Pain Anxiety Symptom Scale: Initial Development and Evaluation of 4 and 8 Item Short Forms.

Elevated levels of anxiety in relation to chronic pain have been consistently associated with greater distress and disability. Thus, accurate measurement of pain-related anxiety is an important requirement in modern pain services. The Pain Anxiety Symptom Scale (PASS) was introduced over 30 years ago, with a shortened 20-item version introduced 10 years later. Both versions of the PASS were derived using Principal Components Analysis, an established method of measure development with roots in classical test theory. Item Response Theory (IRT) is a complementary approach to measure development that can reduce the number of items needed and maximize item utility with minimal loss of statistical and clinical information. The present study used IRT to shorten the 20-item PASS (PASS-20) in a large sample of people with chronic pain (N = 2,669). Two shortened versions were evaluated, 1 composed of the single best-performing item from each of its 4 subscales (PASS-4) and the other with the 2 best-performing items from each subscale (PASS-8). Several supplementary analyses were performed, including comparative item convergence evaluations based on sample characteristics (ie, female or male sex; clinical or online sample), factor invariance testing, and criterion validity evaluation of the 4, 8, and 20-item versions of the PASS in hierarchical regression models predicting pain-related distress and interference. Overall, both shortened PASS versions performed adequately across these supplemental tests, although the PASS-4 had more consistent item convergence between samples, stronger evidence for factor invariance, and accounted for 83% of the variance accounted for by the PASS-20% and 92% of the variance accounted for by the PASS-8 in criterion variables. Consequently, the PASS-4 is recommended for use in situations where a briefer evaluation of pain-related anxiety is appropriate. PERSPECTIVE: The Pain Anxiety Symptom Scale (PASS) is an established measure of pain-related fear. This study derived 4 and 8-item versions of the PASS using IRT. Both versions showed strong psychometric properties, stability of factor structure, and relation to important aspects of pain-related functioning.

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

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.

Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281).

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.

Profiles of Pain Acceptance and Values-Based Action in the Assessment and Treatment of Chronic Pain.

Pain acceptance and values-based action are relevant to treatment outcomes in those with chronic pain. It is unclear if patterns of responding in these 2 behavioral processes can be used to classify patients into distinct classes at treatment onset and used to predict treatment response. This observational cohort study had 2 distinct goals. First, it sought to classify patients at assessment based on pain acceptance and values-based action (N = 1746). Second, it sought to examine treatment outcomes based on class membership in a sub-set of patients completing an interdisciplinary pain rehabilitation program of Acceptance and Commitment Therapy for chronic pain (N = 343). Latent profile analysis was used in the larger sample to identify 3 distinct patient classes: low acceptance and values-based (AV) action (Low AV; n = 424), moderate acceptance and values-based action (Moderate AV; n = 983) and high acceptance and values-based action (High AV; n = 339). In the smaller treated sample, participants in the Low AV and Moderate AV class demonstrated improvements across all outcome variables, whereas those in the High AV class did not. These findings support the role of pain acceptance and values-based action in those with chronic pain. PERSPECTIVE: Individuals with chronic pain can be classified with respect to pain acceptance and values-based action and these groups may respond differently to treatment.

Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial.

BACKGROUND: A randomized controlled trial (RCT) of stratified care demonstrated superior clinical outcomes and cost-effectiveness for low back pain (LBP) patients in UK primary care. This is the first study in Europe, outside of the original UK study, to investigate the clinical efficacy and cost-effectiveness of stratified care compared with current practice for patients with non-specific LBP. METHODS: The study was a two-armed RCT. Danish primary care patients with LBP were randomized to stratified care (n = 169) or current practice (n = 164). Primary outcomes at 3- and 12-months' follow-up were Roland Morris Disability Questionnaire (RDMQ), patient-reported global change and time off work. Secondary outcomes included pain intensity, patient satisfaction, healthcare resource utilization and quality-adjusted life years. RESULTS: Intention-to-treat analyses found no between-group difference in RMDQ scores at 3 months (0.5, 95% CI -1.8 to 0.9) or 12 months (0.4, -2.1 to 1.3). No overall differences were found between the arms at 3 and 12 months with respect to time off work or secondary outcomes. Stratified care intervention resulted in significantly fewer treatment sessions (3.5 [SD 3.1] vs. 4.5 [3.5]) and significantly lower total healthcare costs (€) (13.4 [529] vs. 228 [830], p = .002). There was no difference in cost-effectiveness (0.09, 0.05 to 0.13 vs. 0.10, 0.07-0.14, p = .70). CONCLUSIONS: There was no significant difference in clinical outcomes between patients with non-specific LBP receiving stratified care and those receiving current practice. However, stratified care may reduce total healthcare costs if implemented in Danish primary care. SIGNIFICANCE: Stratified care for low back pain based on risk profile is recommended by recent evidence based clinical guidelines. This study is the first broad replication of the STarT Back Trial in Europe. Therefore, the study adds to the body of knowledge evaluating the effectiveness of stratified care for low back pain in primary care, and provides insight into the effects of stratification on clinical practice.

Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.

BACKGROUND: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS: A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION: North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN28555470.

Initial evaluation of the Chronic Pain Acceptance Questionnaire - 2.

Greater acceptance of chronic pain is associated with lesser levels of pain-related distress and disability and better overall functioning. Pain acceptance is most often assessed using the Chronic Pain Acceptance Questionnaire (CPAQ), which includes both an eight-item short form (CPAQ-8) and a twenty item parent measure (CPAQ-20). This study derived a two-item CPAQ for use in busy clinical settings and for repeated measurement during treatment, the CPAQ-2. An Item Response Theory (IRT) approach was used to identify the strongest items from the CPAQ-20, one from each of its two subscales. Next, regression analyses were conducted to evaluate the utility of the CPAQ-2 by examining variance accounted for in the CPAQ-8, CPAQ-20, and in measures of depression, pain-related fear, physical disability, and psychosocial disability. Four clinical databases were combined (N = 1,776) for the analyses. Items 9 and 14 were identified as the strongest CPAQ-20 items in the IRT analyses. The sum score of these two items accounted for over 60% of the variance in the CPAQ-8 and CPAQ-20. Furthermore, this score accounted for significant variance in measures of depression, pain-related fear, physical disability, and psychosocial disability after controlling for data collection method (i.e. in clinic or online), participant age, education, pain duration and usual pain. Finally, the amount of variance accounted for by the CPAQ-2 was comparable to that accounted for by both the CPAQ-8 and CPAQ-20. These results provide initial support for the CPAQ-2 and suggest that it is well-suited as a brief assessment of chronic pain acceptance. SIGNIFICANCE: The most frequently used measure of pain acceptance is the CPAQ, which includes both an eight-item short form, the CPAQ-8, and a longer twenty item parent measure, the CPAQ-20. The present study sought to derive a two-item measure of the CPAQ for use in busy clinical settings and for repeated measurement during treatment, the CPAQ-2. An IRT approach was used to identify the strongest items from the CPAQ-20, one from each of its two subscales in a large sample of 1,776 individuals with chronic pain. The two item measure accounted for significant variance in measures of depression, pain-related fear, physical disability, and psychosocial disability. The brief measure will be useful in assessing pain acceptance in busy clinical setting and longitudinal designs.

An analysis of within-treatment change trajectories in valued activity in relation to treatment outcomes following interdisciplinary Acceptance and Commitment Therapy for adults with chronic pain.

A key issue in chronic pain treatment concerns changes necessary for reduced pain-related distress and disability. Acceptance and Commitment Therapy (ACT), a behavior change approach, theorizes several important treatment processes. Increased engagement in valued activities appears highly relevant as previous work has indicated it is related to current and future functioning and to treatment outcomes. This study sought to examine change trajectory in valued activity over the course of an interdisciplinary program of ACT and its relation to outcomes at treatment conclusion and three-month follow-up (N = 242). Latent change trajectories of valued activity were assessed weekly over four weeks of treatment and analyzed via latent growth curve and growth mixture modeling. A single latent trajectory with an increasing linear slope was indicated. Overall, slope of change in valued activity was predictive of improvement in psychosocial outcomes at post-treatment, including psychosocial disability, depression, pain anxiety, and discrepancy between values importance and success. Slope was not related to change in pain intensity or physical disability at post-treatment, nor was it related to change in any variable at follow-up. Findings are discussed in relation to the ACT model, in that support was provided in relation to post-treatment improvements for psychosocial variables.