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

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

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial.

QUESTION: How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? DESIGN: This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control. PARTICIPANTS: Two hundred and fifty-five people with chronic low back pain. DATA ANALYSIS: All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE). RESULTS: Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%). CONCLUSION: Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain.

A Person-Centred Prehabilitation Program based on Cognitive Behavioural Physical Therapy for patients scheduled for Lumbar Fusion surgery: A mediation analysis to assess fear of movement (kinesiophobia), self-efficacy and catastrophizing as mediators of health outcomes.

OBJECTIVE: To investigate whether early changes in fear of movement (kinesiophobia), self-efficacy and catastrophizing were mediators of the relationship between allocation to the pre-habilitation intervention and later changes in health outcomes. METHODS: The original pre-habilitation trial (PREPARE, ISRCTN17115599) recruited 118 participants awaiting lumbar fusion surgery, half of whom received a prehabilitation intervention designed based on the modified fear-avoidance model and half of whom received usual care. Mediation analysis was performed to test each mediator separately. Analysis was performed on each outcome of interest separately (Oswestry disability index, patient-specific function, EQ general health and moderate/vigorous physical activity). Mediation analysis was carried out using PROCESS. Beta coefficients and bootstrapped 95% CIs were used to interpret the results. RESULTS: None of the potential mediators was found to mediate the relationship between allocation to the intervention and 3-month scores on any of the health outcomes tested. CONCLUSIONS: Screening patients for higher levels of catastrophizing and fear avoidance and lower levels of self-efficacy could help ensure only the patients who are most likely to benefit from the intervention are included. SIGNIFICANCE: Prehabilitation interventions for spinal fusion surgery have been found to improve health outcomes for patients. Theory-based interventions that target key mechanisms are more effective at improving outcomes than non-theory-based interventions. While no mediating effects were found for this particular intervention, the analysis suggests that the underlying theoretical model and treatment targets are appropriate and could drive improvement if more strongly targeted.

A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: The AGReMA Statement.

Importance: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal. Objective: To develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA). Design, Setting, and Participants: The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020). Results: A previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists. Conclusions and Relevance: The AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible.

Self-reported prognostic factors in adults reporting neck or low back pain: An umbrella review.

BACKGROUND: Numerous systematic reviews have attempted to synthesize evidence on prognostic factors for predicting future outcomes such as pain, disability and return-to-work/work absence in neck and low back pain populations. DATABASES AND DATATREATMENT: An umbrella review of systematic reviews was conducted to summarize the magnitude and quality of the evidence for each prognostic factor investigated. Searches were limited to the last 10 years (2008-11th April 2018, updated 28th September 2020). A two-stage approach was undertaken: in stage one, data on prognostic factors was extracted from systematic reviews identified from the systematic search that met the inclusion criteria. Where a prognostic factor was investigated in ≥1 systematic review and where 50% or more of those reviews found an association between the prognostic factor and one of the outcomes of interest, it was taken forward to stage two. In stage two, additional information extracted included the strength of association found, consistency of effects and risk of bias. The GRADE approach was used to grade confidence in the evidence. RESULTS: Stage one identified 41 reviews (90 prognostic factors), with 35 reviews (25 prognostic factors) taken forward to stage two. Seven prognostic factors (disability/activity limitation, mental health; pain intensity; pain severity; coping; expectation of outcome/recovery and fear-avoidance) were judged as having moderate confidence for robust findings. CONCLUSIONS: Although there was conflicting evidence for the strength of association with outcome, these factors may be used for identifying vulnerable subgroups or people able to self-manage. Further research can investigate the impact of using such prognostic information on treatment/referral decisions and patient outcomes.

Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines.

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.

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).

INTRODUCTION: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. METHODS AND ANALYSIS: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. ETHICS AND DISSEMINATION: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. TRIAL REGISTRATION NUMBER: ISRCTN14736486.

Predictors of functional outcome in musculoskeletal healthcare: An umbrella review.

BACKGROUND: Multiple cohort and systematic review studies exist, reporting independent predictive factors associated with outcome in musculoskeletal populations. These studies have found evidence for a number of "generic" factors that have been shown to predict outcome across musculoskeletal patient cohorts. This review provides a higher level review of the evidence with a focus on generic patient factors associated with functional musculoskeletal outcome with a view to informing predictive modelling. OBJECTIVES: (a) Identify patient factors found to have evidence to support their association with functional outcome, and (b) review these findings across body areas/conditions to identify generic predictive factors. DATABASES AND DATA TREATMENT: Electronic databases of MEDLINE, AMED, EMBASE, CINAHL and Cochrane were searched for eligible studies. Two reviewers independently extracted data and assessed quality using an established checklist for umbrella reviews. RESULTS: Twenty-one systematic reviews met inclusion criteria, all were of moderate/high quality. Six independent predictors were found to have strong evidence of association with worse musculoskeletal functional outcome across anatomical body sites (worse baseline function, higher symptom/pain severity, worse mental well-being, more comorbidities, older age and higher body mass index). Longer duration of symptoms, worse pain coping, presence of workers compensation, lower vitality and lower education were also found to have moderate evidence of association with worse functional outcome across body sites. CONCLUSIONS: This study identifies a number of factors associated with musculoskeletal functional outcome. The generic predictive factors identified should be considered for inclusion into musculoskeletal prognostic models, including models used for case-mix-adjustment of patient reported outcome measure data. SIGNIFICANCE: This article identifies "generic" patient factors that predict functional outcome (measured using Patient Reported Outcome Measures (PROMs)) across musculoskeletal conditions. Findings provide support for the development and content of generic musculoskeletal prognostic models including models used to case-mix adjust PROM data for baseline complexity. Generic musculoskeletal models and functional PROMs would facilitate more feasible comparison and benchmarking of musculoskeletal services in order to identify variation and address health inequalities.

Reasons why osteoarthritis predicts mortality: path analysis within a Cox proportional hazards model.

Objectives: To identify potentially modifiable factors that mediate the association between symptomatic osteoarthritis (OA) and premature mortality. Methods: A population-based prospective cohort study; primary care medical record data were linked to self-report information collected by questionnaire in adults aged 50 years and over (n=10 415). OA was defined by primary care consultation and moderate-to-severe pain interference in daily life. A Cox proportional hazards analysis determined the total effect (TE) of OA on mortality after adjustment for potential confounders. Within the Cox model, path analysis was used to decompose the TE to assess the indirect and direct effects for selected potential mediators (anxiety, depression, unrefreshed sleep and walking frequency). Results are expressed as HRs with 95% CIs derived from bootstrap resampling. Results: OA was significantly associated with mortality (TE-adjusted HR 1.14; 95% CI 1.00 to 1.29). The indirect effects for walking frequency were 1.05 (95% CI 1.04 to 1.06), depression 1.02 (95% CI 1.02 to 1.03), anxiety 1.01 (95% CI 1.00 to 1.02) and unrefreshed sleep 1.01 (95% CI 1.00 to 1.01). Conclusions: The analysis indicates that encouraging people to walk and 'get out and about' in addition to targeting OA could be protective against excessive mortality. The findings also suggest that depression, anxiety and unrefreshed sleep have a role in premature mortality for people with OA; however, this has low clinical significance.

An overview of systematic reviews found suboptimal reporting and methodological limitations of mediation studies investigating causal mechanisms.

OBJECTIVES: The objective of this study was to investigate whether systematic reviews of mediation studies identify limitations in reporting quality and methodological conduct. STUDY DESIGN AND SETTING: We conducted an overview of systematic reviews. We searched four databases (MEDLINE, PsycINFO, Cochrane Database of Systematic Reviews, and PubMed) to identify systematic reviews of studies that used mediation analysis to investigate mechanisms of health care interventions or exposures in clinical populations between 2007 and 2017. Two reviewers independently screened titles and abstracts. Summary data on the characteristics, reporting quality, and methodological conduct of the studies included in the systematic reviews were extracted independently by two reviewers. The protocol was prospectively registered on PROSPERO (CRD42017059834). RESULTS: Fifty-four systematic reviews were included, representing 11 health care fields, 26 health conditions, and 2008 mediation studies. Eighteen of fifty-four systematic reviews (33%) explicitly stated that the reporting of primary studies was suboptimal. Of these, 14/18 (78%) reviews noted incomplete reporting of effect sizes and precision estimates from mediation analyses. Twenty-nine of fifty-four systematic reviews (54%) identified limitations in the methodological conduct of primary studies. CONCLUSION: The reporting and methodological conduct of studies investigating mechanisms in health care seems to be suboptimal. Guidance is needed to improve the quality, completeness, and transparency of mediation studies.

Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care.

PURPOSE: A multifaceted workplace intervention consisting of participatory ergonomics, physical training, and cognitive-behavioural training (CBT) has shown effectiveness for reducing low back pain (LBP). However, the mechanisms of action underlying these intervention components are not well understood. METHODS: This was a mediation analysis of a cluster-randomised controlled trial of a multifaceted intervention in 420 workers in elderly care. Mediation analysis was carried out via structural equation modelling. Potential mediators investigated were: fear-avoidance beliefs, perceived muscle strength, use of assistive devices at work and perceived physical exertion at work. LBP outcomes assessed were: days with LBP, LBP intensity and days with bothersome LBP. RESULTS: There were no significant indirect effects of the intervention on LBP outcomes. There were significant effects of the intervention on both fear-avoidance measures [ß = - 0.63, 95% CI (1.23, 0.03); ß = - 1.03, 95% CI (- 1.70, - 0.34)] and the use of assistive devices [ß = - 0.55, 95% CI (- 1.04, - 0.05)], but not on perceived muscle strength [ß = - 0.18, 95% CI (- 0.50, 0.13)] or physical exertion [ß = - 0.05, 95% CI (- 0.40, 0.31)]. The only potential mediator with a significant effect on LBP outcomes was physical exertion, which had a significant effect on LBP intensity [ß = 0.14, 95% CI (0.04, 0.23)]. CONCLUSIONS: A multifaceted intervention consisting of participatory ergonomics, physical training, and CBT was able to decrease fear-avoidance beliefs and increase use of assistive devices in the workplace. However, these changes did not explain the effect of any of the intervention components on days with LBP, LBP intensity and days with bothersome LBP.

Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study.

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.

Identification of Indirect Effects in a Cognitive Patient Education (COPE) Intervention for Low Back Pain.

BACKGROUND: Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery. OBJECTIVE: The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome. DESIGN: This study was a secondary analysis of the COPE randomized controlled trial. METHODS: Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline - posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis. RESULTS: Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 [95% CI = 0.03 to 0.16]; pain catastrophizing standardized indirect effect = 0.05 [95% CI = 0.01 to 0.12]). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant. LIMITATIONS: This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects. CONCLUSIONS: The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.

Mediators of Treatment Effect in the Back In Action Trial: Using Latent Growth Modeling to Take Change Over Time Into Account.

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.

Exploring What Factors Mediate Treatment Effect: Example of the STarT Back Study High-Risk Intervention.

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.

Behaviour change and self-management interventions in persistent low back pain.

Self-management interventions for persistent low back pain (LBP) promote active involvement of the patient in managing their condition. Such interventions can be characterised as behaviour change interventions, in that they are designed to help the patient learn and adopt a set of health behaviours that they can use in everyday life to benefit their condition by reducing or managing their symptoms. Self-management interventions are recommended in several key guidelines for the treatment of persistent LBP, but the evidence for the effectiveness of these types of interventions is inconclusive. In this article, we discuss the existing literature within self-management interventions for persistent LBP and make suggestions for how research in this area can be improved, specifically addressing areas where evidence is currently lacking. Existing definitions of self-management are examined, and the importance of the choice of an underlying theory and appropriate outcome measures are discussed.

Symptom perceptions and help-seeking behaviour prior to lung and colorectal cancer diagnoses: a qualitative study.

BACKGROUND: Lung and colorectal cancer are common and have high UK mortality rates. Early diagnosis is important in reducing cancer mortality, but the literature on lung and colorectal cancers suggests many people wait for a considerable time before presenting symptoms. OBJECTIVE: To gain in-depth understanding of patients' interpretations of symptoms of lung and colorectal cancer prior to diagnosis, and to explore processes leading to help-seeking. METHODS: Semi-structured interviews were conducted with patients diagnosed with lung (N=9) or colorectal (N=20) cancer within the previous 12 months. Patients were asked about symptoms experienced in the period preceding diagnosis, their interpretations of symptoms, and decision making for help-seeking. Thematic analysis was conducted and comparisons drawn within and across the patient groups. RESULTS: Patients were proactive and rational in addressing symptoms; many developed alternative, non-cancer explanations based on their knowledge and experience. Discussions with important others frequently provided the impetus to consult, but paradoxically others often initially reinforced alternative explanations. Fear and denial did not emerge as barriers to help-seeking, but help-seeking was triggered when patients' alternative explanations could no longer be maintained, for instance due to persistence or progression of symptoms. CONCLUSION: Patients' reasoning, decision making and interpersonal interactions prior to diagnosis were complex. Prompting patients for additional detail on symptoms within consultations could elicit critical contextual information to aid referral decisions. Findings also have implications for the design of public health campaigns.

How does pain lead to disability? A systematic review and meta-analysis of mediation studies in people with back and neck pain.

Disability is an important outcome from a clinical and public health perspective. However, it is unclear how disability develops in people with low back pain or neck pain. More specifically, the mechanisms by which pain leads to disability are not well understood. Mediation analysis is a way of investigating these mechanisms by examining the extent to which an intermediate variable explains the effect of an exposure on an outcome. This systematic review and meta-analysis aimed to identify and examine the extent to which putative mediators explain the effect of pain on disability in people with low back pain or neck pain. Five electronic databases were searched. We found 12 studies (N = 2961) that examined how pain leads to disability with mediation analysis. Standardized regression coefficients (ß) of the indirect and total paths were pooled. We found evidence to show that self-efficacy (ß = 0.23, 95% confidence interval [CI] = 0.10 to 0.34), psychological distress (ß = 0.10, 95% CI = 0.01 to 0.18), and fear (ß = 0.08, 95% CI = 0.01 to 0.14) mediated the relationship between pain and disability, but catastrophizing did not (ß = 0.07, 95% CI = -0.06 to 0.19). The methodological quality of these studies was low, and we highlight potential areas for development. Nonetheless, the results suggest that there are significant mediating effects of self-efficacy, psychological distress, and fear, which underpins the direct targeting of these constructs in treatment.

Critical items for assessing risk of lung and colorectal cancer in primary care: a Delphi study.

BACKGROUND: Patients with lung or colorectal cancer often present late and have a poor prognosis. Identifying diagnostic indicators to optimally assess the risk of these cancers in primary care would support early identification and timely referral for patients at increased risk. AIM: To obtain consensus regarding potential diagnostic indicators that are important for assessing the risk of lung or colorectal cancer in primary care consulters presenting with lung or abdominal symptoms. DESIGN AND SETTING: A Delphi study was conducted with 28 participants from primary and secondary care and academic settings in the UK and Europe. METHOD: Indicators were obtained from systematic reviews, recent primary studies and consultation with experts prior to the Delphi study being conducted. Over three rounds, participants rated each diagnostic indicator in terms of its importance, ranked them in order of importance, and rated each item as crucial or not crucial to assess during a GP consultation. RESULTS: The final round resulted in 25 items remaining for each type of cancer, including established cancer symptoms such as rectal bleeding for colorectal cancer and haemoptysis for lung cancer, but also less frequently used indicators such as patients' concerns about cancer. CONCLUSION: This study highlights the items clinicians feel would be most crucial to include in the clinical assessment of primary care patients, a number of which have rarely been noted in the previous literature. Their importance in assessing the risk of lung or colorectal cancer will be tested as part of a large prospective cohort study (CANDID).