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ObjectiveThe SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.DesignThis was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).SettingPrimary care in the UK (England).Participants46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.InterventionAn internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.AnalysisData were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.ResultsFour explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.ConclusionsDigital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

ObjectivesMost patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.DesignA mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.SettingPrimary care.MethodsThe study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.Results19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.ConclusionThis study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.Trial registration numberNCT04543097.

ObjectivesTo identify potentially modifiable factors that mediate the association between symptomatic osteoarthritis (OA) and premature mortality.MethodsA 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.ResultsOA 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).ConclusionsThe 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.

IntroductionSelf-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 analysisA 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 disseminationThis 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 numberISRCTN14736486.

Abstract 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.

Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society.

Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population. Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society.

The objective of this study was to investigate whether systematic reviews of mediation studies identify limitations in reporting quality and methodological conduct. 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). 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. 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.

Background Comorbid mental health problems have been shown to have an adverse effect on the quality of life of people with common eye disorders. This study aims to assess whether symptoms of anxiety and/or depression are more prevalent in people with age-related macular degeneration (AMD) than in people without this condition. Methods A systematic search of electronic databases (Medline, CINAHL, EMBASE, PsycINFO) from inception to February 2012 was conducted to identify studies of AMD populations which measured symptoms of anxiety and/or depression. Reference checking of relevant articles was also performed. Data on the study setting, prevalence and how anxiety and depression were measured were extracted from the papers. Critical appraisal was performed using the Critical Appraisal Skills Programme (CASP) tools. Results A total of 16 papers were included in the review, from an original search result of 597. The prevalence estimates, taken from nine cross-sectional and cohort studies, ranged from 15.7%-44% for depressive symptoms and 9.6%-30.1% for anxiety symptoms in people with AMD. The seven case–control studies found that people with AMD were more likely to experience symptoms of depression compared with those without AMD, but not more likely to experience symptoms of anxiety. Conclusions Overall, the evidence suggests that symptoms of depression are more prevalent amongst AMD populations than anxiety symptoms. The heterogeneity of the studies included in this review means that it is difficult to draw strong conclusions as to the true estimates of depression and anxiety symptoms in AMD populations and prevented formal meta-analysis. Further research which specifies clinical anxiety and gives clear definitions as to the type of AMD being investigated is required.

PurposeA 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.MethodsThis 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.ResultsThere were no significant indirect effects of the intervention on LBP outcomes. There were significant effects of the intervention on both fear-avoidance measures [β = − 0.63, 95% CI (1.23, 0.03); β = − 1.03, 95% CI (− 1.70, − 0.34)] and the use of assistive devices [β = − 0.55, 95% CI (− 1.04, − 0.05)], but not on perceived muscle strength [β = − 0.18, 95% CI (− 0.50, 0.13)] or physical exertion [β = − 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 [β = 0.14, 95% CI (0.04, 0.23)].ConclusionsA 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.