Patient preferences for models of care for fibromyalgia: A discrete choice experiment.

BACKGROUND: Fibromyalgia is a common reason for referral to a rheumatologist and is a centralised pain state with symptoms beginning in adolescence/early adulthood and manifests as pain throughout the body, fatigue and cognitive dysfunction. Whilst there is considerable evidence on effective treatments, diagnosis and management are complex. There is almost no evidence on how to organise health services to deliver recommended therapies. The aim of the current study was to understand patient preferences for different features of healthcare services for fibromyalgia. METHODOLOGY: We use the Discrete Choice Experiment Method (DCE), a choice-based survey that quantifies preferences for attributes of goods, services or policy interventions, to elicit preferences in relation to alternative models of care for people with fibromyalgia. In this study, attributes describe different models of care for fibromyalgia. We based attributes and levels on earlier phases of the PACFiND project and a literature review on fibromyalgia models of care. The final analysis sample consisted of 518 respondents who completed the survey in full. RESULTS: The final analysis sample consisted of 518 respondents ((patients living in the UK, over 18 years old, with a diagnosis of fibromyalgia), who completed the survey in full. The model of care most preferred is one characterised by earlier diagnosis and ongoing management by a Rheumatologist, via Face-to-face or Phone/video call appointments, with a stronger preference for the latter mode of support. The most preferred treatment was Medication, followed by Physical Therapy, with the least preferred being Talking Therapy. Relative to a Waiting Time for treatment of 6 months, respondents would prefer a lower Waiting Time of 3 months and dislike waiting 12 months for treatment. Respondents showed willingness to receive Ongoing Help and Advice by a Nurse Practitioner or a GP, instead of a Specialist Rheumatologist, provided they were compensated by other changes in the model of care. CONCLUSION: This study has found that, although respondents express a preference for specialist care, provided by a Rheumatologist, they may be willing to trade-off this preference against other features within a model of care. This willingness to accept a different skill-mix (e.g., appointments with a GP or a Nurse Practitioner) has important implications for practice and policy, as this is a more feasible option in settings where the availability of specialist care is highly constrained.

BayesGmed: An R-package for Bayesian causal mediation analysis.

BACKGROUND: The past decade has seen an explosion of research in causal mediation analysis. However, most analytic tools developed so far rely on frequentist methods which may not be robust in the case of small sample sizes. In this paper, we propose a Bayesian approach for causal mediation analysis based on Bayesian g-formula, which will overcome the limitations of the frequentist methods. METHODS: We created BayesGmed, an R-package for fitting Bayesian mediation models in R. The application of the methodology (and software tool) is demonstrated by a secondary analysis of data collected as part of the MUSICIAN study, a randomised controlled trial of remotely delivered cognitive behavioural therapy (tCBT) for people with chronic pain. We tested the hypothesis that the effect of tCBT would be mediated by improvements in active coping, passive coping, fear of movement and sleep problems. We then demonstrate the use of informative priors to conduct probabilistic sensitivity analysis around violations of causal identification assumptions. RESULT: The analysis of MUSICIAN data shows that tCBT has better-improved patients' self-perceived change in health status compared to treatment as usual (TAU). The adjusted log-odds of tCBT compared to TAU range from 1.491 (95% CI: 0.452-2.612) when adjusted for sleep problems to 2.264 (95% CI: 1.063-3.610) when adjusted for fear of movement. Higher scores of fear of movement (log-odds, -0.141 [95% CI: -0.245, -0.048]), passive coping (log-odds, -0.217 [95% CI: -0.351, -0.104]), and sleep problem (log-odds, -0.179 [95% CI: -0.291, -0.078]) leads to lower odds of a positive self-perceived change in health status. The result of BayesGmed, however, shows that none of the mediated effects are statistically significant. We compared BayesGmed with the mediation R- package, and the results were comparable. Finally, our sensitivity analysis using the BayesGmed tool shows that the direct and total effect of tCBT persists even for a large departure in the assumption of no unmeasured confounding. CONCLUSION: This paper comprehensively overviews causal mediation analysis and provides an open-source software package to fit Bayesian causal mediation models.

UK healthcare services for people with fibromyalgia: results from two web-based national surveys (the PACFiND study).

BACKGROUND: The UK's "Getting It Right First Time" programme recommends that management of people with fibromyalgia should centre on primary care. However, it remains unclear as to how best to organise health systems to deliver services to optimise patient outcomes. AIM: To profile UK healthcare services for people with fibromyalgia: provision of National Health Services (NHS) and use of non-NHS services by people with fibromyalgia. METHODS: Two online open surveys (A and B) incorporating questions about diagnosis, treatment and management of fibromyalgia and gaps in healthcare services were conducted between 11th September 2019 and 3rd February 2020. These were targeted to NHS healthcare professionals consulting with people with fibromyalgia (Survey A) and people ≥16 years diagnosed with fibromyalgia using non-NHS services to manage their condition (Survey B). Descriptive statistics were used to report quantitative data. Thematic analysis was undertaken for qualitative data. RESULTS: Survey A received 1701 responses from NHS healthcare professionals across the UK. Survey B received 549 responses from people with fibromyalgia. The results show that NHS services for people with fibromyalgia are highly disparate, with few professionals reporting care pathways in their localities. Diagnosing fibromyalgia is variable among NHS healthcare professionals and education and pharmacotherapy are mainstays of NHS treatment and management. The greatest perceived unmet need in healthcare for people with fibromyalgia is a lack of available services. From the pooled qualitative data, three themes were developed: 'a troublesome label', 'a heavy burden' and 'a low priority'. Through the concept of candidacy, these themes provide insight into limited access to healthcare for people with fibromyalgia in the UK. CONCLUSION: This study highlights problems across the NHS in service provision and access for people with fibromyalgia, including several issues less commonly discussed; potential bias towards people with self-diagnosed fibromyalgia, challenges facing general practitioners seeking involvement of secondary care services for people with fibromyalgia, and a lack of mental health and multidisciplinary holistic services to support those affected. The need for new models of primary and community care that offer timely diagnosis, interventions to support self-management with access to specialist services if needed, is paramount.

Enabling work participation for people with musculoskeletal conditions: lessons from work changes imposed by COVID-19: a mixed-method study.

OBJECTIVES: To understand what we can learn from the impact of the COVID-19 pandemic and lockdown about what enables work participation for people with inflammatory arthritis and chronic pain conditions. DESIGN: Qualitative interviews embedded within an observational questionnaire study of individuals with musculoskeletal (MSK) conditions. SETTING: UK primary care (general practices), and secondary care-based rheumatology services. PARTICIPANTS: Individuals with axial spondyloarthritis, psoriatic arthritis and MSK pain from three established cohorts completed an online/paper-based questionnaire (July-December 2020). A subset of respondents were selected for semistructured interviews. PRIMARY AND SECONDARY OUTCOME MEASURES: The survey quantified the effects of lockdown on work circumstances. Qualitative interviews explored the impacts of these changes and the advantages and disadvantages of changes in work circumstances. RESULTS: 491 people (52% female, median age 49 years) who were employed at the time of lockdown responded to the questionnaire. The qualitative analysis included 157 free-text comments on work from the questionnaire and data collected within 18 interviews.Participants reported impacts on mental and physical health, and significant financial anxieties. The impact of work changes varied depending on individual and home circumstances. Some felt forced to ignore advice to shield and continue working. The flexibility offered by home working and changes in commuting enabled greater physical activity for some, while others missed the exercise normally undertaken as part of their commute. Others reported a constant need to be 'present' online, which heightened anxiety and worsened MSK symptoms. CONCLUSION: Lockdown showed that flexible working arrangements, which consider the positive and negative aspects of commuting, posture, movement, and work environment matter for work participation, and can have wider benefits in terms of health and well-being for those with long-term MSK conditions. Incorporating these into new models of work will help make the workplace more equitable and inclusive for people with long-term MSK conditions.

Association between alcohol consumption and chronic pain: a systematic review and meta-analysis.

INTRODUCTION: Chronic pain represents a global health problem with a considerable economic burden. The relation of alcohol intake and chronic pain conditions was assessed in several studies with conflicting results. We used dose-response meta-analysis techniques to answer the question of whether alcohol intake is related to chronic pain occurrence. METHODS: We searched MEDLINE, Embase, and other databases to identify cohort and case-control studies on alcohol consumption and chronic pain. Sixteen studies were eligible with a total population of 642 587 individuals. Fixed-effects and random-effects pooled estimates were obtained by weighting log odds ratios (ORs) in case-control studies and log incidence rate ratios in cohort studies by the inverse of their variance. A heterogeneity assessment and a dose-response analysis were carried out. Quality scoring was also performed. RESULTS: Our results show that any alcohol consumption was related to lower odds of chronic pain (pooled OR=0.76; 95% confidence interval [CI], 0.61-0.95). The association was non-linear. The ORs by quartile of alcohol doses were as follows: OR2nd quartile=0.74; 95% CI, 0.64-0.87; OR3rd quartile=0.67; 95% CI, 0.53-0.86; and OR4th quartile=0.75; 95% CI, 0.50-1.14. This association was observed for cohort studies (OR=0.77; 95% CI, 0.61-0.98) and European studies (OR=0.65; 95% CI, 0.48-0.87) only. Studies with complete adjustment for confounding factors showed a stronger relation than those with incomplete adjustment (OR=0.69; 95% CI, 0.48-0.99 and OR=0.85; 95% CI, 0.65-1.11, respectively). CONCLUSION: Alcohol consumption presents a non-linear inverse association with the occurrence of chronic pain. Although plausible mechanisms could explain this protective effect, other explanations, including reverse causation, are probable.

Lessons from experiences of accessing healthcare during the pandemic for remobilizing rheumatology services: a national mixed methods study.

Objectives: To understand the impact of the coronavirus disease 2019 pandemic on access to healthcare services for patients with inflammatory and non-inflammatory musculoskeletal (MSK) conditions. Methods: Three established cohorts that included individuals with axial SpA, psoriatic arthritis and MSK pain completed a questionnaire between July and December 2020. In parallel, a subset of individuals participated in semistructured interviews. Results: A total of 1054 people (45% female, median age 59 years) were included in the quantitative analyses. Qualitative data included 447 free-text questionnaire responses and 23 interviews. A total of 57% of respondents had tried to access care since the start of the UK national lockdown. More than a quarter reported being unable to book any type of healthcare appointment. General practice appointments were less likely to be delayed or cancelled compared with hospital appointments. Younger age, unemployment/health-related retirement, DMARD therapy, anxiety or depression and being extremely clinically vulnerable were associated with a greater likelihood of attempting to access healthcare. People not in work, those reporting anxiety or depression and poorer quality of life were less likely to be satisfied with remotely delivered healthcare. Participants valued clear, timely and transparent care pathways across primary care and specialist services. While remote consultations were convenient for some, in-person appointments enabled physical assessment and facilitated the development and maintenance of clinical relationships with care providers. Conclusions: We identified patient factors that predict access to and satisfaction with care and aspects of care that patients value. This is important to inform remobilisation of rheumatology services to better meet the needs of patients.

Comparing the Impact of Symptoms and Health Care Experiences of People Who Have and Have Not Received a Diagnosis of Fibromyalgia: A Cross-Sectional Survey Within the PACFiND Study.

OBJECTIVE: To compare the impact of symptoms and health care utilization of people diagnosed with fibromyalgia, people who fulfill the criteria but are not diagnosed, and people with chronic pain. METHODS: We recruited people who had participated in a previous population survey across Scotland and who reported some typical fibromyalgia symptoms or had received a diagnosis of fibromyalgia. Responses to a postal questionnaire were used to define mutually exclusive groups: people who had a fibromyalgia diagnosis, who met criteria for fibromyalgia, and who had chronic pain. RESULTS: Participants included 85 people with a diagnosis of fibromyalgia, 110 who met criteria for fibromyalgia, and 133 with chronic pain. The mean age across groups ranged 57-59 years, but the percentage female varied markedly: 86%, 64%, and 67%, respectively. Compared to those with chronic pain, participants with a fibromyalgia diagnosis were more likely to be out of employment due to health. An average of 3 years was needed to receive a fibromyalgia diagnosis, and more than half were diagnosed in secondary care (most commonly rheumatology). The fibromyalgia diagnosis and criteria groups were similar in terms of symptom impact, quality of life, and life satisfaction but were worse than the chronic pain group. Participants who had received a diagnosis of fibromyalgia reported the poorest health care experiences. CONCLUSION: An urgent need exists for a model of care for fibromyalgia to ensure prompt diagnosis, access to evidence-based care, and long-term support, with the aim of improving function. The data suggest that diagnosis in men may be overlooked, and this finding warrants further study.

Erratum to: Development of a clinical risk score for pain and function following total knee arthroplasty: results from the TRIO study.

[This corrects the article DOI: 10.1093/rap/rky021.][This corrects the article DOI: 10.1093/rap/rky021.].

The effect of COVID-19 public health restrictions on the health of people with musculoskeletal conditions and symptoms: the CONTAIN study.

OBJECTIVE: To quantify the change in quality of life, disease-specific indicators, health and lifestyle before and during the COVID-19 pandemic among people with musculoskeletal diagnoses and symptoms. METHODS: We undertook an additional follow-up of two existing UK registers involving people with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) and participants in a trial in the UK who had regional pain and were identified at high risk of developing chronic widespread pain. Participants completed the study questionnaire between July and December 2020, throughout which time there were public health restrictions in place. RESULTS: The number of people taking part in the study was 1054 (596 axSpA, 162 PsA, 296 regional pain). In comparison with their previous (pre-pandemic) assessment, there was an age-adjusted significant, small decrease in quality of life measured by EQ-5D [-0.020 (95% CI -0.030, -0.009)] overall and across all population groups examined. This was primarily related to poorer mental health and pain. There was a small increase in fibromyalgia symptoms, but a small decrease in sleep problems. There was a small deterioration in axSpA disease activity, and disease-specific quality of life and anxiety in PsA participants. Predictors of poor quality of life were similar pre- and during the pandemic. The effect of lockdown on activity differed according to age, gender and deprivation. CONCLUSION: Important lessons include focusing on addressing anxiety and providing enhanced support for self-management in the absence of normal health care being available, and awareness that all population groups are likely to be affected.

Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study).

OBJECTIVE: Cognitive-behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk. METHODS: A population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment. RESULTS: 996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI -£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention. CONCLUSIONS: A short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02668003).

The epidemiology of regular opioid use and its association with mortality: Prospective cohort study of 466 486 UK biobank participants.

BACKGROUND: Opioids have, at most, small benefits for non-cancer pain in the medium and long-term but there is good evidence that they cause harm. The current study describes the characteristics and clinical status of people taking regular opioids in Great Britain and determines whether use is associated with mortality risk. METHODS: An analysis of participants in UK Biobank, a prospective population-based study. At recruitment (2006-10) participants reported medicines which they regularly used in addition to lifestyle and health-related factors. Information was available on deaths until October 2016. FINDINGS: There were 466 486 participants (54% women) aged 40-69 years and without a prior history of cancer of whom 5.5% were regularly using opioids. Use increased with age-group, was more common in females (6.3% v. 4.6%) and 87% of persons using them reported chronic pain. The highest rates of use (~1 in 9) were in people with low household income, who left school <16 years and lived in areas with high deprivation. Amongst 15,032 people who could not work because of ill-health, 1 in 3 were regularly taking opioids. Regular users reported insomnia (88.7%), a recent major recent life event (57.3%) and were much more likely than non-users to rate their health as poor (RR 5.5, 99% CI (4.9, 6.1)). Those taking weak (4.2% of participants) or strong (1.4%) opioids were more likely to die during follow-up (6.9% and 9.1% respectively v. 3.3% in non-users) an excess which remained after adjustment for demographic, socio-economic, health and lifestyle factors (MRR 1.18 99% CI (1.06, 1.32) and 1.20 99% CI (1.01, 1.43)) respectively. INTERPRETATION: Regular use of opioids is common in Great Britain, particularly in groups of low socio-economic status. Most users still report chronic pain, poor health generally and are at increased risk of premature death although it is not established that this relationship is causal. FUNDING: There were no external sources of funding obtained for the current analyses.

Telephone cognitive behavioural therapy to prevent the development of chronic widespread pain: a qualitative study of patient perspectives and treatment acceptability.

BACKGROUND: Telephone cognitive behavioural therapy (tCBT) is an acceptable and effective treatment for patients with chronic widespread pain (CWP). Preventing the onset of CWP offers considerable benefits to the individual and society and the MAmMOTH study is the first aimed at CWP prevention. The study is a two-arm randomised trial testing a course of tCBT against usual care for prevention of CWP. This nested qualitative study explores patients' treatment experiences, with a view to understanding their potential influences on acceptability of the intervention. METHODS: The MAmMOTH Study recruited 1002 participants, half of whom were randomised to receive tCBT. Participants were eligible for invitation to the trial if they had pain for which they had consulted their GP, or had pain and visited a doctor frequently, and had 2 of 3 risk factors for development of CWP. Participants randomised to tCBT who had completed treatment were eligible for invitation to qualitative interviews for this study. Individual qualitative interviews were conducted with a sub-sample (n = 33) of patients at high risk of developing CWP who had been allocated to the intervention arm. Semi-structured telephone interviews explored treatment experiences and intervention acceptability. Data was analysed using Framework analysis. RESULTS: Participants presented with a range of musculoskeletal and auto-immune conditions and almost half described their pain as 'chronic' on study entry. Many participants perceived the trial intervention to be aimed at treatment of pain rather than prevention of pain. Initial expectations prior to treatment varied, with scepticism more likely for those who had little prior knowledge of CBT approaches. All participants provided positive feedback post intervention particularly in relation to the modality, therapist experience and skills and the intervention. The majority of participants described positive changes in either their subjective level of pain or pain-management post-intervention and some attributed the positive change directly to the intervention as a result of empowerment, increased self-management and cognitive restructuring. CONCLUSIONS: This study extends our understanding of the acceptability and suitability of preventative interventions for chronic widespread pain and provides further evidence for the acceptability of tCBT. TRIAL REGISTRATION: Clinical Trials.gov NCT02668003 (registered 29th January, 2016).

What is the effect of alcohol consumption on the risk of chronic widespread pain? A Mendelian randomisation study using UK Biobank.

Studies have shown that moderate alcohol consumption is strongly associated with reduced reporting of chronic widespread pain (CWP). The study designs used, however, are prone to confounding and are not able to establish the direction of causality. The current study overcomes these problems using the Mendelian randomisation design to determine the effect of alcohol consumption on the likelihood of reporting CWP. The UK Biobank recruited 500,000 participants aged between 40 and 69 years. Data collected included questions on chronic pain and alcohol consumption, and biological samples providing genotypic information. Alcohol consumption was categorised as "weekly consumption" or "nonfrequent or infrequent." Participants were classified by genotype according to alleles of the rs1229984 single-nucleotide polymorphism, either "GG" or "AA/AG." Chronic widespread pain was defined as pain all over the body for more than 3 months that interfered with activities. Associations between genotype, CWP, and alcohol consumption were tested by logistic regression. Instrumental variable analysis was used to calculate the causal effect of weekly alcohol consumption on CWP. Persons with "GG" genotype had an increased risk of CWP (odds ratio [OR] 1.17, 99% confidence interval 1.01-1.35) and were more likely to consume alcohol weekly (OR 1.76, 1.70-1.81) compared to those with "AA/AG" genotype. Weekly consumption of alcohol was associated with reduced risk of CWP (OR 0.33, 0.31-0.35), but instrumental variable analysis did not show a causal effect of alcohol consumption on reducing CWP (OR 1.29, 0.96-1.74). An interpretation of observational population studies as showing a protective effect of alcohol on CWP is not supported.

Development of a clinical risk score for pain and function following total knee arthroplasty: results from the TRIO study.

OBJECTIVES: The aim was to develop and validate a simple clinical prediction model, based on easily collected preoperative information, to identify patients at high risk of pain and functional disability 6 months after total knee arthroplasty (TKA). METHODS: This was a multicentre cohort study of patients from nine centres across the UK, who were undergoing a primary TKA for OA. Information on sociodemographic, psychosocial, clinical and quality-of-life measures were collected at recruitment. The primary outcome measure for this analysis was the Oxford knee score (OKS), measured 6 months postoperatively by postal questionnaire. Multivariable logistic regression was used to develop the model. Model performance (discrimination and calibration) and internal validity were assessed, and a simple clinical risk score was developed. RESULTS: Seven hundred and twenty-one participants (mean age 68.3 years; 53% female) provided data for the present analysis, and 14% had a poor outcome at 6 months. Key predictors were poor clinical status, widespread body pain, high expectation of postoperative pain and lack of active coping. The developed model based on these variables demonstrated good discrimination. At the optimal cut-off, the final model had a sensitivity of 83%, specificity of 61% and positive likelihood ratio of 2.11. Excellent agreement was found between observed and predicted outcomes, and there was no evidence of overfitting in the model. CONCLUSION: We have developed and validated a clinical prediction model that can be used to identify patients at high risk of a poor outcome after TKA. This clinical risk score may be an aid to shared decision-making between patient and clinician.

Impact of Moving From a Widespread to Multisite Pain Definition on Other Fibromyalgia Symptoms.

OBJECTIVE: To investigate whether associations between pain and the additional symptoms associated with fibromyalgia are different in persons with chronic widespread pain (CWP) compared to multisite pain (MSP), with or without joint areas. METHODS: Six studies were used: 1958 British birth cohort, Epidemiology of Functional Disorders, Kid Low Back Pain, Managing Unexplained Symptoms (Chronic Widespread Pain) in Primary Care: Involving Traditional and Accessible New Approaches, Study of Health and its Management, and Women's Health Study (WHEST; females). MSP was defined as the presence of pain in ≥8 body sites in adults (≥10 sites in children) indicated on 4-view body manikins, conducted first to include joints (positive joints) and second without (negative joints). The relationship between pain and fatigue, sleep disturbance, somatic symptoms, and mood impairment was assessed using logistic regression. Results are presented as odds ratios (ORs) with 95% confidence intervals (95% CIs). RESULTS: There were 34,818 participants across the study populations (adults age range 42-56 years, male 43-51% [excluding WHEST], and CWP prevalence 12-17%). Among those reporting MSP, the proportion reporting CWP ranged between 62% and 76%. Among those reporting the symptoms associated with fibromyalgia, there was an increased likelihood of reporting pain, the magnitude of which was similar regardless of the definition used. For example, within WHEST, reporting moderate/severe fatigue (Chalder fatigue scale 4-11) was associated with a >5-fold increase in likelihood of reporting pain (CWP OR 5.2 [95% CI 3.9-6.9], MSP-positive joints OR 6.5 [95% CI 5.0-8.6], and MSP-negative joints OR 6.5 [95% CI 4.7-9.0]). CONCLUSION: This large-scale study demonstrates that regardless of the pain definition used, the magnitude of association between pain and other associated symptoms of fibromyalgia is similar. This finding supports the continued collection of both when classifying fibromyalgia, but highlights the fact that pain may not require to follow the definition outlined within the 1990 American College of Rheumatology criteria.

Investigating generalizability of results from a randomized controlled trial of the management of chronic widespread pain: the MUSICIAN study.

The generalisability of randomised controlled trials will be compromised if markers of treatment outcome also affect trial recruitment. In a large trial of chronic widespread pain, we aimed to determine the extent to which randomised participants represented eligible patients, and whether factors predicting randomisation also influenced trial outcome. Adults from 8 UK general practices were surveyed to determine eligibility for a trial of 2 interventions (exercise and cognitive behavioural therapy [CBT]). Amongst those eligible, logistic regression identified factors associated with reaching the randomisation step in the recruitment process. The main trial analysis was recomputed, weighting for the inverse of the likelihood of reaching the randomisation stage, and the numbers needed to treat were calculated for each treatment. Eight hundred eighty-four persons were identified as eligible for the trial, of whom 442 (50%) were randomised. Several factors were associated with the likelihood of reaching the randomisation stage: higher body mass index (odds ratio: 1.99; 0.85-4.61); more severe/disabling pain (1.90; 1.21-2.97); having a treatment preference (2.11; 1.48-3.00); and expressing positivity about interventions offered (exercise: 2.66; 1.95-3.62; CBT: 3.20; 2.15-4.76). Adjusting for this selection bias decreased the treatment effect associated with exercise and CBT but increased that observed for combined therapy. All were associated with changes in numbers needed to treat. This has important implications for the design and interpretation of pain trials generally.

Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain.

Background: Patients' beliefs and attitudes toward a treatment can affect treatment response. In unblinded trials this can affect outcomes. Aims: The aim of this analysis was to examine the association between treatment preference and expectation and outcome in a trial of pain treatments. Methods: In a randomized trial (ISRCTN67013851) of four treatments for chronic widespread pain, participants were asked which they would prefer and what improvement they expect from each. The proportion of participants reporting positive health outcomes at three time points after treatment were compared between those matched or unmatched with their preference and between those with and without expectation for improvement. Odds ratios were calculated adjusted for baseline characteristics associated with preference and expectation. Results: Four hundred forty-two participants were recruited to the trial (69.5% female). The proportion reporting positive outcomes among participants matched to their preference compared to those unmatched was 33.3% vs. 34.4% at the end of treatment (adjusted odds ratio [aOR] = 0.80, 95% confidence interval [CI], 0.44-1.46), 34.4% vs. 29.0% at 3 months (aOR = 1.23, 95% CI, 0.67-2.26), and 34.8% vs. 30.3% at 2 years (aOR = 1.31, 95% CI, 0.70-2.46). The proportion of participants reporting positive outcomes among those expecting improvement compared to those not expecting improvement was 36.6% vs. 15.0% at the end of treatment (aOR = 2.03, 95% CI, 1.07-3.85), 34.1% vs. 13.2% at 3 months (aOR = 2.31, 95% CI, 1.22-4.38), and 32.8% vs. 19.1% at 2 years (aOR = 1.16, 95% CI, 0.67-2.36). Conclusions: Treatment preference had no clear effect on outcomes, but expectation did. These results could inform future approaches to management, and researchers assessing treatments should take into account this expectation effect.

Contexte: Les croyances et les attitudes des patients à l'égard d'un traitement peuvent influencer la réponse à ce traitement. Dans des essais sans insu, il peut y avoir un effet sur les résultats. Buts: Le but de cette analyse était d'étudier le lien entre les préférences et les attentes à l'égard du traitement, et le résultat obtenu dans un essai portant sur les traitements de la douleur. Méthodes: Dans un essai randomisé (ISRCTN67013851) portant sur quatre traitements pour la douleur chronique généralisée, on a demandé aux participants quelle était leur préférence quant au traitement, ainsi que l'amélioration qu'ils attendaient de chacun de ces traitements. Une comparaison de la proportion de participants ayant rapporté des résultats positifs sur leur santé à trois moments différents après le traitement a été effectuée entre ceux qui ont reçu le traitement qu'ils préféraient et ceux qui ont reçu un traitement autre que celui qu'ils préféraient, ainsi qu'entre ceux qui s'attendaient à une amélioration et ceux qui n'avaient pas de telles attentes. Les rapports de cotes ont été calculés et ajustés selon les caractéristiques de départ en ce qui concerne la préférence et les attentes. Résultats: Le nombre de participants recrutés pour cet essai était de 442 (69,5 % de femmes). La proportion de participants ayant rapporté un résultat positif parmi ceux qui ont reçu le traitement qu'ils préféraient comparativement à ceux qui ont reçu un traitement autre que celui qu'ils préféraient était de 33,3 % comparativement à 34,4 % à la fin du traitement (RC ajusté 0,80, 95 % IC 0,44-1,46); de 34,4 % comparativement à 29,0 % après trois mois (RCa 1,23, 0,67 ­ 2,26) et de 34,8 % comparativement à 30,3 % après deux ans (RCa 1,31, 0,70 ­ 2,46). La proportion de participants ayant rapporté des résultats positifs parmi ceux qui s'attendaient à une amélioration comparativement à ceux qui n'avaient pas de telles attentes était de 36,6 % comparativement à 15,0 % à la fin du traitement (RCa 2,03, 1,07-3,85), de 34,1 % comparativement à 13,2 % après trois mois (RCa 2,31, 1,22-4,38), et de 32,8 % comparativement à 19,1 % après deux ans (RCa 1,16, 0,67-2,36).Conclusions: La préférence en matière de traitement n'a pas eu d'effet clair sur les résultats, contrairement aux attentes. Ces résultats pourraient inspirer les approches futures en matière de prise en charge, tandis que les chercheurs qui évaluent des traitements devraient tenir compte de l'effet des attentes.

Is alcohol consumption related to likelihood of reporting chronic widespread pain in people with stable consumption? Results from UK biobank.

Studies have suggested that alcohol consumption is strongly related to reduced reporting of chronic widespread pain (CWP) and level of disability in people with CWP or fibromyalgia. Direction of causality has not been established, that is whether the association is due to people's health influencing their alcohol consumption or vice versa. UK Biobank recruited over 500,000 people aged 40 to 69 years, registered at medical practices nationwide. Participants provided detailed information on health and lifestyle factors including pain and alcohol consumption. Total units consumed per week were calculated for current drinkers. Information was also collected on changes in alcohol consumption and reasons for such changes. Analysis was performed with logistic regression expressed as odds ratios (ORs) with 95% confidence intervals, then adjusted for a large number of potential confounding factors (adjORs). In males who reported drinking the same as 10 years previously, there was a U-shaped relationship between amount drunk and odds of reporting CWP (nondrinkers CWP prevalence 2.4%, 19.1-32.1 units/wk 0.4%, >53.6 units/wk 1.0%; adjORs 2.53 95% confidence intervals [1.78-3.60] vs 1 vs 1.52 [1.05-2.20]). In females, there was a decrease in the proportion reporting CWP up to the modal category of alcohol consumption with no further change in those drinking more (nondrinkers CWP prevalence 3.4%, 6.4-11.2 units/wk 0.7%, >32.1 units/wk 0.7%; adjORs 2.11 [1.67-2.66] vs 1 vs 0.86 [0.54-1.39]). This large study has shown a clear relationship between alcohol consumption and reporting of pain even in people who had not reported changing consumption because of health concerns, after adjustment for potential confounding factors.

The Maintaining Musculoskeletal Health (MAmMOTH) Study: Protocol for a randomised trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain.

BACKGROUND: Cognitive behavioural therapy (CBT) has been shown to improve outcomes for patients with fibromyalgia, and its cardinal feature chronic widespread pain (CWP). Prediction models have now been developed which identify groups who are at high-risk of developing CWP. It would be beneficial to be able to prevent the development of CWP in these people because of the high cost of symptoms and because once established they are difficult to manage. We will test the hypothesis that among patients who are identified as at high-risk, a short course of telephone-delivered CBT (tCBT) reduces the onset of CWP. We will further determine the cost-effectiveness of such a preventative intervention. METHODS: The study will be a two-arm randomised trial testing a course of tCBT against usual care for prevention of CWP. Eligible participants will be identified from a screening questionnaire sent to patients registered at general practices within three Scottish health boards. Those returning questionnaires indicating they have visited their doctor for regional pain in the last 6 months, and who have two of, sleep problems, maladaptive behaviour response to illness, or high number of somatic symptoms, will be invited to participate. After giving consent, participants will be randomly allocated to either tCBT or usual care. We aim to recruit 473 participants to each treatment arm. Participants in the tCBT group will have an initial assessment with a CBT therapist by telephone, then 6 weekly sessions, and booster sessions 3 and 6 months after treatment start. Those in the usual care group will receive no additional intervention. Follow-up questionnaires measuring the same items as the screening survey questionnaire will be sent 3, 12 and 24 months after start of treatment. The main outcome will be CWP at the 12 month questionnaire. DISCUSSION: This will be the first trial of an intervention aimed at preventing fibromyalgia or CWP. The results of the study will help to inform future treatments for the prevention of chronic pain, and aetiological models of its development. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02668003URL: Please check that the following URLs are working. If not, please provide alternatives: NCT02668003Alternative is: https://www.clinicaltrials.gov/ct2/show/NCT02668003> . Date registered: 28-Jan-2016.