Opioid prescribing for chronic musculoskeletal pain in UK primary care: results from a cohort analysis of the COPERS trial.

OBJECTIVE: To establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs. DESIGN: Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731). SETTING: 25 general practices and two community musculoskeletal services in the UK (London and Midlands). PARTICIPANTS: 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial. MAIN OUTCOME MEASURES: Anonymised prescribing data over 12 months extracted from GP electronic records. RESULTS: Of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person. CONCLUSIONS: Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines. TRIAL REGISTRATION NUMBER: ISRCTN24426731; Post-results.

Sleep in patients with primary dystonia: A systematic review on the state of research and perspectives.

Patients with primary dystonia, the third most prevalent movement disorder, suffer from a markedly reduced quality of life. This might, at least in part, be mediated by non-motor symptoms, including sleep disturbances. Characterising and treating sleep disturbances might provide new inroads to improve relevant patient-centred outcomes. This review evaluates the state of research on sleep in patients with dystonia and outlines an agenda for future research. A literature search was performed in July 2014 using PubMed, Medline via Ovid, PsycInfo, PsycArticles via Proquest and Embase via Ovid. Search results were screened for eligibility by two independent raters. Peer-reviewed publications reporting on sleep in patients with primary dystonia were included. Of 1445 studies identified through the search strategy, 18 met the inclusion criteria. In total, the included studies reported on 708 patients diagnosed with focal dystonia (cervical dystonia or blepharospasm), torsion dystonia, and dopa-responsive dystonia. The results indicate that at least half of the patients with focal cranial dystonia suffer from sleep disturbances, but excessive daytime sleepiness is uncommon. Sleep disturbance is associated with depressive symptoms. The frequency and duration of dystonic movements is markedly reduced during sleep. Reduced sleep quality appears to persist after treatment with botulinum toxin that successfully reduces motor symptoms. The findings are limited by a high clinical and methodological heterogeneity. Future research is needed to i) further characterize subjective and PSG sleep in patients with different types of dystonia, ii) determine the aetiology of sleep disturbances (e.g., abnormal brain function associated with dystonia, side effects of medication, psychological reasons), and iii) test whether targeted sleep interventions improve sleep and quality of life in patients with primary dystonia.

Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.

BACKGROUND: Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations (Step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (Step 2). METHODS: Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I-III. The hospitals were randomised by clusters to either active management or usual care consultations. In Step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in Step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. FINDINGS: Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In Step 1, 12 NHS Trusts were randomised, and 3851 of 6952 eligible patients agreed to participate (1598 patients were assigned to usual care and 2253 patients were assigned to active management). 2704 (70%) of 3851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0·5, 95% CI -1·5 to 2·5). In Step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference -3·7, -6·1 to -1·3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. INTERPRETATION: Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. FUNDING: NIHR Health Technology Assessment programme.

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343.

BACKGROUND: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. METHODS/DESIGN: 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. DISCUSSION: This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.

Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).

Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less.

Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.

BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was 1786 pound sterling, and the probability of cost-effectiveness was greater than 90% at a threshold of 3000 pound sterling per QALY. There were no serious adverse events attributable to either treatment. INTERPRETATION: Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial.

BACKGROUND: Low back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. METHODS/DESIGN: This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6-8 participants. A parallel qualitative study will aid the evaluation of the intervention. DISCUSSION: In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.

Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders.

BACKGROUND: A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. METHODS: Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. CONCLUSION: This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.

Asking older people about fear of falling did not have a negative effect.

BACKGROUND AND OBJECTIVE: To assess whether completing a questionnaire on risk of falling could affect outcome measures: fear of falling, reported falls, and health service contacts in older people (panel conditioning). METHODS: We used a postal questionnaire to assess the effect on falls risk of implementing falls injury prevention guidelines within a single locality in outer London, UK. We compared responses for the baseline and 6-month follow-up surveys with those for a fresh survey. The latter was sent to a new pool of subjects drawn from the same population, and was sent only once; timing coincided with the follow-up survey. RESULTS: At baseline, we received 498 responses for 1,000 (50%) surveys sent; of these, 358 (72%) subsequently returned the follow-up survey. For the fresh survey, we received 1,261 out of 2,000 (61%) responses to the fresh survey. The odds ratio for the effect of panel conditioning on fear of falling was 0.92 (95% confidence interval CI = 0.64-1.33), within our predefined limit for equivalence. Odds ratios for the effect on reported falls and health service contacts were 0.87 (95% CI = 0.59-1.29) and 0.75 (95% CI = 0.55-1.02), respectively. CONCLUSION: The proportions of subjects who feared falling in the follow-up survey and in the fresh survey were equivalent. Reduced reporting of falls and health service use in the follow-up survey suggest that the potential for panel effects cannot be ignored.

Back pain and health policy research: the what, why, how, who, and when.

STUDY DESIGN: A background literature, supported by discussion and outcomes on the subject of Health Policy and Back Pain, from the Fifth International Forum on Low Back Pain Research in Primary Care, in Montreal in May 2002. SUMMARY OF BACKGROUND DATA: A multitude of randomized controlled trials and systematic reviews have been completed in the field of back pain research. There has been limited health policy research in the field of back pain but a greater amount of health policy research in other medical fields. METHODS: The focus of the workshop was on the contribution health policy could make in the area of back pain, the methodologies that are appropriate to research in back pain, and the barriers to back pain health policy research. The workshop was supported by the workshop coordinators' literature review. RESULTS: There was consensus about the lack of improved outcomes from randomized controlled trials and individual treatments and general agreement on the importance supporting current research initiatives with health policy research. That policy-makers were developing policy in this area was agreed, and study methodology to support evidence based policy development was explored. CONCLUSIONS: Health policy research is a relatively underdeveloped area of research in back pain. Back pain as a public health problem may be supported by a broader research approach and a collaborative association with policy-makers in this area.

Important determinants of self-efficacy in patients with chronic musculoskeletal pain.

OBJECTIVE: To define the presenting characteristics of a population of patients with chronic musculoskeletal pain seen in a tertiary rheumatology clinic, and to investigate which factors are associated with self-efficacy in these patients. METHODS: Data were collected prospectively for 196 patients who attended the clinic for the first time between October 2000 and August 2002. The primary outcome measure was self-efficacy, measured using the Pain Self-Efficacy Questionnaire. Secondary outcome measures were pain intensity and disability due to pain. The data were analyzed using both univariate and multiple regression methods. RESULTS: These patients had typically undergone extensive investigations and tried various therapies but were left with persisting pain and poor self-efficacy. Multiple regression analysis showed that after adjustment for other factors, the presence of depressive symptoms and employment status were associated with self-efficacy. Patients who reported depressive symptoms had mean self-efficacy scores 7.0 units lower (95% confidence interval, CI: 2.2-11.9) than those who did not. Being employed was associated with higher self-efficacy. The retired had scores 8.3 units lower than employed people (95% CI: 2.4-14.2), whereas housewives and the unemployed had scores approximately 14 units lower (95% CI: 8.0-20.9 and 7.5-19.0, respectively) than employed people. There was also some evidence that distribution of painful sites was associated with self-efficacy. Patients with extensive pain had scores 4.1 units (95% CI: -0.4-8.6) lower than those with limited pain. CONCLUSION: Depressive symptoms, occupational status, and possibly distribution of pain are associated with the reported confidence of these patients with chronic pain in their ability to carry out everyday activities. Possible links to the idea of legitimacy of pain are discussed.

Homelessness: a problem for primary care?

Homelessness is a social problem that affects all facets of contemporary society. This paper discusses the concept of homelessness in terms of its historical context and the dominance of the pervasive 'victim blaming' ideologies, which, together with the worldwide economic changes that have contributed to a fiscal crisis of the state, and the resultant policies and circumstances, have led to an increase in the number of 'new homeless' people. This paper attempts to challenge the dominant political discourse on homelessness. The widespread healthcare problems and heterogeneity of homeless people have a particular impact on health services, with many homeless people inappropriately accessing local accident and emergency (A&E) departments because of barriers inhibiting adequate access to primary care. A number of primary care schemes have been successfully implemented to enable the homeless to have better access to appropriate care. However, there is no consistency in the level of services around the United Kingdom (UK), and innovations in service are not widespread and by their nature they are ad hoc. Despite the successes of such schemes, many homeless people still access health care inappropriately. Until homeless people are fully integrated into primary care the situation will not change. The question remains, how can appropriate access be established? A start can be made by building on some of the positive work that is already being done in primary care, but in reality general practitioners (GPs) will be 'swimming against the tide' unless a more integrated policy approach is adopted to tackle homelessness.

An evaluation of personal medical services: the times they are a changin'.

The Personal Medical Services (PMS) pilot sites, launched in England in 1997 by the Secretary of State for the then Conservative government, introduced a local contract for primary care, aimed at promoting flexibility, innovation and policy participation. As part of the National Evaluation of PMS, this paper considers the professional and organisational relationships established between service providers working in those PMS sites which specifically set out to address inequalities in access to primary care for vulnerable populations. The introduction of PMS enabled a change of cultural values in primary care, particularly regarding GPs' relationships with nurses and practice staff. However, PMS has not necessarily led to equal partnerships within primary care teams. Rather,in the selected sites evaluated new interprofessional relationships emerged. There was evidence of intra and interprofessional partnerships being forged, providing the basis for further improved intersectoral collaboration. There was also evidence that the GP based medical model made way for a community oriented/public health model with emphasis on health maintenance for the vulnerable.

Disseminating and implementing the results of back pain research in primary care.

STUDY DESIGN: Description of a workshop entitled "Implementation and Dissemination: Getting Research into Practice," that was held at the Fourth International Forum on Low Back Pain Research in Primary Care, in Israel in March 2000. SUMMARY OF BACKGROUND DATA: A gap exists between research endeavors and the dissemination and implementation of new research findings. OBJECTIVES: To describe the outcomes of a workshop on implementation and dissemination of research findings. METHODS: The Fourth International Forum on Low Back Pain Research in Primary Care aimed to encourage open discussion and consensus building among leading experts in the field, and to develop a research agenda. The workshop on implementation and dissemination focused on issues surrounding the gap between research results and actual practice. These issues were introduced by several presentations. The broad conclusions of the subsequent debate are summarized in this paper as a series of responses to key questions: 1) who should do the implementation?, 2) what should researchers do to help implementation?, 3) what are the key outcomes?, and 4) what are important ingredients for successful implementation? RESULTS: There was consensus about the importance of implementation of research findings, about the ineffectiveness of merely publishing or disseminating research findings, and about the need for prospective randomized trials evaluating the cost-effectiveness of different implementation strategies. The majority view is that the health provider professions and the professional bodies are the central organizations to implement guidelines, rather than the researchers themselves. Success in getting guidelines or research results into practice is dependent on involving local health service groups, experts, and opinion leaders (both local and national). Patient-centered outcomes and cost-effectiveness of guideline implementation were considered important. It was acknowledged that there are many potentially effective ingredients for successful implementation, but a clear indication of the contents of an effective implementation strategy is still lacking. CONCLUSIONS: The plenary and workshops focused on closing the gap between research results and actual practice. As long as we do not fully understand how best to influence and change physician behavior, the choice of implementation strategies should be based on the present knowledge of potentially effective interventions and should include considerations of available resources for, and potential barriers to, implementation.