Do national health priorities align with Global Burden of Disease estimates on disease burden? An analysis of national health plans and official governmental websites.

OBJECTIVE: To investigate the alignment of national health priorities with a country's burden of disease as measured by disability-adjusted life years (DALYs). METHODS: We identified priorities in national health plans and the 20 most burdensome conditions measured by DALYs from the 2017 Global Burden of Disease Study. We computed point-biserial correlations (rpb) between DALYs and being nominated as a health priority and the pooled proportion (95% confidence intervals [CIs]) of the 20 most burdensome conditions nominated as a priority across countries. RESULTS: We identified national health plans and official governmental websites in 145 countries. There was little to no correlation (rpb = 0.06, 95% CI: 0.02 to 0.09) between national DALY data and whether a condition was nominated as a health priority. The pooled proportion of the 20 most burdensome conditions nominated as priorities across countries was 46%. HIV/AIDS had the greatest number of nominations as a national health priority (62 countries) as well as the greatest match with the burden of disease (among the top 20 most burdensome conditions in 51 [82%] countries). Low back pain, headache disorders and congenital birth defects had the lowest proportion of nominations as health priorities in countries where they were in the top 20 most burdensome conditions (6%, 6% and 11%, respectively). CONCLUSION: Globally, there were low correlations between national health priorities and GBD estimates on disease burden. Failing to prioritise health priorities according to burden may mean that insufficient resources have been directed to improve health outcomes for people with those health conditions.

Can modifications to how medical imaging findings are reported improve quality of care? A systematic review.

AIM: To synthesise the available evidence about the effects of modifications to diagnostic imaging reports that aim to optimise patient care. MATERIALS AND METHODS: Cochrane methods were used and CENTRAL, MEDLINE, EMBASE, and clinical trials registers were searched from inception to 31 March 2021. Randomised controlled trials of modifications to imaging reports aimed at optimising patient care for any condition were included. Two authors selected studies independently for inclusion, extracted data, assessed risk of bias, and judged certainty of evidence using GRADE. The primary outcome was quality of care (e.g., increased guideline-adherent care, reduced/increased imaging as appropriate). RESULTS: Five trials met eligibility criteria. One tested provision of information about appropriate osteoporosis treatment in bone density reports; two tested provision of criteria and treatment for heart failure in echocardiogram reports; one tested provision of reminders for when routine imaging is not needed in lumbar spine and knee radiography reports; and one tested inclusion of epidemiological data in lumbar spine imaging reports. All trials were susceptible to bias, and four did not blind all participants. Low certainty evidence from two trials found adding information about appropriate care may increase care quality compared to a standard report (RR 1.20 (95% CI 0.96 to 1.50), two trials, 1,548 participants, I2 = 49). This was supported by outcomes of two additional trials that also provided specific clinical guidance. CONCLUSIONS: The present review suggests that providing specific guidance on appropriate clinical intervention in imaging reports may improve patient care. Further high-quality trials are needed to confirm these findings. Prospective PROSPERO registration CRD42020153961.

What proportion of patients with chronic noncancer pain are prescribed an opioid medicine? Systematic review and meta-regression of observational studies.

Guidelines now discourage opioid analgesics for chronic noncancer pain because the benefits frequently do not outweigh the harms. We aimed to determine the proportion of patients with chronic noncancer pain who are prescribed an opioid, the types prescribed and factors associated with prescribing. Database searches were conducted from inception to 29 October 2018 without language restrictions. We included observational studies of adults with chronic noncancer pain measuring opioid prescribing. Opioids were categorized as weak (e.g. codeine) or strong (e.g. oxycodone). Study quality was assessed using a risk of bias tool designed for observational studies measuring prevalence. Individual study results were pooled using a random-effects model. Meta-regression investigated study-level factors associated with prescribing (e.g. sampling year, geographic region as per World Health Organization). The overall evidence quality was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. Of the 42 studies (5,059,098 participants) identified, the majority (n = 28) were from the United States of America. Eleven studies were at low risk of bias. The pooled estimate of the proportion of patients with chronic noncancer pain prescribed opioids was 30.7% (95% CI 28.7% to 32.7%, n = 42 studies, moderate-quality evidence). Strong opioids were more frequently prescribed than weak (18.4% (95% CI 16.0-21.0%, n = 15 studies, low-quality evidence), versus 8.5% (95% CI 7.2-9.9%, n = 15 studies, low-quality evidence)). Meta-regression determined that opioid prescribing was associated with year of sampling (more prescribing in recent years) (P = 0.014) and not geographic region (P = 0.056). Opioid prescribing for patients with chronic noncancer pain is common and has increased over time.

Use of The Global Alliance for Musculoskeletal Health survey module for estimating the population prevalence of musculoskeletal pain: findings from the Solomon Islands.

BACKGROUND: Musculoskeletal (MSK) conditions are common and the biggest global cause of physical disability. The objective of the current study was to estimate the population prevalence of MSK-related pain using a standardized global MSK survey module for the first time. METHODS: A MSK survey module was constructed by the Global Alliance for Musculoskeletal Health Surveillance Taskforce and the Global Burden of Disease MSK Expert Group. The MSK module was included in the 2015 Solomon Islands Demographic and Health Survey. The sampling design was a two-stage stratified, nationally representative sample of households. RESULTS: A total of 9214 participants aged 15-49 years were included in the analysis. The age-standardized four-week prevalence of activity-limiting low back pain, neck pain, and hip and/or knee pain was 16.8, 8.9, and 10.8%, respectively. Prevalence tended to increase with age, and be higher in those with lower levels of education. CONCLUSIONS: Prevalence of activity-limited pain was high in all measured MSK sites. This indicates an important public health issue for the Solomon Islands that needs to be addressed. Efforts should be underpinned by integration with strategies for other non-communicable diseases, aging, disability, and rehabilitation, and with other sectors such as social services, education, industry, and agriculture. Primary prevention strategies and strategies aimed at self-management are likely to have the greatest and most cost-effective impact.

A systematic review and evidence synthesis of qualitative studies to identify primary care clinicians' barriers and enablers to the management of osteoarthritis.

OBJECTIVE: Primary care management of osteoarthritis (OA) is variable and often inconsistent with clinical practice guidelines (CPGs). This study aimed to identify and synthesize available qualitative evidence on primary care clinicians' views on providing recommended management of OA. DESIGN: Eligibility criteria included full reports published in peer-reviewed journals, with data collected directly from primary care clinicians using qualitative methods for collection and analysis. Five electronic databases (MEDLINE, Cochrane Central Register, EMBASE, CINAHL and PsychInfo) were searched to August 2016. Two independent reviewers identified eligible reports, conducted critical appraisal (based on Critical Appraisal Skills Programme (CASP) criteria), and extracted data. Three reviewers independently, then collaboratively, synthesized and interpreted data through an inductive and iterative process to derive new themes. The Confidence in Evidence from Reviews of Qualitative research (CERQual) approach was used to determine a confidence profile for each finding. RESULTS: Eight studies involving approximately 83 general practitioners (GPs), 24 practice nurses, 12 pharmacists and 10 physical therapists, from Australia, France, United Kingdom, Germany and Mexico were included. Four barriers were identified as themes 1) OA is not that serious, 2) Clinicians are, or perceive they are, under-prepared, 3) Personal beliefs at odds with providing recommended practice, and 4) Dissonant patient expectations. No themes were enablers. Confidence ratings were moderate or low. CONCLUSIONS: Synthesising available data revealed barriers that collectively point towards a need to address clinician knowledge gaps, and enhance clinician communication and behaviour change skills to facilitate patient adherence, enable effective conversations and manage dissonant patient expectations. REGISTRATION: PROSPERO (http://www.crd.york.ac.uk/PROSPERO) [4/11/2015, CRD42015027543].

Development and preliminary evaluation of the OsteoArthritis Questionnaire (OA-Quest): a psychometric study.

OBJECTIVE: This study reports the development of the OsteoArthritis Questionnaire (OA-Quest) - a new measure designed to comprehensively capture the potentially modifiable burden of osteoarthritis. DESIGN: Item development was guided by the a priori conceptual framework of the Personal Burden of Osteoarthritis (PBO) which captures 8 dimensions of osteoarthritis burden (Physical distress, Fatigue, Physical limitations, Psychosocial distress, Physical de-conditioning, Financial hardship, Sleep disturbances, Lost productivity). One hundred and twenty three candidate items were pretested in a clinical sample of 18 osteoarthritis patients. The measurement properties of the OA-Quest were assessed with exploratory factor analysis (EFA), Rasch modelling, and confirmatory factor analysis (CFA) in a community-based sample (n = 792). RESULTS: EFA replicated 7 of the 8 PBO domains. An exception was PBO Fatigue domain, with items merging into the Physical distress subscale in the OA-Quest. Following item analysis, a 42-item 7-subscale questionnaire was constructed, measuring Physical distress (seven items, Cronbach's α = 0.93), Physical limitations (11 items, α = 0.95), Psychosocial distress (seven items, α = 0.93), Physical de-conditioning (four items, α = 0.87), Financial hardship (four items, α = 0.93), Sleep disturbances (five items, α = 0.96), and Lost productivity (four items α = 0.90). A highly restricted 7-factor CFA model had excellent fit with the data (χ(2)(113) = 316.36, P < 0.001; chi-square/degrees of freedom = 2.8; comparative fit index [CFI] = 0.97; root mean square error of approximation [RMSEA] = 0.07), supporting construct validity of the new measure. CONCLUSIONS: The OA-Quest is a new measure of osteoarthritis burden that is founded on a comprehensive conceptual model. It has strong evidence of construct validity and provides reliable measurement across a broad range of osteoarthritis burden.

Prevalence of cam hip shape morphology: a systematic review.

OBJECTIVE: Cam hip shape morphology is a recognised cause of femoroacetabular impingement (FAI) and is associated with hip osteoarthritis. Our aim was to systematically review the available epidemiological evidence assessing the prevalence of cam hip shape morphology in the general population and any studied subgroups including subjects with and without hip pain. DESIGN: All studies that reported the prevalence of cam morphology, measured by alpha angles, in subjects aged 18 and over, irrespective of study population or presence of hip symptoms were considered for inclusion. We searched AMED, MEDLINE, EMBASE, CINAHL and CENTRAL in October 2015. Two authors independently identified eligible studies and assessed risk of bias. We planned to pool data of studies considered clinically homogenous. RESULTS: Thirty studies met inclusion criteria. None of the included studies were truly population-based: three included non-representative subgroups of the general population, 19 included differing clinical populations, while eight included professional athletes. All studies were judged to be at high risk of bias. Due to substantial clinical heterogeneity meta analysis was not possible. Across all studies, the prevalence estimates of cam morphology ranged from 5 to 75% of participants affected. We were unable to demonstrate a higher prevalence in selected subgroups such as athletes or those with hip pain. CONCLUSIONS: There is currently insufficient high quality data to determine the true prevalence of cam morphology in the general population or selected subgroups. Well-designed population-based epidemiological studies that use homogenous case definitions are required to determine the prevalence of cam morphology and its relationship to hip pain.

Evaluation of measurement properties of self-administered PROMs aimed at patients with non-specific shoulder pain and "activity limitations": a systematic review.

OBJECTIVE: To critically appraise and compare the measurement properties of self-administered patient-reported outcome measures (PROMs) focussing on the shoulder, assessing "activity limitations." STUDY DESIGN: Systematic review. The study population had to consist of patients with shoulder pain. We excluded postoperative patients or patients with generic diseases. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using the COSMIN checklist. RESULTS: Out of a total of 3427 unique hits, 31 articles, evaluating 7 different questionnaires, were included. The SPADI is the most frequently evaluated PROM and its measurement properties seem adequate apart from a lack of information regarding its measurement error and content validity. CONCLUSION: For English, Norwegian and Turkish users, we recommend to use the SPADI. Dutch users could use either the SDQ or the SST. In German, we recommend the DASH. In Tamil, Slovene, Spanish and the Danish languages, the evaluated PROMs were not yet of acceptable validity. None of these PROMs showed strong positive evidence for all measurement properties. We propose to develop a new shoulder PROM focused on activity limitations, taking new knowledge and techniques into account.

Health literacy: applying current concepts to improve health services and reduce health inequalities.

The concept of 'health literacy' refers to the personal and relational factors that affect a person's ability to acquire, understand and use information about health and health services. For many years, efforts in the development of the concept of health literacy exceeded the development of measurement tools and interventions. Furthermore, the discourse about and development of health literacy in public health and in clinical settings were often substantially different. This paper provides an update about recently developed approaches to measurement that assess health literacy strengths and limitations of individuals and of groups across multiple aspects of health literacy. This advancement in measurement now allows diagnostic and problem-solving approaches to developing responses to identified strengths and limitations. In this paper, we consider how such an approach can be applied across the diverse range of settings in which health literacy has been applied. In particular, we consider some approaches to applying health literacy in the daily practice of health-service providers in many settings, and how new insights and tools--including approaches based on an understanding of diversity of health literacy needs in a target community--can contribute to improvements in practice. Finally, we present a model that attempts to integrate the concept of health literacy with concepts that are often considered to overlap with it. With careful consideration of the distinctions between prevailing concepts, health literacy can be used to complement many fields from individual patient care to community-level development, and from improving compliance to empowering individuals and communities.

Risk factors for herpes zoster in rheumatoid arthritis patients: the role of tumour necrosis factor-α inhibitors.

AIM: To determine whether exposure to tumour necrosis factor (TNF)-α inhibitors increases the risk of herpes zoster (HZ) among people with rheumatoid arthritis (RA). METHODS: We performed a cohort study of people with RA participating in the Australian Rheumatology Association Database. We identified self-reported cases of HZ and verified using medical records. For the primary analysis, we only included doctor-verified cases. For TNF-α inhibitor exposed groups, we excluded HZ episodes that occurred before TNF-α inhibitor initiation, and for the control group we excluded HZ episodes that occurred prior to 2000 or RA diagnosis. The risk of HZ among participants exposed versus not exposed to TNF-α inhibitors was compared using Cox proportional hazards models including significant covariates affecting the risk. Adjusted hazard ratios (HR) were calculated for TNF inhibitors as a class and for individual agents. RESULTS: Among 2157 active RA participants, there were 442 self-reported cases of HZ. From 346 responses from doctors, 249 cases were verified and four were false positives (false positive rate 1.6%). Crude incidence of verified HZ in the entire RA cohort was 15.9/1000 person-years (95% confidence interval (CI): 13.5-18.8). An increased risk of HZ was found for all TNF-α inhibitors combined (fully adjusted HR 1.71; 95% CI: 1.00-2.92) and adalimumab (fully adjusted HR 2.33; 95% CI: 1.22-4.45), but in the fully adjusted model was not increased with etanercept (fully adjusted HR 1.65; 95% CI: 0.90-3.03). No increased risk was found with infliximab (HR 1.29; 95% CI: 0.37-4.47). CONCLUSIONS: TNF-α inhibitors are associated with an increased risk of HZ in people with RA compared with those who have not been exposed.

OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis.

OBJECTIVES: To recommend a consensus-derived set of performance-based tests of physical function for use in people diagnosed with hip or knee osteoarthritis (OA) or following joint replacement. METHODS: An international, multidisciplinary expert advisory group was established to guide the study. Potential tests for consideration in the recommended set were identified via a survey of selected experts and through a systematic review of the measurement properties for performance-based tests. A multi-phase, consensus-based approach was used to prioritize and select performance-based tests by applying decision analysis methodology (1000Minds software) via online decision surveys. The recommended tests were chosen based on available measurement-property evidence, feasibility of the tests, scoring methods and expert consensus. RESULTS: Consensus incorporated the opinions of 138 experienced clinicians and researchers from 16 countries. The five tests recommended by the advisory group and endorsed by Osteoarthritis Research Society International (OARSI) were the 30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, timed up-and-go test and 6-min walk test. The first three were recommended as the minimal core set of performance-based tests for hip or knee OA. CONCLUSION: The OARSI recommended set of performance-based tests of physical function represents the tests of typical activities relevant to individuals diagnosed with hip or knee OA and following joint replacements. These tests are complementary to patient-reported measures and are recommended as prospective outcome measures in future OA research and to assist decision-making in clinical practice. Further research should be directed to expanding the measurement-property evidence of the recommended tests.

Should patients with systemic sclerosis-related pulmonary arterial hypertension be anticoagulated?

Pulmonary arterial hypertension (PAH) is a major cause of mortality in scleroderma and despite 'advanced' therapies confers a median survival of less than 5 years. Anticoagulation in systemic sclerosis-related PAH (SSc-PAH) is currently one of the most contentious issues in the management of patients with connective tissue disease. While some studies have shown a survival benefit with warfarin therapy in this disease, others have not. Accordingly, a state of clinical equipoise exists in relation to anticoagulation in SSc-PAH. With an over fivefold reduction in mortality demonstrated in some observational studies, the issue of anticoagulation in SSc-PAH demands resolution through a well-designed randomised controlled trial.

Surgery for rotator cuff disease.

BACKGROUND: This review is one in a series of Cochrane reviews of interventions for shoulder disorders. OBJECTIVES: To determine the effectiveness and safety of surgery for rotator cuff disease. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, (The Cochrane Library Issue 1, 2006), MEDLINE, EMBASE, CINAHL, Sports Discus, Science Citation Index (Web of Science) in March 2006 unrestricted by date or language. SELECTION CRITERIA: Only studies described as randomised or quasi-randomised clinical trials (RCTs) studying participants with rotator cuff disease and surgical interventions compared to placebo, no treatment, or any other treatment were included. DATA COLLECTION AND ANALYSIS: Two independent review authors assessed methodological quality of each included trial and extracted data. MAIN RESULTS: We included 14 RCTs involving 829 participants. Eleven trials included participants with impingement, two trials included participants with rotator cuff tear and one trial included participants with calcific tendinitis. No study met all methodological quality criteria and minimal pooling could be performed. Three trials compared either open or arthroscopic subacromial decompression with active non operative treatment (exercise programme, physiotherapy regimen of exercise and education, or graded physiotherapy strengthening program). No differences in outcome between these treatment groups were reported in any of these trials. One trial which also included a placebo arm (12 sessions detuned soft laser) reported that the Neer score of participants in both active treatment arms improved significantly more than those who received placebo at six months. Six trials that compared arthroscopic with open subacromial decompression reported no significant differences in outcome between groups at any time point although four trials reported a quicker recovery and/or return to work with arthroscopic decompression. Adverse events, which occurred in three trials and included infection, capsulitis, pain, deltoid atrophy, and reoperation, did not differ between surgical groups. AUTHORS' CONCLUSIONS: Based upon our review of 14 trials examining heterogeneous interventions and all susceptible to bias, we cannot draw firm conclusions about the effectiveness or safety of surgery for rotator cuff disease. There is "Silver" (www.cochranemsk.org) level evidence from three trials that there are no significant differences in outcome between open or arthroscopic subacromial decompression and active non-operative treatment for impingement. There is also "Silver" level evidence from six trials that there are no significant differences in outcome between arthroscopic and open subacromial decompression although four trials reported earlier recovery with arthroscopic decompression.

Arthrographic distension for adhesive capsulitis (frozen shoulder).

BACKGROUND: Adhesive capsulitis (frozen shoulder or painful stiff shoulder) is characterised by spontaneous onset of shoulder pain accompanied by progressive stiffness and disability. It is usually self-limiting but often has a prolonged course over two to three years. OBJECTIVES: To determine the effectiveness and safety of arthrographic distension of the glenohumeral joint in the treatment of adults with adhesive capsulitis. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Review Group Register, CENTRAL, MEDLINE, CINAHL, and EMBASE to November 2006, unrestricted by date or language. SELECTION CRITERIA: We included randomised controlled trials and controlled clinical trials comparing arthrographic distension with placebo or other interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study quality and extracted data. MAIN RESULTS: Five trials with 196 people were included. One three-arm trial (47 participants) compared arthrographic distension using steroid and air to distension using air alone and to steroid injection alone. One trial (46 participants) compared arthrographic distension using steroid and saline to placebo. Two trials (45 and 22 participants) compared arthrographic distension using steroid to steroid injection alone. One trial (36 participants) compared arthrographic distension using steroid and saline plus physical therapy to physical therapy alone. Trials included similar study participants, but quality and reporting of data were variable. Only one trial was at low risk of bias. No meta-analysis was performed.The trial with low risk of bias demonstrated that distension with saline and steroid was better than placebo for pain (number needed to treat to benefit (NNTB) = 2), function (NNTB = 3) and range of movement at three weeks. This benefit was maintained at six and 12 weeks only for one of two scores measuring function (NNT = 3). A second trial with high risk of bias also reported that distension combined with physical therapy improved range of movement and median percent improvement in pain (but not pain score) at eight weeks compared to physical therapy alone. Three further trials, all at high risk of bias, reported conflicting, variable effects of arthrographic distension with steroid compared to distension alone, and arthrographic distension with steroid compared to intra-articular steroid injection. The trials reported a small number of minor adverse effects, mainly pain during and after the procedure. AUTHORS' CONCLUSIONS: There is "silver" level evidence that arthrographic distension with saline and steroid provides short-term benefits in pain, range of movement and function in adhesive capsulitis. It is uncertain whether this is better than alternative interventions.

WITHDRAWN: Interventions for shoulder pain.

BACKGROUND: Shoulder pain is a common problem and although there are many accepted standard forms of conservative therapy for shoulder disorders including non-steroidal anti-inflammatory drugs, glucocorticosteroid injections, oral glucocorticosteroid medication, manipulation under anaesthesia, physical therapy, hydrodilatation (distension arthrography) and surgery, evidence of their efficacy is not well established. OBJECTIVES: To review the efficacy of common interventions for shoulder pain. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group trials register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, and Science Citation Index) up to May 1998, and hand searched major textbooks, bibliographies of relevant literature, the fugitive literature, and the subject indices of relevant journals including: American College of Rheumatology;British College of Rheumatologists; the Biennial Conference of the Manipulative Physiotherapy Association of Australia;International Federation of Manual Therapists conference proceedings; British Orthopaedic Association;and American Orthopaedic Association. SELECTION CRITERIA: Each identified study was assessed for possible inclusion by two independent reviewers based on the blinded methods sections. The determinants for inclusion were that the trial include an intervention of interest (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, manipulation under anaesthesia, hydrodilatation, or surgery); that treatment allocation was randomized; and that the outcome assessment was blinded. DATA COLLECTION AND ANALYSIS: Methodological quality was assessed by two independent, blinded reviewers. Data relating to selection criteria, outcome measurement and treatment effect was extracted from the blinded trials. Range of motion scores were entered as degrees of restriction to movement, and all pain and overall effect scores were transformed to 100 point scales. For continuous outcome measures, where standard deviation was not reported it was either calculated from the raw data or converted from standard error of the mean. If neither of these were reported, authors were contacted in an effort to obtain the missing values. Effect sizes were calculated and combined in a pooled analysis if study population, endpoint and intervention were comparable. MAIN RESULTS: Thirty one trials met inclusion criteria. Mean methodological quality score was 16.8 (9.5 - 22) out of possible score of 40. Selection criteria varied widely even for the same diagnostic label. There was no uniformity in outcome measures used and their measurement properties were rarely reported. Effect sizes for individual trials were small (-1.4 to 3.0). The results of only three studies investigating "rotator cuff tendonitis" could be pooled. Benefit of subacromial steroid injection over placebo for improving range of abduction (weighted difference between means (WMD) 35 degrees , 95% CI 14 to 55) was the only positive finding. AUTHORS' CONCLUSIONS: There is little evidence to support or refute the efficacy of common interventions for shoulder pain. As well as, the need for further well designed clinical trials, more research is needed to establish a uniform method of defining shoulder disorders and developing outcome measures which are valid, reliable and responsive in these study populations.

Effect of treatment with biological agents for arthritis in Australia: the Australian Rheumatology Association Database.

BACKGROUND: The Australian Rheumatology Association Database (ARAD), a voluntary national registry, has been established to collect health information from Australian patients with inflammatory arthritis for the purpose of monitoring the benefits and safety of new treatments, in particular the biological disease-modifying anti-rheumatic drugs (bDMARDs). These drugs are proving to be very effective, yet little is known of their long-term effectiveness or safety. Patient registries that systematically gather data on large cohorts of unselected patients are increasingly believed to be an essential means of answering questions of the long-term effectiveness and safety of new drugs. The aim of this report is to describe the role, development and structure of ARAD and provide some preliminary data. METHODS: As of 1 August 2006, 563 patients with rheumatoid arthritis prescribed a bDMARD have been enrolled in ARAD, involving 105 rheumatologists from across Australia. RESULTS: The data collected will enable examination of multiple domains of patient responses to bDMARDs, including quality of life, health-care utilization, incidence of adverse events and the effects of therapy switching. CONCLUSION: Evidence-based information about the long-term outcome of bDMARD therapy is essential for clinicians, consumers, policy-makers, drug development companies and approval agencies, to enable better care and improved outcomes for patients with inflammatory arthritis.

Oral steroids for adhesive capsulitis.

BACKGROUND: This review is one in a series of Cochrane reviews of interventions for shoulder pain in adults. OBJECTIVES: To determine the efficacy and safety of oral steroids for adhesive capsulitis. SEARCH STRATEGY: Searches of the Cochrane Library including CENTRAL, Issue 4, 2005, Cochrane Musculoskeletal Review Group Register, MEDLINE, EMBASE, CINAHL were conducted in November 2005, unrestricted by date or language. SELECTION CRITERIA: Only studies described as randomised controlled trials studying participants with adhesive capsulitis, frozen shoulder, stiff painful shoulder or periarthritis and interventions of oral steroids compared to placebo, no treatment, or any other treatment were included. DATA COLLECTION AND ANALYSIS: Two independent reviewers assessed methodological quality of each included trial and extracted data. Standard Cochrane methodology was used to analyse the extracted data. MAIN RESULTS: Five small trials were included: two trials (30 and 49 participants) of oral steroids or placebo; one trial (40 participants) of oral steroids or no treatment; one trial (28 participants) of oral or intra-articular steroids; and one trial (32 participants) of manipulation under anaesthesia and intraarticular steroid injection with or without oral steroids. Study participants were similar across trials, but no trial used the same oral steroid regimen or dosage. Trials were of variable quality (only one of high quality) and some were poorly reported. No meta-analyses could be performed as no raw data could be extracted from one placebo-controlled trial and three trials used different comparators. One trial reported significant short-term benefits of oral steroids versus placebo: 48% more participants reported success (RR = 2 (95% CI 1.3 to 3.1, NNT=2); overall improvement in pain 2.7 (95% CI 1.4 to 4.0) on a 0 to 10 point scale; total shoulder abduction increased by 23.3 degrees (95% CI 11.3 to 35.3); Shoulder Pain and Disability Index (SPADI) score improved by 18.1 (95% CI 7.6 to 28.6) on a 0 to 100 point scale. But benefits were not maintained at 6 weeks. A second trial reported no significant differences between oral steroid and placebo in pain or range of movement but it suggested improvement occurred earlier in the steroid treated group. A third trial reported that oral steroids provided a more rapid initial improvement in pain compared to no treatment but negligible differences by five months. There were minimal adverse effects reported. AUTHORS' CONCLUSIONS: Available data from two placebo-controlled trials and one no-treatment controlled trial provides "Silver" level evidence (www.cochranemsk.org) that oral steroids provides significant short-term benefits in pain, range of movement of the shoulder and function in adhesive capsulitis but the effect may not be maintained beyond six weeks.