Patients' and clinicians' perspectives towards primary care consultations for shoulder pain: qualitative findings from the Prognostic and Diagnostic Assessment of the Shoulder (PANDA-S) programme.

BACKGROUND: Clinical management of musculoskeletal shoulder pain can be challenging due to diagnostic uncertainty, variable prognosis and limited evidence for long-term treatment benefits. The UK-based PANDA-S programme (Prognostic And Diagnostic Assessment of the Shoulder) is investigating short and long-term shoulder pain outcomes. This paper reports linked qualitative research exploring patients' and clinicians' views towards primary care consultations for shoulder pain. METHODS: Semi-structured interviews were conducted with 24 patients and 15 primary care clinicians. Twenty-two interviews (11 patients, 11 clinicians) were conducted as matched patient-clinician 'dyads'. Data were analysed thematically. RESULTS: Clinicians reported attempts to involve patients in management decisions; however, there was variation in whether patients preferred treatment choice, or for decisions to be clinician-led. Some patients felt uncertain about the decisions made, due to a lack of discussion about available management options. Many General Practitioners expressed a lack of confidence in diagnosing the underlying cause of shoulder pain. Patients reported either not being given a diagnosis, or receiving different diagnoses from different professionals, resulting in confusion. Whilst clinicians reported routinely discussing prognosis of shoulder pain, patients reported that prognosis was not raised. Patients also expressed concern that their shoulder pain could be caused by serious pathology; however, clinicians felt that this was not a common concern for patients. CONCLUSIONS: Findings showed disparities between patients' and clinicians' views towards shoulder pain consultations, indicating a need for improved patient-clinician communication. Findings will inform the design of an intervention to support treatment and referral decisions for shoulder pain that will be tested in a randomised controlled trial.

The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol.

INTRODUCTION: This pilot trial will inform the design and methods of a future full-scale randomized controlled trial (RCT) and examine the feasibility, acceptability and fidelity of the Increasing Physical activity in Older People with chronic Pain (iPOPP) intervention, a healthcare assistant (HCA)-supported intervention to promote walking in older adults with chronic musculoskeletal pain in a primary care setting. METHODS AND ANALYSIS: The iPOPP study is an individually randomized, multicentre, three-parallel-arm pilot RCT. A total of 150 participants aged ≥65 years with chronic pain in one or more index sites will be recruited and randomized using random permuted blocks, stratified by general practice, to: (i) usual care plus written information; (ii) pedometer plus usual care and written information; or (iii) the iPOPP intervention. A theoretically informed mixed-methods approach will be employed using semi-structured interviews, audio recordings of the HCA consultations, self-reported questionnaires, case report forms and objective physical activity data collection (accelerometry). Follow-up will be conducted 12 weeks post-randomization. Collection of the quantitative data and statistical analysis will be performed blinded to treatment allocation, and analysis will be exploratory to inform the design and methods of a future RCT. Analysis of the HCA consultation recordings will focus on the use of a checklist to determine the fidelity of the iPOPP intervention delivery, and the interview data will be analysed using a constant comparison approach in order to generate conceptual themes focused around the acceptability and feasibility of the trial, and then mapped to the Theoretical Domains Framework to understand barriers and facilitators to behaviour change. A triangulation protocol will be used to integrate quantitative and qualitative data and findings.

An evidence-based approach to laboratory tests in usual care of patients with rheumatoid arthritis.

Laboratory tests often are regarded as the most important information in clinical care by patients and doctors, and dominate clinical decisions in many chronic diseases such as diabetes and hyperlipidemia. Most patients with rheumatoid arthritis (RA) have a positive test for rheumatoid factor or anti-cyclic citrullinated peptide antibodies (ACPA), or an elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). However, about a third of RA patients, have negative tests for rheumatoid factor or ACPA, and more than 40% have a normal ESR or CRP at presentation ('false-negative' results). Furthermore, many normal people have a positive test for rheumatoid factor or ACPA but do not have RA, even among those with extensive musculoskeletal pain ('false-positive' results). Abnormal laboratory tests are the most significant predictor of high levels of radiographic progression, and therefore regarded as indicators of 'poor prognosis RA'. By contrast, laboratory tests are far less predictive of severe long-term outcomes such as work disability and premature mortality than functional difficulties reported on a patient questionnaire. A patient questionnaire score is abnormal in 89% of RA patients at presentation, and therefore more useful than ESR or CRP to document subsequent clinical improvement or deterioration. In clinical practice, patient questionnaire scores and RAPID3, an index of physical function, pain, and patient global estimate of status, identify incomplete responses to methotrexate more effectively than ESR. Improved understanding of the limitations of laboratory tests in diagnosis and management of individual patients with RA (and all rheumatic diseases) could improve patient care and outcomes.

Relative efficiencies of the 7 rheumatoid arthritis Core Data Set measures to distinguish active from control treatments in 9 comparisons from clinical trials of 5 agents.

The 7 Core Data Set measures to assess rheumatoid arthritis (RA) were analysed for their relative efficiencies to distinguish active from control treatments in 9 comparisons of 5 agents, methotrexate, leflunomide, infliximab, adalimumab, and abatacept, in 8 clinical trials. Among the 7 measures, levels of relative efficiencies were in a similar range, highest for the physician global estimate, followed by, in order, patient global estimate, physical function on a health assessment questionnaire (HAQ), pain, swollen joint count (SJC), an acute phase reactant laboratory test - erythrocyte sedimentation (ESR) or C-reactive protein (CRP), and tender joint count (TJC). Comparisons of only 3 measures, SJC and ESR/CRP (regarded as optimal indicators of inflammation) and HAQ function (regarded as most likely to be affected by joint damage and therefore least reversible) indicated relative efficiencies for HAQ function at least as great as for SJC or ESR/CRP, although 8 of the nine comparisons involved patients with disease duration > 6.9 years. The findings indicate a strong rationale for a Core Data Set of 7 measures, as no single measure was clearly superior in relative efficiency in all clinical trials. At the same time, 'objective' laboratory ESR/CRP, TJC and SJC were not superior to 'subjective' global estimates of the physician or patient or patient self-report measures of physical function or pain, to differentiate active from control treatments. The findings challenge a traditional view that laboratory and clinical examination findings are more robust than patient self-report scores and physician global estimates to assess and monitor RA patients.

Low back pain patients' responses to videos of avoided movements.

BACKGROUND: Fear avoidance (FA) has been identified as a risk factor for poor prognosis and a target for intervention in patients with low back pain (LBP), but the mechanisms involved need clarification. Experimental studies would benefit from the use of carefully developed and controlled stimuli representing avoided movements in back pain, and matched stimuli of movements to provide a credible control stimuli. Existing stimuli depicting avoided movements in LBP are static, do not include a set of control stimuli and do not control for possible systematic observer biases. METHODS: Two studies were carried out aiming to develop and test LBP patients' responses to videos of models depicting commonly avoided movements associated with back pain, and those associated with a control condition, wrist pain. Two samples of LBP patients rated how much pain and harm each movement would cause them. They also reported how often they avoided the movement. RESULTS: The findings from the first study (n = 99) indicate that using videos of commonly avoided movements in low back pain is viable, and that movements associated with wrist pain provide an acceptable control stimuli. Participants in the second study (n = 85) consistently rated movements depicted by females as causing more harm, and more frequently avoided than the same movements depicted by males. CONCLUSIONS: The use of video stimuli could advance research into the processes associated with FA through experimental paradigms. However, although small, the model gender effects should be carefully considered.

Will shared decision making between patients with chronic musculoskeletal pain and physiotherapists, osteopaths and chiropractors improve patient care?

BACKGROUND: Chronic musculoskeletal pain (CMP) is treated in primary care by a wide range of health professionals including chiropractors, osteopaths and physiotherapists. AIMS: To explore patients and chiropractors, osteopaths and physiotherapists' beliefs about CMP and its treatment and how these beliefs influenced care seeking and ultimately the process of care. METHODS: Depth interviews with a purposive sample of 13 CMP patients and 19 primary care health professionals (5 osteopaths, 4 chiropractors and 10 physiotherapists). RESULTS: Patients' models of their CMP evolved throughout the course of their condition. Health professionals' models also evolved throughout the course of their treatment of patients. A key influence on patients' consulting behaviour appeared to be finding someone who would legitimate their suffering and their condition. Health professionals also recognized patients' need for legitimation but often found that attempts to explore psychological factors, which may be influencing their pain could be construed by patients as delegitimizing. Patients developed and tailored their consultation strategies throughout their illness career but not always in a strategic fashion. Health professionals also reflected on how patients' developing knowledge and changing beliefs altered their expectations. Therefore, overall within our analysis, we identified three themes: 'the evolving nature of patients and health professionals models of understanding CMP'; 'legitimating suffering' and 'development and tailoring of consultation and treatment strategies throughout patients' illness careers'. CONCLUSIONS: Seeking care for any condition is not static but a process particularly for long-term conditions such as CMP. This may need to be taken into account by both CMP patients and their treating health professionals, in that both should not assume that their views about causation and treatment are static and that instead they should be revisited on a regular basis. Adopting a shared decision-making approach to treatment may be useful particularly for long-term conditions; however, in some cases, this may be easier said than done due to both patients' and health professionals' sometimes discomfort with adopting such an approach. Training and support for both health professionals and patients may be helpful in facilitating a shared decision-making approach.

The clinical efficacy of 3 mg/day prednisone in patients with rheumatoid arthritis: evidence from a randomized, double-blind, placebo-controlled withdrawal clinical trial.

A randomised, double-blind, placebo-controlled, withdrawal clinical trial was conducted of prednisone <5 mg/ day versus placebo in 31 patients with rheumatoid arthritis (RA). These patients had been treated with long-term 1-4 mg/day of prednisone, 22 with 3 mg/day, in usual clinical care at a single academic clinical setting. Stable clinical status over 12 weeks prior to screening for the trial was documented quantitatively by patient questionnaire scores. The protocol involved three phases: a) 'equivalence' - 1-4 study prednisone 1-mg tablets taken for 12 weeks, to ascertain their efficacy versus the patient's usual prednisone tablets prior to randomisation; b) 'transfer' - substitution of a 1-mg prednisone or identical placebo tablet at a rate of a single 1-mg tablet every 4 weeks (over 0-12 weeks) to the same number as baseline prednisone; c) 'comparison' - observation over 24 subsequent weeks taking the same number of either placebo or prednisone tablets as at baseline. The primary outcome was withdrawal due to patient-reported lack of efficacy versus continuation in the trial for 24 weeks. Thirty-one patients were randomised, 15 to prednisone and 16 to placebo, with 3 administrative discontinuations. In 'intent-to-treat' analyses, 3/15 prednisone and 11/16 placebo participants withdrew (p=0.03). Among participants eligible for the primary outcome of withdrawal for lack of efficacy, 3/13 prednisone versus 11/15 placebo participants withdrew (p=0.02). No meaningful adverse events were reported, as anticipated. These data document statistically significant differences between the efficacy of 1-4 mg prednisone vs. placebo in only 31 patients, which may suggest a robust treatment effect.

Long-term prednisone in doses of less than 5 mg/day for treatment of rheumatoid arthritis: personal experience over 25 years.

This article summarises the experience of one academic rheumatologist in treatment of patients with rheumatoid arthritis (RA) over 25 years from 1980-2004 with low-dose prednisone, most with <5 mg/day over long periods. A database was available which included medications and multidimensional health assessment questionnaire (MDHAQ) scores for physical function, pain, and routine assessment of patient index data (RAPID3), completed by all patients at all visits in the infrastructure of care. Most patients were treated with long-term low-dose prednisone, often from the initial visit and indefinitely, and with methotrexate after 1990. The mean initial prednisone dose declined from 10.3 mg/day in 1980-1984 to 3.6 mg/day in 2000-2004. Although no formal criteria were used to determine the initial dose, prednisone doses were higher in patients who had more severe MDHAQ/RAPID3 scores, as expected, reflecting confounding by indication. Similar improvements were seen in clinical status over 12 months in patients treated with <5 vs. ≥ 5 mg/day prednisone, and maintained for >8 years. Adverse effects were primarily bruising and skin-thinning, with low levels of hypertension, diabetes, and cataracts, although this information was based only on self-report rather than systematic assessment by a health professional. These data reflect limitations of observational data. However, a consecutive patient database may provide long-term information not available from clinical trials. The data document that prednisone at doses <5 mg/day over long periods appears acceptable and effective for many patients with RA at this time. Further clinical trials and long-term observational studies are needed to develop optimal treatment strategies for patients with RA with low-dose prednisone.

Underestimation of the efficacy, effectiveness, tolerability, and safety of weekly low-dose methotrexate in information presented to physicians and patients.

Ten specific examples of the underestimation of the efficacy, effectiveness and tolerability, and overestimation of adverse events of weekly, low-dose methotrexate, administered with folic acid, in treatment of rheumatic diseases are summarised. These examples include: 1) meta-analyses of clinical trials suggest that methotrexate has an efficacy similar to other disease-modifying anti-rheumatic drugs (DMARDs); 2) information in textbooks and websites may overstate adverse events and drug interactions associated with weekly low-dose methotrexate; 3) information presented to patients when filling a prescription for methotrexate understates 'side effects' of RA and overstates those of methotrexate; 4) an admonition to patients to refrain entirely from consumption of alcohol while taking methotrexate may be unnecessary; 5) frequent blood testing in patients who take methotrexate may be overused; 6) eligibility of only a small minority of patients for clinical trials to compare biologic agents and methotrexate; 7) Step-up design in most comparisons of biologic agents with methotrexate includes only patients who had experienced an incomplete response to methotrexate; 8) in parallel design trials, the efficacy of biologic agents is not substantially greater than that of methotrexate; 9) low, inflexible dosage schedules of methotrexate and requirement for withdrawal with minimal liver function abnormalities in many clinical trials may underestimate efficacy, effectiveness, tolerability and safety; 10) interpretation of clinical trial results may overstate the clinical significance of lower radiographic progression in patients treated with biologic agents versus patients treated with methotrexate. More accurate interpretation of information for physicians and other health professionals, as well as patients, concerning use of weekly low-dose methotrexate in contemporary care could improve care and outcomes for patients with RA and other rheumatic diseases.

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database.

OBJECTIVE: To analyse associations between the clinical status of patients with rheumatoid arthritis (RA) and the gross domestic product (GDP) of their resident country. METHODS: The Quantitative Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST-RA) cohort includes clinical and questionnaire data from 6004 patients who were seen in usual care at 70 rheumatology clinics in 25 countries as of April 2008, including 18 European countries. Demographic variables, clinical characteristics, RA disease activity measures, including the disease activity score in 28 joints (DAS28), and treatment-related variables were analysed according to GDP per capita, including 14 "high GDP" countries with GDP per capita greater than US$24,000 and 11 "low GDP" countries with GDP per capita less than US$11,000. RESULTS: Disease activity DAS28 ranged between 3.1 and 6.0 among the 25 countries and was significantly associated with GDP (r = -0.78, 95% CI -0.56 to -0.90, r(2) = 61%). Disease activity levels differed substantially between "high GDP" and "low GDP" countries at much greater levels than according to whether patients were currently taking or not taking methotrexate, prednisone and/or biological agents. CONCLUSIONS: The clinical status of patients with RA was correlated significantly with GDP among 25 mostly European countries according to all disease measures, associated only modestly with the current use of antirheumatic medications. The burden of arthritis appears substantially greater in "low GDP" than in "high GDP" countries. These findings may alert healthcare professionals and designers of health policy towards improving the clinical status of patients with RA in all countries.

Test-retest reliability of disease activity core set measures and indices in rheumatoid arthritis.

AIM: To examine the test-retest reliability of the rheumatoid arthritis (RA) core disease activity measures and derived composite indices. METHODS: A total of 28 stable patients with RA had 2 complete assessments within 1 week, which included the 7 RA core disease activity measures and derived disease activity indices (28-joint Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), RA Disease Activity Index (RADAI) and Routine Assessment of Patient Index Data (RAPID3)). The intraclass correlations (ICC), the smallest detectable difference (SDD) and minimal detectable change as percentage of the maximum score (MDC%) were estimated as measures of test-retest reliability. RESULTS: Correlations for the disease activity indices were high. SDDs (MDC%) to detect a true improvement or deterioration with 95% confidence were: DAS28 1.32 (14.4%), SDAI 8.26 (9.6%), CDAI 8.05 (10.6%), RAPID3 1.48 (14.8%) and RADAI 1.49 (14.9%). Thus, SDDs were rather high, and the MDC% values were of a similar magnitude of 10% to 15% for all seven core data set measures. CONCLUSIONS: SDDs of the DAS28, SDAI and CDAI were close to limits to detect important improvement. Clinicians should be aware of measurement error. Nonetheless, RA core data set measures and indices obtained from a health professional, laboratory and patient self-report had similar reliability.

Efficacy of prednisone 1-4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial.

OBJECTIVE: A randomised double-blind placebo controlled withdrawal clinical trial of prednisone versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1-4 mg/day prednisone, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets. METHODS: All patients were from one academic setting and all trial visits were conducted in usual clinical care. Patients were taking stable doses of 1-4 mg prednisone with stable clinical status, documented quantitatively by patient questionnaire scores. The protocol included three phases: (1) equivalence: 1-4 study prednisone 1 mg tablets taken for 12 weeks to ascertain their efficacy compared with the patient's usual tablets before randomisation; (2) transfer: substitution of a 1 mg prednisone or identical placebo tablet every 4 weeks (over 0-12 weeks) to the same number as baseline prednisone; (3) comparison: observation over 24 subsequent weeks taking the same number of either placebo or prednisone tablets as at baseline. The primary outcome was withdrawal due to patient-reported lack of efficacy versus continuation in the trial for 24 weeks. RESULTS: Thirty-one patients were randomised, 15 to prednisone and 16 to placebo, with three administrative discontinuations. In "intent-to-treat" analyses, 3/15 prednisone and 11/16 placebo participants withdrew (p = 0.03). Among participants eligible for the primary outcome, 3/13 prednisone and 11/15 placebo participants withdrew for lack of efficacy (p = 0.02). No meaningful adverse events were reported, as anticipated. CONCLUSION: Efficacy of 1-4 mg prednisone was documented. Evidence of statistically significant differences with only 31 patients may suggest a robust treatment effect.

Should an order to "monitor long-term vital signs," including mortality outcomes, be as routine as an order for a laboratory test in patients with rheumatic diseases?

Vital signs alert a health professional to problems which may threaten patient well-being and survival. Clinicians are highly familiar with vital signs for acute disease such as blood pressure, pulse, temperature, but unfamiliar with vital signs for chronic disease, such as physical function, pain, global status, exercise frequency and smoking. Long-term vital signs should be collected at each visit and stored in a computer database, ideally in a flow sheet format, as the memory of clinicians and patients is not reliable over long periods. The structure of the database should be identical from one site to another, so that data may be pooled to analyze large series of patients, particularly those with rare diseases, such as systemic sclerosis, polymyositis, and vasculitis. Of course, appropriate additional information beyond simple "long-term vital signs" from a physical examination, radiograph and laboratory are needed for further accurate assessment of prognosis and outcomes, in both acute and chronic diseases, and optimal information will emerge from specialized research centers. A common long-term vital signs database would be a major advance from current descriptive, non-quantitative monitoring of patients with rheumatic diseases, and would allow any rheumatologist to contribute to improved knowledge and mortality outcomes of rheumatic diseases.