Is establishing a specialist back pain assessment and management service in primary care a safe and effective model? Twelve-month results from the Back pain Assessment Clinic (BAC) prospective cohort pilot study.

OBJECTIVES: To report on the design, implementation and evaluation of the safety and effectiveness of the Back pain Assessment Clinic (BAC) model. DESIGN: BAC is a new, community-based specialist service for assessing and managing neck and low back pain (LBP). The BAC pilot was supported by a Victorian Department of Health and Human Services grant and was evaluated using the Victorian Innovation Reform Impact Assessment Framework (VIRIAF). Data were obtained by auditing BAC activity (22 July 2014 to 30 June 2015) and conducting surveys and interviews of patients, stakeholders and referrers. SETTING: Tertiary and primary care. PARTICIPANTS: Adult patients with neck and LBP referred for outpatient surgical consultation. MAIN OUTCOME MEASURES: VIRIAF outcomes: (1) access to care; (2) appropriate and safe care; (3) workforce optimisation and integration; and (4) efficiency and sustainability. RESULTS: A total of 522 patients were seen during the pilot. Most were referred to hospital services by general practitioners (87%) for LBP (63%) and neck pain (24%). All patients were seen within 10 weeks of referral and commenced community-based allied health intervention within 2-4 weeks of assessment in BAC. Of patients seen, 34% had medications adjusted, 57% were referred for physiotherapy, 3.2% to pain services, 1.1% to rheumatology and 1.8% for surgical review. Less MRI scans were ordered in BAC (6.4%) compared with traditional spinal surgical clinics (89.8%), which translated to a cost-saving of $52 560 over 12 months. Patient and staff satisfaction was high. There have been no patient complaints or adverse incidents. CONCLUSION: Evaluation of the BAC pilot suggests it is a potentially safe and cost-saving alternative model of care. Results of the BAC pilot merit further evaluation to determine the potential cost-effectiveness, longer term and broader societal impact of implementing BAC more widely.

Suppression of inflammatory disease activity in rheumatoid arthritis is associated with improvements in retinal microvascular health.

OBJECTIVE: To investigate the effect of suppressing inflammation on retinal microvascular health in patients with RA. METHODS: Two groups of patients with RA were recruited and studied concurrently. Group A included patients with moderate to high disease activity [28-joint DAS with CRP (DAS28-CRP) >3.2] requiring treatment escalation, while group B had stable low disease activity (DAS28-CRP ≤3.2) not requiring treatment escalation. Retinal photography was performed at baseline and weeks 6 and 24 in group A and at baseline and week 12 in group B. RESULTS: Group A included 26 patients with a mean age of 50.7 years (s.d. 3.5) and a mean disease duration of 7.1 years (s.d. 8.0). Disease activity significantly improved during follow-up and was accompanied by a significant reduction in retinal venular calibre at week 6 [mean difference (MD) -7.9 µm (95% CI -13.3, -2.5)] and at week 24 [MD -6.8 µm (95% CI -12.2, -1.4)]. No significant change in retinal arteriolar calibre was identified at week 6 [MD -0.6 µm (95% CI -4.5, 3.28)] or week 24 [MD 0.7 µm (95% CI -3.1, 4.5)]. Group B included 27 patients with a mean age of 54.6 years (s.d. 1.8) and a mean disease duration of 14.5 years (s.d. 10.9). Disease activity and therapy remained unchanged during follow-up and no significant changes in retinal venular [MD 1.81 µm (95% CI -2.32, 5.95)] or arteriolar [MD 0.54 µm (95% CI -2.77, 3.86)] calibre were observed. CONCLUSION: We demonstrated that suppression of inflammation in RA is associated with a reduction of retinal venular calibre, suggesting that therapies targeting inflammation could improve vascular health in RA.

Australian and New Zealand recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion in the 3e Initiative.

AIM: To develop evidence-based recommendations for the diagnosis and management of gout in Australia and New Zealand as part of the multi-national 3e Initiative. METHOD: Using a formal voting process, a panel of 78 international rheumatologists selected 10 key clinical questions pertinent to the diagnosis and management of gout. An additional question was also developed by participating Australian and New Zealand rheumatologists. Each question was investigated with a systematic literature review. MEDLINE, EMBASE, Cochrane CENTRAL and abstracts from 2010 to 2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, 47 Australian and New Zealand rheumatologists developed national recommendations. For each recommendation the level of agreement was assessed and the level of evidence graded. RESULT: Eleven recommendations were produced relating to the diagnosis of gout, different aspects of the management of gout, cardiovascular and renal comorbidities and the management of asymptomatic hyperuricemia. The mean level of agreement with the recommendations was 9.1 on a 1-10 scale, with 10 representing full agreement. CONCLUSION: Eleven Australian and New Zealand recommendations on the diagnosis and management of gout were developed combining systematically reviewed evidence with local expertise, enhancing their utility in clinical practice.

The efficacy and safety of treatments for acute gout: results from a series of systematic literature reviews including Cochrane reviews on intraarticular glucocorticoids, colchicine, nonsteroidal antiinflammatory drugs, and interleukin-1 inhibitors.

OBJECTIVE: To determine the efficacy and safety of glucocorticoids (GC), colchicine, nonsteroidal antiinflammatory drugs (NSAID), interleukin-1 (IL-1) inhibitors, and paracetamol to treat acute gout. METHODS: We searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials to September 2011. Randomized controlled trials (RCT) or quasi-RCT in adults with acute gout that compared GC, colchicine, NSAID, IL-1 inhibitors, and paracetamol to no treatment, placebo, another intervention, or combination therapy were included. Two authors independently extracted data and assessed risk of bias. Primary endpoints were pain and adverse events. Data were pooled where appropriate. RESULTS: Twenty-six trials evaluating GC (N = 5), NSAID (N = 21), colchicine (N = 2), and canakinumab (N = 1) were included. No RCT assessed paracetamol or intraarticular (IA) GC. No RCT compared systemic GC with placebo. Moderate quality evidence (3 trials) concluded that systemic GC were as effective as NSAID but safer. Low quality evidence (1 trial) showed that both high- and low-dose colchicine were more effective than placebo, and low-dose colchicine was no different to placebo with respect to safety but safer than high-dose colchicine. Low quality evidence (1 trial) showed no difference between NSAID and placebo with regard to pain or inflammation. No NSAID was superior to another. Moderate quality evidence (1 trial) found that 150 mg canakinumab was more effective than a single dose of intramuscular GC (40 mg triamcinolone) and equally safe. CONCLUSION: GC, NSAID, low-dose colchicine, and canakinumab all effectively treat acute gout. There was insufficient evidence to rank them. Systemic GC appeared safer than NSAID and lower-dose colchicine was safer than higher-dose colchicine.

Lifestyle interventions for the treatment of gout: a summary of 2 Cochrane systematic reviews.

OBJECTIVE: To determine the efficacy and safety of lifestyle interventions for treating gout. METHODS: Two Cochrane systematic reviews assessed the efficacy and safety of lifestyle interventions for the treatment of acute and chronic gout. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to September 2011, and the 2010-2011 American College of Rheumatology and European League Against Rheumatism conference abstracts. Primary outcomes of interest were joint pain for acute gout, frequency of gout attacks for chronic gout, and withdrawals due to adverse events for both reviews. RESULTS: One trial met inclusion criteria for each review. An unblinded trial (19 participants), at high risk of bias, found that topical ice added to prednisolone and colchicine for acute gout resulted in significantly greater pain reduction at 1 week [mean difference (MD) -3.33 cm, 95% confidence interval (95% CI) -5.84 to -0.82 on 10 cm visual analog scale]. Adverse events were not described. The second trial (120 participants), at moderate risk of bias, compared enriched skim milk powder (glycomacropeptide and G600 milk fat extract) to non-enriched skim milk and lactose powders for treating chronic gout. There were no between-group differences in gout attack frequency over 3 months [MD -0.21 (95% CI -0.76 to 0.34)] or withdrawals due to adverse events [relative risk 1.27 (95% CI 0.53 to 3.03)]. CONCLUSION: While there is observational evidence for an association between lifestyle risk factors and gout development, there are no high quality trials to support or refute the use of lifestyle interventions for treating acute or chronic gout.

Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative.

We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010-2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1-10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice.

Lifestyle interventions for acute gout.

BACKGROUND: Although lifestyle interventions are often recommended in the management of chronic gout, the evidence from trial data of the benefits and safety of using lifestyle interventions for treating acute gout attacks have not previously been examined in a systematic review. OBJECTIVES: The objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with acute gout. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE for studies (up to 5 April 2013). We also searched the 2010 to 2011 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) abstracts and performed a handsearch of the reference lists of included articles. SELECTION CRITERIA: Studies were included if they were randomised or quasi-randomised controlled trials which compared lifestyle interventions to another therapy (active or placebo) in patients with acute gout. Outcomes of interest were the change in participant-reported pain in the target joint(s), target joint inflammation and function, health-related quality of life (HRQoL), patient global assessment, study participant withdrawals due to adverse events (AEs) and serious adverse events (SAEs). DATA COLLECTION AND ANALYSIS: Two review authors independently applied methods recommended by The Cochrane Collaboration for the selection, appraisal, data collection and synthesis of studies. We assessed the quality of the body of evidence for each outcome using the GRADE approach. MAIN RESULTS: Only one study (19 participants) at high risk of bias was included in the review. Patients were randomised to receive oral prednisolone and colchicine with or without concomitant topical ice therapy. Topical ice therapy provided significant additional benefit over oral prednisolone and colchicine alone with respect to pain, but did not significantly reduce swelling during acute gout episodes. Mean pain reduction with standard medical treatment was 4.4 cm on a 0 to 10 cm visual analogue scale (VAS) after one week; the addition of topical ice reduced pain by an additional 3.33 cm (95% CI 5.84 to 0.82), or an absolute reduction of 33% (8% to 58% reduction). Joint swelling was reduced by a mean of 3.8 cm in the standard medical treatment group; the addition of topical ice therapy did not reduce swelling significantly (mean difference (MD) 2.07 cm, 95% CI -1.56 to 5.70). Target joint function, HRQoL, patient global assessment, study participant withdrawals due to AEs and SEAs were not reported in this study. AUTHORS' CONCLUSIONS: There is low quality evidence, from a single trial at high risk of bias, that the addition of topical ice therapy to oral prednisolone and colchicine for oligoarticular attacks of acute gout results in significantly greater pain reduction at one week.

Lifestyle interventions for chronic gout.

BACKGROUND: Although lifestyle interventions are commonly recommended in the management of patients with chronic gout, the evidence from trial data for their benefits and safety has not been previously examined in a systematic review. OBJECTIVES: The objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with chronic gout. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE for studies on 5 April 2013. We also searched the 2010 to 2011 American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) abstracts and performed a handsearch of the reference lists of included articles. SELECTION CRITERIA: Studies were included if they were randomised or quasi-randomised controlled trials (RCTs or CCTs) which compared lifestyle interventions to another therapy (active or placebo) in patients with chronic gout. Outcomes of interest were changes in gout attack frequency, joint pain, serum urate levels, tophus size, function, quality of life and adverse effects. DATA COLLECTION AND ANALYSIS: Two review authors independently applied methods recommended by The Cochrane Collaboration for the selection, appraisal, data collection and synthesis of studies. We assessed the quality of the body of evidence for each outcome using the GRADE approach. MAIN RESULTS: Only one study (120 participants), at moderate risk of bias, was included in the review. Patients were randomised to one of three interventions: either skim milk powder (SMP) enriched with glycomacropeptide (GMP) and G600, non-enriched SMP or lactose powder, over a three-month period. The frequency of acute gout attacks, measured as the number of flares per month, decreased in all three groups over the three-month study period. Low quality evidence indicated that there was no difference between the SMP/GMP/G600 group and combined control groups (SMP and lactose powder) at three months (mean difference (MD) -0.21, 95% confidence interval (CI) -0.76 to 0.34). There were no significant between-group differences in terms of withdrawals due to adverse effects (risk ratio (RR) 1.27, 95% CI 0.53 to 3.03), and serious adverse events resulting in hospitalisation (2/40 SMP/GMP/G600 group versus 3/80 controls; RR 1.33, 95% CI 0.23 to 7.66). Gastrointestinal adverse effects were the most commonly reported. Pain from self reported gout flares, measured on a 10-point Likert scale, improved more in the SMP/GMP/G600 group compared to controls (MD -1.03, 95% CI -1.96 to -0.10), an absolute difference of 10% (absolute risk difference -0.10, 95% CI -0.20 to -0.01). This is unlikely to be of clinical significance. Physical function, tophus regression and serum urate normalisation were not reported in this study. AUTHORS' CONCLUSIONS: While there is good evidence from observational studies of an association between various lifestyle risk factors and gout development, there is a paucity of high-quality evidence from randomised controlled trials to either support or refute the use of lifestyle modifications for improving outcomes in people with chronic gout.