Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care.

OBJECTIVES: To compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care. METHODS: This was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0-10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1-7 by intention to treat. RESULTS: Between 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1-7 (colchicine vs naproxen: mean difference -0.18; 95% CI -0.53 to 0.17; p=0.32). During days 1-7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54). CONCLUSION: We found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications. TRIAL REGISTRATION NUMBER: ISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Cost-effectiveness of a model consultation to support self-management in patients with osteoarthritis.

Objectives: The aim of this study was to estimate the cost-effectiveness of a model OA consultation for OA to support self-management compared with usual care. Methods: An incremental cost-utility analysis using patient responses to the three-level EuroQoL-5D (EQ-5D) questionnaire was undertaken from a UK National Health Service perspective alongside a two-arm cluster-randomized controlled trial. Uncertainty was explored through the use of cost-effectiveness acceptability curves. Results: Differences in health outcomes between the model OA consultation and usual care arms were not statistically significant. On average, visits to the orthopaedic surgeon were lower in the model OA consultation arm by -0.28 (95% CI: -0.55, -0.06). The cost-utility analysis indicated that the model OA consultation was associated with a non-significant incremental cost of £-13.11 (95% CI: -81.09 to 54.85) and an incremental quality adjusted life year (QALY) of -0.003 (95% CI: -0.03 to 0.02), with a 44% chance of being cost-effective at a threshold of £20 000 per QALY gained. The percentage of participants who took time off and the associated productivity cost were lower in the model OA consultation arm. Conclusion: Implementing National Institute for Health and Care Excellence guidelines using a model OA consultation in primary care does not appear to lead to increased costs, but health outcomes remain very similar to usual care. Even though the intervention seems to reduce the demand for orthopaedic surgery, overall it is unlikely to be cost-effective.

The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial): A cluster randomised trial in primary care.

BACKGROUND: This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. METHODS AND FINDINGS: We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). CONCLUSIONS: In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. TRIAL REGISTRATION: ISRCTN registry ISRCTN40721988.

How common is depression in patients with polymyalgia rheumatica?

Depression is common in inflammatory disorders such as rheumatoid arthritis and systemic lupus erythematosus and negatively impacts on outcomes. Given the long-term nature of polymyalgia rheumatica (PMR) and its glucocorticoid treatment, these patients may be at an increased risk of depression, although few studies exist to date. This study aimed to investigate the prevalence of, and factors associated with, depression in PMR patients. Prevalent PMR patients (with a first diagnostic code for PMR in the last 3 years) were mailed a postal questionnaire (n = 704) examining PMR symptoms, glucocorticoid use and patient reported comorbidities. Depressive symptoms were assessed using the Patient Health Questionnaire-8 (PHQ-8), with a score of ≥10 defined as current depressive symptoms. Logistic regression was used to examine association between demographics, comorbidity and current depressive symptoms. Five hundred fifty (78%) patients responded, of which 365 (66%) were female, with a mean (SD) age of 74.1 years (8.4). The prevalence of current depressive symptoms was 15% (n = 81) and was significantly associated with female gender: OR 1.87 (95%CI 1.08-3.22), current PMR symptoms: OR 2.1 (1.11-3.97), self-reported acid reflux: OR 1.75 (1.05-2.93) and diabetes: OR 2.86 (1.6-5.09). Older patients were less likely to report current depressive symptoms (OR 0.35 (0.13-0.9) for those >80 years versus those aged 50-59 years). Depressive symptoms are common in patients with PMR patients, especially younger patients and those with comorbidities. Clinicians should consider screening these patients for depressive symptoms and managing them appropriately, as untreated depression may negatively impact on health-related outcomes and quality of life.

Cost-Utility Analysis of Routine Anxiety and Depression Screening in Patients Consulting for Osteoarthritis: Results From a Clinical, Randomized Controlled Trial.

OBJECTIVE: To investigate the cost-effectiveness (cost-utility) of introducing general practitioner screening for anxiety and depression in patients consulting for osteoarthritis (OA). METHODS: A cluster-randomized trial-based economic evaluation to assess general practitioners screening for anxiety and depression symptoms in patients consulting for OA compared to usual care (screening for pain intensity) was undertaken over a 12-month period from a UK National Health Service and societal perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were estimated, and cost-effectiveness acceptability curves controlling for cluster-level data were constructed. The base-case analysis used the net benefit regressions approach. The 2-stage nonparametric sampling technique was explored in a sensitivity analysis. RESULTS: The base-case analysis demonstrated that the intervention was as costly as, and less effective than, the control (QALY differential -0.029 [95% confidence interval -0.062, 0.003]). In the base-case analyses, general practitioner screening for anxiety and depression was unlikely to be a cost-effective option (probability <5% at £20,000/QALY). Similar results were observed in all sensitivity analyses. CONCLUSION: Prompting general practitioners to routinely screen and manage comorbid anxiety and depression in patients presenting with OA is unlikely to be cost-effective. Further research is needed to explore clinically effective and cost-effective models of managing anxiety and depression in patients presenting with clinical OA.

Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol.

BACKGROUND: There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. DESIGN: A mixed methods study with a nested cluster randomised controlled trial. METHOD: This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive 'whole-system' evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations. DISCUSSION: The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance. TRIAL REGISTRATION: ISRCTN number: ISRCTN06984617.