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The philosophical underpinning of trials of complex interventions is critiqued for not taking into account causal mechanisms that influence potential outcomes. In this article, we draw from in-depth interviews (with practice nurses and patients) and observations of practice meetings and consultations to investigate the outcomes of a complex intervention to promote self-management (in particular exercise) for osteoarthritis in primary care settings. We argue that nurses interpreted the intervention as underpinned by the need to educate rather than work with patients, and, drawing from Habermasian theory, we argue that expert medicalised knowledge (system) clashed with lay 'lifeworld' prerogatives in an uneven communicative arena (the consultation). In turn, the advice and instructions given to patients were not always commensurate with their 'lifeworld'. Consequently, patients struggled to embed exercise routines into their daily lives for reasons of unsuitable locality, sense-making that 'home' was an inappropriate place to exercise and using embodied knowledge to test the efficacy of exercise on pain. We conclude by arguing that using Habermasian theory helped to understand reasons why the trial failed to increase exercise levels. Our findings suggest that communication styles influence the outcomes of self-management interventions, reinforce the utility of theoretically informed qualitative research embedded within trials to improve conduct and outcomes and indicate incorporating perspectives from human geography can enhance Habermas-informed research and theorising.

Background: This study assessed the measurement properties of two commonly used self-report physical activity (PA) measures: the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and the Physical Activity Scale for the elderly (PASE) in adults with osteoarthritis., Methods: Secondary analysis of the MOSAICS cluster randomised controlled trial baseline and 3-month follow-up questionnaires, total scores and subdomains of the IPAQ-SF and PASE were compared. Intra-class correlations (ICC) were used to assess test-retest reliability, measurement error was assessed using standard error of measurement (SEM), smallest detectable change (SDC) and 95% limits of agreement (LoA). Responsiveness was assessed using effect size (ES), standard responsive measurement (SRM) and response ratio (RR)., Results: There was moderate correlation (r = 0.56) between the total IPAQ-SF scores (score ranges 0-16,398) and the total PASE scores (score ranges 0-400). Subdomain correlations were also moderate (ranges 0.39-0.57). The PASE showed greater reliability compared to the IPAQ-SF (ICC = 0.68; 0.61-0.74 95% CI and ICC = 0.64; 0.55-0.72, respectively). Measurement errors in both measures were large: PASE SEM = 46.7, SDC = 129.6 and 95% LoA ranges = -117 to 136, the IPAQ-SF SEM = 3532.2 METS -1 min-1 week , SDC = 9790.8 and 95% LoA ranges = -5222 to 5597. Responsiveness was poor: ES -0.14 and -0.16, SRM -0.21 and -0.21, and RR 0.12 and 0.09 for the IPAQ-SF and PASE, respectively., Discussion: The IPAQ-SF and PASE appear limited in reliability, measurement error and responsiveness. Researchers and clinicians should be aware of these limitations, particularly when comparing different levels of PA and monitoring PA levels changes over time in those with osteoarthritis., (© 2021 John Wiley & Sons Ltd.)

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.

Objective: To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice., Method: Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England., Participants: 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression., Results: 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3)., Conclusion: Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months., Trial Registration: ISRCTN06984617., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: To determine the effect of a model osteoarthritis (OA) consultation (MOAC) informed by National Institute for Health and Care Excellence (NICE) recommendations compared with usual care on recorded quality of care of clinical OA in general practice., Design: Two-arm cluster randomised controlled trial., Setting: Eight general practices in Cheshire, Shropshire, or Staffordshire UK., Participants: General practitioners and nurses with patients consulting with clinical OA., Intervention: Following six-month baseline period practices were randomised to intervention (n = 4) or usual care (n = 4). Intervention practices delivered MOAC (enhanced initial GP consultation, nurse-led clinic, OA guidebook) to patients aged ≥45 years consulting with clinical OA. An electronic (e-)template for consultations was used in all practices to record OA quality care indicators., Outcomes: Quality of OA care over six months recorded in the medical record., Results: 1851 patients consulted in baseline period (1015 intervention; 836 control); 1960 consulted following randomisation (1118 intervention; 842 control). At baseline wide variations in quality of care were noted. Post-randomisation increases were found for written advice on OA (4-28%), exercise (4-22%) and weight loss (1-15%) in intervention practices but not controls (1-3%). Intervention practices were more likely to refer to physiotherapy (10% vs 2%, odds ratio 5.30; 95% CI 2.11, 13.34), and prescribe paracetamol (22% vs 14%, 1.74; 95% CI 1.27, 2.38)., Conclusions: The intervention did not improve all aspects of care but increased core NICE recommendations of written advice on OA, exercise and weight management. There remains a need to reduce variation and uniformly enhance improvement in recorded OA care., Trial Registration Number: ISRCTN06984617., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The National Institute for Health and Care Excellence's Osteoarthritis (OA) guidelines recommended that future research should consider the benefits of combination therapies in people with OA across multiple joint sites. However, the clinical effectiveness of such approaches to OA management is unknown. This systematic review therefore aimed to identify the clinical and cost effectiveness of multidisciplinary approaches targeting multiple joint sites for OA in primary care., Methods: A systematic review of randomised controlled trials. Computerised bibliographic databases were searched (MEDLINE, EMBASE, CINAHL, PsychINFO, BNI, HBE, HMIC, AMED, Web of Science and Cochrane). Studies were included if they met the following criteria; a randomised controlled trial (RCT), a primary care population with OA across at least two different peripheral joint sites (multiple joint sites), and interventions undertaken by at least two different health disciplines (multidisciplinary). The Cochrane 'Risk of Bias' tool and PEDro were used for quality assessment of eligible studies. Clinical and cost effectiveness was determined by extracting and examining self-reported outcomes for pain, function, quality of life (QoL) and health care utilisation. The date range for the search was from database inception until August 2015., Results: The search identified 1148 individual titles of which four were included in the review. A narrative review was conducted due to the heterogeneity of the included trials. Each of the four trials used either educational or exercise interventions facilitated by a range of different health disciplines. Moderate clinical benefits on pain, function and QoL were reported across the studies. The beneficial effects of exercise generally decreased over time within all studies. Two studies were able to show a reduction in healthcare utilisation due to a reduction in visits to a physiotherapist or a reduction in x-rays and orthopaedic referrals. The intervention that showed the most promise used educational interventions delivered by GPs with reinforcement by practice nurses., Conclusions: There are currently very few studies that target multidisciplinary approaches suitable for OA across multiple joint sites, in primary care. A more consistent approach to outcome measurement in future studies of this nature should be considered to allow for better comparison.

Objective: To define the core content for an opportunistic consultation between a health care professional (HCP) and a patient with osteoarthritis (OA) in primary care., Methods: An ideas generation round and a 2-round Delphi postal consensus study allowed participants to rank the importance of tasks for an opportunistic consultation. The study was conducted with a lay group (n = 18) and 3 groups of HCPs (n = 30 for general practitioners, n = 19 for practice nurses, and n = 37 for allied health professionals)., Results: The ideas generation round formulated 35 consultation tasks. There was a 50% response rate to the 2-round postal exercise (n = 52). Consensus was reached on 12 tasks for an opportunistic OA consultation using a >80% level of agreement across all groups. Three of these consultation tasks were defined at 100%. The 3 tasks were questions asked by the HCP about how things are going with the condition, the type and amount of pain the patient has, and whether the patient is taking regular analgesia., Conclusion: In a Delphi study to define the content of an opportunistic primary care OA consultation, 12 consultation tasks provided the content of a comprehensive consultation. Three of these tasks with 100% agreement could be adopted in any multidisciplinary consultation for OA in primary care. Inquiring about the condition, the type and amount of pain the patient has, and whether analgesia is being taken forms a core set of questions that are considered important by both lay and health professional groups in an opportunistic consultation., (Copyright © 2013 by the American College of Rheumatology.)

Abstract: 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. [ABSTRACT FROM AUTHOR]