First Contact Physiotherapy: An evaluation of clinical effectiveness and costs.

BACKGROUND: First Contact Physiotherapy Practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. AIM: To determine the clinical effectiveness and costs of FCPP-led compared to GP-led models of care. DESIGN AND SETTING: Multiple site case study design. UK GP practices. METHOD: General Practice sites were recruited representing three models: 1. GP-led care; 2. FCPPs who could not prescribe/inject (Standard (St)); 3. FCPPs who could prescribe/inject (Additional Qualifications (AQ)). Patient participants from each site completed clinical outcome data at baseline, 3 and 6 months. The primary outcome was the SF-36v.2 Physical Component Score (PCS). Healthcare usage was collected for 6 months. RESULTS: N=426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF36-PCS) across all three arms at 6 months (p=0.999). At 3 months a significant difference in numbers improving was seen between arms: 54.7% GP consultees; 72.4% FCPP-St, 66.4% FCPP-AQ; (p=0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%) compared with FCPP-St (17.5%) and FCPP-AQ (22.8%); (p<0.001). NHS costs (initial consultation and over 6 months follow up) were significantly higher in the GP-led model (median £105.50) vs FCPP-St (£41) and FCPP-AQ (£44); (p<0.001). CONCLUSION: FCPP led models provide safe, clinically effective and cost-beneficial management for patients with MSKDs in general practice and reduced opioid use in this cohort.

Benefits of realist evaluation for rapidly changing health service delivery.

Realist evaluation is a methodology that addresses the questions: 'what works, for whom, in which circumstances, and how?'. In this approach, programme theories are developed and tested against available evidence. However, when complex interventions are implemented in rapidly changing environments, there are many unpredictable forces that determine the programme's scope and architecture, as well as resultant outcome. These forces can be theorised, in real time, and included in realist evaluation outputs for current and future optimisation of programmes. Reflecting on a realist evaluation of first-contact physiotherapy in primary care (the FRONTIER Study), five important considerations are described for improving the quality of realist evaluation outputs when studying rapidly changing health service delivery. These are: (1) ensuring that initial programme theories are developed through creative thinking sessions, empirical and non-empirical literature, and stakeholder consultation; (2) testing the causal impact of formal and informal (eg, emergent) components of service delivery models; (3) contrasting initial programme theories with rival theory statements; (4) envisioning broad system impacts beyond the immediate implementation setting; and (5) incorporating rapidly evolving service developments and context changes into the theory testing process in real-time (eg, Additional Role Reimbursement Scheme, COVID-19). Through the reflections presented, the aim is to clarify the benefit of realist evaluation to assess emerging models of care and rapidly changing health service delivery.

Beliefs, motives and gains associated with physical activity in people with osteoarthritis.

OBJECTIVES: Osteoarthritis (OA) affects approximately 8.75 million people in the United Kingdom. Physical activity is recommended as a core treatment, yet 44% of people with OA are inactive. Motivation and self-efficacy for exercise are considered to be key factors contributing to sustained engagement with physical activity. The aim of this study was to explore the beliefs, motives (what an individual aims to attain through participating in physical activity) and gains (what people feel they might get from participation) associated with physical activity engagement in a group of people with OA. DESIGN AND METHOD: This study adopted a cross-sectional survey research design, using two validated questionnaires: the Exercise Motives and Gains Inventory and the Exercise Self-Efficacy Scale. RESULTS: Data were gathered from 262 people with OA between August 2015 and January 2016. Those who were most active reported higher levels of both motivation and self-efficacy and were active for enjoyment, to avoid negative health, and for health and fitness reasons. A comparison of motives and gains revealed higher gain scores for social engagement and enjoyment, compared with associated motive scores. CONCLUSION: This study provides evidence of the central role that motives, gains and self-efficacy play in facilitating engagement with physical activity in this population. Future interventions should aim to foster increased self-efficacy for physical activity and promote autonomous forms of motivation by emphasising the importance of choosing activities which are enjoyable, as well as highlighting the value of social engagement.

Provision of first contact physiotherapy in primary care across the UK: a survey of the service.

BACKGROUND: First Contact Physiotherapy (FCP) is an emerging model of care whereby a specialist physiotherapist located within general practice undertakes the first patient assessment, diagnosis and management without a prior GP consultation. Despite institutional and professional body support for this model and NHS commitment to its implementation, data regarding current FCP provision are limited. OBJECTIVES: To identify current FCP service provision across the UK, including models of provision and key professional capabilities. DESIGN: Cross-sectional online survey, targeting physiotherapists and service managers involved in FCP. METHODS: Recruitment involved non-probability sampling targeting those involved in FCP service provision through emails to members of known clinical networks, snowballing and social media. The survey gathered data about respondents, FCP services and the role and scope of physiotherapists providing FCP. RESULTS: The authors received 102 responses; 32 from service managers and 70 working in FCP practice from England (n=60), Scotland (n=22), Wales (n=14), and Northern Ireland (n=2). Most practitioners were NHS band 7 or 8a (91%, n=63), with additional skills (e.g. requesting investigations, prescribing). 17% (12/70) worked 37.5hours/week; 37% (26/70) ≤10hours; most (71%, 50/70) used 20-minute appointments (range 10-30minutes); varying arrangements were reported for administration and follow-up. Services covered populations of 1200 to 600,000 (75% <100,000); access mostly involved combinations of self-booking and reception triage. Commissioning and funding arrangements varied widely; NHS sources provided 90% of services. CONCLUSIONS: This survey provides new evidence regarding variation in FCP practice across the UK, indicating that evidence-informed, context specific guidance on optimal models of provision is required.

Investigating Dimensions of Stiffness in Rheumatoid and Psoriatic Arthritis: The Australian Rheumatology Association Database Registry and OMERACT Collaboration.

OBJECTIVE: It is not known how the experience of stiffness varies between diagnoses or how best to measure stiffness. The aims of our study were to (1) compare stiffness in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) using patient-reported outcomes, (2) investigate how dimensions of stiffness are associated with each other and reflect the patient experience, and (3) analyze how different dimensions of stiffness are associated with physical function. METHODS: An online survey was sent to Australian Rheumatology Association Database participants (158 PsA, and 158 age- and sex-matched RA), assessing stiffness severity, duration, impact, importance, coping, and physical function [modified Health Assessment Questionnaire (mHAQ)]. Scores were compared between diagnoses and correlations among stiffness dimensions calculated. Multivariate regression was performed for stiffness severity, impact, and duration on mHAQ, adjusting for age, sex, disease duration, obesity, and pain. Cognitive debriefing was conducted through semistructured telephone interviews. RESULTS: Overall, 240/316 (75.9%) responded [124/158 RA (78.5%) and 116/158 PsA (73.4%)], with no significant difference in stiffness ratings between diagnoses. Scores for all stiffness dimensions were strongly correlated (r = 0.52-0.89), and severity and impact were associated with mHAQ in both diagnoses. Stiffness duration was not associated with mHAQ in RA. In cognitive debriefing, participants described stiffness severity and impact by their effect on daily activities (10/16 and 14/16 participants, respectively). CONCLUSION: Stiffness ratings were similar between PsA and RA. Different dimensions of stiffness were strongly correlated. Stiffness severity and impact both independently predicted mHAQ. Stiffness was important to participants; however, measuring multiple dimensions of stiffness may have minimal additive value.

The OMERACT Emerging Leaders Program: The Good, the Bad, and the Future.

OBJECTIVE: To describe the experience of the first OMERACT Emerging Leaders Program (ELP). METHODS: A Delphi process identified positive aspects, areas for improvement, and future directions. Core items were defined as essential if they received ≥ 70% ratings. RESULTS: Participants valued relatable/accessible mentors (100%), including an OMERACT Executive mentor (100%), and a support network of peers (90%). Key items for future development were funding support (100%) and developing knowledge about OMERACT processes (90%) and politics (80%). CONCLUSION: The ELP has the potential to provide targeted training for early career researchers to develop relevant skills for future leadership roles within OMERACT.

Advancing Stiffness Measurement in Rheumatic Disease: Report from the Stiffness Special Interest Group at OMERACT 2018.

OBJECTIVE: To improve measurement of stiffness in rheumatic disease. METHODS: Data presented included (1) 2 qualitative projects, (2) the rheumatoid arthritis (RA) stiffness patient-reported outcome measure (RAST), and (3) 3 items assessing stiffness severity, duration, and interference. RESULTS: Stiffness is multidimensional and includes aspects of stiffness experience such as duration, severity, and effect. Stiffness items showed construct validity in RA. Further efforts are required to develop an instrument that will be taken through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 for instrument selection. CONCLUSION: The research agenda for the group includes domain content voting for individual diseases, and development of stiffness item banks and disease-specific short forms.

Dose reduction of biologic therapy in inflammatory arthritis: A qualitative study of patients' perceptions and needs.

OBJECTIVE: Successful biologic disease-modifying anti-rheumatic drug (bDMARD) dose reduction appears increasingly possible from clinical trials. The present study aimed to understand the patient perspective of bDMARD dose reduction. METHODS: Patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis who were self-administering subcutaneous bDMARDs therapy at two National Health Service trusts participated in semi-structured interviews. To capture multiple experiences, patients were purposefully sampled for a range of age, gender, disease duration, reducing/not reducing bDMARDs and either within 3-12 months of bDMARD initiation or ≥12 months and in remission/low disease activity. Inductive thematic analysis was utilized. RESULTS: Fifteen patients were interviewed (six on dose reduction). Five overarching themes were identified. When thinking about dose reduction, patients reflected on their difficult life before bDMARDs ("Where I was then") compared with their transformative effects ("Where I am now"). All raised concerns that a dose reduction would take them back to where they used to be ("Fears for the future") and most believed it to be a cost-cutting exercise. Most had "Hopes for the future", that a reduction would lower their risk of side effects, and release funds for other patients. They wanted a clear rationale for reduction, collaborative decision making, and control over flexible dosing ("Information needs"). CONCLUSION: Patients were fearful of reducing the dose of their bDMARDs, having previously experienced uncontrollable symptoms. However, most were willing to try, provided that there was a clear rationale and that it was in their best interests, with opportunities for collaboration and dose control. These patient perspectives will inform the provision of patient information to guide clinical discussions.

Development and testing of candidate items for inclusion in a new rheumatoid arthritis stiffness patient-reported outcome measure.

Objective: To qualitatively develop and test a set of candidate items for a new RA stiffness patient-reported outcome measure (PROM) that capture the patient perspective. This is an essential first step in PROM development, prior to quantitative development, assessment and validation. Methods: Focus groups further examined the previously developed stiffness conceptual model and explored the patient perspective regarding stiffness assessment. Data were analysed using thematic analysis. An iterative process of item development was then performed by the expert study team of researchers, patients and clinicians, based on the two qualitative datasets and informed by measurement theory and guidelines. Finally, these candidate items were tested using formal cognitive interview methodology and subsequently refined. Results: Sixteen RA patients from the UK participated in focus groups. Data confirmed the conceptual model of the RA patient experience of stiffness and provided insight into stiffness assessment, including suggestions regarding patient-relevant stiffness assessment categories such as impact, location and timing. These data informed the development of 77 candidate stiffness PROM items, including multiple formats for some. Eleven RA patients participated in cognitive interviews. Minor changes were made to items to enhance understanding and 32 items were removed, resulting in 45 candidate PROM items. Conclusion: Rigorous qualitative methodology and considerable patient involvement has underpinned items for a new RA stiffness PROM with strong content validity. Crucially, patient involvement broadened assessment beyond early morning stiffness duration, which may address existing PROM limitations. Items are now suitable for quantitative item reduction, structural development of the final PROM and validation.

Stiffness Is the Cardinal Symptom of Inflammatory Musculoskeletal Diseases, Yet Still Variably Measured: Report from the OMERACT 2016 Stiffness Special Interest Group.

OBJECTIVE: The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group (SIG) are to characterize stiffness as an outcome in rheumatic disease and to identify and validate a stiffness patient-reported outcome (PRO) in rheumatology. METHODS: At OMERACT 2016, international groups presented and discussed results of several concurrent research projects on stiffness: a literature review of rheumatoid arthritis (RA) stiffness PRO measures, a qualitative investigation into the RA and polymyalgia rheumatica patient perspective of stiffness, data-driven stiffness conceptual model development, development and testing of an RA stiffness PRO measure, and a quantitative work testing stiffness items in patients with RA and psoriatic arthritis. RESULTS: The literature review identified 52 individual stiffness PRO measures assessing morning or early morning stiffness severity/intensity or duration. Items were heterogeneous, had little or inconsistent psychometric property evidence, and did not appear to have been developed according to the PRO development guidelines. A poor match between current stiffness PRO and the conceptual model identifying the RA patient experience of stiffness was identified, highlighting a major flaw in PRO selection according to the OMERACT filter 2.0. CONCLUSION: Discussions within the Stiffness SIG highlighted the importance of further research on stiffness and defined a research agenda.

Health Professionals' Perceptions of the Effects of Exercise on Joint Health in Rheumatoid Arthritis Patients.

OBJECTIVES: Although exercise is an important factor in the management of rheumatoid arthritis (RA), research indicates that patients perceive that health professionals (HPs) are uncertain about the place of exercise in treatment and its relationship with joint damage. The present study investigated the perceptions of HPs regarding the effects of exercise on joint health in RA patients. METHODS: A questionnaire investigating perceptions of exercise and joint health was distributed via professional networks and websites. Confirmatory factor analysis (CFA) was used to analyse questionnaire data and develop a focus group interview guide. Focus groups were conducted with multidisciplinary teams (MDTs) of rheumatology HPs and analysed using framework analysis. RESULTS: A total of 137 rheumatology HPs (95 female; 27-65 years of age) completed questionnaires. CFA showed that a four-factor model provided a marginally acceptable fit. Analysis of four focus groups (n = 24; 19 female; 30-60 years of age) identified five themes relating to HPs' perceptions of exercise and joint health in RA patients: 'Exercise is beneficial', 'Concerns about damage to joints', 'Patients have barriers to exercise', 'HP knowledge differs' and 'Patients may think service delivery is vague'. CONCLUSIONS: HPs were highly aware of the benefits and importance of exercise for RA patients. However, to remove the patient perception that HPs lack certainty and clarity regarding exercise it is important to ensure: (i) consistent promotion of exercise across the whole MDT; (ii) clear provision of information regarding rest, joint protection and exercise; (iii) HP education to ensure consistent, accurate knowledge, and understanding of the potential for conflicting advice when promoting exercise as part of an MDT. Copy © 2016 John Wiley & Sons, Ltd.

Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. METHODS: A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. RESULTS: Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR. CONCLUSION: A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.

More than Just Minutes of Stiffness in the Morning: Report from the OMERACT Rheumatoid Arthritis Flare Group Stiffness Breakout Sessions.

OBJECTIVE: Stiffness was endorsed within the rheumatoid arthritis (RA) flare core domain set at the previous Outcome Measures in Rheumatology meeting (OMERACT 11). Two stiffness breakout groups at the present OMERACT 12 RA flare workshop discussed results of new qualitative studies in RA stiffness. METHODS: Results from 2 independent studies of RA stiffness were presented to breakout group participants, followed by group discussions about stiffness measurement. RESULTS: Both studies identified stiffness as complex, variable with the level of disease activity, and as encompassing concepts of impact, intensity, timing, location, and duration. That stiffness has an effect on multiple dimensions of health was a common finding. Participants agreed that stiffness is an important aspect of RA flare. Whether measuring only morning stiffness duration, the traditional approach in RA, was sufficient in coverage of the concept was unclear. Groups agreed that more research on stiffness measurement is needed considering the importance patients place on the effect of stiffness. CONCLUSION: Results from independent studies highlight stiffness effect as an important feature of RA, in addition to intensity, timing, location, and duration. Additional work is needed to identify optimal ways to assess stiffness in RA and other rheumatologic diseases.

Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop an approach to identify and measure RA flares. An overview of our OMERACT 2014 plenary is provided. METHODS: Feasibility and validity of flare domains endorsed at OMERACT 11 (2012) were described based on initial data from 3 international studies collected using a common set of questions specific to RA flare. Mean flare frequency, severity, and duration data were presented, and domain scores were compared by flare status to examine known-groups validity. Breakout groups provided input for stiffness, self-management, contextual factors, and measurement considerations. RESULTS: Flare data from 501 patients in an observational study indicated 39% were in flare, with mean (SD) severity of 6.0 (2.6) and 55% lasting > 14 days. Pain, physical function, fatigue, participation, and stiffness scores averaged ≥ 2 times higher (2 of 11 points) in flaring individuals. Correlations between flare domains and corresponding legacy instruments were obtained: r = 0.46 to 0.93. A combined definition (patient report of flare and 28-joint Disease Activity Score increase) was evaluated in 2 other trials, with similar results. Breakout groups debated specific measurement issues. CONCLUSION: These data contribute initial evidence of feasibility and content validation of the OMERACT RA Flare Core Domain Set. Our research agenda for OMERACT 2016 includes establishing duration/intensity criteria and developing criteria to identify RA flares using existing disease activity measures. Ongoing work will also address discordance between patient and physician ratings, facilitate application of flare criteria to clinical care, elucidate the role of self-management, and finalize recommendations for RA flare measurement.

Stiffness is more than just duration and severity: a qualitative exploration in people with rheumatoid arthritis.

OBJECTIVE: Stiffness is internationally recognized as an important indicator of inflammatory activity in RA but is poorly understood and difficult to measure. The aim of this study was to explore the experience of stiffness from the patient perspective. METHODS: Semi-structured interviews conducted with 16 RA patients were analysed independently by researchers and pat.ient partners using inductive thematic analysis. RESULTS: Six themes were identified. Part of having RA identified stiffness as a normal consequence of RA, perceived as associated with disease-related aspects such as fluctuating disease activity, other RA symptoms and disease duration. Local and widespread highlighted stiffness occurring not only in joints, but also over the whole body, being more widespread during the morning or flare. Linked to behaviour and environment illustrated factors that influence stiffness, including movement, medications and weather. Highly variable captured the fluctuating nature of stiffness within and between patients and in relation to temporality, duration and intensity. Impacts on daily life emphasized the effect of stiffness on a range of domains, including physical function, quality of life, psychological well-being, activities of daily living and participation in work and leisure activities. Requires self-management detailed self-management strategies targeting both the symptom and its consequences. CONCLUSION: Patients' experiences of stiffness were varied, complex and not exclusive to the morning period. Importantly, stiffness was reported in terms of impact rather than the traditional measurement concepts of severity or duration. Based on these findings, further research is needed to develop a patient-centred measure that adequately reflects inflammatory activity.