Co-development and testing of an extended community pharmacy model of service delivery for managing osteoarthritis: protocol for a sequential, multi-methods study (PharmOA).

BACKGROUND: Osteoarthritis is a common, painful and disabling long-term condition. Delivery of high-quality guideline-informed osteoarthritis care that successfully promotes and maintains supported self-management is imperative. However, osteoarthritis care remains inconsistent, including under use of core non-pharmacological approaches of education, exercise and weight loss. Community pharmacies are an accessible healthcare provider. United Kingdom government initiatives are promoting their involvement in a range of long-term conditions, including musculoskeletal conditions. It is not known what an enhanced community pharmacy role for osteoarthritis care should include, what support is needed to deliver such a role, and whether it would be feasible and acceptable to community pharmacy teams. In this (PharmOA) study, we aim to address these gaps, and co-design and test an evidence-based extended community pharmacy model of service delivery for managing osteoarthritis. METHODS: Informed by the Theoretical Domains Framework, Normalisation Process Theory, and the Medical Research Council (MRC) framework for developing complex interventions, we will undertake a multi-methods study involving five phases: 1. Systematic review to summarise currently available evidence on community pharmacy roles in supporting adults with osteoarthritis and other chronic (non-cancer) pain. 2. Cross-sectional surveys and one-to-one qualitative interviews with patients, healthcare professionals and pharmacy staff to explore experiences of current, and potential extended community pharmacy roles, in delivering osteoarthritis care. 3. Stakeholder co-design to: a) agree on the extended role of community pharmacies in osteoarthritis care; b) develop a model of osteoarthritis care within which the extended roles could be delivered (PharmOA model of service delivery); and c) refine existing tools to support community pharmacies to deliver extended osteoarthritis care roles (PharmOA tools). 4. Feasibility study to explore the acceptability and feasibility of the PharmOA model of service delivery and PharmOA tools to community pharmacy teams. 5. Final stakeholder workshop to: a) finalise the PharmOA model of service delivery and PharmOA tools, and b) if applicable, prioritise recommendations for its wider future implementation. DISCUSSION: This novel study paves the way to improving access to and availability of high-quality guideline-informed, consistent care for people with osteoarthritis from within community pharmacies.

A new measure of exercise adherence: the ATEMPT (Adherence To Exercise for Musculoskeletal Pain Tool).

OBJECTIVES: This study aimed to (1) develop a new measure of adherence to exercise for musculoskeletal (MSK) pain (Adherence To Exercise for Musculoskeletal Pain Tool: ATEMPT) based on previously conceptualised domains of exercise adherence, (2) report the content and structural validity, internal consistency, test-retest reliability, and measurement error for the ATEMPT outcome measure in patients managed with exercise for MSK pain. METHODS: ATEMPT was created using statements describing adherence generated by patients, physiotherapists and researchers, with content validity established. Baseline and retest questionnaires were distributed to patients recommended exercise for MSK pain in 11 National Health Service physiotherapy clinics. Items demonstrating low response variation were removed and the following measurement properties assessed: structural validity, internal consistency, test-retest reliability and measurement error. RESULTS: Baseline and retest data were collected from 382 and 112 patients with MSK pain, respectively. Confirmatory factor analysis established that a single factor solution was the best fit according to Bayesian Information Criterion. The 6-item version of the measure (scored 6-30) demonstrated optimal internal consistency (Cronbach's Alpha 0.86, 95% CI 0.83 to 0.88) with acceptable levels of test-retest reliability (intraclass correlation coefficient 0.84, 95% CI 0.78 to 0.88) and measurement error (smallest detectable change 3.77, 95% CI 3.27 to 4.42) (SE of measurement 2.67, 95% CI 2.31 to 3.16). CONCLUSION: The 6-item ATEMPT was developed from the six domains of exercise adherence. It has adequate content and structural validity, internal consistency, test-retest reliability and measurement error in patients with MSK pain, but should undergo additional testing to establish the construct validity and responsiveness.

Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial.

OBJECTIVES: To determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity. METHODS: 88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests. RESULTS: The intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported. CONCLUSION: A VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity. TRIAL REGISTRATION NUMBER: NIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

OBJECTIVES: Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising advice and education plus a single ultrasound-guided intra-articular hip injection (USGI) of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T) versus BCT alone. METHODS: A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a United Kingdom (UK) National Health Service (NHS) perspective. RESULTS: BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: £-161.6, 95% CI: £-583.95 to £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487, 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists, and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION: Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION: EudraCT: 2014-003412-37 (August 8, 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (July 28, 2015). TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0#citeas. DOI: doi.org/10.1186/s12891-018-2153-0.

Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial.

BACKGROUND: Obesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program. METHODS: 88 participants with painful knee OA and body mass index (BMI) > 27 kg/m2 will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20-30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50-75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures. DISCUSSION: This trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity. TRIAL REGISTRATION: NIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).

Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review.

OBJECTIVE: To establish the meaning of the term 'adherence' (including conceptual and measurement definitions) in the context of therapeutic exercise (TE) for musculoskeletal (MSK) pain. DESIGN: Systematic review using a search strategy including terms for: adherence, TE and MSK pain. Identified studies were independently screened for inclusion by two researchers. Two independent researchers extracted data on: study type; MSK pain population; type of TE used; definitions, parameters, measurement methods and values of adherence. DATA SOURCES: Seven electronic databases were searched from inception to December 2016. ELIGIBILITY CRITERIA: Any study type featuring TE for adults with MSK pain and containing a definition of adherence, or a description of how adherence was measured. RESULTS: 459 studies were identified and 86 were included in the review. Most were prospective cohort studies and featured back and/or neck pain. Strengthening and stretching were the most common types of TE. A clearly identifiable definition of adherence was provided in 40% of the studies, with 12% using the same definition. Exercise frequency was the most commonly measured parameter of adherence, with self-report logs the most common measurement method. The most common value range used to determine satisfactory adherence was 80%-99% of the recommended exercise dose. CONCLUSION: No single definition of adherence to TE was apparent. We found no definition of adherence that specifically related to TE for MSK pain or described the dimensions of TE that should be measured. We recommend conceptualising adherence to TE for MSK pain from the perspective of all relevant stakeholders.

Priorities for the effective implementation of osteoarthritis management programs: an OARSI international consensus exercise.

OBJECTIVE: The Joint Effort Initiative was endorsed by Osteoarthritis Research Society International (OARSI) in 2018 as a collaboration between international researchers and clinicians with an interest in the implementation of osteoarthritis management programs (OAMPs). This study aimed to identify and prioritise activities for future work of the Joint Effort Initiative. DESIGN: A survey was emailed to delegates of the 2018 OARSI World Congress attending a pre-conference workshop or with a known interest in OAMPs (n = 115). Delegates were asked about the most important issues regarding OAMP implementation. The top 20 issues were synthesised into 17 action statements, and respondents were invited to participate in a priority ranking exercise to determine the order of importance of the statements. RESULTS: Survey respondents (n = 51, 44%) were most commonly female (71%), with an allied health background (57%), affiliated with universities (73%) from Oceania (37%), and Europe/UK (45%). The five highest ranked action statements were: CONCLUSION: Prioritising statements will bring focus to the future work of the Joint Effort Initiative in the future and provide a basis for longer-term actions.

Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial.

BACKGROUND: Exercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical functioning in older adults with knee osteoarthritis in cross-sectional studies. However, to date no studies have investigated if change in physical activity level during exercise interventions can explain clinical outcomes of pain and function. This study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. METHODS: Secondary longitudinal data analyses of a three armed exercise intervention randomised controlled trial. Participants were adults with knee pain attributed to osteoarthritis, over the age of 45 years old (n = 514) from Primary Care Services in the Midlands and Northwest regions of England. Crude and adjusted associations between absolute change in physical activity from baseline to 3 months (measured by the self-report Physical Activity Scale for the Elderly (PASE)) and i) pain ii) physical function (Western Ontario and McMaster Universities Osteoarthritis Index) and iii) treatment response (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up were investigated using linear and logistic regression. RESULTS: Change in physical activity level was not associated with future pain, function or treatment response outcomes in crude or adjusted models at 3 or 6 months (P > 0.05). A 10 point increase in PASE was not associated with pain ß = - 0.01 (- 0.05, 0.02), physical function ß = - 0.09 (- 0.19, 0.02) or likelihood (odds ratio) of treatment response 1.02 (0.99, 1.04) at 3 months adjusting for sociodemographics, clinical covariates and the trial intervention arm. Findings were similar for 6 month outcome models. CONCLUSIONS: Change in physical activity did not explain future clinical outcomes of pain and function in this study. Other factors may be responsible for clinical improvements following exercise interventions. However, the PASE may not be sufficiently responsive to measure change in physical activity level. We also recommend further investigation into the responsiveness of commonly used physical activity measures. TRIAL REGISTRATION: ( ISRCTN93634563 ). Registered 29th September 2011.

A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol.

BACKGROUND: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. METHODS: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. DISCUSSION: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. TRIAL REGISTRATION: ISRCTN: 50550256 , 28th July 2015.

Quality and acceptability of measures of exercise adherence in musculoskeletal settings: a systematic review.

Objective: To recommend robust and relevant measures of exercise adherence for application in the musculoskeletal field. Method: A systematic review of measures was conducted in two phases. Phase 1 sought to identify all reproducible measures used to assess exercise adherence in a musculoskeletal setting. Phase 2 identified published evidence of measurement and practical properties of identified measures. Eight databases were searched (from inception to February 2016). Study quality was assessed against the Consensus-based Standards for the Selection of Health Measurement Instruments guidelines. Measurement quality was assessed against accepted standards. Results: Phase 1: from 8511 records, 326 full-text articles were reviewed; 45 reproducible measures were identified. Phase 2: from 2977 records, 110 full-text articles were assessed for eligibility; 10 articles provided evidence of measurement/practical properties for just seven measures. Six were exercise adherence-specific measures; one was specific to physical activity but applied as a measure of exercise adherence. Evidence of essential measurement and practical properties was mostly limited or not available. Assessment of relevance and comprehensiveness was largely absent and there was no evidence of patient involvement during the development or evaluation of any measure. Conclusion: The significant methodological and quality issues encountered prevent the clear recommendation of any measure; future applications should be undertaken cautiously until greater clarity of the conceptual underpinning of each measure is provided and acceptable evidence of essential measurement properties is established. Future research should seek to engage collaboratively with relevant stakeholders to ensure that exercise adherence assessment is high quality, relevant and acceptable.

Content and Evaluation of the Benefits of Effective Exercise for Older Adults With Knee Pain Trial Physiotherapist Training Program.

OBJECTIVE: To explore whether participating in the Benefits of Effective Exercise for knee Pain (BEEP) trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain in older adults. DESIGN: Before/after training program evaluation. Physiotherapists were asked to complete a questionnaire before the BEEP trial training program, immediately after, and 12 to 18 months later (postintervention delivery in the BEEP trial). The questionnaire included a case vignette and associated clinical management questions. Questionnaire responses were compared over time and between physiotherapists trained to deliver each intervention within the BEEP trial. SETTING: Primary care. PARTICIPANTS: Physiotherapists (N=53) who completed the BEEP trial training program. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Self-confidence in the diagnosis and management of knee pain in older adults; and intended clinical behavior measured by a case vignette and associated clinical management questions. RESULTS: Fifty-two physiotherapists (98%) returned the pretraining questionnaire, and 44 (85%) and 39 (74%) returned the posttraining and postintervention questionnaires, respectively. Posttraining, self-confidence in managing older adults with knee pain increased, and intended clinical behavior regarding exercise for knee pain in older adults appeared more in line with clinical guidelines. However, not all positive changes were maintained in the longer-term. CONCLUSIONS: Participating in the BEEP trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain, but by 12 to 18 months later, some of these positive changes were lost. This suggests that brief training programs are useful, but additional strategies are likely needed to successfully maintain changes in clinical behavior over time.

Interventions to increase adherence to therapeutic exercise in older adults with low back pain and/or hip/knee osteoarthritis: a systematic review and meta-analysis.

OBJECTIVE: To evaluate whether interventions aimed at increasing adherence to therapeutic exercise increase adherence greater than a contextually equivalent control among older adults with chronic low back pain and/or hip/knee osteoarthritis. DESIGN: A systematic review and meta-analysis. DATA SOURCES: Five databases (MEDLINE (PubMed), CINAHL, SportDISCUS (EBSCO), Embase (Ovid) and Cochrane Library) were searched until 1 August 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials that isolated the effects of interventions aiming to improve adherence to therapeutic exercise among adults ≥45 years of age with chronic low back pain and/or hip/knee osteoarthritis were included. RESULTS: Of 3899 studies identified, nine studies (1045 participants) were eligible. Four studies, evaluating strategies that aimed to increase motivation or using behavioural graded exercise, reported significantly better exercise adherence (d=0.26-1.23). In contrast, behavioural counselling, action coping plans and/or audio/video exercise cues did not improve adherence significantly. Meta-analysis using a random effects model with the two studies evaluating booster sessions with a physiotherapist for people with osteoarthritis revealed a small to medium significant pooled effect in favour of booster sessions (standardised mean difference (SMD) 0.39, 95% CI 0.05 to 0.72, z=2.26, p=0.02, I2=35%). CONCLUSIONS: Meta-analysis provides moderate-quality evidence that booster sessions with a physiotherapist assisted people with hip/knee osteoarthritis to better adhere to therapeutic exercise. Individual high-quality trials supported the use of motivational strategies in people with chronic low back pain and behavioural graded exercise in people with osteoarthritis to improve adherence to exercise.

Exercise and physical activity in older adults with knee pain: a mixed methods study.

OBJECTIVES: To describe and explore current exercise and physical activity behaviour in older adults with knee pain in the UK. METHODS: A survey was mailed to 2234 adults ≥50 years of age registered with one general practice within the UK to determine the presence and severity of knee pain and levels of physical activity. Semi-structured interviews were conducted with 22 questionnaire responders with knee pain. RESULTS: The questionnaire response rate was 59% (n = 1276) and 611 respondents reported knee pain. Only ∼40% of individuals with knee pain were sufficiently active to meet physical activity recommendations. Interviews revealed individual differences in the type and setting of physical activity completed and some self-monitored their symptoms in response to physical activity in order to guide future behaviour. CONCLUSION: Innovative interventions that can be adapted to suit individual needs and preferences are required to help older adults with knee pain become more physically active.

A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563).

BACKGROUND: Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. METHODS/DESIGN: Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. DISCUSSION: This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. TRIAL REGISTRATION ISRCTN: ISRCTN93634563.

Exploring the potential extended role of community pharmacy in the management of osteoarthritis: A multi-methods study with pharmacy staff and other healthcare professionals.

INTRODUCTION: Osteoarthritis is the commonest form of chronic joint pain, which patients often self-manage before seeking healthcare advice. Patients frequently seek advice from community pharmacies, and a recent policy has recommended integrating community pharmacies into long-term condition pathways. This study explored community pharmacy teams' (CPs) and other healthcare professionals' (HCPs) views on community pharmacies providing an extended role for osteoarthritis management, identifying potential barriers and facilitators to this. METHODS: A multi-methods study comprising surveys of CPs and other HCPs, followed by qualitative interviews. Descriptive statistics were used in an exploratory analysis of the survey data. Qualitative data were analysed using reflexive thematic analysis and the identified barriers and facilitators were mapped to the Theoretical Domains Framework. RESULT: CPs and other HCPs in the surveys and interviews reported that an extended role for osteoarthritis management could include: a subjective assessment, explaining the joint problem and its treatment, medication management and support for self-care. There was less consensus on diagnosing the problem as OA and completing an objective assessment. A key facilitator was training to deliver the role, whilst barriers were high workload and lack of access to General Practitioner medical records. DISCUSSION: Acceptable elements of an extended community pharmacy role for osteoarthritis centre around the provision of information, advice on medication and supported self-management. CONCLUSION: CPs are well placed to contribute towards evidenced-based osteoarthritis management. Feasibility testing of delivering the extended role is needed and future implementation requires training for CPs and raising public awareness of the extended role.

Conceptualising adherence to exercise for musculoskeletal pain: A concept mapping study.

BACKGROUND: The concept of adherence to exercise for musculoskeletal (MSK) pain is poorly defined and inadequately measured. This study aimed to, (1) conceptualise adherence to exercise therapy for MSK pain, and (2) identify statements most representative of the new conceptualisation that could be developed into items for a new measurement tool. METHODS: Concept mapping methodology was used, which is an integrated mixed methods approach. Focus groups with stakeholders generated statements describing adherence to exercise for MSK pain. Statements were grouped according to themes and rated for importance. Data analysis via multidimensional scaling and hierarchical cluster analysis produced a series of concept maps, which were refined during a further stakeholder workshop to produce the final conceptualisation of exercise adherence. Mean importance ratings established statements most suitable for future development. RESULTS: Twenty-eight participants produced 100 unique statements concerning adherence, which were sorted and rated. Analysis of the sort data with further participant refinement concluded that adherence to exercise consists of six domains: communication with experts; targets; how exercise is prescribed; patient knowledge and understanding; motivation and support; and psychological approach and attitudes. Fifty-six statements were rated with above average importance for inclusion in a new measure of adherence to exercise for MSK pain. CONCLUSION: Adherence to exercise for MSK pain is a complex and multi-dimensional construct represented by six distinct domains. Statements that best represent these domains have been identified by key stakeholders and will inform the development of a new measure of adherence to exercise for MSK pain.

Improving the Effectiveness of Exercise Therapy for Adults With Knee Osteoarthritis: A Pragmatic Randomized Controlled Trial (BEEP Trial).

Objective: To investigate whether knee osteoarthritis (OA) related pain and function can be improved by offering enhanced physical therapist-led exercise interventions. Design: Three-arm prospectively designed pragmatic randomized controlled trial. Setting: General practices and National Health Service physical therapy services in England. Participants: 514 adults (252 men, 262 women) aged ≥45 years with a clinical diagnosis of knee osteoarthritis (N=514). Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at baseline were 8.4 for pain and 28.1 for function. Interventions: Participants were individually randomized (1:1:1 allocation) to usual physical therapy care (UC control: up to 4 sessions of advice and exercise over 12 weeks), individually tailored exercise (ITE: individualized, supervised, and progressed lower limb exercises, 6-8 sessions over 12 weeks), or targeted exercise adherence (TEA: transitioning from lower limb exercise to general physical activity, 8-10 contacts over 6 months). Main Outcome Measures: Primary outcomes were pain and physical function measured by the WOMAC at 6 months. Secondary outcomes were measured at 3, 6, 9, 18, and 36 months. Results: Participants receiving UC, ITE, and TEA all experienced moderate improvement in pain and function. There were no significant differences between groups at 6 months (adjusted mean differences (95% confidence intervals): pain UC vs ITE, -0.3 (-1.0 to 0.4), UC vs TEA, -0.3 (-1.0 to 0.4); function UC vs ITE, 0.5 (-1.9 to 2.9), UC vs TEA, -0.9 (-3.3 to 1.5)), or any other time-point. Conclusions: Patients receiving UC experienced moderate improvement in pain and function; however, ITE and TEA did not lead to superior outcomes. Other strategies for patients with knee osteoarthritis to enhance the benefits of exercise-based physical therapy are needed.

Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. METHODS: A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. DISCUSSION: Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. TRIAL REGISTRATION: ISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.

Experiences of living with hip osteoarthritis and of receiving advice, education and ultrasound-guided intra-articular hip injection in the hip injection trial. A qualitative study.

OBJECTIVES: The Hip Injection Trial (HIT) compared the effectiveness of adding a single ultrasound-guided intra-articular injection of either corticosteroid and local anaesthetic or local anaesthetic alone to advice and education among people with hip osteoarthritis (OA). This nested qualitative study explored participants' experiences of living with hip OA and of the trial treatment they received. METHOD: Semi-structured telephone interviews were undertaken with a purposeful sample of trial participants after a 2-month trial follow-up. Interviewers were blinded to which injection participants had received. Thematic analysis using constant comparison was undertaken prior to knowing the trial results. RESULTS: 34 trial participants were interviewed across all arms. OA causes pain, physical limitations, difficulties at work, lowered mood, and disrupted sleep. Those who received advice and education alone felt that they had not received 'treatment' and described little/no benefit. Participants in both injection groups described marked improvements in pain, physical function, and other aspects of life (e.g., sleep, confidence). The perceived magnitude of benefit appeared greater among those who received the corticosteroid injection; however, the length of benefit varied in both injection groups. There was uncertainty about the longer-term benefits of injection and repeated injections. CONCLUSION: Hip OA is highly burdensome. Participants perceived little/no benefit from advice and education alone but reported marked improvements when combined with either injection. However, the magnitude of benefit was greater among those who received corticosteroid. The varying duration of response to injection and uncertainty regarding longer-term benefits of injection and repeated injections suggests that these areas are important for future research. TRIAL REGISTRATION: EudraCT 2014-003412-37; ISRCTN50550256.