Development of the intelligent knee osteoarthritis lifestyle app: a person-based approach.

BACKGROUND: Knee osteoarthritis is one of the most prevalent long term health conditions globally. Exercise and physical activity are now widely recognised to significantly reduce joint pain, improve physical function and quality of life in patients with knee osteoarthritis. However, prescribed exercise without regular contact with a healthcare professional often results in lower adherence and poorer health outcomes. Digital mobile health (mHealth) technologies offer great potential to support people with long-term conditions such as knee osteoarthritis more efficiently and effectively and with relatively lower cost than existing interventions. However, there are currently very few mHealth interventions for the self-management of knee osteoarthritis. The aim of the present study was to describe the development process of a mHealth app to extend the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through self-management, personalised physical activity, education, and social support. METHODS: The development of the intelligent knee osteoarthritis lifestyle application intervention involved an iterative and interconnected process comprising intervention 'planning' and 'optimisation' informed by the person-based approach framework for the development of digital health interventions. The planning phase involved a literature review and collection of qualitative data obtained from focus groups with individuals with knee osteoarthritis (n = 26) and interviews with relevant physiotherapists (n = 5) to generate 'guiding principles' for the intervention. The optimisation phase involved usability testing (n = 7) and qualitative 'think aloud' sessions (n = 6) with potential beneficiaries to refine the development of the intervention. RESULTS: Key themes that emerged from the qualitative data included the need for educational material, modifying activities to suit individual abilities and preferences as well as the inclusion of key features such as rehabilitation exercises. Following a user-trial further changes were made to improve the usability of the application. CONCLUSIONS: Using a systematic person-based, development approach, we have developed the intelligent knee osteoarthritis lifestyle application to help people maintain physical activity behaviour. The app extends the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through personalised physical activity guidance, education, and social support.

Adaptation and Implementation of a Shared Decision-Making Tool From One Health Context to Another: Partnership Approach Using Mixed Methods.

BACKGROUND: Osteoarthritis is a leading cause of pain and disability. Knee osteoarthritis accounts for nearly four-fifths of the burden of osteoarthritis internationally, and 10% of adults in the United Kingdom have the condition. Shared decision-making (SDM) supports patients to make more informed choices about treatment and care while reducing inequities in access to treatment. We evaluated the experience of a team adapting an SDM tool for knee osteoarthritis and the tool's implementation potential within a local clinical commissioning group (CCG) area in southwest England. The tool aims to prepare patients and clinicians for SDM by providing evidence-based information about treatment options relevant to disease stage. OBJECTIVE: This study aimed to explore the experiences of a team adapting an SDM tool from one health context to another and the implementation potential of the tool in the local CCG area. METHODS: A partnership approach using mixed methods was used to respond to recruitment challenges and ensure that study aims could be addressed within time restrictions. A web-based survey was used to obtain clinicians' feedback on experiences of using the SDM tool. Qualitative interviews were conducted by telephone or video call with a sample of stakeholders involved in adapting and implementing the tool in the local CCG area. Survey findings were summarized as frequencies and percentages. Content analysis was conducted on qualitative data using framework analysis, and data were mapped directly to the Theoretical Domains Framework (TDF). RESULTS: Overall, 23 clinicians completed the survey, including first-contact physiotherapists (11/23, 48%), physiotherapists (7/23, 30%), specialist physiotherapists (4/23, 17%), and a general practitioner (1/23, 4%). Eight stakeholders involved in commissioning, adapting, and implementing the SDM tool were interviewed. Participants described barriers and facilitators to the adaptation, implementation, and use of the tool. Barriers included a lack of organizational culture that supported and resourced SDM, lack of clinician buy-in and awareness of the tool, challenges with accessibility and usability, and lack of adaptation for underserved communities. Facilitators included the influence of clinical leaders' belief that SDM tools can improve patient outcomes and National Health Service resource use, clinicians' positive experiences of using the tool, and improving awareness of the tool. Themes were mapped to 13 of the 14 TDF domains. Usability issues were described, which did not map to the TDF domains. CONCLUSIONS: This study highlights barriers and facilitators to adapting and implementing tools from one health context to another. We recommend that tools selected for adaptation should have a strong evidence base, including evidence of effectiveness and acceptability in the original context. Legal advice should be sought regarding intellectual property early in the project. Existing guidance for developing and adapting interventions should be used. Co-design methods should be applied to improve adapted tools' accessibility and acceptability.

A feasibility randomised controlled trial of a Fibromyalgia Self-management Programme for adults in a community setting with a nested qualitative study (FALCON).

BACKGROUND: Fibromyalgia is a condition associated with widespread musculoskeletal pain, fatigue and sleep problems. Fibromyalgia treatment guidelines recommend non-pharmacological interventions and the development of self-management skills. An example of a programme that fits these guidelines is the Fibromyalgia Self-management Programme (FSMP) which consists of one 2.5-hour weekly session over six successive weeks and includes education about fibromyalgia, goal setting, pacing, sleep hygiene and nutritional advice. The FSMP is currently provided in a secondary care hospital setting and co-delivered by a multidisciplinary team. Delivery in a primary care setting has the potential to improve the accessibility of the programme to people with fibromyalgia. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial of the FSMP in a community setting. METHOD: An exploratory, parallel-arm, one-to-one, randomised controlled trial. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial several were tested. The Revised Fibromyalgia Impact Questionnaire, Arthritis Self-Efficacy Scale-8, Chalder Fatigue Scale, Short form 36, 5-Level EQ-5D version and Jenkins Sleep Scale were collected at baseline, 6 weeks and 6 months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP in a community setting. RESULTS: A total of 74 participants were randomised to the FSMP intervention (n = 38) or control arm (n = 36). Attrition from the trial was 42% (31/74) at 6 months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions with six of the 13 withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. Three overarching themes were derived from the interview data; (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes. CONCLUSION: It is feasible to recruit people with fibromyalgia from Primary Care to participate in a randomised controlled trial testing the FSMP in a community setting. However, improvement in trial attrition and engagement with the intervention is needed. TRIAL REGISTRATION: The trial is registered with ISRCTN registry and was assigned on 29/04/2019. The registration number is ISRCTN10824225.

A new integrated behavioural intervention for knee osteoarthritis: development and pilot study.

BACKGROUND: Exercise-based approaches have been a cornerstone of physiotherapy management of knee osteoarthritis for many years. However, clinical effects are considered small to modest and the need for continued adherence identified as a barrier to clinical efficacy. While exercise-based approaches focus on muscle strengthening, biomechanical research has identified that people with knee osteoarthritis over activate their muscles during functional tasks. Therefore, we aimed to create a new behavioural intervention, which integrated psychologically informed practice with biofeedback training to reduce muscle overactivity, and which was suitable for delivery by a physiotherapist. METHODS: Through literature review, we created a framework linking theory from pain science with emerging biomechanical concepts related to overactivity of the knee muscles. Using recognised behaviour change theory, we then mapped a set of intervention components which were iteratively developed through ongoing testing and consultation with patients and physiotherapists. RESULTS: The underlying framework incorporated ideas related to central sensitisation, motor responses to pain and also focused on the idea that increased knee muscle overactivity could result from postural compensation. Building on these ideas, we created an intervention with five components: making sense of pain, general relaxation, postural deconstruction, responding differently to pain and functional muscle retraining. The intervention incorporated a range of animated instructional videos to communicate concepts related to pain and biomechanical theory and also used EMG biofeedback to facilitate visualization of muscle patterns. User feedback was positive with patients describing the intervention as enabling them to "create a new normal" and to be "in control of their own treatment." Furthermore, large reductions in pain were observed from 11 patients who received a prototype version of the intervention. CONCLUSION: We have created a new intervention for knee osteoarthritis, designed to empower individuals with capability and motivation to change muscle activation patterns and beliefs associated with pain. We refer to this intervention as Cognitive Muscular Therapy. Preliminary feedback and clinical indications are positive, motivating future large-scale trials to understand potential efficacy. It is possible that this new approach could bring about improvements in the pain associated with knee osteoarthritis without the need for continued adherence to muscle strengthening programmes. TRIAL REGISTRATION: ISRCTN51913166 (Registered 24-02-2020, Retrospectively registered).

Developing a group intervention to manage fatigue in rheumatoid arthritis through modifying physical activity.

BACKGROUND: Fatigue is a major symptom of rheumatoid arthritis (RA). There is some evidence that physical activity (PA) may be effective in reducing RA fatigue. However, few PA interventions have been designed to manage fatigue and there is limited evidence of end-user input into intervention development. The aim of this research was to co-design an intervention to support self-management of RA fatigue through modifying PA. METHODS: A series of studies used mixed methodological approaches to co-design a fatigue management intervention focused on modifying PA based on UK Medical Research Council guidance, and informed by the Behaviour Change Wheel theoretical framework. Development was based on existing evidence, preferences of RA patients and rheumatology healthcare professionals, and practical issues regarding intervention format, content and implementation. RESULTS: The resulting group-based intervention consists of seven sessions delivered by a physiotherapist over 12 weeks. Each session includes an education and discussion session followed by supervised PA chosen by the participant. The intervention is designed to support modification and maintenance of PA as a means of managing fatigue. This is underpinned by evidence-based behaviour change techniques that might support changes in PA behaviour. Intervention delivery is interactive and aims to enhance capability, opportunity and motivation for PA. CONCLUSION: This study outlines stages in the systematic development of a theory-based intervention designed through consultation with RA patients and healthcare professionals to reduce the impact of RA fatigue. The feasibility of future evaluation of the intervention should now be determined.

Physiotherapy management of lower limb osteoarthritis.

Background: Osteoarthritis (OA) of the lower limb affects millions of people worldwide, and results in pain and reduced function. We reviewed guidelines and Cochrane reviews for physical therapy interventions to manage the condition. Sources of data: Evidence from meta-analyses and systematic reviews was included. We also identified the recommendations from guidelines relevant to practice in the UK. Areas of agreement: There is strongest evidence to support the use of exercise to improve pain, function and quality of life. Areas of controversy: There is limited evidence to support the use of some commonly utilized physiotherapy interventions. National Institute for Health and Clinical Excellence do not recommend the use of acupuncture. Growing points: Programmes that include single exercise type may be more beneficial than combined strengthening and aerobic interventions. Areas timely for developing research: Further research is required to determine how to facilitate long-term engagement with exercise to sustain the beneficial effects on pain, function and quality of life. Studies that investigate packages of care, combining interventions require further investigation.

Rehabilitation Interventions for Adults With Complex Regional Pain Syndrome: A Scoping Review Protocol.

OBJECTIVES: This scoping review will explore the literature related to rehabilitation interventions for the treatment of adults living with complex regional pain syndrome (CRPS), describe the domains and outcome measures used to assess their effectiveness, and examine the neurophysiological bases of these interventions. INTRODUCTION: The unremitting symptoms of CRPS, a chronic pain condition, are associated with long-term disability, poor psychological health, decreased emotional and social well-being, and reduced quality of life. Effective treatment for persistent symptoms is notoriously difficult. Therapeutic approaches such as graded motor imagery or pain exposure therapy are recommended for CRPS but show mixed results, insufficient effectiveness, variability in outcome measures, and unclear neurophysiological bases. INCLUSION CRITERIA: This review will consider studies that include any form of non-invasive rehabilitation intervention delivered by a healthcare professional in any setting for adults with a CRPS diagnosis. Quantitative, qualitative and observational studies, text and opinion papers will be considered. METHODS: The Joanna Briggs Institute (JBI) methodology will be used to conduct this scoping review. MEDLINE, Embase, Scopus, APA PsycINFO, CINAHL, Cochrane, OpenGrey Google and ProQuest Dissertations and Theses Global (ProQuest) will be searched for studies in English published between 2007 and 2024. Two independent reviewers will screen the titles, abstracts, and full texts of the selected studies. Data collection will be performed using a tool developed by the researchers based on the standardised JBI tool. Data will be presented in a comprehensive narrative summary. TRAIL REGISTRATION: https://doi.org/10.17605/OSF.IO/P967T.

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 models compared with GP-led models of care. DESIGN AND SETTING: Multiple site case-study design of general practices in the UK. METHOD: General practice sites were recruited representing the following three models: 1) GP-led care; 2) FCPPs who could not prescribe or inject (FCPPs-standard [St]); and 3) FCPPs who could prescribe and/or inject (FCPPs-additional qualifications [AQ]). Patient participants from each site completed outcome data at baseline, 3 months, and 6 months. The primary outcome was the SF-36 Physical Component Summary (PCS) score. Healthcare usage was collected for 6 months. RESULTS: In total, 426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF-36 PCS) across all three arms at 6 months (P = 0.667). At 3 months, a significant difference in numbers improving was seen between arms: 54.7% (n = 47) GP consultees, 72.4% (n = 71) FCPP-St, and 66.4% (n = 101) 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%, n = 42), compared with FCPP-St (18.4%, n = 21) and FCPP-AQ (24.7%, n = 40) (P<0.001). NHS costs (initial consultation and over 6-month follow-up) were significantly higher in the GP-led model (median £105.5 per patient) versus FCPP-St (£41.0 per patient) and FCPP-AQ (£44.0 per patient) (P<0.001). CONCLUSION: FCPP-led models of care provide safe, clinically effective patient management, with cost-benefits and reduced opioid use in this cohort.

Development and Validation of Multivariable Prediction Models for In-Hospital Death, 30-Day Death, and Change in Residence After Hip Fracture Surgery and the "Stratify-Hip" Algorithm.

BACKGROUND: To develop and validate the stratify-hip algorithm (multivariable prediction models to predict those at low, medium, and high risk across in-hospital death, 30-day death, and residence change after hip fracture). METHODS: Multivariable Fine-Gray and logistic regression of audit data linked to hospital records for older adults surgically treated for hip fracture in England/Wales 2011-14 (development n = 170 411) and 2015-16 (external validation, n = 90 102). Outcomes included time to in-hospital death, death at 30 days, and time to residence change. Predictors included age, sex, pre-fracture mobility, dementia, and pre-fracture residence (not for residence change). Model assumptions, performance, and sensitivity to missingness were assessed. Models were incorporated into the stratify-hip algorithm assigning patients to overall low (low risk across outcomes), medium (low death risk, medium/high risk of residence change), or high (high risk of in-hospital death, high/medium risk of 30-day death) risk. RESULTS: For complete-case analysis, 6 780 of 141 158 patients (4.8%) died in-hospital, 8 693 of 149 258 patients (5.8%) died by 30 days, and 4 461 of 119 420 patients (3.7%) had residence change. Models demonstrated acceptable calibration (observed:expected ratio 0.90, 0.99, and 0.94), and discrimination (area under curve 73.1, 71.1, and 71.5; Brier score 5.7, 5.3, and 5.6) for in-hospital death, 30-day death, and residence change, respectively. Overall, 31%, 28%, and 41% of patients were assigned to overall low, medium, and high risk. External validation and missing data analyses elicited similar findings. The algorithm is available at https://stratifyhip.co.uk. CONCLUSIONS: The current study developed and validated the stratify-hip algorithm as a new tool to risk stratify patients after hip fracture.

Development of evidence-based guidelines for the treatment and management of periprosthetic hip infection.

Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines. The consensus panel comprised 21 clinical experts in orthopaedics, primary care, rehabilitation, and healthcare commissioning. The final output from the consensus process was a 14-item guideline. The guidelines make recommendations regarding increased vigilance and monitoring of those at increased risk of infection; diagnosis including strategies to ensure the early recognition of prosthetic infection and referral to orthopaedic teams; treatment, including early use of DAIR and revision strategies; and postoperative management including appropriate physical and psychological support and antibiotic strategies. We believe the implementation of the INFORM guidelines will inform treatment protocols and clinical pathways to improve the treatment and management of periprosthetic hip infection.

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.

A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study (FALCON): Study protocol.

BACKGROUND: Fibromyalgia (FM) is a complex long-term condition associated with chronic widespread pain, fatigue, sleep problems, memory and concentration difficulties and irritable bowel syndrome. Current guidelines for the treatment of FM recommend nonpharmacological interventions. The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention. It aims to provide education and teach core skills, enabling those affected by FM to self-manage. The FSMP is currently codelivered by a multidisciplinary team within a secondary care service. The aim of this feasibility randomised controlled trial (RCT) is to determine the practicality and acceptability of delivering the FSMP in a community setting, informing a future RCT of effectiveness. METHODS: The feasibility RCT aims to recruit 70 people with FM. Participants will be randomised to either a community FSMP or control arm. All participants will be asked to complete six patient-reported outcome measures and one health economics questionnaire on three occasions; baseline, 6 weeks (end of the intervention) and 6 months. Between 12 and 16 participants and four therapists delivering the FSMP will be invited to take part in a semi-structured interview to explore their experiences of the FSMP. Patient participants will be purposively selected based upon key characteristics. ANALYSIS: Quantitative data will be analysed descriptively to summarise recruitment and attendance, participant reported outcomes and health economic data. Semi-structured interviews will be transcribed, anonymised and inductively coded. The codes will be grouped into categories and theoretically thematically analysed, comparing the results to existing literature. TRIAL REGISTRATION: The trial is registered with ISRCTN registry and was assigned on 29th of April 2020. The registration number is ISRCTN10824225.

Fibromyalgia Self-Management: Mapping the behaviour change techniques used in a practice-based programme.

BACKGROUND: Fibromyalgia (FM) is a complex long-term condition associated with pain, fatigue and concentration difficulties. There is limited robust evidence for the effectiveness of pharmacological treatments for FM, with current guidelines recommending nonpharmacological interventions. The clinically developed Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary education group intervention. The FSMP aims to provide condition-specific, patient-centred education and exercise advice, supporting the development of core self-management skills. This research aimed to map the FSMP to a recommended behaviour change taxonomy (BCT). METHODS: Non-participatory observations of the 4- and 6-week FSMP were conducted. Detailed notes on the content of the course, therapist delivery and any additional content not included in the manual were recorded. Subsequently, semistructured interviews were conducted with both therapists (n = 4) and patients (n = 9). Observation and a review of the FSMP manual data were deductively coded to the BCT. Interview data were added to the framework. RESULTS: The review of the FSMP manual and observations of the course showed that the programme coded onto 12 of the 16 BCT domains, encompassing 22 behaviour change techniques. Both patient and therapist interviews indicated that patients made positive changes, including increased activity levels, pacing, better quality sleep and improved communication with family members. Patients reported improvements to symptoms as a result of attending the course. CONCLUSIONS: The FSMP utilises a range of behaviour change techniques. Patients who attend the course feel supported to make changes to their behaviour, enabling them to manage their symptoms more effectively.

Promoting engagement in physical activity in early rheumatoid arthritis: A proof-of-concept intervention study.

OBJECTIVE(S): The aim of this study is to test the feasibility and acceptability of promoting engagement in physical activity in early rheumatoid arthritis (PEPA-RA) to inform a future trial. DESIGN: A 'proof of concept' study was carried out. SETTING: This study was conducted in community hospitals delivered by musculoskeletal primary care physiotherapists. PARTICIPANTS: Participants were 12 adults with rheumatoid arthritis (RA) diagnosed 6-24 months previously (nine females, three males; mean age 58 years, range 23-79). INTERVENTION: The intervention consisted of five sessions, that is, four group sessions and one individual session facilitated by a physiotherapist over 12 weeks including patient education and support for behaviour change as well as supervised practical exercise. MAIN OUTCOMES: The main outcomes were attendance, completion of outcome measures, adverse events, and participant and physiotherapist feedback views relating to the intervention. RESULTS: Overall attendance was 85%, with sessions missed due to illness or RA flare. Outcome measure completion ranged from 83% to 100%. There were no clinically meaningful changes in pain or function at 12 weeks, but mean 6-min walk distance improved from 394 to 440 m. No serious adverse events were reported, and participants were generally positive about the intervention. Suggested minor modifications for the group sessions included venue accessibility and ensuring that physical activity time was protected. Several participants indicated that they would have liked to receive the intervention earlier following diagnosis. CONCLUSIONS: PEPA-RA and the outcomes appear feasible and acceptable. Overall, small beneficial effects were noted at 12 weeks for most outcomes. Challenges to recruitment resulted in a smaller than anticipated sample size, and the majority of participants were active at baseline indicating that future recruitment needs to target less active individuals.

Effectiveness and clinical applicability of integrated rehabilitation programs for knee osteoarthritis.

PURPOSE OF REVIEW: Knee osteoarthritis is a common and increasing cause of pain and disability. Exercise and self-management interventions reduce pain and improve function. These interventions are usually delivered separately but, theoretically, the benefits of the physical approach of exercise and the educational approach of self-management interventions could be additive. If correct, rehabilitation programmes that integrate exercise and self-management components might be more effective. This review summarizes and comments on the clinical effectiveness, practicality, cost and implementation of recent studies of integrated rehabilitation programmes. RECENT FINDINGS: The programmes varied considerably in content and duration, but in general were safe and effective (improving pain, physical function and other relevant variables). The length, complexity and burden of some programmes limit their acceptability, clinical applicability and increase costs. The most recent programmes have addressed these issues producing programmes that are more clinically and cost-effective than usual care. Implementation of these programmes will require considerable effort and commitment. SUMMARY: Integrated rehabilitation programmes that are acceptable, clinically effective, deliverable and affordable may be the best way of managing the large and increasing number of people suffering chronic knee pain.

Physical activity engagement in early rheumatoid arthritis: a qualitative study to inform intervention development.

BACKGROUND: Physical activity (PA) in patients with rheumatoid arthritis (RA) is lower than in the general population. PA can improve physical function in RA, decrease chronic inflammation and reduce pain, without adversely affecting disease activity. OBJECTIVES: To explore patient's views on approaches to delivering PA programmes and inform a programme to maximise functional ability through long-term engagement with PA. METHODS: Qualitative data were collected via three focus groups which explored the views of people with RA of their PA support needs following diagnosis; experiences relating to PA; motivators and facilitators to support PA engagement and the suitability for people with RA of evidence based PA programmes designed for other long-term conditions. RESULTS: Study participants (15 female, 4 male; 59.9 (standard deviation (SD) 10.3) years) had a mean time (SD) since diagnosis of 44 (34) months. Data analysis yielded 4 key themes relating to PA programmes: (1) why people join and why they drop out; (2) venue and timing; (3) what people want to do and hear; and (4) who should deliver programmes and how. CONCLUSION: Patients with RA are interested in PA programmes 6 to 12 months after diagnosis, which support safe exercise and provide expert physiotherapist input. Recommendation by trusted health professionals and promotion of the benefits for 'people like me' would positively impact recruitment and retention. Key elements of the programme include proficient, safety-oriented exercise guidance, RA education, peer support, relaxation, coping strategies and self-set goals. Findings indicate that a group-based programme with a social aspect would support adherence.

Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

BACKGROUND: The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system. METHODS: The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory. RESULTS: The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback. CONCLUSIONS: The SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

INTRODUCTION: International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. METHODS/ANALYSIS: This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. ETHICS/DISSEMINATION: This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. TRIAL REGISTRATION NUMBER: ISRCTN 49875385; Pre-results.

Feasibility of an exercise-based rehabilitation programme for chronic hip pain.

BACKGROUND: Chronic hip pain is prevalent and disabling and has considerable consequences for the individual, and health and social care. Evidence-based guidelines recommend that patients with chronic hip pain benefit from exercise, but these guidelines are predominantly based on the efficacy of knee rehabilitation programmes. Studies investigating hip rehabilitation programmes suggest that these may not be feasible, citing issues with case identification. This study evaluated the feasibility of an exercise-based rehabilitation programme in a primary care hospital. METHODS: Forty-eight participants with chronic hip pain were randomly allocated to receive a five-week exercise and self-management programme or to continue under the management of their general practitioner (GP). Participants were assessed at baseline, six weeks and six months. Outcome measures included Western Ontario and McMaster Universities osteoarthritis index physical function subscale, pain, objective functional performance, self-efficacy, anxiety and depression. RESULTS: This programme was feasible, well tolerated and easily implemented into a primary healthcare facility. Adherence to the programme was high (81% attendance). Immediately following rehabilitation, all outcomes measures improved (effect sizes 0.2-0.4), although these improvements diminished at six months. There were no differences between the groups (all p > 0.05). CONCLUSIONS: An exercise-based rehabilitation programme was found to be feasible and well tolerated by people with chronic hip pain. The moderate effects in all outcomes immediately following rehabilitation suggested that it warrants further investigation. Issues with diagnosis and adaptations to the programme were identified and will be addressed in a randomized controlled trial.