Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. METHODS: A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged < 80 years and no specific health conditions, will also be offered six videoconferencing dietitian consultations to undertake a weight loss program. Participants in the control group will be provided with similar educational information about managing hip OA via a custom website. All participants will be reassessed at 6 and 12 months. Primary outcomes are hip pain on walking and physical function. Secondary outcomes include measures of pain; hip function; weight; health-related quality of life; physical activity levels; global change in hip problem; willingness to undergo hip replacement surgery; rates of hip replacement; and use of oral pain medications. A health economic evaluation at 12 months will be conducted and reported separately. DISCUSSION: Findings will determine whether a telehealth-delivered clinician-supported lifestyle management program including education, exercise/physical activity and, for those with overweight or obesity, weight loss, is more effective than information only in people with hip OA. Results will inform the implementation of such programs to increase access to core recommended treatments. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622000461796).

Lessons learnt from a nationally funded training and mentoring programme for early-mid career musculoskeletal researchers in Australia.

INTRODUCTION: Quality training and mentoring are crucial components of successful career development for early mid career researchers (EMCRs). This paper describes the overarching framework of novel ongoing national Training and Mentoring Programme Melbourne University Sydney Queensland:Impact (MUSQ:Impact) for musculoskeletal researchers, including a description of how it was set up and established, and lessons learned from its implementation. RESULTS: The MUSQ:Impact programme spans four multidisciplinary musculoskeletal research teams across three universities in Australia, comprising 40-60 EMCR members. It was established to provide EMCRs with a unique learning environment and opportunities to gain exposure to, and network with, other national musculoskeletal research teams. Specific goals are to focus on core research competencies (e.g. writing skills, managing grant budgets, public speaking and media engagement, research translation), provide career mentoring, fund development activities (e.g. conference attendance, laboratory visits, skill development courses), and share training resources (e.g. data dictionaries, project summaries). A Steering Committee of 10-12 EMCR members, co-chaired by a senior researcher and one EMCR, is responsible for overseeing MUSQ:Impact and organising regular activities, including a monthly webinar series, a mentor/mentee scheme, annual group research retreats, annual infographic competition, and funding awards. An evaluation survey found that most participants perceived each activity to be beneficial and of value to their research career and development. CONCLUSION: This paper presents the structure of national training and mentoring programme that serves as a potential template for other research teams to adapt within their own contexts.

Cost-Effectiveness of Telehealth-Delivered Exercise and Dietary Weight Loss Programs for Knee Osteoarthritis Within a Twelve-Month Randomized Trial.

OBJECTIVE: To evaluate the cost-effectiveness of telehealth-delivered exercise and diet-plus-exercise programs within 12 months. METHODS: An economic evaluation within a 12-month, 3-arm, parallel randomized trial of two 6-month telehealth-delivered exercise programs, with and without a dietary component. A total of 415 people with knee osteoarthritis ages 45-80 years and body mass index of 28-40 kg/m2 were assigned to 1 of 2 telehealth-delivered exercise programs, 1 without (n = 172) and 1 with (n = 175) a dietary component (ketogenic very low calorie diet), or to an education control (n = 67), for 6 months, with 6 months follow-up. The primary economic outcomes were quality-adjusted life years (QALYs) and health system costs. Measured costs were the direct intervention (consultations, equipment/resources, and meal replacements) and health care use in 2020 Australian dollars ($AU1.5 = $US1). Secondary analysis included weight loss and work productivity gains. RESULTS: The clinical trial demonstrated greater improvements in pain and function compared to information only for individuals with knee osteoarthritis and overweight/obesity. We can be 88% confident that diet plus exercise is cost effective ($45,500 per QALY), 53% confident that exercise is cost-effective ($67,600 per QALY) compared to the control, and 86% confident that augmenting exercise with the diet program is cost effective ($21,100 per QALY). CONCLUSION: Telehealth-delivered programs targeting exercise with dietary intervention for people with knee osteoarthritis who have overweight/obesity are likely to be cost-effective, particularly if potential long-term gains from weight loss and work productivity are realized.

Clinician-administered performance-based tests via telehealth in people with chronic lower limb musculoskeletal disorders: Test-retest reliability and agreement with in-person assessment.

INTRODUCTION: Uptake of telehealth has surged, yet no previous studies have evaluated the clinimetric properties of clinician-administered performance-based tests of function, strength, and balance via telehealth in people with chronic lower limb musculoskeletal pain. This study investigated the: (i) test-retest reliability of performance-based tests via telehealth, and (ii) agreement between scores obtained via telehealth and in-person. METHODS: Fifty-seven adults aged ≥45 years with chronic lower limb musculoskeletal pain underwent three testing sessions: one in-person and two via videoconferencing. Tests included 30-s chair stand, 5-m fast-paced walk, stair climb, timed up and go, step test, timed single-leg stance, and calf raises. Test-retest reliability and agreement were assessed via intraclass correlation coefficients (ICC; lower limit of 95% confidence interval (CI) ≥0.70 considered acceptable). ICCs were interpreted as poor (<0.5), moderate (0.5-0.75), good (0.75-0.9), or excellent (>0.9). RESULTS: Test-retest reliability was good-excellent with acceptable lower CI for stair climb test, timed up and go, right leg timed single-leg stance, and calf raises (ICC = 0.84-0.91, 95% CI lower limit = 0.71-0.79). Agreement between telehealth and in-person was good-excellent with acceptable lower CI for 30-s chair stand, left leg single-leg stance, and calf raises (ICC = 0.82-0.91, 95% CI lower limit = 0.71-0.85). DISCUSSION: Stair climb, timed up and go, right leg timed single-leg stance, and calf raise tests have acceptable reliability for use via telehealth in research and clinical practice. If re-testing via a different mode (telehealth/in-person), clinicians and researchers should consider using the 30-s chair stand test, left leg timed single-leg stance, and calf raise tests.

Progressive resistance training in young people with Prader-Willi syndrome: protocol for a randomised trial (PRESTO).

INTRODUCTION: Preliminary evidence suggests that progressive resistance training may be beneficial for people with Prader-Willi Syndrome (PWS), a rare genetic condition that results in muscle weakness and low muscle tone.To establish whether community-based progressive resistance training is effective in improving the muscle strength of people with PWS; to determine cost-effectiveness; and, to complete a process evaluation assessing intervention fidelity, exploring mechanisms of impact, understanding participant experiences and identifying contextual factors affecting implementation. METHODS AND ANALYSIS: A multisite, randomised controlled trial will be completed. Sixty participants with PWS will be randomised to receive either progressive resistance training (experimental) or non-progressive exercise (placebo control). Participants will be aged 13 to 60 years, be able to follow simple instructions in English and have no contraindications to performing progressive resistance training. The experimental group will complete progressive resistance training two times weekly for 24 weeks supervised by an exercise professional at a community gym. The control group will receive all aspects of the intervention except progressive overload. Outcomes will be assessed at week 25 (primary endpoint) and week 52 by a blinded assessor. The primary outcome is muscle strength assessed using one repetition maximum for upper limb and lower limb. Secondary outcomes are muscle mass, functional strength, physical activity, community participation, health-related quality of life and behaviour. Health economic analysis will evaluate cost-effectiveness. Process evaluation will assess safety and intervention fidelity, investigate mechanism of impact, explore participant experiences and identify contextual factors affecting implementation. Data collection commenced in February 2020 and will conclude in September 2023. ETHICS AND DISSEMINATION: Ethical approval was obtained from The Royal Children's Hospital Human Research Ethics Committee (HREC/50874/RCHM-2019) under the National Mutual Acceptance initiative. Research governance approvals were obtained from five clinical sites. Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups. TRIAL REGISTRATION NUMBER: ACTRN12620000416998; Australian and New Zealand Clinical Trial Registry.

Exploring experiences with telehealth-delivered allied healthcare services for people with permanent and significant disabilities funded through a national insurance scheme: a qualitative study examining challenges and suggestions to improve services.

OBJECTIVES: In people with a disability, or their caregivers, who reported suboptimal experiences, the objectives were to explore: (1) challenges with telehealth-delivered allied health services during the COVID-19 pandemic and (2) suggestions to improve such services. DESIGN: Qualitative study based on an interpretivist paradigm and a phenomenological approach. SETTING: Participants who accessed allied healthcare via telehealth during the pandemic. PARTICIPANTS: Data saturation was achieved after 12 interviews. The sample comprised three people with permanent or significant disabilities, and nine carers/partners/family members of people with permanent or significant disabilities, who were funded by the Australian National Disability Insurance Scheme and had suboptimal experiences with telehealth. Semistructured one-on-one interviews explored experiences with telehealth and suggestions on how such services could be improved. An inductive thematic analysis was performed. RESULTS: Six themes relating to the first study objective (challenges with telehealth) were developed: (1) evoked behavioural issues in children; (2) reliant on caregiver facilitation; (3) inhibits clinician feedback; (4) difficulty building rapport and trust; (5) lack of access to resources and (6) children disengaged/distracted. Five themes relating to the second study objective (suggestions to improve telehealth services) were developed: (1) establish expectations; (2) increase exposure to telehealth; (3) assess suitability of specific services; (4) access to support workers and (5) prepare for telehealth sessions. CONCLUSIONS: Some people with permanent and significant disabilities who accessed allied healthcare via telehealth during the pandemic experienced challenges, particularly children. These unique barriers to telehealth need customised solutions so that people with disabilities are not left behind when telehealth services become more mainstream. Increasing experience with telehealth, setting expectations before consultations, supplying resources for therapy and assessing the suitability of clients for telehealth may help overcome some of the challenges experienced.

Exploring changes, and factors associated with changes, in behavioural determinants from a low-cost, scalable education intervention about knee osteoarthritis: An observational cohort study.

OBJECTIVE: To explore the relationships between participant characteristics, perceptions of a short educational video about osteoarthritis and its management, and immediate changes in behavioural determinants for effective self-management behaviours. METHODS: Seventy-eight participants with knee OA (77% female, mean age 63.0 ± 8.7) watched the 9-min video that included evidence-based content and was designed to foster empowerment to self-manage effectively. Data were collected by online questionnaire at baseline and immediately after watching the video. Associations were tested between baseline health and information processing characteristics (health literacy, need for cognition), perceptions of the video (enjoyment, helpfulness, believability, novelty and relevance) and pre-post changes in behavioural determinants (self-efficacy for managing arthritis, attitude to self-management or 'activation', and importance/confidence for physical activity). RESULTS: All behavioural determinants improved immediately after watching the video. Positive perceptions were associated with greater improvements in self-efficacy for arthritis (Spearman's rho, ρ = 0.26-0.47). Greater perceived relevance was associated with increased self-rated importance of being physically active (ρ = 0.43). There were small positive associations between health literacy domains related to health information and positive viewer perceptions of the video. People with higher need for cognition may achieve greater improvement in confidence to be physically active (ρ = 0.27). CONCLUSION: The educational video may help achieve outcomes important for increasing self-management behaviours in people with knee osteoarthritis. Positive perceptions appear to be important in achieving these improvements. People with lower health literacy and lower need for cognition may respond less well to this information about knee osteoarthritis delivered in this way.

Trends in management of hip and knee osteoarthritis in general practice in Australia over an 11-year window: a nationwide cross-sectional survey.

BACKGROUND: We aimed to describe trends in knee and hip OA management by general medical practitioners (GPs) in Australia. METHODS: We analysed cross-sectional survey data from the Bettering the Evaluation and Care of Health (BEACH) program (1,000 randomly-selected GPs annually recording 100 consecutive patient encounters) over two periods: Period one April 1, 2005-March 31, 2010 and period two April 1, 2010-March 31, 2016. This included data from 10,738 GPs and 1,073,800 patient encounters with 6,565 GPs and 9,196 patient encounters for hip/knee OA. Data were summarized using descriptive statistics and 95% confidence intervals around point estimates. FINDINGS: Rate of knee OA problems managed by GPs increased in period two (7•1 (6•9-7•4) vs 6•2 (95% CI 6•0-6•5) per 1,000 all encounters), with a similar trend for hip OA. Encounter rates rose for some subgroups but remained stable for vulnerable subgroups. Although use of Medicare chronic disease management items, referral to allied health professionals and advice/education and lifestyle management (knee OA) increased, rates remained low. Use of MRI imaging rose. Overall medication rates were stable but substantially higher than non-pharmacological treatments. Declining reliance on non-steroidal anti-inflammatory drugs and glucosamine and increased reliance on paracetamol (knee OA) and opioids were demonstrated. INTERPRETATION: GPs in Australia are more frequently managing knee and hip OA. While small changes in GP management actions occured, rates of recommended first-line non-pharmacological treatments remained low and imaging, medications, and surgical referral rates high. Strategies are needed to optimise lifestyle management and reduce low-value care, with attention to healthcare disparities. FUNDING: Funding was provided for this report by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Translational Research in Musculoskeletal Pain (#1079078).

Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial).

INTRODUCTION: Musculoskeletal (MSK) conditions constitute the highest burden of disease globally, with healthcare services often utilised inappropriately and overburdened. The aim of this trial is to evaluate the effectiveness of a novel clinical PAthway of CarE programme (PACE programme), where care is provided based on people's risk of poor outcome. METHODS AND ANALYSIS: Multicentre randomised controlled trial. 716 people with MSK conditions (low back pain, neck pain or knee osteoarthritis) will be recruited in primary care. They will be stratified for risk of a poor outcome (low risk/high risk) using the Short Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMSPQ) then randomised to usual care (n=358) or the PACE programme (n=358). Participants at low risk in the PACE programme will receive up to 3 sessions of guideline based care from their primary healthcare professional (HCP) supported by a custom designed website (mypainhub.com). Those at high risk will be referred to an allied health MSK specialist who will conduct a comprehensive patient-centred assessment then liaise with the primary HCP to determine further care. Primary outcome (SF 12-item PCS) and secondary outcomes (eg, pain self-efficacy, psychological health) will be collected at baseline, 3, 6 and 12 months. Cost-effectiveness will be measured as cost per quality-adjusted life-year gained. Health economic analysis will include direct and indirect costs. Analyses will be conducted on an intention-to-treat basis. Primary and secondary outcomes will be analysed independently, using generalised linear models. Qualitative and mixed-methods studies embedded within the trial will evaluate patient experience, health professional practice and interprofessional collaboration. ETHICS AND DISSEMINATION: Ethics approval has been received from the following Human Research Ethics Committees: The University of Sydney (2018/926), The University of Queensland (2019000700/2018/926), University of Melbourne (1954239), Curtin University (HRE2019-0263) and Northern Sydney Local Health District (2019/ETH03632). Dissemination of findings will occur via peer-reviewed publications, conference presentations and social media. TRIAL REGISTRATION NUMBER: ACTRN12619000871145.

The Impact of Financial Incentives on Physical Activity: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate the effects of financial incentives on physical activity (PA). DATA SOURCES: MEDLINE, Embase, 7 other databases, and 2 trial registries until July 17, 2019. STUDY INCLUSION AND EXCLUSION CRITERIA: Randomized controlled trials with adults aged ≥18 years assessing the effect of financial incentives on PA. Any comparator was eligible provided the only difference between groups was the incentive strategy. DATA EXTRACTION: Two independent reviewers extracted data and assessed study quality. Of 5765 records identified, 57 records (51 unique trials; n = 17 773 participants) were included. DATA SYNTHESIS: Random-effects models pooling data for each of the 5 PA domains. RESULTS: Financial incentives increase leisure time PA (gym or class attendance; standardized mean difference [95% CI], 0.46 [0.28-0.63], n = 5057) and walking behavior (steps walked; 0.25 [0.13-0.36], n = 3254). No change in total minutes of PA (0.52 [-0.09 to 1.12], n = 968), kilocalories expended (0.19 [-0.06 to 0.44], n = 247), or the proportion of participants meeting PA guidelines (risk ratio [95% CI] 1.53 [0.53-4.44], n = 650) postintervention was observed. After intervention has ceased, incentives sustain a slight increase in leisure time PA (0.10 [0.02-0.18], n = 2678) and walking behavior (0.11 [0.00-0.22], n = 2425). CONCLUSIONS: Incentives probably improve leisure time PA and walking at intervention end, and small improvements may be sustained over time once incentives have ceased. They lead to little or no difference in kilocalories expended or minutes of PA. It is uncertain whether incentives change the likelihood of meeting PA guidelines because the certainty of the evidence is low.

Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.

INTRODUCTION: Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists. METHODS AND ANALYSIS: This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other. ETHICS AND DISSEMINATION: Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers. TRIAL REGISTRATION NUMBER: ACTRN12618001983291.

PARTNER: a service delivery model to implement optimal primary care management of people with knee osteoarthritis: description of development.

OBJECTIVE: Implementation strategies, such as new models of service delivery, are needed to address evidence practice gaps. This paper describes the process of developing and operationalising a new model of service delivery to implement recommended care for people with knee osteoarthritis (OA) in a primary care setting. METHODS: Three development stages occurred concurrently and iteratively. Each stage considered the healthcare context and was informed by stakeholder input. Stage 1 involved the design of a new model of service delivery (PARTNER). Stage 2 developed a behavioural change intervention targeting general practitioners (GPs) using the behavioural change wheel framework. In stage 3, the 'Care Support Team' component of the service delivery model was operationalised. RESULTS: The focus of PARTNER is to provide patients with education, exercise and/or weight loss advice, and facilitate effective self-management through behavioural change support. Stage 1 model design: based on clinical practice guidelines, known evidence practice gaps in current care, chronic disease management frameworks, input from stakeholders and the opportunities and constraints afforded by the Australian primary care context, we developed the PARTNER service-delivery model. The key components are: (1) an effective GP consultation and (2) follow-up and ongoing care provided remotely (telephone/email/online resources) by a 'Care Support Team'. Stage 2 GP behavioural change intervention: a multimodal behavioural change intervention was developed comprising a self-audit/feedback activity, online professional development and desktop software to provide decision support, patient information resources and a referral mechanism to the 'Care Support Team'. Stage 3 operationalising the 'care support team'-staff recruited and trained in evidence-based knee OA management and behavioural change methodology. CONCLUSION: The PARTNER model is the result of a comprehensive implementation strategy development process using evidence, behavioural change theory and intervention development guidelines. Technologies for scalable delivery were harnessed and new primary evidence was generated as part of the process.Trial registration number ACTRN12617001595303 (UTN U1111-1197-4809).

"I Could Do It in My Own Time and When I Really Needed It": Perceptions of Online Pain Coping Skills Training For People With Knee Osteoarthritis.

OBJECTIVE: To qualitatively explore the perceptions and experiences of people with knee osteoarthritis (OA) who used an online automated pain coping skills training program (PCST). METHODS: This was a descriptive qualitative study (based on interpretivist methodology) embedded within a randomized controlled trial. Individual semistructured interviews were conducted with 12 people with knee OA who had participated in an 8-week automated online PCST program while also receiving exercise advice and support from a physical therapist via Skype. Interviews in this study focused specifically on the online PCST program, rather than the physical therapy component. Interviews were audiorecorded, transcribed verbatim, and thematically analyzed. RESULTS: Five themes arose: 1) easy to understand and follow (clearly explained, presented well), 2) better able to cope with pain (controlling pain, helping relax, pacing self, incorporating skills into exercise program), 3) anonymity and flexibility (no judgement by clinician, work at own pace, accessibility), 4) not always relatable or engaging (some techniques not useful, Americanization of the program, annoying character examples, time consuming and slow-paced), and 5) support from clinician desirable (follow-up from a clinician would be beneficial, worked in tandem with physical therapist-prescribed exercise, desire referral to the program by a trusted source). CONCLUSION: People with knee OA had generally positive experiences using an online PCST program, suggesting that online PCST is a broadly acceptable and accessible way to help people with OA to manage their pain. User engagement may be enhanced by redesigning some aspects of the program and by provision of support from a clinician.

Stratified exercise therapy compared with usual care by physical therapists in patients with knee osteoarthritis: A randomized controlled trial protocol (OCTOPuS study).

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.

Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial.

OBJECTIVE: Evaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis. METHODS: Participant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5-10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0-10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included. RESULTS: 165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources. CONCLUSION: Telephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (#12616000054415).

Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol.

BACKGROUND: Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeutic agent that aims to address underlying biological processes responsible for OA pathogenesis. As such, it has the potential to improve both symptoms and joint structure. The aim of this clinical trial is to determine whether a series of injections of PRP into the knee joint will lead to a significantly greater reduction in knee pain, and less loss of medial tibial cartilage volume over 12 months when compared to a series of placebo saline injections in people with knee OA. METHODS: This will be a two-group, superiority, randomised, participant-, interventionist- and assessor-blinded, placebo-controlled trial. Two hundred and eighty-eight participants aged over 50 years with painful knee OA and mild to moderate structural change on x-ray (Kellgren and Lawrence grade 2 and 3) will be randomly allocated to receive either three PRP injections or three normal saline injections into the knee joint at weekly intervals. The primary outcomes will be 12-month change in average overall knee pain severity (numeric rating scale) and medial tibial cartilage volume (magnetic resonance imaging (MRI)). Secondary outcomes include additional measures of knee pain and other symptoms, function in daily living and sport and recreation, quality of life, participant-perceived global ratings of change, and other MRI structural outcomes including meniscal and cartilage morphology, synovitis, effusion, bone marrow lesions and cartilage defects. A range of additional measures will be recorded, and a separate health economic evaluation will be performed. DISCUSSION: The findings from this study will help determine whether PRP improves both clinical and structural knee OA outcomes over 12 months when compared to a series of placebo saline injections. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617000853347 . Prospectively registered 9th of June 2017.

Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY.

BACKGROUND: To increase the uptake of key clinical recommendations for non-surgical management of knee osteoarthritis (OA) and improve patient outcomes, we developed a new model of service delivery (PARTNER model) and an intervention to implement the model in the Australian primary care setting. We will evaluate the effectiveness and cost-effectiveness of this model compared to usual general practice care. METHODS: We will conduct a mixed-methods study, including a two-arm, cluster randomised controlled trial, with quantitative, qualitative and economic evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales. The interventions will target both general practitioners (GPs) and their patients at the practice level. Practices will be randomised at a 1:1 ratio. Patients will be recruited if they are aged ≥45 years and have experienced knee pain ≥4/10 on a numerical rating scale for more than three months. Outcomes are self-reported, patient-level validated measures with the primary outcomes being change in pain and function at 12 months. Secondary outcomes will be assessed at 6 and 12 months. The implementation intervention will support and provide education to intervention group GPs to deliver effective management for patients with knee OA using tailored online training and electronic medical record support. Participants with knee OA will have an initial GP visit to confirm their diagnosis and receive management according to GP intervention or control group allocation. As part of the intervention group GP management, participants with knee OA will be referred to a centralised multidisciplinary service: the PARTNER Care Support Team (CST). The CST will be trained in behaviour change support and evidence-based knee OA management. They will work with patients to develop a collaborative action plan focussed on key self-management behaviours, and communicate with the patients' GPs. Patients receiving care by intervention group GPs will receive tailored OA educational materials, a leg muscle strengthening program, and access to a weight-loss program as appropriate and agreed. GPs in the control group will receive no additional training and their patients will receive usual care. DISCUSSION: This project aims to address a major evidence-to-practice gap in primary care management of OA by evaluating a new service delivery model implemented with an intervention targeting GP practice behaviours to improve the health of people with knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617001595303 , date of registration 1/12/2017.

The impact of financial incentives on physical activity in adults: a systematic review protocol.

BACKGROUND: Most adults fail to meet global physical activity guidelines set out by the World Health Organization. In recent years, behavioural economic principles have been used to design novel interventions that increase physical activity. Immediate financial rewards, for instance, can motivate an individual to change physical activity behaviour by lowering the opportunity costs of exercise. This systematic review will summarise the evidence about the effectiveness of financial incentive interventions for improving physical activity in adults. METHODS: We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, Scopus, PsycINFO, EconLit, SPORTDiscus, the National Health Service Economic Evaluation Database, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform from inception using a comprehensive, electronic search strategy. The search strategy will include terms related to 'financial incentive' and 'physical activity'. Only randomised controlled trials that investigate the effect of financial incentives on physical activity in adult populations and that are written in the English language will be included. Two review authors will independently screen abstracts and titles, complete full text reviews and extract data on objective and self-reported physical activity outcomes. The authors will also assess the study quality using the Cochrane risk of bias tool and provide a systematic presentation and synthesis of the included studies' characteristics and results. If more than two studies are sufficiently similar in population, settings and interventions, we will pool the data to conduct a meta-analysis. If we are unable to perform a meta-analysis, we will conduct a narrative synthesis of the results and produce forest plots for individual studies. Our subgroup analyses will examine the differential effects of an intervention in healthy populations compared to populations with disease pathology and compare the effects of interventions using financial rewards to interventions using financial penalties. DISCUSSION: This systematic review will determine the effectiveness of positive and negative financial incentives on physical activity in adults. Findings will help inform the development of public health interventions and research in this field. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2017: CRD42017068263.

General practitioners' perspectives on a proposed new model of service delivery for primary care management of knee osteoarthritis: a qualitative study.

BACKGROUND: Effective management of people with knee osteoarthritis (OA) requires development of new models of care, and successful implementation relies on engagement of general practitioners (GPs). This study used a qualitative methodology to identify potential factors influencing GPs' engagement with a proposed new model of service delivery to provide evidence-based care for patients with knee OA and achieve better patient outcomes. METHODS: Semi-structured telephone interviews with 11 GPs were conducted. Based on a theoretical model of behaviour, interview questions were designed to elicit perspectives on a remotely-delivered (telephone-based) service to support behaviour change and self-management for patients with knee OA, with a focus on exercise and weight loss. Transcripts were analysed using an inductive thematic approach, and GPs' opinions were organised using the APEASE (affordability, practicability, effectiveness, acceptability, safety/side effects and equity) criteria as themes. RESULTS: GPs expressed concerns about potential for confusion, incongruence of information and advice, disconnect with other schemes and initiatives, loss of control of patient care, lack of belief in the need and benefits of proposed service, resistance to change because of lack of familiarity with the procedures and the service, and reluctance to trust in the skills and abilities of the health professionals providing the care support. GPs also recognised the potential benefits of the extra support for patients, and improved access for remote patients to clinicians with specialist knowledge. CONCLUSION: The findings can be used to optimise implementation and engagement with a remotely-delivered 'care support team' model by GPs.

Physical Therapists, Telephone Coaches, and Patients With Knee Osteoarthritis: Qualitative Study About Working Together to Promote Exercise Adherence.

BACKGROUND: Integrated models of care are recommended for people with knee osteoarthritis (OA). Exercise is integral to management, yet exercise adherence is problematic. Telephone-based health coaching is an attractive adjunct to physical therapist-prescribed exercise that may improve adherence. Little is known about the perceptions and interpretations of physical therapists, telephone coaches, and patients engaged in this model of care. OBJECTIVES: The purpose of this study was to explore how stakeholders (physical therapists, telephone coaches, and patients) experienced, and made sense of, being involved in an integrated program of physical therapist-supervised exercise and telephone coaching for people with knee OA. DESIGN: A cross-sectional qualitative design drawing from symbolic interactionism was used. METHODS: Semistructured interviews with 10 physical therapists, 4 telephone coaches, and 6 patients with painful knee OA. Interviews were audiorecorded, transcribed, and analyzed using thematic analysis informed by grounded theory. RESULTS: Four themes emerged: (1) genuine interest and collaboration, (2) information and accountability, (3) program structure, and (4) roles and communication in teamwork. Patients reported they appreciated personalized, genuine interest from therapists and coaches and were aware of their complementary roles. A collaborative approach, with defined roles and communication strategies, was identified as important for effectiveness. All participants highlighted the importance of sharing information, monitoring, and being accountable to others. Coaches found the lack of face-to-face contact with patients hampered relationship building. Therapists and coaches referred to the importance of teamwork in delivering the intervention. LIMITATIONS: The small number of physical therapists and telephone coaches who delivered the intervention may have been biased toward favorable experiences with the intervention and may not be representative of their respective professions. CONCLUSIONS: Integrated physical therapy and telephone coaching was perceived as beneficial by most stakeholders. Programs should be structured but have some flexibility to give therapists and coaches some freedom to adjust treatment to individual patient needs as required. Opportunities for visual communication between telephone coaches and patients could facilitate relationship building.