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Objective To explore experiences maintaining weight loss 6 months after completing a multicomponent weight loss programme for knee osteoarthritis.Design Qualitative study based on an interpretivist paradigm and a phenomenological approach that was embedded within a randomised controlled trial.Setting Semistructured interviews were conducted with participants 6 months after completing a 6-month weight loss programme (ACTRN12618000930280) involving a ketogenic very low calorie diet (VLCD), exercise and physical activity programme, videoconferencing consultations with a dietitian and physiotherapist, and provision of educational and behaviour change resources and meal replacement products. Interviews were audio recorded, transcribed verbatim and data were analysed based on the principles of reflexive thematic analysis.Participants 20 people with knee osteoarthritis.Results Three themes were developed: (1) successfully maintained weight loss; (2) empowering self-management of weight (understand importance of exercise; increased knowledge about food and nutrition; resources from programme still useful; knee pain as a motivator; confidence in ability to self-regulate weight) and (3) challenges keeping on track (loss of accountability to dietitian and study; old habits and social situations; stressful life events or changes in health).Conclusion Participants had overall positive experiences maintaining their weight loss since completing the weight loss programme and were confident in their ability to self-regulate their weight in the future. Findings suggest a programme incorporating dietitian and physiotherapist consultations, a VLCD, and educational and behaviour change resources supports confidence maintaining weight loss in the medium term. Further research is required to explore strategies to overcome barriers like loss of accountability and returning to old eating habits.

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.

Objectives To determine if motion control walking shoes are superior to neutral walking shoes in reducing knee pain on walking in people with lateral knee osteoarthritis (OA).Design Participant-blinded and assessor-blinded, comparative effectiveness, superiority randomised controlled trial.Setting Melbourne, Australia.Participants People with symptomatic radiographic lateral tibiofemoral OA from the community and our volunteer database.Intervention Participants were randomised to receive either motion control or neutral shoes and advised to wear them >6 hours/day over 6 months.Primary and secondary outcome measures The primary outcome was change in average knee pain on walking over the previous week (11-point Numeric Rating Scale (NRS), 0–10) at 6 months. The secondary outcomes included other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity.Results We planned to recruit 110 participants (55 per arm) but ceased recruitment at 40 (n=18 motion control shoes, n=22 neutral shoes) due to COVID-19-related impacts. All 40 participants completed 6-month outcomes. There was no evidence that motion control shoes were superior to neutral shoes for the primary outcome of pain (mean between-group difference 0.4 NRS units, 95% CI −1.0 to 1.7) nor for any secondary outcome. The number of participants experiencing any adverse events was similar between groups (motion control shoes: n=5, 28%; neutral shoes: n=4, 18.2%) and were minor.Conclusions Motion control shoes were not superior to neutral shoes in improving knee pain on walking in symptomatic radiographic lateral tibiofemoral joint OA. Further research is needed to identify effective treatments in this important but under-researched knee OA subgroup.Trial registration number ACTRN12618001864213.

Objective Physiotherapists commonly provide non-surgical care for people with knee osteoarthritis (OA). It is unknown if patients are receiving high-quality physiotherapy care for their knee OA. This study aimed to explore the experiences of people who had recently received physiotherapy care for their knee OA in Australia and how these experiences aligned with the national Clinical Care Standard for knee OA.Design Qualitative study using semistructured individual telephone interviews and thematic analysis, where themes/subthemes were inductively derived. Questions were informed by seven quality statements of the OA of the Knee Clinical Care Standard. Interview data were also deductively analysed according to the Standard.Setting Participants were recruited from around Australia via Facebook and our research volunteer database.Participants Interviews were conducted with 24 people with recent experience receiving physiotherapy care for their knee OA. They were required to be aged 45 years or above, had activity-related knee pain and any knee-related morning stiffness lasted no longer than 30 min. Participants were excluded if they had self-reported inflammatory arthritis and/or had undergone knee replacement surgery for the affected knee.Results Six themes emerged: (1) presented with a pre-existing OA diagnosis (prior OA care from other health professionals; perception of adequate OA knowledge); (2) wide variation in access and provision of physiotherapy care (referral pathways; funding models; individual vs group sessions); (3) seeking physiotherapy care for pain and functional limitations (knee symptoms; functional problems); (4) physiotherapy management focused on function and exercise (assessment of function; various types of exercises prescribed; surgery, medications and injections are for doctors; adjunctive treatments); (5) professional and personalised care (trust and/or confidence; personalised care) and (6) physiotherapy to postpone or prepare for surgery.Conclusion Patients’ experiences with receiving physiotherapy care for their knee OA were partly aligned with the standard, particularly regarding comprehensive assessment, self-management, and exercise.

Introduction In the context of a highly contagious virus with only recently approved vaccines and no cure, the key to slowing the spread of the COVID-19 disease and successfully transitioning through the phases of the pandemic, including vaccine uptake, is public adherence to rapidly evolving behaviour-based public health policies. The overall objective of the iCARE Study is to assess public awareness, attitudes, concerns and behavioural responses to COVID-19 public health policies, and their impacts, on people around the world and to link behavioural survey data with policy, mobility and case data to provide behavioural science, data-driven recommendations to governments on how to optimise current policy strategies to reduce the impact of the COVID-19 pandemic.Methods and analyses The iCARE study (www.icarestudy.com) uses a multiple cross-sectional survey design to capture self-reported information on a variety of COVID-19 related variables from individuals around the globe. Survey data are captured using two data capture methods: convenience and representative sampling. These data are then linked to open access data for policies, cases and population movement.Ethics and dissemination The primary ethical approval was obtained from the coordinating site, the Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal (REB#: 2020–2099/03–25–2020). This study will provide high-quality, accelerated and real-time evidence to help us understand the effectiveness of evolving country-level policies and communication strategies to reduce the spread of the COVID-19. Due to the urgency of the pandemic, results will be disseminated in a variety of ways, including policy briefs, social media posts, press releases and through regular scientific methods.

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.

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)

IntroductionThis protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against ‘usual care’. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary ‘Care Support Team’. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability.Methods and analysisThe UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of ‘usual care’. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model.Ethics and disseminationThe primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context.Trial registration numberACTRN12617001595303; Pre-results.

Introduction Chronic obstructive pulmonary disease is generally progressive and associated with reduced physical activity. Both pharmacological therapy and exercise training can improve exercise capacity; however, these are often not sufficient to change the amount of daily physical activity a patient undertakes. Behaviour-change self-management programmes are designed to address this, including setting motivational goals and providing social support. We present and discuss the necessary methodological considerations when integrating behaviour-change interventions into a multicentre study.Methods and analysis PHYSACTO is a 12-week phase IIIb study assessing the effects on exercise capacity and physical activity of once-daily tiotropium+olodaterol 5/5 µg with exercise training, tiotropium+olodaterol 5/5 µg without exercise training, tiotropium 5 µg or placebo, with all pharmacological interventions administered via the Respimat inhaler. Patients in all intervention arms receive a behaviour-change self-management programme to provide an optimal environment for translating improvements in exercise capacity into increases in daily physical activity. To maximise the likelihood of success, special attention is given in the programme to: (1) the Site Case Manager, with careful monitoring of programme delivery; (2) the patient, incorporating patient-evaluation/programme-evaluation measures to guide the Site Case Manager in the self-management intervention; and (3) quality assurance, to help identify and correct any problems or shortcomings in programme delivery and ensure the effectiveness of any corrective steps. This paper documents the comprehensive methods used to optimise and standardise the behaviour-change self-management programme used in the study to facilitate dialogue on the inclusion of this type of programme in multicentre studies.Ethics and dissemination The study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The results of this study will be disseminated through relevant, peer-reviewed journals and international conference presentations.Trial registration number NCT02085161.

Introduction Reduced thrombin generation is an important component of post cardiopulmonary bypass (CPB) coagulopathy. To replenish coagulation factors and enhance thrombin generation in bleeding surgical patients, frozen plasma (FP) and four-factor prothrombin complex concentrate (4F-PCC) are used. However, the efficacy–safety balance of 4F-PCC relative to FP in cardiac surgery is unconfirmed.Methods and analysis LEX-211 (FARES-II) is an active-control, randomised, phase 3 study comparing two coagulation factor replacement therapies in bleeding adult cardiac surgical patients at 12 hospitals in Canada and the USA. The primary objective is to determine whether 4F-PCC (Octaplex/Balfaxar, Octapharma) is clinically non-inferior to FP for haemostatic effectiveness. Inclusion criteria are any index (elective or non-elective) cardiac surgery employing CPB and coagulation factor replacement with 4F-PCC or FP ordered in the operating room for bleeding management. Patients will be randomised to receive 1500 or 2000 international units of 4F-PCC or 3 or 4 units of FP, depending on body weight. The primary endpoint of haemostatic treatment response is ‘effective’ if no additional haemostatic intervention is required from 60 min to 24 hours after the first initiation of 4F-PCC or FP; or ‘ineffective’ if any other haemostatic intervention (including a second dose of study drug) is required. An estimated 410 evaluable patients will be required to demonstrate non-inferiority (one-sided α of 0.025, power ≥90%, non-inferiority margin 0.10). Secondary outcomes include transfusions, bleeding-related clinical endpoints, coagulation parameters and safety.Ethics and dissemination The trial has been approved by the institutional review boards of all participating centres. Trial completion is anticipated at the end of 2024, and results will be disseminated via publications in peer-reviewed journals and conference presentations in 2025. The results will advance our understanding of coagulation management in bleeding surgical patients, potentially reducing the need for allogeneic blood products and improving outcomes in surgical patients.Trial registration number NCT05523297.

Objectives This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort.Methods We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.Results A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.Conclusions BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.

Introduction Despite greater needs in rural areas, occupational therapists are maldistributed to urban spaces which limits service access and health outcomes for rural people and communities. Preparation of students for rural practice may improve rural workforce recruitment and retention; however, the range and scope of preparation strategies employed by education providers are unclear. This scoping review aims to understand and describe the range of strategies education services use to prepare occupational therapy students for rural practice across the globe.Methods and analysis The study will include all publications about strategies used to prepare occupational therapy students for future rural practice, prior to enrolment, during the programme or on graduation. MEDLINE (Ovid), Emcare (Ovid), APA PsychInfo (Ovid), CINAHL (EBSCOhost), Health Source: Nursing/Academic (EBSCOHost), Educational Resources Information Centre (ERIC), Open Access Theses and Dissertations (OATD), and Scientific Electronic Library Online (SciELO) databases will be systematically searched in English, Spanish, French and Portuguese languages. Citations will be screened by two or more independent researchers against inclusion criteria and data extracted from included publications using a customised extraction tool. Frequency counts will be provided for study type, student location and sociodemographics, and the timing/educational strategy. The extracted data will be analysed using a matrix framework and presented in diagrammatic/tabular form and accompanied by a narrative summary which will describe how the results relate to the reviews’ questions.Ethics and dissemination This study will not involve human/animal subjects and does not require ethics approval. Results will be disseminated to relevant groups in peer-reviewed journal(s) and at relevant occupational therapy, higher education and/or rural health conferences. Results will also be translated and shared in blogs/social media to support access for non-research audiences and shared with other regional universities to influence curriculum design.

Introduction Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.Methods and analysis The RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.Ethics and dissemination The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.Trial registration number NCT05654961.

Objectives To adapt the content and functionalities of Brain Health PRO, a web-based multidomain program designed to increase dementia literacy, to the context and needs of users, providers and community organisations across Québec, Canada.Design Five consecutive qualitative co-creation focus group sessions 30–90 min in duration each, exploring potential barriers and facilitators to usability, accessibility, comprehensibility, participant recruitment and retention.Setting Virtual meetings.Participants A 15-member team based in Québec and Ontario, Canada, consisting of 9 researchers (including a graduate student and the project coordinator), representing occupational therapy, sensory rehabilitation, neuropsychology, psychology, health science and research methods, 3 informal caregivers of older adults living with cognitive decline and 3 members of the Federation of Quebec Alzheimer Societies.Data analysis Session recordings were summarised through both qualitative description and thematic analysis.Results The synthesised recommendations included adjustments around diversity, the complexity and presentation styles of the materials, suggestions on refining the web interface and the measurement approaches; it influenced aspects of participant recruitment, retention efforts and engagement with the content of Brain Health PRO.Conclusions Co-creation in dementia prevention research is important because it involves collaboration between researchers, community support and service providers, and persons with lived experience as care providers, in the design and implementation of clinical studies. This approach helps to ensure that the content and presentation of educational material is relevant and meaningful to the target population and those involved in its delivery, and it leads to a greater understanding of their needs and perspectives.