Effectiveness of an eHealth-Delivered Program to Empower People With Musculoskeletal Pain in Rural Australia: A Randomized Controlled Trial.

OBJECTIVE: Our objective was to evaluate the effectiveness of a three-month physiotherapist-delivered eHealth physical activity program compared with usual care to improve function in adults with low back pain or knee osteoarthritis in rural Australia. METHODS: This was a parallel, two-group, pragmatic, superiority, randomized controlled trial involving three- and six-month posttreatment follow-ups. There was a total of 156 adults with chronic nonspecific low back pain (n = 97) or knee osteoarthritis (n = 59) from rural Australia. The intervention involved an eHealth physical activity and an exercise program that included five to eight teleconsultations with a physiotherapist (primary time point three months) or usual care (eg, general practitioner, physiotherapy, and pain medication). The primary outcome was the Patient-Specific Functional Scale (0-30), with a three-point difference between groups being considered the minimum clinically important difference. RESULTS: Participants receiving the eHealth intervention (n = 78) reported significantly greater and clinically worthwhile improvements in function (mean between-group difference 3.6; 95% confidence interval [CI] 1.3-5.9) compared to participants receiving usual care (n = 78). Small but statistically significantly greater improvements in disability (7.2 of 100; 95% CI 2.1-12.3) and quality of life (4.5 of 100; 95% CI 0.0-9.0) also favored the eHealth group. No clinical or statistical differences between groups were found for the secondary outcomes of pain, coping skills, and physical activity levels. CONCLUSION: A physiotherapist-delivered eHealth intervention is effective and provides clinically meaningful improvements in function compared to usual care for people with musculoskeletal pain in rural communities. These findings highlight the potential for eHealth-based programs to improve access to evidence-based exercise interventions for people with musculoskeletal pain in rural communities.

Barriers and facilitators to reducing paracetamol use in low back pain: A qualitative study.

BACKGROUND: Paracetamol is widely used for low back pain (LBP), but research questions its efficacy and safety. Patient education booklets have been explored for promoting deprescribing, but barriers and facilitators specific to LBP deprescribing remain unexamined. OBJECTIVE: To identify contextual factors facilitating and obstructing successful deprescribing of paracetamol for LBP after receiving an educational booklet. STUDY DESIGN: This study is part of an uncontrolled cohort feasibility study (CEASE NOW) in the community, recruiting from Musculoskeletal Australia and painaustralia. PATIENT SAMPLE: Twenty-four participants with acute, sub-acute, or chronic LBP, self-reporting paracetamol consumption, were included. METHODS: Thematic content analysis was used to analyze qualitative data on barriers and facilitators. Data were categorized by deprescribing outcomes: i) successful deprescribing, ii) attempted but failed, or iii) no attempt. Semi-structured telephone interviews were conducted within one week after each participant completed the one-month follow-up. RESULTS: Successful deprescribing was facilitated by supportive healthcare professionals, willingness, high self-efficacy, fear of future illness, and diverse strategies for deprescribing plans. Barriers included unsupportive healthcare professionals and fear of flare-ups. Participants not attempting deprescribing believed it unnecessary, perceived it as effortful, unquestioningly trusted healthcare professionals, and lacked risk awareness. CONCLUSIONS: Support from healthcare professionals, patient willingness, perceived necessity, risk awareness, effort, and varied strategies influence deprescribing outcomes for LBP patients using paracetamol. Addressing these factors is crucial when designing interventions to promote safe and effective deprescribing in LBP management.

Effect of Aspirin vs Enoxaparin on 90-Day Mortality in Patients Undergoing Hip or Knee Arthroplasty: A Secondary Analysis of the CRISTAL Cluster Randomized Trial.

Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.

Which clinical research questions are the most important? Development and preliminary validation of the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network Research Question Importance Tool (ANZMUSC-RQIT).

BACKGROUND AND AIMS: High quality clinical research that addresses important questions requires significant resources. In resource-constrained environments, projects will therefore need to be prioritized. The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network aimed to develop a stakeholder-based, transparent, easily implementable tool that provides a score for the 'importance' of a research question which could be used to rank research projects in order of importance. METHODS: Using a mixed-methods, multi-stage approach that included a Delphi survey, consensus workshop, inter-rater reliability testing, validity testing and calibration using a discrete-choice methodology, the Research Question Importance Tool (ANZMUSC-RQIT) was developed. The tool incorporated broad stakeholder opinion, including consumers, at each stage and is designed for scoring by committee consensus. RESULTS: The ANZMUSC-RQIT tool consists of 5 dimensions (compared to 6 dimensions for an earlier version of RQIT): (1) extent of stakeholder consensus, (2) social burden of health condition, (3) patient burden of health condition, (4) anticipated effectiveness of proposed intervention, and (5) extent to which health equity is addressed by the research. Each dimension is assessed by defining ordered levels of a relevant attribute and by assigning a score to each level. The scores for the dimensions are then summed to obtain an overall ANZMUSC-RQIT score, which represents the importance of the research question. The result is a score on an interval scale with an arbitrary unit, ranging from 0 (minimal importance) to 1000. The ANZMUSC-RQIT dimensions can be reliably ordered by committee consensus (ICC 0.73-0.93) and the overall score is positively associated with citation count (standardised regression coefficient 0.33, p<0.001) and journal impact factor group (OR 6.78, 95% CI 3.17 to 14.50 for 3rd tertile compared to 1st tertile of ANZMUSC-RQIT scores) for 200 published musculoskeletal clinical trials. CONCLUSION: We propose that the ANZMUSC-RQIT is a useful tool for prioritising the importance of a research question.

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

BACKGROUND: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial. METHODS: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test. DISCUSSION: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial. TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

(C)onsumer focused (E)ducation on p(A)racetamol (S)ide (E)ffects, i(N)adequate (O)utcomes and (W)eaning (CEASE NOW) for individuals with low back pain: results of a feasibility study.

OBJECTIVES: To determine the feasibility of a patient-education booklet to support patients with low back pain (LBP) to reduce paracetamol intake. DESIGN: Single group, repeated measures feasibility study. SETTING: Community. PARTICIPANTS: Adults experiencing LBP of any kind and self-reporting consumption of paracetamol for LBP weekly for at least 1 month were invited to participate. INTERVENTION: Participants received a patient-education booklet 1 week after the baseline measures were collected. The intervention was designed to change beliefs, increase knowledge and self-efficacy to deprescribe paracetamol for their LBP and create discussion with a health professional through the mechanisms of motivation, capacity and opportunity. PRIMARY OUTCOME MEASURES: Feasibility of recruitment procedures, data collection and acceptability of the intervention. SECONDARY OUTCOME MEASURES: Changes in motivation, self-efficacy, opportunity to deprescribe paracetamol for their LBP, paracetamol usage and LBP clinical outcomes at baseline, 1-week and 1-month follow-up. RESULTS: A total of 24 participants were recruited into the study within the timeframe of 3 months from study advertisement and all completed the study follow-up. There were no missing data for any outcome measure across all follow-up points, 22 (91.6%) participants were willing to participate in a future randomised control trial (RCT) and over 60% of participants responded positively to questions regarding acceptability of the patient-educational booklet. Overall, at the 1-month follow-up, approximately two thirds (15/24) of participants had an increase in motivation and self-efficacy scores and had discussed or intended to discuss their paracetamol use for LBP with a health professional. CONCLUSIONS: The results of this study demonstrate that the patient-education booklet is feasible to implement, and both the intervention and study design were well-received by participants. This study supports the undertaking an RCT to assess the effects of the patient-education booklet on deprescribing paracetamol in people with LBP.

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial.

Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA. Design, Setting, and Participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021. Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation. Main Outcomes and Measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group. Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group. Conclusions and Relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis. Trial Registration: ANZCTR Identifier: ACTRN12618001879257.

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial.

BACKGROUND: Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. METHODS: Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. DISCUSSION: This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. CONCLUSION: Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia. TRIAL REGISTRATION: Prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12620000889954 ) on 10/09/2020.

TEXT4myBACK - The Development Process of a Self-Management Intervention Delivered Via Text Message for Low Back Pain.

OBJECTIVE: To develop a bank of text messages for a lifestyle-based self-management intervention for people with low back pain (LBP). DESIGN: Iterative development process. SETTING: Community and primary care. PARTICIPANTS: Fifteen researchers, clinicians, and consumer representatives participated in the concept and initial content development phase. Twelve experts (researchers and clinicians) and 12 consumers participated in the experts and consumers review phase. Full study sample of participants was N=39. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We first conducted two 2-hour workshops to identify important domains for people with LBP, sources of content, appropriate volume, and timing of the messages. The messages were then drafted by a team of writers. Second, we invited expert researchers and clinicians to review and score the messages using a 5-item psychometric scale according to (1) the appropriateness of the content and (2) the likelihood of clinical effectiveness and to provide written feedback. Messages scoring ≤8 out of 10 points would be modified accordingly. Consumers were invited to review the messages and score them using a 5-item psychometric scale according to the utility of the content, the understanding of the content, and language acceptability and to provide feedback. Messages scoring ≤12 out of 15 points would be improved. RESULTS: Exercise, education, mood, sleep, use of care, and medication domains were identified and 82 domain-specific evidence-based messages were written. Messages received a mean score of 8.3 out of 10 points by experts. Twenty-nine messages were modified accordingly. The mean score of the messages based on consumers feedback was of 12.5 out of 15 points. Thirty-six messages were improved. CONCLUSIONS: We developed a bank of text messages for an evidence-based self-management intervention using a theory-based, iterative, codesign process with researchers, consumers, and clinicians. This article provides scientific support for future development of text message interventions within the pain field.

TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain-Protocol of a Randomized Controlled Trial.

OBJECTIVE: The authors sought to describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control in people with low back pain (LBP). METHODS: A single-blind (assessor and statistician), randomized controlled trial with economic analysis and process evaluation will be conducted. A total of 304 people with non-specific LBP of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive 4 semi-personalized text messages per week providing advice, motivation, and information about LBP, physical activity, sleep, mood, use of care, and medication during 12 weeks. The control group will receive 1 text message with a link to a LBP and diet online information package. Outcomes will be assessed at baseline and 3, 6, and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life, and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization, and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted. IMPACT: This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with LBP. This study can inform clinical practice of a simple, scalable, and affordable intervention for managing LBP.

EHealth to empower patients with musculoskeletal pain in rural Australia (EMPoweR) a randomised clinical trial: study protocol.

BACKGROUND: Low back pain (LBP) and knee osteoarthritis (OA) are major contributors to disability worldwide. These conditions result in a significant burden at both individual and societal levels. Engagement in regular physical activity and exercise programs are known to improve physical function in both chronic LBP and knee OA populations. For people residing in rural areas, musculoskeletal conditions are often more frequent and disabling compared to urban populations, which could be the result of reduced access to appropriate health services and resources in rural settings. EHealth is an innovative solution to help provide equitable access to treatment for people with musculoskeletal pain living in rural settings. METHODS/DESIGN: We will conduct a randomised clinical trial investigating the effects of an eHealth intervention compared to usual care, for people with chronic non-specific LBP or knee OA in rural Australia. We will recruit 156 participants with non-specific chronic LBP or knee OA. Following the completion of baseline questionnaires, participants will be randomly allocated to either the eHealth intervention group, involving a tailored physical activity and progressive resistance exercise program remotely delivered by a physiotherapist (n = 78), or usual care (n = 78) involving referral to a range of care practices in the community. Outcomes will be measured at baseline, 3 and 6 months post-randomisation. The primary outcome will be physical function assessed by the Patient-Specific Functional Scale (PSFS). Secondary outcomes include pain intensity, physical activity levels, activity limitations, quality of life, pain coping. We will also collect process evaluation data such as recruitment rate, attendance and adherence, follow-up rate, participants' opinions and any barriers encountered throughout the trial. DISCUSSION: The findings from this trial will establish the effectiveness of eHealth-delivered interventions that are known to be beneficial for people with LBP and knee OA when delivered in person. As a result, this trial will help to inform health care policy and clinical practice in Australia and beyond for those living in non-urban areas. TRIAL REGISTRATION: This study was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12618001494224 ) registered 09.05.2018.

Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control). METHODS AND ANALYSIS: A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective. ETHICS AND DISSEMINATION: Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12619001134112.

Early development of the Australia and New Zealand Musculoskeletal Clinical Trials Network.

The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network was formed to build capacity and infrastructure for high-quality musculoskeletal clinical trials in our region. The purpose of this paper is to describe the steps taken in its formation to help others interested in establishing similar networks. In particular, we describe the steps taken to form the collaboration and our progress in achieving our vision and mission. Our aim is to focus on trials of highest importance and quality to provide definitive answers to the most pressing questions in our field.

CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

INTRODUCTION: Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. METHODS AND ANALYSIS: This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals. ETHICS AND DISSEMINATION: Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.

Scoping review of priority setting of research topics for musculoskeletal conditions.

OBJECTIVE: Describe research methods used in priority-setting exercises for musculoskeletal conditions and synthesise the priorities identified. DESIGN: Scoping review. SETTING AND POPULATION: Studies that elicited the research priorities of patients/consumers, clinicians, researchers, policy-makers and/or funders for any musculoskeletal condition were included. METHODS AND ANALYSIS: We searched MEDLINE and EMBASE from inception to November 2017 and the James Lind Alliance top 10 priorities, Cochrane Priority Setting Methods Group, and Cochrane Musculoskeletal and Back Groups review priority lists. The reported methods and research topics/questions identified were extracted, and a descriptive synthesis conducted. RESULTS: Forty-nine articles fulfilled our inclusion criteria. Methodologies and stakeholders varied widely (26 included a mix of clinicians, consumers and others, 16 included only clinicians, 6 included only consumers or patients and in 1 participants were unclear). Only two (4%) reported any explicit inclusion criteria for priorities. We identified 294 broad research priorities from 37 articles and 246 specific research questions from 17 articles, although only four (24%) of the latter listed questions in an actionable format. Research priorities for osteoarthritis were identified most often (n=7), followed by rheumatoid arthritis (n=4), osteoporosis (n=4) and back pain (n=4). Nearly half of both broad and specific research priorities were focused on treatment interventions (n=116 and 111, respectively), while few were economic (n=8, 2.7% broad and n=1, 0.4% specific), implementation (n=6, 2% broad and n=4, 1.6% specific) or health services and systems research (n=15, 5.1% broad and n=9, 3.7% specific) priorities. CONCLUSIONS: While many research priority-setting studies in the musculoskeletal field have been performed, methodological limitations and lack of actionable research questions limit their usefulness. Future studies should ensure they conform to good priority-setting practice to ensure that the generated priorities are of maximum value. PROSPERO REGISTRATION NUMBER: CRD42017059250.

The Use of Web-Based Technologies in Health Research Participation: Qualitative Study of Consumer and Researcher Experiences.

BACKGROUND: Health consumers are often targeted for their involvement in health research including randomized controlled trials, focus groups, interviews, and surveys. However, as reported by many studies, recruitment and engagement of consumers in academic research remains challenging. In addition, there is scarce literature describing what consumers look for and want to achieve by participating in research. OBJECTIVE: Understanding and responding to the needs of consumers is crucial to the success of health research projects. In this study, we aim to understand consumers' needs and investigate the opportunities for addressing these needs with Web-based technologies, particularly in the use of Web-based research registers and social networking sites (SNSs). METHODS: We undertook a qualitative approach, interviewing both consumer and medical researchers in this study. With the help from an Australian-based organization supporting people with musculoskeletal conditions, we successfully interviewed 23 consumers and 10 researchers. All interviews were transcribed and analyzed with thematic analysis methodology. Data collection was stopped after the data themes reached saturation. RESULTS: We found that consumers perceive research as a learning opportunity and, therefore, expect high research transparency and regular updates. They also consider the sources of the information about research projects, the trust between consumers and researchers, and the mobility of consumers before participating in any research. Researchers need to be aware of such needs when designing a campaign for recruitment for their studies. On the other hand, researchers have attempted to establish a rapport with consumer participants, design research for consumers' needs, and use technologies to reach out to consumers. A systematic approach to integrating a variety of technologies is needed. CONCLUSIONS: On the basis of the feedback from both consumers and researchers, we propose 3 future directions to use Web-based technologies for addressing consumers' needs and engaging with consumers in health research: (1) researchers can make use of consumer registers and Web-based research portals, (2) SNSs and new media should be frequently used as an aid, and (3) new technologies should be adopted to remotely collect data and reduce administrative work for obtaining consumers' consent.

The currency, completeness and quality of systematic reviews of acute management of moderate to severe traumatic brain injury: A comprehensive evidence map.

OBJECTIVE: To appraise the currency, completeness and quality of evidence from systematic reviews (SRs) of acute management of moderate to severe traumatic brain injury (TBI). METHODS: We conducted comprehensive searches to March 2016 for published, English-language SRs and RCTs of acute management of moderate to severe TBI. Systematic reviews and RCTs were grouped under 12 broad intervention categories. For each review, we mapped the included and non-included RCTs, noting the reasons why RCTs were omitted. An SR was judged as 'current' when it included the most recently published RCT we found on their topic, and 'complete' when it included every RCT we found that met its inclusion criteria, taking account of when the review was conducted. Quality was assessed using the AMSTAR checklist (trichotomised into low, moderate and high quality). FINDINGS: We included 85 SRs and 213 RCTs examining the effectiveness of treatments for acute management of moderate to severe TBI. The most frequently reviewed interventions were hypothermia (n = 17, 14.2%), hypertonic saline and/or mannitol (n = 9, 7.5%) and surgery (n = 8, 6.7%). Of the 80 single-intervention SRs, approximately half (n = 44, 55%) were judged as current and two-thirds (n = 52, 65.0%) as complete. When considering only the most recently published review on each intervention (n = 25), currency increased to 72.0% (n = 18). Less than half of the 85 SRs were judged as high quality (n = 38, 44.7%), and nearly 20% were low quality (n = 16, 18.8%). Only 16 (20.0%) of the single-intervention reviews (and none of the five multi-intervention reviews) were judged as current, complete and high-quality. These included reviews of red blood cell transfusion, hypothermia, management guided by intracranial pressure, pharmacological agents (various) and prehospital intubation. Over three-quarters (n = 167, 78.4%) of the 213 RCTs were included in one or more SR. Of the remainder, 17 (8.0%) RCTs post-dated or were out of scope of existing SRs, and 29 (13.6%) were on interventions that have not been assessed in SRs. CONCLUSION: A substantial number of SRs in acute management of moderate to severe TBI lack currency, completeness and quality. We have identified both potential evidence gaps and also substantial research waste. Novel review methods, such as Living Systematic Reviews, may ameliorate these shortcomings and enhance utility and reliability of the evidence underpinning clinical care.

Interventions for managing skeletal muscle spasticity following traumatic brain injury.

BACKGROUND: Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI. OBJECTIVES: To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI. SEARCH METHODS: In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data. MAIN RESULTS: We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. AUTHORS' CONCLUSIONS: The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.

Engaging Consumers with Musculoskeletal Conditions in Health Research: A User-Centred Perspective.

Consumers are frequently involved in different kinds of health research, such as clinical trials, focus groups, and surveys. As pointed out by different studies, recruiting and involving consumers to participate in academic research can be challenging. While different research and guidelines are provided to instruct researchers to recruit participants ethically, they seldom consider the needs and expectations of consumers. In this research, we interviewed 23 consumers with musculoskeletal conditions in Australia, to understand their needs and motivations for participating in research from a user-centred perspective. Based on these data, we systematically summarise consumers' feedback into four main themes: (1) Research as Learning Opportunity; (2) The Important Role of Communities and Health Professionals; (3) Research Transparency and Updates; and (4) Special Needs for People with MSK Conditions. As a result, a few recommendations are proposed and researchers should further consider these when designing consumer-based studies. Ultimately, with a better understanding of consumers, we hope that our research can enhance consumer engagement and improve their participation in health research.