Search

Aim: To describe the Heart Matters (HM) trial which aims to evaluate the effectiveness of a community heart attack education intervention in high-risk areas in Victoria, Australia. These local government areas (LGAs) have high rates of acute coronary syndrome (ACS), out-of-hospital cardiac arrest (OHCA), cardiovascular risk factors, and low rates of emergency medical service (EMS) use for ACS., Methods: The trial follows a stepped-wedge cluster randomised design, with eight clusters (high-risk LGAs) randomly assigned to transition from control to intervention every four months. Two pairs of LGAs will transition simultaneously due to their proximity. The intervention consists of a heart attack education program delivered by trained HM Coordinators, with additional support from opportunistic media and a geo-targeted social media campaign. The primary outcome measure is the proportion of residents from the eight LGAs who present to emergency departments by EMS during an ACS event. Secondary outcomes include prehospital delay time, rates of OHCA and heart attack awareness. The primary and secondary outcomes will be analysed at the patient/participant level using mixed-effects logistic regression models. A detailed program evaluation is also being conducted. The trial was registered on August 9, 2021 (NCT04995900)., Results: The intervention was implemented between February 2022 and March 2023, and outcome data will be collected from administrative databases, registries, and surveys. Primary trial data is expected to be locked for analysis by October 31st 2023, with a follow-up planned until March 31st 2024., Conclusion: The results from this trial will provide high-level evidence the effectiveness of a community education intervention targeting regions at highest-risk of ACS and low EMS use., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Background: Standard stepped wedge trials, where clusters switch from the control to the intervention condition in a staggered manner, can be costly and burdensome. Recent work has shown that the amount of information contributed by each cluster in each period differs, with some cluster-periods contributing a relatively small amount of information. We investigate the patterns of the information content of cluster-period cells upon iterative removal of low-information cells, assuming a model for continuous outcomes with constant cluster-period size, categorical time period effects, and exchangeable and discrete-time decay intracluster correlation structures., Methods: We sequentially remove pairs of "centrosymmetric" cluster-period cells from an initially complete stepped wedge design which contribute the least amount of information to the estimation of the treatment effect. At each iteration, we update the information content of the remaining cells, determine the pair of cells with the lowest information content, and repeat this process until the treatment effect cannot be estimated., Results: We demonstrate that as more cells are removed, more information is concentrated in the cells near the time of the treatment switch, and in "hot-spots" in the corners of the design. For the exchangeable correlation structure, removing the cells from these hot-spots leads to a marked reduction in study precision and power, however the impact of this is lessened for the discrete-time decay structure., Conclusions: Removing cluster-period cells distant from the time of the treatment switch may not lead to large reductions in precision or power, implying that certain incomplete designs may be almost as powerful as complete designs., (© 2023. The Author(s).)

Background: The effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with sepsis receiving unplanned invasive mechanical ventilation in the intensive care unit (ICU) is uncertain., Objective: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Sepsis trial., Design Setting and Participants: The Mega-ROX Sepsis trial is an international randomised clinical trial that will be conducted within an overarching 40,000-patient registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We anticipate that between 10,000 and 13,000 patients with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU will be enrolled in this trial., Main Outcome Measures: The primary outcome is in-hospital all-cause mortality up to 90 days from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of patients discharged home., Results and Conclusions: Mega-ROX Sepsis will compare the effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU. The protocol and a prespecified approach to analyses are reported here to mitigate analysis bias., (© 2023 The Authors.)

Background: The effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults who have nonhypoxic ischaemic encephalopathy acute brain injuries and conditions and are receiving invasive mechanical ventilation in the intensive care unit (ICU) is uncertain., Objective: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial., Design Setting and Participants: Mega-ROX Brains is an international randomised clinical trial, which will be conducted within an overarching 40,000-participant, registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We expect to enrol between 7500 and 9500 participants with nonhypoxic ischaemic encephalopathy acute brain injuries and conditions who are receiving unplanned invasive mechanical ventilation in the ICU., Main Outcome Measures: The primary outcome is in-hospital all-cause mortality up to 90 d from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of participants discharged home., Results and Conclusions: Mega-ROX Brains will compare the effect of conservative vs. liberal oxygen therapy regimens on 90-day in-hospital mortality in adults in the ICU with acute brain injuries and conditions. The protocol and planned analyses are reported here to mitigate analysis bias., Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976)., (© 2023 The Author(s).)

Objectives: To assess the mental health and wellbeing of health and aged care workers in Australia during the second and third years of the coronavirus disease 2019 (COVID-19) pandemic, overall and by occupation group., Design, Setting, Participants: Longitudinal cohort study of health and aged care workers (ambulance, hospitals, primary care, residential aged care) in Victoria: May-July 2021 (survey 1), October-December 2021 (survey 2), and May-June 2022 (survey 3)., Main Outcome Measures: Proportions of respondents (adjusted for age, gender, socio-economic status) reporting moderate to severe symptoms of depression (Patient Health Questionnaire-9, PHQ-9), anxiety (Generalized Anxiety Disorder scale, GAD-7), or post-traumatic stress (Impact of Event Scale-6, IES-6), burnout (abbreviated Maslach Burnout Inventory, aMBI), or high optimism (10-point visual analogue scale); mean scores (adjusted for age, gender, socio-economic status) for wellbeing (Personal Wellbeing Index-Adult, PWI-A) and resilience (Connor Davidson Resilience Scale 2, CD-RISC-2)., Results: A total of 1667 people responded to at least one survey (survey 1, 989; survey 2, 1153; survey 3, 993; response rate, 3.3%). Overall, 1211 survey responses were from women (72.6%); most respondents were hospital workers (1289, 77.3%) or ambulance staff (315, 18.9%). The adjusted proportions of respondents who reported moderate to severe symptoms of depression (survey 1, 16.4%; survey 2, 22.6%; survey 3, 19.2%), anxiety (survey 1, 8.8%; survey 2, 16.0%; survey 3, 11.0%), or post-traumatic stress (survey 1, 14.6%; survey 2, 35.1%; survey 3, 14.9%) were each largest for survey 2. The adjusted proportions of participants who reported moderate to severe symptoms of burnout were higher in surveys 2 and 3 than in survey 1, and the proportions who reported high optimism were smaller in surveys 2 and 3 than in survey 1. Adjusted mean scores for wellbeing and resilience were similar at surveys 2 and 3 and lower than at survey 1. The magnitude but not the patterns of change differed by occupation group., Conclusion: Burnout was more frequently reported and mean wellbeing and resilience scores were lower in mid-2022 than in mid-2021 for Victorian health and aged care workers who participated in our study. Evidence-based mental health and wellbeing programs for workers in health care organisations are needed., Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12621000533897 (observational study; retrospective)., (© 2023 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)

Introduction: Clinical trial designs based on the assumption of independent observations are well established. Clustered clinical trial designs, where all observational units belong to a cluster and outcomes within clusters are expected to be correlated, have also received considerable attention. However, many clinical trials involve partially clustered data, where only some observational units belong to a cluster. Examples of such trials occur in neonatology, where participants include infants from both singleton and multiple births, and ophthalmology, where one or two eyes per participant may need treatment. Partial clustering can also arise in trials of group-based treatments (e.g. group education or counselling sessions) or treatments administered individually by a discrete number of health care professionals (e.g. surgeons or physical therapists), when this is compared to an unclustered control arm. Trials involving partially clustered data have received limited attention in the literature and the current lack of standardised terminology may be hampering the development and dissemination of methods for designing and analysing these trials., Methods and Examples: In this article, we present an overarching definition of partially clustered trials, bringing together several existing trial designs including those for group-based treatments, clustering due to facilitator effects and the re-randomisation design. We define and describe four types of partially clustered trial designs, characterised by whether the clustering occurs pre-randomisation or post-randomisation and, in the case of pre-randomisation clustering, by the method of randomisation that is used for the clustered observations (individual randomisation, cluster randomisation or balanced randomisation within clusters). Real life examples are provided to highlight the occurrence of partially clustered trials across a variety of fields. To assess how partially clustered trials are currently reported, we review published reports of partially clustered trials., Discussion: Our findings demonstrate that the description of these trials is often incomplete and the terminology used to describe the trial designs is inconsistent, restricting the ability to identify these trials in the literature. By adopting the definitions and terminology presented in this article, the reporting of partially clustered trials can be substantially improved, and we present several recommendations for reporting these trial designs in practice. Greater awareness of partially clustered trials will facilitate more methodological research into their design and analysis, ultimately improving the quality of these trials.

Introduction: Women living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services but have not been evaluated in Australian general practice. The primary aim of the ORIENT trial (ImprOving Rural and regIonal accEss to long acting reversible contraceptioN and medical abortion through nurse-led models of care, Tasksharing and telehealth) is to assess the effectiveness of a nurse-led model of care in general practice at increasing uptake of LARC and improving access to medical abortion in rural and regional areas., Methods and Analysis: ORIENT is a stepped-wedge pragmatic cluster-randomised controlled trial. We will enrol 32 general practices (clusters) in rural or regional Australia, that have at least two general practitioners, one practice nurse and one practice manager. The nurse-led model of care (the intervention) will be codesigned with key women's health stakeholders. Clusters will be randomised to implement the model sequentially, with the comparator being usual care. Clusters will receive implementation support through clinical upskilling, educational outreach and engagement in an online community of practice. The primary outcome is the change in the rate of LARC prescribing comparing control and intervention phases; secondary outcomes include change in the rate of medical abortion prescribing and provision of related telehealth services. A within-trial economic analysis will determine the relative costs and benefits of the model on the prescribing rates of LARC and medical abortion compared with usual care. A realist evaluation will provide contextual information regarding model implementation informing considerations for scale-up. Supporting nurses to work to their full scope of practice has the potential to increase LARC and medical abortion access in rural and regional Australia., Ethics and Dissemination: Ethics approval was obtained from the Monash University Human Research Ethics Committee (Project ID: 29476). Findings will be disseminated via multiple avenues including a knowledge exchange workshop, policy briefs, conference presentations and peer-reviewed publications., Trial Registration Number: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000086763)., Competing Interests: Competing interests: DM has received research and conference attendance funding, speaker fees and been an advisory board member for Bayer, Organon and MSD. DB has provided education for doctors sponsored by Bayer and Organon and has been an advisory board member for Bayer, Organon and MSD. DB has never received personal remuneration for these services. During this study WVN was a member of the Board of Directors of the Society of Family Planning. She receives family planning research grants from Canadian and UK governments and not for profit associations, none of which are related to this project., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

OBJECTIVE: To investigate mediators and moderators of effects of an education-plus-exercise program compared to corticosteroid injections or wait and see on perceived improvement in individuals with gluteal tendinopathy. METHODS: Exploratory analysis from a clinical trial (n = 204) comparing education plus exercise, corticosteroid injection, and wait and see on global rating of change at 52 weeks. Potential mediators measured at baseline and 8 weeks were hip active abduction range, abductor muscle torque, pain self-efficacy, pain constancy, and patient-specific function. Potential moderators at baseline were Victorian Institute of Sport Assessment for gluteal tendinopathy, menopausal status, symptom duration, magnetic resonance imaging-determined tendon pathology, and pain catastrophizing. RESULTS: There is evidence from mediation analysis that the beneficial effect of education plus exercise on global rating of change relative to corticosteroid injection or wait and see may be due to changes in patient-specific function (indirect effect relative risk; 95% CI: 1.14 [1.05-1.29], 1.29 [1.12-1.58], respectively), pain constancy (1.12 [1.03-1.27], 1.2 [1.08-1.41]), and pain self-efficacy (1.1 [1.02-1.25], 1.18 [1.04-1.44])-not active hip movement/muscle torque. Moderation analysis did not support our included patient characteristics. CONCLUSION: Education plus exercise is likely to improve global rating of change for persons with gluteal tendinopathy relative to corticosteroid injection and wait and see through improvements in patient-specific function, pain self-efficacy, and reduced pain constancy. We found no evidence of differences in the effect of education plus exercise in patient subgroups based on disability, menopausal status, symptom duration, tendon pathology, or pain catastrophizing. J Orthop Sports Phys Ther 2022;52(12):826-836. Epub: 17 October 2022. doi:10.2519/jospt.2022.11261 .

Background: We compared baseline characteristics and outcomes and evaluated the subgroup effects of randomised interventions by sex in males and females in large international perioperative trials., Methods: Nine randomised trials and two cohort studies recruiting adult patients, conducted between 1995 and 2020, were included. Baseline characteristics and outcomes common to six or more studies were evaluated. Regression models included terms for sex, study, and an interaction between the two. Comparing outcomes without adjustment for baseline characteristics represents the 'total effect' of sex on the outcome., Results: Of 54 626 participants, 58% were male and 42% were female. Females were less likely to have ASA physical status ≥3 (56% vs 64%), to smoke (15% vs 23%), have coronary artery disease (21% vs 32%), or undergo vascular surgery (10% vs 23%). The pooled incidence of death was 1.6% in females and 1.8% in males (risk ratio [RR] 0.92; 95% confidence interval [CI]: 0.81-1.05; P=0.20), of myocardial infarction was 4.2% vs 4.5% (RR 0.92; 95% CI: 0.81-1.03; P=0.10), of stroke was 0.5% vs 0.6% (RR 1.03; 95% CI: 0.79-1.35; P=0.81), and of surgical site infection was 8.6% vs 8.3% (RR 1.03; 95% CI: 0.79-1.35; P=0.70). Treatment effects of three interventions demonstrated statistically significant effect modification by sex., Conclusions: Females were in the minority in all included studies. They were healthier than males, but outcomes were comparable. Further research is needed to understand the reasons for this discrepancy., Clinical Trial Registration: International Registry of Meta-Research (UID: IRMR_000011; 5 January 2021)., (Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Abstract: Risk factors for low back pain (LBP) flares have been considered about self-reported measures. This case-crossover study aimed to investigate whether (1) objective measures of physical activity and sleep were associated with the risk of experiencing LBP flares and (2) these associations differed for flares defined as pain 2 or more points greater than average pain over the period using an 11-point Numerical rating scale (0-no pain and 10-worst pain imaginable) (pain-defined flare: PDF) and flares identified by participants according to a broader definition that considered emotions or coping (self-reported flare [SRF]). We included 126 participants who had experienced LBP for >3 months. Physical activity and sleep were monitored for 28 days using wearable sensors. Occurrence of flares (PDF or SRF) was assessed daily using a smartphone application. Data on exposure to risk factors 1, 2, and 3 days preceding PDF or SRF were compared with nonflare control periods. Conditional logistic regression determined association between each factor and flares. Data show that day-to-day variation in physical activity and in-bed time are associated with the risk of LBP flares, but associations differ depending on how flare is defined. Longer in-bed time increased the risk of PDF but not SRF. Although physical activity was not associated with the risk of PDF, greater sedentary behaviour increased the risk of SRF and being more physically active decreased the risk for SRF. These results highlight the potential role of targeting sleep and physical activity in interventions to prevent LBP flares and indicate that risk factors differ depending on how LBP flares are defined., (Copyright © 2022 International Association for the Study of Pain.)

Stepped wedge designs are an increasingly popular variant of longitudinal cluster randomized trial designs, and roll out interventions across clusters in a randomized, but step-wise fashion. In the standard stepped wedge design, assumptions regarding the effect of time on outcomes may require that all clusters start and end trial participation at the same time. This would require ethics approvals and data collection procedures to be in place in all clusters before a stepped wedge trial can start in any cluster. Hence, although stepped wedge designs are useful for testing the impacts of many cluster-based interventions on outcomes, there can be lengthy delays before a trial can commence. In this article, we introduce "batched" stepped wedge designs. Batched stepped wedge designs allow clusters to commence the study in batches, instead of all at once, allowing for staggered cluster recruitment. Like the stepped wedge, the batched stepped wedge rolls out the intervention to all clusters in a randomized and step-wise fashion: a series of self-contained stepped wedge designs. Provided that separate period effects are included for each batch, software for standard stepped wedge sample size calculations can be used. With this time parameterization, in many situations including when linear models are assumed, sample size calculations reduce to the setting of a single stepped wedge design with multiple clusters per sequence. In these situations, sample size calculations will not depend on the delays between the commencement of batches. Hence, the power of batched stepped wedge designs is robust to unexpected delays between batches., (© 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.)

Background: When designing and analysing longitudinal cluster randomised trials, such as the stepped wedge, the similarity of outcomes from the same cluster must be accounted for through the choice of a form for the within-cluster correlation structure. Several choices for this structure are commonly considered for application within the linear mixed model paradigm. The first assumes a constant intra-cluster correlation for all pairs of outcomes from the same cluster (the exchangeable/Hussey and Hughes model); the second assumes that correlations of outcomes measured in the same period are higher than outcomes measured in different periods (the block exchangeable model) and the third is the discrete-time decay model, which allows the correlation between pairs of outcomes to decay over time. Currently, there is limited guidance on how to select the most appropriate within-cluster correlation structure., Methods: We simulated continuous outcomes under each of the three considered within-cluster correlation structures for a range of design and parameter choices, and, using the ASReml-R package, fit each linear mixed model to each simulated dataset. We evaluated the performance of the Akaike and Bayesian information criteria for selecting the correct within-cluster correlation structure for each dataset., Results: For smaller total sample sizes, neither criteria performs particularly well in selecting the correct within-cluster correlation structure, with the simpler exchangeable model being favoured. Furthermore, in general, the Bayesian information criterion favours the exchangeable model. When the cluster auto-correlation (which defines the degree of dependence between observations in adjacent time periods) is large and number of periods is small, neither criteria is able to distinguish between the block exchangeable and discrete time decay models. However, for increasing numbers of clusters, periods, and subjects per cluster period, both the Akaike and Bayesian information criteria perform increasingly well in the detection of the correct within-cluster correlation structure., Conclusions: With increasing amounts of data, be they number of clusters, periods or subjects per cluster period, both the Akaike and Bayesian information criteria are increasingly likely to select the correct correlation structure. We recommend that if there are sufficient data available when planning a trial, that the Akaike or Bayesian information criterion is used to guide the choice of within-cluster correlation structure in the absence of other compelling justifications for a specific correlation structure. We also suggest that researchers conduct supplementary analyses under alternate correlation structures to gauge sensitivity to the initial choice.

Background: There are very few patient-centred global outcome measures of recovery in the days or weeks after surgery. This meta-analysis evaluated the psychometric properties and clinical acceptability of the 15-item quality of recovery (QoR-15) scale., Methods: We searched bibliographic databases for studies undertaking psychometric evaluation of the QoR-15 or using the QoR-15 as an outcome measure after surgery. Record screening, data extraction, and quality assessments were independently done by two researchers. Weighted averages estimating overall summary statistics across all the studies were calculated using random-effects meta-analysis. Pooled correlation coefficients were transformed using a Fisher z-transformation and then back-transformed to calculate pooled results. The four co-primary endpoints were validity, reliability, responsiveness, and clinical utility of the QoR-15 scale., Results: A total of 26 unique studies met the eligibility criteria, yielding up to 22 847 patients across 16 countries, in 15 languages. A further 172 studies in a further 18 countries and six languages used the QoR-15 as an outcome measure. The QoR-15 had excellent discriminant validity, with the mean difference in QoR-15 scores in patients with and without postoperative complications (9.6; 95% confidence interval [CI], 5.9-13.3; P<0.001), and good convergent validity (for a global visual analogue recovery scale, pooled r=0.63; 95% CI, 0.54-0.71). There was excellent reliability: internal consistency (pooled α=0.85; 95% CI, 0.83-0.87), split-half reliability=0.80 (95% CI, 0.75-0.84), and test-retest reliability=0.97 (95% CI, 0.95-0.98). There was also high responsiveness (pooled standardised response mean=0.87; 95% CI, 0.65-1.08), patient recruitment into evaluation studies (96%; 95% CI, 93-99), and excellent completion and return rates (91%; 95% CI, 84-96). The mean time to complete the QoR-15 was 2.7 (95% CI, 2.2-3.1) min., Conclusions: The QoR-15 is a valid, reliable, and responsive patient-centred outcome metric in surgical patients. It is highly acceptable to both patients and clinicians., Registration: Open Science Framework Identifier: DOI 10.17605/OSF.IO/78HTA., Competing Interests: Declaration of interest PM was the co-developer of the QoR-15 scale, and is an editor of the Brtish Journal of Anaesthesia. PM, MAS and JK received grants from the Australian National Health and Medical Research Council. No other disclosures were reported., (Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Objective: the COVID-19 pandemic has incurred psychological risks for healthcare workers (HCWs). We established a Victorian HCW cohort (the Coronavirus in Victorian Healthcare and Aged-Care Workers (COVIC-HA) cohort study) to examine COVID-19 impacts on HCWs and assess organisational responses over time., Methods: mixed-methods cohort study, with baseline data collected via an online survey (7 May-18 July 2021) across four healthcare settings: ambulance, hospitals, primary care, and residential aged-care. Outcomes included self-reported symptoms of depression, anxiety, post-traumatic stress (PTS), wellbeing, burnout, and resilience, measured using validated tools. Work and home-related COVID-19 impacts and perceptions of workplace responses were also captured., Results: among 984 HCWs, symptoms of clinically significant depression, anxiety, and PTS were reported by 22.5%, 14.0%, and 20.4%, respectively, highest among paramedics and nurses. Emotional exhaustion reflecting moderate-severe burnout was reported by 65.1%. Concerns about contracting COVID-19 at work and transmitting COVID-19 were common, but 91.2% felt well-informed on workplace changes and 78.3% reported that support services were available., Conclusions: Australian HCWs employed during 2021 experienced adverse mental health outcomes, with prevalence differences observed according to occupation. Longitudinal evidence is needed to inform workplace strategies that support the physical and mental wellbeing of HCWs at organisational and state policy levels.

Background: Stepped wedge trials are an appealing and potentially powerful cluster randomized trial design. However, they are frequently implemented with a small number of clusters. Standard analysis methods for these trials such as a linear mixed model with estimation via maximum likelihood or restricted maximum likelihood (REML) rely on asymptotic properties and have been shown to yield inflated type I error when applied to studies with a small number of clusters. Small-sample methods such as the Kenward-Roger approximation in combination with REML can potentially improve estimation of the fixed effects such as the treatment effect. A Bayesian approach may also be promising for such multilevel models but has not yet seen much application in cluster randomized trials., Methods: We conducted a simulation study comparing the performance of REML with and without a Kenward-Roger approximation to a Bayesian approach using weakly informative prior distributions on the intracluster correlation parameters. We considered a continuous outcome and a range of stepped wedge trial configurations with between 4 and 40 clusters. To assess method performance we calculated bias and mean squared error for the treatment effect and correlation parameters and the coverage of 95% confidence/credible intervals and relative percent error in model-based standard error for the treatment effect., Results: Both REML with a Kenward-Roger standard error and degrees of freedom correction and the Bayesian method performed similarly well for the estimation of the treatment effect, while intracluster correlation parameter estimates obtained via the Bayesian method were less variable than REML estimates with different relative levels of bias., Conclusions: The use of REML with a Kenward-Roger approximation may be sufficient for the analysis of stepped wedge cluster randomized trials with a small number of clusters. However, a Bayesian approach with weakly informative prior distributions on the intracluster correlation parameters offers a viable alternative, particularly when there is interest in the probability-based inferences permitted within this paradigm., (© 2022. The Author(s).)

Background: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions., Objective: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention., Design: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280)., Setting: Australian private health insurance members., Participants: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m 2 who were aged 45 to 80 years., Intervention: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources., Measurements: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery., Results: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months., Limitation: Participants and clinicians were unblinded., Conclusion: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise., Primary Funding Source: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.

Objective: To determine whether the effect of hip exercise on patellofemoral pain is mediated through changes in hip muscle strength or psychological factors., Design: Secondary mediation analysis of a randomized clinical trial, in which 218 participants with patellofemoral pain were randomly assigned to receive foot orthoses or hip exercises., Methods: Pain (Knee injury and Osteoarthritis Outcome Score pain subscale) and number of pain-free squats at 12 weeks were the outcomes for this mediation analysis, as they are pathognomonic of patellofemoral pain. Hip strength dynamometry (abduction, adduction, and external rotation) and psychological characteristics (pain catastrophizing, kinesiophobia, and anxiety) measured at 6 weeks were considered as potential mediators. We used mediation analysis to decompose the total effect of treatment on the outcome into (1) the "indirect effect" (ie, the portion acting through the mediator) and (2) the "direct effect.", Results: The effect of hip exercise on pain and squats was not mediated by any of the strength or psychological mediators analyzed. All indirect effects were small and showed wide 95% confidence intervals (CIs) that contained zero (eg, for pain-free squats: abduction strength, -0.13; 95% CI: -0.49, 0.23; Tampa Scale of Kinesiophobia, -0.17; 95% CI: -0.64, 0.30)., Conclusion: Hip strength improved after hip exercise, yet strength did not mediate improvements in pain and pain-free squats, and alternative psychological mediators were not implicated. J Orthop Sports Phys Ther 2021;51(12):602-610. doi:10.2519/jospt.2021.10674 .

Importance: Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing., Objective: To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA., Design, Setting, and Participants: This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n = 288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020., Interventions: Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants)., Main Outcomes and Measures: The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up., Results: Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of -2.1 vs -1.8 points, respectively (difference, -0.4 [95% CI, -0.9 to 0.2] points; P = .17). The mean change in medial tibial cartilage volume was -1.4% vs -1.2%, respectively (difference, -0.2% [95% CI, -1.9% to 1.5%]; P = .81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences., Conclusions and Relevance: Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA., Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617000853347.

Background: Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis., Methods: Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups., Discussion: This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124., (© 2021. The Author(s).)

In cluster-randomized trials, sometimes the effect of the intervention being studied differs between clusters, commonly referred to as treatment effect heterogeneity. In the analysis of stepped wedge and cluster-randomized crossover trials, it is possible to include terms in outcome regression models to allow for such treatment effect heterogeneity yet this is not frequently considered. Outside of some simulation studies of specific cases where the outcome is binary, the impact of failing to include terms for treatment effect heterogeneity on the variance of the treatment effect estimator is unknown. We analytically examine the impact of failing to include terms for treatment effect heterogeneity on the variance of the treatment effect estimator, when outcomes are continuous. Using analysis of variance and feasible generalized least squares we provide expressions for this variance. For both the cluster-randomized crossover design and the stepped wedge design, our analytic derivations indicate that failing to include treatment effect heterogeneity results in the estimates for variance of the treatment effect that are too small, leading to inflation of type I error rates. We therefore recommend assessing the sensitivity of sample size calculations and conclusions drawn from the analysis of cluster randomized trials to the inclusion of treatment effect heterogeneity.

Background: Sample size calculations for longitudinal cluster randomised trials, such as crossover and stepped-wedge trials, require estimates of the assumed correlation structure. This includes both within-period intra-cluster correlations, which importantly differ from conventional intra-cluster correlations by their dependence on period, and also cluster autocorrelation coefficients to model correlation decay. There are limited resources to inform these estimates. In this article, we provide a repository of correlation estimates from a bank of real-world clustered datasets. These are provided under several assumed correlation structures, namely exchangeable, block-exchangeable and discrete-time decay correlation structures., Methods: Longitudinal studies with clustered outcomes were collected to form the CLustered OUtcome Dataset bank. Forty-four available continuous outcomes from 29 datasets were obtained and analysed using each correlation structure. Patterns of within-period intra-cluster correlation coefficient and cluster autocorrelation coefficients were explored by study characteristics., Results: The median within-period intra-cluster correlation coefficient for the discrete-time decay model was 0.05 (interquartile range: 0.02-0.09) with a median cluster autocorrelation of 0.73 (interquartile range: 0.19-0.91). The within-period intra-cluster correlation coefficients were similar for the exchangeable, block-exchangeable and discrete-time decay correlation structures. Within-period intra-cluster correlation coefficients and cluster autocorrelations were found to vary with the number of participants per cluster-period, the period-length, type of cluster (primary care, secondary care, community or school) and country income status (high-income country or low- and middle-income country). The within-period intra-cluster correlation coefficients tended to decrease with increasing period-length and slightly decrease with increasing cluster-period sizes, while the cluster autocorrelations tended to move closer to 1 with increasing cluster-period size. Using the CLustered OUtcome Dataset bank, an RShiny app has been developed for determining plausible values of correlation coefficients for use in sample size calculations., Discussion: This study provides a repository of intra-cluster correlations and cluster autocorrelations for longitudinal cluster trials. This can help inform sample size calculations for future longitudinal cluster randomised trials.

Background: Approaches to routine diagnostic testing in the intensive care unit include time-scheduled testing and targeted testing. Blood tests and chest radiographs requested on a routine, time-scheduled basis may reduce the risk of missing important findings. Targeted testing, considering individual patient needs, may reduce unnecessary testing, wasted clinician time, and costs. However, existing evidence of targeted testing interventions is generally of low quality, and the optimal testing approach is uncertain., Objectives: The aim of the study was to describe the development of an intervention to reduce unnecessary diagnostic test ordering by clinicians working in intensive care, with the aim of informing the design of a pivotal clinical trial., Methods: The Capability, Opportunity, Motivation-Behaviour model was used as a theoretical framework for change. The intervention components were informed by systematically identifying, assessing, and classifying targeted testing interventions in behavioural terms. Feedback from intensive care clinicians and patients was sought using surveys and a consumer reference group., Results: The mean percentage of routine tests considered unnecessary by 201 intensive care clinicians was 33 (standard deviation = 16). When presented with a statement of the pros and cons for targeted versus liberal testing (n = 154), 93 (60%) consumer survey respondents preferred a more liberal approach, 33 (21%) preferred a more restrictive approach, and 28 (18%) were unsure. There were 24 behavioural interventions identified and incorporated into the final intervention. This had five major components: (i) a management committee to acquire, disseminate, and coordinate intervention-related information, (ii) a targeted testing guideline for sites, (iii) educational material for sites, (iv) site medical and nursing champions, and (v) site audit and feedback., Conclusions: Although surveyed intensive care clinicians report substantial unnecessary routine diagnostic testing, on the basis of currently available evidence, consumers prefer a more liberal approach. This feedback, and a framework to identify behavioural interventions, has been used to inform the design of a proposed targeted testing clinical trial., (Copyright © 2020 Australian College of Critical Care Nurses Ltd. All rights reserved.)

Background: The internet is used for information related to health conditions, including low back pain (LBP), but most LBP websites provide inaccurate information. Few studies have investigated the effectiveness of internet resources in changing health literacy or treatment choices., Objective: This study aims to evaluate the effectiveness of the MyBackPain website compared with unguided internet use on health literacy, choice of treatments, and clinical outcomes in people with LBP., Methods: This was a pragmatic, web-based, participant- and assessor-blinded randomized trial of individuals with LBP stratified by duration. Participants were randomly allocated to have access to the evidence-based MyBackPain website, which was designed with input from consumers and expert consensus or unguided internet use. The coprimary outcomes were two dimensions of the Health Literacy Questionnaire (dimension 2: "having sufficient information to manage my health;" dimension 3: "actively managing my health;" converted to scores 1-100) at 3 months. Secondary outcomes included additional Health Literacy Questionnaire dimensions, quality of treatment choices, and clinical outcomes., Results: A total of 453 participants were recruited, and 321 (70.9%) completed the primary outcomes. Access to MyBackPain was not superior to unguided internet use on primary outcomes (dimension 2: mean difference -0.87 units, 95% CI -3.56 to 1.82; dimension 3: mean difference -0.41 units, 95% CI -2.78 to 1.96). Between-group differences in other secondary outcomes had inconsistent directions and were unlikely to be clinically important, although a small improvement of unclear importance in the quality of stated treatment choices at 1 month was found (mean difference 0.93 units, 95% CI 0.03 to 1.84)., Conclusions: MyBackPain was not superior to unguided internet use for health literacy, but data suggest some short-term improvement in treatment choices. Future research should investigate if greater interactivity and engagement with the website may enhance its impact., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001292369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372926., International Registered Report Identifier (irrid): RR2-10.1136/bmjopen-2018-027516., (©Paul William Hodges, Leanne Hall, Jenny Setchell, Simon French, Jessica Kasza, Kim Bennell, David Hunter, Bill Vicenzino, Samuel Crofts, Chris Dickson, Manuela Ferreira. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 15.06.2021.)

Importance: Exercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake., Objective: To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA., Design, Setting, and Participants: The participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks., Interventions: The control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence., Main Outcomes and Measures: Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction., Results: Of 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P <. 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P < .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences., Conclusions and Relevance: This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population., Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001167257.

Abstract: Adolescent knee pain has a propensity for chronicity, impacting physical activity and health into adulthood. The aim of this study is to investigate prognostic factors in adolescents with knee pain using individual participant data (IPD) meta-analysis. Studies were identified through a systematic search and a collaborative group. We included IPD from prospective studies of adolescents (age 10-19 years) with nontraumatic knee pain (13 studies and 1516 adolescents with 1281 unique participants). Primary outcomes were pain intensity and function (Knee Injury and Osteoarthritis Outcome Score "Sport/Rec" subscale). Primary endpoint was 12 months. Risk of bias was appraised with Quality in Prognosis Studies tool. Harmonised IPD was analysed by multilevel modelling. Fifty-one percent reported knee pain after 12-months. Lower baseline pain frequency was associated with lower pain intensity at 12 months ("less than weekly"; 12 (95% confidence interval [CI] 7-17) and "monthly"; 15 (95% CI 9-22) points lower on a 100-point pain scale, compared with "almost daily pain"). Other factors most strongly associated with 1-year pain prognosis were lower quality of life (30, 95% CI 19-42 points per unit change in the EQ5D index score), female sex (8 points, 95% CI 4-12 higher compared with males), and bilateral pain (7, 95% CI 1-13 points higher pain). Similar factors were associated with function. Body mass index, pain sensitivity, and knee strength were not associated with prognosis of pain or function. Adolescent knee pain is associated with clinically relevant long-term pain and functional deficits. Self-reported characteristics may help identify those at risk of poor prognosis., (Copyright © 2021 International Association for the Study of Pain.)

Analysis of time-to-event data, otherwise known as survival analysis, is a common investigative tool in ophthalmic research. For example, time-to-event data is useful when researchers are interested in investigating how long it takes for an ocular condition to worsen or whether treatment can delay the development of a potentially vision-threatening complication. Its implementation requires a different set of statistical tools compared to those required for analyses of other continuous and categorial outcomes. In this installment of the Focus on Data series, we present an overview of selected concepts relating to analysis of time-to-event data in eye research. We introduce censoring, model selection, consideration of model assumptions, and best practice for reporting. We also consider challenges that commonly arise when analyzing time-to-event data in ophthalmic research, including collection of data from two eyes per person and the presence of multiple outcomes of interest. The concepts are illustrated using data from the Laser Intervention in Early Stages of Age-Related Macular Degeneration study and statistical computing code for Stata is provided to demonstrate the application of the statistical methods to illustrative data.

Purpose: Although risk factors for new low back pain (LBP) episodes and acute-to-chronic transition have been identified, risk factors for flares of LBP remain largely unknown. This case-crossover study aimed to identify: (1) risk factors LBP flares and (2) whether risk factors differed when flare is defined by pain increase (pain-defined flare: PDF) or identified by participants according to a broader flare definition that considered emotions and coping (self-reported flare: SRF)., Methods: One hundred and twenty-six participants with LBP for > 3 months were included. Candidate risk factors and flares (PDF/SRF) were assessed daily using a smartphone application for 28 days. Data on exposure to risk factors one, two and three days preceding PDF/SRF were compared to control periods. Conditional logistic regression estimated associations between risk factors and PDF/SRF., Results: Odds of PDF and SRF were increased by poor sleep quality and morning pain. Good sleep quality reduced odds of flare. Odds for increased pain (PDF), but not SRF, were increased after days with higher afternoon and evening pain, fatigue, fear of physical activity and leisure physical activity., Conclusion: LBP flare has been largely ignored but is more reflective of the LBP experience than conventional definitions of acute, sub-acute and chronic LBP. This study highlights risk factors for flare and that these differ depending on whether flare is defined by pain alone (PDF) or a broad multidimensional definition (SRF). Potential targets to reduce the intensity/frequency of LBP flares are identified, with strong indication for the potential role of sleep intervention to mitigate LBP flare risk.

Objective: The term flare is commonly used to describe low back pain (LBP) fluctuations, but individuals with LBP consider that it does not always correspond to increased pain. This case cross-over study aimed to: (1) determine the extent to which days with a flare identified according to a multidimensional definition (self-reported flare, SRF) corresponded to days with greater than average pain (pain-defined flare, PDF) and (2) to investigate whether physical and psychosocial features differ between PDF and SRF., Materials and Methods: Individuals with LBP for ≥3 months (N=126) provided data on flares, physical, and psychosocial features daily for 28 days using a smartphone application., Results: Most days with SRF (68%) did not have greater than average pain (ie, PDF), but most days with greater than average pain (64%) were reported as an SRF. On days with SRF-only all physical and psychosocial features were worse than nonflare days. SRF+PDF had lower sleep quality and higher pain intensity, fatigue, disability, pain catastrophizing, and fear avoidance than SRF-only. SRF+PDF had higher pain in the afternoon and evening, disability and pain catastrophizing than PDF-only. Self-efficacy at work and during leisure activities was worse on SRF+PDF days than SRF-only and PDF-only days., Discussion: These findings highlight that when individuals with LBP consider they have a flare, they do not always have greater than average pain, but have worse psychosocial features. This emphasizes that flare has broader dimensions than pain alone. Consideration of flare according to broad dimensions is important when investigating symptom fluctuations across different LBP trajectories., Competing Interests: Supported by a Program grant (APP1091302); Centres of Research Excellence grant (APP1079078) and Fellowship (P.W.H.—APP1102905; M.F.—APP1143593) from the National Health and Medical Research Council (NHMRC), Canberra, ACT, Australia. The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Experts recommend that persons with knee osteoarthritis wear stable supportive shoes; however, evidence suggests that flat flexible shoes may be more beneficial., Objective: To compare flat flexible with stable supportive shoes for knee osteoarthritis symptoms., Design: Participant- and assessor-blinded randomized trial. (Prospectively registered with the Australian New Zealand Clinical Trials Registry [ACTRN12617001098325])., Setting: Community., Participants: 164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis., Intervention: Flat flexible ( n  = 82) or stable supportive shoes ( n  = 82), worn for at least 6 hours a day for 6 months., Measurements: Primary outcomes were changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale of 0 to 68 points) at 6 months. Secondary outcomes included additional pain and function measures, physical activity, and quality of life. Other measures included adverse events., Results: Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes. No evidence was found that flat flexible shoes were superior to stable supportive shoes in primary outcomes. Evidence did show a between-group difference in change in pain favoring stable supportive shoes (mean difference, 1.1 units [95% CI, 0.5 to 1.8 units]; P  = 0.001) but not function (mean difference, 2.3 units [CI, -0.9 to 5.5 units]; P  = 0.167). Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively). Flat flexible shoes were not superior to stable supportive shoes for any secondary outcome. Fewer participants reported adverse events with stable supportive shoes ( n  = 12 [15%]) compared with flat flexible shoes ( n  = 26 [32%]) (risk difference, -0.17 [CI, -0.30 to -0.05])., Limitation: No "usual shoes" control group and a select patient subgroup, which may limit generalizability., Conclusion: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes., Primary Funding Source: National Health and Medical Research Council.

In practice, stepped wedge trials frequently include clusters of differing sizes. However, investigations into the theoretical aspects of stepped wedge designs have, until recently, typically assumed equal numbers of subjects in each cluster and in each period. The information content of the cluster-period cells, clusters, and periods of stepped wedge designs has previously been investigated assuming equal cluster-period sizes, and has shown that incomplete stepped wedge designs may be efficient alternatives to the full stepped wedge. How this changes when cluster-period sizes are not equal is unknown, and we investigate this here. Working within the linear mixed model framework, we show that the information contributed by design components (clusters, sequences, and periods) does depend on the sizes of each cluster-period. Using a particular trial that assessed the impact of an individual education intervention on log-length of stay in rehabilitation units, we demonstrate how strongly the efficiency of incomplete designs depends on which cells are excluded: smaller incomplete designs may be more powerful than alternative incomplete designs that include a greater total number of participants. This also serves to demonstrate how the pattern of information content can be used to inform a set of incomplete designs to be considered as alternatives to the complete stepped wedge design. Our theoretical results for the information content can be extended to a broad class of longitudinal (ie, multiple period) cluster randomized trial designs., (© 2021 John Wiley & Sons, Ltd.)

Competing Interests: Competing interests: BTV reports grants from Commonwealth of Australia National Health and Medical Research Council (Ref: 631717) and from Vionics International for this research. MM is supported by an Australian Postgraduate Award. BTV and TM are voluntary (non-compensated) members by invitation on the Vasyli Think Tank.

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.

Background: The therapeutic alliance between patients and physical therapists has been shown to influence clinical outcomes in patients with chronic low back pain when consulting in-person. However, no studies have examined whether the therapeutic alliance developed between patients with knee osteoarthritis and physical therapists during telephonic consultations influences clinical outcomes., Objective: This study aims to investigate whether the therapeutic alliance between patients with knee osteoarthritis and physical therapists measured after the second consultation is associated with outcomes following telephone-delivered exercise and advice., Methods: Secondary analysis of 87 patients in the intervention arm of a randomized controlled trial allocated to receive 5 to 10 telephone consultations with one of 8 physical therapists over a period of 6 months, involving education and prescription of a strengthening and physical activity program. Separate regression models investigated the association between patient and therapist ratings of therapeutic alliance (measured after the second consultation using the Working Alliance Inventory Short Form) and outcomes (pain, function, self-efficacy, quality of life, global change, adherence to prescribed exercise, physical activity) at 6 and 12 months, with relevant covariates included., Results: There was some evidence of a weak association between patient ratings of the alliance and some outcomes at 6 months (improvements in average knee pain: regression coefficient -0.10, 95% CI -0.16 to -0.03; self-efficacy: 0.16, 0.04-0.28; global improvement in function: odds ratio 1.26, 95% CI 1.04-1.39, and overall improvement: odds ratio 1.26, 95% CI 1.06-1.51; but also with worsening in fear of movement: regression coefficient -0.13, 95% CI -0.23 to -0.04). In addition, there was some evidence of a weak association between patient ratings of the alliance and some outcomes at 12 months (improvements in self-efficacy: regression coefficient 0.15, 95% CI 0.03-0.27; global improvement in both function, odds ratio 1.19, 95% CI 0.03-1.37; and pain, odds ratio 1.14, 95% CI 1.01-1.30; and overall improvement: odds ratio 1.21, 95% CI 1.02-1.42). The data suggest that associations between therapist ratings of therapeutic alliance and outcomes were not strong, except for improved quality of life at 12 months (regression coefficient 0.01, 95% CI 0.0003-0.01)., Conclusions: Higher patient ratings, but not higher therapist ratings, of the therapeutic alliance were weakly associated with improvements in some clinical outcomes and with worsening in one outcome. Although the findings suggest that patients who perceive a stronger alliance with their therapist may achieve better clinical outcomes, the observed relationships were generally weak and unlikely to be clinically significant. The limitations include the fact that measures of therapeutic alliance have not been validated for use in musculoskeletal physical therapy settings. There was a risk of type 1 error; however, findings were interpreted on the basis of clinical significance rather than statistical significance alone., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000054415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369204., (©Belinda Joan Lawford, Kim L Bennell, Penny K Campbell, Jessica Kasza, Rana S Hinman. Originally published in JMIR Rehabilitation and Assistive Technology (http://rehab.jmir.org), 18.01.2021.)

Background: First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA., Methods: The FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity., Discussion: This study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA., Trial Registration: Prospectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134 ) on 3/07/2019.

Objectives: To test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility., Methods: A two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18-40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility ( high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks., Results: Of 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%)., Conclusion: Midfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain., Trial Registration Number: ACTRN12614000260628., Competing Interests: Competing interests: BV reports grants from Commonwealth of Australia National Health and Medical Research Council (Ref: 631717) and from Vionics International for this research. MM is supported by an Australian Postgraduate Award. BV and TM are voluntary (non-compensated) members by invitation on the Vasyli Think Tank., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: We consider the design of stepped wedge trials with continuous recruitment and continuous outcome measures. Suppose we recruit from a fixed number of clusters where eligible participants present continuously, and suppose we have fine control over when each cluster crosses to the intervention. Suppose also that we want to minimise the number of participants, leading us to consider "incomplete" designs (i.e. without full recruitment). How can we schedule recruitment and cross-over at different clusters to recruit efficiently while achieving good precision?, Methods: The large number of possible designs can make exhaustive searches impractical. Instead we consider an algorithm using iterative improvements to hunt for an efficient design. At each iteration (starting from a complete design) a single participant - the one with the smallest impact on precision - is removed, and small changes preserving total sample size are made until no further improvement in precision can be found., Results: Striking patterns emerge. Solutions typically focus recruitment and cross-over on the leading diagonal of the cluster-by-time diagram, but in some scenarios clusters form distinct phases resembling before-and-after designs., Conclusions: There is much to be learned about optimal design for incomplete stepped wedge trials. Algorithmic searches could offer a practical approach to trial design in complex settings generally.

Background: Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision., Objective: This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS., Methods: A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m 2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory-informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia., Results: A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes., Conclusions: An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes., Trial Registration: Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5., International Registered Report Identifier (irrid): RR2-10.1186/s12891-019-2801-z., (©Kim Bennell, Rachel K Nelligan, Sarah Schwartz, Jessica Kasza, Alexander Kimp, Samuel JC Crofts, Rana S Hinman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.09.2020.)

Background: Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services., Methods: This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30-45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience. Non-inferiority will be assessed using the per-protocol dataset., Discussion: Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA., Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12619001240134. http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377672&isReview=true.

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)., Competing Interests: Competing interests: JG owns HealthChange Australia, which trained the physiotherapists in behavioural change methodology and employs CB as a training facilitator. AMB was a salaried employee of Arthritis and Osteoporosis Victoria (now known as Musculoskeletal Australia) at the time this trial was designed and grant funding awarded. SJB is employed as Medibank’s Clinical Research Advisor., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Different exercise types may yield different outcomes in osteoarthritis (OA) subgroups. The objective was to directly compare effectiveness of two exercise programs for people with medial knee OA and co-morbid obesity., Design: We performed a participant- and assessor-blinded randomized controlled trial. 128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2 were recruited from the community. Interventions were home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise for 12 weeks. Primary outcomes were change in overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 12 weeks. Secondary outcomes included other pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength., Results: 123 (96%) participants were retained. There was no evidence of a between-group difference in change in pain (mean difference 0.73 units (95% confidence intervals (0.05,1.50)) or function (2.80 units (-1.17,6.76)), with both groups reporting improvements. For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98). Although adverse events were minor, more NWB group participants reported ≥1 adverse event (26/66 (39%) vs 14/62 (23%), p = 0.04)., Conclusions: Both exercise types similarly improved primary outcomes of pain and function and can be recommended for people with knee OA and obesity. WB exercise may be preferred given fewer adverse events and potential additional benefits on some secondary outcomes., Registration: Prospectively registered (Australian New Zealand Clinical Trials Registry #12617001013358, 14/7/2017)., (Copyright © 2020 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

It has long been recognized that sample size calculations for cluster randomized trials require consideration of the correlation between multiple observations within the same cluster. When measurements are taken at anything other than a single point in time, these correlations depend not only on the cluster but also on the time separation between measurements and additionally, on whether different participants (cross-sectional designs) or the same participants (cohort designs) are repeatedly measured. This is particularly relevant in trials with multiple periods of measurement, such as the cluster cross-over and stepped-wedge designs, but also to some degree in parallel designs. Several papers describing sample size methodology for these designs have been published, but this methodology might not be accessible to all researchers. In this article we provide a tutorial on sample size calculation for cluster randomized designs with particular emphasis on designs with multiple periods of measurement and provide a web-based tool, the Shiny CRT Calculator, to allow researchers to easily conduct these sample size calculations. We consider both cross-sectional and cohort designs and allow for a variety of assumed within-cluster correlation structures. We consider cluster heterogeneity in treatment effects (for designs where treatment is crossed with cluster), as well as individually randomized group-treatment trials with differential clustering between arms, for example designs where clustering arises from interventions being delivered in groups. The calculator will compute power or precision, as a function of cluster size or number of clusters, for a wide variety of designs and correlation structures. We illustrate the methodology and the flexibility of the Shiny CRT Calculator using a range of examples., (© The Author(s) 2020. Published by Oxford University Press on behalf of the International Epidemiological Association.)

Background: The World Health Organization Disability Assessment Schedule 2.0 has been used to measure postoperative disability in several clinical trials and cohort studies. It is uncertain what the minimal clinically important difference or patient-acceptable symptom state scores are for this scale in patients recovering from surgery., Methods: The authors analyzed prospectively collected data from three studies that measured disability 3 and 6 months after surgery. Three distribution-based methods (0.3 multiplied by SD, standard error of the measurement, and 5% range) and two anchor-based methods (anchored to two patient-rated health status questions and separately to unplanned hospital readmission) were averaged to estimate the minimal clinically important difference for the World Health Organization Disability Assessment Schedule 2.0 score converted to a percentage scale. Scores consistent with a patient-acceptable symptom state and clinically significant disability were determined by an anchored 75th centile method., Results: Data from 4,361 patients were analyzed. The average minimal clinically important difference estimate for the World Health Organization Disability Assessment Schedule 2.0 was 5%, with similar estimates in patients with or without preoperative disability. The patient-acceptable symptom state score was 16%, and the score consistent with at least moderate clinically significant disability was 35%. Using these estimates, between baseline and 6 months after surgery, 21% of patients had a significant increase in disability, and 73% achieved a patient-acceptable symptom state., Conclusions: A change in World Health Organization Disability Assessment Schedule 2.0 score of 5% or more after surgery is consistent with a clinically important change in disability. Patients with a score less than 16% after surgery have an acceptable symptom state and can be considered as disability-free, whereas patients with a score of 35% or more can be considered as having at least moderate clinically significant disability.

Objective: To explore therapeutic alliance between physical therapists and patients with knee osteoarthritis during telephone consultations. Specifically, to describe and compare physical therapist and patient ratings, to determine whether alliance changes over time, and to evaluate whether individual characteristics are associated with alliance., Methods: We performed a secondary analysis of 84 patients in the intervention arm of a randomized controlled trial who completed 5-10 consultations with 1 of 8 physical therapists via telephone over 26 weeks, involving education, advice, and prescription of a strengthening and physical activity program. Therapeutic alliance was measured after the second (week 4) and final consultations (week 26), using the Working Alliance Inventory-Short Form., Results: Patient and physical therapist ratings of the alliance were high. At week 4, patients rated the overall alliance, and all 3 subscales, higher than therapists. At 26 weeks, patients rated the Task subscale higher than therapists. Patient ratings for the Goal subscale decreased over time, while physical therapist ratings for total alliance and the Bond subscale increased. For patients, the variables of living with others, consulting with a therapist with no previous experience delivering care remotely, having more telephone consultations, and having a higher self-efficacy were associated with greater alliance ratings. Therapists were more likely to perceive a stronger alliance if they had less clinical experience and when treating patients who were younger and had higher self-efficacy., Conclusion: Physical therapist perceptions of the therapeutic alliance tended to be lower than those of patients early in treatment, but differences were small and of unclear clinical significance. Some subgroups of patients rated the alliance more strongly than others., (© 2019, American College of Rheumatology.)

Background: The aim of this study was to examine the relationship between psychological characteristics and physical activity levels, measured as the average number of steps per day, in people with knee osteoarthritis (OA)., Methods: This study analysed baseline data from a randomized controlled trial (Australian New Zealand Clinical Trials Registry reference: ACTRN12612000308897). A total of 167 adults aged over 50 years, with knee pain rated as four or more on an 11-point numeric rating scale, and knee OA diagnosed using American College of Rheumatology clinical criteria, were recruited from the community (62 men and 105 women, mean age, 62.2 ± 7.5 years). The average number of steps per day over seven consecutive days was measured using an accelerometer-based device. Psychological characteristics evaluated were: depressive symptoms (Depression Anxiety Stress Scale), self-efficacy (Arthritis Self-Efficacy Scale for pain and other symptoms), fear of movement (Brief Fear of Movement Scale for Osteoarthritis), and pain catastrophizing (Pain Catastrophizing Scale). The association between the average number of steps per day and psychological characteristics was analyzed using a multiple linear regression analysis, with the average number of steps per day as the dependent variable, adjusting for each psychological characteristic separately, and age, sex, body mass index, and pain entered as covariates., Results: There was evidence that the amount of physical activity was associated with fear of movement (coefficient [B]: - 117, 95% confidence interval [95%CI]: - 227 to - 8) and with pain catastrophizing (B: -44, 95%CI: - 86 to - 1). The association with self-efficacy was similar (B:117, 95%CI: - 12 to 246). However, the direction of the association with depressive symptoms was less clear (B: -59, 95%CI: - 138 to 19)., Conclusions: The results of this study revealed that the relationship was such that lower fear of movement and lower pain catastrophizing may be associated with more steps per day. It may be hypothesized that fear of moving and pain catastrophizing lead to activity avoidance and that strategies to improve these disease-related psychological aspects may be useful in enhancing physical activity participation, although this hypothesis is highly speculative and needs further testing given the cross-sectional design of this study.