Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial.

Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear. Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score ≥6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-min reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model. ACTRN12618001799246; ClinicalTrials.govNCT03907748. Findings: Between 27th November 2019 and 7th July 2022, we randomised 432 eligible of 805 screened dyads (music n = 143, reading n = 144, UC n = 145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (-0.15, 95% CI -1.41 to 1.10, p = 0.81) or reading (-1.12, 95% CI -2.38 to 0.14, p = 0.082) and UC alone at 90-days. No related adverse events occurred. Interpretation: Our findings suggested that music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: Our funding was provided by National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer's Society, UK, as part of the Joint Programme for Neurodegenerative Diseases consortia scheme.

A self-directed digital exercise program for hip osteoarthritis ("My Hip Exercise"): protocol for a randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading global cause of chronic pain and disability. Given there is no cure for OA, patient self management is vital with education and exercise being core recommended treatments. However, there is under-utilisation of these treatments due to a range of clinician and patient factors. Innovative service models that increase patient accessibility to such treatments and provide support to engage are needed. This study primarily aims to determine the effects of a self-directed digital exercise intervention comprising online education and exercise supported by a mobile app to facilitate adherence on the primary outcomes of changes in hip pain during walking and patient-reported physical function at 24-weeks when compared to online education control for people with hip OA. METHODS: We will conduct a two-arm, superiority parallel-design, randomised controlled trial involving 182 community volunteers aged 45 years and over, with painful hip OA. After completing the baseline assessment, participants will be randomly assigned to either: i) digital exercise intervention; or ii) digital education (control). Participants randomised to the intervention group will have access to a website that provides information about hip OA and its management, advice about increasing their physical activity levels, a 24-week lower limb strength exercise program to be undertaken at home three times per week, and a mobile app to reinforce home exercise program adherence. Participants in the control group will have access to a website containing only information about hip OA and its management. All participants will be reassessed at 24 weeks after randomisation. Primary outcomes are severity of hip pain while walking using an 11-point numeric rating scale and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes are the Hip dysfunction and Osteoarthritis Outcome Score subscales of pain, hip-related quality of life, and function, sports and recreational activities; global change in hip condition; health-related quality of life; measures of physical activity levels; fear of movement; self efficacy for pain and for exercise; and use of oral pain medications. DISCUSSION: Innovative and scalable approaches to OA education, physical activity, and exercise are required in order to improve exercise participation/engagement and mitigate physical inactivity in the hip OA population. This will help minimise the burden of this major public health issue on individuals and society. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622001533785).

Scaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: protocol for the TransformUs hybrid effectiveness-implementation trial.

INTRODUCTION: Efficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children's (5-12 years) physical activity and reducing their sedentary behaviour within school and home settings. This paper describes the study protocol of a 5-year effectiveness-implementation trial to assess the scalability and effectiveness of the TransformUs programme. METHODS AND ANALYSIS: A type II hybrid implementation-effectiveness trial, TransformUs is being disseminated to all primary schools in the state of Victoria, Australia (n=1786). Data are being collected using mixed methods at the system (state government, partner organisations), organisation (school) and individual (teacher, parent and child) levels. Evaluation is based on programme Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. RE-AIM domains are being measured using a quasi-experimental, pre/post, non-equivalent group design, at baseline, 12 and 24 months. Effectiveness will be determined in a subsample of 20 intervention schools (in Victoria) and 20 control schools (in New South Wales (NSW), Australia), at baseline, 12 and 24 months. Primary outcomes include TransformUs Reach, Adoption, Implementation and organisational Maintenance (implementation trial), and children's physical activity and sedentary time assessed using accelerometers (effectiveness trial). Secondary outcomes include average sedentary time and moderate to vigorous-intensity physical activity on weekdays and during school hours, body mass index z-scores and waist circumference (effectiveness trial). Linear mixed-effects models will be fitted to compare outcomes between intervention and control participants accounting for clustering of children within schools, confounding and random effects. ETHICS AND DISSEMINATION: The trial was approved by the Deakin University Human Research Ethics Committee (HEAG-H 28_2017), Victorian Department of Education, the NSW Department of Education, Australian Catholic University (2017-145R), Melbourne Archdiocese Catholic Schools and Catholic Schools NSW. Partners, schools/teachers and parents will provide an informed signed consent form prior to participating. Parents will provide consent for their child to participate in the effectiveness trial. Findings will be disseminated via peer-reviewed publications, scientific conferences, summary reports to schools and our partner organisations, and will inform education policy and practice on effective and sustainable ways to promote physical activity and reduce sedentary behaviours population-wide. TRIAL REGISTRATION NUMBER: Australian Clinical Trials Registration Registry (ACTRN12617000204347).

Effects of Hip Pain Diagnostic Labels and Their Explanations on Beliefs About Hip Pain and How to Manage It: An Online Randomized Controlled Trial.

OBJECTIVES: To compare the effects of diagnostic labels and their explanations on people's beliefs about managing hip pain. DESIGN: Online randomized controlled trial involving 626 participants. METHODS: Participants aged ≥45 years with and without hip pain considered a hypothetical scenario (initial doctor consultation for hip pain). They were randomized to receive a diagnostic label and explanation of (1) hip osteoarthritis, (2) persistent hip pain, or (3) hip degeneration. Primary outcomes were the beliefs (1) exercise would damage the hip and (2) surgery is necessary at some stage (scales, 0 = definitely would not/unnecessary, 10 = definitely would/necessary). Secondary outcomes included beliefs about other treatments and care providers. RESULTS: Compared to hip degeneration, participants who were allocated to hip osteoarthritis and persistent hip pain believed exercise was less damaging (mean difference -1.3 [95% CI: -1.9, -0.7] and -1.8 [-2.3, -1.2], respectively) and surgery less necessary (-1.5 [-2.1, -1.0] and -2.2 [-2.7, -1.6], respectively). Compared to hip osteoarthritis, participants who were allocated to persistent hip pain believed surgery was less necessary (-0.7 [-1.2, -0.1]), but not that exercise was less damaging (-0.5 [-1.1, 0.1]). Compared to hip degeneration, participants who were allocated to hip osteoarthritis and persistent hip pain were less concerned about their hip and believed exercise and care from an exercise and sports physician, rheumatologist, or physiotherapist would be more helpful, and care from an orthopaedic surgeon less helpful. CONCLUSIONS: People who were allocated a diagnostic label and explanation of hip osteoarthritis or persistent hip pain believed exercise was less damaging and surgery less necessary for a hip problem than hip degeneration. J Orthop Sports Phys Ther 2023;53(11):673-684. Epub 5 October 2023. doi:10.2519/jospt.2023.11984.

Socioeconomic differences in associations between living in a 20-min neighbourhood and diet, physical activity and self-rated health: Cross-sectional findings from ProjectPLAN.

The 20-min neighbourhood (20MN) concept aims to enable residents to meet daily needs using resources within a 20-min trip from home noting that there is no single definition of what services and amenities are required for daily needs nor what modes of transport constitute a 20 min trip. Whether 20MNs promote better health and whether associations differ by socio-economic status (SES) is unknown. Using cross-sectional data from adults randomly sampled in 2018-19 from Melbourne or Adelaide, Australia, we examined whether associations between neighbourhood type (20MN/non-20MN) and diet, physical activity or self-rated health vary according to individual- or area-level SES. We found no consistent patterns of interactions. The results do not consistently support the often assumed belief that 20MNs support more healthful behaviour and that these relationships vary by SES.

The effect of time before diagnosis and treatment on colorectal cancer outcomes: systematic review and dose-response meta-analysis.

BACKGROUND: This systematic review and meta-analysis aimed to evaluate existing evidence on the relationship between diagnostic and treatment intervals and outcomes for colorectal cancer. METHODS: Four databases were searched for English language articles assessing the role of time before initial treatment in colorectal cancer on any outcome, including stage and survival. Two reviewers independently screened articles for inclusion and data were synthesised narratively. A dose-response meta-analysis was performed to examine the association between treatment interval and survival. RESULTS: One hundred and thirty papers were included in the systematic review, eight were included in the meta-analysis. Forty-five different intervals were considered in the time from first symptom to treatment. The most common finding was of no association between the length of intervals on any outcome. The dose-response meta-analysis showed a U-shaped association between the treatment interval and overall survival with the nadir at 45 days. CONCLUSION: The review found inconsistent, but mostly a lack of, association between interval length and colorectal cancer outcomes, but study design and quality were heterogeneous. Meta-analysis suggests survival becomes increasingly poorer for those commencing treatment more than 45 days after diagnosis. REGISTRATION: This review was registered, and the protocol is available, in PROSPERO, the international database of systematic reviews, with the registration ID CRD42021255864.

Modelling count, bounded and skewed continuous outcomes in physical activity research: beyond linear regression models.

BACKGROUND: Inference using standard linear regression models (LMs) relies on assumptions that are rarely satisfied in practice. Substantial departures, if not addressed, have serious impacts on any inference and conclusions; potentially rendering them invalid and misleading. Count, bounded and skewed outcomes, common in physical activity research, can substantially violate LM assumptions. A common approach to handle these is to transform the outcome and apply a LM. However, a transformation may not suffice. METHODS: In this paper, we introduce the generalized linear model (GLM), a generalization of the LM, as an approach for the appropriate modelling of count and non-normally distributed (i.e., bounded and skewed) outcomes. Using data from a study of physical activity among older adults, we demonstrate appropriate methods to analyse count, bounded and skewed outcomes. RESULTS: We show how fitting an LM when inappropriate, especially for the type of outcomes commonly encountered in physical activity research, substantially impacts the analysis, inference, and conclusions compared to a GLM. CONCLUSIONS: GLMs which more appropriately model non-normally distributed response variables should be considered as more suitable approaches for managing count, bounded and skewed outcomes rather than simply relying on transformations. We recommend that physical activity researchers add the GLM to their statistical toolboxes and become aware of situations when GLMs are a better method than traditional approaches for modeling count, bounded and skewed outcomes.

Effects of a Massive Open Online Course on osteoarthritis knowledge and pain self-efficacy in people with hip and/or knee osteoarthritis: protocol for the MOOC-OA randomised controlled trial.

BACKGROUND: Osteoarthritis (OA) is a prevalent, chronic joint condition that commonly affects the knee and hip causing pain, impaired function, and reduced quality of life. As there is no cure, the main goal of treatment is to alleviate symptoms via ongoing self-management predominantly consisting of exercise and weight loss (if indicated). However, many people with OA do not feel adequately informed about their condition and management options to self-manage effectively. Patient education is recommended by all OA Clinical Practice Guidelines to support appropriate self-management, but little is known about the optimal delivery method and content. Massive Open Online Courses (MOOCs) are free, interactive, e-learning courses. They have been used to deliver patient education in other chronic health conditions but have not been used in OA. METHODS: A two-arm parallel-design, assessor- and participant-blinded superiority randomised controlled trial. People with persistent knee/hip pain consistent with a clinical diagnosis of knee/hip OA (n = 120) are being recruited from the Australia-wide community. Participants are randomly allocated into one of two groups i) electronic information pamphlet (control group) or ii) MOOC (experimental group). Those allocated to the control group receive access to an electronic pamphlet about OA and its recommended management, currently available from a reputable consumer organisation. Those allocated to the MOOC receive access to a 4-week 4-module interactive consumer-facing e-Learning course about OA and its recommended management. Course design was informed by behaviour theory and learning science, and consumer preferences. The two primary outcomes are OA knowledge and pain self-efficacy with a primary endpoint of 5 weeks and a secondary endpoint of 13 weeks. Secondary outcomes include measures of fear of movement, exercise self-efficacy, illness perceptions, OA management and health professional care seeking intentions, physical activity levels, and actual use of physical activity/exercise and weight loss, pain medication, and health professional care seeking to manage joint symptoms. Clinical outcomes and process measures are also collected. DISCUSSION: Findings will determine whether a comprehensive consumer-facing MOOC improves OA knowledge and confidence to self-manage joint pain compared to a currently available electronic OA information pamphlet. TRIAL REGISTRATION: Prospectively registered (Australian New Zealand Clinical Trials Registry ID: ACTRN12622001490763).

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects.

OBJECTIVE: To explore the mediators of effects of two 6-month telehealth-delivered exercise programs, including exercise with and without weight-loss diet, on pain and function improvements in knee osteoarthritis (OA). METHODS: Secondary analysis of 345 participants from a 3-arm randomized controlled trial of exercise (Exercise program) and exercise plus diet (Diet + Exercise program) versus information (Control program) was conducted. Outcomes were changes in pain (11-point numeric rating scale) and function (Western Ontario and McMaster Universities Osteoarthritis Index [score range 0-68]) at 12 months. Potential mediators were change at 6 months in attitudes toward self-management, fear of movement, arthritis self-efficacy, weight, physical activity, and willingness for knee surgery. For the Diet + Exercise program versus the Exercise program, only change in weight was evaluated. RESULTS: Possible mediators of the Exercise program versus the Control program included reduced fear of movement (accounting for -1.11 units [95% confidence interval (95% CI) -2.15, -0.07] improvement in function) and increased arthritis self-efficacy (-0.40 units [95% CI -0.75, -0.06] reduction in pain, -1.66 units [95% CI -3.04, -0.28] improvement in function). The Diet + Exercise program versus the Control program mediators included reduced fear of movement (-1.13 units [95% CI -2.17, -0.08] improvement in function), increased arthritis self-efficacy (-0.77 units [95% CI -1.26, -0.28] reduction in pain, -5.15 units [95% CI -7.34, -2.96] improvement in function), and weight loss (-1.20 units [95% CI -1.73, -0.68] reduction in pain, -5.79 units [95% CI -7.96, -3.63] improvement in function). Weight loss mediated the Diet + Exercise program versus the Exercise program (-0.89 units [95% CI -1.31, -0.47] reduction in pain, -4.02 units [95% CI -5.77, -2.26] improvement in function). CONCLUSION: Increased arthritis self-efficacy, reduced fear of movement, and weight loss may partially mediate telehealth-delivered exercise program effects, with and without diet, on pain and/or function in knee OA. Weight loss may partially mediate the effect of diet and exercise compared to exercise alone.

Content development and validation for a mobile application designed to train family caregivers in the use of music to support care of people living with dementia.

Background: Music therapy is increasingly recognized as an effective support for people living with dementia. However, with incidences of dementia increasing, and limited availability of music therapists, there is a need for affordable and accessible ways that caregivers can learn to use music-therapy based strategies to support the people they care for. The MATCH project aims to address this by creating a mobile application that can train family caregivers in the use of music to support people living with dementia. Methods: This study details the development and validation of training material for the MATCH mobile application. Training modules developed based on existing research were assessed by 10 experienced music therapist clinician-researchers, and seven family caregivers who had previously completed personalized training in music therapy strategies via the HOMESIDE project. Participants reviewed the content and scored each training module based on content (music therapists) and face (caregivers) validity scales. Descriptive statistics were used to calculate scores on the scales, while thematic analysis was used to analyze short-answer feedback. Results: Participants scored the content as valid and relevant, however, they provided additional suggestions for improvement via short-answer feedback. Conclusion: The content developed for the MATCH application is valid and will be trailed by family caregivers and people living with dementia in a future study.

The impact of strict lockdowns on the mental health and well-being of people living in Australia during the first year of the COVID-19 pandemic.

BACKGROUND: There are limited longitudinal studies on the effects of the COVID-19 pandemic on mental health and well-being, including the effects of imposed restrictions and lockdowns. AIMS: This study investigates how living in a pandemic, and related lockdowns and restrictions, affected the mental health of people living in Australia during the first year of the COVID-19 pandemic. METHOD: A total of 875 people living in Australia participated in a longitudinal survey from 27 May to 14 December 2020. This time period includes dates that span pre-, during and post-wave 2 lockdowns in Australia, with strict and sustained public health measures. Linear mixed models were fitted to investigate the effect of lockdown on depression and anxiety symptoms. RESULTS: Symptoms of depression and anxiety improved over time, during and after lockdowns. More adverse mental health symptoms were observed for people with a history of medical or mental health problems, caring responsibilities, more neurotic personality traits or less conscientiousness, and for people who were younger. People who reported being more conscientious reported better mental health. CONCLUSIONS: Despite notoriously strict lockdowns, participants did not experience a deterioration of mental health over time. Results suggest a lack of significant adverse effects of lockdown restrictions on mental health and well-being. Findings highlight cohorts that could benefit from targeted mental health support and interventions, so that public policy can be better equipped to support them, particularly if future strict public health measures such as lockdowns are being considered or implemented for the COVID-19 pandemic and other disasters.

Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia.

BACKGROUND: Most people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. METHODS AND ANALYSIS: HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. DISCUSSION: This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019.

Do 20-minute neighbourhoods moderate associations between work and commute hours with food consumption?

OBJECTIVE: To examine associations between work and commute hours with food consumption and test whether neighbourhood type (20-minute neighbourhood (20MN)/non-20MN) moderate associations. DESIGN: Cross-sectional analysis of the Places and Locations for Activity and Nutrition study (ProjectPLAN). Exposures were work hours (not working (0 h), working up to full-time (1-38 h/week), working overtime (> 38 h/week)), and among those employed, combined weekly work and commute hours (continuous). Outcomes were usual consumption of fruit, vegetables, takeaway food, snacks and soft drinks, and number of discretionary food types (takeaway, snacks and soft drinks) consumed weekly. Generalised linear models were fitted to examine associations between each exposure and outcome. The moderating role of neighbourhood type was examined through interaction terms between each exposure and neighbourhood type (20MN/non-20MN). SETTING: Melbourne and Adelaide, Australia, 2018-2019. PARTICIPANTS: Adults ≥ 18 years old (n 769). RESULTS: Although all confidence intervals contained the null, overall, patterns suggested non-workers and overtime workers have less healthy food behaviours than up-to-full-time workers. Among those employed, analysis of continuous work and commute hours data suggested longer work and commute hours were positively associated with takeaway consumption (OR = 1·014, 95 % CI 0·999, 1·030, P-value = 0·066). Patterns of better behaviours were observed across most outcomes for those in 20MN than non-20MN. However, differences in associations between work and commute hours with food consumption across neighbourhood type were negligible. CONCLUSIONS: Longer work and commute hours may induce poorer food behaviours. There was weak evidence to suggest 20MN moderate associations between work and commute hours with food consumption, although behaviours appeared healthier for those in 20MN.

Shoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol.

BACKGROUND: Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate 'stable supportive' shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA. METHODS: This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures. DISCUSSION: This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.

A systematic review of methodological considerations in time to diagnosis and treatment in colorectal cancer research.

Research focusing on timely diagnosis and treatment of colorectal cancer is necessary to improve outcomes for people with cancer. Previous attempts to consolidate research on time to diagnosis and treatment have noted varied methodological approaches and quality, limiting the comparability of findings. This systematic review was conducted to comprehensively assess the scope of methodological issues in this field and provide recommendations for future research. Eligible articles had to assess the role of any interval up to treatment, on any outcome in colorectal cancer, in English, with no limits on publication time. Four databases were searched (Ovid Medline, EMBASE, EMCARE and PsycInfo). Papers were screened by two independent reviewers using a two-stage process of title and abstract followed by full text review. In total, 130 papers were included and had data extracted on specific methodological and statistical features. Several methodological problems were identified across the evidence base. Common issues included arbitrary categorisation of intervals (n = 107, 83%), no adjustment for potential confounders (n = 65, 50%), and lack of justification for included covariates where there was adjustment (n = 40 of 65 papers that performed an adjusted analysis, 62%). Many articles introduced epidemiological biases such as immortal time bias (n = 37 of 80 papers that used survival as an outcome, 46%) and confounding by indication (n = 73, 56%), as well as other biases arising from inclusion of factors outside of their temporal sequence. However, determination of the full extent of these problems was hampered by insufficient reporting. Recommendations include avoiding artificial categorisation of intervals, ensuring bias has not been introduced due to out-of-sequence use of key events and increased use of theoretical frameworks to detect and reduce bias. The development of reporting guidelines and domain-specific risk of bias tools may aid in ensuring future research can reliably contribute to recommendations regarding optimal timing and strengthen the evidence base.

Removing Pathoanatomical Content From Information Pamphlets About Knee Osteoarthritis Did Not Affect Beliefs About Imaging or Surgery, but Led to Lower Perceptions That Exercise Is Damaging and Better Osteoarthritis Knowledge: An Online Randomised Controlled Trial.

OBJECTIVE: Compare the effects of osteoarthritis information, with or without pathoanatomical content, on people's beliefs about managing osteoarthritis. DESIGN: Online randomized controlled trial involving 556 participants. METHODS: Participants considered a hypothetical scenario where their doctor informed them that they had knee osteoarthritis. Participants were randomized to a control condition, where they received currently available osteoarthritis information with pathoanatomical content or an experimental condition, where they received the same osteoarthritis information but without pathoanatomical content. Primary outcomes were participants' beliefs about the need for x-ray to confirm diagnosis and joint replacement surgery in the future. RESULTS: There were no between-group differences in primary outcomes for x-ray (mean difference [MD], -0.3; 95% confidence interval [CI]: -0.9, 0.4) and surgery (MD, -0.2; 95% CI: -0.7, 0.2), each rated on an 11-point numeric rating scale. Participants in the experimental group had lower perceptions that exercise would damage the knee (MD, -0.4; 95% CI: -0.8, 0.0; rated on an 11-point numeric rating scale) and better osteoarthritis knowledge (MD, 0.9; 95% CI: 0.0, 1.9; rated on a scale ranging from 11 to 55). Among those without tertiary education, participants in the experimental group had lower perceptions that x-ray was necessary than control (MD, -0.8; 95% CI: -1.5, -0.1). Among those who had never sought care for knee pain, participants in the experimental group had lower perceptions about the need for surgery (MD, -0.7; 95% CI: -1.2, -0.2). CONCLUSIONS: Removing pathoanatomical content may not change beliefs about imaging and surgery but may lead to lower perceptions that exercise is damaging and may improve osteoarthritis knowledge. However, effects were small and of unclear clinical relevance. Tertiary education or a history of care seeking for knee pain may moderate effects on primary outcomes. J Orthop Sports Phys Ther 2023;53(4):1-15. Epub: 12 December 2022. doi:10.2519/jospt.2022.11618.

Effect of Information Content and General Practitioner Recommendation to Exercise on Treatment Beliefs and Intentions for Knee Osteoarthritis: An Online Multi-Arm Randomized Controlled Trial.

OBJECTIVE: To evaluate effects of general osteoarthritis (OA) information in addition to a treatment option grid and general practitioner (GP) recommendation to exercise on treatment beliefs and intentions. METHODS: An online randomized trial of 735 people 45 years old or older without OA who were recruited from a consumer survey network. Participants read a hypothetical scenario about visiting their GP for knee problems and were randomized to the following: i) 'general information', ii) 'option grid' (general information plus option grid), or iii) 'option grid plus recommendation' (general information plus option grid plus GP exercise recommendation). The primary outcome was an agreement that exercise is the best management option (0-10 numeric rating scale; higher scores indicating higher agreement that exercise is best). The secondary outcomes were beliefs about other management options and management intentions. Linear regression models estimated the mean (95% confidence interval [CI]) between-group difference in postintervention scores, adjusted for baseline. RESULTS: Option grid plus recommendation led to higher agreement that exercise is the best management by a mean of 0.4 units (95% CI: 0.1-0.6) compared with general information. There were no other between-group differences for the primary outcome. Option grid led to higher agreement that surgery was best, and x-rays were necessary, compared with general information (mean between-group differences: 0.7 [CI: 0.2-1.1] and 0.5 [CI: 0.1-1.0], respectively) and option grid plus recommendation (0.5 [CI: 0.1-0.9] and 0.9 [CI: 0.4-1.3]). CONCLUSION: Addition of an option grid and GP exercise recommendation to general OA information led to more favorable views that exercise was best for the hypothetical knee problem. However, differences were small and of unclear clinical importance.

Ethics guidelines use and Indigenous governance and participation in Aboriginal and Torres Strait Islander health research: a national survey.

OBJECTIVES: To assess the use of NHMRC Indigenous research guidelines by Australian researchers and the degree of Aboriginal and Torres Strait Islander governance and participation in Indigenous health research. DESIGN, SETTING, PARTICIPANTS: Cross-sectional survey of people engaged in Indigenous health research in Australia, comprising respondents to an open invitation (social media posts in general and Indigenous health research networks) and authors of primary Indigenous health research publications (2015-2019) directly invited by email. MAIN OUTCOME MEASURES: Reported use of NHMRC guidelines for Indigenous research; reported Indigenous governance and participation in Indigenous health research. RESULTS: Of 329 people who commenced the survey, 247 people (75%) provided responses to all questions, including 61 Indigenous researchers (25%) and 195 women (79%). The NHMRC guidelines were used "all the time" by 206 respondents (83%). Most respondents (205 of 247, 83%) reported that their research teams included Indigenous people, 139 reported dedicated Indigenous advisory boards (56%), 91 reported designated seats for Indigenous representatives on ethics committees (37%), and 43 reported Indigenous health research ethics committees (17%); each proportion was larger for respondents working in Indigenous community-controlled organisations than for those working elsewhere. More than half the respondents reported meaningful Indigenous participation during five of six research phases; the exception was data analysis (reported as apparent "none" or "some of the time" by 143 participants, 58%). CONCLUSIONS: Indigenous health research in Australia is largely informed by non-Indigenous world views, led by non-Indigenous people, and undertaken in non-Indigenous organisations. Re-orientation and investment are needed to give control of the framing, design, and conduct of Indigenous health research to Indigenous people.

Ambulatory assessment to predict problem anger in trauma-affected adults: Study protocol.

BACKGROUND: Problem anger is common after experiencing a traumatic event. Current evidence-driven treatment options are limited, and problem anger negatively affects an individual's capacity to engage with traditional psychological treatments. Smartphone interventions hold significant potential in mental health because of their ability to deliver low-intensity, precision support for individuals at the time and place they need it most. While wearable technology has the capacity to augment smartphone-delivered interventions, there is a dearth of evidence relating to several key areas, including feasibility of compliance in mental health populations; validity of in vivo anger assessment; ability to predict future mood states; and delivery of timely and appropriate interventions. METHODS: This protocol describes a cohort study that leverages 10 days of ambulatory assessment in the form of ecological momentary assessment and a wearable. Approximately 100 adults with problem anger will complete four-hourly in vivo mobile application-delivered micro-surveys on anger intensity, frequency, and verbal and physical aggression, as well as other self-reported mental health and wellbeing measures. Concurrently, a commercial wearable device will continuously record indicators of physiological arousal. The aims are to test the feasibility and acceptability of ambulatory assessment in a trauma-affected population, and determine whether a continuously measured physiological indicator of stress predicts self-reported anger intensity. DISCUSSION: This study will contribute new data around the ability of physiological indicators to predict mood state in individuals with psychopathology. This will have important implications for the design of smartphone-delivered interventions for trauma-affected individuals, as well as for the digital mental health field more broadly.