Protocol for a randomised controlled trial of a healthy relationship tool for men who use intimate partner violence (BETTER MAN).

BACKGROUND: Intimate partner violence (IPV) is common globally, but there is a lack of research on how to intervene early with men who might be using IPV. Building on evidence supporting the benefits of online interventions for women victim/survivors, this study aims to test whether a healthy relationship website (BETTER MAN) is effective at improving men's help seeking, their recognition of behaviours as IPV and their readiness to change their behaviours. METHODS/DESIGN: In this two-group, pragmatic randomised controlled trial, men aged 18-50 years residing in Australia who have been in an adult intimate relationship (female, male or non-binary partner) in the past 12 months are eligible. Men who report being worried about their behaviour or have had others express concerns about their behaviour towards a partner in the past 12 months will be randomised with a 1:1 allocation ratio to receive the BETTER MAN website or a comparator website (basic healthy relationships information). The BETTER MAN intervention includes self-directed, interactive reflection activities spread across three modules: Better Relationships, Better Values and Better Communication, with a final "action plan" of strategies and resources. Using an intention to treat approach, the primary analysis will estimate between-group difference in the proportion of men who report undertaking help-seeking behaviours for relationship issues in the last 6 months, at 6 months post-baseline. Analysis of secondary outcomes will estimate between-group differences in: (i) mean score of awareness of behaviours in relationships as abusive immediately post-use of website; (ii) mean score on readiness to change immediately post-use of website and 3 months after baseline; and (iii) cost-effectiveness. DISCUSSION: This trial will evaluate the effectiveness of an online healthy relationship tool for men who may use IPV. BETTER MAN could be incorporated into practice in community and health settings, providing an evidence-informed website to assist men to seek help to promote healthy relationships and reduce use of IPV. TRIAL REGISTRATION: ACTRN12622000786796 with the Australian New Zealand Clinical Trials Registry: 2 June 2022. Version: 1 (28 September 2023).

Towards a health promoting university: descriptive findings on health, wellbeing and academic performance amongst university students in Australia.

BACKGROUND: Universities are increasingly recognised as institutions where health and wellbeing can be promoted to maximise academic outcomes, career transitions, and lifelong positive health behaviours. There is concern about the mental health of university students and other factors which affect academic outcomes particularly for subgroups such as international students. There are few cohort studies of the breadth of issues that can impact on mental health and academic outcomes for both local and international students. We conducted a baseline prevalence survey of students at a large Australian university covering health, academic, and social determinants of wellbeing. The purpose was to inform the university's new student health and wellbeing framework with a view to follow-up to determine predictors of mental ill-health and academic outcomes in the subsequent year. In this paper we present the baseline prevalence data and report on selected mental health and health care access issues for local and international students. METHODS: The entire university population as of April 2019 of over 56,375 students aged 18 or above were invited to complete the online survey. Questions explored eight domains: demographic characteristics, general health and wellbeing, mental health, risk taking behaviours, psychosocial stressors, learning and academic factors, social and cultural environment, and awareness of and access to health and wellbeing services. Records of academic results were also accessed and matched with survey data for a large subset of students providing consent. RESULTS: Fourteen thousand eight hundred eighty (26.4%) students commenced our survey and were representative of the entire student population on demographic characteristics. Three quarters were aged between 18 to 25 years and one third were international students. Eighty-five percent consented to access of their academic records. Similar proportions of local and international students experienced symptoms of a depression or anxiety disorder, however international students were less aware of and less likely to access available health services both inside and external to the university. We also reported on the prevalence of: general lifestyle factors (diet, exercise, amount of daily sleep); risk-taking behaviours (including alcohol, tobacco and other drug use; unprotected sexual activity); psychosocial stressors (financial, intimate partner violence, discrimination, academic stressors, acculturative stress); subjects failed; resilience; social supports; social media use; and health services accessed online. CONCLUSIONS: This rigorous and comprehensive examination of the health status of local and international students in an Australian university student population establishes the prevalence of mental health issues and other psychosocial determinants of health and wellbeing, along with academic performance. This study will inform a university-wide student wellbeing framework to guide health and wellbeing promotion and is a baseline for a 12-month follow-up of the cohort in 2020 during the COVID-19 pandemic.

When should matching be used in the design of cluster randomized trials?

For cluster randomized trials (CRTs) with a small number of clusters, the matched-pair (MP) design, where clusters are paired before randomizing one to each trial arm, is often recommended to minimize imbalance on known prognostic factors, add face-validity to the study, and increase efficiency, provided the analysis recognizes the matching. Little evidence exists to guide decisions on when to use matching. We used simulation to compare the efficiency of the MP design with the stratified and simple designs, based on the mean confidence interval width of the estimated intervention effect. Matched and unmatched analyses were used for the MP design; a stratified analysis was used for the stratified design; and analyses without and with post-stratification adjustment for factors that would otherwise have been used for restricted allocation were used for the simple design. Results showed the MP design was generally the most efficient for CRTs with 10 or more pairs when the correlation between cluster-level outcomes within pairs (matching correlation) was moderate to strong (0.3-0.5). There was little gain in efficiency for the MP or stratified designs compared to simple randomization when the matching correlation was weak (0.05-0.1). For trials with four pairs of clusters, the simple and stratified designs were more efficient than the MP design because greater degrees of freedom were available for the analysis, although an unmatched analysis of the MP design recovered precision for weak matching correlations. Practical guidance on choosing between the MP, stratified, and simple designs is provided.

The CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial.

BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

Assessing the suitability of general practice electronic health records for clinical prediction model development: a data quality assessment.

BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.

Psychological therapies for women who experience intimate partner violence.

BACKGROUND: Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm. OBJECTIVES: To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list. DATA COLLECTION AND ANALYSIS: Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials. MAIN RESULTS: We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women). AUTHORS' CONCLUSIONS: There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.

Antidepressant treatment for primary care patients with depressive symptoms: Data from the diamond longitudinal cohort study.

BACKGROUND: In light of emerging evidence questioning the safety of antidepressants, it is timely to investigate the appropriateness of antidepressant prescribing. This study estimated the prevalence of possible over- and under-treatment with antidepressants among primary care attendees and investigated the factors associated with potentially inappropriate antidepressant use. METHODS: In all, 789 adult primary care patients with depressive symptoms were recruited from 30 general practices in Victoria, Australia, in 2005 and followed up every 3 months in 2006 and annually from 2007 to 2011. For this study, we first assessed appropriateness of antidepressant use in 2007 at the 2-year follow-up to enable history of depression to be taken into account, providing 574 (73%) patients with five yearly assessments, resulting in a total of 2870 assessments. We estimated the prevalence of use of antidepressants according to the adapted National Institute for Health and Care Excellence guidelines and used regression analysis to identify factors associated with possible over- and under-treatment. RESULTS: In 41% (243/586) of assessments where antidepressants were indicated according to adapted National Institute for Health and Care Excellence guidelines, patients reported not taking them. Conversely in a third (557/1711) of assessments where guideline criteria were unlikely to be met, participants reported antidepressant use. Being female and chronic physical illness were associated with antidepressant use where guideline criteria were not met, but no factors were associated with not taking antidepressants where guideline criteria were met. CONCLUSIONS: Much antidepressant treatment in general practice is for people with minimal or mild symptoms, while people with moderate or severe depressive symptoms may miss out. There is considerable scope for improving depression care through better allocation of antidepressant treatment.

Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

BACKGROUND: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. OBJECTIVE: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. DESIGN: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). SETTING: Community in Australia. PARTICIPANTS: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. INTERVENTIONS: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. MEASUREMENTS: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. RESULTS: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. LIMITATION: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. CONCLUSION: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.

Presentations to general practice before a cancer diagnosis in Victoria: a cross-sectional survey.

OBJECTIVE: To assess variations in the number of general practitioner visits preceding a cancer diagnosis, and in the length of the interval between the patient first suspecting a problem and their seeing a hospital specialist. DESIGN, SETTING AND PARTICIPANTS: Analysis of data provided to the Cancer Patient Experience Survey (CPES; survey response rate, 37.7%) by 1552 patients with one of 19 cancer types and treated in one of five Victorian Comprehensive Cancer Centre hospitals, 1 October 2012 - 30 April 2013. MAIN OUTCOME MEASURES: The primary outcome was the proportion of patients who had had three or more GP consultations about cancer-related health problems before being referred to hospital. The secondary outcome was the interval between the patient first suspecting a problem and their seeing a hospital specialist. RESULTS: 34% of the patients included in the final analyses (426 of 1248) had visited a GP at least three times before referral to a hospital doctor. The odds ratios (reference: rectal cancer; adjusted for age, sex, language spoken at home, and socio-economic disadvantage index score) varied according to cancer type, being highest for pancreatic cancer (3.2; 95% CI, 1.02-9.9), thyroid cancer (2.5; 95% CI, 0.9-6.6), vulval cancer (2.5; 95% CI, 0.7-8.7) and multiple myeloma (2.4; 95% CI, 1.1-5.5), and lowest for patients with breast cancer (0.4; 95% CI, 0.2-0.8), cervical cancer (0.5; 95% CI, 0.1-2.1), endometrial cancer (0.5; 95% CI, 0.2-1.4) or melanoma (0.7; 95% CI, 0.3-1.5). Cancer type also affected the duration of the interval from symptom onset to seeing a hospital doctor; it took at least 3 months for more than one-third of patients with prostate or colon cancer to see a hospital doctor. CONCLUSION: Certain cancer types were more frequently associated with multiple GP visits, suggesting they are more challenging to recognise early. In Victoria, longer intervals from the first symptoms to seeing a hospital doctor for colon or prostate cancer may reflect poorer community symptom awareness, later GP referral, or limited access to gastroenterology and urology services.

The Health Service Use of Frequent Users of Telephone Helplines in a Cohort of General Practice Attendees with Depressive Symptoms.

We examined the relationship between frequent use of telephone helplines and health service use over time in a cohort of 789 general practice attendees with depressive symptoms. Telephone helpline use (no use, non-frequent use, frequent use) was measured at 3, 6, 9 and 12 months and analysed using ordered logistic regression. Sixteen participants (2 %) reported frequent use of telephone helplines. Reporting frequent use was associated with visiting multiple general practitioners, using emergency services and visiting mental health specialists in the previous 3 months. Despite this pattern of service use, there was evidence that these services were not meeting the needs of frequent users of telephone helplines, as they were also more likely to report dissatisfaction with their access to health services compared to non-frequent and non-users of telephone helplines. Our findings suggest that a model of care which addresses the complex needs of frequent users of telephone helplines is needed.

Screening and counselling in the primary care setting for women who have experienced intimate partner violence (WEAVE): a cluster randomised controlled trial.

BACKGROUND: Evidence for a benefit of interventions to help women who screen positive for intimate partner violence (IPV) in health-care settings is limited. We assessed whether brief counselling from family doctors trained to respond to women identified through IPV screening would increase women's quality of life, safety planning and behaviour, and mental health. METHODS: In this cluster randomised controlled trial, we enrolled family doctors from clinics in Victoria, Australia, and their female patients (aged 16-50 years) who screened positive for fear of a partner in past 12 months in a health and lifestyle survey. The study intervention consisted of the following: training of doctors, notification to doctors of women screening positive for fear of a partner, and invitation to women for one-to-six sessions of counselling for relationship and emotional issues. We used a computer-generated randomisation sequence to allocate doctors to control (standard care) or intervention, stratified by location of each doctor's practice (urban vs rural), with random permuted block sizes of two and four within each stratum. Data were collected by postal survey at baseline and at 6 months and 12 months post-invitation (2008-11). Researchers were masked to treatment allocation, but women and doctors enrolled into the trial were not. Primary outcomes were quality of life (WHO Quality of Life-BREF), safety planning and behaviour, mental health (SF-12) at 12 months. Secondary outcomes included depression and anxiety (Hospital Anxiety and Depression Scale; cut-off ≥8); women's report of an inquiry from their doctor about the safety of them and their children; and comfort to discuss fear with their doctor (five-point Likert scale). Analyses were by intention to treat, accounting for missing data, and estimates reported were adjusted for doctor location and outcome scores at baseline. This trial is registered with the Australian New Zealand Clinical Trial Registry, number ACTRN12608000032358. FINDINGS: We randomly allocated 52 doctors (and 272 women who were eligible for inclusion and returned their baseline survey) to either intervention (25 doctors, 137 women) or control (27 doctors, 135 women). 96 (70%) of 137 women in the intervention group (seeing 23 doctors) and 100 (74%) of 135 women in the control group (seeing 26 doctors) completed 12 month follow-up. We detected no difference in quality of life, safety planning and behaviour, or mental health SF-12 at 12 months. For secondary outcomes, we detected no between-group difference in anxiety at 12 months or comfort to discuss fear at 6 months, but depressiveness caseness at 12 months was improved in the intervention group compared with the control group (odds ratio 0·3, 0·1-0·7; p=0·005), as was doctor enquiry at 6 months about women's safety (5·1, 1·9-14·0; p=0·002) and children's safety (5·5, 1·6-19·0; p=0·008). We recorded no adverse events. INTERPRETATION: Our findings can inform further research on brief counselling for women disclosing intimate partner violence in primary care settings, but do not lend support to the use of postal screening in the identification of those patients. However, we suggest that family doctors should be trained to ask about the safety of women and children, and to provide supportive counselling for women experiencing abuse, because our findings suggest that, although we detected no improvement in quality of life, counselling can reduce depressive symptoms. FUNDING: Australian National Health and Medical Research Council.

Self-rated health and long-term prognosis of depression.

PURPOSE: Indicators of prognosis should be considered to fully inform clinical decision making in the treatment of depression. This study examines whether self-rated health predicts long-term depression outcomes in primary care. METHODS: Our analysis was based on the first 5 years of a prospective 10-year cohort study underway since January 2005 conducted in 30 randomly selected Australian primary care practices. Participants were 789 adult patients with a history of depressive symptoms. Main outcome measures include risks, risk differences, and risk ratios of major depressive syndrome (MDS) on the Patient Health Questionnaire. RESULTS: Retention rates during the 5 years were 660 (84%), 586 (74%), 560 (71%), 533 (68%), and 517 (66%). At baseline, MDS was present in 27% (95% CI, 23%-30%). Cross-sectional analysis of baseline data showed participants reporting poor or fair self-rated health had greater odds of chronic illness, MDS, and lower socioeconomic status than those reporting good to excellent self-rated health. For participants rating their health as poor to fair compared with those rating it good to excellent, risk ratios of MDS were 2.10 (95% CI, 1.60-2.76), 2.38 (95% CI, 1.77-3.20), 2.22 (95% CI, 1.70-2.89), 1.73 (95% CI, 1.30-2.28), and 2.15 (95% CI, 1.59-2.90) at 1, 2, 3, 4, and 5 years, after accounting for missing data using multiple imputation. After adjusting for age, sex, multimorbidity, and depression status and severity, self-rated health remained a predictor of MDS up to 5 years. CONCLUSIONS: Self-rated health offers family physicians an efficient and simple way to identify patients at risk of poor long-term depression outcomes and to inform therapeutic decision making.

Should I Take Aspirin? (SITA): RCT of a decision aid for cancer chemoprevention.

Background Australian guidelines recommend that all people aged 50-70 years old consider taking low-dose aspirin to reduce the risk of colorectal cancer (CRC). Aim To determine the effect of a consultation with a researcher in general practice using a decision aid about taking low-dose aspirin to prevent CRC on informed decision-making and low-dose aspirin uptake compared to a general CRC prevention brochure. Design and Setting Individually randomised controlled trial in six general practices in Victoria, Australia, from October 2020 to March 2021. Method Patients aged 50-70 years attending a general practitioner (GP) were recruited consecutively. The intervention was a consultation using a decision aid to discuss taking aspirin to reduce CRC risk; control consultations discussed reducing CRC risk generally. The self-reported co-primary outcomes were informed choices about taking aspirin at one month and low-dose aspirin uptake at six months. Results 261 participants (86% of eligible patients) were randomised into trial arms (129 intervention, 132 control). 17.7% (20/113) of intervention and 7.6% (9/118) control participants reported making an informed choice at one month, an estimated 9.1% (95% CI 0.29% to 18.5) between-arm difference in proportions [odds ratio (OR) 2.47 (97.5% CI:0.94 to 6.52) p=0.074]. The proportions of individuals who reported using aspirin at six months were: 10.2% (12/118) intervention vs 13.8% (16/116) control (estimated between-arm difference: -4.0% (95% CI: -13.5 to 5.5); [OR= 0.68 (97.5% CI:0.27 to 1.70), p= 0.692]. Conclusion The decision aid improved informed decision-making; but has little effect on long-term regular use of aspirin to reduce CRC risk.

Increasing bowel cancer screening using SMS in general practice: the SMARTscreen cluster randomised trial.

BACKGROUND: Australia has one of the highest incidences of colorectal cancer (CRC) worldwide. The Australian National Bowel Cancer Screening Program (NBCSP) is a best-practice, organised screening programme, but uptake is low (40.9%) and increasing participation could reduce morbidity and mortality associated with CRC. Endorsement by GPs is strongly associated with increasing screening uptake. AIM: This study (SMARTscreen) aimed to test whether a multi-intervention short message service (SMS) sent by general practices to 50-60-year-old patients who were due to receive the NBCSP kit would increase NBCSP uptake, by comparing it with usual care. DESIGN AND SETTING: A stratified cluster randomised controlled trial was undertaken, involving 21 Australian general practices in Western Victoria, Australia. METHOD: For intervention practices, people due to receive the NBCSP kit within a 6-month study period were sent an SMS just before receiving the kit. The SMS included a personalised message from the person's general practice endorsing the kit, a motivational narrative video, an instructional video, and a link to more information. Control practices continued with usual care, comprising at-home testing with a faecal immunochemical test (FIT) through the NBCSP. The primary outcome was the between-arm percentage difference in uptake of FIT screening within 12 months from randomisation, which was estimated using generalised linear model regression. RESULTS: In total, 39.2% (1143/2914) of people in 11 intervention practices and 23.0% (583/2537) of people in 10 control practices had a FIT result in their electronic health records - a difference of 16.5% (95% confidence interval = 2.02 to 30.9). CONCLUSION: The SMS intervention increased NBCSP kit return in 50-60-year-old patients in general practice. This finding informed a larger trial - SMARTERscreen - to test this intervention in a broader Australian population.

Chiropractic Observation and Analysis Study (COAST): providing an understanding of current chiropractic practice.

OBJECTIVES: COAST (Chiropractic Observation and Analysis Study) aimed to describe the clinical practices of chiropractors in Victoria, Australia. DESIGN: Cross-sectional study using the BEACH (Bettering the Evaluation and Care of Health) methods for general practice. SETTING AND PARTICIPANTS: 180 chiropractors in active clinical practice in Victoria were randomly selected from the list of 1298 chiropractors registered on Chiropractors Registration Board of Victoria. Twenty-four chiropractors were ineligible, 72 agreed to participate, and 52 completed the study. MAIN OUTCOME MEASURES: Each participating chiropractor documented encounters with up to 100 consecutive patients. For each chiropractor-patient encounter, information collected included patient health profile, patient reasons for encounter, problems and diagnoses, and chiropractic care. RESULTS: Data were collected on 4464 chiropractor-patient encounters from 52 chiropractors between 11 December 2010 and 28 September 2012. In most (71%) encounters, patients were aged 25-64 years; 1% of encounters were with infants (age < 1 year; 95% CI, 0.3%-3.2%). Musculoskeletal reasons for encounter were described by patients at a rate of 60 per 100 encounters (95% CI, 54-67 encounters) and maintenance and wellness or check-up reasons were described at a rate of 39 per 100 encounters (95% CI, 33-47 encounters). Back problems were managed at a rate of 62 per 100 encounters (95% CI, 55-71 encounters). The most frequent care provided by the chiropractors was spinal manipulative therapy and massage. CONCLUSIONS: A range of conditions are managed by chiropractors in Victoria, Australia, but most commonly these conditions are musculoskeletal-related. These results can be used by stakeholders of the chiropractic profession in workforce development, education and health care policy.

Changes in mental health across the COVID-19 pandemic for local and international university students in Australia: a cohort study.

PURPOSE: Previous research has indicated that university students experienced substantial mental health issues during the global COVID-19 pandemic, but few studies have considered changes relative to pre-pandemic levels across population groups. Hence, the aim of this study was to compare changes in mental health and associated stressors across the pandemic for international and local university students studying in Australia. METHODS: In a cohort of 4407 university students, we assessed depression (Patient Health Questionnaire 2), anxiety (Generalized Anxiety Disorder-2), social support (Medical Outcomes Study-Social Support Survey), inability to afford food, fear of partner, and experiences of discrimination, both pre-pandemic (April-May 2019) and during the pandemic (September-October 2020). Change in prevalence between local and international students were estimated with logistic regression, adjusting for baseline factors. RESULTS: Compared to local students, international students experienced an increase in probable major depression (odds ratio (OR) 1.43, 95% Confidence Interval (CI) 1.23, 1.66), low social support (OR 2.63, 95% CI 2.23, 3.11), inability to afford food (OR 5.21, 95% CI 3.97, 6.83) race-based discrimination (OR 2.21, 95% CI 1.82, 2.68) and fear of partner (OR 3.46, 95% CI 2.26, 5.13). Interaction analyses indicated that these issues were more likely to be experienced by students living outside their country of origin, inclusive of international students based in Australia (depression p value interaction term 0.02). CONCLUSION: The pandemic had a substantial negative impact on international students, particularly those living outside of their country of origin during the pandemic. The inequalities exacerbated by the pandemic were present prior to the pandemic and are likely to continue post-pandemic without action. Interventions to build the supports for international students need to be urgently explored.

Will a fee-for-service payment for a young people's health assessment in general practice increase the detection of health risk behaviours and health conditions? Protocol for a cluster randomised controlled trial (RAd Health Trial).

INTRODUCTION: Adolescence is a period of major transition in physical, cognitive, social and emotional development, and the peak time for the onset of mental health conditions, substance use disorders and sexual and reproductive health risks. Prevention and treatment during this time can improve health and well-being now and into the future. However, despite clinical guidelines recommending annual preventive health assessments for young people, health professionals cite lack of consultation time and adequate funding as key barriers. This trial aims to determine whether a specific fee-for-service ('rebate payment') for a young person's health assessment, is effective and cost-effective at increasing the detection and management of health risk behaviours and conditions among young people. METHODS AND ANALYSIS: This cluster randomised controlled trial will be conducted in Australian general practice. 42 general practices (clusters) will be randomly allocated 1:1 to either an intervention arm where general practitioners receive a rebate payment for each annual health assessment undertaken for 14-24-year-olds during a 2 year study period, or a control arm (no rebate). The rebate amount will be based on the Medical Benefits Schedule (Australia's list of health professional services subsidised by the Australian Government) currently available for similar age-based assessments. Our primary outcome will be the annual rate of risk behaviours and health conditions recorded in the patient electronic health record (eg, alcohol/drug use, sexual activity and mental health issues). Secondary outcomes include the annual rate of patient management activities related to health risks and conditions identified (eg, contraception prescribed, sexually transmitted infection tests ordered). A process evaluation will assess acceptability, adoption, fidelity and sustainability of the rebate; an economic evaluation will assess its cost-effectiveness. Analyses will be intention-to-treat. ETHICS AND DISSEMINATION: Ethics approval has been obtained from University of Melbourne Human and Research Ethics Committee (2022-23435-29990-3). Findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000114741.

The Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening.

BACKGROUND: A risk-stratified approach to colorectal cancer (CRC) screening could result in a more acceptable balance of benefits and harms, and be more cost-effective. AIM: To determine the effect of a consultation in general practice using a computerised risk assessment and decision support tool (Colorectal cancer RISk Prediction, CRISP) on risk-appropriate CRC screening. DESIGN AND SETTING: Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018. METHOD: Participants were recruited from a consecutive sample of patients aged 50-74 years attending their GP. Intervention consultations included CRC risk assessment using the CRISP tool and discussion of CRC screening recommendations. Control group consultations focused on lifestyle CRC risk factors. The primary outcome was risk-appropriate CRC screening at 12 months. RESULTS: A total of 734 participants (65.1% of eligible patients) were randomised (369 intervention, 365 control); the primary outcome was determined for 722 (362 intervention, 360 control). There was a 6.5% absolute increase (95% confidence interval [CI] = -0.28 to 13.2) in risk-appropriate screening in the intervention compared with the control group (71.5% versus 65.0%; odds ratio [OR] 1.36, 95% CI = 0.99 to 1.86, P = 0.057). In those due CRC screening during follow-up, there was a 20.3% (95% CI = 10.3 to 30.4) increase (intervention 59.8% versus control 38.9%; OR 2.31, 95% CI = 1.51 to 3.53, P<0.001) principally by increasing faecal occult blood testing in those at average risk. CONCLUSION: A risk assessment and decision support tool increases risk-appropriate CRC screening in those due screening. The CRISP intervention could commence in people in their fifth decade to ensure people start CRC screening at the optimal age with the most cost-effective test.

SMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program.

BACKGROUND: Australia persistently has one of the highest rates of colorectal cancer (CRC) in the world. Australia's National Bowel Cancer Screening Program (NBCSP) sends a biennial Faecal Immunochemical Test (FIT)-the 'NBCSP kit'-to everyone eligible for the programme between 50 and 74 years old; however, participation in the programme is low, especially in the 50- to 60-year-old age group. Our previous efficacy trial ('SMARTscreen') demonstrated an absolute increase in uptake of 16.5% (95% confidence interval = 2.02-30.9%) for people sent an SMS with motivational and instructional videos, from their general practice prior to receiving their NBCSP kit, compared to those receiving usual care. Building on the strengths of the SMARTscreen trial and addressing limitations, the 'SMARTERscreen' trial will test the effect on participation in the NBCSP of sending either an SMS only or an SMS with online video material to general practice patients due to receive their NBCSP compared to 'usual care'. METHODS: SMARTERscreen is a three-arm stratified cluster randomised controlled trial involving 63 general practices in two states in Australia. Eligible patients are patients who are aged 49-60 years and due to receive their NBCSP kit within the next 2 weeks during the intervention period. General practices will be equally randomised to three trial arms (21:21:21, estimated average 260 patients/practice). The two interventions include (i) an SMS with an encouraging message from their general practice or (ii) the same SMS with weblinks to additional motivational and instructional videos. The control arm will receive 'usual care'. Using the intention-to-treat approach, primary analysis will estimate the three pair-wise between-arm differences in the proportion of eligible patients who participate in the NBCSP within 6 months of when their kit is sent, utilising screening data from the Australian National Cancer Screening Register (NCSR). Patient intervention adherence to the interventions will also be evaluated. Findings will be incorporated into the Policy1-Bowel microsimulation model to estimate the long-term health benefits and cost-effectiveness of the interventions. DISCUSSION: SMARTERscreen will provide high-level evidence determining whether an SMS or an SMS with web-based material sent to general practice patients prior to receiving their NBCSP kit increases participation in bowel cancer screening. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000036617. Registered on 13 January 2023. Trial URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385119&isClinicalTrial=False.

The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care.

BACKGROUND: The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. METHODS: The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18-65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. DISCUSSION: This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.