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IntroductionThe world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these advances can improve health at older ages. Statins are one class of drug with the potential to prevent or delay the onset of several causes of incapacity in older age, particularly major cardiovascular disease (CVD). This paper presents the protocol for the STAtins in Reducing Events in the Elderly (STAREE) trial, a randomised double-blind placebo-controlled trial examining the effects of statins in community dwelling older people without CVD, diabetes or dementia.Methods and analysisWe will conduct a double-blind, randomised placebo-controlled trial among people aged 70 years and over, recruited through Australian general practice and with no history of clinical CVD, diabetes or dementia. Participants will be randomly assigned to oral atorvastatin (40 mg daily) or matching placebo (1:1 ratio). The co-primary endpoints are disability-free survival defined as survival-free of dementia and persistent physical disability, and major cardiovascular events (cardiovascular death or non-fatal myocardial infarction or stroke). Secondary endpoints are all-cause death, dementia and other cognitive decline, persistent physical disability, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, heart failure, atrial fibrillation, fatal and non-fatal cancer, all-cause hospitalisation, need for permanent residential care and quality of life. Comparisons between assigned treatment arms will be on an intention-to-treat basis with each of the co-primary endpoints analysed separately in time-to-first-event analyses using Cox proportional hazards regression models.Ethics and disseminationSTAREE will address uncertainties about the preventive effects of statins on a range of clinical outcomes important to older people. Institutional ethics approval has been obtained. All research outputs will be disseminated to general practitioner co-investigators and participants, published in peer-reviewed journals and presented at national and international conferences.Trial registration numberNCT02099123.

Background Prevalence of sexually transmissible infections (STIs) has been associated with availability of alcohol. This paper investigates potential associations between prevalent cases of chlamydia in young people in Australia and the availability of alcohol within their local area, defined as postcode of residence. Methods Alcohol availability was determined at the postcode level using liquor licensing data, classified as total number of licences, number of 'take-away' licences and number of licenses by population. Participant data were drawn from a survey targeting Australians aged 16-29years in rural and regional Australia, capturing demographic details including postcode of residence, indicators of sexual behaviour including condom use and chlamydia test results. Mixed-effects logistic regression was used to examine potential associations between first, alcohol availability and chlamydia, and second, between condom use and chlamydia. Results We found little evidence of associations between alcohol availability and chlamydia in either unadjusted or adjusted models. After adjusting for alcohol availability, we observed significant associations between inconsistent condom use and chlamydia prevalence, whether alcohol availability was measured as total number (adjusted odds ratio (AOR) 2.20; 95% confidence interval (CI) 1.20, 3.70), number of take-away licenses (AOR 2.19; 95% CI1.30, 3.69) or licenses per 1000 population (AOR 2.19; 95% CI 1.30, 3.68). Conclusion Little evidence of association between alcohol availability and chlamydia at the postcode level was found. Further research is required to determine appropriate measures of 'local area' and how characteristics thereof may impact on sexual health.

Background Australian Aboriginal and Torres Strait Islander (Indigenous) peoples face major health disadvantage across many conditions. Recording of patients’ Indigenous status in general practice records supports equitable delivery of effective clinical services. National policy and accreditation standards mandate recording of Indigenous status in patient records, however for a large proportion of general practice patient records it remains incomplete. We assessed the completeness of Indigenous status in general practice patient records, and compared the patient self-reported Indigenous status to general practice medical records. Methods A cross sectional analysis of Indigenous status recorded at 95 Australian general practices, participating in the Australian Chlamydia Control Effectiveness Pilot (ACCEPt) in 2011. Demographic data were collected from medical records and patient surveys from 16 to 29 year old patients at general practices, and population composition from the 2011 Australian census. General practitioners (GPs) at the same practices were also surveyed. Completeness of Indigenous status in general practice patient records was measured with a 75% benchmark used in accreditation standards. Indigenous population composition from a patient self-reported survey was compared to Indigenous population composition in general practice records, and Australian census data. Results Indigenous status was complete in 56% (median 60%, IQR 7–81%) of general practice records for 109,970 patients aged 16–29 years, and Indigenous status was complete for 92.5% of the 3355 patients aged 16–29 years who completed the survey at the same clinics. The median proportion per clinic of patients identified as Indigenous was 0.9%, lower than the 1.8% from the patient surveys and the 1.7% in clinic postcodes (ABS). Correlations between the proportion of Indigenous people self-reporting in the patient survey (5.2%) compared to status recorded in all patient records (2.1%) showed a fair association (r = 0.6468; p  < 0.01). After excluding unknown /missing data, correlations weakened. Conclusions Incomplete Indigenous status records may under-estimate the true proportion of Indigenous people attending clinics but have higher association with self-reported status than estimates which exclude missing/unknown data. The reasons for incomplete Indigenous status recording in general practice should be explored so efforts to improve recording can be targeted and strengthened. Trial registration ACTRN12610000297022 . Registered 13th April 2010.

IntroductionCerebrovascular disease and neurodegeneration are causes of cognitive decline and dementia, for which primary prevention options are currently lacking. Statins are well-tolerated and widely available medications that potentially have neuroprotective effects. The STAREE-Mind Imaging Study is a randomised, double-blind, placebo-controlled clinical trial that will investigate the impact of atorvastatin on markers of neurovascular health and brain atrophy in a healthy, older population using MRI. This is a nested substudy of the ‘Statins for Reducing Events in the Elderly’ (STAREE) primary prevention trial.MethodsParticipants aged 70 years or older (n=340) will be randomised to atorvastatin or placebo. Comprehensive brain MRI assessment will be undertaken at baseline and up to 4 years follow-up, including structural, diffusion, perfusion and susceptibility imaging. The primary outcome measures will be change in brain free water fraction (a composite marker of vascular leakage, neuroinflammation and neurodegeneration) and white matter hyperintensity volume (small vessel disease). Secondary outcomes will include change in perivascular space volume (glymphatic drainage), cortical thickness, hippocampal volume, microbleeds and lacunae, prefrontal cerebral perfusion and white matter microstructure.Ethics and disseminationAcademic publications from this work will address the current uncertainty regarding the impact of statins on brain structure and vascular integrity. This study will inform the utility of repurposing these well-tolerated, inexpensive and widely available drugs for primary prevention of neurological outcomes in older individuals. Ethics approval was given by Monash University Human Research Ethics Committee, Protocol 12206.Trial registration numberClinicalTrials.gov Identifier: NCT05586750.

Background Female general practitioners (GPs) have higher chlamydia testing rates than male GPs, yet it is unclear whether this is due to lack of knowledge among male GPs or because female GPs consult and test more female patients. Methods GPs completed a survey about their demographic details and knowledge about genital chlamydia. Chlamydia testing and consultation data for patients aged 16-29 years were extracted from the medical records software for each GP and linked to their survey responses. Chi-square tests were used to determine differences in a GP’s knowledge and demographics. Two multivariable models that adjusted for the gender of the patient were used to investigate associations between a GP and their chlamydia testing rates ― Model 1 included GPs’ characteristics such as age and gender, Model 2 excluded these characteristics to specifically examine any associations with knowledge. Results Female GPs were more likely than male GPs to know when to re-test a patient after a negative chlamydia test (18.8% versus 9.7%, p = 0.01), the correct symptoms suggestive of PID (80.5% versus 67.8%, p = 0.01) and the correct tests for diagnosing PID (57.1% versus 42.6%, p = 0.01). Female GPs tested 6.5% of patients, while male GPs tested 2.2% (p < 0.01). Model 1 found factors associated with chlamydia testing were being a female GP (OR = 2.5, 95% CI: 1.9, 3.3) and working in a metropolitan clinic (OR = 3.2; 95% CI: 2.4, 4.3). Model 2 showed that chlamydia testing increased as knowledge of testing guidelines improved (3-5 correct answers – AOR = 2.0, 95% CI: 1.0, 4.2; 6+ correct answers – AOR = 2.9, 95% CI: 1.4, 6.2). Conclusions Higher rates of chlamydia testing are strongly associated with GPs who are female, based in a metropolitan clinic and among those with more knowledge of the recommended guidelines. Improving chlamydia knowledge among male GPs may increase chlamydia testing.

•Cardiovascular aging is associated with myocardial dysfunction, with consequent atrial fibrillation and heart failure.•STAREE-HEART is a clinical trial assessing the effect of atorvastatin compared with placebo on markers of cardiovascular aging in a healthy older population.•A total of 369 participants underwent a comprehensive cardiac evaluation before randomization, which will be repeated at 3 years.•Atorvastatin may provide a population-wide prevention strategy for cardiovascular aging. Statins may prevent myocardial dysfunction associated with aging, and consequent atrial fibrillation (AF) and heart failure (HF). STAREE-HEART is a randomized, double-blind, placebo-controlled clinical trial assessing atorvastatin on markers of cardiovascular aging in a healthy older population. This ancillary study is nested in the STAtins in Reducing Events in the Elderly (STAREE) primary prevention trial. Participants ≥ 70 years (n = 369) have been randomized to atorvastatin or placebo. Assessment at baseline and 3-years includes echocardiogram, electrocardiography and blood collection for biomarker assessment. The primary endpoint is change in global longitudinal strain (GLS), a measure of left ventricular systolic function. An estimated 184 participants per group enables detection of mean GLS at 3 years in the placebo group being 2.0 percentage points lower than mean GLS in the statin group at 3 years, assuming SD = 5 percentage points and a 15% attrition rate, with power >90%. We present summary statistics describing participants at baseline. The mean age of the 369 STAREE-HEART participants was 73.0 years (SD 3.4). Mean left ventricular (LV) ejection fraction was 64.0% (SD 6.1), and mean GLS was 19.2% (SD 2.2). Mean GLS was similar between females and males (19.4% vs 19.0%) and slightly higher in those aged 70 to 74 compared to ≥75 years (19.4% vs 18.6%). AF was detected on screening in 4.5% of participants. The STAREE-HEART ancillary study will provide mechanistic detail concerning myocardial dysfunction and its consequences, to determine if atorvastatin affects left ventricular systolic function associated with aging. clinicaltrials.gov. Unique identifier: NCT04536870.

BackgroundThe Australian Chlamydia Control Effectiveness Pilot (ACCEPt) was a cluster randomised controlled trial designed to assess the effectiveness of annual chlamydia testing through general practice in Australia. The trial showed that testing rates increased among sexually active men and women aged 16–29 years, but after 3 years the estimated chlamydia prevalence did not differ between intervention and control communities. We developed a mathematical model to estimate the potential longer-term impact of chlamydia testing on prevalence in the general population.MethodsWe developed an individual-based model to simulate the transmission of Chlamydia trachomatis in a heterosexual population, calibrated to ACCEPt data. A proportion of the modelled population were tested for chlamydia and treated annually at coverage achieved in the control and intervention arms of ACCEPt. We estimated the reduction in chlamydia prevalence achieved by increasing retesting and by treating the partners of infected individuals up to 9 years after introduction of the intervention.ResultsIncreasing the testing coverage in the general Australian heterosexual population to the level achieved in the ACCEPt intervention arm resulted in reduction in the population-level prevalence of chlamydia from 4.6% to 2.7% in those aged 16–29 years old after 10 years (a relative reduction of 41%). The prevalence reduces to 2.2% if the proportion retested within 4 months of treatment is doubled from the rate achieved in the ACCEPt intervention arm (a relative reduction of 52%), and to 1.9% if the partner treatment rate is increased from 30%, as assumed in the base case, to 50% (a relative reduction of 59%).ConclusionA reduction in C. trachomatis prevalence could be achieved if the level of testing as observed in the ACCEPt intervention arm can be maintained at a population level. More substantial reductions can be achieved with intensified case management comprising retesting of those treated and treatment of partners of infected individuals.

To compare the data quality, logistics, and cost of a self-administered sexual behavior questionnaire administered either using a computer-assisted survey instrument (CASI) or by paper and pencil in a primary care clinic. A self-administered sexual behavior questionnaire was administered to 16–29 year olds attending general practice. Questionnaires were administered by either paper and pencil (paper) or CASI. A personal digital assistant was used to self-administer the CASI. A total of 4,491 people completed the questionnaire, with 46.9% responses via CASI and 53.2% by paper. Completion of questions was greater for CASI than for paper for sexual behavior questions: number of sexual partners [odds ratio (OR), 6.85; 95% confidence interval (CI): 3.32, 14.11] and ever having had sex with a person of the same gender (OR, 2.89; 95% CI: 1.52, 5.49). The median number of questions answered was higher for CASI than for paper (17.6 vs. 17.2; P < 0.01). CASI was cheaper to run at $8.18 per questionnaire compared with $11.83 for paper. Electronic devices using CASI are a tool that can increase participants' questionnaire responses and deliver more complete data for a sexual behavior questionnaire in primary care clinics.

Modern research management, particularly for publicly funded studies, assumes a data governance model in which grantees are considered stewards rather than owners of important data sets. Thus, there is an expectation that collected data are shared as widely as possible with the general research community. This presents problems in complex studies that involve sensitive health information. The latter requires balancing participant privacy with the needs of the research community. Here, we report on the data operation ecosystem crafted for the Accelerating Medicines Partnership® Schizophrenia project, an international observational study of young individuals at clinical high risk for developing a psychotic disorder. We review data capture systems, data dictionaries, organization principles, data flow, security, quality control protocols, data visualization, monitoring, and dissemination through the NIMH Data Archive platform. We focus on the interconnectedness of these steps, where our goal is to design a seamless data flow and an alignment with the FAIR (Findability, Accessibility, Interoperability, and Reusability) principles while balancing local regulatory and ethical considerations. This process-oriented approach leverages automated pipelines for data flow to enhance data quality, speed, and collaboration, underscoring the project’s contribution to advancing research practices involving multisite studies of sensitive mental health conditions. An important feature is the data’s close-to-real-time quality assessment (QA) and quality control (QC). The focus on close-to-real-time QA/QC makes it possible for a subject to redo a testing session, as well as facilitate course corrections to prevent repeating errors in future data acquisition. Watch Dr. Sylvain Bouix discuss his work and this article: https://vimeo.com/1025555648.

The Accelerating Medicines Partnership Schizophrenia (AMP® SCZ) program integrates lived experience into psychosis research, leveraging over three decades of foundational studies to improve research quality, promote community engagement, and ensure ethical implementation of precision psychiatry. Lived experience is embedded in the program’s governance, shaping study protocols, recruitment strategies, and digital tools such as the mindLAMP platform. Study sites also integrate lived experience through youth advisory boards, peer support specialists, and advisory committees, ensuring diverse perspectives inform research design and implementation. These efforts aim to develop predictive tools and therapeutic strategies while maintaining ethical and participant-centered practices. Advocacy organizations, such as the National Alliance on Mental Illness (NAMI), have fostered collaboration among government, industry, and academic partners, shaping outreach and engagement strategies. Dissemination efforts, led by the Website and Outreach Workgroup (WOW), include an accessible, Section 508-compliant website and co-designed resources, building trust and engagement within communities. By integrating lived experience at every stage, the program aims to foster trust, enhance research outcomes, and inform future strategies for treatment and prevention. Watch Dr. Tina Kapur, Dr. Kathryn Eve Lewandowski, and Dr. Carlos A. Larrauri discuss this article and their work at: https://vimeo.com/1050068801.