SmilesUp text message intervention for early childhood dental caries prevention: A protocol for a randomised controlled trial.

INTRODUCTION: Despite improvements in health outcomes for children, early childhood dental caries (ECC) remains a chronic lifestyle-mediated disease that affects an estimated 600 million children worldwide. Parental influence on oral health-promoting behaviours is pivotal in preventing ECC. The latest WHO publications Ending Early Childhood Dental Caries and Mobile Technologies for Oral Health highlights the opportunity for mobile Health programs (including text message programs) to improve oral health behaviours and oral health self-efficacy. In response, our team of parents, oral health professionals (academics and health promotion experts), and IT specialists co-designed a 12-week, behavioural theory-informed text message program (called SmilesUp) to address behavioural risk factors specific to ECC. This randomised trial aims to assess whether the SmilesUp program improves parents' oral health promoting behaviours (like tooth brushing twice a day with toothpaste) and oral health self-efficacy for their children compared to usual care. METHODS AND ANALYSIS: A randomised controlled trial with a 1:1 parallel design will be conducted among 150 parents with children diagnosed with ECC and accessing public dental care in NSW, Australia. Patients will be stratified by hospital site, and modality of care (Dental General Anaesthetic (DGA) or not) and then randomly assigned to either immediately receive the SMILESup text messaging intervention or receive the program at the end of the study period. The primary outcome at 12 weeks is twice daily brushing with fluoride toothpaste. Secondary outcomes include changes in the intake frequency of sugared drinks and foods, oral health promoting bedtime routines and oral health self-efficacy. The primary analysis will follow an intention-to-treat principle. In addition, a process evaluation will examine barriers, enablers, and opportunities to scale the program. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Western Sydney Local Health District Human Research Ethics Committee 2022/ETH01920. Study results will be disseminated via peer-reviewed publications and presentations at conferences. TRIAL REGISTRATION: Trial registration number: This clinical trial has been prospectively registered on the ANZCTR from the 27th of March 2023. Registration number: ACTRN12623000325606.

A randomised controlled implementation study integrating patient self-screening with a remote central monitoring system to screen community-dwellers aged 75 years and older for atrial fibrillation.

AIMS: Diagnosis of atrial fibrillation (AF) provides opportunities to reduce stroke risk. This study aimed to compare AF diagnosis rates, participant satisfaction and feasibility of an electrocardiogram (ECG) self-screening virtual care system with usual care. METHODS: This randomised controlled implementation study involving community-dwelling people aged ≥75 years was conducted from May 2021 to June 2023. Participants were given a handheld single-lead ECG device and trained to self-record ECGs once daily on weekdays for 12 months. The control group received usual care with their general practitioners in the first 6 months and participated in the subsequent 6 months. AF diagnosis and participant satisfaction were assessed at 6 months. RESULTS: 200 participants (mean age 79.0±3.4 years; 54.0% female; 72.5% urban). AF was diagnosed in 10/97 (10.3%) intervention participants and 2/100 (2.0%) in the control group (Odds Ratio 5.6, 95% CI 1.4-37.3, p=0.03). In the intervention, 80% of AF cases were diagnosed within 3 months. 91/93 (97.9%) intervention participants and 55/93 (59.1%) control-waitlisted participants (p<0.001) were satisfied with AF screening. Of the expected 20 days per month, the overall monthly median number of days participants self-recorded ECGs was 20 (interquartile range 17-22). Participants were confident using the device (93%), reported it was easy to use (98%) and found screening efficient (96%). CONCLUSIONS: Patient-led AF self-screening using single-lead ECG devices with a remote central monitoring system was feasible, acceptable, and effective in diagnosing AF among older people. This screening model could be adapted for implementation, interfacing with integrated care models within existing health systems.

Our screening model involves virtual enrolment and training participants aged ≥75 years to use handheld single-lead ECG devices. With a remote central support system, older people are empowered to use handheld devices to self-screen atrial fibrillation (AF) at home or elsewhere in the community. This innovative screening model was feasible and acceptable, with high adherence to self-screening among older participants (mean age of 79 years). It yielded a 5-fold higher rate of AF diagnosis at 6 months compared to standard usual care and needed 12 participants screened to find one additional AF. This screening model can be implemented, interfacing with (i.e., communicating, connecting and supporting) the existing healthcare systems. If implemented at scale, it could provide better access and quality of AF screening and care to remote and high-risk populations.

A Cross-Sectional Survey of Fixed-Dose Combination Antihypertensive Medicine Prescribing in Twenty-Four Countries, Including Qualitative Insights.

Background: Treatment inertia, non-adherence and non-persistence to medical treatment contribute to poor blood pressure (BP) control worldwide. Fixed dose combination (FDC) antihypertensive medicines simplify prescribing patterns and improve adherence. The aim of this study was to identify factors associated with prescribing FDC antihypertensive medicines and to understand if these factors differ among doctors worldwide. Methods: A cross-sectional survey was conducted online from June 2023 to January 2024 to recruit doctors. We collaborated with an international network of researchers and clinicians identified through institutional connections. A passive snowballing recruitment strategy was employed, where network members forwarded the survey link to their clinical colleagues. The survey instrument, developed through a literature review, interviews with academic and clinical researchers, and pilot testing, assessed participants perspectives on prescribing FDC antihypertensive medicines for hypertension. Participants rated their level of agreement (5-point Likert scale) with statements representing six barriers and four facilitators to FDC use. Findings: Data from 191 surveys were available for analysis. 25% (n = 47) of participants worked in high-income countries, 38% (n = 73) in upper-middle income, 25% (n = 48) in lower-middle income, 6% (n = 10) in low-income countries. Forty percent (n = 70) of participants were between 36-45 years of age; two thirds were male. Cost was reported as a barrier to prescribing FDC antihypertensive medicines [51% (n = 87) agreeing or strongly agreeing], followed by doctors' confidence in BP measured in clinic [40%, (n = 70)], access [37%, (n = 67)], appointment duration [35%, (n = 61)], concerns about side-effects [(21%, n = 37)], and non-adherence [12%, (n = 21)]. Facilitators to FDC antihypertensive polypills prescribing were clinician facing, such as access to educational supports [79%, (n = 143)], more BP measurement data [67%, (n = 120)], a clinical nudge in health records [61%, (n = 109)] and patient-facing including improved patient health literacy [49%, (n = 88)]. The levels of agreement and strong agreement across all barriers and facilitators were similar for participants working in higher or lower income countries. Across all countries, participants rated FDC antihypertensive medications highly valuable for managing patients with non-adherence, (82% reported high or very high value), for patients with high pill burden (80%). Interpretation: Cost and access were the most common barriers to prescribing FDCs across high- and low-income countries. While greater educational support for clinicians was perceived as the leading potential facilitator of FDC use, this seems unlikely to be effective without addressing access.

A Call to Action to Improve Cardiac Arrest Outcomes: A Report From the National Summit for Cardiac Arrest.

Sudden cardiac arrest (SCA) represents a major cause of premature mortality globally, with enormous impact and financial cost to victims, families, and communities. SCA prevention should be considered a health priority in Australia. National Cardiac Arrest Summits were held in June 2022 and March 2023, with inclusion from multi-faceted endeavours related to SCA prevention. It was agreed to establish a multidisciplinary Australian Sudden Cardiac Arrest Alliance (AuSCAA) working group charged with developing a national unified strategy, with clear and measurable quality indicators and standardised outcome measures, to amplify the goal of SCA prevention throughout Australia. A multi-faceted prevention strategy will include i) endeavours to progress community awareness, ii) improved fundamental mechanistic understanding, iii) implementation of best-practice resuscitation strategies for all demographics and locations, iv) secondary risk assessment directed to family members, and v) development of (near) real-time registry of cardiac arrest cases to inform areas of need and effectiveness of interventions. Together, we can and should reduce the impact of SCA in Australia.

Assessing the built environment through photographs and its association with obesity in 21 countries: the PURE Study.

BACKGROUND: The built environment can influence human health, but the available evidence is modest and almost entirely from urban communities in high-income countries. Here we aimed to analyse built environment characteristics and their associations with obesity in urban and rural communities in 21 countries at different development levels participating in the Prospective Urban and Rural Epidemiology (PURE) Study. METHODS: Photographs were acquired with a standardised approach. We used the previously validated Environmental Profile of a Community's Health photo instrument to evaluate photos for safety, walkability, neighbourhood beautification, and community disorder. An integrated built environment score (ie, a minimum of 0 and a maximum of 20) was used to summarise this evaluation across built environment domains. Associations between built environment characteristics, separately and combined in the integrated built environment score, and obesity (ie, a BMI >30kg/m2) were assessed using multilevel regression models, adjusting for individual, household, and community confounding factors. Attenuation in the associations due to walking was examined. FINDINGS: Analyses include 143 338 participants from 530 communities. The mean integrated built environment score was higher in high-income countries (13·3, SD 2·8) compared with other regions (10·1, 2·5) and urban communities (11·2, 3·0). More than 60% of high-income country communities had pedestrian safety features (eg, crosswalks, sidewalks, and traffic signals). Urban communities outside high-income countries had higher rates of sidewalks (176 [84%] of 209) than rural communities (59 [28%] of 209). 15 (5%) of 290 urban communities had bike lanes. Litter and graffiti were present in 372 (70%) of 530 communities, and poorly maintained buildings were present in 103 (19%) of 530. The integrated built environment score was significantly associated with reduced obesity overall (relative risk [RR] 0·58, 95% CI 0·35-0·93; p=0·025) for high compared with low scores and for increasing trend (0·85, 0·78-0·91; p<0·0001). The trends were statistically significant in urban (0·85, 0·77-0·93; p=0·0007) and rural (0·87, 0·78-0·97; p=0·015) communities. Some built environment features were associated with a lower prevalence of obesity: community beautification RR 0·75 (95% CI 0·61-0·92; p=0·0066); bike lanes RR 0·58 (0·45-0·73; p<0·0001); pedestrian safety RR 0·75 (0·62-0·90; p=0·0018); and traffic signals RR 0·68 (0·52-0·89; p=0·0055). Community disorder was associated with a higher prevalence of obesity (RR 1·48, 95% CI 1·17-1·86; p=0·0010). INTERPRETATION: Community built environment features recorded in photographs, including bike lanes, pedestrian safety measures, beautification, traffic density, and disorder, were related to obesity after adjusting for confounders, and stronger associations were found in urban than rural communities. The method presents a novel way of assessing the built environment's potential effect on health. FUNDING: Population Health Research Institute, Hamilton Health Sciences Research Institute, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research's Strategy for Patient Oriented Research, Ontario Support Unit, Ontario Ministry of Health and Long-Term Care, AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline.

Evaluating the impact of oral hygiene instruction and digital oral health education within cardiac rehabilitation clinics: A protocol for a novel, dual centre, parallel randomised controlled trial.

INTRODUCTION: Diseases of the periodontal tissues including gingivitis and periodontitis can affect up to 90% and 50% of the population respectively. These conditions are multifactorial inflammatory conditions involving a dysbiotic biofilm that, if left untreated, can lead to the destruction of the supporting structures of the teeth and have significant systemic implications, specifically on cardiovascular health. The elevation of inflammatory markers, particularly high-sensitive C-reactive protein (hsCRP), are strongly associated with an increased risk of atherosclerosis, a key risk factor for cardiovascular disease (CVD). HsCRP as well as other inflammatory markers can be detected in blood samples as early as 21 days after ceasing toothbrushing, due to the immune response to stagnant oral biofilm. The most effective way to ensure oral biofilm cannot remain on oral tissues, thus preventing periodontitis and reducing inflammatory CVD risk, is with good oral hygiene. The primary aim of this study is to assess whether individualised oral hygiene instruction (OHI) partnered with a digital oral health education (DOHE) package can improve the oral health of patients living with CVD. METHODS AND ANALYSIS: A total of 165 participants will be recruited from the Westmead and Blacktown Mt Druitt cardiac rehabilitation out-patient clinics into this dual centre, single blind, parallel design, randomised controlled trial. A baseline oral health clinical examination will be completed, followed by a self-report questionnaire before they are randomised in a 1:1:1 ratio into one of 3 arms as follows: individualised OHI partnered with DOHE (Group A), (Group B) DOHE only (Group B), and control/usual care (no oral health education) (Group C). Groups will have their intervention repeated at the 6-week follow-up. After completing the 12-week follow-up, Group B and Group C will receive tailored OHI. Group C will also receive the DOHE package. The primary outcome is the change in approximal plaque index score between baseline and 6-week follow up. ETHICS AND DISSEMINATION: The study has been approved by the Western Sydney Local Health District Human Ethics Committee 2023/ETH00516. Results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12623000449639p ANZCTR: https://www.anzctr.org.au/.

Use of digital patient decision-support tools for atrial fibrillation treatments: a systematic review and meta-analysis.

OBJECTIVES: To assess the effects of digital patient decision-support tools for atrial fibrillation (AF) treatment decisions in adults with AF. STUDY DESIGN: Systematic review and meta-analysis. ELIGIBILITY CRITERIA: Eligible randomised controlled trials (RCTs) evaluated digital patient decision-support tools for AF treatment decisions in adults with AF. INFORMATION SOURCES: We searched MEDLINE, EMBASE and Scopus from 2005 to 2023.Risk-of-bias (RoB) assessment: We assessed RoB using the Cochrane Risk of Bias Tool 2 for RCTs and cluster RCT and the ROBINS-I tool for quasi-experimental studies. SYNTHESIS OF RESULTS: We used random effects meta-analysis to synthesise decisional conflict and patient knowledge outcomes reported in RCTs. We performed narrative synthesis for all outcomes. The main outcomes of interest were decisional conflict and patient knowledge. RESULTS: 13 articles, reporting on 11 studies (4 RCTs, 1 cluster RCT and 6 quasi-experimental) met the inclusion criteria. There were 2714 participants across all studies (2372 in RCTs), of which 26% were women and the mean age was 71 years. Socioeconomically disadvantaged groups were poorly represented in the included studies. Seven studies (n=2508) focused on non-valvular AF and the mean CHAD2DS2-VASc across studies was 3.2 and for HAS-BLED 1.9. All tools focused on decisions regarding thromboembolic stroke prevention and most enabled calculation of individualised stroke risk. Tools were heterogeneous in features and functions; four tools were patient decision aids. The readability of content was reported in one study. Meta-analyses showed a reduction in decisional conflict (4 RCTs (n=2167); standardised mean difference -0.19; 95% CI -0.30 to -0.08; p=0.001; I2=26.5%; moderate certainty evidence) corresponding to a decrease in 12.4 units on a scale of 0 to 100 (95% CI -19.5 to -5.2) and improvement in patient knowledge (2 RCTs (n=1057); risk difference 0.72, 95% CI 0.68, 0.76, p<0.001; I2=0%; low certainty evidence) favouring digital patient decision-support tools compared with usual care. Four of the 11 tools were publicly available and 3 had been implemented in healthcare delivery. CONCLUSIONS: In the context of stroke prevention in AF, digital patient decision-support tools likely reduce decisional conflict and may result in little to no change in patient knowledge, compared with usual care. Future studies should leverage digital capabilities for increased personalisation and interactivity of the tools, with better consideration of health literacy and equity aspects. Additional robust trials and implementation studies are warranted. PROSPERO REGISTRATION NUMBER: CRD42020218025.

Impact of the COVID-19 pandemic from the perspective of patients with cardiovascular disease in Australia: mixed-methods study.

OBJECTIVES: The study explored the perceived impacts of COVID-19 and its associated policies and social restrictions on health, self-management and access to healthcare. DESIGN: Cross-sectional observational (online survey) and qualitative study (semi-structured interviews and thematic analysis). SETTING: Australia. PARTICIPANTS: People with self-reported cardiovascular disease (CVD) and/or risk factors. RESULTS: Survey responses were collected from 690 participants (43.8% women, 40.1% over 65 years). Participants reported that their heart health had been affected by the pandemic (26.3%), were less likely to exercise (47.1%), have a healthy diet (25.9%) and take medications (9.4%). A large proportion were admitted to hospital (46.2%) and presented to the emergency department (40.6%). Difficulties in accessing healthcare providers (53.2%) and use of telemedicine (63.6%) were reported. We conducted 16 semi-structured interviews and identified five key themes: adding burden in seeking medical care, impediments in accessing a readjusted health system, exacerbating vulnerability and distress, coping with self-management and adapting to telehealth. CONCLUSIONS: Patients with CVD expressed an additional burden in seeking medical care and difficulties navigating a readjusted health system during the COVID-19 pandemic. Associated policies and access issues heightened vulnerabilities and distress, making self-management of health difficult for patients with CVD.

Lipidomic Risk Score to Enhance Cardiovascular Risk Stratification for Primary Prevention.

BACKGROUND: Accurate risk stratification is vital for primary prevention of cardiovascular disease (CVD). However, traditional tools such as the Framingham Risk Score (FRS) may underperform within the diverse intermediate-risk group, which includes individuals requiring distinct management strategies. OBJECTIVES: This study aimed to develop a lipidomic-enhanced risk score (LRS), specifically targeting risk prediction and reclassification within the intermediate group, benchmarked against the FRS. METHODS: The LRS was developed via a machine learning workflow using ridge regression on the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab; n = 10,339). It was externally validated with the Busselton Health Study (n = 4,492), and its predictive utility for coronary artery calcium scoring (CACS)-based outcomes was independently validated in the BioHEART cohort (n = 994). RESULTS: LRS significantly improved discrimination metrics for the intermediate-risk group in both AusDiab and Busselton Health Study cohorts (all P < 0.001), increasing the area under the curve for CVD events by 0.114 (95% CI: 0.1123-0.1157) and 0.077 (95% CI: 0.0755-0.0785), with a net reclassification improvement of 0.36 (95% CI: 0.21-0.51) and 0.33 (95% CI: 0.15-0.49), respectively. For CACS-based outcomes in BioHEART, LRS achieved a significant area under the curve improvement of 0.02 over the FRS (0.76 vs 0.74; P < 1.0 × 10-5). A simplified, clinically applicable version of LRS was also created that had comparable performance to the original LRS. CONCLUSIONS: LRS, augmenting the FRS, presents potential to improve intermediate-risk stratification and to predict atherosclerotic markers using a simple blood test, suitable for clinical application. This could facilitate the triage of individuals for noninvasive imaging such as CACS, fostering precision medicine in CVD prevention and management.

Accuracy of a Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias Compared Against Cardiac Electrophysiology Study.

BACKGROUND: Single-lead electrocardiogram (ECG) devices may allow detection and diagnosis of cardiac rhythms. However, data on their accuracy for detecting cardiac arrhythmias beyond atrial fibrillation are limited. We aimed to determine the accuracy of the AliveCor KardiaMobile (AC) (AliveCor Inc, Mountain View, CA, USA) for the diagnosis of arrhythmias against gold standard cardiac electrophysiology study (EPS). METHOD: Patients undergoing clinically indicated EPS underwent simultaneous rhythm recording with an AC, standard 12-lead ECG, and EP catheters for intracardiac electrograms. Rhythms recorded during EPS were classified based on electrogram, 12-lead ECG, and clinical findings. Blinded reviewers provided differential diagnoses for the single-lead AC tracings; a separate reviewer compared diagnoses made between the AC tracings and EPS findings. RESULTS: In 49 patients, 843 cardiac rhythms were captured during 502 AC recordings. Analysis of tracings containing sinus rhythm (n=273) returned an overall accuracy of 92%, with sensitivity and specificity values of 93% and 92%, respectively. Accuracy for tracings per rhythm was atrial fibrillation 91% (n=51); supraventricular tachycardia accuracy was 89% (n=191), ventricular tachycardia 91% (n=198), ventricular fibrillation 98% (n=11), and asystole 100% (n=5). Accuracy for supraventricular ectopy was 93% (n=28) and for premature ventricular complexes was 91% (n=86). Overall accuracy was 94% for solitary rhythms and 93% in tracings from patients with baseline bundle branch block. CONCLUSIONS: When compared against the gold standard EPS diagnosis, the interpretation of arrhythmias recorded by an AliveCor single-lead ECG device had reasonable diagnostic accuracy.

The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a nonhigh-sensitivity troponin T assay after noncardiac surgery.

INTRODUCTION: Troponin elevation after noncardiac surgery is associated with an elevated risk of 30-day mortality. Little is known about relative merit of using a high-sensitivity Troponin T (hsTnT), the fifth-generation assay, vs the nonhigh sensitivity Troponin T (non-hsTnT), the fourth-generation assay, in the noncardiac surgery setting. We aimed to identify whether hsTnT can identify additional patients at risk that would have gone undetected with non-hsTnT measurement. METHODS: The VISION Study included 40,004 noncardiac surgery patients with postoperative troponin measurements. Among them, 1,806 patients had both fourth-generation non-hsTnT and fifth-generation hsTnT concomitant measurements (4,451 paired results). We compared the absolute concentrations, the timing, and the impact of different thresholds on predicting 30-day major cardiovascular complications (composite of death, nonfatal cardiac arrest, coronary revascularization, and congestive heart failure). RESULTS: Based on the manufacturers' threshold of 14 ng/L, 580 (32.1%) patients had postoperative hsTnT concentrations greater than the threshold, while their non-hsTnT concentrations were below the manufacturer's threshold. These 580 patients had higher risk of major cardiovascular events (OR 2.33; CI 95% 1.04-5.23; P = .049) than patients with hsTnT concentrations below the manufacturer threshold. Among patients with myocardial injury after noncardiac surgery, only 50% would be detected by the fourth-generation non-hsTnT assay at 6 to 12 hours postoperative as compared to 85% with the fifth-generation hsTnT assay (P-value < .001). CONCLUSIONS: Within the first 3 postoperative days, fifth-generation hsTnT identified at least 1 in 3 patients with troponin elevation that would have gone undetected by fourth-generation non-hsTnT using published thresholds in this setting. Furthermore, fifth-generation hsTnT identified patients with an elevation earlier than fourth-generation non-hsTnT, indicating potential to improve postoperative risk stratification.

Shop-to-Stop Hypertension: A multicenter cluster-randomized controlled trial protocol to improve screening and text message follow-up of adults with high blood pressure at health kiosks in hardware retail stores.

High blood pressure (BP) is the leading preventable risk factor for death, but only one in three patients achieve target BP control. A key contributor to this problem is poor population awareness of high BP, as the majority of patients are asymptomatic. The Shop-To-Stop Hypertension study is a multicenter, cluster-randomized controlled trial to identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. In participants with high BP measured by SiSU Health Stations located in major hardware chain stores across New South Wales, Australia, we will determine whether text message-based nudges will encourage repeat BP checks and visits to their doctor. Based on pilot data, we anticipate 65,340 participants will be screened over 12 months, of which 18% will have high BP. Thirty hardware stores will be randomized (1:1) to: (i) Intervention: participants detected with high BP (≥140/≥90 mmHg) will receive text message-based nudges to return for a repeat SiSU Health Station BP check and to visit their general practitioner (GP) to check and manage their BP; (ii) Control: participants with high BP will not receive text messages. The primary outcome is the difference in the proportion of participants with high BP having a repeat BP check at hardware Health Stations in the intervention vs. control group at 12 months. This novel setting for screening utilises a novel 'citizen science' approach inviting the general public to perform their own BP screening at health kiosks and foster behavioral change. This will allow screening in a low-stress environment.

Health economic analysis of polygenic risk score use in primary prevention of coronary artery disease - A system dynamics model.

Background: Primary prevention programs utilising traditional risk scores fail to identify all individuals who suffer acute cardiovascular events. We aimed to model the impact and cost effectiveness of incorporating a Polygenic risk scores (PRS) into the cardiovascular disease CVD primary prevention program in Australia, using a whole-of-system model. Methods: System dynamics models, encompassing acute and chronic CVD care in the Australian healthcare setting, assessing the cost-effectiveness of incorporating a CAD-PRS in the primary prevention setting. The time horizon was 10-years. Results: Pragmatically incorporating a CAD-PRS in the Australian primary prevention setting in middle-aged individuals already attending a Heart Health Check (HHC) who are determined to be at low or moderate risk based on the 5-year Framingham risk score (FRS), with conservative assumptions regarding uptake of PRS, could have prevented 2, 052 deaths over 10-years, and resulted in 24, 085 QALYs gained at a cost of $19, 945 per QALY with a net benefit of $724 million. If all Australians overs the age of 35 years old had their FRS and PRS performed, and acted upon, 12, 374 deaths and 60, 284 acute coronary events would be prevented, with 183, 682 QALYs gained at a cost of $18, 531 per QALY, with a net benefit of $5, 780 million. Conclusions: Incorporating a CAD-PRS in a contemporary primary prevention setting in Australia would result in substantial health and societal benefits and is cost-effective. The broader the uptake of CAD-PRS in the primary prevention setting in middle-aged Australians, the greater the impact and the more cost-effective the strategy.

Process evaluation of a data-driven quality improvement program within a cluster randomised controlled trial to improve coronary heart disease management in Australian primary care.

BACKGROUND: This study evaluates primary care practices' engagement with various features of a quality improvement (QI) intervention for patients with coronary heart disease (CHD) in four Australian states. METHODS: Twenty-seven practices participated in the QI intervention from November 2019 -November 2020. A combination of surveys, semi-structured interviews and other materials within the QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease (QUEL) study were used in the process evaluation. Data were summarised using descriptive statistical and thematic analyses for 26 practices. RESULTS: Sixty-four practice team members and Primary Health Networks staff provided feedback, and nine of the 63 participants participated in the interviews. Seventy-eight percent (40/54) were either general practitioners or practice managers. Although 69% of the practices self-reported improvement in their management of heart disease, engagement with the intervention varied. Forty-two percent (11/26) of the practices attended five or more learning workshops, 69% (18/26) used Plan-Do-Study-Act cycles, and the median (Interquartile intervals) visits per practice to the online SharePoint site were 170 (146-252) visits. Qualitative data identified learning workshops and monthly feedback reports as the key features of the intervention. CONCLUSION: Practice engagement in a multi-featured data-driven QI intervention was common, with learning workshops and monthly feedback reports identified as the most useful features. A better understanding of these features will help influence future implementation of similar interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.

Using Artificial Intelligence to Predict Heart Failure Risk from Single-lead Electrocardiographic Signals: A Multinational Assessment.

Importance: Despite the availability of disease-modifying therapies, scalable strategies for heart failure (HF) risk stratification remain elusive. Portable devices capable of recording single-lead electrocardiograms (ECGs) can enable large-scale community-based risk assessment. Objective: To evaluate an artificial intelligence (AI) algorithm to predict HF risk from noisy single-lead ECGs. Design: Multicohort study. Setting: Retrospective cohort of individuals with outpatient ECGs in the integrated Yale New Haven Health System (YNHHS) and prospective population-based cohorts of UK Biobank (UKB) and Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Participants: Individuals without HF at baseline. Exposures: AI-ECG-defined risk of left ventricular systolic dysfunction (LVSD). Main Outcomes and Measures: Among individuals with ECGs, we isolated lead I ECGs and deployed a noise-adapted AI-ECG model trained to identify LVSD. We evaluated the association of the model probability with new-onset HF, defined as the first HF hospitalization. We compared the discrimination of AI-ECG against the pooled cohort equations to prevent HF (PCP-HF) score for new-onset HF using Harrel's C-statistic, integrated discrimination improvement (IDI), and net reclassification improvement (NRI). Results: There were 194,340 YNHHS patients (age 56 years [IQR, 41-69], 112,082 women [58%]), 42,741 UKB participants (65 years [59-71], 21,795 women [52%]), and 13,454 ELSA-Brasil participants (56 years [41-69], 7,348 women [55%]) with baseline ECGs. A total of 3,929 developed HF in YNHHS over 4.5 years (2.6-6.6), 46 in UKB over 3.1 years (2.1-4.5), and 31 in ELSA-Brasil over 4.2 years (3.7-4.5). A positive AI-ECG screen was associated with a 3- to 7-fold higher risk for HF, and each 0.1 increment in the model probability portended a 27-65% higher hazard across cohorts, independent of age, sex, comorbidities, and competing risk of death. AI-ECG's discrimination for new-onset HF was 0.725 in YNHHS, 0.792 in UKB, and 0.833 in ELSA-Brasil. Across cohorts, incorporating AI-ECG predictions in addition to PCP-HF resulted in improved Harrel's C-statistic (Δ=0.112-0.114), with an IDI of 0.078-0.238 and an NRI of 20.1%-48.8% for AI-ECG vs. PCP-HF. Conclusions and Relevance: Across multinational cohorts, a noise-adapted AI model with lead I ECGs as the sole input defined HF risk, representing a scalable portable and wearable device-based HF risk-stratification strategy.

Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial.

BACKGROUND: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of 'watchful waiting'. METHODS: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. RESULTS: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. CONCLUSIONS: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.

Cardiovascular outcomes for people hospitalised with COVID-19 in Australia, and the effect of vaccination: an observational cohort study.

OBJECTIVES: To assess the frequency of clinical cardiovascular outcomes for people hospitalised with coronavirus disease 2019 (COVID-19), and the impact of vaccination. STUDY DESIGN: Observational cohort study. SETTING, PARTICIPANTS: All index admissions of adults with laboratory-confirmed COVID-19 to 21 hospitals participating in the Australian Cardiovascular COVID-19 Registry (AUS-COVID), 4 September 2020 - 11 July 2022. MAIN OUTCOME MEASURES: Frequency of elevated troponin levels, new arrhythmia, new or deteriorating heart failure or cardiomyopathy, new pericarditis or myocarditis, new permanent pacemaker or implantable cardioverter-defibrillator, and pulmonary embolism. SECONDARY OUTCOMES: impact of COVID-19 vaccination on likelihood of in-hospital death, intubation, troponin elevation, and clinical cardiovascular events. RESULTS: The mean age of the 1714 people admitted to hospital with COVID-19 was 60.1 years (standard deviation, 20.6 years); 926 were men (54.0%), 181 patients died during their index admissions (10.6%), 299 required intensive care (17.4%). Thirty-eight patients (2.6%) developed new atrial fibrillation or flutter, 27 (2.6%) had pulmonary embolisms, new heart failure or cardiomyopathy was identified in 13 (0.9%), and pre-existing cardiomyopathy or heart failure was exacerbated in 21 of 110 patients (19%). Troponin was elevated in 369 of the 986 patients for whom it was assessed (37.4%); in-hospital mortality was higher for people with elevated troponin levels (86, 23% v 23, 3.7%; P < 0.001). The COVID-19 vaccination status of 580 patients was known (no doses, 232; at least one dose, 348). The likelihood of in-hospital death (adjusted odds ratio [aOR], 0.38; 95% confidence interval [CI], 0.18-0.79) and intubation (aOR, 0.30; 95% CI, 0.15-0.61) were lower for people who had received at least one vaccine dose, but not the likelihood of troponin elevation (aOR, 1.44; 95% CI, 0.80-2.58) or clinical cardiovascular events (aOR, 1.56; 95% CI, 0.59-4.16). CONCLUSIONS: Although troponin levels were elevated in a considerable proportion of people hospitalised with COVID-19, clinical cardiovascular events were infrequent, and their likelihood was not influenced by vaccination. COVID-19 vaccination, however, was associated with reduced likelihood of in-hospital death and intubation. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12620000486921 (prospective).

Sex differences in risk of incident microvascular and macrovascular complications: a population-based data-linkage study among 25 713 people with diabetes.

BACKGROUND: The global prevalence of diabetes is similar in men and women; however, there is conflicting evidence regarding sex differences in diabetes-related complications. The aim of this study was to investigate sex differences in incident microvascular and macrovascular complications among adults with diabetes. METHODS: This prospective cohort study linked data from the 45 and Up Study, Australia, to administrative health records. The study sample included 25 713 individuals (57% men), aged ≥45 years, with diabetes at baseline. Incident cardiovascular disease (CVD), eye, lower limb, and kidney complications were determined using hospitalisation data and claims for medical services. Multivariable Cox proportional hazards models were used to assess the association between sex and incident complications. RESULTS: Age-adjusted incidence rates per 1000 person years for CVD, eye, lower limb, and kidney complications were 37, 52, 21, and 32, respectively. Men had a greater risk of CVD (adjusted hazard ratio (aHR) 1.51, 95% CI 1.43 to 1.59), lower limb (aHR 1.47, 95% CI 1.38 to 1.57), and kidney complications (aHR 1.55, 95% CI 1.47 to 1.64) than women, and a greater risk of diabetic retinopathy (aHR 1.14, 95% CI 1.03 to 1.26). Over 10 years, 44%, 57%, 25%, and 35% of men experienced a CVD, eye, lower limb, or kidney complication, respectively, compared with 31%, 61%, 18%, and 25% of women. Diabetes duration (<10 years vs ≥10 years) had no substantial effect on sex differences in complications. CONCLUSIONS: Men with diabetes are at greater risk of complications, irrespective of diabetes duration. High rates of complications in both sexes highlight the importance of targeted complication screening and prevention strategies from diagnosis.

Participants' views of ultra-low dose combination therapy for high blood pressure: a mixed-methods study from the QUARTET trial.

Single-pill combination therapy containing four quarter-dose medications for high blood pressure improves BP control compared to monotherapy, however patient-reported acceptance of the quadpill as a treatment strategy remains undescribed. We collected within-trial feedback and interviewed participants from the quadruple ultra-low-dose treatment for hypertension (QUARTET) trial to characterise patient attitudes to this intervention. All trial participants were asked about ease and preference for the quadpill and provided an opportunity to give further comments on the trial at 12 weeks (trial primary endpoint) and 52 weeks extended follow-up. Separately, we used purposive and quota sampling for the semi-structured telephone interviews, with the resultant verbatim transcripts analysed using an inductive thematic analysis approach. Themes were re-evaluated after each successive interview, and at suspected data saturation, an additional interview conducted for confirmation. At 12 weeks follow-up, 502 of 591 (85%) participants responded to acceptability questions, and 359 of 417 (86%) responded at week 52. Most reported the trial capsule easy or very easy to take. From eight sites, 16 participants were interviewed between 5 August 2020 and 19 November 2020. All described a positive experience, preferred once-daily morning dosing and found routine facilitated adherence. Participants valued individual responsibility for adherence, and involvement of the general practitioner in blood-pressure management. Most reported capsule size did not deter adherence but desired a smaller capsule. Participants described a preference for minimising number and dosage of medications, reduced capsule size, and once-daily morning dosing. These findings suggest a preference for single-pill combination therapy for blood pressure lowering.