An Economic Evaluation of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial.

PURPOSE: Children who require specialist outpatient care typically wait substantial periods during which their condition may progress, making treatment more difficult and costly. Timely and effective therapy during this period may reduce the need for lengthy specialist care. This study evaluated the cost-effectiveness of an individualized, evidence-informed, web-based program for children with urinary incontinence awaiting a specialist appointment (Electronic Advice and Diagnosis Via the Internet following Computerized Evaluation [eADVICE]) compared to usual care. eADVICE was supervised by a primary physician and delivered by an embodied conversational agent. MATERIALS AND METHODS: A trial-based cost-effectiveness analysis was performed from the perspective of the health care funder as a substudy of eADVICE, a multicenter, waitlist-controlled, randomized trial. Outcomes measures were incremental cost per incremental change in continence status and quality of life on an intention-to-treat basis. Uncertainty was examined using cost-effectiveness planes, scenarios, and 1-way sensitivity analyses. Costs were valued in 2021 Australian dollars. RESULTS: The use of eADVICE was found to be cost saving and beneficial (dominant) over usual care, with a higher proportion of children dry over 14 days at 6 months (risk difference 0.13; 95%CI 0.02-0.23, P = .03) and mean health care costs reduced by $188 (95%CI $61-$315) per participant. CONCLUSIONS: An individualized, evidence-informed, web-based program delivered by an embodied conversational agent is likely cost saving for children with urinary incontinence awaiting a specialist appointment. The potential economic impact of such a program is favorable and substantial, and may be transferable to outpatient clinic settings for other chronic health conditions.

A Randomized Controlled Trial of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial.

PURPOSE: Children referred to specialist outpatient clinics by primary care providers often have long waiting times before being seen. We assessed whether an individualized, web-based, evidence-informed management support for children with urinary incontinence while waiting reduced requests for specialist appointments. MATERIALS AND METHODS: A multicenter, waitlisted randomized controlled trial was conducted for children (5-18 years) with urinary incontinence referred to tertiary pediatric continence clinics. Participants were randomized to the web-based eHealth program electronic Advice and Diagnosis Via the Internet following Computerized Evaluation (eADVICE), which used an embodied conversational agent to engage with the child at the time of referral (intervention) or 6 months later (control). The primary outcome was the proportion of participants requesting a clinic appointment at 6 months. Secondary outcomes included persistent incontinence, and the Paediatric incontinence Questionnaire (PinQ) score. RESULTS: From 2018 to 2020, 239 children enrolled, with 120 randomized to eADVICE and 119 to the control arm. At baseline, participants' mean age was 8.8 years (SD 2.2), 62% were males, mean PinQ score was 5.3 (SD 2.2), 36% had daytime incontinence, and 97% had nocturnal enuresis. At 6 months, 78% of eADVICE participants vs 84% of controls requested a clinic visit (relative risk 0.92, 95% CI 0.79, 1.06, P = .3), and 23% eADVICE participants vs 10% controls were completely dry (relative risk 2.23, 95% CI 1.10, 4.50, P = .03). The adjusted mean PinQ score was 3.5 for eADVICE and 3.9 for controls (MD -0.37, 95% CI -0.71, -0.03, P = .03). CONCLUSIONS: The eADVICE eHealth program for children awaiting specialist appointments doubled the proportion who were dry at 6 months and improved quality of life but did not reduce clinic appointment requests.

Development and validation of a risk score to predict unplanned hospital readmissions in ICU survivors: A data linkage study.

BACKGROUND: Intensive Care Unit (ICU) follow-up clinics are growing in popularity internationally; however, there is limited evidence as to which patients would benefit most from a referral to this service. OBJECTIVES: The objective of this study was to develop and validate a model to predict which ICU survivors are most likely to experience an unplanned hospital readmission or death in the year after hospital discharge and derive a risk score capable of identifying high-risk patients who may benefit from referral to follow-up services. METHODS: A multicentre, retrospective observational cohort study using linked administrative data from eight ICUs was conducted in the state of New South Wales, Australia. A logistic regression model was developed for the composite outcome of death or unplanned readmission in the 12 months after discharge from the index hospitalisation. RESULTS: 12,862 ICU survivors were included in the study, of which 5940 (46.2%) patients experienced unplanned readmission or death. Strong predictors of readmission or death included the presence of a pre-existing mental health disorder (odds ratio [OR]: 1.52, 95% confidence interval [CI]: 1.40-1.65), severity of critical illness (OR: 1.57, 95% CI: 1.39-1.76), and two or more physical comorbidities (OR: 2.39, 95% CI: 2.14-2.68). The prediction model demonstrated reasonable discrimination (area under the receiver operating characteristic curve: 0.68, 95% CI: 0.67-0.69) and overall performance (scaled Brier score: 0.10). The risk score was capable of stratifying patients into three distinct risk groups-high (64.05% readmitted or died), medium (45.77% readmitted or died), and low (29.30% readmitted or died). CONCLUSIONS: Unplanned readmission or death is common amongst survivors of critical illness. The risk score presented here allows patients to be stratified by risk level, enabling targeted referral to preventative follow-up services.

Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome: The TEXTMEDS Randomized Clinical Trial.

BACKGROUND: TEXTMEDS (Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome) examined the effects of text message-delivered cardiac education and support on medication adherence after an acute coronary syndrome. METHODS: TEXTMEDS was a single-blind, multicenter, randomized controlled trial of patients after acute coronary syndrome. The control group received usual care (secondary prevention as determined by the treating clinician); the intervention group also received multiple motivational and supportive weekly text messages on medications and healthy lifestyle with the opportunity for 2-way communication (text or telephone). The primary end point of self-reported medication adherence was the percentage of patients who were adherent, defined as >80% adherence to each of up to 5 indicated cardioprotective medications, at both 6 and 12 months. RESULTS: A total of 1424 patients (mean age, 58 years [SD, 11]; 79% male) were randomized from 18 Australian public teaching hospitals. There was no significant difference in the primary end point of self-reported medication adherence between the intervention and control groups (relative risk, 0.93 [95% CI, 0.84-1.03]; P=0.15). There was no difference between intervention and control groups at 12 months in adherence to individual medications (aspirin, 96% vs 96%; ß-blocker, 84% vs 84%; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, 77% vs 80%; statin, 95% vs 95%; second antiplatelet, 84% vs 84% [all P>0.05]), systolic blood pressure (130 vs 129 mm Hg; P=0.26), low-density lipoprotein cholesterol (2.0 vs 1.9 mmol/L; P=0.34), smoking (P=0.59), or exercising regularly (71% vs 68%; P=0.52). There were small differences in lifestyle risk factors in favor of intervention on body mass index <25 kg/m2 (21% vs 18%; P=0.01), eating ≥5 servings per day of vegetables (9% vs 5%; P=0.03), and eating ≥2 servings per day of fruit (44% vs 39%; P=0.01). CONCLUSIONS: A text message-based program had no effect on medical adherence but small effects on lifestyle risk factors. REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364448; Unique identifier: ANZCTR ACTRN12613000793718.

Optimizing electrophysiology studies to prevent sudden cardiac death after myocardial infarction.

AIMS: This study assessed associations of minimum final extrastimulus coupling interval utilized within electrophysiology study (EPS) after myocardial infarction (MI) and possible site of origin of induced ventricular tachycardia (VT) with long-term occurrence of spontaneous ventricular tachyarrhythmia and long-term survival. METHODS AND RESULTS: This prospective study recruited consecutive patients with left ventricular ejection fraction (LVEF) ≤ 40% who underwent EPS days 3-5 after MI between 2004 and 2017. Positive EPS was defined as sustained monomorphic VT cycle length ≥200 ms for ≥10 s or shorter duration if haemodynamic compromise occurred. Each of the four extrastimuli was shortened by 10 ms at a time, until it failed to capture the ventricle (ventricular refractoriness) or induced ventricular tachyarrhythmia. Outcomes included spontaneous ventricular tachyarrhythmia occurrence and all-cause mortality. Shorter coupling interval length of final extrastimulus that induced VT was associated with higher risk of spontaneous ventricular tachyarrhythmia (P < 0.001). Significantly higher rates of spontaneous ventricular tachyarrhythmia (65.2% vs. 23.2%; P < 0.001) were observed for final coupling interval at EPS <200 ms vs. >200 ms. Right bundle branch block (RBBB) morphology of induced VT, with possible site of origin from the left ventricle, was associated with all-cause mortality [hazard ratio (HR) 3.2, P = 0.044] and a composite of spontaneous ventricular tachyarrhythmia recurrence or mortality (HR 1.8, P = 0.043). CONCLUSION: Ventricular tachycardia induced with shorter coupling intervals was associated with higher risk of spontaneous ventricular tachyarrhythymia on follow-up, indicating that the final extrastimulus coupling interval at EPS early after MI should be determined by ventricular refractoriness. Induced VT with possible origin from left ventricle was associated with increased risk of spontaneous ventricular tachyarrhythmia recurrence or death.

Stakeholder preferences for attributes of digital health technologies to consider in health service funding.

OBJECTIVES: Health service providers are currently making decisions on the public funding of digital health technologies (DHTs) for managing chronic diseases with limited understanding of stakeholder preferences for DHT attributes. This study aims to understand the community, patient/carer, and health professionals' preferences to help inform a prioritized list of evaluation criteria. METHODS: An online best-worst scaling survey was conducted in Australia, New Zealand, Canada, and the United Kingdom to ascertain the relative importance of twenty-four DHT attributes among stakeholder groups using an efficient incomplete block design. The attributes were identified from a systematic review of DHT evaluation frameworks for consideration in a health technology assessment. Results were analyzed with multinomial models by stakeholder group and latent class. RESULTS: A total of 1,251 participants completed the survey (576 general community members, 543 patients/carers, and 132 health professionals). Twelve attributes achieved a preference score above 50 percent in the stakeholder group model, predominantly related to safety but also covering technical features, effectiveness, ethics, and economics. Results from the latent class model supported this prioritization. Overall, connectedness with the patient's healthcare team seemed the most important; with "Helps health professionals respond quickly when changes in patient care are needed" as the most highly prioritized of all attributes. CONCLUSIONS: It is proposed that these prioritized twelve attributes be considered in all evaluations of DHTs that manage chronic disease, supplemented with a limited number of attributes that reflect the specific perspective of funders, such as equity of access, cost, and system-level implementation considerations.

Effect of Mobile Phone Text Messaging Self-Management Support for Patients With Diabetes or Coronary Heart Disease in a Chronic Disease Management Program (SupportMe) on Blood Pressure: Pragmatic Randomized Controlled Trial.

BACKGROUND: Maintaining engagement and support for patients with chronic diseases is challenging. SMS text messaging programs have complemented patient care in a variety of situations. However, such programs have not been widely translated into routine care. OBJECTIVE: We aimed to examine the implementation and utility of a customized SMS text message-based support program for patients with type 2 diabetes (T2D), coronary heart disease, or both within a chronic disease integrated care program. METHODS: We conducted a 6-month pragmatic parallel-group, single-blind randomized controlled trial that recruited people with T2D or coronary heart disease. Intervention participants received 4 semipersonalized SMS text messages per week providing self-management support to supplement standard care. Preprogrammed algorithms customized content based on participant characteristics, and the messages were sent at random times of the day and in random order by a fully automated SMS text messaging engine. Control participants received standard care and only administrative SMS text messages. The primary outcome was systolic blood pressure. Evaluations were conducted face to face whenever possible by researchers blinded to randomization. Participants with T2D were evaluated for glycated hemoglobin level. Participant-reported experience measures were evaluated using questionnaires and focus groups and summarized using proportions and thematic analysis. RESULTS: A total of 902 participants were randomized (n=448, 49.7% to the intervention group and n=454, 50.3% to the control group). Primary outcome data were available for 89.5% (807/902) of the participants. At 6 months, there was no difference in systolic blood pressure between the intervention and control arms (adjusted mean difference=0.9 mm Hg, 95% CI -1.1 to 2.1; P=.38). Of 642 participants with T2D, there was no difference in glycated hemoglobin (adjusted mean difference=0.1%, 95% CI -0.1% to 0.3%; P=.35). Self-reported medication adherence was better in the intervention group (relative risk=0.82, 95% CI 0.68-1.00; P=.045). Participants reported that the SMS text messages were useful (298/344, 86.6%) and easily understood (336/344, 97.7%) and motivated change (217/344, 63.1%). The lack of bidirectional messaging was identified as a barrier. CONCLUSIONS: The intervention did not improve blood pressure in this cohort, possibly because of high clinician commitment to improved routine patient care as part of the chronic disease management program as well as favorable baseline metrics. There was high program engagement, acceptability, and perceived value. Feasibility as part of an integrated care program was demonstrated. SMS text messaging programs may supplement chronic disease management and support self-care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001689460; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371769&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-025923.

Trends in Modifiable Risk Factors Amongst First Presentation ST Elevation Myocardial Infarction Patients in a Large Longitudinal Registry.

BACKGROUND: Recent studies suggest that the risk factor profile of patients presenting with ST elevation myocardial infarction (STEMI) is changing. AIM: The aim is to determine if there has been a shift of cardiovascular risk factors to cardiometabolic causes in the first presentation STEMI population. METHOD: We analysed data from a STEMI registry from a large tertiary referral percutaneous coronary intervention centre to determine the prevalence and trends of the modifiable risk factors of hypertension, diabetes, smoking and hypercholesterolaemia. PARTICIPANTS: Consecutive first presentation STEMI patients between January 2006 to December 2018. RESULTS: Among the 2,366 patients included (mean age 59, SD 12.66, 80% male) the common risk factors were hypertension (47%), hypercholesterolaemia (47%) current smoking (42%) and diabetes (27%). Over the 13 years, patients with diabetes (20% to 26%, OR 1.09 per year, CI 1.06-1.11, p<0.001) and patients with no modifiable risk factors increased (9% to 17%, OR 1.08, CI 1.04-1.11, p<0.001). Concurrently there was a fall in prevalence of hypercholesterolaemia, (47% to 37%, OR 0.94 per year, CI 0.92-0.96, p<0.001) and smoking (44% to 41%, OR 0.94, CI 0.92-0.96, p<0.001) but no significant change in rates of hypertension (53% to 49%, OR 0.99, CI 0.97-1.01, p=0.25). CONCLUSION: The risk factor profile of first presentation STEMI has changed over time with a reduction in smoking and a concurrent rise in patients with no traditional risk factors. This suggests the mechanism of STEMI may be changing and further investigation of potential causal factors is warranted for the prevention and management of cardiovascular disease.

Can existing electronic medical records be used to quantify cardiovascular risk at point of care?

BACKGROUND: Using electronic data for cardiovascular risk stratification could help in prioritising healthcare access and optimise cardiovascular prevention. AIMS: To determine whether assessment of absolute cardiovascular risk (Australian absolute cardiovascular disease risk (ACVDR)) and short-term ischaemic risk (History, ECG, Age, Risk factors, and Troponin (HEART) score) is possible from available data in Electronic Medical Record (EMR) and My Health Record (MHR) of patients presenting with acute cardiac symptoms to a Rapid Access Cardiology Clinic (RACC). METHODS: Audit of EMR and MHR on 200 randomly selected adults who presented to RACC between 1 March 2017 and 4 February 2020. The main outcomes were the proportion of patients for which ACVDR score and HEART score could be calculated. RESULTS: Mean age was 55.2 ± 17.8 years and 43% were female. Most (85%) were referred from emergency for chest pain (52%). Forty-six percent had hypertension, 35% obesity, 20% diabetes mellitus, 17% ischaemic heart disease and 18% were current smokers. There was no significant difference in MHR accessibility with age, gender and number of comorbidities. An ACVDR score could be estimated for 17.5% (EMR) and 0% (MHR) of patients. None had complete data to estimate HEART score in either EMR or MHR. Most commonly missing variables for ACVDR score were blood pressure (MHR) and high-density lipoprotein cholesterol (EMR), and for HEART score the missing variables were body mass index and comorbidities (MHR and EMR). CONCLUSIONS: Significant gaps are apparent in electronic medical data capture of key variables to perform cardiovascular risk assessment. Medical data capture should prioritise the collection of clinically important data to help address gaps in cardiovascular management.

Text messages for primary prevention of cardiovascular disease: The TextMe2 randomized clinical trial.

BACKGROUND: Primary prevention guidelines emphasize the importance of lifestyle modification, but many at high-risk have suboptimal cardiovascular risk factor (CVRF) control. Text message support may improve control, but the evidence is sparse. Our objective was to determine the impact of text messages on multiple CVRFs in a moderate-high risk primary prevention cohort. METHODS: This study was a single-blind randomized clinical trial comparing semi-personalized text message-based support to standard care. A random sample of adults with 10-year absolute cardiovascular risk score ≥10% and without coronary heart disease, referred from February 2019 to January 2020, were recruited from an outpatient cardiology clinic in a large tertiary hospital in Sydney, Australia. Patients were randomized 1:1 to intervention or control. Intervention participants received 4 texts per week over 6 months, and standard care, with content covering: diet, physical activity, smoking, general cardiovascular health, and medication adherence. Controls received standard care only. Content was semipersonalized (smoking status, vegetarian or not-vegetarian, physical ability, taking medications or not) and delivered randomly using automated software. The primary outcome was the difference in the proportion of patients who have ≥3 uncontrolled CVRFs (out of: low-density lipoprotein cholesterol >2.0 mmol/L, blood pressure >140/90 mm Hg, body mass index ≥25 kg/m2, physical inactivity, current smoker) at 6 months adjusted for baseline. Secondary outcomes included differences in biomedical and behavioral CVRFs. RESULTS: Among 295 eligible participants, 246 (mean age, 58.6 ± 10.7 years; 39.4% female) were randomized to intervention (n = 124) or control (n = 122). At 6 months, there was no significant difference in the proportion of patients with ≥3 uncontrolled CVRFs (adjusted relative risk [RR] 0.98; 95% confidence interval [CI] 0.75-1.29; P = .88). Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95% CI 0.57-0.92; P = .01), but there were no significant changes in other single CVRFs. More intervention participants reduced the number of uncontrolled CVRFs at 6-months from baseline than controls (86% vs 75%; RR 1.15; 95% CI 1.00-1.32; P = .04). CONCLUSIONS: In moderate-high cardiovascular risk primary prevention, text message-based support did not significantly reduce the proportion of patients with ≥3 uncontrolled CVRFs. However, the program did motivate behavior change and significantly improved cardiovascular risk factor control overall. Larger multicenter studies are needed.

Health technology assessment for digital technologies that manage chronic disease: a systematic review.

OBJECTIVE: A growing number of evaluation frameworks have emerged over recent years addressing the unique benefits and risk profiles of new classes of digital health technologies (DHTs). This systematic review aims to identify relevant frameworks and synthesize their recommendations into DHT-specific content to be considered when performing Health Technology Assessments (HTAs) for DHTs that manage chronic noncommunicable disease at home. METHODS: Searches were undertaken of Medline, Embase, Econlit, CINAHL, and The Cochrane Library (January 2015 to March 2020), and relevant gray literature (January 2015 to August 2020) using keywords related to HTA, evaluation frameworks, and DHTs. Included framework reference lists were searched from 2010 until 2015. The EUNetHTA HTA Core Model version 3.0 was selected as a scaffold for content evaluation. RESULTS: Forty-four frameworks were identified, mainly covering clinical effectiveness (n = 30) and safety (n = 23) issues. DHT-specific content recommended by framework authors fell within 28 of the 145 HTA Core Model issues. A further twenty-two DHT-specific issues not currently in the HTA Core Model were recommended. CONCLUSIONS: Current HTA frameworks are unlikely to be sufficient for assessing DHTs. The development of DHT-specific content for HTA frameworks is hampered by DHTs having varied benefit and risk profiles. By focusing on DHTs that actively monitor/treat chronic noncommunicable diseases at home, we have extended DHT-specific content to all nine HTA Core Model domains. We plan to develop a supplementary evaluation framework for designing research studies, undertaking HTAs, and appraising the completeness of HTAs for DHTs.

Application of a health technology assessment framework to digital health technologies that manage chronic disease: a systematic review.

BACKGROUND: As health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown. OBJECTIVES: To summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA. METHODS: Medline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed. RESULTS: A total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains. CONCLUSIONS: Although DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.

Rapid Access Arrhythmia Clinics (RAACs) Versus Usual Care: Improving Efficiency and Safety of Arrhythmia Management.

BACKGROUND: Rapid access cardiology services have been proposed for assessment of acute cardiac conditions via an outpatient model-of-care that potentially could reduce hospitalisations. We describe a new Rapid Access Arrhythmia Clinic (RAAC) and compare major safety endpoints to usual care. METHODS: We matched 312 adult patients with suspected arrhythmia in RAAC to historical age and sex-matched controls discharged from hospital within Western Sydney Local Health District with suspected arrhythmia. The primary endpoint was a composite of time to first unplanned cardiovascular hospitalisation or cardiac death over 12 months. RESULTS: The average age of RAAC patients was 52.2±18.8 years and 51.6±18.8 years for controls, and 48.4% were female in both groups. Mean time from referral to first attended RAAC appointment was 10.5 days. Most were referred from emergency (177, 56.7%) and cardiologists at time of discharge (65, 20.8%). The most common reason for referral was palpitations (180, 57.7%). In total, 155 (49.7%) had a documented arrhythmia, with the most common being atrial fibrillation/flutter (88, 28.2%). The primary endpoint occurred in 35 (11.2%) patients in the RAAC pathway (97.1[95% CI 70-131.3] per 1,000 person-years), compared to 72 (23.1%) patients for usual care controls (229.5[95% CI 180.2-288.1] per 1,000 person-years). Using a propensity score analysis, RAAC pathway significantly reduced the primary endpoint by 59% compared to usual care (HR 0.41, 95% CI 0.27-0.62; p<0.001). CONCLUSIONS: RAACs for the early investigation and management of suspected arrhythmia is superior to usual care in terms of reduction in unplanned cardiovascular hospitalisation and death.

Evaluation and Optimisation of a Patient Portal Implementation: An Action Research Approach.

Patient portals can support care delivery and have demonstrated mixed impacts on patients, clinicians and health services. These variable impacts are primarily due to barriers to uptake and challenges associated with successfully implementing patient portals. As little is currently known about how implementation barriers can be addressed in practice, this project used an action research approach to evaluate and optimise the implementation of a patient portal in a real-world setting. Whilst the study is ongoing, the preliminary findings are reported in this paper, along with plans to use the findings to improve the portal in the next round of the action research cycle.

Therapeutic Inertia With Initial Low-Dose Quadruple Combination Therapy for Hypertension: Results From the QUARTET Trial.

BACKGROUND: Low-dose combinations are a promising intervention for improving blood pressure (BP) control but their effects on therapeutic inertia are uncertain. METHODS: Analysis of 591 patients randomized to an ultra-low-dose quadruple pill or initial monotherapy. The episode of therapeutic inertia was defined as a patient visit with a BP of >140/90 mm Hg without intensification of antihypertensive treatment. We compared the frequency of therapeutic inertia episodes between Quadpill and initial monotherapy as a proportion of the total population (intention-to-treat analysis with the denominator being all participants randomized) and as a proportion of people with uncontrolled BP (with the denominator being participants with uncontrolled BP). RESULTS: Therapeutic inertia occurred in fewer participants randomized to Quadpill compared with monotherapy. For example, among the 390 participants with a 6-month follow-up, therapeutic inertia according to unattended BP was 21/192 (11%) versus 45/192 (23%), P=0.002. There were similar rates of therapeutic inertia among those with uncontrolled unattended BP in each group (all P>0.4). Consistent observations were seen with the use of attended office BP measures. The major determinants of not intensifying treatment during follow-up were BP readings that were close to target and large improvements in BP compared with the previous visit. CONCLUSIONS: Among all treated individuals, low-dose Quadpill reduced the number of therapeutic inertia episodes compared with initial monotherapy. After the first follow-up visit, most high BP values did not lead to treatment intensification in both groups. Education is needed about the importance of treatment intensification despite a significant improvement in BP or BP being close to target. REGISTRATION: URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12616001144404; Unique identifier: ACTRN12616001144404.

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.

Out-of-hospital cardiac arrests and bystander response by socioeconomic disadvantage in communities of New South Wales, Australia.

BACKGROUND & AIM: Bystander response to out-of-hospital cardiac arrest (OHCA) may relate to area-level factors, including socioeconomic status (SES). We aimed to examine whether OHCA among individuals in more disadvantaged areas are less likely to receive bystander cardiopulmonary resuscitation (CPR) compared to those in more advantaged areas. METHODS: We analysed data on OHCAs in New South Wales, Australia collected prospectively through a statewide, population-based register. We excluded non-medical arrests; arrests witnessed by a paramedic; occurring in a medical centre, nursing home, police station; or airport, and among individuals with a Do-Not-Resuscitate order. Area-level SES for each arrest was defined using the Australian Bureau of Statistics' Index of Relative Socioeconomic Disadvantage and its relationship to likelihood of receiving bystander CPR was examined using hierarchical logistic regression models. RESULTS: Overall, 39% (6622/16,914) of arrests received bystander CPR (71% of bystander-witnessed). The OHCA burden in disadvantaged areas was higher (age-standardised incidence 76-87/100,000/year in more disadvantaged quintiles 1-4 versus 52 per 100,000/year in most advantaged quintile 5). Bystander CPR rates were lower (38%) in the most disadvantaged quintile and highest (42%) in the most advantaged SES quintile. In adjusted models, younger age, being bystander-witnessed, arresting in a public location, and urban location were all associated with greater likelihood of receiving bystander CPR; however, the association between area-level SES and bystander CPR rate was not significant. CONCLUSIONS: There are lower rates of bystander CPR in less advantaged areas, however after accounting for patient and location characteristics, area-level SES was not associated with bystander CPR. Concerted efforts to engage with communities to improve bystander CPR in novel ways could improve OHCA outcomes.

Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population.

OBJECTIVE: This study aims to examine the incidence of pregnancy-related cardiometabolic conditions and severe cardiovascular outcomes, and their relationship in US Medicaid-funded women. METHODS: Medicaid is a government-sponsored health insurance programme for low-income families in the USA. We report the incidence of pregnancy-related cardiometabolic conditions (hypertensive disorders and diabetes in, or complicated by, pregnancy) and severe cardiovascular outcomes (myocardial infarction, stroke, acute heart failure, cardiomyopathy, cardiac arrest, ventricular fibrillation, ventricular tachycardia, aortic dissection/aneurysm and peripheral vascular disease) among Medicaid-funded women with a birth (International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code O80 or O82) over the period January 2015-June 2019, from the states of Georgia, Ohio and Indiana. In this cross-sectional cohort, we examined the relationship between pregnancy-related cardiometabolic conditions and severe cardiovascular outcomes from pregnancy through to 60 days after birth using multivariable models. RESULTS: Among 74 510 women, mean age 26.4 years (SD 5.5), the incidence per 1000 births of pregnancy-related cardiometabolic conditions was 224.3 (95% CI 221.3 to 227.3). The incidence per 1000 births of severe cardiovascular conditions was 10.8 (95% CI 10.1 to 11.6). Women with pregnancy-related cardiometabolic conditions were at greater risk of having a severe cardiovascular condition with an age-adjusted OR of 3.1 (95% CI 2.7 to 3.5). CONCLUSION: This US cohort of Medicaid-funded women have a high incidence of severe cardiovascular conditions during pregnancy. Cardiometabolic conditions of pregnancy conferred threefold higher odds of severe cardiovascular outcomes.

Impact of various night-time period definitions on nocturnal ambulatory blood pressure.

BACKGROUND: Several definitions of night-time BP exist for the calculation of nocturnal blood pressure (BP) based on 24-h BP measurements. How much these methods differ regarding the resulting nocturnal blood pressure values, under which circumstances these differences become clinically meaningful, and under which circumstances diary-adjusted measurements should be used preferentially remains uncertain. METHODS: Data of 512 24-h BP recordings were analysed regarding differences in nocturnal BP based on three alternative definitions of night-time: 2300-0700 h, 0100-0500 h, and diary-adjusted measures. RESULTS: Mean systolic nocturnal BP between 2300-0700 h was 2.5 mmHg higher than between 0100 and 0500 h and 1.6 mmHg higher than diary adjusted estimates. Up to 38.3% of individuals showed BP differences of more than 5 mmHg when comparing temporal definitions of night-time, resulting in significant proportions of individuals being re-classified as hypertensive. When diary-derived sleeping patterns differed by less than 2 h from the 2300 to 0700 h fixed time definition, mean BP discrepancies remained below 3 mmHg. Absolute time discrepancies between diary and 2300-0700 h fixed time definition of 2-4, 4-8 or at least 8 h led to SBP/DBP differences of 4.1/3.1, 6.8/6.1, and 14.5/9.1mmHg, respectively. CONCLUSION: Average differences of nocturnal BP between varying definitions in study/cohort data are small and would be of limited relevance in many settings. However, substantial differences can be observed in individual cases, which may affect clinical decision-making in specific patients. In patients whose sleeping patterns differs by more than 2 h from defined fixed night-times, diaries should be used for adjustment.

Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): study protocol.

INTRODUCTION: Cardiovascular disease (CVD) is the leading cause of death in women around the world. Aboriginal and Torres Strait Islander women (Australian Indigenous women) have a high burden of CVD, occurring on average 10-20 years earlier than non-Indigenous women. Traditional risk prediction tools (eg, Framingham) underpredict CVD risk in women and Indigenous people and do not consider female-specific 'risk-enhancers' such as hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM) and premature menopause. A CT coronary artery calcium score ('CT-calcium score') can detect calcified atherosclerotic plaque well before the onset of symptoms, being the single best predictor for future cardiac events. A CT-calcium score may therefore help physicians intensify medical therapy in women with risk-enhancing factors. METHODS AND ANALYSIS: This multisite, single-blind randomised (1:1) controlled trial of 700 women will assess the effectiveness of a CT-calcium score-guided approach on cardiovascular risk factor control and healthy lifestyle adherence, compared with standard care. Women without CVD aged 40-65 (35-65 for Aboriginal and Torres Strait Islander women) at low-intermediate risk on standard risk calculators and with at least one risk-enhancing factor (eg, HDP, GDM, premature menopause) will be recruited. Aboriginal and Torres Strait Islander women will be actively recruited, aiming for ~10% of the sample size. The 6-month coprimary outcomes will be low-density lipoprotein cholesterol and systolic blood pressure. Barriers and enablers will be assessed, and a health economic analysis performed. ETHICS AND DISSEMINATION: Western Sydney Local Health District Research Ethics Committee (HREC 2021/ETH11250) provided ethics approval. Written informed consent will be obtained before randomisation. Consent will be sought for access to individual participant Medicare Benefits Schedule, Pharmaceutical Benefits Scheme claims usage through Medicare Australia and linked Admitted Patient Data Collection. Study results will be disseminated via peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001738819p.