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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.
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COVID-19 , Enfermedades Cardiovasculares , Accesibilidad a los Servicios de Salud , Investigación Cualitativa , Humanos , COVID-19/epidemiología , Femenino , Masculino , Enfermedades Cardiovasculares/epidemiología , Estudios Transversales , Australia/epidemiología , Persona de Mediana Edad , Anciano , SARS-CoV-2 , Adulto , Telemedicina/estadística & datos numéricos , Automanejo , Aceptación de la Atención de Salud/estadística & datos numéricos , Pandemias , Adaptación PsicológicaRESUMEN
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.
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Enfermedades Cardiovasculares , Prevención Primaria , Humanos , Prevención Primaria/métodos , Medición de Riesgo/métodos , Femenino , Enfermedades Cardiovasculares/prevención & control , Persona de Mediana Edad , Masculino , Lipidómica/métodos , Anciano , Factores de Riesgo de Enfermedad Cardiaca , Australia/epidemiología , Aprendizaje Automático , AdultoRESUMEN
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.
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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.
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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.
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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.
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Enfermedad Coronaria , Atención Primaria de Salud , Mejoramiento de la Calidad , Femenino , Humanos , Masculino , Australia , Enfermedad Coronaria/terapia , Manejo de la EnfermedadRESUMEN
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.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Calidad de Vida , Humanos , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Enfermedades Asintomáticas , Índice de Severidad de la Enfermedad , Análisis Costo-Beneficio , Válvula Aórtica/cirugía , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , FemeninoRESUMEN
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.
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Angiopatías Diabéticas , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Anciano , Incidencia , Australia/epidemiología , Factores Sexuales , Angiopatías Diabéticas/epidemiología , Factores de Riesgo , Modelos de Riesgos Proporcionales , Enfermedades Cardiovasculares/epidemiología , Almacenamiento y Recuperación de la Información , Complicaciones de la Diabetes/epidemiologíaRESUMEN
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).
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Vacunas contra la COVID-19 , COVID-19 , Enfermedades Cardiovasculares , Hospitalización , Humanos , COVID-19/mortalidad , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/complicaciones , Masculino , Femenino , Persona de Mediana Edad , Anciano , Hospitalización/estadística & datos numéricos , Australia/epidemiología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/epidemiología , Mortalidad Hospitalaria , Adulto , Estudios de Cohortes , Vacunación/estadística & datos numéricos , SARS-CoV-2 , Troponina/sangre , Sistema de RegistrosRESUMEN
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.
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Antihipertensivos , Presión Sanguínea , Combinación de Medicamentos , Hipertensión , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Hipertensión/diagnóstico , Prioridad del Paciente , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: The 2023 Australian guideline for assessing and managing cardiovascular disease risk provides updated evidence-based recommendations for the clinical assessment and management of cardiovascular disease (CVD) risk for primary prevention. It includes the new Australian CVD risk calculator (Aus CVD Risk Calculator), based on an equation developed from a large New Zealand cohort study, customised and recalibrated for the Australian population. The new guideline replaces the 2012 guideline that recommended CVD risk assessment using the Framingham risk equation. MAIN RECOMMENDATIONS: The new guideline recommends CVD risk assessment in people without known CVD: all people aged 45-79 years, people with diabetes from 35 years, and First Nations people from 30 years. The new Aus CVD Risk Calculator should be used to estimate and categorise CVD risk into low (< 5% risk over five years), intermediate (5% to < 10% risk over five years) or high risk (≥ 10% over five years). The following reclassification factors may be applied to recategorise calculated risk to improve accuracy of risk prediction, particularly in individuals close to a risk threshold: Indigenous status/ethnicity, estimated glomerular filtration rate, urine albumin to creatinine ratio measurements, severe mental illness, coronary artery calcium score and family history of premature CVD. A variety of communication formats is available to communicate CVD risk to help enable shared decision making. Healthy lifestyle modification, including smoking cessation, nutrition, physical activity and limiting alcohol, is encouraged for all individuals. Blood pressure-lowering and lipid-modifying pharmacotherapies should be prescribed for high risk and considered for intermediate risk individuals, unless contraindicated or clinically inappropriate. Reassessment of CVD risk should be considered within five years for individuals at low risk and within two years for those with intermediate risk. Reassessment of CVD risk is not recommended for individuals at high risk. CHANGES IN ASSESSMENT AND MANAGEMENT AS A RESULT OF THE GUIDELINE: The updated guideline recommends assessment over a broader age range and uses the Aus CVD Risk Calculator, which replaces the previous Framingham-based equation. It incorporates new variables: social disadvantage, diabetes-specific risk markers, diagnosis of atrial fibrillation and use of blood pressure-lowering and lipid-modifying therapies. Reclassification factors are also a new addition. Updated risk categories and thresholds are based on the new Aus CVD Risk Calculator. The proportion of the population in the high risk category (≥ 10% over five years) is likely to be broadly comparable to more than 15% risk from the Framingham-based equation. The full guideline and Aus CVD Risk Calculator can be accessed at www.cvdcheck.org.au.
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Enfermedades Cardiovasculares , Humanos , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/terapia , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Australia , Medición de Riesgo/métodos , Persona de Mediana Edad , Anciano , Femenino , Masculino , Factores de Riesgo de Enfermedad Cardiaca , Guías de Práctica Clínica como Asunto , Prevención Primaria , AdultoRESUMEN
New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.
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Amlodipino , Antihipertensivos , Bencimidazoles , Compuestos de Bifenilo , Bisoprolol , Presión Sanguínea , Hipertensión , Tetrazoles , Humanos , Femenino , Masculino , Hipertensión/tratamiento farmacológico , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Antihipertensivos/efectos adversos , Antihipertensivos/administración & dosificación , Método Doble Ciego , Bencimidazoles/uso terapéutico , Bencimidazoles/efectos adversos , Bencimidazoles/administración & dosificación , Amlodipino/administración & dosificación , Amlodipino/efectos adversos , Amlodipino/uso terapéutico , Tetrazoles/uso terapéutico , Tetrazoles/efectos adversos , Tetrazoles/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Anciano , Resultado del Tratamiento , Bisoprolol/uso terapéutico , Bisoprolol/administración & dosificación , Indapamida/uso terapéutico , Indapamida/administración & dosificación , Indapamida/efectos adversos , Adulto , Quimioterapia CombinadaRESUMEN
BACKGROUND: Psoriasis is a risk factor for cardiovascular disease. Biologic agents have revolutionised psoriatic skin control. This study aims to assess the change in cardiovascular risk factors in a cohort of patients treated with 1 year of continuous biologic treatment. METHODS: A retrospective medical record review was conducted of consecutive patients receiving biologic therapy for chronic plaque psoriasis in a single dermatology centre at a major tertiary hospital in Australia. The effect of biologic therapy on psoriasis was assessed using a psoriasis area severity index (PASI). Cardiovascular risk factors included systolic blood pressure (SBP), diastolic BP (DBP), heart rate (HR) and body mass index (BMI). Measurements at baseline and 1-year follow-up were compared using paired t-tests. RESULTS: A total of 106 patients were reviewed with a median age of 44 years, and 63% of the patients were male. At baseline, mean BMI was 30 (SD 7), mean SBP was 129 (SD 17), mean DBP was 81 (SD 9) and mean HR was 82 (SD 14). Over 12 months, the PASI was reduced from 17.4 (SD 8.5) to 1.4 (SD 1.7, p < 0.001) indicating skin improvement. There was no significant difference from baseline in SBP (difference 2.3 mmHg, 95% CI - 1.4-5.9), DBP (0.6 mmHg, 95% CI - 1.2-2.5), BMI (difference - 0.1 kg/m2, 95% CI - 0.9-0.7) or HR (difference 1.3, 95% CI - 3.9-6.4). CONCLUSION: In patients with psoriasis, markers of cardiovascular disease risk did not improve after 1 year of biologic therapy despite significant improvements in psoriasis skin severity.
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PURPOSE: To assess whether bystander cardiopulmonary resuscitation (CPR) differed by patient sex among bystander-witnessed out-of-hospital cardiac arrests (OHCA). METHODS: This study is a retrospective analysis of paramedic-attended OHCA in New South Wales (NSW) between January 2017 to December 2019 (restricted to bystander-witnessed cases). Exclusions included OHCA in aged care, medical facilities, with advance care directives, from non-medical causes. Multivariate logistic regression examined the association of patient sex with bystander CPR. Secondary outcomes were OHCA recognition, bystander AED application, initial shockable rhythm, and survival outcomes. RESULTS: Of 4,491cases, females were less likely to receive bystander CPR in private residential (Adjusted Odds ratio [AOR]: 0.82, 95%CI: 0.70-0.95) and public locations (AOR: 0.58, 95%CI:0.39-0.88). OHCA recognition during the emergency call was lower for females arresting in public locations (84.6% vs 91.6%, p = 0.002) and this partially explained the association of sex with bystander CPR (â¼44%). This difference in recognition was not observed in private residential locations (p = 0.2). Bystander AED use was lower for females (4.8% vs 9.6%, p < 0.001); however, after adjustment for location and other covariates, this relationship was no longer significant (AOR: 0.83, 95%CI: 0.60-1.12). Females were less likely to be in an initial shockable rhythm (AOR: 0.52, 95%CI: 0.44-0.61), but more likely to survive the event (AOR: 1.34, 95%CI: 1.15-1.56). There was no sex difference in survival to hospital discharge (AOR: 0.96, 95%CI: 0.77-1.19). CONCLUSION: OHCA recognition and bystander CPR differ by patient sex in NSW. Research is needed to understand why this difference occurs and to raise public awareness of this issue.
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Reanimación Cardiopulmonar , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/terapia , Paro Cardíaco Extrahospitalario/mortalidad , Femenino , Masculino , Reanimación Cardiopulmonar/métodos , Reanimación Cardiopulmonar/estadística & datos numéricos , Estudios Retrospectivos , Nueva Gales del Sur/epidemiología , Persona de Mediana Edad , Anciano , Factores Sexuales , Servicios Médicos de Urgencia/estadística & datos numéricos , Servicios Médicos de Urgencia/métodos , Adulto , Desfibriladores/estadística & datos numéricosRESUMEN
Gestational diabetes (GDM) is associated with a long-term risk of diabetes. We aimed to determine whether a text-messaging-based lifestyle support program would improve diabetes risk factors following GDM. Women with GDM were randomised following delivery to receive four text messages per week supporting a healthy lifestyle and parenting for 6 months, with feedback from an activity monitor (intervention), or to receive the activity monitor only (control). The primary outcome was a composite of weight, physical activity and dietary goals. There were 177 women randomised, with 88 intervention and 89 control participants. All the participants experienced COVID-19 lockdowns during the study. Six-month primary outcome data were obtained for 57 intervention participants and 56 controls. There were 7/57 (12%) intervention and 6/56 (11%) control participants who met the primary outcome (relative risk, 1.08; 95%CI, 0.63-1.85; p = 0.79). Two intervention participants met the dietary goals compared to none of the control participants (p = NS). The intervention participants were more likely to record >1000 steps/day (on 102 ± 59 vs. 81 ± 59 days, p = 0.03). When analysed monthly, this was not initially different but became significant 3-6 months post-partum. Interviews and surveys indicated that with the Intervention, healthier choices were made, but these were negatively impacted by COVID-19 restrictions. Participants found the messages motivational (74%) and the activity monitor useful (71%). In conclusion, no improvement in the diabetes risk factors occurred among the women receiving the text messaging intervention when affected by COVID-19 restrictions.
Asunto(s)
COVID-19 , Diabetes Gestacional , Envío de Mensajes de Texto , Embarazo , Humanos , Femenino , Diabetes Gestacional/prevención & control , Estilo de Vida , Factores de Riesgo , COVID-19/prevención & controlRESUMEN
BACKGROUND: A combination of four ultra-low-dose blood pressure (BP) medications lowered office BP more effectively than initial monotherapy in the QUARTET trial. The effects on average ambulatory BP changes at 12âweeks have not yet been reported in detail. METHODS: Adults with hypertension who were untreated or on monotherapy were eligible for participation. Overall, 591 participants were randomized to either the quadpill (irbesartan 37.5âmg, amlodipine 1.25âmg, indapamide 0.625âmg, and bisoprolol 2.5âmg) or monotherapy control (irbesartan 150âmg). The difference in 24-h, daytime, and night-time systolic and diastolic ambulatory BP at 12âweeks along further metrics were predefined secondary outcomes. RESULTS: Of 576 participants, 289 were randomized to the quadpill group and 287 to the monotherapy group. At 12âweeks, mean 24-h ambulatory SBP and DBP were 7.7 [95% confidence interval (95% CI) 9.6-5.8] and 5.3 (95% CI: 6.5-4.1) mmHg lower in the quadpill vs. monotherapy group ( P â<â0.001 for both). Similar reductions in the quadpill group were observed for daytime (8.1/5.7âmmHg lower) and night-time (6.3/4.0âmmHg lower) BP at 12âweeks (all P â<â0.001) compared to monotherapy. The rate of BP control (24-h average BPâ<â130/80âmmHg) at 12âweeks was higher in the quadpill group (77 vs. 50%; P â<â0.001). The reduction in BP load was also more pronounced with the quadpill. CONCLUSION: A quadruple quarter-dose combination compared with monotherapy resulted in greater ambulatory BP lowering across the entire 24-h period with higher ambulatory BP control rates and reduced BP variability at 12âweeks. These findings further substantiate the efficacy of an ultra-low-dose quadpill-based BP lowering strategy.
Asunto(s)
Antihipertensivos , Monitoreo Ambulatorio de la Presión Arterial , Presión Sanguínea , Quimioterapia Combinada , Hipertensión , Humanos , Antihipertensivos/administración & dosificación , Antihipertensivos/uso terapéutico , Monitoreo Ambulatorio de la Presión Arterial/métodos , Masculino , Presión Sanguínea/efectos de los fármacos , Femenino , Persona de Mediana Edad , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Anciano , Bisoprolol/administración & dosificación , Bisoprolol/uso terapéutico , Amlodipino/administración & dosificación , Adulto , Indapamida/administración & dosificación , Indapamida/uso terapéuticoRESUMEN
BACKGROUND: Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater chance of suffering a recurrent cardiovascular event than people without known CVDs. Although drug interventions have been shown to be cost-effective in reducing the risk of recurrent cardiovascular events, adherence to medication remains suboptimal. As a scalable and cost-effective approach, mobile phone text messaging presents an opportunity to convey health information, deliver electronic reminders, and encourage behaviour change. However, it is uncertain whether text messaging can improve medication adherence and clinical outcomes. This is an update of a Cochrane review published in 2017. OBJECTIVES: To evaluate the benefits and harms of mobile phone text messaging for improving medication adherence in people with CVDs compared to usual care. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We also checked the reference lists of all primary included studies and relevant systematic reviews and meta-analyses. The date of the latest search was 30 August 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim of improving adherence to medication for the secondary prevention of cardiovascular events. The comparator was usual care. We excluded cluster-RCTs and quasi-RCTs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were medication adherence, fatal cardiovascular events, non-fatal cardiovascular events, and combined CVD event. Secondary outcomes were low-density lipoprotein cholesterol for the effect of statins, blood pressure for antihypertensive drugs, heart rate for the effect of beta-blockers, urinary 11-dehydrothromboxane B2 for the antiplatelet effects of aspirin, adverse effects, and patient-reported experience. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 18 RCTs involving a total of 8136 participants with CVDs. We identified 11 new studies in the review update and seven studies in the previous version of the review. Participants had various CVDs including acute coronary syndrome, coronary heart disease, stroke, myocardial infarction, and angina. All studies were conducted in middle- and high-income countries, with no studies conducted in low-income countries. The mean age of participants was 53 to 64 years. Participants were recruited from hospitals or cardiac rehabilitation facilities. Follow-up ranged from one to 12 months. There was variation in the characteristics of text messages amongst studies (e.g. delivery method, frequency, theoretical grounding, content used, personalisation, and directionality). The content of text messages varied across studies, but generally included medication reminders and healthy lifestyle information such as diet, physical activity, and weight loss. Text messages offered advice, motivation, social support, and health education to promote behaviour changes and regular medication-taking. We assessed risk of bias for all studies as high, as all studies had at least one domain at unclear or high risk of bias. Medication adherence Due to different evaluation score systems and inconsistent definitions applied for the measurement of medication adherence, we did not conduct meta-analysis for medication adherence. Ten out of 18 studies showed a beneficial effect of mobile phone text messaging for medication adherence compared to usual care, whereas the other eight studies showed either a reduction or no difference in medication adherence with text messaging compared to usual care. Overall, the evidence is very uncertain about the effects of mobile phone text messaging for medication adherence when compared to usual care. Fatal cardiovascular events Text messaging may have little to no effect on fatal cardiovascular events compared to usual care (odds ratio 0.83, 95% confidence interval (CI) 0.47 to 1.45; 4 studies, 1654 participants; low-certainty evidence). Non-fatal cardiovascular events We found very low-certainty evidence that text messaging may have little to no effect on non-fatal cardiovascular events. Two studies reported non-fatal cardiovascular events, neither of which found evidence of a difference between groups. Combined CVD events We found very low-certainty evidence that text messaging may have little to no effect on combined CVD events. Only one study reported combined CVD events, and did not find evidence of a difference between groups. Low-density lipoprotein cholesterol Text messaging may have little to no effect on low-density lipoprotein cholesterol compared to usual care (mean difference (MD) -1.79 mg/dL, 95% CI -4.71 to 1.12; 8 studies, 4983 participants; very low-certainty evidence). Blood pressure Text messaging may have little to no effect on systolic blood pressure (MD -0.93 mmHg, 95% CI -3.55 to 1.69; 8 studies, 5173 participants; very low-certainty evidence) and diastolic blood pressure (MD -1.00 mmHg, 95% CI -2.49 to 0.50; 5 studies, 3137 participants; very low-certainty evidence) when compared to usual care. Heart rate Text messaging may have little to no effect on heart rate compared to usual care (MD -0.46 beats per minute, 95% CI -1.74 to 0.82; 4 studies, 2946 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Due to limited evidence, we are uncertain if text messaging reduces medication adherence, fatal and non-fatal cardiovascular events, and combined cardiovascular events in people with cardiovascular diseases when compared to usual care. Furthermore, text messaging may result in little or no effect on low-density lipoprotein cholesterol, blood pressure, and heart rate compared to usual care. The included studies were of low methodological quality, and no studies assessed the effects of text messaging in low-income countries or beyond the 12-month follow-up. Long-term and high-quality randomised trials are needed, particularly in low-income countries.
Asunto(s)
Enfermedades Cardiovasculares , Teléfono Celular , Cumplimiento de la Medicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Prevención Secundaria , Envío de Mensajes de Texto , Humanos , Prevención Secundaria/métodos , Enfermedades Cardiovasculares/prevención & control , Sistemas Recordatorios , Sesgo , Persona de Mediana Edad , Accidente Cerebrovascular/prevención & control , Infarto del Miocardio/prevención & controlRESUMEN
BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among cancer survivors. Mental health is considered an important risk factor affecting the treatment of cardiovascular disease. However, little is known about the use of secondary prevention strategies for CVD in patients with both cancer and CVD. This study aimed to compare the utilisation of primary care chronic disease management plans, mental health care and guideline-indicated cardioprotective medications among CVD patients with and without cancer. METHODS: Retrospective cross-sectional study utilising clinical data of patients with CVD from 50 Australian primary care practices. Outcomes included the use of chronic disease management plans, mental health care, guideline-indicated cardioprotective medications and influenza vaccination. Logistic regression, accounting for demographic and clinical covariates and clustering effects by practices, was used to compare the two groups. RESULTS: Of the 15,040 patients with CVD, 1,486 patients (9.9%) concurrently had cancer. Patients with cancer, compared to those without, were older (77.6 vs 71.8 years, p<0.001), more likely to drink alcohol (62.6% vs 55.7%, p<0.001), have lower systolic (130.3±17.8 vs 132.5±21.1 mmHg, p<0.001) and diastolic (72.2±11 vs 75.3±34 mmHg, p<0.001) blood pressure. Although suboptimal for both groups, patients with cancer were significantly more likely to have general practice management plans (GPMPs) (51.4% vs 43.2%, p<0.001), coordination of team care arrangements (TCAs) (46.2% vs 37.0%, p<0.001), have a review of either GPMP or TCA (42.8% vs 34.7%, p<0.001), have a mental health treatment consultation (15.4% vs 10.5%, p=0.004) and be prescribed blood pressure-lowering medications (70.1% vs 66.0%, p=0.002). However, there were no statistical differences in the prescription of lipid-lowering or antiplatelet medications. After adjustments for covariates and multiple testing, patients with cancer did not show a difference in GPMPs, TCAs, and a review of either, but were more likely to receive mental health treatment consultations than those without cancer (odds ratio 1.76; 95% confidence interval 1.42-2.19). CONCLUSIONS: Less than half of patients with CVD had a GPMP, TCA or review of either. Although those patients with cancer were more likely to receive these interventions, still around half the patients did not. Medicare-funded GPMPs, TCAs and a review of either GPMP or TCA were underutilised, and future studies should seek to identify ways of improving access to these services.