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2.
JACC Heart Fail ; 2024 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-39243242

RESUMEN

The pathophysiology of heart failure (HF) is related to the overactivation of the mineralocorticoid receptor, leading to fluid retention and adverse myocardial remodeling. Although mineralocorticoid receptor antagonists (MRAs) are recommended for the treatment of heart failure with reduced ejection fraction (HFrEF), they remain underused due to adverse effects such as hyperkalemia; and their efficacy is controversial in heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF). Recent trials in people with diabetes and kidney disease have supported the use of nonsteroidal MRAs in reducing HF-related morbidity and mortality and have fewer side effects than their steroidal counterparts. The efficacy and safety of nonsteroidal MRAs have not been tested in HF and are currently being evaluated in additional clinical trials. This review comprehensively examines the current data regarding MRAs for HF and the future direction of nonsteroidal MRA research while exploring the causes of MRA underutilization.

3.
Egypt Heart J ; 76(1): 97, 2024 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-39101961

RESUMEN

BACKGROUND: Functional health status is increasingly being recognized as a viable endpoint in heart failure (HF) trials. We sought to assess its prognostic impact and relationship with traditional clinical outcomes in patients with HF. METHODS: MEDLINE and Cochrane central were searched up to January 2021 for post hoc analyses of trials or observational studies that assessed independent association between baseline health/functional status, and mortality and hospitalization in patients with HF across the range of left ventricular ejection fractions to evaluate the prognostic ability of NYHA class [II, III, IV], KCCQ, MLHFQ, and 6MWD. Hazard ratios (HR) with 95% confidence intervals were pooled. RESULTS: Twenty-two studies were included. Relative to NYHA I, NYHA class II (HR 1.54 [1.16-2.04]; p < 0.01), NYHA class III (HR 2.08 [1.57-2.77]; p < 0.01), and NYHA class IV (HR 2.53 [1.25-5.12]; p = 0.01) were independently associated with increased risk of mortality. 6MWD (per 10 m) was associated with decreased mortality (HR 0.98 [0.98-0.99]; p < 0.01). A 5-point increase in KCCQ-OSS (HR 0.94 [0.91-0.96]; p < 0.01) was associated with decreased mortality. A high MLHFQ score (> 45) was significantly associated with increased mortality (HR 1.30 [1.14-1.47]; p < 0.01). NHYA class, 6MWD (per 10 m), KCCQ-OSS, and MLHFQ all significantly associated with all-cause mortality in patients with HF. CONCLUSION: Identifying such patients with poor health status using functional health assessment can offer a complementary assessment of disease burden and trajectory which carries a strong prognostic value.

4.
JACC Adv ; 3(9): 101131, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39184855

RESUMEN

Heart failure (HF) is a leading cause of hospitalization in older adults. Patients are at high risk of readmission and death following hospitalization for HF. There is no standard approach of health care delivery during the hospital-to-home transition period, leaving missed opportunities in care optimization. In this review, we discuss contemporary randomized clinical trials that tested decongestion strategies, disease-modifying therapies, and health care services that inform the care of patients with worsening HF. We provide evidence-informed recommendations for optimizing therapies and improving outcomes during and following hospitalization for HF. These include adequate decongestion with loop diuretics and select sequential nephron blockade strategies based on early evaluation of diuretic response; initiation of disease-modifying pharmacotherapies prior to hospital discharge with close follow-up and optimization after discharge; cardiac rehabilitation; and transitional or palliative care referral post-hospitalization. Evidence-based implementation strategies to facilitate broad uptake include digital health tools and algorithm-driven optimization of pharmacotherapies.

5.
Nat Cardiovasc Res ; 3(2): 110-117, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-39196202

RESUMEN

Phase 3 randomized controlled trials (RCTs), while the gold standard for treatment efficacy and safety, are not always feasible, are expensive, can be prolonged and can be limited in generalizability. Other under-recognized sources of evidence can also help advance drug development. Basic science, proof-of-concept studies and early-phase RCTs can provide evidence regarding the potential for clinical benefit. Real-world evidence generated from registries or observational datasets can provide insights into the treatment of rare diseases that often pose a challenge for trial recruitment. Pragmatic trials embedded in healthcare systems can assess the treatment effects in clinical settings among patient populations sometimes excluded from trials. This Perspective discusses potential sources of evidence that may be used to complement explanatory phase 3 RCTs and to speed the development of new cardiovascular medications. Content is derived from the 19th Global Cardiovascular Clinical Trialists meeting (December 2022), involving clinical trialists, patients, clinicians, regulators, funders and industry representatives.


Asunto(s)
Desarrollo de Medicamentos , Humanos , Desarrollo de Medicamentos/métodos , Fármacos Cardiovasculares/uso terapéutico , Fármacos Cardiovasculares/efectos adversos , Ensayos Clínicos Fase III como Asunto , Ensayos Clínicos Pragmáticos como Asunto/métodos , Proyectos de Investigación/normas , Enfermedades Cardiovasculares/tratamiento farmacológico , Medicina Basada en la Evidencia/métodos , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Estudios Observacionales como Asunto/métodos
6.
Circ Cardiovasc Qual Outcomes ; 17(9): e000132, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39116212

RESUMEN

This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the "2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures." The new performance measures are taken from the "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis.


Asunto(s)
American Heart Association , Cardiología , Insuficiencia Cardíaca , Indicadores de Calidad de la Atención de Salud , Humanos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/fisiopatología , Indicadores de Calidad de la Atención de Salud/normas , Estados Unidos , Cardiología/normas , Resultado del Tratamiento , Consenso , Mejoramiento de la Calidad/normas , Evaluación de Procesos y Resultados en Atención de Salud/normas
7.
J Am Coll Cardiol ; 84(12): 1123-1143, 2024 Sep 17.
Artículo en Inglés | MEDLINE | ID: mdl-39127953

RESUMEN

This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the "2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures." The new performance measures are taken from the "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis.


Asunto(s)
American Heart Association , Cardiología , Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/terapia , Estados Unidos , Cardiología/normas , Adulto
8.
Lancet Digit Health ; 2024 Aug 29.
Artículo en Inglés | MEDLINE | ID: mdl-39214762

RESUMEN

Digital health technologies can generate data that can be used to train artificial intelligence (AI) algorithms, which have been particularly transformative in cardiovascular health-care delivery. However, digital and health-care data repositories that are used to train AI algorithms can introduce bias when data are homogeneous and health-care processes are inequitable. AI bias can also be introduced during algorithm development, testing, implementation, and post-implementation processes. The consequences of AI algorithmic bias can be considerable, including missed diagnoses, misclassification of disease, incorrect risk prediction, and inappropriate treatment recommendations. This bias can disproportionately affect marginalised demographic groups. In this Series paper, we provide a brief overview of AI applications in cardiovascular health care, discuss stages of algorithm development and associated sources of bias, and provide examples of harm from biased algorithms. We propose strategies that can be applied during the training, testing, and implementation of AI algorithms to mitigate bias so that all those at risk for or living with cardiovascular disease might benefit equally from AI.

9.
Diabetes Metab Syndr ; 18(7): 103074, 2024 Jul 16.
Artículo en Inglés | MEDLINE | ID: mdl-39033649

RESUMEN

AIMS: Little is known about the enrollment practice of both Black, Indigenous and People of Color (BIPOC) and females in the US diabetes trials. We aimed to perform a chronological survey to evaluate the enrollment of BIPOC and female participants in the US diabetes randomized controlled trials (RCTs) over the past two decades. METHODS: We searched databases to systematically include the US diabetes RCTs from 2000 January 1st to 2020 December 31st. Primary outcome was the adequate enrollment of both BIPOC and females, defined by the participation to prevalence ratio (PPR) > 0.8. We tested the temporal trend in adequate enrollment over time and used logistic regression analysis to explore the relationship between adequate enrollment and trial characteristics. RESULTS: A total of 69 US diabetes trials were included for analyses, with a median BIPOC and female enrollment percentage of 29.0 % and 45.4 % respectively. There were 22 (31.9 %) trials with adequate enrollment of both BIPOC and females. No significant trend of adequate enrollment percentage of BIPOC and females over time was observed (P = 0.16). Of trial types, those with medication interventions were significantly related to decreased odds of adequate enrollment, when compared to trials with non-drug interventions (odds ratio = 0.29, 95 % confidence interval: 0.11-0.84). CONCLUSIONS: Less than one third of the US diabetes trials adequately enrolled both BIPOC and females over the past two decades, and no temporal improvement in BIPOC and female participant enrollment was observed. These results highlight the need for more endeavors to mitigate inadequate representation regarding BIPOC and female enrollment in diabetes trials.

10.
J Clin Epidemiol ; 172: 111405, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38838963

RESUMEN

OBJECTIVES: Data sharing statements are considered routine in clinical trial reporting and represent a step toward data transparency. The International Committee of Medical Journal Editors (ICMJE) required clinical trials to publish data sharing statements. We aimed to assess the requirement for data sharing statements of individual participant data by biomedical journals and explore associations between journal characteristics and journal requirements for data sharing statements. STUDY DESIGN AND SETTING: In this cross-sectional study, we included all biomedical journals that published clinical trials from January 1, 2019, to December 31, 2022, and that were indexed by the Journal Citation Reports. The study outcome was the journal requirement for data sharing statements. Multivariable logistic regression analysis was used to assess the relationship between journal characteristics and requirement for data sharing statements. RESULTS: Of the 3229 biomedical journals included in the analysis, 2345 (72.6%) required authors to include data sharing statements. Journals published in the UK (OR, 3.19 [95% CI, 2.43-4.22]) and endorsing the Consolidated Standards of Reporting Trials (OR, 3.30 [95% CI, 2.78-3.92]) had greater odds of requiring data sharing statements. Journals that were open access, non-English language, in the Journal Citation Reports group of clinical medicine, and on the ICMJE list had lower odds of requiring data sharing statements, with ORs ranging from 0.18 to 0.81. CONCLUSION: Despite ICMJE recommendations, more than 27% of the biomedical journals that published clinical trials did not require clinical trials to include data sharing statements, highlighting room for improved transparency.


Asunto(s)
Ensayos Clínicos como Asunto , Políticas Editoriales , Difusión de la Información , Publicaciones Periódicas como Asunto , Difusión de la Información/métodos , Estudios Transversales , Humanos , Ensayos Clínicos como Asunto/normas , Publicaciones Periódicas como Asunto/normas , Publicaciones Periódicas como Asunto/estadística & datos numéricos
11.
J Am Coll Cardiol ; 83(25): 2690-2707, 2024 Jun 25.
Artículo en Inglés | MEDLINE | ID: mdl-38897679

RESUMEN

Cardiovascular diseases (CVDs) are responsible for approximately 35% of all deaths in women. In 2019, the global age-standardized CVD prevalence and mortality of women were 6,403 per 100,000 and 204 per 100,000, respectively. Although the age- and population-adjusted prevalence has decreased globally, opposite trends are evident in regions of socioeconomic deprivation. Cardiovascular health and outcomes are influenced by regional socioeconomic, environmental, and community factors, in addition to health care system and individual factors. Cardiovascular care in women is commonly plagued by delayed diagnoses, undertreatment, and knowledge gaps, particularly in women-specific or women-predominant conditions. In this paper, we describe the global epidemiology of CVD and highlight multilevel determinants of cardiometabolic health. We review knowledge and health care gaps that serve as barriers to improving CVD outcomes in women. Finally, we present national, community, health care system, and research strategies to comprehensively address cardiometabolic risk and improve outcomes in women.


Asunto(s)
Enfermedades Cardiovasculares , Salud Global , Humanos , Enfermedades Cardiovasculares/epidemiología , Femenino , Salud de la Mujer , Prevalencia
13.
Kidney Int Rep ; 9(4): 898-906, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38765601

RESUMEN

Introduction: Women are underrepresented in the leadership of and participation in randomized controlled trials (RCTs). We conducted a bibliometric review of nephrology RCTs to examine trial leadership by women and participation of women in nephrology RCTs. Methods: A bibliometric review of RCTs published in top medical, surgical, or nephrology journals was conducted using MEDLINE and EMBASE from January 2011 to December 2021. Leadership by women as corresponding authors, women trial participation, and trial characteristics were examined with duplicate independent data extraction. Logistic regression was used to examine associations between trial characteristics and women leadership and trial participation. Results: A total of 1770 studies were screened and 395 RCTs met eligibility criteria. The number (%) of women in corresponding, first, and last authorship positions were as follows: 89 (22%), 109 (28%), and 74 (19%), respectively, without change over time (P = 0.94). The median percentage (interquartile range [IQR]) of women trial participants was 39.0% (13.5%) with no difference between women or men lead authors (P = 0.15). Men lead authors were statistically less likely to enroll women in RCTs. Women lead authors were less likely to be funded by industry (odds ratio [OR]: 0.30; 95% confidence interval [CI]: 0.14-0.63; P = 0.002) or lead international trials (OR: 0.11; 95% CI: 0.01-0.83; P = 0.03). Trials with sex-specific eligibility criteria were more likely to have women leaders (OR: 2.56; 95% CI: 1.19-5.49; P = 0.02) than those without. Discussion: Gender inequalities in RCT leadership and RCT participation exist in nephrology and did not improve over time. Strategies to improve inequalities need to be implemented and evaluated.

14.
J Am Heart Assoc ; 13(10): e033840, 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38761084

RESUMEN

BACKGROUND: Evidence for the relationship between remnant cholesterol (RC) and incident atrial fibrillation (AF) risk remains sparse and limited. METHODS AND RESULTS: Participants were enrolled between 2006 and 2010 and followed up to 2021. The multivariable Cox proportional hazards model was used to examine the relationship between RC quartiles and risk of incident AF. Subgroup analyses and sensitivity analyses were performed to explore the potential modification of the association and the robustness of the main findings. A total of 422 316 participants (mean age, 56 years; 54% women) were included for analyses. During a median follow-up of 11.9 years (first quartile-third quartile, 11.6-13.2 years), there were 24 774 AF events documented with an incidence of 4.92 events per 1000 person-years (95% CI, 4.86-4.98). Participants in higher RC quartiles had a lower risk of incident AF than those in the lowest quartile (first quartile): hazard ratio (HR)=0.96 (95% CI, 0.91-1.00) for second quartile; HR=0.92 (95% CI, 0.88-0.96) for third quartile; and HR=0.85 (95% CI, 0.81-0.89) for fourth quartile (P for trend <0.001). The association between RC quartiles and risk of incident AF was stronger in participants aged ≥65 years, in men, and in participants without history of diabetes when compared with control groups (P<0.001 for interaction). CONCLUSIONS: On the basis of data from this large-scale prospective cohort study, elevated RC was associated with a lower risk of incident AF.


Asunto(s)
Fibrilación Atrial , Colesterol , Humanos , Fibrilación Atrial/epidemiología , Fibrilación Atrial/sangre , Fibrilación Atrial/diagnóstico , Masculino , Femenino , Persona de Mediana Edad , Incidencia , Estudios Prospectivos , Colesterol/sangre , Factores de Riesgo , Anciano , Medición de Riesgo , Biomarcadores/sangre
15.
Value Health ; 27(8): 1130-1148, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38608875

RESUMEN

OBJECTIVES: Health-related quality-of-life (HRQoL) instruments for cardiovascular diseases (CVD) have been commonly used to measure important patient-reported outcomes (PROs) in clinical trials and practices. This study aimed at systematically identifying and assessing the content validity of CVD-specific HRQoL instruments in clinical studies. METHODS: The research team searched Cumulative Index to Nursing and Allied Health Literature, Embase, and PubMed from inception to January 20, 2022. The research team included studies that reported the development and content validity for CVD-specific instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating content validity of PROs. Content analysis was used to categorize the items included in the instruments. RESULTS: The research team found 69 studies reporting the content validity of 40 instruments specifically developed for CVD. Fourteen (35.0%) were rated "sufficient" with very low to moderate quality of evidence. For PRO development, all instruments were rated "doubtful" or "inadequate." Twenty-eight (70.0%) instruments cover the core concepts of HRQoL. CONCLUSIONS: The quality of development and content validity vary among existing CVD-specific instruments. The evidence on the content validity should be considered when choosing a HRQoL instrument in CVD clinical studies and health economic evaluations.


Asunto(s)
Enfermedades Cardiovasculares , Medición de Resultados Informados por el Paciente , Calidad de Vida , Humanos , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Psicometría
16.
JACC Heart Fail ; 12(8): 1365-1377, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38597866

RESUMEN

BACKGROUND: U.S. nationwide estimates of the proportion of patients newly diagnosed with heart failure with reduced ejection fraction (HFrEF) eligible for quadruple medical therapy, and the associated benefits of rapid implementation, are not well characterized. OBJECTIVES: This study sought to characterize the degree to which patients newly diagnosed with HFrEF are eligible for quadruple medical therapy, and the projected benefits of in-hospital initiation. METHODS: Among patients hospitalized for newly diagnosed HFrEF in the Get With The Guidelines-Heart Failure registry from 2016 to 2023, eligibility criteria based on regulatory labeling, guidelines, and expert consensus documents were applied for angiotensin receptor-neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor therapies. Of those eligible, the projected effect of quadruple therapy on 12-month mortality was modeled using treatment effects from pivotal clinical trials utilized by the AHA/ACC/HFSA Guideline for the Management of Heart Failure, and compared with observed outcomes among patients treated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blockers. RESULTS: Of 33,036 patients newly diagnosed with HFrEF, 27,158 (82%) were eligible for quadruple therapy, and 30,613 (93%) were eligible for ≥3 components. From 2021 to 2023, of patients eligible for quadruple therapy, 15.3% were prescribed quadruple therapy and 41.5% were prescribed triple therapy. Among Medicare beneficiaries eligible for quadruple therapy, 12-month incidence of mortality was 24.7% and HF hospitalization was 22.2%. Applying the relative risk reductions in clinical trials, complete implementation of quadruple therapy by time of discharge was projected to yield absolute risk reductions in 12-month mortality of 10.4% (number needed to treat = 10) compared with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blocker, and 24.8% (number needed to treat = 4) compared with no GDMT. CONCLUSIONS: In this nationwide U.S. cohort of patients hospitalized for newly diagnosed HFrEF, >4 of 5 patients were projected as eligible for quadruple therapy at discharge; yet, <1 in 6 were prescribed it. If clinical trial benefits can be fully realized, in-hospital initiation of quadruple medical therapy for newly diagnosed HFrEF would yield large absolute reductions in mortality.


Asunto(s)
Antagonistas Adrenérgicos beta , Antagonistas de Receptores de Angiotensina , Inhibidores de la Enzima Convertidora de Angiotensina , Quimioterapia Combinada , Insuficiencia Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Volumen Sistólico , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/mortalidad , Masculino , Antagonistas Adrenérgicos beta/uso terapéutico , Femenino , Anciano , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Volumen Sistólico/fisiología , Estados Unidos/epidemiología , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Inhibidores del Cotransportador de Sodio-Glucosa 2/administración & dosificación , Sistema de Registros , Neprilisina/antagonistas & inhibidores , Persona de Mediana Edad , Hospitalización/estadística & datos numéricos , Anciano de 80 o más Años , Determinación de la Elegibilidad
17.
Eur J Heart Fail ; 26(6): 1369-1380, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38623814

RESUMEN

AIM: Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (ß = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (ß = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (ß = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). CONCLUSION: The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.


Asunto(s)
Adhesión a Directriz , Insuficiencia Cardíaca , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Insuficiencia Cardíaca/terapia , Proyectos de Investigación/normas
18.
Circulation ; 149(19): e1143-e1163, 2024 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-38567497

RESUMEN

Guideline-directed medical therapies and guideline-directed nonpharmacological therapies improve quality of life and survival in patients with heart failure (HF), but eligible patients, particularly women and individuals from underrepresented racial and ethnic groups, are often not treated with these therapies. Implementation science uses evidence-based theories and frameworks to identify strategies that facilitate uptake of evidence to improve health. In this scientific statement, we provide an overview of implementation trials in HF, assess their use of conceptual frameworks and health equity principles, and provide pragmatic guidance for equity in HF. Overall, behavioral nudges, multidisciplinary care, and digital health strategies increased uptake of therapies in HF effectively but did not include equity goals. Few HF studies focused on achieving equity in HF by engaging stakeholders, quantifying barriers and facilitators to HF therapies, developing strategies for equity informed by theory or frameworks, evaluating implementation measures for equity, and titrating strategies for equity. Among these HF equity studies, feasibility was established in using various educational strategies to promote organizational change and equitable care. A couple include ongoing randomized controlled pragmatic trials for HF equity. There is great need for additional HF implementation trials designed to promote delivery of equitable guideline-directed therapy.


Asunto(s)
American Heart Association , Equidad en Salud , Insuficiencia Cardíaca , Ciencia de la Implementación , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/diagnóstico , Humanos , Estados Unidos , Disparidades en Atención de Salud
19.
Curr Heart Fail Rep ; 21(3): 194-202, 2024 06.
Artículo en Inglés | MEDLINE | ID: mdl-38619690

RESUMEN

PURPOSE OF REVIEW: To review ongoing and planned clinical trials of weight loss among individuals with or at high risk of heart failure. RECENT FINDINGS: Intentional weight loss via semaglutide among persons with heart failure and preserved ejection fraction and obesity significantly improves weight loss and health status as assessed by the KCCQ-CSS score and is associated with improvements in 6-min walk test. Ongoing and planned trials will explore the role of intentional weight loss with treatments such as semaglutide or tirzepatide for individuals with heart failure across the entire ejection fraction spectrum.


Asunto(s)
Insuficiencia Cardíaca , Obesidad , Pérdida de Peso , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/fisiopatología , Obesidad/complicaciones , Obesidad/tratamiento farmacológico , Ensayos Clínicos como Asunto , Volumen Sistólico/fisiología
20.
CJC Open ; 6(2Part B): 220-257, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38487042

RESUMEN

Despite significant progress in medical research and public health efforts, gaps in knowledge of women's heart health remain across epidemiology, presentation, management, outcomes, education, research, and publications. Historically, heart disease was viewed primarily as a condition in men and male individuals, leading to limited understanding of the unique risks and symptoms that women experience. These knowledge gaps are particularly problematic because globally heart disease is the leading cause of death for women. Until recently, sex and gender have not been addressed in cardiovascular research, including in preclinical and clinical research. Recruitment was often limited to male participants and individuals identifying as men, and data analysis according to sex or gender was not conducted, leading to a lack of data on how treatments and interventions might affect female patients and individuals who identify as women differently. This lack of data has led to suboptimal treatment and limitations in our understanding of the underlying mechanisms of heart disease in women, and is directly related to limited awareness and knowledge gaps in professional training and public education. Women are often unaware of their risk factors for heart disease or symptoms they might experience, leading to delays in diagnosis and treatments. Additionally, health care providers might not receive adequate training to diagnose and treat heart disease in women, leading to misdiagnosis or undertreatment. Addressing these knowledge gaps requires a multipronged approach, including education and policy change, built on evidence-based research. In this chapter we review the current state of existing cardiovascular research in Canada with a specific focus on women.


En dépit des avancées importantes de la recherche médicale et des efforts en santé publique, il reste des lacunes dans les connaissances sur la santé cardiaque des femmes sur les plans de l'épidémiologie, du tableau clinique, de la prise en charge, des résultats, de l'éducation, de la recherche et des publications. Du point de vue historique, la cardiopathie a d'abord été perçue comme une maladie qui touchait les hommes et les individus de sexe masculin. De ce fait, la compréhension des risques particuliers et des symptômes qu'éprouvent les femmes est limitée. Ces lacunes dans les connaissances posent particulièrement problème puisqu'à l'échelle mondiale la cardiopathie est la cause principale de décès chez les femmes. Jusqu'à récemment, la recherche en cardiologie, notamment la recherche préclinique et clinique, ne portait pas sur le sexe et le genre. Le recrutement souvent limité aux participants masculins et aux individus dont l'identité de genre correspond au sexe masculin et l'absence d'analyses de données en fonction du sexe ou du genre ont eu pour conséquence un manque de données sur la façon dont les traitements et les interventions nuisent aux patientes féminines et aux individus dont l'identité de genre correspond au sexe féminin, et ce, de façon différente. Cette absence de données a mené à un traitement sous-optimal et à des limites de notre compréhension des mécanismes sous-jacents de la cardiopathie chez les femmes, et est directement reliée à nos connaissances limitées, et à nos lacunes en formation professionnelle et en éducation du public. Le fait que les femmes ne connaissent souvent pas leurs facteurs de risque de maladies du cœur ou les symptômes qu'elles peuvent éprouver entraîne des retards de diagnostic et de traitements. De plus, le fait que les prestataires de soins de santé ne reçoivent pas la formation adéquate pour poser le diagnostic et traiter la cardiopathie chez les femmes les mène à poser un mauvais diagnostic ou à ne pas traiter suffisamment. Pour pallier ces lacunes de connaissances, il faut une approche à plusieurs volets, qui porte notamment sur l'éducation et les changements dans les politiques, et qui repose sur la recherche fondée sur des données probantes. Dans ce chapitre, nous passons en revue l'état actuel de la recherche existante sur les maladies cardiovasculaires au Canada, plus particulièrement chez les femmes.

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