Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.09.1227
Hiroki A. Ueyama, Kevin F. Kennedy, Jennifer A. Rymer, Alexander T. Sandhu, Toshiki Kuno, Frederick A. Masoudi, John A. Spertus, Shun Kohsaka
Background
Although high rates of P2Y12 inhibitor pretreatment (defined as the administration before coronary angiography) for non–ST-segment elevation acute coronary syndrome (NSTE-ACS) have been reported, contemporary U.S. practice patterns are not well studied.
Objectives
The goal of this study was to investigate the temporal U.S. trends, variability, and clinical outcomes of P2Y12 inhibitor pretreatment in NSTE-ACS.
Methods
Consecutive patients who underwent early invasive strategy for NSTE-ACS (coronary angiography ≤24 hours of arrival) in the National Cardiovascular Data Registry Chest Pain-Myocardial Infarction (MI) Registry were analyzed. A time-trend analysis was conducted on a complete cohort between January 1, 2013, and March 31, 2023. Subsequently, a more recent cohort (January 1, 2019, to March 31, 2023) with a complete set of variables was used to construct hierarchical regression models to quantify the variability in the use of pretreatment among operators and institutions. For this contemporary cohort, instrumental variable analysis, with operator preference as the instrument, was performed to compare the in-hospital outcomes between patients who received pretreatment and those who did not.
Results
Use of P2Y12 inhibitor pretreatment decreased from 24.8% in 2013Q1 to 12.4% in 2023Q1. Among the contemporary cohort of 110,148 patients (2019-2023; mean age 63.9 ± 12.5 years; 33.0% female), 17,509 (15.9%) received pretreatment. Significant variability in P2Y12 inhibitor pretreatment was observed (range: 0%-100%): hierarchical regression model demonstrated that 2 similar patients would have a >3-fold difference in the odds of pretreatment from 1 random operator or institution as compared with another (median OR: 3.74 [95% CI: 3.57-3.91] and 3.63 [95% CI: 3.51-3.74], respectively). Instrumental variable analysis demonstrated no significant differences in in-hospital all-cause death (1.5% vs 1.7%; P = 0.07), recurrent MI (0.6% vs 0.6%; P = 0.98), or major bleeding (2.7% vs 2.8%; P = 0.98) with pretreatment. However, in patients who underwent coronary artery bypass surgery, pretreatment was associated with a longer length of stay (11.2 ± 5.1 days vs 9.8 ± 5.0 days; P < 0.01).
Conclusions
In a national U.S. registry, we observed significant variability in the use of P2Y12 inhibitor pretreatment among NSTE-ACS patients. Given the lack of clear advantages and the potential for prolonged hospital stays, our findings highlight the importance of efforts to improve standardization.
{"title":"P2Y12 Inhibitor Pretreatment in Non–ST-Segment Elevation Acute Coronary Syndrome: The NCDR Chest Pain-MI Registry","authors":"Hiroki A. Ueyama, Kevin F. Kennedy, Jennifer A. Rymer, Alexander T. Sandhu, Toshiki Kuno, Frederick A. Masoudi, John A. Spertus, Shun Kohsaka","doi":"10.1016/j.jacc.2024.09.1227","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.09.1227","url":null,"abstract":"<h3>Background</h3>Although high rates of P2Y<sub>12</sub> inhibitor pretreatment (defined as the administration before coronary angiography) for non–ST-segment elevation acute coronary syndrome (NSTE-ACS) have been reported, contemporary U.S. practice patterns are not well studied.<h3>Objectives</h3>The goal of this study was to investigate the temporal U.S. trends, variability, and clinical outcomes of P2Y<sub>12</sub> inhibitor pretreatment in NSTE-ACS.<h3>Methods</h3>Consecutive patients who underwent early invasive strategy for NSTE-ACS (coronary angiography ≤24 hours of arrival) in the National Cardiovascular Data Registry Chest Pain-Myocardial Infarction (MI) Registry were analyzed. A time-trend analysis was conducted on a complete cohort between January 1, 2013, and March 31, 2023. Subsequently, a more recent cohort (January 1, 2019, to March 31, 2023) with a complete set of variables was used to construct hierarchical regression models to quantify the variability in the use of pretreatment among operators and institutions. For this contemporary cohort, instrumental variable analysis, with operator preference as the instrument, was performed to compare the in-hospital outcomes between patients who received pretreatment and those who did not.<h3>Results</h3>Use of P2Y<sub>12</sub> inhibitor pretreatment decreased from 24.8% in 2013Q1 to 12.4% in 2023Q1. Among the contemporary cohort of 110,148 patients (2019-2023; mean age 63.9 ± 12.5 years; 33.0% female), 17,509 (15.9%) received pretreatment. Significant variability in P2Y<sub>12</sub> inhibitor pretreatment was observed (range: 0%-100%): hierarchical regression model demonstrated that 2 similar patients would have a >3-fold difference in the odds of pretreatment from 1 random operator or institution as compared with another (median OR: 3.74 [95% CI: 3.57-3.91] and 3.63 [95% CI: 3.51-3.74], respectively). Instrumental variable analysis demonstrated no significant differences in in-hospital all-cause death (1.5% vs 1.7%; <em>P</em> = 0.07), recurrent MI (0.6% vs 0.6%; <em>P</em> = 0.98), or major bleeding (2.7% vs 2.8%; <em>P</em> = 0.98) with pretreatment. However, in patients who underwent coronary artery bypass surgery, pretreatment was associated with a longer length of stay (11.2 ± 5.1 days vs 9.8 ± 5.0 days; <em>P</em> < 0.01).<h3>Conclusions</h3>In a national U.S. registry, we observed significant variability in the use of P2Y<sub>12</sub> inhibitor pretreatment among NSTE-ACS patients. Given the lack of clear advantages and the potential for prolonged hospital stays, our findings highlight the importance of efforts to improve standardization.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"9 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.10.099
Joseph M. Kim, Robert W. Yeh, Eric A. Secemsky
Section snippets
Funding Support and Author Disclosures
Dr Kim has received research funding from the National Institutes of Health (T32HL160522). Dr Yeh has received research funding from Boston Scientific, Abbott, and Medtronic; and has served as a consultant for Boston Scientific, Abbott, Medtronic, Edwards Lifesciences, CathWorks, and Shockwave. Dr Secemsky has received research funding from the National Institutes of Health National Heart, Lung, and Blood Institute (K23HL150290), the U.S. Food and Drug Administration, SCAI, Abbott/CSI, Becton
{"title":"What Is the Rush?: Optimizing the Timing of P2Y12 Inhibition in Non–ST-Segment Elevation Acute Coronary Syndromes","authors":"Joseph M. Kim, Robert W. Yeh, Eric A. Secemsky","doi":"10.1016/j.jacc.2024.10.099","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.099","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Funding Support and Author Disclosures</h2>Dr Kim has received research funding from the National Institutes of Health (T32HL160522). Dr Yeh has received research funding from Boston Scientific, Abbott, and Medtronic; and has served as a consultant for Boston Scientific, Abbott, Medtronic, Edwards Lifesciences, CathWorks, and Shockwave. Dr Secemsky has received research funding from the National Institutes of Health National Heart, Lung, and Blood Institute (K23HL150290), the U.S. Food and Drug Administration, SCAI, Abbott/CSI, Becton</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"35 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.11.013
Daniel M. Blumenthal, John Hsu
No Abstract
无摘要
{"title":"Understanding The Impact of Vertical Integration on Cardiovascular Care Quality: A Complex and Worthwhile Endeavor","authors":"Daniel M. Blumenthal, John Hsu","doi":"10.1016/j.jacc.2024.11.013","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.11.013","url":null,"abstract":"No Abstract","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"64 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.11.002
Charles B. Eaton
Section snippets
Funding Support and Author Disclosures
The author has reported that he has no relationships relevant to the content of this paper to disclose.
章节片段资金支持和作者披露作者报告称，他没有与本文内容相关的关系需要披露。
{"title":"Sedentary Behavior and Risk of Cardiovascular Disease","authors":"Charles B. Eaton","doi":"10.1016/j.jacc.2024.11.002","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.11.002","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Funding Support and Author Disclosures</h2>The author has reported that he has no relationships relevant to the content of this paper to disclose.</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"37 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.10.109
Ali Moghtaderi, David J. Magid, Andy Ye Yuan, Bernard Black, Qian (Eric) Luo, Vinay Kini
Background
Cardiologists are increasingly moving from independent practice to direct employment by hospitals. Hospital employment has the potential to improve care coordination and delivery, but little is known about its effect on care quality and outcomes.
Objectives
In this study, we sought to assess the association between hospital employment of cardiologists and patient outcomes, care quality, and utilization among patients hospitalized with incident acute myocardial infarction (AMI) or heart failure (HF).
Methods
We used a sample of Medicare fee-for-service beneficiaries hospitalized with incident AMI or HF from 2008 to 2019. We identified the accountable cardiologists that cared for these patients and determined their employment status by means of tax identification numbers. We used difference-in-differences methods to compare clinical outcomes, quality measures, and utilization for patients treated by hospital-employed cardiologists after switching from independent to hospital-employed practice, to outcomes for patients treated by cardiologists who remained independent. Models were adjusted for time trends and patient, hospital, and cardiologist characteristics. Patient outcomes were in-hospital mortality, 30-day mortality, and 30-day readmission. Quality measures were receipt of: 1) a guideline-recommended test to assess cardiac function; and 2) a 30-day follow-up clinic visit. Utilization measures were length of stay and, for AMI patients, the proportion receiving coronary revascularization.
Results
The proportion of U.S. cardiologists employed by hospitals increased from 26% in 2008 to 63% in 2019. We identified 186,052 AMI and 259,849 HF patients cared for by cardiologists who switched to hospital employment and 168,052 AMI and 245,769 HF patients cared for by independent cardiologists. Patient characteristics were similar (mean age 80.8 years; 47% men). We found no significant differences in outcomes (eg, adjusted difference in 30-day mortality 0.03% [95% CI: −0.39% to 0.45%] for AMI patients and −0.05% [95% CI: −0.37% to 0.27%] for HF patients); no differences in most quality metrics except a small increase in the proportion of HF patients with 30-day follow-up (adjusted difference: 1.04%; 95% CI: 0.46%-1.62%); and no differences in utilization between patients treated by hospital-employed cardiologists (postswitch) vs independent cardiologists.
Conclusions
Among U.S. cardiologists, there has been a large shift from independent practice to direct employment by hospitals. We found minimal evidence that cardiologist employment by hospitals improves care quality or outcomes.
{"title":"The Association of Hospital-Cardiologist Integration With Patient Outcomes, Care Quality, and Utilization","authors":"Ali Moghtaderi, David J. Magid, Andy Ye Yuan, Bernard Black, Qian (Eric) Luo, Vinay Kini","doi":"10.1016/j.jacc.2024.10.109","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.109","url":null,"abstract":"<h3>Background</h3>Cardiologists are increasingly moving from independent practice to direct employment by hospitals. Hospital employment has the potential to improve care coordination and delivery, but little is known about its effect on care quality and outcomes.<h3>Objectives</h3>In this study, we sought to assess the association between hospital employment of cardiologists and patient outcomes, care quality, and utilization among patients hospitalized with incident acute myocardial infarction (AMI) or heart failure (HF).<h3>Methods</h3>We used a sample of Medicare fee-for-service beneficiaries hospitalized with incident AMI or HF from 2008 to 2019. We identified the accountable cardiologists that cared for these patients and determined their employment status by means of tax identification numbers. We used difference-in-differences methods to compare clinical outcomes, quality measures, and utilization for patients treated by hospital-employed cardiologists after switching from independent to hospital-employed practice, to outcomes for patients treated by cardiologists who remained independent. Models were adjusted for time trends and patient, hospital, and cardiologist characteristics. Patient outcomes were in-hospital mortality, 30-day mortality, and 30-day readmission. Quality measures were receipt of: 1) a guideline-recommended test to assess cardiac function; and 2) a 30-day follow-up clinic visit. Utilization measures were length of stay and, for AMI patients, the proportion receiving coronary revascularization.<h3>Results</h3>The proportion of U.S. cardiologists employed by hospitals increased from 26% in 2008 to 63% in 2019. We identified 186,052 AMI and 259,849 HF patients cared for by cardiologists who switched to hospital employment and 168,052 AMI and 245,769 HF patients cared for by independent cardiologists. Patient characteristics were similar (mean age 80.8 years; 47% men). We found no significant differences in outcomes (eg, adjusted difference in 30-day mortality 0.03% [95% CI: −0.39% to 0.45%] for AMI patients and −0.05% [95% CI: −0.37% to 0.27%] for HF patients); no differences in most quality metrics except a small increase in the proportion of HF patients with 30-day follow-up (adjusted difference: 1.04%; 95% CI: 0.46%-1.62%); and no differences in utilization between patients treated by hospital-employed cardiologists (postswitch) vs independent cardiologists.<h3>Conclusions</h3>Among U.S. cardiologists, there has been a large shift from independent practice to direct employment by hospitals. We found minimal evidence that cardiologist employment by hospitals improves care quality or outcomes.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"246 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.10.065
Ezimamaka Ajufo, Shinwan Kany, Joel T. Rämö, Timothy W. Churchill, J. Sawalla Guseh, Krishna G. Aragam, Patrick T. Ellinor, Shaan Khurshid
Background
Beyond serving as a marker for insufficient physical activity, sedentary behavior may directly affect future cardiovascular (CV) disease risk.
Objectives
This study sought to examine associations between accelerometer-measured sedentary behavior with risk of specific CV outcomes, including potential relations with moderate to vigorous physical activity (MVPA).
Methods
Among participants of the UK Biobank prospective cohort study, we fit Cox models adjusted for demographic and lifestyle factors to assess associations between accelerometer-measured daily sedentary time with incident atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), and CV mortality. We assessed the potential effect of MVPA on associations between sedentary time and CV disease by including MVPA as an adjustment variable, as well as performing subgroup analyses stratified at the guideline-recommended MVPA threshold (ie, ≥150 min/wk). We then performed compositional analyses to estimate the effects of reallocating sedentary time to other activities.
Results
Among 89,530 individuals (age 62 ± 8 years, 56.4% women) undergoing 1 week of accelerometry, median sedentary time was 9.4 h/d (Q1-Q3: 8.2-10.6). In multivariable models, using the second quartile (8.2-9.4 h/d) as a referent, sedentary time in the top quartile (>10.6 h/d) was associated with greater risks of HF (HR: 1.45; 95% CI: 1.28-1.65) and CV mortality (HR: 1.62; 95% CI: 1.34-1.96), with an inflection of risk at 10.6 h/d. Higher sedentary time was also associated with greater risks of incident AF (HR: 1.11; 95% CI: 1.01-1.21) and MI (HR: 1.15; 95% CI: 1.00-1.32), with an approximately linear relation. Associations with HF and CV mortality persisted among individuals meeting guideline-recommended MVPA levels. Among individuals with >10.6 h/d of sedentary time, reallocating sedentary behavior to other activities substantially reduced the excess CV risk conferred by sedentary behavior (eg, 30-minute decrease in sedentary time for HF: HR: 0.93; 95% CI: 0.90-0.96), even among individuals meeting guideline-recommended MVPA (HR: 0.93; 95% CI: 0.87-0.99).
Conclusions
Sedentary behavior is broadly associated with future adverse CV outcomes, with particularly prominent effects on HF and CV mortality, where risk inflected at approximately 10.6 h/d. Although guideline-adherent MVPA partially mitigates excess risk, optimizing sedentary behavior appears to be important even among physically active individuals.
{"title":"Accelerometer-Measured Sedentary Behavior and Risk of Future Cardiovascular Disease","authors":"Ezimamaka Ajufo, Shinwan Kany, Joel T. Rämö, Timothy W. Churchill, J. Sawalla Guseh, Krishna G. Aragam, Patrick T. Ellinor, Shaan Khurshid","doi":"10.1016/j.jacc.2024.10.065","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.10.065","url":null,"abstract":"<h3>Background</h3>Beyond serving as a marker for insufficient physical activity, sedentary behavior may directly affect future cardiovascular (CV) disease risk.<h3>Objectives</h3>This study sought to examine associations between accelerometer-measured sedentary behavior with risk of specific CV outcomes, including potential relations with moderate to vigorous physical activity (MVPA).<h3>Methods</h3>Among participants of the UK Biobank prospective cohort study, we fit Cox models adjusted for demographic and lifestyle factors to assess associations between accelerometer-measured daily sedentary time with incident atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), and CV mortality. We assessed the potential effect of MVPA on associations between sedentary time and CV disease by including MVPA as an adjustment variable, as well as performing subgroup analyses stratified at the guideline-recommended MVPA threshold (ie, ≥150 min/wk). We then performed compositional analyses to estimate the effects of reallocating sedentary time to other activities.<h3>Results</h3>Among 89,530 individuals (age 62 ± 8 years, 56.4% women) undergoing 1 week of accelerometry, median sedentary time was 9.4 h/d (Q1-Q3: 8.2-10.6). In multivariable models, using the second quartile (8.2-9.4 h/d) as a referent, sedentary time in the top quartile (>10.6 h/d) was associated with greater risks of HF (HR: 1.45; 95% CI: 1.28-1.65) and CV mortality (HR: 1.62; 95% CI: 1.34-1.96), with an inflection of risk at 10.6 h/d. Higher sedentary time was also associated with greater risks of incident AF (HR: 1.11; 95% CI: 1.01-1.21) and MI (HR: 1.15; 95% CI: 1.00-1.32), with an approximately linear relation. Associations with HF and CV mortality persisted among individuals meeting guideline-recommended MVPA levels. Among individuals with >10.6 h/d of sedentary time, reallocating sedentary behavior to other activities substantially reduced the excess CV risk conferred by sedentary behavior (eg, 30-minute decrease in sedentary time for HF: HR: 0.93; 95% CI: 0.90-0.96), even among individuals meeting guideline-recommended MVPA (HR: 0.93; 95% CI: 0.87-0.99).<h3>Conclusions</h3>Sedentary behavior is broadly associated with future adverse CV outcomes, with particularly prominent effects on HF and CV mortality, where risk inflected at approximately 10.6 h/d. Although guideline-adherent MVPA partially mitigates excess risk, optimizing sedentary behavior appears to be important even among physically active individuals.","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"128 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/j.jacc.2024.09.1215
Lucas X. Marinacci, ZhaoNian Zheng, Stephen Mein, Rishi K. Wadhera
Section snippets
Funding Support and Author Disclosures
Dr Marinacci has received research support from grant T32-HL160522 from the National Institutes of Health. Dr Wadhera has received research support from the National Heart, Lung, and Blood Institute at the National Institutes of Health (R01HL164561, R01HL174549), the National Institute for Nursing Research at the National Institutes of Health (R01NR021686), the American Heart Association Established Investigator Award, and the Donaghue Foundation (West Hartford, CT); and has served as a
{"title":"Rural-Urban Differences in Cardiovascular Mortality in the United States, 2010-2022","authors":"Lucas X. Marinacci, ZhaoNian Zheng, Stephen Mein, Rishi K. Wadhera","doi":"10.1016/j.jacc.2024.09.1215","DOIUrl":"https://doi.org/10.1016/j.jacc.2024.09.1215","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Funding Support and Author Disclosures</h2>Dr Marinacci has received research support from grant T32-HL160522 from the National Institutes of Health. Dr Wadhera has received research support from the National Heart, Lung, and Blood Institute at the National Institutes of Health (R01HL164561, R01HL174549), the National Institute for Nursing Research at the National Institutes of Health (R01NR021686), the American Heart Association Established Investigator Award, and the Donaghue Foundation (West Hartford, CT); and has served as a</section></section>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"69 1","pages":""},"PeriodicalIF":24.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142637582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-04DOI: 10.1016/j.jacc.2024.08.068
Harriette G.C. Van Spall MD , Laura Desveaux PhD , Tracy Finch PhD , Cara C. Lewis PhD , George A. Mensah MD , Yves Rosenberg MD , Kavita Singh PhD , Francois Venter PhD , Bryan J. Weiner PhD , Faiez Zannad MD
The delayed and modest uptake of evidence-based treatments following cardiovascular clinical trials highlights the need for greater attention to implementation early in the development and testing of treatments. However, implementation science is not well understood and is often an afterthought following phase 3 trials. In this review, we describe the goals, frameworks, and methods of implementation science, along with common multilevel barriers and facilitators of implementation. We propose that some of the approaches used for implementation well after a trial has ended can be incorporated into the design of phase 3 trials to foster early post-trial implementation. Approaches include, but are not limited to, engaging broad stakeholders including patients, clinicians, and decision-makers in trial advisory boards; using less restrictive eligibility criteria that ensure both internal validity and generalizability; having trial protocols reviewed by regulators; integrating trial execution with the health care system; evaluating and addressing barriers and facilitators to deployment of the intervention; and undertaking cost-effectiveness and cost utility analyses across jurisdictions. We provide case examples to highlight concepts and to guide end-of-trial implementation.
{"title":"A Guide to Implementation Science for Phase 3 Clinical Trialists","authors":"Harriette G.C. Van Spall MD , Laura Desveaux PhD , Tracy Finch PhD , Cara C. Lewis PhD , George A. Mensah MD , Yves Rosenberg MD , Kavita Singh PhD , Francois Venter PhD , Bryan J. Weiner PhD , Faiez Zannad MD","doi":"10.1016/j.jacc.2024.08.068","DOIUrl":"10.1016/j.jacc.2024.08.068","url":null,"abstract":"<div><div>The delayed and modest uptake of evidence-based treatments following cardiovascular clinical trials highlights the need for greater attention to implementation early in the development and testing of treatments. However, implementation science is not well understood and is often an afterthought following phase 3 trials. In this review, we describe the goals, frameworks, and methods of implementation science, along with common multilevel barriers and facilitators of implementation. We propose that some of the approaches used for implementation well after a trial has ended can be incorporated into the design of phase 3 trials to foster early post-trial implementation. Approaches include, but are not limited to, engaging broad stakeholders including patients, clinicians, and decision-makers in trial advisory boards; using less restrictive eligibility criteria that ensure both internal validity and generalizability; having trial protocols reviewed by regulators; integrating trial execution with the health care system; evaluating and addressing barriers and facilitators to deployment of the intervention; and undertaking cost-effectiveness and cost utility analyses across jurisdictions. We provide case examples to highlight concepts and to guide end-of-trial implementation.</div></div>","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Pages 2063-2072"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-04DOI: 10.1016/j.jacc.2024.07.053
Ruirui Hou MD, Jian Ren MD
{"title":"Gender Disparities in Cardiovascular Literature","authors":"Ruirui Hou MD, Jian Ren MD","doi":"10.1016/j.jacc.2024.07.053","DOIUrl":"10.1016/j.jacc.2024.07.053","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Page e279"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-04DOI: 10.1016/j.jacc.2024.05.085
Christiaan J.M. Vrints MD, PhD
{"title":"Let Us Focus on Angina Mechanisms in Many, Not Just Typical Symptoms in a Few","authors":"Christiaan J.M. Vrints MD, PhD","doi":"10.1016/j.jacc.2024.05.085","DOIUrl":"10.1016/j.jacc.2024.05.085","url":null,"abstract":"","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"84 20","pages":"Page e275"},"PeriodicalIF":21.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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