{"title":"The European Heart Journal. Quality of Care and Clinical Outcome in the years to come: a salutation from the incoming Editor-in-Chief.","authors":"Massimo Piepoli, Andrea Attanasio","doi":"10.1093/ehjqcco/qcaf013","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcaf013","url":null,"abstract":"","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nikolaus Marx, Katharina Schütt, Dirk Müller-Wieland, Emanuele Di Angelantonio, William G Herrington, Ramzi A Ajjan, Alexandra Kautzky-Willer, Bianca Rocca, Naveed Sattar, Laurent Fauchier, Maddalena Lettino, Massimo Federici
ESC Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force Chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes, which are freely available on the ESC website (https://www.escardio.org/Guidelines). The document also underwent external review, including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology, the Asian Pacific Society of Cardiology, and the Asean Federation of Cardiology.
{"title":"Key priorities for the implementation of the 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes in low-resource settings.","authors":"Nikolaus Marx, Katharina Schütt, Dirk Müller-Wieland, Emanuele Di Angelantonio, William G Herrington, Ramzi A Ajjan, Alexandra Kautzky-Willer, Bianca Rocca, Naveed Sattar, Laurent Fauchier, Maddalena Lettino, Massimo Federici","doi":"10.1093/ehjqcco/qcae105","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcae105","url":null,"abstract":"<p><p>ESC Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force Chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes, which are freely available on the ESC website (https://www.escardio.org/Guidelines). The document also underwent external review, including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology, the Asian Pacific Society of Cardiology, and the Asean Federation of Cardiology.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert Byrne, J J Coughlan, Xavier Rossello, Borja Ibanez
ESC Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force Chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of acute coronary syndromes, which are freely available on the ESC website (https://www.escardio.org/Guidelines). This document also underwent external review including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology (IASC), the Pan-African Society of Cardiology (PASCAR), the Asian Pacific Society of Cardiology (APSC), and the ASEAN Federation of Cardiology (AFC).
{"title":"Key priorities for the implementation of the 2023 ESC Guidelines for the management of acute coronary syndromes in low-resource settings.","authors":"Robert Byrne, J J Coughlan, Xavier Rossello, Borja Ibanez","doi":"10.1093/ehjqcco/qcae107","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcae107","url":null,"abstract":"<p><p>ESC Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force Chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of acute coronary syndromes, which are freely available on the ESC website (https://www.escardio.org/Guidelines). This document also underwent external review including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology (IASC), the Pan-African Society of Cardiology (PASCAR), the Asian Pacific Society of Cardiology (APSC), and the ASEAN Federation of Cardiology (AFC).</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thalia Melamed, Sveeta Badiani, Stephen Harlow, Nabila Laskar, Thomas A Treibel, Nay Aung, Sanjeev Bhattacharyya, Guy Lloyd
Aims: The prevalence of mitral valve prolapse (MVP) varies across populations and age groups; its natural history and clinical outcomes remain unclear. This meta-analysis established the prevalence of MVP in the general population, in associated syndromes and at different ages. It also determined the rate of progression and the incidence of adverse outcomes.
Methods and results: A systematic search identified original reports on the prevalence of MVP and related outcomes. 83 studies met inclusion: 47 (n = 992 944) non-syndrome associated; 31 (n = 3067) syndrome associated. 5 (n = 1287) described mitral regurgitation progression or adverse outcomes. In the general population the prevalence was 1.35% but higher in hospital cohorts (8.7%). Age-stratified prevalence was 0.5%, 1.8%, 2.7% and 2.0% in neonates, children, adolescents and adults, respectively. Meta-regression and subgroup analysis found no significant difference (p = 0.81) across ages but revealed a significantly higher prevalence in older compared to young adults (2.87% vs. 0.67%, p = 0.01). Prevalence rates were markedly higher in patients with genetic syndromes. Mitral regurgitation (MR) progressed at 5.5 per 100 person-years, overall. Event rates for all-cause mortality, development of heart failure and need for mitral valve intervention were 1.7, 1.0 and 1.2 per 100 person-years, respectively.
Conclusions: MVP is common, with greater prevalence in syndromes. Although more common with age, MVP is observed in infants. MVP related MR is progressive, especially in moderate MR, and there is a signal of excess mortality for unclear reasons. Valve services must manage the whole life journey and the potential risks associated with MVP.
{"title":"Prevalence, Progression and Clinical Outcomes of Mitral Valve Prolapse: A Systematic Review and Meta-Analysis.","authors":"Thalia Melamed, Sveeta Badiani, Stephen Harlow, Nabila Laskar, Thomas A Treibel, Nay Aung, Sanjeev Bhattacharyya, Guy Lloyd","doi":"10.1093/ehjqcco/qcaf016","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcaf016","url":null,"abstract":"<p><strong>Aims: </strong>The prevalence of mitral valve prolapse (MVP) varies across populations and age groups; its natural history and clinical outcomes remain unclear. This meta-analysis established the prevalence of MVP in the general population, in associated syndromes and at different ages. It also determined the rate of progression and the incidence of adverse outcomes.</p><p><strong>Methods and results: </strong>A systematic search identified original reports on the prevalence of MVP and related outcomes. 83 studies met inclusion: 47 (n = 992 944) non-syndrome associated; 31 (n = 3067) syndrome associated. 5 (n = 1287) described mitral regurgitation progression or adverse outcomes. In the general population the prevalence was 1.35% but higher in hospital cohorts (8.7%). Age-stratified prevalence was 0.5%, 1.8%, 2.7% and 2.0% in neonates, children, adolescents and adults, respectively. Meta-regression and subgroup analysis found no significant difference (p = 0.81) across ages but revealed a significantly higher prevalence in older compared to young adults (2.87% vs. 0.67%, p = 0.01). Prevalence rates were markedly higher in patients with genetic syndromes. Mitral regurgitation (MR) progressed at 5.5 per 100 person-years, overall. Event rates for all-cause mortality, development of heart failure and need for mitral valve intervention were 1.7, 1.0 and 1.2 per 100 person-years, respectively.</p><p><strong>Conclusions: </strong>MVP is common, with greater prevalence in syndromes. Although more common with age, MVP is observed in infants. MVP related MR is progressive, especially in moderate MR, and there is a signal of excess mortality for unclear reasons. Valve services must manage the whole life journey and the potential risks associated with MVP.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael A Borger, Suzanne de Waha, Nina Ajmone Marsan, Liesl Zühlke, Carlos A Mestres, Emil Fosbol, Nikolaos Bonaros, María Nazarena Pizzi, Margarita Brida, Alessandro Sionis, Victoria Delgado
European Society of Cardiology (ESC) Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of endocarditis, which are freely available on the ESC website (https://www.escardio.org/Guidelines). This document also underwent external review including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology (IASC), The Pan-African Society of Cardiology (PASCAR), the Asian Pacific Society of Cardiology and the ASEAN Federation of Cardiology.
{"title":"Key priorities for the implementation of the 2023 ESC Guidelines for the management of endocarditis in low-resource settings.","authors":"Michael A Borger, Suzanne de Waha, Nina Ajmone Marsan, Liesl Zühlke, Carlos A Mestres, Emil Fosbol, Nikolaos Bonaros, María Nazarena Pizzi, Margarita Brida, Alessandro Sionis, Victoria Delgado","doi":"10.1093/ehjqcco/qcae106","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcae106","url":null,"abstract":"<p><p>European Society of Cardiology (ESC) Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of endocarditis, which are freely available on the ESC website (https://www.escardio.org/Guidelines). This document also underwent external review including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology (IASC), The Pan-African Society of Cardiology (PASCAR), the Asian Pacific Society of Cardiology and the ASEAN Federation of Cardiology.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero
Introduction: Quality registries may involve specific inclusion criteria, detailed investigations or selected hospitals and practitioners, which are not random. Whether the care and outcomes in quality registries are generalizable to the broader population is not well known. We here examine care indicators and outcomes in heart failure (HF) patients enrolled vs. non-enrolled in Swedish Heart Failure (SwedeHF) quality registry.
Methods: Observational study of 90-day survivors after a HF in Stockholm (2012-2021). We linked health records from the Stockholm Creatinine Measurements (SCREAM) project with SwedeHF. Participants enrolled in SwedeHF were compared to those non-enrolled, focusing on settings of care, use of guideline-recommended therapies, treatment adherence, dose titration, persistence, and outcomes. Analyses considered stratification by settings of management (primary care, cardiology-outpatient and cardiology-inpatient care).
Results: We identified 48,374 incident HF cases of which 4,878 (10%) were enrolled in SwedeHF within 90 days. Enrolled participants were younger, more often men and had fewer comorbidities than non-enrolled. Enrolled participants were more likely to initiate, persist and adhere to, and achieve higher dosages of guideline-recommended HF therapies (P<0.05 for all). Enrolled participants were less likely to experience a major cardiovascular event (CV death, nonfatal myocardial infarction or stroke; HR 0.92, 95% CI 0.86-0.99) and all-cause death (HR 0.87, 95% CI 0.82-0.92), but had similar rates of HF hospitalization (HR 1.03, 95% CI 0.94-1.15) compared to non-enrolled ones. Findings were similar across settings of management.
Conclusion: Enrollment in the SwedeHF registry occurred in a minority of patients, and was associated with better adherence to guideline-recommended heart failure therapies and fewer major cardiovascular events and lower mortality. The generalizability of these HF registry findings to all HF patients was, however, limited.
{"title":"Characteristics, use of guideline-recommended medical therapies and clinical outcomes of patients with heart failure not enrolled in a quality registry: A comparison with the Swedish Heart Failure Registry.","authors":"Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero","doi":"10.1093/ehjqcco/qcaf019","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcaf019","url":null,"abstract":"<p><strong>Introduction: </strong>Quality registries may involve specific inclusion criteria, detailed investigations or selected hospitals and practitioners, which are not random. Whether the care and outcomes in quality registries are generalizable to the broader population is not well known. We here examine care indicators and outcomes in heart failure (HF) patients enrolled vs. non-enrolled in Swedish Heart Failure (SwedeHF) quality registry.</p><p><strong>Methods: </strong>Observational study of 90-day survivors after a HF in Stockholm (2012-2021). We linked health records from the Stockholm Creatinine Measurements (SCREAM) project with SwedeHF. Participants enrolled in SwedeHF were compared to those non-enrolled, focusing on settings of care, use of guideline-recommended therapies, treatment adherence, dose titration, persistence, and outcomes. Analyses considered stratification by settings of management (primary care, cardiology-outpatient and cardiology-inpatient care).</p><p><strong>Results: </strong>We identified 48,374 incident HF cases of which 4,878 (10%) were enrolled in SwedeHF within 90 days. Enrolled participants were younger, more often men and had fewer comorbidities than non-enrolled. Enrolled participants were more likely to initiate, persist and adhere to, and achieve higher dosages of guideline-recommended HF therapies (P<0.05 for all). Enrolled participants were less likely to experience a major cardiovascular event (CV death, nonfatal myocardial infarction or stroke; HR 0.92, 95% CI 0.86-0.99) and all-cause death (HR 0.87, 95% CI 0.82-0.92), but had similar rates of HF hospitalization (HR 1.03, 95% CI 0.94-1.15) compared to non-enrolled ones. Findings were similar across settings of management.</p><p><strong>Conclusion: </strong>Enrollment in the SwedeHF registry occurred in a minority of patients, and was associated with better adherence to guideline-recommended heart failure therapies and fewer major cardiovascular events and lower mortality. The generalizability of these HF registry findings to all HF patients was, however, limited.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chris P Gale, Gerhard Hindricks, Ramesh Nadarajah, Jan Tijssen, Serge Boveda, Jens Cosedis Nielsen, Jose Luis Merino, Radoslaw Lenarczyk, Milos Taborsky, Nikolaos Dagres
{"title":"Implantable cardioverter defibrillators in heart failure with reduced ejection fraction after myocardial infarction: the need for contemporary evidence.","authors":"Chris P Gale, Gerhard Hindricks, Ramesh Nadarajah, Jan Tijssen, Serge Boveda, Jens Cosedis Nielsen, Jose Luis Merino, Radoslaw Lenarczyk, Milos Taborsky, Nikolaos Dagres","doi":"10.1093/ehjqcco/qcaf018","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcaf018","url":null,"abstract":"","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Cantone, Saidi A Mohiddin, Massimiliano Lorenzini
{"title":"Specialist services for cardiomyopathy: quality care requires diagnostic accuracy.","authors":"Anna Cantone, Saidi A Mohiddin, Massimiliano Lorenzini","doi":"10.1093/ehjqcco/qcae044","DOIUrl":"10.1093/ehjqcco/qcae044","url":null,"abstract":"","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J J Coughlan, R A Byrne, G C M Siontis, L McGovern, R Durand, A Lübbeke, A Bano, A G Fraser
Introduction: Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes and cardiovascular) approved in the European Union (EU).
Methods: This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high risk orthopaedic, diabetes and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex and ethnicity of participants, and the performance of stratified analyses based on these factors.
Results: The majority (>90%) of studies in all three device categories (orthopaedics, diabetes and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of patients in the included orthopaedic and diabetes device studies, but less than 40% of patients in the included cardiovascular device studies (p < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.
Conclusions: Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed if these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies. Study registration Cardiovascular device systematic review: PROSPERO (CRD42022308593, Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).
{"title":"Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union.","authors":"J J Coughlan, R A Byrne, G C M Siontis, L McGovern, R Durand, A Lübbeke, A Bano, A G Fraser","doi":"10.1093/ehjqcco/qcaf007","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcaf007","url":null,"abstract":"<p><strong>Introduction: </strong>Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes and cardiovascular) approved in the European Union (EU).</p><p><strong>Methods: </strong>This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high risk orthopaedic, diabetes and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex and ethnicity of participants, and the performance of stratified analyses based on these factors.</p><p><strong>Results: </strong>The majority (>90%) of studies in all three device categories (orthopaedics, diabetes and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of patients in the included orthopaedic and diabetes device studies, but less than 40% of patients in the included cardiovascular device studies (p < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.</p><p><strong>Conclusions: </strong>Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed if these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies. Study registration Cardiovascular device systematic review: PROSPERO (CRD42022308593, Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Ischaemic heart disease (IHD) is a major cause of heart failure (HF), a condition expected to increasingly affect global health and economics. This study evaluates the global burden, trends, and disparities of HF linked to IHD, aiming to inform health policy development.
Methods and results: Data from the Global Burden of Disease Study 2021 (GBD2021) are analysed using joinpoint regression, decomposition analysis, and Bayesian age-period-cohort analysis (BAPC). Health disparities are assessed through the Socio-demographic Index (SDI) via the Slope Index of Inequality and the Concentration Index, with future trends projected from 2022 to 2045. In 2021, global HF cases due to IHD were over 19.16 million, with an age-standardized prevalence rate (ASPR) of 228.31 per 100 000 [95% Uncertainty Interval (UI), 188.18-279.55] and age-standardized years lived with disability (ASYLDs) rate of 20.43 per 100 000 [95% UI, 13.55-28.7]. In 2021, there was a 2.87% increase in ASPR and ASYLDs compared with 1990, primarily driven by population growth and aging. Significant reductions in global ASPR and ASYLDs disparities are observed, though the disease burden has intensified in countries with lower SDI levels. Projections indicate that by 2045, while the prevalence and years lived with disability for HF caused by IHD will increase, the ASPR and ASYLDs are expected to decrease.
Conclusion: The global burden of HF due to IHD remains a significant concern. Urgent improvements in the allocation of medical resources and the implementation of effective prevention and management strategies are necessary to address this issue.
{"title":"The burden and trends of heart failure caused by ischaemic heart disease at the global, regional, and national levels from 1990 to 2021.","authors":"Hongwei Zhang, Xiaoyu Zheng, Pingping Huang, Lijun Guo, Yuan Zheng, Dawu Zhang, Xiaochang Ma","doi":"10.1093/ehjqcco/qcae094","DOIUrl":"10.1093/ehjqcco/qcae094","url":null,"abstract":"<p><strong>Background: </strong>Ischaemic heart disease (IHD) is a major cause of heart failure (HF), a condition expected to increasingly affect global health and economics. This study evaluates the global burden, trends, and disparities of HF linked to IHD, aiming to inform health policy development.</p><p><strong>Methods and results: </strong>Data from the Global Burden of Disease Study 2021 (GBD2021) are analysed using joinpoint regression, decomposition analysis, and Bayesian age-period-cohort analysis (BAPC). Health disparities are assessed through the Socio-demographic Index (SDI) via the Slope Index of Inequality and the Concentration Index, with future trends projected from 2022 to 2045. In 2021, global HF cases due to IHD were over 19.16 million, with an age-standardized prevalence rate (ASPR) of 228.31 per 100 000 [95% Uncertainty Interval (UI), 188.18-279.55] and age-standardized years lived with disability (ASYLDs) rate of 20.43 per 100 000 [95% UI, 13.55-28.7]. In 2021, there was a 2.87% increase in ASPR and ASYLDs compared with 1990, primarily driven by population growth and aging. Significant reductions in global ASPR and ASYLDs disparities are observed, though the disease burden has intensified in countries with lower SDI levels. Projections indicate that by 2045, while the prevalence and years lived with disability for HF caused by IHD will increase, the ASPR and ASYLDs are expected to decrease.</p><p><strong>Conclusion: </strong>The global burden of HF due to IHD remains a significant concern. Urgent improvements in the allocation of medical resources and the implementation of effective prevention and management strategies are necessary to address this issue.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":"186-196"},"PeriodicalIF":4.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}