Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap

被引:51
作者
Reza, Nosheen [1 ,3 ]
Gruen, Jadry [1 ]
Bozkurt, Biykem [2 ]
机构
[1] Univ Penn, Perelman Sch Med, Div Cardiovasc Med, Philadelphia, PA USA
[2] Baylor Coll Med, Cardiovasc Res Inst, Winters Ctr Heart Failure Res, DeBakey VA Med Ctr,Dept Med,Cardiol Sect, Houston, TX USA
[3] Univ Penn, Dept Med, Div Cardiovasc Med, Perelman Sch Med, 11 South Tower,Room 11-145,3400 Civ Ctr Blvd, Philadelphia, PA 19104 USA
来源
AMERICAN HEART JOURNAL PLUS: CARDIOLOGY RESEARCH AND PRACTICE | 2022年 / 13卷
基金
美国国家卫生研究院;
关键词
Heart failure; Female; Sex characteristics; Clinical trials; Patient participation; Diversity; RANDOMIZED-TRIALS; SEX-DIFFERENCES; NATIONAL HEART; MINORITIES; GENDER; PARTICIPATION; LUNG;
D O I
10.1016/j.ahjo.2022.100093
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Heart failure is a significant public health burden that differentially impacts women. Important sex- and genderbased differences in HF risk factors, presentation, and treatment exist, and the generation of high-quality evidence is critical to elucidate these differences. Despite the remarkable growth of the heart failure clinical research enterprise over the last four decades, women remain underrepresented in heart failure clinical trials relative to the population prevalence of heart failure in women. This disparity has resulted in significant knowledge gaps regarding the optimal care of women with heart failure. In this review, we summarize the existing literature regarding the participation of women in heart failure clinical trials. Additionally, we explain the evidence surrounding sex- and gender-specific barriers to enrollment in heart failure clinical trials and describe interventions that should be implemented throughout the clinical trial lifespan to achieve sex and gender parity.
引用
收藏
页数:6
相关论文
共 54 条
[1]   Sex differences in outcome after implantable cardioverter defibrillator implantation in nonischemic cardiomyopathy [J].
Albert, Christine M. ;
Quigg, Rebecca ;
Saba, Samir ;
Estes, Mark ;
Shaechter, Andi ;
Subacius, Haris ;
Howard, Adam ;
Levine, Joseph ;
Kadish, Alan .
AMERICAN HEART JOURNAL, 2008, 156 (02) :367-372
[2]   Evaluation and management of heart failure with preserved ejection fraction [J].
Borlaug, Barry A. .
NATURE REVIEWS CARDIOLOGY, 2020, 17 (09) :559-573
[3]  
C. I. of H. R. Government of Canada, 2018, How to integrate sex and gender into research-CIHR
[4]  
Cheung AM, 2000, NEW ENGL J MED, V343, P1972
[5]  
ClinicalTrials.gov, Background
[6]   Differences in Specialist Consultations for Cardiovascular Disease by Race, Ethnicity, Gender, Insurance Status, and Site of Primary Care [J].
Cook, Nakela L. ;
Ayanian, John Z. ;
Orav, E. John ;
Hicks, Leroi S. .
CIRCULATION, 2009, 119 (18) :2463-U76
[7]   Representation of Women in Cardiovascular Clinical Trial Leadership [J].
Denby, Kara J. ;
Szpakowski, Natalie ;
Silver, Julie ;
Walsh, Mary Norine ;
Nissen, Steve ;
Cho, Leslie .
JAMA INTERNAL MEDICINE, 2020, 180 (10) :1382-1383
[8]   Epidemiologic Characterization of Heart Failure with Reduced or Preserved Ejection Fraction Populations Identified Using Medicare Claims [J].
Desai, Rishi J. ;
Mahesri, Mufaddal ;
Chin, Kristyn ;
Levin, Raisa ;
Lahoz, Raquel ;
Studer, Rachel ;
Vaduganathan, Muthiah ;
Patorno, Elisabetta .
AMERICAN JOURNAL OF MEDICINE, 2021, 134 (04) :E241-+
[9]   Epidemiology of heart failure with preserved ejection fraction [J].
Dunlay, Shannon M. ;
Roger, Veronique L. ;
Redfield, Margaret M. .
NATURE REVIEWS CARDIOLOGY, 2017, 14 (10) :591-602
[10]   Temporal Trends and Clinical Trial Characteristics Associated With the Inclusion of Women in Heart Failure Trial Steering Committees A Systematic Review [J].
Eliya, Yousif ;
Whitelaw, Sera ;
Thabane, Lehana ;
Voors, Adriaan A. ;
Douglas, Pamela S. ;
Van Spall, Harriette G. C. .
CIRCULATION-HEART FAILURE, 2021, 14 (08) :E008064