Women in clinical research what we need for progress

Circulation: Cardiovascular Quality and Outcomes

Volumn 8, Issue , 2015, Pages S1-S3

  Bucholz, Emily M ^a,b   Krumholz, Harlan M ^c,d  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b YALE UNIVERSITY   (United States)

^c ROBERT WOOD JOHNSON FOUNDATION   (United States)

^d YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID;

CARDIOVASCULAR RISK; CARDIOVASCULAR SYSTEM; CAROTID ARTERY STENTING; CAROTID ENDARTERECTOMY; CLINICAL RESEARCH; CORONARY ARTERY BYPASS GRAFT; FEMALE; HEALTH CARE POLICY; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MENOPAUSE; NATIONAL HEALTH ORGANIZATION; PERCUTANEOUS CORONARY INTERVENTION; POSTMENOPAUSE; PREGNANCY; PRIMARY PREVENTION; PRIORITY JOURNAL; REVIEW; SEX DIFFERENCE; THERAPY EFFECT; WOMEN'S HEALTH; CARDIOVASCULAR DISEASES; FORECASTING; HEALTH CARE DISPARITY; HEALTH DISPARITY; MASS COMMUNICATION; MEDICAL RESEARCH; PATHOPHYSIOLOGY; RISK FACTOR; TRENDS;

BIOMEDICAL RESEARCH; CARDIOVASCULAR DISEASES; DIFFUSION OF INNOVATION; FEMALE; FORECASTING; HEALTH STATUS DISPARITIES; HEALTHCARE DISPARITIES; HUMANS; RISK FACTORS; SEX FACTORS; WOMEN'S HEALTH;

EID: 84965088439     PISSN: 19417713     EISSN: 19417705     Source Type: Journal    
DOI: 10.1161/CIRCOUTCOMES.115.001756     Document Type: Review

References (40)

1. Zusterzeel R, Spatz ES, Curtis JP, Sanders WE, Selzman KA, Piña IL, Bao H, Ponirakis A, Varosy PD, Masoudi FA, Caños DA, Strauss DG. Cardiac resynchronization therapy in women versus men: observational comparative effectiveness study from the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015;8:S4-S11. DOI: 10.1161/CIRCOUTCOMES.114.001548.
2. Lauck SB, Sawatzky R, Johnson JL, Humphries K, Bennett MT, Chakrabarti S, Kerr CR, Tung S, Yeung-Lai-Wah JA, Ratner PA. Sex is associated with differences in individual trajectories of change in social health after implantable cardioverter-defibrillator. Circ Cardiovasc Qual Outcomes. 2015;8:S21-S30. DOI: 10.1161/CIRCOUTCOMES.114.001607.
3. Lichtman JH, Leifheit-Limson EC, Watanabe E, Allen NB, Garavalia B, Garavalia LS, Spertus JA, Krumholz HM, Curry LA. Symptom recognition and healthcare experiences of young women with acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015;8:S31-S38. DOI: 10.1161/CIRCOUTCOMES.114.001612.
4. Davis MB, Maddox TM, Langner P, Plomondon ME, Rumsfeld JS, Duvernoy CS. Characteristics and outcomes of women veterans undergoing cardiac catheterization in the veterans affairs healthcare system: insights from the VA CART program. Circ Cardiovasc Qual Outcomes. 2015;8:S39-S47. DOI: 10.1161/CIRCOUTCOMES.114.001613.
5. Lip GYH, Rushton-Smith SK, Goldhaber SZ, Fitzmaurice DA, Mantovani LG, Goto S, Haas S, Bassand JP, Cam AJ, Ambrosio G, Janský P, Al Mahmeed W, Oh S, van Eiekels M, Raatikainen P, Steffel J, Oto A, Kayani G, Accetta G, Kakkar AK; for the GARFIELD-AF Investigators. Does sex affect anticoagulant use for stroke prevention in the nonvalvular atrial fibrillation?: the Prospective Global Anticoagulant Registry in the FIELDAtrial Fibrillation? Circ Cardiovasc Qual Outcomes. 2015;8:S12-S20. DOI: 10.1161/CIRCOUTCOMES.114.001556.
6. Joynt KE, Mega JL, O'Donoghue ML. Difference or disparity: will big data improve our understanding of sex and cardiovascular disease? Circ Cardiovasc Qual Outcomes. 2015;8:S52-S55. DOI: 10.1161/CIRCOUTCOMES.115.001701.
7. Pedrotty DM, Jessup M. "Frailty, thy name is woman": syndrome of women with heart failure with preserved ejection fraction. Circ Cardiovasc Qual Outcomes. 2015;8:S48-S51. DOI: 10.1161/CIRCOUTCOMES.115.001700.
8. Cook JL, Grady KL, Colvin M, Joseph SM, Brisco MA, Walsh MN; for the genVAD Work Group. Sex differences in the care of patients with advanced heart failure. Circ Cardiovasc Qual Outcomes. 2015;8:S56-S59. DOI: 10.1161/CIRCOUTCOMES.115.001730.
9. Brown N. How the American Heart Association helped change women's heart health. Circ Cardiovasc Qual Outcomes. 2015;8:S60-S62. DOI: 10.1161/CIRCOUTCOMES.115.001734.
10. Arnett DK. Plugging the leaking pipeline: why men have a stake in the recruitment and retention of women in cardiovascular medicine and research. Circ Cardiovasc Qual Outcomes. 2015;8:S63-S64. DOI: 10.1161/CIRCOUTCOMES.115.001757.
11. Hennekens CH, Buring JE. Methodologic considerations in the design and conduct of randomized trials: the US Physicians' Health Study. Control Clin Trials. 1989;10(4 suppl):142S-150S.
12. Hennekens CH, Eberlein K. A randomized trial of aspirin and beta-carotene among US physicians. Prev Med. 1985;14:165-168.
13. The Multiple Risk Factor Intervention Trial Group. Statistical design considerations in the NHLBI multiple risk factor intervention trial (MRFIT). J Chronic Dis. 1977;30:261-275.
14. Multiple Risk Factor Intervention Trial Research Group. Multiple Risk Factor Intervention Trial. Risk factor changes and mortality results. JAMA. 1982;248:1465-1477.
15. National Institutes of Health. Revitalization Act of 1993; United States public law 103-43.
16. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. 1994;59(part VIII):14508-14513.
17. United States Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. 1993;58:39406-39416.
18. United States General Accounting Office. Women sufficiently represented in new drug testing, but FDA oversight needs improvement. 2001; http://www.gao.gov/new.items/d01754.pdf.
19. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4:165-171. doi: 10.1161/CIRCOUTCOMES.110.958215.
20. Melloni C, Berger JS, Wang TY, Gunes F, Stebbins A, Pieper KS, Dolor RJ, Douglas PS, Mark DB, Newby LK. Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3:135-142. doi: 10.1161/CIRCOUTCOMES.110.868307.
21. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162:1682-1688.
22. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001;286:708-713.
23. Harris DJ, Douglas PS. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med. 2000;343:475-480. doi: 10.1056/NEJM200008173430706.
24. Kim ES, Carrigan TP, Menon V. Enrollment of women in National Heart, Lung, and Blood Institute-funded cardiovascular randomized controlled trials fails to meet current federal mandates for inclusion. J Am Coll Cardiol. 2008;52:672-673. doi: 10.1016/j.jacc.2008.05.025.
25. Mosca L, Linfante AH, Benjamin EJ, Berra K, Hayes SN, Walsh BW, Fabunmi RP, Kwan J, Mills T, Simpson SL. National study of physician awareness and adherence to cardiovascular disease prevention guidelines. Circulation. 2005;111:499-510. doi: 10.1161/01.CIR.0000154568.43333.82.
26. Chang AM, Mumma B, Sease KL, Robey JL, Shofer FS, Hollander JE. Gender bias in cardiovascular testing persists after adjustment for presenting characteristics and cardiac risk. Acad Emerg Med. 2007;14:599-605. doi: 10.1197/j.aem.2007.03.1355.
27. Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S, Gersh BJ, Dubé R, Taleghani CK, Burke JE, Williams S, Eisenberg JM, Escarce JJ. The effect of race and sex on physicians' recommendations for cardiac catheterization. N Engl J Med. 1999;340:618-626. doi: 10.1056/NEJM199902253400806.
28. Johnson SM, Karvonen CA, Phelps CL, Nader S, Sanborn BM. Assessment of analysis by gender in the Cochrane reviews as related to treatment of cardiovascular disease. J Womens Health (Larchmt). 2003;12:449-457. doi: 10.1089/154099903766651577.
29. Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-Analysis of randomized controlled trials. JAMA. 2006;295:306-313. doi: 10.1001/jama.295.3.306.
30. Ghanbari H, Dalloul G, Hasan R, Daccarett M, Saba S, David S, Machado C. Effectiveness of implantable cardioverter-defibrillators for the primary prevention of sudden cardiac death in women with advanced heart failure: a meta-Analysis of randomized controlled trials. Arch Intern Med. 2009;169:1500-1506. doi: 10.1001/archinternmed.2009.255.
31. Champney KP, Frederick PD, Bueno H, Parashar S, Foody J, Merz CN, Canto JG, Lichtman JH, Vaccarino V; NRMI Investigators. The joint contribution of sex, age and type of myocardial infarction on hospital mortality following acute myocardial infarction. Heart. 2009;95:895-899. doi: 10.1136/hrt.2008.155804.
32. Gupta A, Wang Y, Spertus JA, Geda M, Lorenze N, Nkonde-Price C, D'Onofrio G, Lichtman JH, Krumholz HM. Trends in acute myocardial infarction in young patients and differences by sex and race, 2001 to 2010. J Am Coll Cardiol. 2014;64:337-345. doi: 10.1016/j. jacc.2014.04.054.
33. Vaccarino V, Horwitz RI, Meehan TP, Petrillo MK, Radford MJ, Krumholz HM. Sex differences in mortality after myocardial infarction: evidence for a sex-Age interaction. Arch Intern Med. 1998;158:2054-2062.
34. Vaccarino V, Parsons L, Every NR, Barron HV, Krumholz HM. Sexbased differences in early mortality after myocardial infarction. National Registry of Myocardial Infarction 2 Participants. N Engl J Med. 1999;341:217-225. doi: 10.1056/NEJM199907223410401.
35. Bellasi A, Raggi P, Merz CN, Shaw LJ. New insights into ischemic heart disease in women. Cleve Clin J Med. 2007;74:585-594.
36. Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999;33:1453-1461.
37. Basso C, Morgagni GL, Thiene G. Spontaneous coronary artery dissection: a neglected cause of acute myocardial ischaemia and sudden death. Heart. 1996;75:451-454.
38. Thompson EA, Ferraris S, Gress T, Ferraris V. Gender differences and predictors of mortality in spontaneous coronary artery dissection: a review of reported cases. J Invasive Cardiol. 2005;17:59-61.
39. Voeks JH, Howard G, Roubin GS, Malas MB, Cohen DJ, Sternbergh WC 3rd, Aronow HD, Eskandari MK, Sheffet AJ, Lal BK, Meschia JF, Brott TG; CREST Investigators. Age and outcomes after carotid stenting and endarterectomy: the carotid revascularization endarterectomy versus stenting trial. Stroke. 2011;42:3484-3490. doi: 10.1161/STROKEAHA.111.624155.
40. Zhang Z, Mahoney EM, Spertus JA, Booth J, Nugara F, Kolm P, Stables RH, Weintraub WS. The impact of age on outcomes after coronary artery bypass surgery versus stent-Assisted percutaneous coronary intervention: one-year results from the Stent or Surgery (SoS) trial. Am Heart J. 2006;152:1153-1160. doi: 10.1016/j.ahj.2006.06.011.