The success of recruiting minorities, women, and elderly into a randomized controlled effectiveness trial

Mount Sinai Journal of Medicine

Volumn 75, Issue 1, 2008, Pages 37-43

  Sisk, Jane E ^a,d   Horowitz, Carol R ^a   Wang, Jason J ^a   McLaughlin, Mary Ann ^a   Hebert, Paul L ^a   Tuzzio, Leah ^b,c  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b CENTER FOR HEALTH STUDIES   (United States)

^c Group Health Inc   (United States)

^d NATIONAL CENTER FOR HEALTH STATISTICS   (United States)

Author keywords

Congestive heart failure; Effectiveness trial; Nurse management; Randomized controlled trial; Recruitment

Indexed keywords

ADULT; AGE DISTRIBUTION; AGED; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ELDERLY CARE; ETHNICITY; FEMALE; HEART FAILURE; HUMAN; INTERVENTION STUDY; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; MINORITY GROUP; MULTICENTER STUDY; NURSING CARE; OUTPATIENT; PATIENT ATTITUDE; PATIENT CARE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL; UNITED STATES; WOMEN'S HEALTH;

AFRICAN AMERICANS; AGED; AMBULATORY CARE; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; HEART FAILURE; HISPANIC AMERICANS; HUMANS; MALE; MIDDLE AGED; MINORITY GROUPS; NURSING CARE; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SELF CARE;

EID: 41549110675     PISSN: 00272507     EISSN: 19317581     Source Type: Journal    
DOI: 10.1002/msj.20014     Document Type: Article

References (26)

1. Lee PY, Alexander KP, Hammill BG, et al. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA 2001; 286: 708-713.
2. Ness RB, Nelson DB, Kumanyika SK, et al. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol 1997; 7: 472-478.
3. Jessup M, Brozena S. Heart failure. N Engl J Med 2003; 348: 2007-2018.
4. International Longevity Center. Clinical trials and older persons: the need for greater representation. Issue Brief, November-December 2002.
5. United States, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: guideline for the study of drugs likely to be used in the elderly. Rockville, November 1989.
6. United States, National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research: notice. RIN 0905-ZA18. 59 Federal Register 11146, Part VIII, March 28, 1994. http://frwebgate4.access.gpo.gov/cgibin/waisgate.cgi?WAISdocID. Accessed November 6, 2003.
7. New York City, Department of City Planning. Community district profiles: Manhattan community district 10, Central Harlem. http://www.nyc.gov/html/ dcp/pdf/lucds/mn10profile.pdf. Accessed March 2, 2004.
8. New York City, Department of City Planning. Community district profiles: Manhattan community district 11, East Harlem. http://www.nyc.gov/html/ dcp/pdf/lucds/mn11profile.pdf. Accessed March 2, 2004.
9. New York City, Department of Health and Mental Hygiene. Community health profiles: Central Harlem. http://www.nyc.gov/html/doh/pdf/data/ 2003nhpmanhattana.pdf. Accessed December 12, 2003.
10. New York City, Department of Health and Mental Hygiene. Community health profiles: East Harlem. http://www.nyc.gov/html/doh/pdf/data/ 2003nhpmanhattana,pdf. Accessed December 12, 2003.
11. Konstam MA, Dracup K, Baker DW, et al. Heart failure: evaluation and care of patients witb left-ventricular systolic dysfunction. Rockville: U.S. Agency for Health Care Policy and Research, Department of Health and Human Services, June 1994.
12. Packer M, Cohn N, Steering Committee and Membership of the Advisory Council to Improve Outcomes Nationwide in Heart Failure. Consensus recommendations for the management of chronic heart failure. Am J Cardiol 1999; 83: 1A-38A.
13. American College of Cardiology/American Heart Association Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult. A report of the ACC/AHA task force on practice guidelines (Committee to revise the 1995 guidelines for the evaluation and management of heart failure), 2001.
14. Corbie-Smith G, Thomas S, Williams M, et al. Attitudes and beliefs of African-Americans toward participation in medical research. J Gen Intern Med 1999; 14: 537-546,
15. Gorelick PB, Harris Y, Burnett M, et al. The recruitment triangle: reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial: an interim report from the African-American antiplatelet stroke prevention study (AAASPS). J Natl Med Assoc 1998; 90: 141-145.
16. Roberson NL. Clinical trial participation: viewpoints from racial/ethnic groups. Cancer 1994; 74 (suppl 9): 2687-2691.
17. Shavers-Hornaday VL, Lynch CF, Burmeister LF, et al. Why are African Americans under-represented in medical research studies? impediments to participation. Ethn Health 1997; 2: 31-45.
18. Swanson GM, Ward AJ, Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst 1995; 87: 1747-1759.
19. Zhang J, Yu KF. What's the relative risk? a method of correcting the odds ratio in cohort studies of common outcomes. JAMA 1998; 280:1690-1691.
20. Senni M, Redfield MM. Heart failure with preserved systolic function: a different natural history? J Am Coll Cardiol 2001; 38: 1277-1282.
21. Vasan RS, Larson MG, Benjamin EJ, et al. Congestive heart failure in subjects with normal versus reduced left ventricular ejection fraction. J Am Coll Cardiol 1999; 33: 1948-1955.
22. McAlister FA, Lawson FME, Teo KK, et al. A systematic review of randomized trials of disease management programs in heart failure. Am J Med 2001; 110: 378-384.
23. Naylor MD, Brooten D, Campbell R, et al. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA 1999; 281: 613-620.
24. Oddone EZ, Weinberger M, Giobbie-Hurder A, et al. Enhanced access to primary care for patients with congestive heart failure. Veterans affairs cooperative study group on primary care and hospital readmission. Eff Clin Pract 1999; 2: 201-209.
25. Rich MW, Beckham V, Wittenberg C, et al. A multidisciplinary intervention to prevent the readmission of elderly people with congestive heart failure. N Engl J Med 1995; 333: 1190-1195.
26. Feit F, Brooks MM, Sopko G, et al., BARI Investigators. Long-term clinical outcome in the bypass angioplasty revascularization investigation registry: comparison with the randomized trial. Circulation 2000; 101: 2795-2802.