Special populations recruitment for the Women's Health Initiative

Successes and limitations

Mona N. Fouad, Giselle Corbie-Smith, David Curb, Barbara V. Howard, Charles Mouton, Michael Simon, Greg Talavera, Joanice Thompson, Ching Yun Wang, Cornelia White, Rosalie Young

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

The Women's Health Initiative (WHI) is a study designed to examine the major causes of death and disability in women. This multi-arm, randomized, controlled trial of over 160,000 post-menopausal women of varying ethnic and socioeconomic backgrounds and a goal of 20% of the study participants from minority populations is perhaps one of the most challenging recruitment efforts ever undertaken. Of the two main study arms, the Clinical Trial (CT) and the Observational Study (OS), the CT arm recruitment goal was to randomize 64,500 postmenopausal women 50-79 years of age. Women enrolled in the study will be followed for a period of 8-12 years. Ten clinical centers, out of a total of 40 throughout the United States, were selected as minority recruitment centers on the basis of their history of interaction with and access to large numbers of women from certain population subgroups. WHI enrollment began in September 1993 and ended in December 1998, resulting in the randomization and enrollment of a total of 161,856 (17.5% minority) women participants (68,135 (18.5% minority) in the CT and 93,721 (16.7%) in the OS). Within the CT arm, WHI achieved 101.7% of the goal of 48,000 participants in the Dietary Modification (DM) component, and 99.4% of the goal of 27,500 in the hormone-replacement component (HRT), with 11.8% overlap between DM and HRT. Of those who expressed initial interest in WHI, African Americans had the highest randomization yields in the DM component and Hispanics had the highest in the HRT component (15.2% and 10.2%, respectively). Overall, mass mailing was the greatest source of randomized participants. In addition, minority clinics found community outreach, personal referrals, and culturally appropriate recruitment materials particularly effective recruitment tools. For minority recruitment, our findings suggest that the key to high yield is reaching the target population through appropriate recruitment strategies and study information that get their attention. Also, once minority subjects are reached, they tend to participate.

Original languageEnglish (US)
Pages (from-to)335-352
Number of pages18
JournalControlled Clinical Trials
Volume25
Issue number4
DOIs
StatePublished - Aug 2004
Externally publishedYes

Fingerprint

Women's Health
Diet Therapy
Clinical Trials
Population
Hormones
Random Allocation
Observational Studies
Community-Institutional Relations
Health Services Needs and Demand
Hispanic Americans
African Americans
Cause of Death
Referral and Consultation
Randomized Controlled Trials

Keywords

  • Community outreach
  • Mass mailing
  • Minority recruitment
  • Randomization yield
  • Recruitment

ASJC Scopus subject areas

  • Pharmacology

Cite this

Special populations recruitment for the Women's Health Initiative : Successes and limitations. / Fouad, Mona N.; Corbie-Smith, Giselle; Curb, David; Howard, Barbara V.; Mouton, Charles; Simon, Michael; Talavera, Greg; Thompson, Joanice; Wang, Ching Yun; White, Cornelia; Young, Rosalie.

In: Controlled Clinical Trials, Vol. 25, No. 4, 08.2004, p. 335-352.

Research output: Contribution to journalArticle

Fouad, MN, Corbie-Smith, G, Curb, D, Howard, BV, Mouton, C, Simon, M, Talavera, G, Thompson, J, Wang, CY, White, C & Young, R 2004, 'Special populations recruitment for the Women's Health Initiative: Successes and limitations', Controlled Clinical Trials, vol. 25, no. 4, pp. 335-352. https://doi.org/10.1016/j.cct.2004.03.005
Fouad, Mona N. ; Corbie-Smith, Giselle ; Curb, David ; Howard, Barbara V. ; Mouton, Charles ; Simon, Michael ; Talavera, Greg ; Thompson, Joanice ; Wang, Ching Yun ; White, Cornelia ; Young, Rosalie. / Special populations recruitment for the Women's Health Initiative : Successes and limitations. In: Controlled Clinical Trials. 2004 ; Vol. 25, No. 4. pp. 335-352.
@article{67b31ec368684c63acf9859d7cc9e459,
title = "Special populations recruitment for the Women's Health Initiative: Successes and limitations",
abstract = "The Women's Health Initiative (WHI) is a study designed to examine the major causes of death and disability in women. This multi-arm, randomized, controlled trial of over 160,000 post-menopausal women of varying ethnic and socioeconomic backgrounds and a goal of 20{\%} of the study participants from minority populations is perhaps one of the most challenging recruitment efforts ever undertaken. Of the two main study arms, the Clinical Trial (CT) and the Observational Study (OS), the CT arm recruitment goal was to randomize 64,500 postmenopausal women 50-79 years of age. Women enrolled in the study will be followed for a period of 8-12 years. Ten clinical centers, out of a total of 40 throughout the United States, were selected as minority recruitment centers on the basis of their history of interaction with and access to large numbers of women from certain population subgroups. WHI enrollment began in September 1993 and ended in December 1998, resulting in the randomization and enrollment of a total of 161,856 (17.5{\%} minority) women participants (68,135 (18.5{\%} minority) in the CT and 93,721 (16.7{\%}) in the OS). Within the CT arm, WHI achieved 101.7{\%} of the goal of 48,000 participants in the Dietary Modification (DM) component, and 99.4{\%} of the goal of 27,500 in the hormone-replacement component (HRT), with 11.8{\%} overlap between DM and HRT. Of those who expressed initial interest in WHI, African Americans had the highest randomization yields in the DM component and Hispanics had the highest in the HRT component (15.2{\%} and 10.2{\%}, respectively). Overall, mass mailing was the greatest source of randomized participants. In addition, minority clinics found community outreach, personal referrals, and culturally appropriate recruitment materials particularly effective recruitment tools. For minority recruitment, our findings suggest that the key to high yield is reaching the target population through appropriate recruitment strategies and study information that get their attention. Also, once minority subjects are reached, they tend to participate.",
keywords = "Community outreach, Mass mailing, Minority recruitment, Randomization yield, Recruitment",
author = "Fouad, {Mona N.} and Giselle Corbie-Smith and David Curb and Howard, {Barbara V.} and Charles Mouton and Michael Simon and Greg Talavera and Joanice Thompson and Wang, {Ching Yun} and Cornelia White and Rosalie Young",
year = "2004",
month = "8",
doi = "10.1016/j.cct.2004.03.005",
language = "English (US)",
volume = "25",
pages = "335--352",
journal = "Controlled Clinical Trials",
issn = "0197-2456",
publisher = "Elsevier BV",
number = "4",

}

TY - JOUR

T1 - Special populations recruitment for the Women's Health Initiative

T2 - Successes and limitations

AU - Fouad, Mona N.

AU - Corbie-Smith, Giselle

AU - Curb, David

AU - Howard, Barbara V.

AU - Mouton, Charles

AU - Simon, Michael

AU - Talavera, Greg

AU - Thompson, Joanice

AU - Wang, Ching Yun

AU - White, Cornelia

AU - Young, Rosalie

PY - 2004/8

Y1 - 2004/8

N2 - The Women's Health Initiative (WHI) is a study designed to examine the major causes of death and disability in women. This multi-arm, randomized, controlled trial of over 160,000 post-menopausal women of varying ethnic and socioeconomic backgrounds and a goal of 20% of the study participants from minority populations is perhaps one of the most challenging recruitment efforts ever undertaken. Of the two main study arms, the Clinical Trial (CT) and the Observational Study (OS), the CT arm recruitment goal was to randomize 64,500 postmenopausal women 50-79 years of age. Women enrolled in the study will be followed for a period of 8-12 years. Ten clinical centers, out of a total of 40 throughout the United States, were selected as minority recruitment centers on the basis of their history of interaction with and access to large numbers of women from certain population subgroups. WHI enrollment began in September 1993 and ended in December 1998, resulting in the randomization and enrollment of a total of 161,856 (17.5% minority) women participants (68,135 (18.5% minority) in the CT and 93,721 (16.7%) in the OS). Within the CT arm, WHI achieved 101.7% of the goal of 48,000 participants in the Dietary Modification (DM) component, and 99.4% of the goal of 27,500 in the hormone-replacement component (HRT), with 11.8% overlap between DM and HRT. Of those who expressed initial interest in WHI, African Americans had the highest randomization yields in the DM component and Hispanics had the highest in the HRT component (15.2% and 10.2%, respectively). Overall, mass mailing was the greatest source of randomized participants. In addition, minority clinics found community outreach, personal referrals, and culturally appropriate recruitment materials particularly effective recruitment tools. For minority recruitment, our findings suggest that the key to high yield is reaching the target population through appropriate recruitment strategies and study information that get their attention. Also, once minority subjects are reached, they tend to participate.

AB - The Women's Health Initiative (WHI) is a study designed to examine the major causes of death and disability in women. This multi-arm, randomized, controlled trial of over 160,000 post-menopausal women of varying ethnic and socioeconomic backgrounds and a goal of 20% of the study participants from minority populations is perhaps one of the most challenging recruitment efforts ever undertaken. Of the two main study arms, the Clinical Trial (CT) and the Observational Study (OS), the CT arm recruitment goal was to randomize 64,500 postmenopausal women 50-79 years of age. Women enrolled in the study will be followed for a period of 8-12 years. Ten clinical centers, out of a total of 40 throughout the United States, were selected as minority recruitment centers on the basis of their history of interaction with and access to large numbers of women from certain population subgroups. WHI enrollment began in September 1993 and ended in December 1998, resulting in the randomization and enrollment of a total of 161,856 (17.5% minority) women participants (68,135 (18.5% minority) in the CT and 93,721 (16.7%) in the OS). Within the CT arm, WHI achieved 101.7% of the goal of 48,000 participants in the Dietary Modification (DM) component, and 99.4% of the goal of 27,500 in the hormone-replacement component (HRT), with 11.8% overlap between DM and HRT. Of those who expressed initial interest in WHI, African Americans had the highest randomization yields in the DM component and Hispanics had the highest in the HRT component (15.2% and 10.2%, respectively). Overall, mass mailing was the greatest source of randomized participants. In addition, minority clinics found community outreach, personal referrals, and culturally appropriate recruitment materials particularly effective recruitment tools. For minority recruitment, our findings suggest that the key to high yield is reaching the target population through appropriate recruitment strategies and study information that get their attention. Also, once minority subjects are reached, they tend to participate.

KW - Community outreach

KW - Mass mailing

KW - Minority recruitment

KW - Randomization yield

KW - Recruitment

UR - http://www.scopus.com/inward/record.url?scp=3543036993&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=3543036993&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2004.03.005

DO - 10.1016/j.cct.2004.03.005

M3 - Article

VL - 25

SP - 335

EP - 352

JO - Controlled Clinical Trials

JF - Controlled Clinical Trials

SN - 0197-2456

IS - 4

ER -