The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y)

Leslie Vaughan; Mark A Espeland; Beverly Snively; Sally A Shumaker; Stephen R Rapp; Jill Shupe; Jennifer G Robinson; Gloria E Sarto; Susan M Resnick; for the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group

doi:10.1016/j.brainres.2013.03.047

Back

The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y)

Journal article

Peer reviewed

The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y)

Leslie Vaughan, Mark A Espeland, Beverly Snively, Sally A Shumaker, Stephen R Rapp, Jill Shupe, Jennifer G Robinson, Gloria E Sarto, Susan M Resnick and for the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group

Brain research, Vol.1514, pp.3-11

06/13/2013

DOI: 10.1016/j.brainres.2013.03.047

PMCID: PMC3684042

PMID: 23578696

View Online

Abstract

The Women's Health Initiative Memory Study-Younger (WHIMS-Y) was designed to assess the effect of prior random assignment to hormone therapy (HT) (conjugated equine estrogen (CEE) alone or CEE plus medroxyprogesterone acetate (MPA)) on global cognitive function in younger middle-aged women relative to placebo. WHIMS-Y was an ancillary study to the Women's Health Initiative (WHI) HT trial and enrolled 1361 women who were aged 50–55 years and postmenopausal at WHI enrollment. WHIMS-Y will examine whether an average of 5.4 years of HT during early menopause has longer term protective effects on global cognitive function and if these effects vary by regimen, time between menopause and study initiation, and prior use of HT. We present the study rationale and design. We describe enrollment, adherence to assigned WHI therapy, and compare risk factor characteristics of the WHIMS-Y cohort at the time of WHI enrollment to similar aged women in the WHI HT who did not enroll in WHIMS-Y. Challenges of WHIMS-Y include lower than expected and differential enrollment. Strengths of WHIMS-Y include balance in baseline risk factors between treatment groups, standardized and masked data collection, and high rates of retention and on-trial adherence and exposure. In addition, the telephone-administered cognitive battery showed adequate construct validity. WHIMS-Y provided an unprecedented chance to examine the hypothesis that HT may have protective effects on cognition in younger postmenopausal women aged 50–55 years. Integrated into the WHI, WHIMS-Y optimized the experience of WHI investigators to ensure high retention and excellent quality assurance across sites. This article is part of a Special Issue entitled Hormone Therapy.

Aging

Cognitive function

Postmenopausal hormone therapy

Details

Title: Subtitle: The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y)
Creators: Leslie Vaughan - Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA
Mark A Espeland - Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA
Beverly Snively - Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA
Sally A Shumaker - Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA
Stephen R Rapp - Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA
Jill Shupe - Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA
Jennifer G Robinson - Departments of Epidemiology and Medicine, Division of Cardiology, University of Iowa, Iowa City, IA 52242, USA
Gloria E Sarto - University of Wisconsin Center for Women's Health Research, University of Wisconsin-Madison, Madison, WI 53715, USA
Susan M Resnick - Laboratory of Personality and Cognition, Intramural Research Program, National Institute on Aging, NIH, 5600 Nathan Shock Drive, Baltimore, MD 21224, USA
for the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group
Resource Type: Journal article
Publication Details: Brain research, Vol.1514, pp.3-11
DOI: 10.1016/j.brainres.2013.03.047
PMID: 23578696
PMCID: PMC3684042
NLM abbreviation: Brain Res
ISSN: 0006-8993
eISSN: 1872-6240
Publisher: Elsevier BV
Grant note: DOI: 10.13039/100000016, name: U.S. Department of Health and Human Services, award: HHSN-271-2011-00004C; DOI: 10.13039/100000049, name: National Institute on Aging; DOI: 10.13039/100000002, name: National Institutes of Health; DOI: 10.13039/100000050, name: National Heart, Lung, and Blood Institute
Language: English
Date published: 06/13/2013
Academic Unit: Epidemiology; Internal Medicine
Record Identifier: 9983995102102771

Metrics

27 Record Views

19 Times Cited - Web of Science