Psychologist Plays Pivotal Roles in Women's Health Initiative

Margaret Chesney, PhD, is juggling two roles in the NIH Women's Health Initiative (WHI), the largest preventive clinical trial ever conducted (see sidebar). Dr. Chesney is a member of the Women's Health Initiative Program Advisory Committee (WHIPAC), which is composed of scientists, health care providers, and lay women's health advocates. She has also been appointed to the clinical trial's Data Safety and Monitoring Board (DSMB), the group of scientists and ethicists concerned with the safety of the protocols and the protection of the 160,000 women who will participate in WHI.

Longtime NIH observers have noted that the presence of a psychologist on the program advisory committee is evidence that social and behavioral measures have been incorporated into WHI. Although psychologists have served in the past on the DSMBs of some clinical trials, they are not usually chosen for medically oriented clinical trials funded by NIH. Dr. Chesney's strong research and methodological skills in the behavioral sciences made her a good choice for both the committees, and this dual role places her in an influential position on a very visible study.

The DSMB recommends to the Director of NIH when to stop a trial, when to extend treatments to all trial participants, and when a study protocol should be modified for health or safety reasons. Only the DSMB and the Clinical Coordinating Committee have access to the clinical trial data while the study is in progress.

While the DSMB focuses on the safety of the participants, WHIPAC concentrates on recruitment and retention of study participants and other broad programmatic issues. WHIPAC wants to ensure that low-income and minority women are represented in great enough numbers to allow group differences to be evaluated.

Dr. Chesney credits the number of psychologists who served in advisory roles on WHI. Karen Matthews, PhD, University of Pittsburgh, and Sally Shumaker, PhD, Bowman Gray School of Medicine, cochair the Behavioral Subcommittee of WHI. In the early planning stages of the project, Sharlene Weiss, PhD, then with the National Center for Nursing Research, and Susan Czajkowski, PhD, and Carolyn Murdaugh, PhD, of the National Heart, Lung and Blood Institute, pushed for the inclusion of psychosocial and cognitive measures in the study.

What Is the Role of Psychology in WHI?

Dr. Chesney cites three main areas where psychology has been influential in the study design. 'The first is adherence; the study involves long-term behavioral change in terms of diet and medication adherence in the estrogen-replacement arm of the study.'

'Second, the study assesses psychosocial status and quality of life. The domains assessed include depression, cognitive functioning, emotional functioning, perception of health and well-being, social functioning, life events, hostility, and loneliness.

'The third main area deals with behavioral treatments involving diet and exercise. We will have unbelievable data on eating patterns when this study is completed.'

Given the role that psychology is playing in the study, Jacques Rossouw, MD, Project Officer for WHI, and others at NIH thought it important to have a psychologist on both the DSMB and WHIPAC. But for Dr. Chesney to be the one member of both bodies with dual roles is probably a testament to the skills she brings as a scientist and as a communicator.

Dr. Chesney is Professor of Epidemiology and Behavioral Medicine at the University of California, San Francisco. She is a past president of the APA Division of Health Psychology and serves on the Executive Committees of that division, the Society of Behavioral Medicine, and the American Psychosomatic Society. She was the only behavioral scientist represented on the Vaccine Working Group, which advises the Director of the National Institute of Allergy and Infectious Diseases. She is also the current chair of the HIV Prevention Research Consortium at the National Institute of Mental Health.

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