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Will Extending the Women's Health Initiative Lead to Better Research and Policy?

      In a time of scarce research dollars, securing support to sustain even highly successful research studies on women's health is difficult, if not impossible. Yet, improving women's health and health care requires data and answers to inform decisions by women, their clinicians, and policy makers (

      Bird, C. E., & Rieker, P. P. (2008). The effects of constrained choices and social policies. Gender and Health New York: Cambridge University Press. Available from: http://www.rand.org/pubs/commercial_books/CB412/.

      ,

      Women's Health Initiative. (2013, November 4). Accessed November 14, 2013, from: http://www.whi.org/.

      ,

      Women's Health Initiative. (2013, November 4). Accessed November 4, 2013 from: https://cleo.whi.org/about/SitePages/WHI%20Extension%202010_2015.aspx.

      ). Although support for women's health research has increased, knowledge gaps that impair or prevent informed decision making loom large. Simply calling on women to be their own advocates and clinicians to provide higher quality care can only get us so far. Thus women, their clinicians, and policymakers should be aware that the next extension of the Women's Health Initiative study (WHI) is up for review at a time when even very high quality studies go unfunded or face severe budget cuts.
      The WHI is an unprecedented National Institutes of Health (NIH)-sponsored study that enrolled 161,000 women ages 50 to 79 from 1993 to 1998 (available at: www.whi.org/). The original 15 years study included both a randomized clinical trial and an observational cohort study. The WHI overcame the initial expectations of many that it would prove to be an expensive validation of what was then prevailing truth regarding the benefits of hormone replacement therapy (
      • Rossouw J.E.
      • Anderson G.L.
      • Prentice R.L.
      • LaCroix A.Z.
      • Kooperberg C.
      • Stefanick M.L.
      • et al.
      Writing Group for the Women's Health Initiative Investigators
      Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative Randomized Controlled Trial FREE.
      ). Fortunately, the returns to the investment in WHI did not end there. The longitudinal follow-up of the WHI cohort has yielded hundreds of breakthrough findings on women's health and health care, including dozens of articles on the effects of estrogen and progestin on outcomes ranging from risk of cardiovascular disease to dementia, cancer, and health related quality of life (see, for example,
      • Manson J.E.
      • Chlebowski R.T.
      • Stefanick M.L.
      • Aragaki A.K.
      • Rossouw J.E.
      • et al.
      Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the WHI Randomized Trials.
      ; for a full bibliography see, www.whi.org/).
      The current extension, which focuses on cardiovascular events and aging, will follow the cohort to 2015 (available at: https://cleo.whi.org/about/SitePages/WHI%20Extension%202010-2015.aspx). It enrolled 93,500 women from the first WHI Extension Study (including both clinical trial and observational cohort study participants). This unusually large cohort allows assessments of both concurrent and earlier life social and biological predictors of health trajectories and transitions. Use of WHI is growing rapidly as an increasingly large and diverse pool of junior and senior researchers employ WHI data to assess an expanding array of women's health behavior and conditions (including mental and cognitive functioning, fractures, cancer, and quality of life) that affect older women and are influenced by factors earlier in the lifespan, many of which are documented in the existing data. However, owing to declines in the NIH budget and in funding to follow large cohorts, questions have arisen as to the potential and relative value of extending the cohort follow up from 2015 to 2020 now that the vast majority of participants have reached their late 60s or beyond and are on Medicare.
      The geographic diversity of the cohort allows assessments of modifiable and actionable contextual (environmental) factors, many of which are outside the control of individual women but are shaped by decisions and actions at the family, community, or larger levels of governance and social policy. Thus, the WHI offers a unique opportunity to assess how variations in women's lives and circumstances contribute to their health and longevity through older ages. For example, what household and community factors are associated with physical activity and exercise and can these factors can be created or supported through local policies and programs? Such work can begin to inform community best practices and programs to support healthy aging over the life course. Moreover, the generalizability of research gleaned from a large, well-studied national longitudinal cohort with exceptionally high retention cannot be matched by smaller studies, particularly in the case of policy research questions aimed beyond a particular geographic area.
      The social and economic costs of decrements to older women's health and functioning are growing rapidly as the size of older cohorts—in which women outnumber men—continues to increase. There are key policy questions we can consider with WHI data, particularly as more women are followed into older age. For example, what individual, household, and community programs and policies facilitate older women's opportunity and ability to “age in place?” Aging in place refers to the ability of older adults to continue to live in the same dwelling as they age. Doing so substantially reduces the costs of housing for many and allows them to maintain social ties and activities in their community of choice. Clearly, some individuals seek to move after or during retirement to be closer to family, specific activities, or communities that they find attractive or desirable. However, such moves are often made in response to either changes in health status and concerns or need for specific supports to address deficits in the types of resources and supports available in their current living arrangement. The WHI is unique in providing the longitudinal health data necessary to assess how health trajectories play into these decisions and whether particular health behaviors or other factors are effective in preventing declines or otherwise enabling women to continue to live in their own homes.
      Continued follow-up of the WHI cohort can help to answer questions regarding the kinds of programs, as well as medical care, that are most effective and cost effective for maintaining health and health-related quality of life. National data on such an extensive and well-documented cohort can provide researchers and funders with a unique opportunity to inform a wide range of state and federal policy decisions with potentially substantial health and economic benefits to both women and tax payers. Conversely, the opportunity costs of failing to fully fund the continued follow-up of this unique cohort may well represent an irrecoverable loss.
      In the face of sequestration, WHI is potentially at risk, not only because research dollars have become exceedingly tight, but also because the NIH lacks an Institute for Women's Health. In recent years, the Office for Minority Health was at long last promoted to the level of institute, providing an opportunity for research proposals aimed at addressing critical minority health research questions to be submitted to an institute and review panels with a full place at the table. In contrast, the Office for Women's Health remains a small and relatively poorly funded endeavor with far fewer resources to allocate to women's health research.
      To be sure, some will argue that a women's health or gender and health institute is not necessary and that women's health issues fall well within the mandates of the other NIH institutes. However, the acknowledged need for both an Office of Women's Health and an Institute of Minority Health speak to the need. Moreover, differences in men's and women's biology and in the social and biological pathways that lead to their health trajectories–including greater longevity for women–and specific health outcomes substantiate the need for more systematic evaluation of whether research findings apply similarly to women's and to men's health. Despite multiple efforts to address this issue, it continues to take a backseat to the explicit missions of the other NIH institutes.

      References

      1. Bird, C. E., & Rieker, P. P. (2008). The effects of constrained choices and social policies. Gender and Health New York: Cambridge University Press. Available from: http://www.rand.org/pubs/commercial_books/CB412/.

        • Manson J.E.
        • Chlebowski R.T.
        • Stefanick M.L.
        • Aragaki A.K.
        • Rossouw J.E.
        • et al.
        Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the WHI Randomized Trials.
        JAMA. 2013; 310: 1353-1368
        • Rossouw J.E.
        • Anderson G.L.
        • Prentice R.L.
        • LaCroix A.Z.
        • Kooperberg C.
        • Stefanick M.L.
        • et al.
        • Writing Group for the Women's Health Initiative Investigators
        Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative Randomized Controlled Trial FREE.
        JAMA. 2002; 288: 321-333
      2. Women's Health Initiative. (2013, November 4). Accessed November 14, 2013, from: http://www.whi.org/.

      3. Women's Health Initiative. (2013, November 4). Accessed November 4, 2013 from: https://cleo.whi.org/about/SitePages/WHI%20Extension%202010_2015.aspx.