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Brief Report |
Health System Responses to the Women's Health Initiative Findings on Estrogen and Progestin: Organizational Response
Affiliations of authors: Kaiser Permanente, Denver, CO (CLH); Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School and Menopause Consultation Service, Harvard Vanguard Medical Associates, Cambridge, MA (MTC); Center for Health Studies, Group Health Cooperative, Seattle, WA (KMN, DSMB); University of Washington, School of Public Health and Community Medicine, Seattle, WA (KMN, DSMB); Meyers Primary Care Institute, Worcester, MA (SEA); HealthPartners Research Foundation, Minneapolis, MN (FW)
Correspondence to: Cynthia Hartsfield, PhD, Kaiser Permanente of Colorado, P.O. Box 378066, Denver, CO 80237 (e-mail: cynthia.hartsfield{at}kp.org).
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Recent randomized trials have indicated that the risks of hormone therapy for menopausal women may outweigh the benefits. The purpose of this study was to describe how health plans responded to the findings of the Women's Health Initiative (WHI) estrogen plus progestin trial. We surveyed five health plans affiliated with the HMO Research Network and the Cancer Research Network to document the response of each plan to the WHI in terms of patient and provider education and guidelines. Every health plan issued responses within 3 months of WHI's termination in a variety of formats. Recommendations were relatively consistent across the organizations. Given the documented changes in hormone therapy use in these five health plans in the post-WHI era, we conclude that attempts on the part of each organization to educate patients and providers about the implications of the WHI may have contributed to the observed changes in hormone therapy use.
Past observational studies have supported the use of hormone therapy (HT) to reduce vasomotor symptoms, urogenital atrophy, osteoporosis, colon cancer, dementia and coronary heart disease (1–12). As a result of these observational studies, previous general clinical consensus, supported by multiple specialty society recommendations, held that expected benefits of HT outweighed the known associated risks (13–14). However, more recent randomized trials assessing HT safety and efficacy have dramatically changed recommendations regarding the use of HT. Studies such as the Heart and Estrogen/Progestin Replacement Study (HERS), the follow-up HERS II, and the Women's Health Initiative (WHI) have highlighted the lack of benefit for long-term prevention of disease when evaluated in light of the unacceptable risk profile (15–17).
In May 2002, the WHI Data and Safety Monitoring Board stopped the estrogen and progestin therapy (EPT) trial 2 years early on the basis of evidence of excess risk of invasive breast cancer, coronary heart disease, stroke, venous thromboembolism, and pulmonary embolism in women receiving treatment versus placebo (17). These results were released to the public in July 2002, and the effect on HT use was swift and substantive. Buist et al. reported that the annualized rate of EPT discontinuation jumped from 2.5% to 13.8%—a 4.5-fold increase—by October 2002 (18). In addition to stopping current therapy, women were half as likely to start EPT during that time period (18).
Although HT use changed dramatically after the publication of the WHI results, it is unclear how WHI data affected physician directed HT recommendations and guidelines and what factors affected women's likelihood to discontinue therapy. In this investigation we collected and reviewed health plan guidelines and educational materials published before and after the release of WHI's EPT trial results, as well as internal communications released in response to the public dissemination of those results, from five health maintenance organizations (HMOs): Group Health Cooperative, Seattle, WA; Harvard Pilgrim Health Care, Boston MA; Fallon Community Health Plan, Worcester, MA; Kaiser Permanente Colorado, Denver CO; and HealthPartners, Minneapolis, MN. Data sharing agreements prevent us from linking HMO names to presented data.
We found that all communications, guidelines, and educational materials distributed by the HMOs after the release of the WHI EPT results encompassed part or all of the American College of Obstetricians and Gynecologists recommendations, including that EPT therapy should not be used for prevention of diseases such as cardiovascular disease, because of the small but significant increased risk of conditions such as breast cancer, heart attack, and thrombosis; hormone therapies are appropriate for the relief of vasomotor symptoms, so long as a woman has weighed the risks and benefits with her doctor; and women who use EPT or ET should take the smallest effective dose for the shortest possible time and annually review the decision to take hormones (19).
Table 1 outlines the types of information distributed by the five health plans and highlights the major points of the various recommendations. Every health plan released some form of communication, educational material, or guideline within 3 months of the release of WHI EPT trial results. Although reviewed materials were mainly directed toward physicians, pharmacists, and other clinical personnel, additional information was also made available to patients through a variety of sources such as Web sites, which sometimes included links to other relevant sites, phone hotlines, pamphlets, and guidebooks (Table 2). Consistent with the new recommendations, the follow-up EPT discontinuation rate across the HMOs was higher among women identified with cardiovascular disease compared to women with no comorbidity (20). In addition, the relative risk for EPT discontinuation was significantly higher among women with known diabetes, but not among women with known fractures compared to women with no comorbidity (20).
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All organizations used a team approach for information collection and document preparation. Members of these teams varied by HMO but were pulled from the following divisions/departments: Clinical Improvement and Education, Drug Information, Drug Utilization, Endocrinology, Family Practice, Health Education, Internal Medicine, Obstetrics/Gynecology, Medical Informatics, Medical Education, Patient Representation, Preventive Medicine, and Women's Health Care. All documents were published as informational only and were not intended to substitute for independent clinical judgment by providers but, rather, to be used as a resource.
Connelly et al. has shown that provider opinion is the leading influence in a woman's decision about HT followed closely by reports in the media (21). Similarly, Ettinger et al. reported most women (93%) had heard about the WHI findings. However, only 57% considered the quality of the information to be good, regardless of the source: media, health plan, or health care practitioner (22). The widespread media attention of the WHI EPT trial results very likely affected the decision of many women to stop EPT. However, what effect individual health plan responses had on a physician or patient's decision to discontinue or not initiate EPT remains unclear. This report illustrates despite the variation in the types of material distributed to physicians and other clinical personnel, the overall decrease in EPT use was remarkably similar across the different HMOs (data not shown). Given the timeliness and consistency in therapeutic recommendations across all sites, these data indicate that provider opinions, potentially informed to some degree by health plan guideline and educational materials, may have played a role in decision making. They also indicate that timeliness of information is important, irrespective of information format.
In conclusion, almost immediately following the release of the WHI EPT trial results, there was a significant decline in EPT use among women (18,20,22–25). Although many studies reported on the changes of HT use among women, there is a paucity of information concerning the response of health plans to the release of these data. This report highlights that all HMOs surveyed reacted quickly by circulating updated materials relating to HT. These data indicate that administrators at the various HMOs were responsive in providing the most current evidence-based information as quickly as possible, although it remains unclear whether these HT recommendations influence physician or patient decision making. Further studies will be necessary to assess the long-term effect of institutional educational material and guidelines on prescribing patterns.
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NOTES |
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This study was funded by a cooperative agreement from the National Cancer Institute (U19-CA-79689–05). This study was conducted with-in the Cancer Research Network, a consortium of research organizations affiliated with non-profit integrated healthcare delivery systems and the National Cancer Institute. Dr. Buist's time was supported in part by a grant from the American Cancer Society (CRTG-03–024–01-CCE).
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