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Developing Guidelines for Prophylactic Oophorectomy: Analysis of 28 years of Epidemiologic Data from the Nurses' Health Study  

Our study has had a significant impact and has opened up a debate in both residency training programs and among practicing gynecologists. In that our study used a combination of selected papers on different disease entities, there is still considerable debate and further information on this important issue is now of critical importance. The Nurses' Health Study database is a well- respected source of data and would allow for the same type of analysis to be conducted using real patient numbers from a single study population.

After our study was published, we contacted Dr. Graham Colditz, head of investigators for the Nurses' Health Study at Harvard Medical School and their group is interested in pursuing this study design with us.

SPECIFIC PROPOSAL

This proposal is a request for seed-money to pay for access to the existing Nurses' Health Study data set to perform the same analysis that was done in our study Ovarian Conservation at the Time of Hysterectomy for Benign Disease. This new analysis would serve as a distinct, new look at this important issue and provide the best information to date to allow women to make this important decision. The objective of the authors to publish a second paper (and possibly others) generated from this new data and that we will be able to establish better guidelines for clinicians and their patients regarding the decision about whether to have or not have a prophylactic oophorectomy at the time of hysterectomy for benign disease.

We are able to access the NHS database at a cost of $25,000. Additional expenses would include transportation to Boston to access the database and salary for a biostatistician for 2 months. None of the study authors are to receive compensation for their work. Total expenses will be approximately $40,000.

The Nurses' Health Study was established in 1976 and it remains one of the largest and longstanding prospective investigations into the risk factors for major chronic diseases in women in the U.S. Approximately 122,000 female registered nurses, ages 30 to 55 in 1976, who were living in the 11 most populous states were enrolled. Every two years cohort members receive a follow-up questionnaire with questions about diseases and health-related topics including smoking, hormone use and menopausal status. The response rates to the questionnaires are 90% for each two-year cycle. This data-base has generated over 600 peer review papers on a variety of issues related to women's health including risk for future cardiovascular disease, hormone therapy and the risk of coronary events or breast cancer, and oral contraceptives and breast cancer risk. For our purposes, this unique population of women with similar educational and socio-economic backgrounds, and well-documented health outcomes, can provide long-term data not presently available elsewhere.

  1. www.channing.harvard.edu/nhs/
  2. Solomon CG, Hu FB, Dunaif A, Rich-Edwards JE, Stampfer MJ, Willett WC, Speizer FE, Manson JE. Menstrual cycle irregularity and risk for future cardiovascular disease. J Clin Endocrinol Metab 2002;87(5):2013-7
  3. Grodstein F, Manson JE, Stampfer MJ. Postmenopausal hormone use and secondary prevention of coronary events in the Nurses' Health Study. A prospective, observational study. Ann Intern Med 2001;135(1):1-8
  4. Colditz GA, Stampfer MJ, Willett WC, Hennekens CH, Rosner B, Speizer FE. Prospective study of estrogen replacement therapy and risk of breast cancer in women. JAMA 1990;264:2648-2653
  5. Stampfer MJ, Willett WC, Colditz GA, Speizer FE, Hennekens CH. A prospective study of past use of oral contraceptives and risk of cardiovascular diseases. N Engl J Med 1988;319:1313-7

 

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