TAILIEUCHUNG - Statistical Issues Arising in the Women’s Health Initiative

The health status of prisoners is generally much poorer than that of the general population, and women’s health needs can be seriously neglected in a male-dominated prison system. Many women in prison have a background of physical and sexual abuse and of alcohol and drug dependence. Many did not receive adequate health care before incarceration. Women in prison generally have more mental health problems than women in the general population. This frequently stems from prior victimization. Mental illness is often both a cause and a consequence of imprisonment and the rates of self-harm and suicide are noticeably higher among. | DOI Biometrics 61 899-941 December 2005 Statistical Issues Arising in the Women s Health Initiative Ross L. Prentice Mary Pettinger and Garnet L. Anderson Division of Public Health Sciences Fred Hutchinson Cancer Research Center . Box 19024 Seattle Washington 98109-1024 . email rprentic@ email mpetting@ email garnet@ Summary. a brief overview of the design of the Women s Health Initiative WHI clinical trial and observational study is provided along with a summary of results from the postmenopausal hormone therapy clinical trial components. Since its inception in 1992 the WHI has encountered a number of statistical issues where further methodology developments are needed. These include measurement error modeling and analysis procedures for dietary and physical activity assessment clinical trial monitoring methods when treatments may affect multiple clinical outcomes either beneficially or adversely study design and analysis procedures for high-dimensional genomic and proteomic data and failure time data analysis procedures when treatment group hazard ratios are time dependent. This final topic seems important in resolving the discrepancy between WHI clinical trial and observational study results on postmenopausal hormone therapy and cardiovascular disease. Key WORDS Chronic disease prevention Clinical trial monitoring Genome-wide scan Hazard ratio Measurement error Nutritional epidemiology Observational study Randomized controlled trial Women s health. 1. Introduction The Women s Health Initiative WHI is perhaps the most ambitious population research investigation ever undertaken. The centerpiece of the WHI program is a randomized controlled clinical trial CT to evaluate the health benefits and risks of four distinct interventions dietary modification two postmenopausal hormone therapy HT interventions and calcium vitamin D supplementation among 68 132 post-menopausal women in the age range 50-79 at .

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