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  • Title: The evaluation of the data collection process for a multicenter, population-based, case-control design.
    Author: Wingo PA, Ory HW, Layde PM, Lee NC.
    Journal: Am J Epidemiol; 1988 Jul; 128(1):206-17. PubMed ID: 3381827.
    Abstract:
    This report details the methods the authors used to conduct the Cancer and Steroid Hormone Study, a multicenter, population-based, case-control study of oral contraceptive use in relation to breast, endometrial, and ovarian cancer diagnosed during 1980-1982. The authors have documented their methods and rationale, and the results of their data collection efforts as a practical guide for the planning and conduct of large case-control studies. They observed the following: 1) the Surveillance, Epidemiology, and End Results program is a useful epidemiologic resource for identifying cases from which to evaluate risk factors for cancer in the United States; 2) random digit dialing is an effective and efficient method for screening for eligible controls for a population-based study; 3) with the cooperation of community pathologists, histologic specimen slides can be retrieved and reviewed for diagnostic confirmation and histologic subclassification of cancer for greater than 95% of the cases interviewed; and 4) data reported during personal interviews of study participants can be validated by reviewing medical records for more than 75% of study participants who reported medical events that occurred during the 10 years before the beginning of the study. This study, a detailed report of the methods used to conduct the Cancer and Steroid Hormone study, is presented in order to aid other researchers in designing and carrying out multicenter case-control studies. Data collection for the study was carried out by the Division of Reproductive Health of the Centers for Disease Control in 8 locations: Atlanta, Detroit, San Francisco, Seattle, Connecticut, Iowa, New Mexico, and Utah. Case ascertainment, interviewing, and retrieval of pathology slides and medical records were carried out by the Surveillance, Epidemiology, and End Results centers of the National Cancer Institute. Cases were women, aged 20-54, newly diagnosed for breast, ovarian or endometrial cancer between December 1, 1980, and December 31, 1982 -- 20 years after the 1st sales of oral contraceptives in the US. Controls were women aged 20-54, selected by random digit dialing of households with telephones. 1 control was selected for each breast cancer case of matching age and geographic location. Interviewers were trained and administered standardized questionnaires to determine medical, reproductive, and oral contraceptive use histories. To aid in accuracy of recall, respondents recorded dates of major life events in a women's health study calendar. They were also given color photographs of all oral contraceptives marketed in the US. Field personnel collected slides of ovarian and endometrial cancers. Slides of benign breast lesions reported by both cases and controls were collected, as were medical records of women who reported diagnoses of infertility or loss of one or both ovaries. 80% of the breast cancer cases, 70% of the ovarian, and 74% of the endometrial cancer cases were interviewed, as were 83% of the controls. Only 2%, 7%, and 6% of the interviews for the breast, ovarian, and endometrial cancers respectively failed to match the Surveillance, Epidemiology, and End Results data. Retrieval for expert review of the pathology slides of recently diagnosed ovarian or endometrial cancer was 97% and 95%. Retrieval of pathologic proof of benign breast disease, infertility diagnoses, and ovary removal was high for the period after 1970 but low for conditions reported to have occurred before 1950. The study concludes that Surveillance, Epidemiology, and End Results tumor registry records are an excellent source for cancer epidemiology data; that random digit dialing is an effective source of controls; that histologic specimen slides can be retrieved to confirm over 95% of cancer cases interviewed; and that data reported during interviews can be substantiated by medical records for over 75% of study participants.
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