Critical evaluation of medical, statistical, and occupational data sourcesin the Kola Peninsula of Russia pertinent to reproductive health studies

Background: The feasibility study described herein was prompted by a report in 1992 of possible reproductive and developmental health concerns among f emale workers in a Russian nickel refinery. Objective: The primary goal was to ascertain whether medical, statistical, and occupational data bases cou ld be accessed for information about the pregnancy histories, occupational histories, and life-style factors of the women affected. Methods: The proje ct was facilitated by construction of a registry of all births in three tow ns with a nickel refinery and verification of its contents against patients ' records obtained from hospital delivery and gynecology departments and co mmunity polyclinics. Municipal Registration Board, Regional Health Statisti cs Board, and nickel company records were also reviewed. Results: Reproduct ive/developmental outcome information and workplace histories were acceptab le. Sample-size calculations indicated that a cohort or cross-sectional stu dy would be amenable and suitable for the detection of an excess risk for s pontaneous abortion with adequate statistical significance and power. Such investigations would need to be supplemented by workplace environmental/bio logical monitoring assessments for evaluation of exposure to occupational h azardous factors and a worker's questionnaire to obtain information about l ife-style factors. A case-control design is recommended for the study of co ngenital defects. Conclusions: A well-designed, comprehensive epidemiology study is technically feasible because of the availability of a favorable po ol of study subjects, reproductive/developmental outcome data, information to control for major confounders, and suitable occupational records.