Background: The feasibility study described herein was prompted by a report in 1992 of possible reproductive and developmental health concerns among female workers in a Russian nickel refinery.
Objective: The primary goal was to ascertain whether medical, statistical, and occupational data bases could be accessed for information about the pregnancy histories, occupational histories, and life-style factors of the women affected.
Methods: The project was facilitated by construction of a registry of all births in three towns with a nickel refinery and verification of its contents against patients' records obtained from hospital delivery and gynecology departments and community polyclinics. Municipal Registration Board, Regional Health Statistics Board, and nickel company records were also reviewed.
Results: Reproductive/developmental outcome information and workplace histories were acceptable. Sample-size calculations indicated that a cohort or cross-sectional study would be amenable and suitable for the detection of an excess risk for spontaneous abortion with adequate statistical significance and power. Such investigations would need to be supplemented by workplace environmental/biological monitoring assessments for evaluation of exposure to occupational hazardous factors and a worker's questionnaire to obtain information about life-style factors. A case-control design is recommended for the study of congenital defects.
Conclusions: A well-designed, comprehensive epidemiology study is technically feasible because of the availability of a favorable pool of study subjects, reproductive/developmental outcome data, information to control for major confounders, and suitable occupational records.