Retrospective data quality audits of the Harvard Six Cities and American Cancer Society studies

The Harvard Six Cities (6-Cities) and American Cancer Society (ACS) studies are longitudinal cohort mortality studies of large populations that provided important information about the human health effects associated with long-term exposure to fine particulate air pollution. Possible changes to federal regulation of particulates prompted a review of data collection methods, analysis, and reported results from these two studies. This article describes the methodology used to conduct quality assurance audits of both studies and summarizes the audit findings. Statistically based, randomly selected samples of 250 health questionnaires and 250 death certificates from each study were audited against data from analysis files. In cases where study-specific data could not be located, validation was performed using information and data from other sources. Some errors were found in programming and data transformation in both studies, but none affected the results of the original investigations. Both audits confirmed that the published studies are an accurate representation of the collected data. The audits also underscored the importance of adequate attention to documentation and record-keeping practices during the conduct of all studies and proper archiving at their conclusion.