Overview of the reanalysis of the Harvard Six Cities Study and American Cancer Society Study of Particulate Air Pollution and Mortality.

This article provides an overview of the Reanalysis Study of the Harvard Six Cities and the American Cancer Society (ACS) studies of particulate air pollution and mortality. The previous findings of the studies have been subject to debate. In response, a reanalysis team, comprised of Canadian and American researchers, was invited to participate in an independent reanalysis project to address the concerns. Phase I of the reanalysis involved the design of data audits to determine whether each study conformed to the consistency and accuracy of their data. Phase II of the reanalysis involved conducting a series of comprehensive analyses using alternative statistical methods. Alternative models were also used to identify covariates that may confound or modify the association of particulate air pollution as well as identify sensitive population subgroups. The audit demonstrated that the data in the original analyses were of high quality, as were the risk estimates reported by the original investigators. The sensitivity analysis illustrated that the mortality risk estimates reported in both studies were found to be robust against alternative Cox models. Detailed investigation of the covariate effects found a significant modifying effect of education and a relative risk of mortality associated with fine particles and declining education levels. The study team applied spatial analytic methods to the ACS data, resulting in various levels of spatial autocorrelations supporting the reported association for fine particles mortality of the original investigators as well as demonstrating a significant association between sulfur dioxide and mortality. Collectively, our reanalysis suggest that mortality may be attributable to more than one component of the complex mixture of ambient air pollutants for U.S. urban areas.

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.