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Analysis of the bovine spongiform encephalopathy maternal cohort study, revisited

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The bovine spongiform encephalopathy (BSE) maternal cohort study provided robust evidence of an enhanced risk of developing BSE for offspring of BSE-affected dams. We present for the first time, but in retrospect, an interim analysis of the BSE maternal cohort study and set it in historical context, some of which has only been revealed through the BSE inquiry. We also consider the implications for design of extending the BSE maternal cohort study once an enhanced risk to exposed calves had been established, to assess the risk to calves born further from the clinical onset of BSE in the dam than those in the original study. We demonstrate that, if a data monitoring committee had been established, conclusions similar to those based on the final results could have been drawn several years before the completion of the BSE maternal cohort study. Further, we conclude that an extension of the cohort study is unlikely to have been commissioned because of the substantial financial investment required, yet low power, and practical difficulties associated with implementation of any worthwhile extension.

Keywords: Bovine spongiform encephalopathy; Cohort study; Interim analysis; Maternal transmission

Document Type: Original Article


Affiliations: Medical Research Council Biostatistics Unit, Cambridge, UK

Publication date: January 1, 2001


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