ArticleClinical trials (London, England)2025
Adjudication of cause of death in older adults: Learnings for death certification from the ASPirin in Reducing Events in the Elderly study.
Article in Clinical trials (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDeath certificates are a legal requirement for a body to be buried or cremated. Many randomised clinical trials utilise disease-specific causes of death as key outcomes informed by these documents. Determination of cause of death is commonly assigned to an adjudication committee, a time- and resource-intensive process which becomes more difficult in trials of older individuals. We sought to assess whether a simple transcription from a death certificate would be adequate to meet trial requirements and whether the certification process itself can be improved to meet public health and research requirements.
methodsRandom audit of 100 death certificates from ASpirin in Reducing Endpoints in the Elderly, a randomised controlled trial conducted in Australian general practice and US community research centres. Participants were Australians (aged 70+ years) and Americans (65+) living in the community and without life-limiting medical conditions at baseline, recruited between 1 March 2010 and 31 December 2014 for the ASpirin in Reducing Endpoints in the Elderly trial. Outcome of interest was misclassification of death rate.
resultsThere were 2757 deaths in the 19,114 study population. In a random sample of 100 of these deaths, misclassification of cause of death was identified through the trial adjudication process in 9% of death certificates.
conclusionIn trials without the resources of ASpirin in Reducing Endpoints in the Elderly, a coding method can be accepted. Based on our experience, we recommend changes to the structure and process of death certification to better serve both clinical research and public health needs, particularly in older, multimorbid populations.
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