4.7 Article

Methodology to Determine Cause of Death for Stillbirths and Neonatal Deaths Using Automated Case Reports and a Cause-of-Death Panel

Journal

CLINICAL INFECTIOUS DISEASES
Volume 73, Issue -, Pages S368-S373

Publisher

OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciab811

Keywords

cause-of-death determination; data management; minimally invasive tissue sampling (MITS); neonatal mortality; stillbirths

Funding

  1. PURPOSe study - Bill and Melinda Gates Foundation [OPP1169824]
  2. Bill and Melinda Gates Foundation [OPP1169824] Funding Source: Bill and Melinda Gates Foundation

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The Project to Understand and Research Preterms and Stillbirths in South Asia (PURPOSe) study utilizes review panels to determine causes of death in LMICs, with computerized case reports averaging 2 to 3 pages and 6 to 8 cases reviewed per 1-hour meeting, reducing bias across panelists and meetings.
Background: Review of data from multiple sources is often necessary to determine cause of death for stillbirths and neonatal deaths, especially in low- to middle-income countries (LMICs) where available data may vary. The minimally invasive tissue sampling (MITS) procedure provides granular histologic and microbiologic data that clinical reports and verbal autopsies cannot provide. Expert panel evaluation of data from individual deaths can be resource-intensive but remains essential to accurately infer causes of death. Methods: The Project to Understand and Research Preterms and Stillbirths in South Asia (PURPOSe) study uses review panels to evaluate causes of death in 2 LMICs. To make the process manageable, a subset of the study variables was selected with professional input and organized into case reports. Case reports include clinical information, laboratory results, fetal or neonatal organ histology and polymerase chain reaction results from tissue obtained by MITS. Panelists evaluated the complete case report forms and then determined the cause of death based on available data. Results: Computerized case reports averaged 2 to 3 pages. Approximately 6 to 8 cases were reviewed and discussed per 1-hour panel meeting. All panelists were provided the same information; missing data were noted. This limited bias between panelists and across meetings. Study teams notably took ownership of data quality. Conclusions: Standardized case reports for cause-of-death determination panel evaluation improve the efficiency of the review process, clarify available information, and limit bias across panelists, time, and location.

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