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

Abstract

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.

The causes of preterm neonatal deaths in India and Pakistan (PURPOSe): a prospective cohort study

“…The panelists determined the primary maternal, placental, and neonatal causes of death and the contributing causes using standard procedures described in detail elsewhere. 15 , 16 These panels comprised obstetricians, paediatricians, pathologists, microbiologists, and other clinicians.…”

Birth asphyxia is under‐rated as a cause of preterm neonatal mortality in low‐ and middle‐income countries: A prospective, observational study from PURPOSe

“…There have been recent advances to improve the ascertainment of causes of preterm neonatal death. First, more complete, accurate data, generally in a standardised format, have been encouraged for COD examinations 20,21 . Also, minimally invasive tissue sampling (MITS) to evaluate various organs, especially the lung, for histology and organism identification has enabled investigators to better assess infectious COD 22–24 .…”

“…First, more complete, accurate data, generally in a standardised format, have been encouraged for COD examinations. 20,21 Also, minimally invasive tissue sampling (MITS) to evaluate various organs, especially the lung, for histology and organism identification has enabled investigators to better assess infectious COD. [22][23][24] Finally, placental histology, including assessment of placental malperfusion and inflammation, are now more widely available.…”

The causes of stillbirths in south Asia: results from a prospective study in India and Pakistan (PURPOSe)

“…For each stillbirth, the primary maternal, placental, and fetal cause of death, as well as the contributing causes, were identified by a panel of experts using standard procedures. 15 , 21 The expert panel approach was used to provide a standardised approach to cause-of-death determination. The expert panels, which were established for each site, comprised obstetricians, paediatricians, pathologists, microbiologists, and other clinicians.…”

“…Case reports included a brief clinical description of the case and all positive clinical maternal, fetal, and placental findings, and results of the PCR bacteriological investigation and MITS histology. 21 Additionally, reference measures, including the tenth percentile for gestational age based on the INTERGROWTH-21st criteria 22 and mean placental weight for gestational age were presented in a standardised data report. Each pair of panellists met to discuss their findings, with any discrepancies resolved through discussion with a third panel member.…”