Validity of a minimally invasive autopsy for cause of death determination in stillborn babies and neonates in Mozambique: An observational study

PLoS Med. 2017 Jun 20;14(6):e1002318. doi: 10.1371/journal.pmed.1002318. eCollection 2017 Jun.

Abstract

Background: Over 5 million stillbirths and neonatal deaths occur annually. Limited and imprecise information on the cause of these deaths hampers progress in achieving global health targets. Complete diagnostic autopsies (CDAs)-the gold standard for cause of death determination-are difficult to perform in most high-burden settings. Therefore, validation of simpler and more feasible methods is needed.

Methods and findings: In this observational study, the validity of a minimally invasive autopsy (MIA) method in determining the cause of death was assessed in 18 stillbirths and 41 neonatal deaths by comparing the results of the MIA with those of the CDA. Concordance between the categories of diseases obtained by the 2 methods was assessed by the Kappa statistic, and the sensitivity, specificity, positive, and negative predictive values of the MIA diagnoses were calculated. A cause of death was identified in 16/18 (89%) and 15/18 (83%) stillborn babies in the CDA and the MIA, respectively. Fetal growth restriction accounted for 39%, infectious diseases for 22%, intrapartum hypoxia for 17%, and intrauterine hypoxia for 11% of stillborn babies. Overall, the MIA showed in this group a substantial concordance with the CDA (Kappa = 0.78, 95% CI [0.56-0.99]). A cause of death was identified in all (100%) and 35/41 (85%) neonatal deaths in the CDA and the MIA, respectively. In this group, the majority of deaths were due to infectious diseases (66%). The overall concordance of the MIA with the CDA in neonates was moderate (Kappa = 0.40, 95% CI [0.18-0.63]). A high percentage of accuracy was observed for the MIA in all the diagnostic categories in both stillbirths and neonates (>75%). The main limitation of this study is that some degree of subjective interpretation is inherent to cause-of-death attribution in both the MIA and the CDA; this is especially so in stillbirths and in relation to fetal growth restriction.

Conclusions: The MIA could be a useful tool for cause-of-death determination in stillbirths and neonatal deaths. These findings may help to accelerate progress towards meeting global health targets by obtaining more accurate information on the causes of death in these age groups, which is essential in guiding the design of new interventions and increasing the effectiveness of those already implemented.

Publication types

  • Observational Study
  • Validation Study

MeSH terms

  • Autopsy / instrumentation
  • Autopsy / methods*
  • Autopsy / standards
  • Cause of Death*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Mozambique
  • Sensitivity and Specificity
  • Stillbirth*

Grants and funding

The CaDMIA research project (Validation of the minimally invasive autopsy tool for cause of death investigation in developing countries) was funded by the Bill & Melinda Gates Foundation (Global Health grant numbers OPP1067522; QB) (http://www.gatesfoundation.org/) and by the Spanish Instituto de Salud Carlos III (FIS, PI12/00757; CM) (https://portalfis.isciii.es). Data analysis has been supported by the CaDMIA plus research project, funded by the Bill & Melinda Gates Foundation (Global health grant numbers OPP1128001; JO) (http://www.gatesfoundation.org/) and the Spanish Instituto de Salud Carlos III (Acciones CIBER; CM) (http://www.ciberisciii.es/). ISGlobal is a member of the CERCA Programme, Generalitat de Catalunya (http://cerca.cat/en/suma/). No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.