Diagnostic accuracy of a simplified minimally invasive tissue sampling protocol for stillbirths in low-resource settings

Résumé fourni par la source

Background Stillbirth rates remain unacceptably high in low- and middle-income countries (LMICs). Understanding the causes of death (CoD) is mandatory to develop effective strategies to reduce this high mortality. Minimally invasive tissue sampling (MITS) is a promising alternative to conventional autopsy (CA) but its validation in stillbirths remains limited. Existing evidence indicates that most samples of conventional MITS (c-MITS) lack diagnostic relevance in stillbirths. This study aimed to validate c-MITS against CA in stillbirths and design and assess a cost-efficient, simplified MITS (s-MITS) protocol. Methods The study comprised two subsets of stillbirths occurring at Maputo Central Hospital, Mozambique. The CaDMIA-Plus cohort ( Cause of Death investigation using Minimally Invasive Autopsy , n=90; 2017–2018), in which both c-MITS and CA were performed, was used to validate c-MITS against the gold standard and to determine the diagnostic value of each sample and design a s-MITS. The MIBio cohort ( Mortality Identification Biomarkers , n=98; 2021–2022), which included only s-MITS, was used to evaluate the performance and cost of the s-MITS in comparison to c-MITS in an independent cohort. Results Almost perfect overall agreement (Kappa=0.82) was observed between the c-MITS and CA-attributed CoD. Lung and placenta samples were identified as the most informative in c-MITS. When using only lung and placenta results to model an s-MITS, substantial agreement (Kappa=0.79) was found between the s-MITS-derived CoD and those attributed by CA. Similar CoD distributions were observed when applying the s-MITS to the MIBio cohort, while costs were reduced by 55.7%. The leading CoDs were primarily related to maternal conditions and pregnancy complications (70.0–72.4%) and infectious diseases (25.6–27.6%). Conclusions c-MITS is a simpler and cost-effective alternative to CA for determining CoD in stillbirths. s-MITS has a diagnostic accuracy similar to that of c-MITS, while significantly reducing costs, making it adequate for implementation in routine clinical practice in LMICs.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.