Diagnostic accuracy of point-of-care testing (POCT) devices for postpartum haemorrhage: A protocol of a systematic review and meta-analysis

Abstract

ABSTRACTIntroductionIn postpartum haemorrhage (PPH), coagulation factors, mainly fibrinogen, are exhausted early during the course of the disease, which can easily lead to disseminated intravascular coagulation (DIC) and cause maternal mortality. Although some studies have reported the efficacy of point-of-care testing (POCT) devices in detecting hypofibrinogenaemia, little research has been conducted on their usefulness in the diagnosis of PPH. We plan to perform a systematic review of the diagnostic accuracy of existing POCT devices for the diagnosis of hypofibrinogenaemia in PPH.Methods and analysisWe plan to identify studies using POCT devices for PPH and perform a systematic review and meta-analysis of their accuracy of diagnosing hypofibrinogenaemia. The results of fibrinogen measurements using the conventional Clauss method are used as reference standards. Literature searches will be conducted using electronic databases (MEDLINE, Embase, Cochrane Database, and Web of Science), and two reviewers will screen independently from the search results. The eligible literature will be used to synthesise true positive, false positive, true negative, and false negative results for the diagnosis of hypofibrinogenaemia. We will estimate the diagnostic accuracy of POCT devices for diagnosing hypofibrinogenaemia in patients with PPH using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve.Ethics and disseminationThis systematic review will be conducted through the secondary use of literature extracted from electronic databases. There are no ethical issues associated with this research. The final integrated results will be submitted to a peer-reviewed journal.Protocol registrationThe study protocol was registered with University Hospital Medical Information Network Clinical Trials (UMIN000048272) and PROSPERO (CRD42023394785).Strengths and limitations of the studyStudies on the usefulness of POCT devices in the diagnosis of PPH are limited. Our study will perform a systematic review of the diagnostic accuracy of existing POCT devices for the diagnosis of hypofibrinogenaemia in PPH.The study will estimate the diagnostic accuracy of POCT devices using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve.The threshold for diagnosing hypofibrinogenaemia, the definition of PPH, and the POCT devices used may vary between studies and could be a potential source of heterogeneity. Since most primary studies are observational, it is expected that many unpublished studies will exist.The applicability of the study results may be limited since this systematic review only pertains to the use of POCT devices in pregnant patients with PPH. The number of studies may be limited since there is a wide variety of POCT devices used in PPH.