Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review

Noémie Kraaijpoel, Tobias Tritschler, Enora Guillo, Philippe Girard, Grégoire Le Gal, Noémie Kraaijpoel, Tobias Tritschler, Enora Guillo, Philippe Girard, Grégoire Le Gal

Abstract

Background: Pulmonary embolism (PE)-related death is a component of the primary outcome in many venous thromboembolism (VTE) studies. The absence of a standardized definition for PE-related death hampers study outcome evaluation and between-study comparisons.

Objectives: To summarize definitions for PE-related death used in recent VTE studies and to assess the PE-related death rate.

Patients/methods: A systematic literature search was conducted on 26 April 2018 from 1 January 2014 up to the search date in MEDLINE, Embase, and CENTRAL. Cohort studies and randomized trials in which PE-related death was included in the primary outcome were eligible. Screening of titles, abstracts, and full-text articles, and data extraction were independently performed in duplicate by two authors. Study outcomes included the definition for PE-related death, VTE case-fatality rate, and death due to PE rate. Descriptive statistics were used to analyze the data.

Results: Of the 6807 identified citations, 83 studies were included of which 27% were randomized trials, 31% were prospective, and 42% retrospective cohort studies. Thirty-five studies (42%) had a central adjudication committee. Thirty-eight (46%) reported a definition for PE-related death of which the most frequently used components were "autopsy-confirmed PE" (50%), "objectively confirmed PE before death" (55%), and "unexplained death" (58%). Median VTE case-fatality rate was 1.8% (interquartile range, 0.0-13).

Conclusions: Only half of the included studies reported definitions for PE-related death, which were very heterogeneous. Case-fatality rate of VTE events varied widely across studies. Standardization of the definition and guidance on adjudication and reporting of PE-related death is needed.

Keywords: cause of death; mortality; outcome assessment (health care); pulmonary embolism; venous thromboembolism.

© 2019 Amsterdam University Medical Center, AMC. Journal of Thrombosis and Haemostasis © 2019 International Society on Thrombosis and Haemostasis.

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