TY - JOUR
T1 - Definitions, adjudication, and reporting of pulmonary embolism–related death in clinical studies: A systematic review
AU - Kraaijpoel, Noémie
AU - Tritschler, Tobias
AU - Guillo, Enora
AU - Girard, Philippe
AU - le Gal, Grégoire
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85070074528&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31301689
U2 - https://doi.org/10.1111/jth.14570
DO - https://doi.org/10.1111/jth.14570
M3 - Review article
C2 - 31301689
SN - 1538-7933
VL - 17
SP - 1590
EP - 1607
JO - Journal of thrombosis and haemostasis
JF - Journal of thrombosis and haemostasis
IS - 10
ER -