Literature DB >> 31301689

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

Noémie Kraaijpoel1, Tobias Tritschler2,3, Enora Guillo2, Philippe Girard4,5, Grégoire Le Gal2,6.   

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

Entities:  

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

Year:  2019        PMID: 31301689     DOI: 10.1111/jth.14570

Source DB:  PubMed          Journal:  J Thromb Haemost        ISSN: 1538-7836            Impact factor:   5.824


  6 in total

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2.  Pulmonary Thromboembolism in Immune Thrombocytopenia: A Report of Five Cases and a Review of the Literature.

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Journal:  Int J Gen Med       Date:  2021-08-13

Review 3.  A mapping review of sacrococcygeal pilonidal sinus disease.

Authors:  M Kumar; W H Clay; M J Lee; S R Brown; D Hind
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4.  Protocol for a scoping review of outcomes in clinical studies of interventions for venous thromboembolism in adults.

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5.  Computed Tomography Pulmonary Perfusion for Prediction of Short-Term Clinical Outcome in Acute Pulmonary Embolism.

Authors:  Lisette F van Dam; Lucia J M Kroft; Menno V Huisman; Maarten K Ninaber; Frederikus A Klok
Journal:  TH Open       Date:  2021-02-10

6.  Age-sex specific pulmonary embolism-related mortality in the USA and Canada, 2000-18: an analysis of the WHO Mortality Database and of the CDC Multiple Cause of Death database.

Authors:  Stefano Barco; Luca Valerio; Walter Ageno; Alexander T Cohen; Samuel Z Goldhaber; Beverley J Hunt; Alfonso Iorio; David Jimenez; Frederikus A Klok; Nils Kucher; Seyed Hamidreza Mahmoudpour; Saskia Middeldorp; Thomas Münzel; Vicky Tagalakis; Aaron M Wendelboe; Stavros V Konstantinides
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  6 in total

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