Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding

[...]in some instances, pre-specified criteria were inconsistent with what was done in the review (e.g., the investigators' bleeding definition attempted to assign a severity, while the review defined overt or clinically overt bleeding as any sign of bleeding, including if only seen on imaging)...

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Bibliographic Details
Published inJournal of the American College of Cardiology Vol. 67; no. 5; pp. 596 - 598
Main Authors Jatene, Tannas, MD, Harrington, Robert A., MD, Stone, Gregg W., MD, Steg, Ph. Gabriel, MD, Gibson, C. Michael, MS, MD, Hamm, Christian W., MD, Price, Matthew J., MD, Prats, Jayne, PhD, Deliargyris, Efthymios N., MD, Mahaffey, Kenneth W., MD, White, Harvey D., DSc, Bhatt, Deepak L., MD, MPH
Format Journal Article
LanguageEnglish
Published New York Elsevier Limited 09.02.2016
Subjects
Acute coronary syndromes
Cardiology
Cardiovascular
Clinical trials
Confidence intervals
Coronary vessels
Heart attacks
Internal Medicine
Laboratories
United States > US
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Summary:[...]in some instances, pre-specified criteria were inconsistent with what was done in the review (e.g., the investigators' bleeding definition attempted to assign a severity, while the review defined overt or clinically overt bleeding as any sign of bleeding, including if only seen on imaging).
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2015.11.027