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Tytuł pozycji:

Contribution of individual components to composite end points in contemporary cardiovascular randomized controlled trials.

Tytuł:
Contribution of individual components to composite end points in contemporary cardiovascular randomized controlled trials.
Autorzy:
Shaikh A; Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Ochani RK; Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Khan MS; Department of Internal Medicine, John H Stroger Jr Hospital of Cook County, Chicago, IL. Electronic address: .
Riaz H; Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH.
Khan SU; Department of Internal Medicine, Robert Packer Hospital, Sayre, PA.
Sreenivasan J; Department of Cardiovascular Medicine, Westchester Medical Center/New York Medical College, White Plains, NY.
Mookadam F; Department of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.
Doukky R; Department of Internal Medicine, John H Stroger Jr Hospital of Cook County, Chicago, IL.
Butler J; Department of Medicine, University of Mississippi, Jackson, MS.
Michos ED; Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD.
Kalra A; Division of Cardiology, Cleveland Clinic, Cleveland, OH.
Krasuski RA; Department of Cardiovascular Medicine, Duke University Health System, Durham, NC.
Źródło:
American heart journal [Am Heart J] 2020 Dec; Vol. 230, pp. 71-81. Date of Electronic Publication: 2020 Sep 15.
Typ publikacji:
Journal Article; Review
Język:
English
Imprint Name(s):
Original Publication: St. Louis, MO : Mosby
MeSH Terms:
Cardiovascular Diseases/*mortality
Randomized Controlled Trials as Topic/*statistics & numerical data
Angina Pectoris/epidemiology ; Angina Pectoris/mortality ; Cardiovascular Diseases/therapy ; Cross-Sectional Studies ; Heart Failure/epidemiology ; Heart Failure/mortality ; Hospitalization/statistics & numerical data ; Humans ; Journal Impact Factor ; Myocardial Infarction/epidemiology ; Myocardial Infarction/mortality ; Myocardial Revascularization/statistics & numerical data ; Periodicals as Topic ; Risk ; Stroke/epidemiology ; Stroke/mortality ; Treatment Outcome
Entry Date(s):
Date Created: 20200917 Date Completed: 20201231 Latest Revision: 20201231
Update Code:
20240104
DOI:
10.1016/j.ahj.2020.09.001
PMID:
32941789
Czasopismo naukowe
Cardiovascular randomized controlled trials (RCTs) typically set composite end points as the primary outcome to enhance statistical power. However, influence of individual component end points on overall composite outcomes remains understudied.
Methods: We searched MEDLINE for RCTs published in 6 high-impact journals (The Lancet, the New England Journal of Medicine, Journal of the American Medical Association, Circulation, Journal of the American College of Cardiology and the European Heart Journal) from 2011 to 2017. Two-armed, parallel-design cardiovascular RCTs which reported composite outcomes were included. All-cause or cardiovascular mortality, myocardial infarction, heart failure, and stroke were deemed "hard" end points, whereas hospitalization, angina, and revascularization were identified as "soft" end points. Type of outcome (primary or secondary), event rates in treatment and control groups for the composite outcome and of its components according to predefined criteria.
Results: Of the 45.8% (316/689) cardiovascular RCTs which used a composite outcome, 79.4% set the composite as the primary outcome. Death was the most common component (89.8%) followed by myocardial infarction (66.1%). About 80% of the trials reported complete data for each component. One hundred forty-seven trials (46.5%) incorporated a "soft" end point as part of their composite. Death contributed the least to the estimate of effects (R 2 change = 0.005) of the composite, whereas revascularization contributed the most (R 2 change = 0.423).
Conclusions: Cardiovascular RCTs frequently use composite end points, which include "soft" end points, as components in nearly 50% of studies. Higher event rates in composite end points may create a misleading interpretation of treatment impact due to large contributions from end points with less clinical significance.
(Copyright © 2020 Elsevier Inc. All rights reserved.)

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