BACKGROUND: Acute gastrointestinal bleeding (GIB) remains a common cause of hospitalisation. However, interpretation and comparisons of published studies in GIB have been hampered by disparate study methodology. AIMS: To make recommendations about outcome measures to be used in future randomised controlled trials (RCTs) of patients with acute bleeding from any GI source (nonvariceal UGI, variceal, small bowel, or colon) and suggest new RCTs in acute GIB for future peer-reviewed funding. METHODS: As part of a National Institutes of Health conference entitled "Hemostatic Outcomes in Clinical Trials", a group of GIB experts performed targeted critical reviews of available evidence with the goal of proposing a bleeding outcome that could potentially be applied to different disciplines. In addition, the panel sought to develop a clinically meaningful primary endpoint specifically for acute GIB, potentially allowing a more contemporary regrouping of clinically relevant outcomes. RESULTS: The primary endpoint proposed was a composite outcome of further bleeding within 30 days after randomisation leading to red blood cell transfusion, urgent intervention (repeat endoscopy; interventional radiology or surgery), or death. Secondary outcomes may include the individual components of the primary outcome, length of hospitalisation, serious adverse events, and health care resource utilisation. CONCLUSION: The proposed endpoint may help move the GIB field forward by focusing on the most clinically relevant outcomes for patients with acute GIB of all types and informing study design and importance of sample size determination for future RCTs in GIB.
BACKGROUND: Acute gastrointestinal bleeding (GIB) remains a common cause of hospitalisation. However, interpretation and comparisons of published studies in GIB have been hampered by disparate study methodology. AIMS: To make recommendations about outcome measures to be used in future randomised controlled trials (RCTs) of patients with acute bleeding from any GI source (nonvariceal UGI, variceal, small bowel, or colon) and suggest new RCTs in acute GIB for future peer-reviewed funding. METHODS: As part of a National Institutes of Health conference entitled "Hemostatic Outcomes in Clinical Trials", a group of GIB experts performed targeted critical reviews of available evidence with the goal of proposing a bleeding outcome that could potentially be applied to different disciplines. In addition, the panel sought to develop a clinically meaningful primary endpoint specifically for acute GIB, potentially allowing a more contemporary regrouping of clinically relevant outcomes. RESULTS: The primary endpoint proposed was a composite outcome of further bleeding within 30 days after randomisation leading to red blood cell transfusion, urgent intervention (repeat endoscopy; interventional radiology or surgery), or death. Secondary outcomes may include the individual components of the primary outcome, length of hospitalisation, serious adverse events, and health care resource utilisation. CONCLUSION: The proposed endpoint may help move the GIB field forward by focusing on the most clinically relevant outcomes for patients with acute GIB of all types and informing study design and importance of sample size determination for future RCTs in GIB.
Authors: P J Devereaux; W Scott Beattie; Peter T-L Choi; Neal H Badner; Gordon H Guyatt; Juan C Villar; Claudio S Cinà; Kate Leslie; Michael J Jacka; Victor M Montori; Mohit Bhandari; Alvaro Avezum; Alexandre B Cavalcanti; Julian W Giles; Thomas Schricker; Homer Yang; Carl-Johan Jakobsen; Salim Yusuf Journal: BMJ Date: 2005-07-04
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Authors: Philip C Spinella; Nahed El Kassar; Andrew P Cap; Andrei L Kindzelski; Christopher S Almond; Alan Barkun; Terry B Gernsheimer; Joshua N Goldstein; John B Holcomb; Alfonso Iorio; Dennis M Jensen; Nigel S Key; Jerrold H Levy; Stephan A Mayer; Ernest E Moore; Simon J Stanworth; Roger J Lewis; Marie E Steiner Journal: J Trauma Acute Care Surg Date: 2021-08-01 Impact factor: 3.697
Authors: Alan N Barkun; Majid Almadi; Ernst J Kuipers; Loren Laine; Joseph Sung; Frances Tse; Grigorios I Leontiadis; Neena S Abraham; Xavier Calvet; Francis K L Chan; James Douketis; Robert Enns; Ian M Gralnek; Vipul Jairath; Dennis Jensen; James Lau; Gregory Y H Lip; Romaric Loffroy; Fauze Maluf-Filho; Andrew C Meltzer; Nageshwar Reddy; John R Saltzman; John K Marshall; Marc Bardou Journal: Ann Intern Med Date: 2019-10-22 Impact factor: 25.391