Document Detail

Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis.
MedLine Citation:
PMID:  19327956     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The objective of this report is to describe the roles, responsibilities and recommendations of a 3-member Event Adjudication Committee (EAC) and a 5-member data monitoring committee (DMC) for a prospective multicenter observational study of critically ill patients with renal insufficiency examining the bioaccumulation and bleeding risk associated with dalteparin thromboprophylaxis. METHODS: The EAC reviewed bleeding events to adjudicate whether they were major or minor and whether they were related to dalteparin (uncertain, unlikely, or likely). The DMC reviewed all bleeds deemed by the EAC as uncertain or likely due to dalteparin then recommended either to continue or suspend enrolment pending review by the steering committee, or requested more information. RESULTS: Consensus on bleeding severity was achieved for all cases. At the second planned interim analysis, the EAC recommended to the DMC and steering committee that the EAC should stop adjudicating whether bleeding was related to dalteparin since attribution was challenging in this population with numerous bleeding risk factors; moreover, no bleeding rates were available from prior studies or historical or concurrent controls. CONCLUSIONS: Adjudication of whether an outcome can be attributed to an intervention in an open-label, uncontrolled observational study gives a potentially misleading impression of research oversight without methodological face validity. In this study, the EAC recommended modification of the adjudication process, and the DMC recommended continuing enrolment to achieve the target sample size.
D Cook; T Sinuff; N Zytaruk; C Rabbat; A Lee; M O'Donnell; L Thabane; L Linkins; D Treleaven; R Patel; M Meade; M Crowther; J C Marshall; J Douketis;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-03-27
Journal Detail:
Title:  Journal of critical care     Volume:  24     ISSN:  1557-8615     ISO Abbreviation:  J Crit Care     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-08     Completed Date:  2009-08-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8610642     Medline TA:  J Crit Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  168-75     Citation Subset:  IM    
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
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MeSH Terms
Anticoagulants / adverse effects*,  therapeutic use
Clinical Trials Data Monitoring Committees / organization & administration*
Clinical Trials as Topic / methods*
Critical Illness
Dalteparin / adverse effects*,  therapeutic use
Intensive Care Units / organization & administration*
Multicenter Studies as Topic
Prospective Studies
Renal Insufficiency / complications
Thromboembolism / complications,  prevention & control*
Reg. No./Substance:
0/Anticoagulants; 0/Dalteparin
Ellen McDonald / ; France Clarke / ; Andrea Tkaczyk / ; Deborah Cook / ; Karen Woods / ; Maureen Meade / ; Christine Wynne / ; Mark Duffett / ; Andreas Freitag / ; Marilyn Steinberg / ; Andrea Matte / ; John Granton / ; France Clarke / ; Andrea Tkaczyk / ; Tim Karachi / ; Mary-Jo Lewis / ; Julia Foxall / ; Guiseppe Pagliarello / ; Irene Watpool / ; Tracy McArdle / ; Paul Hebert / ; Johanne Harvey / ; Yoanna Skrobik / ; Carole Sirois / ; Carole Nadon / ; Martin Albert / ; Mel Keogh / ; Craig Dale / ; Rob Fowler / ; Orla Smith / ; Andrea Richards / ; Ines DeCampos / ; Jan Friedrich / ; John Marshall / ; James Douketis / ; Deborah Cook / ; Mark Crowther / ; Maureen Meade / ; Gordon Guyatt / ; David Anderson / ; William Geerts / ; Nicole Zytaruk / ; Diane Heels-Ansdell / ; Christian Rabbat / ; Agnes Lee / ; Martin O'Donnell / ; Lehana Thabane / ; Lori Linkins / ; Darin Treleaven / ; Tasnim Sinuff / ; Rakesh Patel /

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