Adjudication of bleeding outcomes in an international thromboprophylaxis trial in critical illness

Thrombosis Research

Volumn 131, Issue 3, 2013, Pages 204-209

  Arnold, Donald M ^a,b   Lauzier, Francois ^c,d   Rabbat, Christian ^a   Zytaruk, Nicole ^a   Barlow Cash, Bronwyn ^a   Clarke, France ^a   Heels Ansdell, Diane ^d   Guyatt, Gordon ^a   Walter, Stephen D ^a   Davies, Andrew ^e   Cook, Deborah J ^a  

^a MCMASTER UNIVERSITY   (Canada)

^b CANADIAN BLOOD SERVICES   (Canada)

^c UNIVERSITÉ LAVAL   (Canada)

^d LAVAL UNIVERSITY   (Canada)

^e McMaster University ^*  (Australia)

Author keywords

Adjudication; Anticoagulation; Bleeding; Clinical trial; Critical care

Indexed keywords

DALTEPARIN; HEPARIN;

ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL ILLNESS; DEEP VEIN THROMBOSIS; HUMAN; INTENSIVE CARE UNIT; LEGAL ASPECT; MAJOR CLINICAL STUDY; PEER COUNSELING; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PROPHYLAXIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ALGORITHMS; CALIBRATION; CRITICAL ILLNESS; HEMORRHAGE; HEPARIN; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; INTENSIVE CARE UNITS; INTERNATIONAL COOPERATION; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS; THROMBOEMBOLISM; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 84875257443     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2012.12.005     Document Type: Article

References (22)

1. D.M. Arnold, L. Donahoe, F.J. Clarke, A.J. Tkaczyk, D. Heels-Ansdell, and N. Zytaruk Bleeding during critical illness: A prospective cohort study using a new measurement tool Clin Invest Med 30 2007 E93 E102
2. PROTECT Investigators. Writing Committee: Cook D, Meade M, Guyatt G, Walter S, Heels-Ansdell D, Warkentin TE, et al. for the Canadian Critical Care Trials Group. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med Apr 7 2011;364(14):1305-14.
3. D. Cook, M. Meade, G. Guyatt, S.D. Walter, D. Heels-Ansdell, W. Geerts for the Canadian Critical Care Trials Group PROphylaxis for ThromboEmbolism in Critical Care Trial protocol and analysis plan J Crit Care 26 2 Apr 2011 223 229
4. D.M. Arnold, F. Lauzier, H. Whittingham, Q. Zhou, M.A. Crowther, and E. McDonald A multifaceted strategy to reduce inappropriate use of frozen plasma transfusions in the intensive care unit J Crit Care 26 6 Dec 2011 636.e7 636.e13
5. J. Douketis, D. Cook, M. Meade, G. Guyatt, W. Geerts, Y. Skrobik for the Canadian Critical Care Trials Group Prophylaxis against deep vein thrombosis in critically ill patients with severe renal insufficiency with the low-molecular-weight heparin dalteparin: an assessment of safety and pharmacodynamics: the DIRECT study Arch Intern Med 168 16 Sep 8 2008 1805 1812
6. W.A. Knaus, E.A. Draper, D.P. Wagner, and J.E. Zimmerman APACHE II: a severity of disease classification system Crit Care Med 13 10 Oct 1985 818 829
7. D.J. Cook, G. Rocker, M. Meade, G. Guyatt, W. Geerts, D. Anderson for the Canadian Critical Care Trials Group Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study J Crit Care 20 4 Dec 2005 364 372
8. R. Orwin Evaluating Coding Decisions H. Cooper, L. Hedges, The Handbook of Research Synthesis 1994 Russel Sage Foundation New York 139 162
9. S. Schulman, and C. Kearon Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients J Thromb Haemost 3 4 Apr 2005 692 694
10. S. Schulman, U. Angeras, D. Bergqvist, B. Eriksson, M.R. Lassen, and W. Fisher Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients J Thromb Haemost 8 1 Jan 2010 202 204
11. S.D. Walter, D.J. Cook, G.H. Guyatt, D. King, and S. Troyan Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group Control Clin Trials 18 1 Feb 1997 27 42
12. C.B. Granger, V. Vogel, S.R. Cummings, P. Held, F. Fiedorek, and M. Lawrence Do we need to adjudicate major clinical events? Clin Trials 5 1 2008 56 60
13. D. Cook, S. Walter, A. Freitag, G. Guyatt, H. Devitt, M. Meade for the Canadian Critical Care Trials Group Adjudicating ventilator-associated pneumonia in a randomized trial of critically ill patients J Crit Care 13 4 Dec 1998 159 163
14. J.L. Petersen, G. Haque, A.S. Hellkamp, G.C. Flaker, N.A. Mark Estes III, and F.E. Marchlinski Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee Contemp Clin Trials 27 3 Jun 2006 260 268
15. K.W. Mahaffey, M.T. Roe, C.K. Dyke, L.K. Newby, N.S. Kleiman, and P. Connolly Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial Am Heart J 143 2 Feb 2002 242 248
16. U. Naslund, L. Grip, J. Fischer-Hansen, T. Gundersen, S. Lehto, and L. Wallentin The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points Eur Heart J 20 10 May 1999 771 777
17. T. Ninomiya, G. Donnan, N. Anderson, C. Bladin, B. Chambers, and G. Gordon Effects of the end point adjudication process on the results of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) Stroke 40 6 Jun 2009 2111 2115
18. J. Pogue, S.D. Walter, and S. Yusuf Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs Clin Trials 6 3 Jun 2009 239 251
19. A. Hrobjartsson, A.S. Thomsen, F. Emanuelsson, B. Tendal, J. Hilden, and I. Boutron Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors BMJ 344 2012 e1119
20. D. Cook, F. Lauzier, M.G. Rocha, M.J. Sayles, and S. Finfer Serious adverse events in academic critical care research CMAJ 178 9 Apr 22 2008 1181 1184
21. L. Saunders, D. Heels-Ansdell, N. Zytaruk, J. Southon, B. Barlow Cash, K. Lutz for the Canadian Critical Care Trials Group Methods Center Personnel Costs for Adjudication of 5 Morbidity Outcomes in a Thromboprophylaxis Trial Am J Respir Crit Care Med 183 2011 A1678
22. J. Kottner, L. Audige, S. Brorson, A. Donner, B.J. Gajewski, and A. Hróbjartsson Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed J Clin Epidemiol 64 1 Jan 2011 96 106