Delphi-consensus weights for ischemic and bleeding events to be included in a composite outcome for RCTs in thrombosis prevention.

• Main Authors: Agnes Dechartres, Pierre Albaladejo, Jean Mantz, Charles Marc Samama, Jean-Philippe Collet, Philippe Gabriel Steg, Philippe Ravaud, Florence Tubach
• Format: Article
• Language: English
• Published: Public Library of Science (PLoS) 2011-04-01
• Series: PLoS ONE
• Online Access: http://europepmc.org/articles/PMC3072399?pdf=render

To weight ischemic and bleeding events according to their severity to be used in a composite outcome in RCTs in the field of thrombosis prevention.Using a Delphi consensus method, a panel of anaesthesiology and cardiology experts rated the severity of thrombotic and bleeding clinical events. The ratings were expressed on a 10-point scale. The median and quartiles of the ratings of each item were returned to the experts. Then, the panel members evaluated the events a second time with knowledge of the group responses from the first round. Cronbach's a was used as a measure of homogeneity for the ratings. The final rating for each event corresponded to the median rating obtained at the last Delphi round.Of 70 experts invited, 32 (46%) accepted to participate. Consensus was reached at the second round as indicated by Cronbach's a value (0.99 (95% CI 0.98-1.00)) so the Delphi was stopped. Severity ranged from under-popliteal venous thrombosis (median = 3, Q1 = 2; Q3 = 3) to ischemic stroke or intracerebral hemorrhage with severe disability at 7 days and massive pulmonary embolism (median = 9, Q1 = 9; Q3 = 9). Ratings did not differ according to the medical specialty of experts.These ratings could be used to weight ischemic and bleeding events of various severity comprising a composite outcome in the field of thrombosis prevention.