by Agnes Dechartres, Pierre Albaladejo, Jean Mantz, Charles Marc Samama, Jean-Philippe Collet, Philippe Gabriel Steg, Philippe Ravaud, Florence Tubach
Background and Objectives 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.
Method 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.
Results 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.
Conclusions These ratings could be used to weight ischemic and bleeding events of various
severity comprising a composite outcome in the field of thrombosis
prevention.
