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Published on: December 6, 2024
Measuring clinical bleeding using a standardized daily report form and a computer algorithm for adjudication of WHO
R A Middelburg1, P F Ypma, P F van der Meer
1Center for Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands. R.A.Middelburg@lumc.nl
Introduction:
Bleeding is increasingly considered an important end point in clinical platelet transfusion studies. Accurate recording and adjudication into well-defined bleeding grades, however, remains a major challenge.
Methods:
We developed a computer algorithm for automatic adjudication. The algorithm's results were compared to those of three independent adjudicators.
Results:
For one of 1186 bleeding days, the clinical report form (CRF) was filled out incorrectly, and the algorithm therefore missed one grade-1 skin bleed. For two bleeding days, the adjudicators incorrectly classified a grade-2 skin bleed as grade-1 while the algorithm correctly classified these days. The algorithm saved approximately six person-hours of adjudication time for the adjudication of 1186 days from 60 patients.
Discussion:
The algorithm can be an invaluable tool for adjudicating large amounts of bleeding data.
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