Measuring clinical bleeding using a standardized daily report form and a computer algorithm for adjudication of WHO bleeding grades.

Abstract:

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.

journal_name

Vox Sang

journal_title

Vox sanguinis

authors

Middelburg RA,Ypma PF,van der Meer PF,van Wordragen-Vlaswinkel RJ,Eissen O,Kerkhoffs JL

doi

10.1111/vox.12030

subject

Has Abstract

pub_date

2013-08-01 00:00:00

pages

144-9

issue

2

eissn

0042-9007

issn

1423-0410

journal_volume

105

pub_type

临床试验,杂志文章,多中心研究
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