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

Authors


Correspondence: Rutger A. Middelburg. PhD, Center for Clinical Transfusion Research, Sanquin Research, Leiden, Plesmanlaan 1A, 2333 BZ Leiden, The Netherlands

E-mail: R.A.Middelburg@lumc.nl

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.

Ancillary