Article2020

Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events

Mary J. Townsend · Hany T. Kamel · Nancy L. Van Buren · Johanna C. Wiersum‐Osselton · Marilyn Rosa‐Bray · Jerome L. Gottschall +1 more

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Blood donation and transfusion practices Pharmacovigilance and Adverse Drug Reactions Blood transfusion and management

Abstract

BACKGROUND: Uniform and consistent reporting and comparison of donor adverse events (DAEs) and severity are well-recognized challenges for donor hemovigilance (DHV). While the 2014 Standard for Surveillance of Complications Related to Blood Donation (SSCRBD), developed by hemovigilance experts from AABB, the International Society of Blood Transfusion, and International Hemovigilance Network, established the DAE definitions, no specific guidelines were provided to grade severity. A group of subject matter experts developed the Severity Grading Tool for Blood Donor Adverse Events (SGT) to enhance objective assignment of severity and conducted a study to validate the tool. STUDY DESIGN AND METHODS: Between January 8, 2019, and February 28, 2019, participants graded severity of 32 cases (34 DAEs) using the SGT. Comments boxes allowed participants to provide rationale for selecting a severity grade for each case. Agreement with expert grading among study participants was evaluated using percentage agreement. Inter-rater reliability was evaluated by Kendall's coefficient of concordance (W). The final SGT was revised based on validation study results and feedback received. RESULTS: The overall agreement was almost perfect with W = 0.84 (confidence interval [CI], 0.78-0.90). Of 34 DAEs, respondent agreement with expert grading of more than 90% was reached for 18 DAEs, 80% to 90% for six DAEs, 70% to 80% for six DAEs, and less than 70% for four DAEs. CONCLUSION: The development and validation of a uniform SGT with objective criteria for assigning severity of DAEs used together with standard reaction definitions will provide opportunities for comparison between blood centers and systems to enhance the field of DHV.

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2010Encyclopedia of Research Design 2008Adverse Reactions to Allogeneic Whole Blood Donation by 16- and 17-Year-Olds 2011Interventions to reduce the vasovagal reaction rate in young whole blood donors 2015Development of standard definitions for surveillance of complications related to blood donation 2019Elevated risk for iron depletion in high‐school age blood donors 2018International validation of harmonized definitions for complications of blood donations 2018Plateletpheresis-associated lymphopenia in frequent platelet donors

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2020Complications of blood donation reported to haemovigilance systems: analysis of eleven years of international surveillance 2022Haemovigilance: current practices and future developments 2021Frequency of rare, serious donor reactions: International perspective 2022Vasovagal reactions in whole blood and apheresis donors: a cross-sectional study on donor haemovigilance data from 2016 to 2019 in Italy.2024The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial

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