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Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to
Mary Townsend1, Hany Kamel1, Nancy Van Buren2
1Vitalant, Scottsdale, Arizona, USA.
Insights
A new Severity Grading Tool (SGT) for blood donor adverse events (DAEs) was developed and validated. This tool enhances objective severity assignment, improving donor hemovigilance (DHV) consistency.
Area of Science:
- Transfusion Medicine
- Hematology
- Public Health
Background:
- Donor hemovigilance (DHV) faces challenges in consistently reporting and comparing donor adverse events (DAEs) and their severity.
- Existing standards define DAEs but lack specific guidelines for grading severity.
- A need existed for an objective tool to standardize DAE severity assessment.
Purpose of the Study:
- To develop a Severity Grading Tool (SGT) for blood donor adverse events (DAEs).
- To validate the developed SGT for objective assignment of DAE severity.
- To improve consistency and comparability in donor hemovigilance.
Main Methods:
- Subject matter experts developed the Severity Grading Tool (SGT).
- A validation study was conducted where participants graded DAE severity using the SGT.
- Inter-rater reliability was assessed using Kendall's coefficient of concordance (W).
Main Results:
- The validation study showed almost perfect overall agreement (W = 0.84).
- Respondent agreement with expert grading exceeded 90% for 18 out of 34 DAEs.
- The SGT was revised based on validation results and participant feedback.
Conclusions:
- The developed and validated SGT provides objective criteria for assigning DAE severity.
- Standardized DAE severity grading enhances comparison between blood centers and systems.
- Implementation of the SGT is expected to advance the field of donor hemovigilance (DHV).
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.
