September 20, 2023
The AABB Severity Grading Tool for Blood Donor Adverse Events (SGT) is an efficient mode to uniformly and objectively report donor adverse reactions (DARs), according to findings published in Vox Sanguinis.
In this study, investigators from the National Coordinating Centre (NCC) of India’s National Blood Donor Vigilance Program (NBDVP) invited blood centers to use the SGT to grade 35 real-world DAR case scenarios. The cases had previously been validated by seven national and two international experts. Investigators analyzed the responses (diagnosis and severity) to determine the degree of agreement between participating centers and the expert group.
Among the 50 blood centers with complete responses, overall agreement with the expert group was 66.4%. Overall agreement was higher than 80% for 12 centers, 60-80% for 27 centers and less than 60% for 11 centers. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. The major causes of disagreement were due to incorrect diagnoses of DAR cases (53.8%) and incorrect severity grading (46.1%).
The investigators noted that the level of agreement in their study was lower than that seen in a 2020 AABB validation study, which found almost perfect agreement (Kendallʼs coefficient of concordance of .84) between survey respondents and experts. According to the researchers, this difference could be attributed to this study being the first of its kind in India, inclusion of new terms and definitions related to SGT, or difference in the level of knowledge among types of respondents between the two studies.
Despite the lower degree of agreement compared with the AABB study, investigators concluded that the study provides clinical and practical insights into the level of understanding of DARs by the participating centers, as well as a framework for the rephrasing of SGT in India. In response to the findings, investigators recommended that the NBDVP implement the SGT on an optional basis and make efforts to train reporting centers on the definitions and categories of DARs. They also encouraged the NCC to conduct regular webinars to discuss study findings and explain cases that had an agreement rate of less than 60%.
The AABB Donor Hemovigilance Working Group designed the SGT to be used with the Standard for Surveillance of Complications Related to Blood Donation published in 2014 by AABB, the International Society of Blood Transfusion and the International Haemovigilance Network.
The tool aims to avoid terms such as mild, moderate and severe. It is patterned after an established clinical severity scale, Common Terminology Criteria for Adverse Events (CTCAE1) v 5.0, which rates severity by grades 1-5 with 1 through 5 being roughly associated with mild, moderate, severe, life-threatening and death; reactions of grade 3 or higher would be classed as "serious" in donor adverse event reporting systems.
Additional information about the SGT is available on the AABB donor hemovigilance web page.