Intravenous immune globulin–related hemolysis: comparing two different methods for case assessment
Bibliographic record
Abstract
BACKGROUND: Hemolysis is a rare adverse event associated with the use of intravenous immune globulin (IVIG). Using the Canadian experience, this article compares two methods used for case ascertainment of hemolysis after IVIG. STUDY DESIGN AND METHODS: This is a retrospective, descriptive analysis of case reports of hemolytic reaction after exposure to IVIG. The cases were ascertained from the Canada Vigilance database using the standardized MedDRA query for hemolytic disorders between the years 2006 and 2012 inclusively. The presence of a causal relationship was determined by using the Transfusion Transmitted Injuries Surveillance System (TTISS) algorithm. Cases were then reviewed against the standardized case definition of IVIG-associated hemolysis proposed by the IVIG Hemolysis Pharmacovigilance Group. RESULTS: A total of 942 adverse event reports after exposure to IVIG had been received by Canada Vigilance during the study period. A search for the adverse event of hemolytic disorder retrieved 313 reports (33%). Using a modified TTISS definition of hemolysis and the TTISS causality assessment algorithm, 226 cases were found to be at least possibly related to administration of IVIG, whereas 69 cases met the definition of the IVIG Hemolysis Pharmacovigilance Group. The amount of IVIG distributed increased over the study period; this trend was not reflected in the number of adverse reaction reports for "hemolytic disorder" received. CONCLUSION: The number of case reports per year received for the adverse event "hemolytic disorder" after exposure to IVIG fluctuated. The number of confirmed case reports varied depending on the case definition being used.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".