Reference set for performance testing of pediatric vaccine safety signal detection methods and systems

Methodology for computing the burden of disease of adverse events following immunization

“…We estimated the disease burden, in DALYS, for example events falling within both broad categories of AEFI: (1) infrequent, but potentially serious events (idiopathic thrombocytopenic purpura [ITP], anaphylaxis); and (2) relatively frequent, but less serious events (febrile convulsions) (Table ). The burden computation was then restricted to only those vaccine‐event pairs with a likelihood of a strong association (based on the Global Research in Pediatrics [GRiP] evaluation of strength of evidence; ie, vaccine‐event pair either identified as a “positive control”, or reported by the Institute of Medicines). Below, we describe the methodology and apply it to a worked example.…”

“…The burden computation was then restricted to only those vaccineevent pairs with a likelihood of a strong association (based on the Global Research in Pediatrics [GRiP] evaluation of strength of evidence; ie, vaccine-event pair either identified as a "positive control", 19 or reported by the Institute of Medicines 20 ). Below, we describe the methodology and apply it to a worked example.…”

“…We conducted a pragmatic literature search for relative risks or absolute risks (defined in terms of cases per vaccine dose) for each of the 6 relevant vaccine‐event pairs that were classified as known associations in the GRiP reference set . A single effect estimate (RR or absolute risk) for each vaccine‐event pair was then chosen for the worked example (Table ).…”

The impact of regulation changes in the spontaneous reporting system for vaccines on reporting trends and signal detection in Japan

“…This definition included 65 types of vaccines. Among the internationally commonly used pediatric vaccines described in the GRiP reference set 9 , the following types of vaccines are defined in the Standard Commodity Classification 1 type, measles-mumps-rubella (MMR): 2 types, oral polio (OPV): 1 type, rotavirus (RV): 2 types and varicella zoster virus (VZV): 2 types. Thereafter, a spontaneous report with at least one suspected vaccine was considered a vaccine report (a spontaneous report of adverse events following immunization).…”

“…7,8 As a result, several studies have proposed a reference set to test the performance of a particular data mining approach. [9][10][11] However, only one previous report, to our knowledge, describes a reference set for testing the performance of a data mining approach for vaccines, especially pediatric vaccines; this reference set was proposed by the Global Research in Paediatrics project (GRiP). 9 A number of previous reports have described the use of stratification in vaccine signal detection, such as by age 12 and by vaccine report-based subgroup.…”