Self-controlled tree temporal scan statistic in active surveillance of vaccine safety

doi:10.19803/j.1672-8629.20220546

Abstract

Abstract: Objective To introduce the self-controlled tree temporal scan statistic, a novel signal detection method applied to post-marketing active surveillance of vaccine safety, so as to provide reference for proactive surveillance of vaccine safety in China. Methods The principles and status quo of the self-controlled tree temporal scan statistic were presented in this overview based on previous literature. Results and Conclusion This method allows detection of potential vaccine-associated adverse events and adjusts for the multiple testing without prespecifying the specific events or postexposure risk intervals of concern. Despite the fast development of this method globally, it has been rarely reported in China.

Key words: tree temporal scan statistic, vaccine, safety, surveillance, adverse drug event

CLC Number:

R954
R994.11

FENG Jingnan, ZHAO Houyu, LIU Zhike, ZHAN Siyan. Self-controlled tree temporal scan statistic in active surveillance of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 68-73.

References

[1] PATERSON P, MEURICE F, STANBERRY LR, et al.Vaccine hesitancy and healthcare providers[J]. Vaccine, 2016, 34(52): 6700-6706.
[2] World Health Organization.Vaccine safety basics (elearning courses) [EB/OL]. [2021-12-25].https://vaccine-safety-training.org/expectations-towards-safety-of-vaccines.html.
[3] GOSTIN LO, HODGE JG, JR, BLOOM BR, et al.The public health crisis of underimmunisation: a global plan of action[J]. Lancet Infect Dis, 2020, 20(1): e11-e16.
[4] DUDLEY MZ, HALSEY NA, OMER SB, et al.The state of vaccine safety science: systematic reviews of the evidence[J]. Lancet Infect Dis, 2020, 20(5): e80-e89.
[5] MACDONALD NE.Vaccine hesitancy: Definition, scope and determinants[J]. Vaccine, 2015, 33(34): 4161-4164.
[6] CRAWFORD NW, CLOTHIER H, HODGSON K, et al.Active surveillance for adverse events following immunization[J]. Expert Rev Vaccines, 2014, 13(2): 265-276.
[7] ISAACS D, LAWRENCE G, BOYD I, et al.Reporting of adverse events following immunization in Australia[J]. J Paediatr Child Health, 2005, 41(4): 163-166.
[8] FLETCHER AP.Spontaneous adverse drug reaction reporting vs event monitoring: a comparison[J]. J R Soc Med, 1991, 84(6): 341-344.
[9] HUANG YL, MOON J, Segal JB.A comparison of active adverse event surveillance systems worldwide[J]. Drug Saf, 2014, 37(8): 581-596.
[10] WINTZELL V, SVANSTRÖM H, MELBYE M, et al. Data mining for adverse events of tumor necrosis factor-alpha inhibitors in pediatric patients: tree-based scan statistic analyses of danish nationwide health data[J]. Clin Drug Investig, 2020, 40(12): 1147-1154.
[11] KULLDORFF M, NAGARWALLA N.Spatial disease clusters: detection and inference[J]. Stat Med, 1995, 14(8): 799-810.
[12] LI HL,ZHAO HY,ZHAN SY.The application of tree-based scan statistic in drug safety surveillance[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2018, 27(3): 209-213.
[13] KULLDORFF M. TreeScan user guide for version 9.7[EB/OL].(2021-01-15) [2021-05-05]. https://www.satscan.org/cgi-bin/satscan/register.pl/SaTScan_Users_Guide.pdf?todo=process_userguide_download.
[14] SUN YX, WANG M, YANG MF, et al.Review on tree-based scan statistic in drug and vaccine safety monitoring[J]. Chin J Epidemiol(中华流行病学杂志), 2021, 42(7): 1286-1291.
[15] MARO JC, NGUYEN M, IZEM R, et al.Signal detection using tree-temporal scan statistics in the sentinel system[J]. Pharmacoepidemiology and Drug Safety, 2018, 27: 346-347.
[16] HAGUINET F, VAN HOLLE L, SCHRAUBEN P, et al.Tree-temporal scan analyses for detecting safety signals in clinical development of vaccines: a simulation study[J]. Pharmacoepidemiology and Drug Safety, 2018, 27: 60.
[17] Mini-Sentinel. Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Protocol[EB/OL].(2016-09-30) [2021-12-05]. https://www.sentinelinitiative.org/sites/default/files/Methods/Mini-Sentinel_PRISM_Pilot-Self-Controlled-Tree-Temporal-Scan-Analysis-Gardasil-Vaccine-Protocol_0.pdf.
[18] Mini-Sentinel. Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Report[EB/OL].(2016-09-30) [2021-12-05].https://www.sentinelinitiative.org/sites/default/files/Methods/Mini-Sentinel_PRISM_Pilot-Self-Controlled-Tree-Temporal-Scan-Analysis-Gardasil-Vaccine-Report.pdf.
[19] YIH WK, MARO JC, NGUYEN M, et al.Assessment of quadrivalent human papillomavirus vaccine safety using the self-controlled tree-temporal scan statistic signal-detection method in the sentinel system[J]. Am J Epidemiol, 2018, 187(6): 1269-1276.
[20] YIH WK, KULLDORFF M, DASHEVSKY I, et al.Using the self-controlled tree-temporal scan statistic to assess the safety of live attenuated herpes zoster vaccine[J]. Am J Epidemiol, 2019, 188(7): 1383-1388.
[21] LI R, WEINTRAUB E, MCNEIL MM, et al.Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method[J]. Pharmacoepidemiol Drug Saf, 2018, 27(4): 391-397.
[22] YIH WK, KULLDORFF M, DASHEVSKY I, et al.A Broad Safety Assessment of the 9-Valent Human Papillomavirus Vaccine[J]. Am J Epidemiol, 2021, 190(7): 1253-1259.
[23] YIH WK, KULLDORFF M, DASHEVSKY I, et al.A broad safety assessment of the recombinant herpes zoster vaccine[J]. Am J Epidemiol, 2022, 191(5): 957-964.
[24] LIU CH, HUANG WT, CHIE WC, et al.Safety surveillance of varicella vaccine using tree-temporal scan analysis[J]. Vaccine, 2021, 39(43): 6378-6384.
[25] Agency for Healthcare Research and Quality. Research Tools[EB/OL].(2017-03-01) [2021-12-05]. https://www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp.
[26] Sentinel. Application of TreeScan Data Mining Method to HPV9 (Gardasil 9) Vaccine[EB/OL].(2019-09-03) [2021-12-05]. https://www.sentinelinitiative.org/sites/default/files/Methods/Application_of_TreeScan_Data_Mining_Method_to_HPV9_Gardasil_9_Vaccine.pdf.