Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases

Suzie Seabroke (), Gianmario Candore, Kristina Juhlin, Naashika Quarcoo, Antoni Wisniewski, Ramin Arani, Jeffery Painter, Philip Tregunno, G. Niklas Norén and Jim Slattery
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Suzie Seabroke: UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Gianmario Candore: European Medicines Agency
Kristina Juhlin: Uppsala Monitoring Centre
Naashika Quarcoo: GlaxoSmithKline
Antoni Wisniewski: AstraZeneca
Ramin Arani: AstraZeneca
Jeffery Painter: GlaxoSmithKline
Philip Tregunno: UK Medicines and Healthcare Products Regulatory Agency (MHRA)
G. Niklas Norén: Uppsala Monitoring Centre
Jim Slattery: European Medicines Agency

Drug Safety, 2016, vol. 39, issue 4, No 9, 355-364

Abstract: Abstract Introduction Disproportionality analyses are used in many organisations to identify adverse drug reactions (ADRs) from spontaneous report data. Reporting patterns vary over time, with patient demographics, and between different geographical regions, and therefore subgroup analyses or adjustment by stratification may be beneficial. Objective The objective of this study was to evaluate the performance of subgroup and stratified disproportionality analyses for a number of key covariates within spontaneous report databases of differing sizes and characteristics. Methods Using a reference set of established ADRs, signal detection performance (sensitivity and precision) was compared for stratified, subgroup and crude (unadjusted) analyses within five spontaneous report databases (two company, one national and two international databases). Analyses were repeated for a range of covariates: age, sex, country/region of origin, calendar time period, event seriousness, vaccine/non-vaccine, reporter qualification and report source. Results Subgroup analyses consistently performed better than stratified analyses in all databases. Subgroup analyses also showed benefits in both sensitivity and precision over crude analyses for the larger international databases, whilst for the smaller databases a gain in precision tended to result in some loss of sensitivity. Additionally, stratified analyses did not increase sensitivity or precision beyond that associated with analytical artefacts of the analysis. The most promising subgroup covariates were age and region/country of origin, although this varied between databases. Conclusions Subgroup analyses perform better than stratified analyses and should be considered over the latter in routine first-pass signal detection. Subgroup analyses are also clearly beneficial over crude analyses for larger databases, but further validation is required for smaller databases.

Date: 2016
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DOI: 10.1007/s40264-015-0388-3

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