Performance of subgrouped proportional reporting ratios in the US Food and Drug Administration (FDA) adverse event reporting system.

BACKGROUND

Many signal detection algorithms give the same weight to information from all products and patients, which may result in signals being masked or false positives being flagged as potential signals. Subgrouped analysis can be used to help correct for this.

RESEARCH DESIGN AND METHODS

The publicly available US Food and Drug Administration Adverse Event Reporting System quarterly data extract files from 1 January 2015 through 30 September 2017 were utilized. A proportional reporting ratio (PRR) analysis subgrouped by either age, sex, ADE report type, seriousness of ADE, or reporter was compared to the crude PRR analysis using sensitivity, specificity, precision, and c-statistic.

RESULTS

Subgrouping by age (n = 78, 34.5% increase), sex (n = 67, 15.5% increase), and reporter (n = 64, 10.3% increase) identified more signals than the crude analysis. Subgrouping by either age or sex increased both the sensitivity and precision. Subgrouping by report type or seriousness resulted in fewer signals (n = 50, -13.8% for both). Subgrouped analyses had higher c-statistic values, with age having the highest (0.468).

CONCLUSIONS

Subgrouping by either age or sex produced more signals with higher sensitivity and precision than the crude PRR analysis. Subgrouping by these variables can unmask potentially important associations.