Masking in Active Comparator Designs in Pharmacovigilance: A
Retrospective Bias Analysis on the Spontaneous Reporting of
Thiazolidinediones and Cardiovascular Events
Abstract
Masking is a reporting bias where drug safety signals are muffled by
elevated reporting of other medications in spontaneous reporting
databases. While impacts of masking are often limited, its effect on
restricted designs, such as active comparators, can be consequential. We
used data from the United States Food and Drugs Administration Adverse
Event Reporting System (1999Q3-2013Q3) to study masking in a real-world
example. Rosiglitazone, a thiazolidinedione with elevated reporting
after safety concerns over cardiovascular risks, was the masking
candidate. We hypothesized stimulated reporting masked signals for
another thiazolidinedione, pioglitazone. We computed estimates of
proportional reporting ratios and information components, using the
Bayesian confidence propagation neural network, for
pioglitazone-myocardial infarction and pioglitazone-cardiac failure
under unrestricted and active comparator designs, both with and without
the mask, and before (1999Q3-2007Q1) and after (2007Q1-2013Q3) safety
concerns. Relative change-in-estimates were computed to compare results
with and without rosiglitazone. From 1999Q3-2007Q1, relative
change-in-estimates of proportional reporting ratio for
pioglitazone-myocardial infarction was 0.00 in unrestricted design and
0.10 in active comparator; For pioglitazone-cardiac failure, the change
was 0.01 and 0.62, respectively. From 2007Q2-2013Q3, relative change in
estimate for pioglitazone-myocardial infarction was 0.41 in unrestricted
design and 18.00 in active comparator; the change for
pioglitazone-cardiac failure was 0.04 and 1.03, respectively. Relative
changes in estimates of information component mirrored these trends. In
conclusion, masking can influence signal detection in active comparator
designs where external events impact reporting rates in reference sets.
Evaluating masking in related contexts is essential for drug safety
monitoring and resource allocation for follow-up studies.