Development of the Adverse Analgesic Drug Event Measure.

Background: Little is known about how people respond to an analgesic adverse drug event despite the significant incidence of deaths and hospitalizations associated with analgesic adverse drug events.

Objective: The purpose of this two-phase instrument development study was to test the validity and reliability of the Analgesic Adverse Drug Event Measure (AADEM).

Methods: Content validity was established during Phase I. Six experts rated the 58-item measure developed from a pilot survey of adults who had experienced an analgesic adverse drug event. Experts' ratings supported a 17-item AADEM with a scale content validity index of .86. Phase II consisted of online administration of the AADEM to a national Qualtrics panel who reported an adverse drug event from a self-administered analgesic. Exploratory factor analysis was conducted using principal axis factoring and oblique rotation including Direct Oblimin and Promax rotations with Kaiser normalization.

Results: Four factors emerged from the analysis: sought care, consulted provider, discontinued or continued analgesic, and attributed adverse drug event with a total explained variance of 55.4%. Scale content validity index for the 13-item AADEM was .88. Internal consistency for the four subscales was acceptable, but low for the full 13-item AADEM.

Discussion: Results establish preliminary evidence for the validity and reliability of the 13-item AADEM to measure response to an analgesic adverse drug event. Next steps involve confirmatory factor analysis in a different sample to examine the underlying construct of the AADEM. The AADEM might help identify people at risk for serious analgesic adverse drug events.