Abstract
In order to explore how the choice of different study designs could influence the risk estimates, a case–crossover and case–time–control study were carried out and their outcomes were compared with those of a traditional case–control study design that evaluated the association between the exposure to psychotropic medications and the risk of having a motor vehicle accident (MVA). A record-linkage database availing data for 3,786 cases and 18,089 controls during the period 2000–2007 was used. The study designs (i.e., case–crossover and case–time–control) were derived from published literature, and the following psychotropic medicines were examined: antipsychotics, anxiolytics, hypnotics and sedatives, and antidepressants, stratified in the two groups selective serotonin reuptake inhibitors (SSRIs) and other antidepressants. Moreover, in order to further investigate the effects of frequency of psychoactive medication exposure on the outcomes of the case–crossover analysis, the data were also stratified by the number of defined daily doses (DDDs) and days of medication use in the 12 months before the motor vehicle accident. Three-thousand seven-hundred fifty-two cases were included in this second part of the case–crossover analysis. The case–crossover design did not show any statistically significant association between psychotropic medication exposure and MVA risk [e.g., SSRIs—Adj. OR = 1.00 (95 % CI: 0.69–1.46); Anxiolytics—Adj. OR = 0.95 (95 % CI: 0.68–1.31)]. The case–time–control design only showed a borderline statistically significant increased traffic accident risk in SSRI users [Adj. OR = 1.16 (95 % CI: 1.01–1.34)]. With respect to the stratifications by the number of DDDs and days of medication use, the analyses showed no increased traffic accident risk associated with the exposure to the selected medication groups [e.g., SSRIs, <20 DDDs—Adj. OR = 0.65 (95 % CI: 0.11–3.87); SSRIs, 16–150 days—Adj. OR = 0.55 (95 % CI: 0.24–1.24)]. In contrast to the above-mentioned results, our recent case–control study found a statistically significant association between traffic accident risk and exposure to anxiolytics [Adj. OR = 1.54 (95 % CI: 1.11–2.15)], and SSRIs [Adj. OR = 2.03 (95 % CI: 1.31–3.14)]. Case–crossover and case–time–control analyses produced different results than those of our recent case–control study (i.e., case–crossover and case–time–control analyses did not show any statistically significant association whereas the case–control analysis showed an increased traffic accident risk in anxiolytic and SSRI users). These divergent results can probably be explained by the differences in the study designs. Given that the case–crossover design is only appropriate for short-term exposures and the case–time–control design is an elaboration of this latter, it can be concluded that, probably, these two approaches are not the most suitable ones to investigate the relation between MVA risk and psychotropic medications, which, on the contrary, are often use chronically.
Highlights
Introduction and aimDriving a motor vehicle is a complex task that involves several psychomotor and cognitive skills [1]
In order to explore how the choice of different study designs could influence the risk estimates, a case– crossover and case–time–control study were carried out and their outcomes were compared with those of a traditional case–control study design that evaluated the association between the exposure to psychotropic medications and the risk of having a motor vehicle accident (MVA)
In order to further investigate the effects of frequency of psychoactive medication exposure on the outcomes of the case–crossover analysis, the data were stratified by the number of defined daily doses (DDDs) and days of Disclaimer: This work has been produced under the project ‘‘Driving under Influence of Drugs, Alcohol and Medicines’’ (DRUID) financed by the European Community within the framework of the EU 6th Framework Programme
Summary
Introduction and aimDriving a motor vehicle is a complex task that involves several psychomotor and cognitive skills [1]. The risk of experiencing a road traffic accident while exposed to psychotropic medications has often been estimated by means of pharmacoepidemiological studies, and, in particular, mainly by case–control and case–crossover studies [3] The results of these studies have frequently shown a positive association between the risk of having a motor vehicle accident (MVA) and the exposure to some groups of psychoactive medications (e.g., benzodiazepines, benzodiazepine-like substances such as zopiclone and zolpidem, tricyclic antidepressants) [3,4,5], but, in some cases, their findings have been rather controversial. Another example is a recent Dutch case–control study [9] which reported a statistically significant association between the risk of experiencing a traffic accident and the exposure to selective serotonin reuptake inhibitors (SSRIs); these results differed from those of Barbone’s case–crossover study, which found no increased MVA risk in SSRI users [7]
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