Validity and reliability of a driving simulator for evaluating the influence of medicinal drugs on driving performance

Iwata, Mari; Iwamoto, Kunihiro; Kitajima, Iwao; Nogi, T; Onishi, Koichi; Kajiyama, Yu; Nishino, Izumi; Ando, Masahiko; Ozaki, Norio

doi:10.1007/s00213-020-05730-6

Cited by 8 publications

(5 citation statements)

References 39 publications

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“…The warnings and precautions in package inserts undoubtedly affect not only the choice of therapeutic agents but can also the social life of the patient. For this reason, we have developed a standardized evaluation system using a driving simulator suitable for evaluating the effect of psychotropic drugs on driving performance 15–17 . However, it is not always feasible to conduct placebo‐controlled trials of already approved drugs with established efficacy and safety, as ethical issues may arise.…”

Section: The Need For Japanese Guidelinementioning

confidence: 99%

“…For this reason, we have developed a standardized evaluation system using a driving simulator suitable for evaluating the effect of psychotropic drugs on driving performance. [15][16][17] However, it is not always feasible to conduct placebo-controlled trials of already approved drugs with established efficacy and safety, as ethical issues may arise. Consequently, the development of Japanese guideline was necessary to evaluate not only drugs in development but also approved drugs.…”

Section: The Need For Japane S E G U Idelinementioning

confidence: 99%

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The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline

Iwamoto

Nakabayashi

Konishi

et al. 2023

Neuropsychopharm Rep

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In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies.Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.

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Section: The Need For Japanese Guidelinementioning

confidence: 99%

Section: The Need For Japane S E G U Idelinementioning

confidence: 99%

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline

Iwamoto

Nakabayashi

Konishi

et al. 2023

Neuropsychopharm Rep

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“…This study was approved by the Ethics Committee of Aichi Medical University, and written informed consent was received from all participants. Driving performance was measured using a standardized driving simulator, the details of which have been described previously 7–9 . The road‐tracking task measures the standard deviation of lateral position (SDLP) on a gently winding road at a constant speed of 100 km/h, which indicates weaving and was the primary outcome.…”

Section: Figurementioning

confidence: 99%

“…Driving performance was measured using a standardized driving simulator, the details of which have been described previously. 7 , 8 , 9 The road‐tracking task measures the standard deviation of lateral position (SDLP) on a gently winding road at a constant speed of 100 km/h, which indicates weaving and was the primary outcome. The mean and SD of speed (SDSpeed) were also calculated.…”

mentioning

confidence: 99%

Driving performance of patients with epilepsy undergoing antiepileptic monotherapy

et al. 2023

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“…Driving simulation studies may be particularly useful as a legal benchmark of impairment (i.e., alcohol) already exists. It is beyond the scope of this article to discuss the relationship between psychomotor testing and driving simulation, but several thorough reviews have recently been published [23 & , [24][25][26].…”

Section: Anesthesia Recoverymentioning

confidence: 99%

Discharging select patients without an escort after ambulatory anesthesia: identifying return to baseline function

Walsh

2021

Current Opinion in Anaesthesiology

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Purpose of reviewThe current standard of care requires ambulatory surgical patients to have an escort for discharge. Recent studies have started to challenge this dogma. Modern ultrashort acting anesthetics have minimal psychomotor effects after a couple of hours. Driving simulator performance and psychomotor testing return to baseline as soon as 1 h following propofol sedation. Recent findingsTwo recent reports of actual experience with thousands of patients found no increase in complications in patients who were discharged without escort or drove themselves from a sedation center. These studies suggest discharge without escort may be safe in select patients but a method to identify appropriate patients remains undefined. SummaryA reliable test to document return of function might allow safe discharge without an escort. Currently, there is intense interest in developing reliable, inexpensive, easy to administer psychomotor function testing to improve workplace safety and legally define the effects of drugs on driving impairment. Future studies may be able to adapt this technology and develop a validated test for residual anesthetic impairment.

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Validity and reliability of a driving simulator for evaluating the influence of medicinal drugs on driving performance

Cited by 8 publications

References 39 publications

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline

Driving performance of patients with epilepsy undergoing antiepileptic monotherapy

Discharging select patients without an escort after ambulatory anesthesia: identifying return to baseline function

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