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

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Abstract

Rationale

Although driving simulators (DS) are receiving increasing attention due to concern over traffic accidents under the influences of drugs, few DS are recognized for their reliability and validity. Therefore, the development of an evaluation system using DS for driving performance is urgently needed.

Objectives

To investigate whether the standard deviation of lateral position (SDLP) increases with blood alcohol concentration (BAC) using a DS with reliability and calculate the SDLP threshold from the difference between BAC levels of 0 and 0.05%.

Methods

Twenty healthy Japanese men performed the DS tasks up to 60 min in Study 1 and DS tasks twice at 1-week intervals in Study 2. Twenty-six healthy men conducted the same DS tasks under BAC level (0, 0.025, 0.05, and 0.09%) in double-blind, randomized, crossover trial in Study 3. The primary outcome was SDLP in a road-tracking test. The test–retest reliability of DS data was assessed, and the estimated difference in SDLP between BAC levels of 0 and 0.05% was calculated using a linear regression model.

Results

The cumulative SDLP values at 5-min intervals were stable, and the intraclass correlation coefficient for its values was 0.93. SDLP increased with BAC in a concentration-dependent manner. The predicted ΔSDLP value for the difference between BAC levels of 0 and 0.05% was 9.23 cm. No participants dropped out because of simulator sickness.

Conclusions

The new DS used in these studies has reliability, validity, and tolerability and is considered suitable for evaluating the influence of drugs on driving performance.

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Acknowledgments

This trial was supported by Taisho Pharmaceutical Company, Ltd.; Research on Regulatory Science of Pharmaceuticals and Medical Devices from the Japan Agency for Medical Research and Development (JP20mk0101137h0002); research grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan; the Ministry of Health, Labour and Welfare of Japan; and a Grant-in-Aid from the “Center of Innovation for Personalized and Diverse Society” carried out under the Center of Innovation Program from the Japan Science and Technology Agency.

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Author notes

  1. Mari Iwata and Kunihiro Iwamoto contributed equally to this paper

Authors and Affiliations

  1. Department of Psychiatry, Nagoya University, Graduate School of Medicine, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan

    Mari Iwata, Kunihiro Iwamoto & Norio Ozaki

  2. Taisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan

    Iwao Kitajima, Takasuke Nogi, Koichi Onishi, Yu Kajiyama & Izumi Nishino

  3. Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Aichi, 466-8560, Japan

    Masahiko Ando

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Correspondence to Kunihiro Iwamoto.

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Conflict of interest

MI has no conflicts of interest to declare. KI has received speakers’ honoraria from or has served as a consultant to Dainippon Sumitomo, Janssen, Meiji Seika Pharma, Mochida, Otsuka, Taisho, Towa, and Pfizer. IK, TN, KO, YK and IN are employees of Taisho Pharmaceutical Co., Ltd., Japan. MA has received subsidies from Kyowa Kirin. NO has received research support or speakers’ honoraria from or has served as a consultant to Abbvie, Asahi Kasei Pharma, Astellas, Dainippon Sumitomo, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Meiji Seika Pharma, Mochida, MSD, Novartis Pharma, Ono, Otsuka, Pfizer, Shionogi, Takeda, Tanabe Mitsubishi, Sanofi, and Yoshitomi.

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Iwata, M., Iwamoto, K., Kitajima, I. et al. Validity and reliability of a driving simulator for evaluating the influence of medicinal drugs on driving performance. Psychopharmacology 238, 775–786 (2021). https://doi.org/10.1007/s00213-020-05730-6

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