Evidence map›Paper›PMID 38624143›Full record

GuidelineNeuropsychopharmacology reports2024

Guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance in Japan: A tiered approach for the assessment of clinically meaningful driving impairment.

Tetsuo Nakabayashi, Kunihiro Iwamoto, Akiko Yamaguchi, Yuki Konishi, Momoe Saji, Reiji Yoshimura, Kousuke Kanemoto, Hirofumi Aoki, Masahiko Ando, Norio Ozaki

Open access · goldAbstract readGuidelineReview
In one paragraph

Guideline in Neuropsychopharmacology reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Tetsuo NakabayashiPharmaceuticals and Medical Devices Agency, Tokyo, Japan.ORCID 0000-0003-4491-4851
Kunihiro IwamotoDepartment of Psychiatry, Graduate School of Medicine, Nagoya University, Nagoya, Japan.ORCID 0000-0003-3868-3372
Akiko YamaguchiDepartment of Psychiatry, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Yuki KonishiDepartment of Psychiatry, University of Occupational and Environmental Health, Fukuoka, Japan.
Momoe SajiDepartment of Neuropsychiatry, Aichi Medical University, Nagakute, Japan.
Reiji YoshimuraDepartment of Psychiatry, University of Occupational and Environmental Health, Fukuoka, Japan.
Kousuke KanemotoDepartment of Neuropsychiatry, Aichi Medical University, Nagakute, Japan.
Hirofumi AokiInstitute of Innovation for Future Society, Nagoya University, Nagoya, Japan.
Masahiko AndoDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Norio OzakiPathophysiology of Mental Disorders, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Nagoya University · JPAichi Medical University · JPUniversity of Occupational and Environmental Health Japan · JPNagoya University Hospital · JPPharmaceuticals and Medical Devices Agency · JP

Funding

Japan Agency for Medical Research and Development 22mk0101227s0201Japan Agency for Medical Research and Development 23mk0101227s0202
6 · The paper itself

Abstract

In December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued and implemented the guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance. This guideline recommends the use of a tiered approach to assess clinically meaningful driving impairment. It is noted that adverse events cannot be solely explained by pharmacokinetics, as the onset and duration of these events vary. Among these adverse events, those affecting alertness, such as drowsiness caused by psychotropic drugs on driving performance, are more frequently observed during initial treatment stages and dose escalation. Hence, when evaluating the effects of psychotropic drugs on driving performance, it becomes crucial to assess the persistence of clinically meaningful impairment. Therefore, the MHLW guideline, developed by the authors, emphasizes the need to assess the temporal profile of adverse events affecting driving in all clinical trials. Additionally, the guideline states that when conducting driving studies, the timing of multiple dosing should consider not only the pharmacokinetics of the investigational drug but also its tolerance.

Indexed as

Automobile DrivingPsychotropic DrugsHumansJapanPsychomotor PerformancePsychotropic Drugsblood alcohol concentrationdriving impairmentguidelinespsychotropic drugstemporal profile

Identifiers

PMID38624143
PMCPMC11144615
OpenAlexW4394836263

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.