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Clinical prediction rule to identify high-risk inpatients for adverse drug events and medication errors in pediatric inpatients

Research Project

Project/Area Number 20K10364
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 58010:Medical management and medical sociology-related
Research InstitutionHyogo Medical University

Principal Investigator

Sakuma Mio  兵庫医科大学, 医学部, 准教授 (60349587)

Co-Investigator(Kenkyū-buntansha) 井田 博幸  東京慈恵会医科大学, 医学部, 教授 (90167255)
森本 剛  兵庫医科大学, 医学部, 教授 (30378640)
武内 治郎  兵庫医科大学, 医学部, 助教 (60791324)
Project Period (FY) 2020-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2022: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2021: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2020: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Keywords薬剤性有害事象 / 薬剤関連エラー / 小児 / 医療の質 / 予測モデル / コホート研究 / 医療安全
Outline of Research at the Start

欧米を中心に医療安全に関する様々な研究や対策が精力的に実施されているが、依然として医療安全は世界的に喫緊の課題である。医原性有害事象の発生頻度を減らすには、それらの発生状況や重症度、エラーの有無など、各事象固有の特性を明らかにし、何がどのような患者に起こりやすいのか、事象特性に応じた患者リスクの同定が不可欠である。研究代表者は、より効果的な医原性有害事象予防を目的に、医原性有害事象のうち最も頻度が高い薬剤性有害事象に注目し、本邦の小児入院患者における薬剤性有害事象並びに薬剤関連エラーの詳細な分析による事象特性の解明と、その事象特性に応じた発生予測モデルの作成及びモデル精度の検証を行う。

Outline of Final Research Achievements

We investigated the detailed clinical epidemiology of adverse drug events (ADEs) and medication errors in pediatric inpatients in Japan, and developed prediction models based on these findings. Our study included 704 pediatric inpatients, and we identified 364 ADEs in 166 patients (24%) and 440 medication errors in 213 patients (30%). Of these errors, 29 resulted in harm, thus, approximately 7% of medical errors resulted in ADEs. Our findings and various prediction models developed based on these findings could contribute to further improvement of safer pediatric care by identifying the high-risk patients or high-risk situations of ADEs and medication errors in pediatric healthcare settings.

Academic Significance and Societal Importance of the Research Achievements

小児入院患者においても高頻度で発生していることが明らかになりつつある医原性有害事象の中で、特に頻度が高い薬剤性有害事象に着目し、小児病棟で発生する薬剤製有害事象及び薬剤関連エラーの頻度や発生状況などの詳細な臨床疫学を明らかにした。更に、それらの結果を基に、各種の事象予測モデルを作成し、どのような患者が薬剤性有害事象や薬剤関連エラーをより経験する傾向にあるのか、ハイリスク患者の同定を試みた。本研究の結果は、小児診療をより安全にするための学術的基盤として、小児診療のさらなる質の向上に貢献することが期待される。

Report

(5 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Research-status Report
  • 2021 Research-status Report
  • 2020 Research-status Report
  • Research Products

    (19 results)

All 2024 2023 2022 2021 2020

All Journal Article (8 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 8 results,  Open Access: 8 results) Presentation (11 results) (of which Int'l Joint Research: 5 results)

  • [Journal Article] Adverse Events in Pediatric Inpatients: The Japan Adverse Event Study2024

    • Author(s)
      Sakuma Mio、Ohta Yoshinori、Takeuchi Jiro、Yuza Yuki、Ida Hiroyuki、Bates David W.、Morimoto Takeshi
    • Journal Title

      Journal of Patient Safety

      Volume: 20 Issue: 1 Pages: 38-44

    • DOI

      10.1097/pts.0000000000001180

    • Related Report
      2023 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Patient-reported outcomes for quality of care among pediatric patients2023

    • Author(s)
      Sakuma Mio、Morimoto Takeshi
    • Journal Title

      International Journal for Quality in Health Care

      Volume: 35 Issue: 2

    • DOI

      10.1093/intqhc/mzad020

    • Related Report
      2023 Annual Research Report 2022 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Monitoring for adverse drug events of high-risk medications with a computerized clinical decision support system: a prospective cohort study2023

    • Author(s)
      Nezu Mari、Sakuma Mio、Nakamura Tsukasa、Sonoyama Tomohiro、Matsumoto Chisa、Takeuchi Jiro、Ohta Yoshinori、Kosaka Shinji、Morimoto Takeshi
    • Journal Title

      International Journal for Quality in Health Care

      Volume: 35 Issue: 4

    • DOI

      10.1093/intqhc/mzad095

    • Related Report
      2023 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Effectiveness of a computerized clinical decision support system for prevention of glucocorticoid-induced osteoporosis2022

    • Author(s)
      Morikawa Toru、Sakuma Mio、Nakamura Tsukasa、Sonoyama Tomohiro、Matsumoto Chisa、Takeuchi Jiro、Ohta Yoshinori、Kosaka Shinji、Morimoto Takeshi
    • Journal Title

      Scientific Reports

      Volume: 12 Issue: 1 Pages: 14967-14967

    • DOI

      10.1038/s41598-022-19079-7

    • Related Report
      2022 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Epidemiology of adverse drug events and medication errors in four nursing homes in Japan : the Japan Adverse Drug Events (JADE) Study2022

    • Author(s)
      Nobutaka Ayani, Nozomu Oya, Riki Kitaoka, Akiko Kuwahara, Takeshi Morimoto, Mio Sakuma, Jin Narumoto
    • Journal Title

      BMJ Quality & Safety

      Volume: 31 Issue: 12 Pages: 878-887

    • DOI

      10.1136/bmjqs-2021-014280

    • Related Report
      2022 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Low Serum Total Protein at Admission Predicts in-Hospital Mortality Among General Inpatients: Historical Cohort Study2022

    • Author(s)
      Inoue Miharu、Takeuchi Jiro、Sakuma Mio、Nakamura Tsukasa、Morimoto Takeshi
    • Journal Title

      International Journal of General Medicine

      Volume: 15 Pages: 7941-7949

    • DOI

      10.2147/ijgm.s385798

    • Related Report
      2022 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] The Burden of Preventable Adverse Drug Events on Hospital Stay and Healthcare Costs in Japanese Pediatric Inpatients: The JADE Study.2021

    • Author(s)
      Iwasaki H, Sakuma M, Ida H, Morimoto T.
    • Journal Title

      Clinical Medicine Insights: Pediatrics

      Volume: 15 Pages: 1-8

    • DOI

      10.1177/1179556521995833

    • Related Report
      2021 Research-status Report 2020 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Differences in adverse drug events and medication errors among pediatric inpatients aged <3 and ≧3 years: The JADE study2021

    • Author(s)
      Takeuchi Jiro、Sakuma Mio、Ohta Yoshinori、Ida Hiroyuki、Morimoto Takeshi
    • Journal Title

      Journal of Patient Safety and Risk Management

      Volume: 26 Issue: 6 Pages: 261-266

    • DOI

      10.1177/25160435211046764

    • Related Report
      2021 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] Medical errors and error-related adverse events in pediatric inpatients in Japan: The JET Study2023

    • Author(s)
      Sakuma Mio, Takeuchi Jiro, Ohta Yoshinori, Morimoto Takeshi
    • Organizer
      39th International Conference of the International Society for Quality in Health Care
    • Related Report
      2023 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Computerized clinical decision support system to adhere to pre-prescription examinations for high-risk drugs2023

    • Author(s)
      Nezu Mari, Nakamura Toru, Sakuma Mio, Morimoto Takeshi
    • Organizer
      39th International Conference of the International Society for Quality in Health Care
    • Related Report
      2023 Annual Research Report
    • Int'l Joint Research
  • [Presentation] The Incidence and characteristics of adverse events in pediatric inpatients in Japan: The JET Study2022

    • Author(s)
      Sakuma Mio、Takeuchi Jiro、Ohta Yoshinori、Morimoto Takeshi
    • Organizer
      38th International Conference of the International Society for Quality in Health Care
    • Related Report
      2022 Research-status Report
    • Int'l Joint Research
  • [Presentation] The Epidemiology of unidentified adverse events in Japan: The JET Study2022

    • Author(s)
      Ohta Yoshinori、Sakuma Mio、Nakamura Tsukasa、Morimoto Takeshi
    • Organizer
      38th International Conference of the International Society for Quality in Health Care
    • Related Report
      2022 Research-status Report
    • Int'l Joint Research
  • [Presentation] Clinical epidemiology in violence and violation in psychiatric inpatients: The GUARD Study: An interim report2022

    • Author(s)
      Ayani Nobutaka、Sakuma Mio、Narumoto Jin、Morimoto Takeshi
    • Organizer
      38th International Conference of the International Society for Quality in Health Care
    • Related Report
      2022 Research-status Report
    • Int'l Joint Research
  • [Presentation] 小児入院患者における医原性有害事象及び医療関連エラーの疫学Ⅱ:the JET Study2022

    • Author(s)
      作間 未織、武内 治郎、湯坐 有希、井田 博幸、森本 剛
    • Organizer
      第125回日本小児科学会学術集会
    • Related Report
      2022 Research-status Report
  • [Presentation] 臨床研究トレーニングに組み入れ可能な能動的研究倫理学習プログラム-研究を実践する診療現場の医療従事者を対象とした教育実践2022

    • Author(s)
      作間 未織、西村 理恵、武内 治郎、内田 和孝、金城 典人、榊原 史啓、根津 麻里、東恩納 美樹、中村 嗣、小阪 真二、吉村 紳一、植田 真一郎、森本 剛
    • Organizer
      第125回日本小児科学会学術集会
    • Related Report
      2022 Research-status Report
  • [Presentation] 児童・思春期精神科病棟入院患者における粗暴・違反行為の疫学:the JET Study2022

    • Author(s)
      武内 治郎、作間 未織、綾仁 信貴、湯坐 有希、井田 博幸、森本 剛
    • Organizer
      第125回日本小児科学会学術集会
    • Related Report
      2022 Research-status Report
  • [Presentation] 小児入院患者における医原性有害事象及び医療関連エラーの検討:the JET Study.2021

    • Author(s)
      作間未織、武内治郎、湯坐有希、井田博幸、森本剛
    • Organizer
      第124回日本小児科学会学術集会
    • Related Report
      2021 Research-status Report
  • [Presentation] 小児入院患者における薬剤性有害事象及び薬剤関連エラーの年齢群別検討:the JEDE Study.2021

    • Author(s)
      武内治郎、作間未織、井田博幸、森本剛
    • Organizer
      第124回日本小児科学会学術集会
    • Related Report
      2021 Research-status Report
  • [Presentation] 小児入院患者における医原性有害事象及びエラーの疫学:the JET Study2020

    • Author(s)
      作間未織、武内治郎、湯坐有希、井田博幸、森本剛
    • Organizer
      第123回日本小児科学会学術集会
    • Related Report
      2020 Research-status Report

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Published: 2020-04-28   Modified: 2025-01-30  

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