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Investigating the detection methods for and incidences of adverse events looked over in daily practice

Research Project

Project/Area Number 18H03032
Research Category

Grant-in-Aid for Scientific Research (B)

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

Principal Investigator

森本 剛  兵庫医科大学, 医学部, 教授 (30378640)

Co-Investigator(Kenkyū-buntansha) 作間 未織  兵庫医科大学, 医学部, 講師 (60349587)
太田 好紀  兵庫医科大学, 医学部, 講師 (10516404)
武内 治郎  兵庫医科大学, 医学部, 助教 (60791324)
Project Period (FY) 2018-04-01 – 2021-03-31
Project Status Granted (Fiscal Year 2020)
Budget Amount *help
¥17,290,000 (Direct Cost: ¥13,300,000、Indirect Cost: ¥3,990,000)
Fiscal Year 2020: ¥5,850,000 (Direct Cost: ¥4,500,000、Indirect Cost: ¥1,350,000)
Fiscal Year 2019: ¥6,630,000 (Direct Cost: ¥5,100,000、Indirect Cost: ¥1,530,000)
Fiscal Year 2018: ¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Keywords医原性有害事象 / 医療安全 / 臨床疫学 / 情報科学 / コホート研究
Outline of Annual Research Achievements

本研究課題は、入院患者や外来患者において日常的に発生していることが分かりつつある医原性有害事象について、診療中には医原性とは認識されずに見逃される、医原性有害事象の頻度や種類などの臨床疫学を明らかにし、そのリスクファクターや防止・緩和可能性を検討することを目的としている。
本年度は、前向きコホート研究のデータの詳細な分析を実施し、解析用データベースが完成した。以下は、解析用データベースから得られた結果の概要である。
前向きコホート研究に1130人(内科系診療科374人、外科系診療科530人、集中治療部門226人)の患者が登録され、平均年齢70歳、男性646人(57%)であった。カルテレビューから、潜在的な有害事象として検出された2977件について分析し、1147件の医原性有害事象が抽出された。最終的に、168件(14.6%)の有害事象が見逃されている可能性が高く、35件(3.1%)が見逃されているかどうか明らかではなく、944件(82.3%)は認識されていた。168件の内訳は薬剤性有害事象133件(79.2%)、手術関連有害事象7件(4.2%)、検査関連有害事象1件(0.6%)、医学的判断による有害事象18件(10.7%)、看護関連有害事象1件(0.6%)、管理関連有害事象8件(4.8%)であった。見逃される医原性有害事象は、意識障害などの中枢神経症状が39%と最も多く、消化器症状27%、代謝・肝機能障害が15%と続いていた。医原性有害事象の重症度では、致死的もしくは生命に関わる有害事象が9件(5.4%)、重大な有害事象が57件(33.9%)、臨床的に重要な有害事象が102件(60.7%)であった。
これにより、日常診療で見逃される医原性有害事象の全体像が明らかとなった。今後の解析を通じて、世界的に日常診療をより安全にするエビデンスを提供することが可能である。

Current Status of Research Progress
Current Status of Research Progress

2: Research has progressed on the whole more than it was originally planned.

Reason

前向きコホート研究のデータの分類が完了し、解析用データベースを作成することができた。これらのデータの解析を進めることで、日常診療で見逃される医原性有害事象の臨床疫学を明らかにすることができるだけでなく、見逃される医原性有害事象に関連するリスクファクターや防止・緩和可能性の分析に繋がると考えられる。次年度は、論文化も予定している。

Strategy for Future Research Activity

研究計画通り、前向きコホート研究の分析を進めながら、詳細な解析及び論文化を進める。また、前年度までにデータ収集を行った外来患者対象の前向きコホート研究について、データの分析及び解析用のデータベース作成を行い、見逃される医原性有害事象を外来患者においても検証する。さらに、見逃される医原性有害事象に関連する診療環境や医療提供体制に関する横断研究を実施し、前向きコホート研究で明らかとなった見逃される医原性有害事象について、要因や対策の分析を行う。
本研究は、単にデータを分析して臨床疫学データを報告するだけではなく、これらの見逃される医原性有害事象の背景にある要因や対策についても分析し、我が国のみならず、多くの先進国の医療における弱点や介入ポイントを明らかにする必要があり、常に共同研究者及び本領域の研究者との情報交換や議論を進めながら、最終的な研究目的に迫っていく予定である。

Report

(2 results)
  • 2019 Annual Research Report
  • 2018 Annual Research Report

Research Products

(25 results)

All 2020 2019 2018

All Journal Article (17 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 17 results,  Open Access: 16 results,  Acknowledgement Compliant: 2 results) Presentation (8 results) (of which Int'l Joint Research: 6 results)

  • [Journal Article] Longer term hemodialysis-dependent chronic renal failure increases the risk of post-cardiac surgery vasoplegic syndrome.2020

    • Author(s)
      Suga M, Kawakami D, Ueta H, Shimozono T, Ito J, Seo R, Nakamori Y, Korenaga A, Morimoto T, Mima H.
    • Journal Title

      Journal of Anesthesia

      Volume: 34 Pages: 243-249

    • DOI

      10.1007/s00540-019-02727-0

    • NAID

      40022213592

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Frequency and Severity of Adverse Drug Events by Medication Classes: The JADE Study.2020

    • Author(s)
      Sakuma M, Kanemoto Y, Furuse A, Bates DW, Morimoto T.
    • Journal Title

      J Patient Saf

      Volume: 印刷中 Pages: 30-35

    • DOI

      10.1097/pts.0000000000000235

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Adverse drug events due to central nervous system depressant drugs in pediatric patients with or without surgery.2020

    • Author(s)
      Yamamoto M, Ohta Y, Sakuma M, Matsumoto C, Morimoto T.
    • Journal Title

      J Pediatr Pharmacol Ther

      Volume: -

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Association between nursing care delivery models and patients' health outcomes in a university hospital: A retrospective cohort study based on the Diagnostic Procedure Combination database.2020

    • Author(s)
      Higaonna M, Morimoto T, Ueda S.
    • Journal Title

      Japan Journal of Nursing Science

      Volume: 17 Issue: 2

    • DOI

      10.1111/jjns.12319

    • NAID

      210000166873

    • ISSN
      1742-7932, 1742-7924
    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Incidence, risk factors, and outcomes for sepsis-associated delirium in patients with mechanical ventilation: A sub-analysis of a multicenter randomized controlled trial.2020

    • Author(s)
      Yamamoto T, Mizobata Y, Kawazoe Y, Miyamoto K, Ohta Y, Morimoto T, Yamamura H.
    • Journal Title

      J Crit Care

      Volume: 56 Pages: 140-144

    • DOI

      10.1016/j.jcrc.2019.12.018

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Association between heart rate on admission and in-hospital mortality among general inpatients: Insights from Japan Adverse Drug Events (JADE) Study.2019

    • Author(s)
      Yamamoto M, Ohta Y, Sakuma M, Takeuchi J, Matsumoto C, Morimoto T.
    • Journal Title

      Medicine

      Volume: 98

    • DOI

      10.1097/md.0000000000015165

    • Related Report
      2019 Annual Research Report 2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Epidemiology of adverse events and medical errors in the care of cardiology patients.2019

    • Author(s)
      Ohta Y, Miki I, Kimura T, Abe M, Sakuma M, Koike K, Morimoto T.
    • Journal Title

      Journal of Patient Safety

      Volume: 印刷中 Pages: 251-256

    • DOI

      10.1097/pts.0000000000000291

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] Effects of aspirin on risks of vascular events and cancer according to bodyweight and dose: analysis of individual patient data from randomised trials.2018

    • Author(s)
      Rothwell PM, Cook NR, Gaziano JM, Price JF, Belch JFF, Roncaglioni MC, Morimoto T, Mehta Z.
    • Journal Title

      Lancet

      Volume: 392 Pages: 387-399

    • DOI

      10.1016/s0140-6736(18)31133-4

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Effect of Aspirin on Cancer Chemoprevention in Japanese Patients With Type 2 Diabetes: 10-Year Observational Follow-up of a Randomized Controlled Trial2018

    • Author(s)
      Okada Sadanori、Morimoto Takeshi、Ogawa Hisao、Sakuma Mio、Matsumoto Chisa、Soejima Hirofumi、Nakayama Masafumi、Doi Naofumi、Jinnouchi Hideaki、Waki Masako、Masuda Izuru、Saito Yoshihiko
    • Journal Title

      Diabetes Care

      Volume: 41 Pages: 1757-1764

    • DOI

      10.2337/dc18-0368

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Clinical characteristics of pyogenic spondylitis and psoas abscess at a tertiary care hospital: a retrospective cohort study.2018

    • Author(s)
      Nakamura T, Morimoto T, Katsube K, Yamamori Y, Mashino J, Kikuchi K.
    • Journal Title

      J Orthop Surg Res

      Volume: 13 Pages: 302-302

    • DOI

      10.1186/s13018-018-1005-9

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial: rationale and study protocol for a randomised controlled trial.2018

    • Author(s)
      Yoshimura J, Yamakawa K, Kinoshita T, Ohta Y, Morimoto T.
    • Journal Title

      Trials

      Volume: 19 Pages: 614-614

    • DOI

      10.1186/s13063-018-2971-2

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Experience of receiving care by interns reduces psychological barrier of community residents to further care in Japan.2018

    • Author(s)
      Takamura A, Morimoto T.
    • Journal Title

      Rural Remote Health

      Volume: 18 Pages: 4613-4613

    • DOI

      10.22605/rrh4613

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Effect of baseline renal and hepatic function on the incidence of adverse drug events: The Japan Adverse Drug Events study.2018

    • Author(s)
      Takahashi Y, Sakuma M, Murayama H, Morimoto T.
    • Journal Title

      Drug Metab Pers Ther

      Volume: 33 Pages: 165-173

    • DOI

      10.1515/dmpt-2018-0018

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Effect of norepinephrine dosage on mortality in patients with septic shock.2018

    • Author(s)
      Yamamura Hitoshi, Kawazoe Yu, Miyamoto Kyohei, Yamamoto Tomonori, Ohta Yoshinori, Morimoto Takeshi.
    • Journal Title

      J Intensive Care

      Volume: 6 Pages: 12-12

    • DOI

      10.1186/s40560-018-0280-1

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Improving the assessment of adverse drug reactions using the Naranjo Algorithm in daily practice: The Japan Adverse Drug Events Study.2018

    • Author(s)
      Murayama Hiroki, Sakuma Mio, Takahashi Yuri, Morimoto Takeshi.
    • Journal Title

      Pharmacol Res Perspect

      Volume: 6

    • DOI

      10.1002/prp2.373

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Shorter duration of antibiotic treatment for acute bacteraemic cholangitis with successful biliary drainage: a retrospective cohort study.2018

    • Author(s)
      Doi A, Morimoto T, Iwata K.
    • Journal Title

      Clin Microbiol Infect

      Volume: 24 Pages: 1184-1189

    • DOI

      10.1016/j.cmi.2018.01.021

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Effect of dexmedetomidine on lactate clearance in patients with septic shock: A sub-analysis of a multicenter randomized controlled trial.2018

    • Author(s)
      Miyamoto Kyohei, Nakashima Tsuyoshi, Shima Nozomu, Kato Seiya, Ueda Kentaro, Kawazoe Yu, Ohta Yoshinori, Morimoto Takeshi, Yamamura Hitoshi.
    • Journal Title

      Shock

      Volume: - Pages: 162-166

    • DOI

      10.1097/shk.0000000000001055

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Presentation] The effects of preventable adverse drug events on hospital stay and healthcare costs in Japanese pediatric inpatients: The JADE Study.2019

    • Author(s)
      Sakuma M, Iwasaki H, Nakamura T, Morimoto T.
    • Organizer
      36th International Conference of the International Society for Quality in Health Care
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Antipsychotic polypharmacy was associated with multiple adverse drug events in psychiatric inpatients: The JADE Study.2019

    • Author(s)
      Ayani N, Sakuma M, Narumoto J, Morimoto T.
    • Organizer
      36th International Conference of the International Society for Quality in Health Care
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Measuring the incidence and the preventability of adverse events in pediatric inpatients in Japan: The JET Study.2018

    • Author(s)
      Sakuma M, Ohta Y, Bates DW, Morimoto T.
    • Organizer
      35th International Conference of the International Society for Quality in Health Care
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Clinical decision support system for appropriate medication orders in outpatient service.2018

    • Author(s)
      Nakamura T, Ogawa M, Sonoyama T, Morimoto T.
    • Organizer
      35th International Conference of the International Society for Quality in Health Care
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Adverse drug events and medication errors in nursing homes in Japan: The JADE Study: An interim report.2018

    • Author(s)
      Ayani N, Sakuma M, Narumoto J, Morimoto T.
    • Organizer
      35th International Conference of the International Society for Quality in Health Care
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Asian patients versus non-Asian patients in the efficacy and safety of direct oral anticoagulants relative to vitamin K antagonist for venous thromboembolism: A systemic review and meta-analysis.2018

    • Author(s)
      Yamashita Y, Morimoto T, Toyota T, Shiomi H, Makiyama T, Ono K, Kimura T.
    • Organizer
      European Society of Cardiology Congress 2018,
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 小児入院患者における鎮静や麻酔による有害事象の臨床疫学2018

    • Author(s)
      山本まるみ,森本剛
    • Organizer
      第9回日本プライマリ・ケア連合学会学術大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] 市中病院の入院患者において、研修医が担当することによる患者アウトカムへの影響2018

    • Author(s)
      岡野裕紀,森本剛
    • Organizer
      第9回日本プライマリ・ケア連合学会学術大会
    • Related Report
      2018 Annual Research Report

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Published: 2018-04-23   Modified: 2021-01-27  

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