Research on design of clinical trials where competing risks should be taken into account to evaluate time to event data

• Project/Area Number: 26330055
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Statistical science
• Research Institution: Jikei University School of Medicine
• Principal Investigator: Nishikawa Masako 東京慈恵会医科大学, 医学部, 教授 (50373395)
• Co-Investigator(Kenkyū-buntansha): 筒井 孝子 兵庫県立大学, 経営研究科, 教授 (20300923) ; 大夛賀 政昭 国立保健医療科学院, 医療・福祉サービス研究部, 主任研究官 (90619115)
• Project Period (FY): 2014-04-01 – 2018-03-31
• Project Status: Completed (Fiscal Year 2017)
• Budget Amount: ¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000); Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000); Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
• Keywords: 医療・福祉 / 医薬生物統計 / 臨床試験 / 医療評価 / 医療統計

Outline of Final Research Achievements

In clinical trials, there is a problem of competing risks. Longitudinal data often suffer from missing due to several reasons. We treated such reasons as competing risks to data to be observed, and considered a trial design and methods for evaluation. We improved conventional method of evaluation by introducing a new concept of beneficial effect for patients, and reported the results at international conferences. For hospitalized patients, the reason of discharge from hospital is not always due to improved condition. Some are worsening, and others are death. These reasons are competing risks. We considered an appropriate analysis to explore the association between intensity of nursing care needs indexes and cause-specific discharge from hospital taking the competing risks into account and reported the results at international conferences.

Research Products

• [Journal Article] Synergistic effects of remote perconditioning with terminal blood cardioplegia in an in vivo piglet model. (2017)
  • Author(s): Takayuki Abe, Kiyozo Morita, Gen Shinohara, Kazuhiro Hashimoto and Masako Nishikawa.
  • Journal Title: European Journal of Cardio-Thoracic Surgery Volume: 52 Issue: 3 Pages: 479-484
  • DOI: 10.1093/ejcts/ezx198
  • Peer Reviewed
• [Presentation] Analysis of cause-specific hazards for discharge of hospitalized patients in acute phase hospitals in Japan using intensity of nursing care needs indexes as time-dependent variables (2018)
  • Author(s): Otaga M, Nishikawa M, Tsutsui T.
  • Organizer: International Biometric Conference 2018
  • Int'l Joint Research
• [Presentation] 看護必要度データを用いた急性期医療機関における入院患者の退院理由別予測の検討. (2017)
  • Author(s): 西川正子. 大夛賀政昭, 筒井孝子.
  • Organizer: 第76回日本公衆衛生学会
• [Presentation] Analysis of cause-specific hazards using time-dependent variables and delayed entry for discharge in hospitalized patients in Japan's acute hospital- Utilization of intensity of nursing care needs indexes - (2017)
  • Author(s): Nishikawa M, Otaga M, Tsutsui T.
  • Organizer: 2017 CSA-KSS-JSS(Chinese Statistical Association（Taiwan）- Korean Statistical Society - Japanese Statistical Society ) International Statistical Symposium.
  • Int'l Joint Research / Invited
• [Presentation] New concept of non-inferiority test from the point of effectiveness (2016)
  • Author(s): Nishikawa, Kiyomi, Tango.
  • Organizer: XXVIIIth International Biometric Conference
  • Place of Presentation: Victoria, British Columbia, Canada
  • Year and Date: 2016-07-10
  • Int'l Joint Research
• [Presentation] 個体内変動係数の比較：対応のあるデータで個体間変動が Measure 間で異なる場合 (2016)
  • Author(s): 清見文明, 西川正子,吉田陽一郎, 野田慶太.
  • Organizer: 日本計算機統計学会第30回大会
  • Place of Presentation: 京都
  • Year and Date: 2016-05-19
• [Presentation] Primary effectiveness analysis in non-inferiority study when longitudinal data may be missing (2015)
  • Author(s): Nishikawa, Kiyomi, Tango
  • Organizer: East Asia Regional Biometric Conference 2015
  • Place of Presentation: Fukuoka, 福岡市
  • Year and Date: 2015-12-20
  • Int'l Joint Research
• [Presentation] Primary effectiveness analysis when longitudinal data may not be followed completely (2015)
  • Author(s): Masako Nishikawa
  • Organizer: The 36th Annual Conference of the International Society for Clinical Biostatistics
  • Place of Presentation: Utrecht, オランダ
  • Year and Date: 2015-08-23
  • Int'l Joint Research
• [Presentation] 部分区間打ち切りデータに対する'IntCox' の適用の問題について. (2014)
  • Author(s): 西川正子, 森川敏彦, 水上英也, 横山徹爾.
  • Organizer: 日本計算機統計学会 第28回シンポジウム.
  • Place of Presentation: 沖縄科学技術大学院大学（沖縄県･恩納村）
  • Year and Date: 2014-11-14 – 2014-11-15
• [Presentation] The analysis of multiple events in cohort study. (2014)
  • Author(s): Matsuba, Nishikawa, Yokoyama.
  • Organizer: XXVII International Biometric Conference.
  • Place of Presentation: Florence, イタリア
  • Year and Date: 2014-07-06 – 2014-07-11
• [Book] 新版 医学統計学ハンドブック． (2018)
  • Author(s): 丹後俊郎，松井茂之，編集．著者五十音順 井元, 植木, 牛嶋, 金森, 川口, 久保川, 小西, 小森, 佐藤健一, 佐藤俊哉, 大門, 高橋, 田中, 田宮, 丹後, 手良向, 内藤, 西浦, 西川正子,他14名
  • Total Pages: 868
  • Publisher: 朝倉書店