Development of standardization technique for clinical research data combining deep learning and semantic analysis

• Project/Area Number: 17K15866
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical and hospital managemen
• Research Institution: Hokkaido University (2018-2022); Kagawa University (2017)
• Principal Investigator: Nishimoto Naoki 北海道大学, 大学病院, 特任准教授 (90599630)
• Project Period (FY): 2017-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000); Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2018: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2017: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
• Keywords: RPA / 深層学習 / マッピング / 臨床研究 / 標準化 / Deep learning / 自然言語処理 / データベース / 変数 / CDISC SDTM / Semantic integration / SPARQL / RDF / CDISC / 変数mapping / 標準 / Java / Python / 仮想化技術 / 生物統計学 / 機械学習 / SDTM / ADaM / Lua / 電子カルテ / 医療情報学 / 生体生命情報学

Outline of Final Research Achievements

Data standardization is necessary for statistical analysis of medical data. The aim of our study was to survey mapping feasibility and developing technique on conversion to existing data standards. As a result of our research, we confirmed approximately 20% improvement in accuracy against simply performing 1-to-1 matching conversion. Based on the program that we created, we trained clinical trial data managers on how to automate their own work.

Academic Significance and Societal Importance of the Research Achievements

本研究の成果は、機械的な辞書を用いた項目の標準化よりも、深層学習を用いた曖昧な記述に対するコード付与が可能であることを明らかにし、その精度を向上することができた。本研究で得られたプログラミングの知識は、robotic process automationとして北海道大学病院データセンターにてデータマネージャの教育に利用した。データマネージャに還元することで、臨床試験の立ち上げから実施、試験終了の手順を加速化させることが期待される。

Research Products

• [Journal Article] Status of the Current Treatment Options and Potential Future Targets in Uterine Leiomyosarcoma: A Review (2022)
  • Author(s): Asano Hiroshi、Isoe Toshiyuki、Ito Yoichi M.、Nishimoto Naoki、Watanabe Yudai、Yokoshiki Saki、Watari Hidemichi
  • Journal Title: Cancers Volume: 14 Issue: 5 Pages: 1180-1180
  • DOI: 10.3390/cancers14051180
• [Journal Article] リハビリテーション職種が知っておくべき臨床統計 基礎から最新の話題まで 14.診断法の統計的評価（感度・特異度・ROC曲線等） (2021)
  • Author(s): 西本 尚樹
  • Journal Title: Journal of Clinical Rehabilitation Volume: 30(12) Pages: 1259-1259
• [Journal Article] Validation of a two‐step approach combining serum biomarkers and liver stiffness measurement to predict advanced fibrosis (2021)
  • Author(s): Fujii Hideki、Enomoto Masaru、Fukumoto Shinya、Kimura Tatsuo、Nadatani Yuji、Takashima Shingo、Hagihara Atsushi、Uchida‐Kobayashi Sawako、Tamori Akihiro、Nishimoto Naoki、Kawada Norifumi
  • Journal Title: JGH Open Volume: 5 Issue: 7 Pages: 801-808
  • DOI: 10.1002/jgh3.12590
  • Peer Reviewed / Open Access
• [Journal Article] The FibroScan-aspartate aminotransferase score can stratify the disease severity in a Japanese cohort with fatty liver diseases (2021)
  • Author(s): Fujii Hideki、Fukumoto Shinya、Enomoto Masaru、Uchida-Kobayashi Sawako、Kimura Tatsuo、Tamori Akihiro、Nadatani Yuji、Takashima Shingo、Nishimoto Naoki、Kawada Norifumi
  • Journal Title: Scientific Reports Volume: 11 Issue: 1 Pages: 13844-13844
  • DOI: 10.1038/s41598-021-93435-x
  • Peer Reviewed / Open Access
• [Journal Article] Multiple system atrophy in Hokkaido, Japan: a prospective registry study of natural history and symptom assessment scales followed for 5 years (2021)
  • Author(s): Matsushima Masaaki、Yabe Ichiro、Sakushima Ken、Kanatani Yasuhiro、Nishimoto Naoki、Matsuoka Takeshi、Sawada Jun、Uesugi Haruo、Sako Kazuya、Takei Asako、Tamakoshi Akiko、Shimohama Shun、Sato Norihiro、Kikuchi Seiji、Sasaki Hidenao
  • Journal Title: BMJ Open Volume: 11 Issue: 2 Pages: e045100-e045100
  • DOI: 10.1136/bmjopen-2020-045100
  • NAID: 120006960641
  • Peer Reviewed
• [Journal Article] Improved time in range and postprandial hyperglycemia with canagliflozin in combination with teneligliptin: Secondary analyses of the CALMER study (2021)
  • Author(s): Cho Kyu Yong、Nomoto Hiroshi、Nakamura Akinobu、Kawata Shinichiro、Sugawara Hajime、Takeuchi Jun、Nagai So、Omori Kazuno、Tsuchida Kazuhisa、Miya Aika、Shigesawa Ikumi、Tsuchida Kenichi、Yanagiya Shingo、Kameda Hiraku、Yokoyama Hiroki、Taneda Shinji、Kurihara Yoshio、Aoki Shin、Nishimoto Naoki, et.al.
  • Journal Title: Journal of Diabetes Investigation Volume: NA Issue: 8 Pages: 1417-1424
  • DOI: 10.1111/jdi.13498
  • NAID: 120007160290
  • Peer Reviewed
• [Journal Article] Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial (2020)
  • Author(s): Fujieda Yuichiro、Horita Tetsuya、Nishimoto Naoki、Tanimura Kazuhide、Amasaki Yoshiharu、Kasahara Hideki、Furukawa Shin、Takeda Tsuyoshi、Fukaya Shinji、Matsui Kazuo、Tsutsumi Akito、Furusaki Akira、Sagawa Akira、Katayama Kou、Takeuchi Kaoru、Katsumata Kazuaki、Kurita Takashi、Shane Peter、Kato Masaru、Oku Kenji
  • Journal Title: Modern Rheumatology Volume: 1 Issue: 3 Pages: 1-7
  • DOI: 10.1080/14397595.2020.1812835
  • Peer Reviewed
• [Journal Article] Chest Compression Depth and Rate ― Effect on Instructor Visual Assessment of Chest Compression Quality ― (2019)
  • Author(s): Nagafuchi Katsuya、Hifumi Toru、Nishimoto Naoki、Kondo Yutaka、Yoshikawa Kei、Iwami Taku、Kuroda Yasuhiro
  • Journal Title: Circulation Journal Volume: 83 Issue: 2 Pages: 418-423
  • DOI: 10.1253/circj.CJ-18-0952
  • NAID: 130007557086
  • ISSN: 1346-9843, 1347-4820
  • Year and Date: 2019-01-25
  • Peer Reviewed / Open Access
• [Journal Article] The Influence for Image Quality of Diffusion Weighted Image by Gradient Coil Systems (2019)
  • Author(s): 山崎達也. 小川和郎. 石森隆司. 西本尚樹
  • Journal Title: Japanese Journal of Radiological Technology Volume: 75 Issue: 4 Pages: 314-321
  • DOI: 10.6009/jjrt.2019_JSRT_75.4.314
  • NAID: 130007635224
  • ISSN: 0369-4305, 1881-4883
  • Peer Reviewed
• [Journal Article] Behavior problems and dysfunctional parenting: a cross-sectional study in Japan (2019)
  • Author(s): Hiromi Suzuki. Yoda, Takeshi. Kanda, Kanae. Nishimoto, Naoki. Miyatake, Nobuyuki. Konishi, Yukihiko. Nishida, Tomoko. Yokoyama, Katsunori. Kusaka, Takashi. Tomohiro, Hirao
  • Journal Title: Pediatrics International Volume: 61(11) Issue: 11 Pages: 1096-1102
  • DOI: 10.1111/ped.13980
  • Peer Reviewed
• [Journal Article] HOMA-IR: An independent predictor of advanced liver fibrosis in nondiabetic non-alcoholic fatty liver disease. (2019)
  • Author(s): Fujii H, Yoneda M, et al.
  • Journal Title: J Gastroenterol Hepatol. Volume: in press Issue: 8 Pages: 1-6
  • DOI: 10.1111/jgh.14595
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Mild decrease in heart rate during early phase of targeted temperature management following tachycardia on admission is associated with unfavorable neurological outcomes after severe traumatic brain injury: a post hoc analysis of a multicenter randomized controlled trial (2018)
  • Author(s): Inoue Akihiko、on behalf of the Brain Hypothermia (B-HYPO) Study Group in Japan、Hifumi Toru、Kuroda Yasuhiro、Nishimoto Naoki、Kawakita Kenya、Yamashita Susumu、Oda Yasutaka、Dohi Kenji、Kobata Hitoshi、Suehiro Eiichi、Maekawa Tsuyoshi
  • Journal Title: Critical Care Volume: 22 Issue: 1 Pages: 352-352
  • DOI: 10.1186/s13054-018-2276-6
  • Peer Reviewed / Open Access
• [Presentation] 高度なIT関連およびプログラミングの知識を有さずともDXを推進するためのPower Automate Desktopを用いた試み (2023)
  • Author(s): 深瀧 恭子,西本 尚樹,吉永 和美,齊藤 栄子,北山 香織理,森木 亜希,伊藤 陽一,樋之津 史郎
  • Organizer: 日本臨床試験学会第14回学術集会総会in金沢
• [Presentation] 臨床試験データセンターにおけるrobotic process automation可能なプロセスの抽出とデータマネージャへの教育 (2022)
  • Author(s): 西本 尚樹,吉永 和美, 齊藤 栄子, 北山 香織理, 森木 亜希, 伊藤 陽一
  • Organizer: 第42回日本医療情報学会学術大会医療情報学連合大会
• [Presentation] 臨床試験データセンターにおけるPythonを用いたrobotic process automationの試行 (2021)
  • Author(s): 西本 尚樹、吉永 和美、 齊藤 栄子、 北山 香織理、 森木 亜希、 深瀧 恭子、 伊藤 陽一
  • Organizer: 第13回日本臨床試験学会総会
• [Presentation] サンプルデータを用いた臨床研究の解析用データベース定義書生成の試み (2021)
  • Author(s): 西本 尚樹、伊藤 陽一、吉永 和美 様、齊藤 栄子、北山 香織理、森木 亜希.
  • Organizer: 第4回北海道支部会オンライン学術大会
• [Presentation] EDCに対する臨床検査値転送システムの導入効果を評価する研究デザインの課題 (2018)
  • Author(s): 西本尚樹、國方淳、横井英人
  • Organizer: 第38回日本医療情報学連合大会
• [Presentation] Estimating sample size for a feasibility study of computer-assisted input support to EDC (2017)
  • Author(s): Naoki Nishimoto, Naomi Tamura, Jun Kunikata, Sumiko Akahori, Tomoaki Sogo, Yuma Tani, Hideto Yokoi
  • Organizer: MEDINFO2017
  • Int'l Joint Research
• [Presentation] 電子カルテデータにおいて発現が観察されない有害事象割合の推定 (2017)
  • Author(s): 西本尚樹, 田村菜穂美2, 谷川原綾子, 横井英人
  • Organizer: 第38回中国四国医療情報学研究会
• [Presentation] Calculation of statistical power in multi-reader, multi-case ROC analysis (2017)
  • Author(s): Naoki Nishimoto, Jun Kunikata, Koji Uemura, Sumiko Akahori, Tomoaki Sogo, Yuma Tani, Hideto Yokoi
  • Organizer: The 3rd International Conference on Radiological Science and Technology
  • Int'l Joint Research
• [Book] 臨床研究アウトプット術 (2020)
  • Author(s): 前田圭介, 室谷健太(編集), 西本 尚樹, 他
  • Total Pages: 386
  • Publisher: 中外医学社
  • ISBN: 9784498048782