{"created":"2023-06-20T15:46:16.703533+00:00","id":867,"links":{},"metadata":{"_buckets":{"deposit":"3b7302f0-cca8-43cc-a255-b439c3b1fe16"},"_deposit":{"created_by":4,"id":"867","owners":[4],"pid":{"revision_id":0,"type":"depid","value":"867"},"status":"published"},"_oai":{"id":"oai:uoeh-u.repo.nii.ac.jp:00000867","sets":["13:21:47"]},"author_link":["3768","3769","3767","3764","3766","3771","3773","3772","3765","3770"],"item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2020-03-01","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"82","bibliographicPageStart":"77","bibliographicVolumeNumber":"42","bibliographic_titles":[{"bibliographic_title":"産業医科大学雑誌"},{"bibliographic_title":"Journl of UOEH","bibliographic_titleLang":"en"}]}]},"item_10001_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"無作為化比較研究（RCT）は医学研究における因果効果推計の最も信頼性の高い研究デザインに位置付けられている．RCTの信頼性が担保されるためには，無作為化割付のプロセスが適切に実施される必要がある．そのための必要な手続きには，1）ランダム化の順番の作成，2）割付の隠蔵，3）割付の実施が適切に実施されなければならない．これらを管理するため中央事務局方式や封筒法・番号付き容器法などの方法が採用されている．医師主導型の臨床研究や比較的小規模な臨床研究においては，予算上の都合から，封筒法・番号付き容器法が多く採用されている．しかしながら，これらの方法は適切なRCTの実施が担保されない．そこで小規模に実施される臨床研究において実施可能なRCTの割付を管理する新しい方法として割付管理帳票を考案した．本稿では，RCTの適切な実施に必要な手続きの観点から，従来の方法との比較を行い，割付管理帳票の利点および限界について考察した．","subitem_description_type":"Abstract"},{"subitem_description":"Randomized controlled trials (RCT) are the most reliable study design for causality estimation in medical research. Proper implementation of the process of randomization is necessary to ensure the reliability of RCT. In order to do so, 1) generation of randomization sequence, 2) allocation concealment, and 3) allocation must be properly implemented. Methods such as the central secretariat method, the envelope method, and the sequentially numbered container method are adopted to secure proper implementation. For investigator-initiated clinical research and relatively small-scale clinical research, the envelope method and the sequentially numbered container method are often adopted because of budgetary reasons, but these methods do not assure the implementation of proper RCT. Therefore, we designed an assignment management note system as a new method to manage the assignment of RCT that can be implemented in small scale clinical research. In this paper, we compare the assignment management note system with the conventional method from the viewpoint of the procedure necessary for the proper implementation of RCT, and discuss the advantages and limitations of the assignment management note system. ","subitem_description_type":"Abstract"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"産業医科大学（産業医科大学学会）"}]},"item_10001_relation_17":{"attribute_name":"関連サイト","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_text":"Journal of UOEH　"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://www.uoeh-u.ac.jp/kouza/journal/intro_e.html","subitem_relation_type_select":"URI"}},{"subitem_relation_name":[{"subitem_relation_name_text":"産業医科大学雑誌"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://www.uoeh-u.ac.jp/kouza/journal/intro_j.html","subitem_relation_type_select":"URI"}}]},"item_10001_select_24":{"attribute_name":"記事区分","attribute_value_mlt":[{"subitem_select_item":"その他"}]},"item_10001_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"ISSN  0387-821X(PRINT), ISSN  2187-2864(ONLINE)","subitem_source_identifier_type":"ISSN"}]},"item_10001_version_type_20":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"藤野 , 善久"},{"creatorName":"フジノ, ヨシヒサ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"3764","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"丹澤 , 和雅"},{"creatorName":"タンザワ, カズマサ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"3765","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"村松　, 圭司"},{"creatorName":"ムラマツ, ケイジ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"3766","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"大谷 , 誠"},{"creatorName":"オオタニ, マコト","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"3767","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"久保 , 達彦"},{"creatorName":"クボ, タツヒコ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"3768","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Fujino, Yoshihisa ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"3769","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Tanzawa, Kazumasa ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"3770","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Muramatsu, Keiji ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"3771","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Otani, Makoto ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"3772","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Kubo, Tatsuhiko ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"3773","nameIdentifierScheme":"WEKO"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2020-06-25"}],"displaytype":"detail","filename":"08-藤野善久.pdf","filesize":[{"value":"1.7 MB"}],"format":"application/pdf","licensetype":"license_11","mimetype":"application/pdf","url":{"label":"S00042108","url":"https://uoeh-u.repo.nii.ac.jp/record/867/files/08-藤野善久.pdf"},"version_id":"9788fd77-4938-4c38-95cb-4fab0ce7ee17"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"無作為化比較研究","subitem_subject_scheme":"Other"},{"subitem_subject":"ランダム割付","subitem_subject_scheme":"Other"},{"subitem_subject":"医師主導型臨床研究","subitem_subject_scheme":"Other"},{"subitem_subject":"randomized controlled trial","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"random allocation","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"investigator-initiated clinical research","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"ランダム化比較試験における割付管理のための方法に関する発案","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"ランダム化比較試験における割付管理のための方法に関する発案"},{"subitem_title":"Development of a Method for Assignment Control in Randomized Controlled Trials","subitem_title_language":"en"}]},"item_type_id":"10001","owner":"4","path":["47"],"pubdate":{"attribute_name":"公開日","attribute_value":"2020-06-30"},"publish_date":"2020-06-30","publish_status":"0","recid":"867","relation_version_is_last":true,"title":["ランダム化比較試験における割付管理のための方法に関する発案"],"weko_creator_id":"4","weko_shared_id":-1},"updated":"2023-06-20T15:54:54.818461+00:00"}