【博士論文】学術データベース

博士論文 / Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials SIDCERインフォームドコンセント書式を用いた研究参加者の内容理解改善:8件の臨床試験を用いたインフォームドコンセントのランダム化比較試験

著者

書誌事項

タイトル

Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials

タイトル別名

SIDCERインフォームドコンセント書式を用いた研究参加者の内容理解改善:8件の臨床試験を用いたインフォームドコンセントのランダム化比較試験

著者名

Koonrungsesomboon Nut

学位授与大学

Nagasaki University (長崎大学) (大学ID:0073) (CAT機関ID:KI000877)

取得学位

博士(医学)

学位授与番号

甲医歯薬第962号

学位授与年月日

2017-03-21

注記・抄録

Purpose: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. Methods: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. Results: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). Conclusions: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants’ understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

開始ページ : 141

終了ページ : 149

元資料の権利情報 : © Springer-Verlag Berlin Heidelberg 2016The final publication is available at link.springer.com

キーワード

Clinical trials, consent forms, Informed consent, Comprehension, Understanding, Clinical studies

各種コード

NII論文ID(NAID)

500001055003

NII著者ID(NRID)
  • 8000001172719
DOI (出版社)

10.1007/s00228-016-2159-1

DOI

info:doi/10.1007/s00228-016-2159-1

本文言語コード

eng

データ提供元

機関リポジトリ / NDLデジタルコレクション

DOI

博士論文 / 長崎大学 / 医学

博士論文 / 長崎大学

博士論文 / 医学

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