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The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF. Design A prospective, randomized, controlled design. Setting Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand. Participants 210 parents of children with thalassemia (age=35.6 ± 13.1 years). Interventions The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial. Primary and secondary outcome measures Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score. 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Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial
http://hdl.handle.net/10069/39575
http://hdl.handle.net/10069/3957572e3218a-833a-4b5a-bc5d-5a60b7cb4c10
名前 / ファイル | ライセンス | アクション |
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BMJOpen9_029530.pdf (400.0 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2019-12-13 | |||||
タイトル | ||||||
タイトル | Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | comprehension | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | consent forms | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | informed consent | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | parental consent | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | pediatrics | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Koonrungsesomboon, Nut
× Koonrungsesomboon, Nut× Traivaree, Chanchai× Tiyapsane, Charnunnut× Karbwang, Juntra |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Objective This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF. Design A prospective, randomized, controlled design. Setting Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand. Participants 210 parents of children with thalassemia (age=35.6 ± 13.1 years). Interventions The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial. Primary and secondary outcome measures Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score. Results Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001). Conclusions The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information. | |||||
書誌情報 |
BMJ Open 巻 9, 号 11, p. e029530, 発行日 2019-11-26 |
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出版者 | ||||||
出版者 | BMJ Publishing Group | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 20446055 | |||||
EISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 20446055 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1136/bmjopen-2019-029530 | |||||
権利 | ||||||
権利情報 | c Author(s)(or theiremployer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | BMJ Open, 9(11), art.no.e029530; 2019 |