患者に情報を提供し,害を及ぼさない患者情報用紙 (PIL) において,潜在的利益と害を記述するための根拠に基づいたガイドラインを策定する
Jeremy Howick1,2, Martina Svobodova1, Shaun Treweek3
1Centre for Trials Research, Cardiff University, Cardiff, UK.
Health technology assessment (Winchester, England)
|August 23, 2025
まとめ
臨床試験の情報の提示方法を改善するために 7つの原則が策定され 害と研究浪費を減らすことを目的としています これらのガイドラインは,患者情報用パンフレットを強化し,倫理的な試験の実践を促進し,利益とリスクをより明確に伝えます.
科学分野:
- 臨床試験
- 患者情報用パンフレット
- 情報に基づく同意
背景:
- 患者試験用パンフレットに 矛盾する情報は ノーセボに害を及ぼし 研究を無駄にしたり 倫理的な懸念を引き起こします
- 臨床試験の倫理的な実施には 潜在的利益と害を明確に伝えることが不可欠です
研究 の 目的:
- 臨床試験の利害関係者への情報提供の原則を 患者情報用小冊子に記載する.
- 臨床試験の募集率と有害事象の発生率の改善におけるこれらの原則の実現可能性を検証する.
- これらの原則を実装するためのガイドラインを作成し,広める.
主な方法:
- 原則を確立するために変更されたデルフィー調査とコンセンサス会議を含む混合方法のアプローチ.
- 既存の患者情報用紙を"原則に基づく患者情報用紙"に変換することで試験の原則
- 試験内の研究 (SWAT) インフラを活用して,採用と有害事象への影響を評価する.
主要な成果:
- 7つのコンセンサス原則が合意され,試験の利益と害を提示しました.
- 5つの主体試験のために,原則に基づいた患者情報用紙が作成されました.
- SWATのメタ分析のためのプロトコルが 成果を合成するために出版されました
結論:
- 7つの原則が確立され,試験の利益と害のコミュニケーションを調和させました.
- これらの原則は,研究浪費と情報に起因する害を減らすことを期待しています.
- これらの原則の実施は 臨床試験の倫理を高めることができます
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