SPIRIT 2025 声明:ランダム化試験のプロトコルに関する更新されたガイドライン
An-Wen Chan1, Isabelle Boutron2,3, Sally Hopewell4
1Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
JAMA
|April 28, 2025
まとめ
更新されたSPIRIT 2025声明は,完全なランダム化試験プロトコルのための証拠に基づいたガイドラインを提供します. これは透明性を確保し,すべての利害関係者のために臨床試験の設計と報告の質を高めます.
科学分野:
- 臨床試験の方法論
- 研究報告基準
背景:
- ランダム化試験プロトコルは,研究計画,実施,および報告に不可欠です.
- 既存のプロトコルには,設計と実行の重要な要素が欠けていることが多い.
- SPIRIT (スタンダード・プロトコル・アイテム: 介入試験のための勧告) 声明は,プロトコル完結性を向上させるために2013年に作成されました.
研究 の 目的:
- ランダム化試験プロトコルにおける最低項目のSPIRITの勧告を体系的に更新する.
- 最新のエビデンスとベストプラクティスを取り入れることで,ガイドラインの有効性を保ちます.
主な方法:
- SPIRIT 2013のチェックリストの潜在的な変更を特定するために,スコーピングのレビューと証拠のデータベースが実施されました.
- SPIRIT/CONSORTの拡張と他の報告ガイドラインが組み込まれました.
- 3ラウンドのデルフィー調査で317人の参加者と30人の専門家によるコンセンサス会議が改訂の基礎となった.
主要な成果:
- 更新されたSPIRIT 2025の声明には,試験プロトコルに関する最低34の項目が含まれています.
- 重要な変更には,新しいオープンサイエンスセクション,有害性や介入の説明に焦点を当て,患者/公衆の関与項目が含まれています.
- 実施のため,拡張チェックリストと説明文書が作成されました.
結論:
- SPIRIT 2025の更新された声明は,ランダム化試験プロトコルの透明性と完全性を高めることを目的としています.
- 研究者,参加者,資金提供者,倫理委員会,ジャーナル,政策立案者にとって 広範な遵守は有益である.
- この改訂は,進化する研究基準と慣行に合わせてガイドラインを更新することを保証します.
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