CONSORT 2025の声明:ランダム化試験の報告に関する最新ガイドライン
Sally Hopewell1, An-Wen Chan2, Gary S Collins3
1Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford UK.
Lancet (London, England)
|April 17, 2025
まとめ
報告試験の統合基準 (CONSORT) 2025の更新された声明は,ランダム化試験の報告品質を改善します. 新しい項目,改訂,より明確で透明な試験出版のためのオープンサイエンスセクションが含まれています.
科学分野:
- 臨床試験の方法論
- 科学的報告基準
- 証拠 に 基づく 医学
背景:
- ランダム化試験は医療介入の証拠に不可欠ですが,報告の質はしばしば最適ではありません.
- 試験報告の統合基準 (CONSORT) の声明は,ランダム化試験の報告の質を向上させることを目的としています.
- CONSORTの以前のバージョンは,1996年,2001年,2010年に発表された.
研究 の 目的:
- 最近の方法論的進歩とユーザーからのフィードバックを取り入れ,更新されたCONSORT 2025声明を提示する.
- ランダム化試験の報告のための修正された最低限の項目セットを提供すること.
- ランダム化試験の結果の報告の明確性と透明性を確保する.
主な方法:
- CONSORTに関連する証拠のプロジェクト特有のデータベースを開発しました.
- 潜在的なチェックリストの変更は,CONSORT拡張の著者からの勧告と他の報告ガイドラインで補足されました.
- 国際オンライン調査 (317名の参加者) と専門家のコンセンサス会議 (30名の専門家) を通じて,提案された変更を評価した.
主要な成果:
- CONSORTのチェックリストには,新しい項目が7つ追加され,3つの項目が修正され,1つの項目が削除され,重要な拡張項目が統合されました.
- CONSORT 2025 ステートメントには30項目のチェックリストと参加者のフロー図が含まれています.
- 再構成されたチェックリストにオープンサイエンスに関する新しいセクションが組み込まれました.
結論:
- CONSORT 2025 ステートメントは,ランダム化試験の報告のための最新の枠組みを提供します.
- チェックリストの拡張版は,支援の実施に利用できます.
- 著者,編集者,査読者は,ランダム化試験の原稿の明確性と透明性を向上させるためにCONSORT 2025を使用すべきである.
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