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非劣等性および同等性ランダム化試験の報告:CONSORT声明の拡張である
Gilda Piaggio1, Diana R Elbourne, Douglas G Altman
1Statistics and Informatics Services Group, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
JAMA
|March 9, 2006
まとめ
この研究は,CONSORT Statementのチェックリストを適応させ,非劣等性および同等性試験の報告を改善します. 報告の質の向上により,読者がこれらの重要な臨床試験結果の妥当性を評価するのに役立ちます.
科学分野:
- 臨床試験の方法論 臨床試験の方法論
- バイオ統計学 バイオ統計学
- 医学研究 報告 報告する
背景:
- CONSORT ステートメントは,ランダム化制御試験 (RCT) の報告を強化します.
- 既存のCONSORTガイドラインは,主に優越性試験を扱っています.
- 非劣等性および同等性試験には,ユニークな設計と解釈の課題があります.
研究 の 目的:
- 非劣等性および同等性試験のためのCONSORTチェックリストを調整する.
- これらの特定の試験設計の報告の質を改善するために.
- 読者が,非劣等性および同等性試験の結果の妥当性を評価するのを助けるために.
主な方法:
- 元のCONSORTチェックリストの項目の変更.
- 修正された項目の説明と例を含める.
- 非劣等性および同等性試験に特有の方法論的特徴に焦点を当てます.
主要な成果:
- 非劣等性および同等性試験に合わせて調整されたCONSORTチェックリストが提示されています.
- 特定の試験要素を報告するための説明と例が提供されています.
- 調整されたチェックリストは,これらの試験における報告の不適切さを解決することを目的としています.
結論:
- 非劣等性および同等性試験の報告の改善は極めて重要です.
- 調整されたCONSORTチェックリストは,治験の有効性のより良い評価を容易にする.
- この研究は,臨床研究におけるより厳格な科学コミュニケーションを支援しています.
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