CONSORTの声明:並列グループランダム化試験の報告の質を改善するための改訂された勧告
D Moher1, K F Schulz, D G Altman
1University of Ottawa, Thomas C Chalmers Centre for Systematic Reviews, Ottawa, Ontario, Canada.
Lancet (London, England)
|April 27, 2001
まとめ
ランダム化対照試験 (RCT) の報告の改善は,研究の有効性を理解するために重要である. 改訂されたCONSORTステートメントは,RCTの結果の透明性と解釈を高めるためのチェックリストとフロー図を提供しています.
科学分野:
- クリニック・トライアル 臨床試験
- 医学研究方法論 医学研究方法論
- 根拠に基づいた医学は,証拠に基づいた医療です.
背景:
- ランダム化対照試験 (RCT) の正確な解釈には,その設計,実施,分析,結果の理解が必要です.
- 教育的な努力にもかかわらず,RCTの報告の質は最適以下のままです.
- 当初のCONSORT (Consolidated Standards of Reporting Trials) ステートメントは,RCTの報告を改善するために作成されました.
研究 の 目的:
- 改訂されたCONSORT声明を提出し,新しい証拠を取り入れ,オリジナルの批判に対処する.
- RCTの報告の透明性と明確性を高めるために.
- 読者が試験結果の妥当性と関連性をよりよく評価できるようにするためです.
主な方法:
- 22項目のCONSORTチェックリストを改訂する.
- 治療効果バイアスと結果の信頼性を判断するために重要な項目を含みます.
- 4つの試験段階 (登録,割り当て,フォローアップ,分析) の参加者の進行を図示するために,CONSORTのフロー図の修正.
主要な成果:
- 改訂されたチェックリストには,透明なRCT報告のための不可欠な項目が含まれています.
- 更新されたフロー図は,プライマリデータ分析の参加者数を明示的に示しています.
- 改訂されたCONSORT声明は,RCTの行動と結果評価の理解を向上させることを目的としています.
結論:
- 改訂されたCONSORT声明は,RCTの報告を改善するための包括的な枠組みを提供します.
- CONSORTのチェックリストとフロー図による透明性の向上は,試験結果の批判的評価を容易にする.
- CONSORTガイドラインの遵守は,臨床試験の証拠の信頼性と解釈性を確保するために不可欠です.
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