PubMed誌に掲載されたランダム化試験の疫学と報告
An-Wen Chan1, Douglas G Altman
1Department of Medicine, University Health Network Toronto, Canada. anwen.chan@utoronto.ca
Lancet (London, England)
|March 30, 2005
まとめ
この研究では,519件のランダム化試験を分析し,多くの試験ではサンプルサイズが小さく,重要な方法論的な詳細の報告が不十分であり,エビデンスベースの医薬品の品質評価を妨げていることが判明しました.
科学分野:
- クリニック・トライアル 臨床試験
- 根拠に基づいた医学は,証拠に基づいた医療です.
- 医学研究方法論 医学研究方法論
背景:
- ランダム化試験は,エビデンスベースの医学にとって根本的なものです.
- 公開されたランダム化試験の一般的な特徴と報告の質に関する理解は限られている.
- これらの試験の疫学と方法論的報告の評価は,研究の信頼性を評価するために重要である.
研究 の 目的:
- 2000年12月に発表されたランダム化試験の流行病学を評価する.
- これらの試験における重要な方法論的詳細の報告を評価する.
- 治験の設計と報告において,証拠の質に影響を及ぼす可能性のある制限を特定すること.
主な方法:
- 2000年12月に発表された,PubMedでインデックスされた519件のランダム化試験の体系的レビュー.
- 設計による試験の分類 (パラレルグループ対クロスオーバー).
- 特定の方法論的要素に関する報告の評価: ブラインド,電力計算,ランダムシーケンスの生成,割り当て隠蔽,および消耗処理.
主要な成果:
- ほとんどの試験 (93%) は専門誌に掲載されました.
- 平均80人の参加者が並列グループ試験に採用され,60%が盲目化を行いました.
- 重要な方法論的特徴 (例えば,ランダムシーケンス生成,割り当て隠蔽) の適切な報告は,出版物全体で50%未満でした.
結論:
- 2000年に発表されたランダム化試験は,小規模なサンプルを多く含んでいた.
- 方法論的特徴の不十分な報告は,公表された多くの治験の質を確実に評価する能力を損なう.
- 方法論的報告の改善は,エビデンスベースの医療の基盤を強化するために不可欠です.
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