主要アウトカムに対する統計的に非有意な結果を持つランダム化比較試験の報告と解釈
Isabelle Boutron1, Susan Dutton, Philippe Ravaud
1Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom. isabelle.boutron@htd.aphp.fr
JAMA
|May 27, 2010
まとめ
著者は,公表されたランダム化対照試験 (RCT) の研究結果をしばしば歪曲し,結果が有意ではない. この"スピン"は,治療の有効性について読者を誤解させ,エビデンスベースの医学に影響を与えます.
科学分野:
- 医学研究報告 医療調査レポート
- 臨床試験の分析 臨床試験の分析
- 科学出版物の完全性 科学出版物の完全性
背景:
- 公開された試験結果は,著者のバイアスのために誤って解釈されることがあります.
- "スピン"を理解することは,科学的解釈を正確にするために極めて重要です.
研究 の 目的:
- ランダム化制御試験 (RCT) での"スピン"の発生率と性質を決定する.
- 著者が統計的に非有意なプライマリアウトカムをどのように提示するかを調査する.
主な方法:
- 2006年12月に発表されたRCTをPubMed経由でMEDLINEで検索しました.
- 統計的に非有意なプライマリアウトカム (P > または = .05) を有する並列グループRCTが含まれています.
- 2人の審査員は,標準化されたフォームを使用して72件の適格な記事を評価しました.
主要な成果:
- "スピン"はタイトルの18%,抽象的な結果の37.5%,抽象的な結論の58.3%に存在していました.
- 主要テキストのセクションも"スピン"を示しました:結果では29.2%,ディスカッションでは43.1%,結論では50%.
- レポートの40%以上は,少なくとも2つの主なテキストセクションで"スピン"を示しました.
結論:
- 非有意なプライマリアウトカムを持つRCTの発見の報告と解釈は,しばしば実際の結果と矛盾しています.
- この広範囲にわたる"スピン"は,読者を誤解させ,臨床意思決定に影響を与える可能性があります.
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