ランダム化試験の多重性 I:エンドポイントと治療法
Kenneth F Schulz1, David A Grimes
1Family Health International, PO Box 13950, Research Triangle Park, NC 27709 USA.
Lancet (London, England)
|May 4, 2005
まとめ
調査的試験は,多くの比較を生成し,重要な発見の偏った報告を危険にさらす可能性があります. 研究者はすべての分析を報告しなければならないし,多重性に関する統計的調整は存在するが,重要な臨床的決定のために慎重に使用すべきである.
科学分野:
- バイオ統計学 バイオ統計学
- 臨床試験の方法論 臨床試験の方法論
- 科学的整合性について
背景:
- 臨床試験は,多くの場合,多数のエンドポイントと治療群の比較を伴うため,多重性の問題を引き起こす可能性があります.
- 調査者は,有意な発見を選択的に報告することができるが,意図的であれば非科学的で,意図的であれば不正である.
研究 の 目的:
- 臨床試験における多重性の問題を強調する.
- 統計分析の選択的な報告の影響を議論する.
- 多重性に対する統計的調整の役割と限界を評価する.
主な方法:
- 多重性に関する統計的原理の議論.
- 臨床研究における選択的報告の実践の分析.
- 仮説テストにおける多重性に対する統計的調整の評価.
主要な成果:
- 単一の試験から数千の潜在的な比較が生じる可能性があります.
- 重要な結果の選択的な報告は,科学的結論を歪める可能性があります.
- 多重性に対する統計的調整は,一般的に粗末であるが,臨床的決定がプライマリエンドポイントの有意性によって左右される場合に有用である.
結論:
- 研究者は,透明性を確保するために,すべての分析されたエンドポイントと比較された治療法を報告する必要があります.
- 分析の潜在的報告不足に対する認識は,読者にとって極めて重要です.
- 多重性に関する統計的調整は,特に臨床的決定が特定のプライマリエンドポイントの結果に依存する場合,慎重に適用されるべきである.
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