治療効果と治療効果の推定のためのランダム化試験を早期に中止する: システマティック・レビューとメタ・リグレッション・アナリスト
Dirk Bassler1, Matthias Briel, Victor M Montori
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
JAMA
|March 25, 2010
まとめ
ランダム化対照試験 (RCT) は,治療効果を過大評価する利益のために早期に中止されました. このバイアスは,停止規則に関係なく持続し,イベント数が少ない小さな研究でより顕著です.
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
- 根拠に基づいた医学は,証拠に基づいた医療です.
背景:
- 理論とシミュレーションは,利益のためにランダム化対照試験 (RCT) を早期に中止すると,治療効果が過大評価されると示唆しています.
- この過大評価は,早期停止を誘発した結果に特に影響を与えます.
研究 の 目的:
- 断片化されたRCTにおける治療効果と,メタ解析に含まれる断片化されていないRCTにおける治療効果を比較する.
- 断片化されたRCTにおける治療効果の過大評価に寄与する要因を特定する.
主な方法:
- 複数のデータベース (MEDLINE,EMBASEなど) の体系的な検索 断片化されたRCTおよび関連するシステマティックレビューについてです.
- 専門家による独立した盲検審査により,切り離されたものと一致する適格な非切り離されたRCTを選択します.
- 方法論的に専門的な審査員による独立したデータ抽出.
主要な成果:
- 分析には,63の研究質問に関する91の断片化されたRCTと424の一致する断片化されていないRCTが含まれていました.
- 断片化されたRCTは,断片化されていないRCTと比較して,相対リスクの総比率は0.71であった.
- 過大評価は,統計的な停止ルールと研究品質とは無関係であり,<500件のイベントを持つ研究で最大でした.
結論:
- 断片化されたRCTは,早期に中止されなかったRCTよりも大きな効果サイズに関連しています.
- 効果の大きさの観察された差異は,統計的な停止ルールや研究の品質に影響されません.
- 断片化されたRCTにおける治療効果の過大評価は,より小さな研究において最も顕著である.
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