臨床研究における出版バイアス
P J Easterbrook1, J A Berlin, R Gopalan
1Division of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205.
Lancet (London, England)
|April 13, 1991
まとめ
出版バイアスは研究で明らかであり,重要な発見は公表される可能性が高い. これは,特に観察研究において,公表されたデータの信頼性に影響を及ぼし,すべての研究結果を見つけるためのより良い戦略を必要とします.
科学分野:
- 医学研究の倫理 医学研究の倫理
- バイオ統計学 バイオ統計学
- 研究の整合性 研究の整合性
背景:
- 出版バイアス,つまりネガティブな結果よりもポジティブな結果を公表する傾向は,科学的な理解を歪める可能性があります.
- 倫理審査委員会は数多くの研究プロジェクトを承認するが,その発表結果は必ずしも透明であるとは限らない.
研究 の 目的:
- 中央倫理委員会によって承認された研究プロジェクトにおける出版バイアスの存在と範囲を調査する.
- 研究成果の公表に影響を与える要因を特定する.
主な方法:
- 1984年から1987年の間に承認された487の研究プロジェクトを遡及的に分析した.
- 285件の分析された研究の出版状況と関連要因を調査した.
- 調整されたオッズ比率 (OR) と95%信頼区間 (CI) を使用して,有意性を評価した.
主要な成果:
- 分析された研究の52%が公表されました.
- 統計的に有意な結果は,公表される確率は2倍以上であった (OR 2.32).
- 観察およびラボベースの研究では,ランダム化臨床試験 (OR 0.84) と比較して,出版バイアスの傾向がより高いことが示されました (OR 3.79).
結論:
- 臨床研究のコホートにおける出版バイアスの存在を確認した.
- この研究結果は,特に観察的研究において,公表されたデータのみから結論を解釈する際には注意すべきことを示唆しています.
- 公開された研究結果と未公開の研究結果の両方を特定するための改善された戦略の必要性を強調した.
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