ランダム化試験における盲目化:誰が何を手に入れたかを隠す
Kenneth F Schulz1, David A Grimes
1Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA. KSchulz@fhi.org
Lancet (London, England)
|March 7, 2002
まとめ
臨床試験における失明はしばしば誤解され,単盲や二盲などの用語は様々な意味を持つ. 誰が盲目になったのか,どのように盲目になったのかを適切に報告することは,研究におけるバイアスの削減を評価する上で極めて重要です.
科学分野:
- 臨床試験の方法論について
- 研究の整合性 研究の整合性
- バイアス削減戦略
背景:
- 研究における失明には長い歴史がありますが,用語は多くの研究者がよく誤解しています.
- ブラインディングとアロケーションの隠蔽はよく混同され,この2つの概念の明確性が欠けていることを示している.
- シングル・ブラインド,ダブル・ブラインド,トリプル・ブラインドといった用語については,世界的に様々な解釈が続いている.
研究 の 目的:
- ランダム化対照試験におけるブラインディングの定義と重要性を明確にする.
- ブラインディングの用語とその適用に関する一般的な誤解に対処するために.
- 研究出版物における盲目化方法の明示的な報告の必要性を強調する.
主な方法:
- この研究は,臨床研究におけるブラインドリングの歴史的文脈と一般的な解釈をレビューしています.
- 情報バイアスを軽減し,コンプライアンスを改善し,共同介入を最小限に抑えることに盲目化の影響を分析しています.
- 本文では,ブラインドリングと配分隠蔽の区別について論じています.
主要な成果:
- ブラインディングは,バイアスを減らすために,参加者,調査者,評価者が割り当てられた介入を知ることを防ぐことを目的としています.
- ダブルブラインディング (参加者,調査者,査定者) は強力な設計を意味しますが,試験の品質を決定する唯一の要因ではありません.
- 誰が盲目になったのか,どのように盲目になったのかを明示的に報告することは,用語のみに頼るよりも価値があります.
結論:
- 研究者は,誰が盲目になったのか,どのような方法が使われたのかなど,盲目化の手続きについて明確に報告すべきである.
- 結果評価者の盲目化は,死亡のような客観的な結果を除いて,特に重要です.
- 偏見の軽減を確実にするために,明確で詳細な報告なしに,盲目化を主張する研究については,懐疑主義が正当化されています.
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