臨床医が好む治療法を用いたランダム化臨床試験

E L Korn¹, S Baumrind

¹Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.

Lancet (London, England)

|January 19, 1991

まとめ

標準的なランダム化臨床試験は,臨床医が特定の治療法を好む状況には適さない場合があります. 代替的なアプローチでは,患者がランダム化されている場合にのみランダム化することを提案しています.

科学分野:

臨床試験の方法論臨床試験の方法論
医療倫理医療倫理について
患者中心のケア

背景:

標準的なランダム化臨床試験 (RCT) は,臨床医が強い治療好みや優位性についての信念を持っている場合,最適以下である可能性があります.
臨床医のバイアスは,従来のRCTにおける試験設計と患者の結果に影響を与える可能性があります.

研究の目的:

臨床医の治療の好みのある状況のための代替試験設計を提案する.
意見の相違がある場合,患者の配分が臨床判断と一致することを保証する.

主な方法:

患者のランダムな割り当ては,最良の選択に関する臨床的な意見の相違が生じた場合にのみ推奨されます.
その後,患者は割り当てられた治療レジメンをサポートする臨床医に割り当てられます.

主要な成果:

この修正されたアプローチは,臨床医の専門知識または好みにより,標準的なRCTが不適切である可能性のあるシナリオに対応しています.
臨床的判断をランダム化プロセスに統合することを目的としています.

結論:

提案された設計は,臨床試験の適用性を実用化するための潜在的な解決策を提供します.
ランダム化と個別化された臨床意思決定のバランスをとろうとしている.

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