出版後の批判と臨床知識の形成について
1The Lancet, 32 Jamestown Rd, London NW1 7BY, England. richard.horton@lancet.com
JAMA
|June 1, 2002
まとめ
大規模な臨床試験の公表後の批判は,しばしば無視されます. 重要な試験の弱点は,実践ガイドラインに組み込まれず,その有効性を弱め,医学的な知識を歪めた.
科学分野:
- 医学研究方法論 医学研究方法論
- 臨床試験の分析 臨床試験の分析
- 根拠に基づいた医学は,エビデンスに基づいた医療です.
背景:
- 編集者への手紙は,出版後のピアレビューと著者の説明責任において極めて重要です.
- 本研究では,高血圧最適治療 (HOT),カプトプリル予防プロジェクト (CAPPP),および高血圧2型高齢患者におけるスウェーデン試験 (STOP-2) の3つの主要なランダム化試験に関する批判的コメントを検証しています.
研究 の 目的:
- 医学文献における3つの著名なランダム化試験の重要な足跡を評価する.
- これらの試験に対する批判が,その後の臨床知識と実践ガイドラインにどの程度影響を与えたかを調査する.
主な方法:
- HOT,CAPPP,およびSTOP-2試験を批判する公開された手紙の質的評価.
- 著者の回答に基づいて,合意された弱点と未解決の批判を特定する.
- 批判の組み込みを評価するために,裁判後公開された実践ガイドラインの MEDLINE 検索.
主要な成果:
- 出版から2000年10月までの間,HOTは9/36のガイドライン,CAPPPは6/36のガイドライン,STOP-2はNONEのガイドラインに登場した.
- HOTは14件の批判を受け,ガイドラインで言及されているのは1件 (パワー不足) だけです.
- CAPPPは14件の批判を受けており,指針に言及されているのは1件 (不均衡) だけで,STOP-2は12件の批判を受け,反応はほとんどありませんでした.
- 通信におけるすべての批判の半分以上は,試験の著者によって答えられませんでした.
結論:
- 主要な臨床試験に関する重要なフィードバックの有意な部分は,著者によって取り上げられていない.
- 主要研究試験で特定された欠陥は,その後の実践ガイドラインではほとんど見過ごされました.
- 批判的なコメントを統合しないことは,臨床ガイドラインの信頼性を損なうし,医学知識を歪める.
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