手術試験におけるプラセボ対照の検討と方法 (ASPIREガイドライン)
David J Beard1, Marion K Campbell2, Jane M Blazeby3
1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Lancet (London, England)
|March 9, 2020
まとめ
手術試験では,倫理的に正当化され,科学的に妥当である場合にプラセボ対照を使用できます.特に証拠が限られている介入の場合です. このアプローチはバイアスを軽減し,これらの複雑なランダム化制御試験の設計と解釈のためのベストプラクティスをガイドします.
科学分野:
- 医学研究方法論
- 外科革新の評価
背景:
- プラセボ対照薬は,外科介入の有効性試験においてますます検討されている.
- 手術によるプラセボ対照は 独特の複雑性と課題を提示します
- 臨床試験の設計に際して その応用を理解することは 極めて重要です
研究 の 目的:
- 手術のランダム化試験におけるプラセボ対照に関する知識を要約する.
- 手術用プラセボの倫理的および規制上の考慮事項を概説する.
- このような試験の設計,実施,解釈に関するガイドラインを提供すること.
主な方法:
- 手術におけるプラセボ対照に関する現在の理解の文献レビューと統合.
- 倫理的な議論と規制上の要求事項の議論
- ベストプラクティスの概要とチェックリスト (ASPIRE) の作成
主要な成果:
- 手術におけるプラセボ対照は 強力な科学的および倫理的な根拠で正当化されています
- 介入の有効性が十分に証明されていない場合や バイアスのリスクが高い場合,特に価値があります.
- 最適な試験設計と実施のために,可行性研究が推奨されます.
結論:
- 手術によるプラセボ対照は,科学的および倫理的な要因を慎重に考慮する必要があります.
- ASPIREのチェックリストは,プラセボによる手術によるランダム化試験の実施に関するガイドラインを提供します.
- 手術の有効な評価には 最良の慣行が不可欠です
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