変数操作室の可用性を持つクラスターランダム化制御試験のためのランダム化戦略
Sheau-Chiann Chen1, Heidi Chen1, Rafael Paez2
1Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Contemporary clinical trials
|August 30, 2025
まとめ
この研究は手術室の割り当てを階層化することで 診断用支氣管検査の試験を最適化しました 新しいランダム化方法は,患者の割り当ての不均衡を大幅に軽減し,臨床結果の比較のためのリソースの割り当てを改善しました.
科学分野:
- 医学研究方法論
- 肺科
- 臨床試験の設計
背景:
- 診断用のブロンコスコーピーの比較には 堅固な試験設計が必要です
- 手術室 (OR) と設備のリソースの制限は,患者のランダム化に挑戦することができます.
- クラスターランダム化対照試験 (cRCT) は実用的な比較に適しているが,慎重な配分戦略が必要である.
研究 の 目的:
- 2つの診断用ブロンコスコーピーの臨床結果 (プラットフォームAとプラットフォームB) を比較する.
- 資源の制限を考慮して,クラスターランダム化制御試験 (cRCT) の効果的なランダム化戦略を開発し評価する.
- 2つのプラットフォームの間の患者の割り当ての不均衡を最小限に抑えるために
主な方法:
- 単一センター,オープンラベル,実用的な,劣等感のないcRCTが設計されました.
- クラスターは手術室 (OR) 日として定義された.
- ORの可用性によって層分化された変位ブロックランダム化法がシミュレートされ,割り当てバランスで評価されました.
主要な成果:
- ORの可用性による分層化は,週日による分層と比較して,割り当て不均衡を有意に減少させた (平均不均衡 = - 0. 006,SD = 0. 690).
- 提案された方法は,プラットフォームAとプラットフォームBの患者の登録の違いを効果的に最小限に抑えました.
- 戦略は,限られたORとブロンコスコピープラットフォームのリソースの割り当てを最適化しました.
結論:
- ORの可用性によって階層化されたパームテッドブロックランダム化方法は,リソースの制限があるcRCTにとって効果的な戦略です.
- この革新的な設計は 診断用支柱鏡検査における 患者の割り当てのバランスを改善します
- この発見は,最適化された資源配分と実用的な試験における信頼性の高い臨床結果の比較を支持する.
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