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臨床試験プロトコルに患者による結果を含めるためのガイドライン:SPIRIT-PROの拡張
Melanie Calvert1, Derek Kyte1, Rebecca Mercieca-Bebber2
1Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England.
JAMA
|February 8, 2018
まとめ
新しいSPIRIT-PRO拡張ガイドラインは,患者によって報告されたアウトカム (PRO) のための臨床試験プロトコルを改善します. これらの勧告は患者中心のケアと意思決定のためのデータ品質を高めます.
科学分野:
- 臨床試験の方法論
- 患者による報告結果 研究
- 健康研究に関するガイドライン
背景:
- 患者によって報告された結果 (PRO) のデータは,共有された意思決定,ラベル付け,ガイドライン,政策にとって極めて重要です.
- 現在の臨床試験プロトコルでは,通常,最適でないPRO含有量があります.
- 既存のSPIRITの記述には,PROに特化した指針がない.
研究 の 目的:
- SPIRIT-PRO拡張として知られる,国際的,コンセンサスに基づく,プロトコル指針を開発する.
- 臨床試験プロトコルにおけるPROデータの完全性と品質を向上させる.
主な方法:
- 開発はEQUATORネットワークのガイドラインフレームワークに従った.
- 体系的なレビュー,ステークホルダー調査,デルフィー演習,コンセンサス会議など
- 研究者,患者,政策立案者など様々な国際的関係者の意見を活用した.
主要な成果:
- 特定された162のPRO特別の勧告は56項目に精製されました.
- SPIRIT 2013のチェックリストに11の拡張と5の詳細を作成しました.
- 推奨事項は,PROの根拠,目標,適格性,評価,機器の選択,データ収集,翻訳,プロキーの完成,欠けているデータ,モニタリングに関するものです.
結論:
- SPIRIT-PROガイドラインは,PROを含む臨床試験プロトコルのための重要な勧告を提供します.
- これらのガイドラインを実装することで 試験の設計を改善し 患者中心の高品質のデータを確保できます
- これは,臨床ケアと健康政策の情報提供のためのPROデータの有用性を高めます.
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