臨床研究における患者による報告結果の含有に関する倫理的検討:PRO倫理ガイドライン
Samantha Cruz Rivera1,2,3, Olalekan Lee Aiyegbusi1,2,4, Jonathan Ives5
1Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
JAMA
|May 17, 2022
まとめ
臨床研究における患者報告結果に関する新しい倫理ガイドラインは,高品質のデータを確保することを目的としています. これらのガイドラインは,参加者と研究者を保護し,医療の意思決定と政策におけるPROの使用を強化するために,重要な倫理問題に対処しています.
科学分野:
- 医療サービス研究
- 臨床研究の倫理
- 患者による報告結果
背景:
- 患者によって報告されたアウトカム (PRO) は,医療決定,政策,および個別化されたケアにおいて極めて重要です.
- 臨床研究におけるPROの使用の増加は,関連する倫理的な考慮事項に対処することを必要としています.
- 既存の倫理的枠組みは,PROの実施に伴うユニークな課題を完全にカバーしていないかもしれません.
研究 の 目的:
- 臨床研究におけるPROの使用について,国際的,コンセンサスに基づく倫理的指針を策定する.
- 研究におけるPROのライフサイクルを通して倫理的な問題に対処するための標準化された枠組みを提供すること.
- 医療と研究にプロの責任ある,効果的な統合を強化する.
主な方法:
- 臨床研究におけるPROの倫理的影響を体系的に検討した.
- 96人の参加者が参加した国際デルフィープロセスと25人の参加者が参加したコンセンサス会議が採用されました.
- ガイドラインの開発は,SPIRIT-PRO Extensionの勧告を組み込んだEQUATORネットワークの枠組みに従った.
主要な成果:
- PROに特化した包括的な倫理ガイドラインがコンセンサスによって開発されました.
- 研究の根拠,データモニタリング,参加者負担,普及など,主な分野です.
- ガイドラインは,PRO評価スケジュール,欠けているデータ,患者パートナーの関与などの問題をカバーしています.
結論:
- 開発されたPRO倫理ガイドラインは,PROの臨床研究における倫理問題に関する勧告を提供します.
- これらのガイドラインを遵守することで,高品質のPROデータ収集が保証されます.
- これらの倫理的な問題に取り組むことで 参加者のリスクと害を最小限に抑え 全体的な福祉を保護できます
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