試験プロトコルにおける結果報告に関するガイドライン:SPIRIT-outcomes 2022の延長
Nancy J Butcher1,2, Andrea Monsour1, Emma J Mew1,3
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
JAMA
|December 13, 2022
まとめ
新しいガイドラインは,結果報告を詳細にすることで,臨床試験プロトコルを強化します. SPIRIT-Outcomes 2022の拡張は,研究における透明性と再現性のための9つの重要な項目を追加しています.
科学分野:
- 臨床試験の方法論
- 健康研究の透明性
- 科学的報告基準
背景:
- 試験プロトコルにおける不一致な結果報告は,規制当局の承認,標準化された行動,および研究再現性を妨げます.
- 成果報告に関する既存の勧告は多様で,調和が欠けていて,明確な指針が必要である.
研究 の 目的:
- 臨床試験プロトコルにおける結果を記述するための,証拠とコンセンサスに基づいた,調和した基準を策定する.
- 標準プロトコル項目:介入試験のための勧告 (SPIRIT) 2013の声明を,結果特有の報告ガイドラインで拡張する.
主な方法:
- 医療研究の質と透明性の向上 (EQUATOR) の方法論的枠組みを利用した.
- 既存のガイドラインのスコーピングレビュー,専門家による協議, 124人のパネリストによる3ラウンドの国際デルフィー投票,25人のパネリストによる個人でのコンセンサス会議を実施しました.
主要な成果:
- 108の勧告を特定し,デルフィの投票のために56の項目に統合しました.
- このコンセンサス・ミーティングでは,SPIRIT 2013のチェックリストの項目を詳細に説明し,成果の定義,正当化,評価,分析を行いました.
結論:
- SPIRIT-Outcomes 2022の拡張は,臨床試験プロトコルのための重要な結果特有の9つの項目を提供しています.
- これらの項目は,試験の有用性,複製性,透明性を向上させ,結果の選択的な非報告を最小限に抑えることを目的としています.
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