試験報告における結果の報告に関するガイドライン:CONSORT-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CONSORT-Outcomes 2022のガイドラインは,臨床試験の報告のための17の必須項目を提供しています. これらの基準は,透明性を高め,証拠に基づいた意思決定をより良くするために,選択的な結果の報告を減らす.
科学分野:
- 臨床試験の方法論
- 健康研究に関する報告基準
背景:
- 臨床医,患者,政策立案者は 証拠に基づいた決定を 臨床試験の結果に依存しています
- 試験計画,方法,結果の完全な透明な報告は,批判的評価に不可欠です.
- 欠陥のある報告慣行により,結果の選択,評価,分析の問題が曖昧になり,改善されたガイドラインが必要になります.
研究 の 目的:
- 臨床試験の報告における結果の報告のための調和した,証拠とコンセンサスに基づく基準を策定する.
- 試験報告の統合基準 (CONSORT) 2010 声明にこれらの基準を統合する.
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.
- 既存の成果報告ガイドラインと専門家による協議の範囲の見直しを行いました.
- 124人のパネリストと25人のパネリストとの個人コンセンサス会議で 3ラウンドの国際デルフィー投票プロセスを採用しました.
主要な成果:
- 128の勧告が特定され,その83%がCONSORT 2010の報告書に含まれていない.
- コンソリデート・レコメンデーションは デルフィでの投票で64項目となり, 30項目がコンセンサス・ミーティングに進められました.
- CONSORT-Outcomes 2022の延長のために17の重要な成果特有の項目を提供しました.
結論:
- CONSORT-Outcomes 2022の拡張は,臨床試験の発表のための17のアウトカム固有の報告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,透明性を高めることを目的としています.
- 実施は,臨床試験の結果の選択的非報告のリスクを最小限に抑えることができます.
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