CONSORTステートメントの使用とランダム化試験の報告の質:比較的な前後評価
1Thomas C. Chalmers Centre for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Rd, Ottawa, Ontario, K1H 8L1 Canada.
JAMA
|April 20, 2001
まとめ
試験報告のための統合基準 (CONSORT) 声明は,ランダム化制御試験 (RCT) の報告を改善しました. CONSORTを採用したジャーナルは,報告の質が著しく向上し,不明瞭な割り当て隠蔽が減少したことを示した.
科学分野:
- 医学研究方法論 医学研究方法論
- 臨床試験報告基準 臨床試験報告基準
背景:
- 試験報告のための統合基準 (CONSORT) 声明は,ランダム化制御試験 (RCT) の報告の質を高めるために開発されました.
- CONSORT声明の目標達成における有効性に関するデータは限られている.
研究 の 目的:
- CONSORT声明の採用がRCT報告書の質の向上と関連しているかどうかを評価する.
- CONSORTガイドラインの実施前と後のRCTレポートを比較する.
主な方法:
- 比較的な前後の研究デザインが採用されました.
- 1994年 (CONSORT前期) の報告書と1998年 (CONSORT後期) の報告書を4つの著名な医学雑誌で比較した.
- 2つのジャーナルはCONSORTを採用し,2つのジャーナルは比較用として機能し,1つのジャーナルはガイドラインを採用しなかった.
主要な成果:
- CONSORTを採用したジャーナルの報告では,CONSORTのチェックリスト項目数が統計的に有意に増加していることが示されました.
- 割り当て隠蔽の不明確な報告の頻度は,採用者のジャーナルで著しく減少した.
- Jadad スケールを用いて評価された試験品質の総合スコアは,CONSORT 声明を採用したジャーナルでは著しく改善しました.
結論:
- 結果は,CONSORTステートメントの使用は,公表されたRCTレポートの質の実証可能な改善と関連していることを示している.
- CONSORTのガイドラインの遵守は,臨床試験の報告の明確さと完全性に好影響を与える.
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