ランダム化制御試験のメタ解析における治療効果の推定値と品質測定値の相関
Ethan M Balk1, Peter A L Bonis, Harry Moskowitz
1Evidence-based Practice Center, Division of Clinical Care Research, Tufts University School of Medicine, New England Medical Center, 750 Washington St, No. 63, Boston, MA 02111, USA.
JAMA
|June 8, 2002
まとめ
ランダム化比較試験における個々の品質測定値は,治療効果の大きさと一貫して関連していない. 特定の医学領域で発見された関連性は,すべての臨床分野に一般化できませんでした.
科学分野:
- 医学研究方法論 医学研究方法論
- 臨床試験の品質評価について
- メタアナリシス メタ分析
背景:
- 試験の質の特徴は,ランダム化研究で観察された治療効果に影響を与える可能性があります.
- 試験の質の評価はメタアナリシスではよくあることですが,治療効果との関連性は,さまざまな医療分野において十分に確立されていません.
研究 の 目的:
- ランダム化制御試験 (RCT) で,特定の品質測定値と治療効果の大きさの関連性を調査する.
主な方法:
- 心血管疾患,感染症,小児科,外科におけるRCTにおける公表されたスケールから評価された品質測定値.
- 少なくとも6つのRCT,二分的な結果,および有意な異質性を持つメタ分析が含まれています.
- 高品質の研究と低品質の研究を比較した相対オッズ比率 (ORs) を分析した.
主要な成果:
- 276件のRCTと26件のメタ解析において,24の品質測定値が治療効果と統計的に有意な関連性を示さなかった (相対 ORs: 0.83-1.26).
- プラセボ対照および盲目化などの特定の測定は,限られた分析で関連性を示しましたが,これらは矛盾していました.
- 品質基準を満たす研究の割合は,4つの医療分野において著しく変動した.
結論:
- 個々の品質測定は,さまざまな研究と医療分野において,治療効果の強さとの信頼性の高い関連性が欠けている.
- 特定の品質測定は,支持する証拠のある定義された分野において関連性があるかもしれないが,その一般化性は限られている.
- 発見は,メタ解析における治療効果と品質測定の関連付けの広範な適用に対して注意を喚起する.
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