心臓代謝臨床試験における死亡原因の頻度,地域的変動,および予測要因: 9件の試験における9259件の死亡の総合分析

Alexander C Fanaroff^1,2, Robert Clare², Karen S Pieper²

¹Division of Cardiology (A.C.F., C.M., J.H.A., W.S.J., R.W.H., T.J.P., S.M.A-K., M.T.R., D.F.K., R.M., R.M.C., K.P.A., R.D.L.), Duke University School of Medicine, Durham, NC.

Circulation

|December 28, 2018

まとめ

心臓代謝試験における死亡の約16%は原因が不明でした. この発見は,将来の臨床研究で不確定死亡を減らすためにデータ収集の改善の必要性を強調しています.

科学分野:

心臓病科
臨床試験
公衆衛生

背景:

心臓代謝の臨床試験では,心血管疾患による死亡を含む複合的な結果が頻繁に使用されます.
死亡原因の判断は標準ですが原因は不明です
これらの試験における不特定死因の流行は,体系的に評価されていません.

研究の目的:

心臓代謝の臨床試験における未特定死因の流行を決定する.
原因不明の死亡に関連する要因を特定する.
臨床試験データの質を評価するための基準を提供すること.

主な方法:

死亡原因が判定された9つの世界的な心臓代謝臨床試験 (2009年−2017年) のデータの分析.
心血管疾患,非心血管疾患,不特定疾患による死亡率の計算
死因の不確定性の患者および試験レベルの予測要因を特定するためのロジスティック回帰.

主要な成果:

127,049人の参加者のうち9,259人の死亡のうち,15.6% (1447人の死亡) の原因は不明でした.
治療領域,地域,出版年によって不確定な死亡率の変動が観察された.
不確定死亡の可能性が高い要因には,急性冠動脈症候群/心房細動試験,死亡までの長い時間,最近の出版年,北米の登録,女性の性別,および高齢が含まれています.

結論:

大規模な心臓代謝試験における死亡の約16%は原因が不明でした.
この流行率は,臨床試験の報告における品質評価の基準となる.
発見は,将来の研究で未定の死亡を最小限に抑えるための運用改善を導くことができます.

キーワード:

死亡原因臨床試験死亡フォローアップ研究品質管理について

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