臨床試験の募集のための患者ポータルと電子メールの通信を比較したランダム化研究
Jeanette Y Ziegenfuss1, Elanadora U Sour1, Erica J Roelofs1
1Center for Evaluation and Survey Research, HealthPartners Institute, Bloomington, MN, USA.
Clinical trials (London, England)
|August 21, 2025
まとめ
患者ポータルのアウトリーチは初期臨床試験の参加率を高めましたが,電子メールと比較して全体的なランダム化率は有意に改善しませんでした. これは,試験の成功率に比例する増加なしに,努力を増やす可能性を示唆しています.
科学分野:
- 臨床試験
- 生物医学研究
- 医療情報学
背景:
- 臨床試験の採用は,代表的な研究集団を確保するために不可欠です.
- 電子医療記録 (EHR) 患者ポータルは 採用戦略として有望です
- EHRポータルのアウトリーチと,従来のEメールの採用の有効性はよく理解されていません.
研究 の 目的:
- 臨床試験の募集のためのEHR患者ポータルとEメールの有効性を比較する.
- 異なるコミュニケーション戦略における採用率と人口表現を評価する.
- コミュニケーションのタイプが採用の成功に与える影響を緩和する要因を特定する.
主な方法:
- 17,989人の潜在的に適格な参加者は,LEAP研究のためのEHRポータルまたは電子メールアウトリーチにランダムに割り当てられました.
- 自己検診開始からランダム化研究までの6つのマイルストーンで,採用の成功が測定されました.
- 多変量分析は,コミュニケーションタイプの有効性の人口統計学的モデレーターを調べた.
主要な成果:
- 患者ポータルのアウトリーチにより,初期自己スクリーニングの完了率は高かった (OR=2. 4),最終的なランダム化率は高かった (OR=1. 43) ではありません.
- 前段階の完了をコントロールする際には,その後のマイルストーン差は有意ではなかった.
- 女性と男性がポータルメッセージに反応する可能性が高い.
結論:
- 患者ポータルのアウトリーチは初期参加者の活性化を促進しますが,臨床試験のランダム化率を全体的に有意に改善しません.
- この戦略は,研究者と参加者の両者の努力を増加させても,入学率に比例しない.
- 採用戦略の選択は,組織の文脈と研究テーマの敏感性に依存するかもしれません.
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