臨床試験の結果を参加者に提供すること: ネガティブな研究の結果を共有すること
Ann H Partridge1, Julia S Wong, Katherine Knudsen
1Department of Medical and Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. ahpartridge@partners.org
Lancet (London, England)
|March 16, 2005
まとめ
臨床試験の参加者に,研究結果が否定的であることを提供することは,実行可能であり,歓迎されています. この乳がん臨床試験の参加者のほとんどは,結果を知りたいと考え,そのプロセスに対するポジティブな感情を報告しました.
科学分野:
- 腫瘍学 腫瘍学
- クリニック・トライアル 臨床試験
- 患者とのコミュニケーション
背景:
- 患者はしばしば臨床試験の結果に関する情報が不足しています.
- ネガティブな研究結果は,参加者と共有されることはめったにありません.
研究 の 目的:
- 臨床試験の被験者に対して否定的な試験結果を共有する過程と影響を評価する.
- 患者の受容と,試験結果を受け取る気持ちを評価する.
主な方法:
- 135人の参加者に,乳がんII相試験の陰性結果を提供した.
- この試験では,乳腺切除のみを,管道性がん in situ の治療法として調査した.
- 参加者の反応と人口統計的要因 (教育レベル) に関するデータを収集します.
主要な成果:
- 回答者の90% (85/94) は,研究結果を受け取ることを選択しました.
- 結果を受け取った参加者は,非受給者よりも高い教育程度でした.
- ほとんどの参加者は,結果と臨床試験の受付についてポジティブな感情を表明しました.
結論:
- 臨床試験のネガティブな結果を参加者と共有することは,実行可能で,肯定的に受け入れられる実践です.
- 試験結果について参加者に知らせることは,彼らの関与と研究に対する認識を高めることができます.
- 臨床試験における患者と医療従事者のコミュニケーションに関するさらなる調査が必要である.
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