Brull Richard, McCartney Colin J L, Chan Vincent W S, Chung Frances, Rawson Regan
Department of Anesthesia, Toronto Western Hospital, University Health Network, Ontario, Canada.
Anesth Analg. 2004 Apr;98(4):1106-1110. doi: 10.1213/01.ANE.0000106801.98537.25.
Consent for clinical anesthesia research trials is often sought on the day of surgery when patients are most anxious and have little privacy or time for reflection. We conducted a retrospective survey of patients' perceptions and concerns regarding consent for clinical anesthesia trials on the day of surgery. Questionnaires were mailed to 175 patients who had participated in 1 of 6 negligible- or minimal-risk clinical anesthesia trials within the preceding year. Seventy-six patients responded (43%). Most patients (80%) reported that they understood the purpose of their trial, did not feel obligated (61%) or pressured (67%) to participate, and were satisfied (mean visual analog scale: 71 mm) with the recruitment and consent process on the day of surgery. Few patients (7%) believed that their well-being was put at risk because of their participation in the trial.
This retrospective survey suggests that patient recruitment and consent for negligible- or minimal-risk clinical anesthesia research trials is appropriate when performed on the day of surgery.
临床麻醉研究试验的同意书通常在手术当天获取，此时患者最为焦虑，几乎没有隐私或时间进行思考。我们对患者在手术当天对临床麻醉试验同意书的认知和担忧进行了一项回顾性调查。问卷被邮寄给了175名在前一年参与了6项可忽略或最小风险临床麻醉试验之一的患者。76名患者进行了回复（回复率43%）。大多数患者（80%）表示他们理解试验的目的，感觉没有义务（61%）或受到压力（67%）参与，并且对手术当天的招募和同意过程感到满意（平均视觉模拟量表评分为71毫米）。很少有患者（7%）认为他们的健康因参与试验而受到威胁。
这项回顾性调查表明，在手术当天进行可忽略或最小风险临床麻醉研究试验的患者招募和同意是合适的。
