Murphy Glenn S, Szokol Joseph W, Avram Michael J, Greenberg Steven B, Shear Torin D, Vender Jeffery S, Landry Elizabeth
From the Department of Anesthesiology, NorthShore University HealthSystem, University of Chicago Pritzker School of Medicine, Evanston, Illinois (G.S.M., J.W.S., S.B.G., T.D.S., J.S.V.); Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (M.J.A.); and Department of Anesthesiology, NorthShore University HealthSystem, Evanston, Illinois (E.L.).
Anesthesiology. 2016 Jun;124(6):1246-55. doi: 10.1097/ALN.0000000000001107.
Opportunities for anesthesia research investigators to obtain consent for clinical trials are often restricted to the day of surgery, which may limit the ability of subjects to freely decide about research participation. The aim of this study was to determine whether subjects providing same-day informed consent for anesthesia research are comfortable doing so.
A 25-question survey was distributed to 200 subjects providing informed consent for one of two low-risk clinical trials. While consent on the day of surgery was permitted for both studies, a preadmission telephone call was required for one. The questionnaire was provided to each subject at the time of discharge from the hospital. The questions were structured to assess six domains relating to the consent process, and each question was graded on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Overall satisfaction with same-day consent was assessed using an 11-point scale with 0 = extremely dissatisfied and 10 = extremely satisfied.
Completed questionnaires were received from 129 subjects. Median scores for satisfaction with the consent process were 9.5 to 10. Most respondents reported that the protocol was well explained and comprehended and that the setting in which consent was obtained was appropriate (median score of 5). Most patients strongly disagreed that they were anxious at the time of consent, felt obligated to participate, or had regrets about participation (median score of 1). Ten percent or less of subjects reported negative responses to any of the questions, and no differences were observed between the study groups.
More than 96% of subjects who provided same-day informed consent for low-risk research were satisfied with the consent process.
麻醉研究调查人员获得临床试验同意的机会通常仅限于手术当天，这可能会限制受试者自由决定是否参与研究的能力。本研究的目的是确定在手术当天提供麻醉研究知情同意书的受试者是否对此感到满意。
向200名参与两项低风险临床试验之一并提供知情同意书的受试者发放了一份包含25个问题的调查问卷。两项研究均允许在手术当天获得同意，但其中一项研究需要在入院前进行电话沟通。问卷在受试者出院时发放。问题的设计旨在评估与同意过程相关的六个领域，每个问题采用5级李克特量表评分（1 = 强烈不同意至5 = 强烈同意）。使用11级量表评估对当天同意的总体满意度，0 = 极其不满意，10 = 极其满意。
共收到129名受试者填写完整的问卷。对同意过程满意度的中位数得分在9.5至10分之间。大多数受访者表示方案得到了充分解释且易于理解，获得同意的环境也合适（中位数得分5分）。大多数患者强烈不同意他们在同意时感到焦虑、觉得有义务参与或对参与感到后悔（中位数得分1分）。10%或更少的受试者对任何问题给出负面回答，两组之间未观察到差异。
超过96%在手术当天为低风险研究提供知情同意书的受试者对同意过程感到满意。
