手术当天获得知情同意的围手术期临床试验患者对方案的理解和焦虑。

Protocol understanding and anxiety in perioperative clinical trial patients approached for consent on the day of surgery.

机构信息

Cleveland Clinic Learner College of Medicine, Cleveland Clinic, Cleveland, Ohio 44195, USA.

出版信息

Mayo Clin Proc. 2013 May;88(5):446-54. doi: 10.1016/j.mayocp.2012.12.014.

DOI:10.1016/j.mayocp.2012.12.014

PMID:23639498

Abstract

OBJECTIVE

To determine whether approaching patients for consent on the day of surgery impairs understanding or produces unacceptable anxiety compared with obtaining consent before the day of surgery.

PATIENTS AND METHODS

We assessed the effect of the timing of obtaining consent for a moderate- to high-risk factorial trial of clonidine and aspirin in patients having noncardiac surgery. Between February 1, 2011, and November 31, 2011, 2 study personnel used the same standardized script to recruit patients before the day of surgery or on the day of surgery. Patients eligible for the trial were preferentially approached to obtain consent before the day of surgery in the preoperative clinic. Patients who did not attend the preoperative clinic or could not be approached that day were approached for consent on the day of surgery. We evaluated anxiety before and after the trial was discussed, protocol knowledge, consent rates, and perceived obligation to participate. All comparisons were adjusted for differences in potentially confounding variables using inverse propensity score weighting.

RESULTS

Patients approached on the day of surgery compared with before the day of surgery had noninferior understanding of the comprehension score (adjusted mean difference, -0.19; 90% CI, -0.47 to 0.10; P<.001 for noninferiority) and a noninferior mean increase in the postapproach anxiety score (adjusted mean difference, 0.19; 90% CI, -0.29 to 0.68; P=.003 for noninferiority). Perceived obligation to participate was not greater on the day of surgery (adjusted mean difference, 0.09; 95% CI, -0.21 to 0.40; P=.57 for superiority); however, consent rates were significantly lower (31% vs 59%; odds ratio, 0.49; 90% CI, 0.33 to 0.72; P=.46 for noninferiority).

CONCLUSION

Approaching patients to obtain consent to participate in a perioperative interventional trial on the day of surgery does not compromise essential elements of the consent process.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01082874.

摘要

目的

确定与术前相比，在手术当天征得患者同意是否会影响理解或产生不可接受的焦虑。

患者和方法

我们评估了在非心脏手术患者中进行可乐定和阿司匹林中危至高危因子试验时，获得同意的时间对试验的影响。在 2011 年 2 月 1 日至 2011 年 11 月 31 日期间，2 名研究人员使用相同的标准化脚本在术前或手术当天招募患者。有资格参加试验的患者在术前诊所被优先邀请获得同意。未参加术前诊所或当天无法联系到的患者在手术当天被邀请获得同意。我们评估了讨论试验前后的焦虑、方案知识、同意率和参与的感知义务。所有比较均使用逆倾向评分加权法对潜在混杂变量的差异进行调整。

结果

与术前相比，在手术当天接受治疗的患者对理解得分的理解没有差异（调整后的平均差异，-0.19；90%置信区间，-0.47 至 0.10；非劣效性 P<.001），并且在术后焦虑评分增加方面具有非劣效性（调整后的平均差异，0.19；90%置信区间，-0.29 至 0.68；非劣效性 P=.003）。在手术当天，参与的感知义务并没有更大（调整后的平均差异，0.09；95%置信区间，-0.21 至 0.40；P=.57 为优势）；然而，同意率明显较低（31%比 59%；比值比，0.49；90%置信区间，0.33 至 0.72；非劣效性 P=.46）。