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麻醉服务单独知情同意书的有效性:来自加勒比地区的一项前瞻性研究。

Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean.

作者信息

Rampersad Kavi, Chen Deryk, Hariharan Seetharaman

机构信息

Anaesthesia and Intensive Care Unit, Department of Clinical Surgical Sciences, Faculty of Medical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago, West Indies.

出版信息

J Anaesthesiol Clin Pharmacol. 2016 Jan-Mar;32(1):18-24. doi: 10.4103/0970-9185.173364.

Abstract

BACKGROUND AND AIMS

This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital.

MATERIAL AND METHODS

We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed.

RESULTS

Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008).

CONCLUSIONS

A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

摘要

背景与目的

本研究旨在确定一份单独的书面同意书是否能提高三级护理教学医院中接受择期手术的成年患者麻醉知情同意过程的效果。

材料与方法

我们前瞻性地将患者随机分为两组。第一组(A组)仅签署医院的标准手术同意书,而第二组(B组)额外签署一份单独的麻醉同意书。术后用一份包含八个条目的问卷对患者进行访谈,回答采用五点李克特量表。根据回答生成一个综合的同意充分性指数并进行分析。

结果

研究了200名患者(每组100名)。所有患者均表示麻醉医生得到了他们进行麻醉护理的许可。B组的平均同意充分性指数得分高于A组(30.6±4.6[标准差(SD)]对27.9±5.2[SD])(P<0.001)。单独的书面同意书对患者对预期麻醉程序的性质和目的的理解有积极影响(P = 0.04),对关于常见副作用(P<0.001)和罕见但严重并发症(P = 0.008)所提供信息的充分性满意度也有积极影响。

结论

一份单独的麻醉书面同意书在关于麻醉的性质和目的、常见副作用以及罕见但严重并发症方面提供了更好的信息,从而提高了知情同意过程的效果。

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