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知情同意在妇产科操作中的实践:来自发展中国家患者的观点。

Informed consent practice for obstetric and gynaecologic procedures: A patients' perspective from a developing country.

机构信息

Prime Institute of Public Health, Riphah International University, Islamabad, Pakistan.

Peshawar Medical College, Riphah International University, Islamabad, Pakistan.

出版信息

J Eval Clin Pract. 2019 Jun;25(3):491-497. doi: 10.1111/jep.13106. Epub 2019 Feb 28.

DOI:10.1111/jep.13106
PMID:30815974
Abstract

OBJECTIVES

To assess the surgical informed consent (SIC) practices for obstetric and gynaecological (OB-GYN) procedures at different hospitals in Pakistan.

METHODS

Study was conducted in five hospitals (three public and two private) of Peshawar, Pakistan. A pretested structured tablet-based questionnaire was administered from October 2016 through January 2017 among post-op OB-GYN patients.

RESULTS

About 27% of the patients (significantly more in private hospitals, P = 0.001) did not remember a formal consent administration. Most patients (80%) felt they had no choice about signing the consent. About 65% (mostly in public as compared with private hospitals) mentioned that they would have signed it regardless of the specifics in it (P < 0.001). Patients had increased odds to recall consent if they felt empowered, odds ratio (OR) = 4.5; had an opportunity to ask questions, OR = 7.2; wanted more explanation, OR = 2.8; and had consent administered in their mother tongue, OR = 6.9.

DISCUSSION

Patients' recall of key elements of consent was low. The time spent with the patient for consenting was much shorter than recommended. The printed consent forms were mostly not available in patients' mother tongue.

CONCLUSIONS

Consent practice for OB-GYN procedures was suboptimal in studied hospitals. Patients' attitude toward informed consent practices largely reflected providers' focus on obtaining a legally valid signed consent as opposed to administering a consent that empowers patients to make an informed decision in the absence of any external pressure.

摘要

目的

评估巴基斯坦不同医院妇产科手术的手术知情同意(SIC)实践情况。

方法

本研究在巴基斯坦白沙瓦的 5 家医院(3 家公立医院和 2 家私立医院)进行。于 2016 年 10 月至 2017 年 1 月期间,使用预先测试的基于平板电脑的问卷对术后妇产科患者进行了调查。

结果

约 27%的患者(私立医院显著更多,P=0.001)不记得正式的同意书管理。大多数患者(80%)认为他们对签署同意书别无选择。约 65%的患者(主要是公立医院而不是私立医院)表示,无论同意书中的具体内容如何,他们都会签署(P<0.001)。如果患者感到有能力、有机会提问、希望得到更多解释或同意书以母语形式呈现,他们回忆起同意书的可能性就会增加,比值比(OR)分别为 4.5、7.2、2.8 和 6.9。

讨论

患者对同意书关键要素的回忆率较低。用于同意书的时间比推荐的时间要短得多。患者的母语中大多没有印刷的同意书。

结论

研究医院妇产科手术的同意书实践情况并不理想。患者对知情同意书实践的态度主要反映了提供者关注的是获得具有法律约束力的已签署同意书,而不是在没有任何外部压力的情况下授权患者做出知情决策。

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