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知情同意对发展中国家接受胃肠手术和活体供肝移植患者及其亲属的影响。

Effect of informed consent on patients undergoing gastrointestinal surgery and living donor liver transplantation and on their relatives in a developing country.

作者信息

Ray S, Mehta N N, Mehrotra S, Lalwani S, Mangla V, Yadav A, Nundy S

机构信息

Department of Surgical Gastroenterology and Liver Transplantation Sir Ganga Ram Hospital New Delhi India.

出版信息

BJS Open. 2018 Feb 7;2(1):34-39. doi: 10.1002/bjs5.37. eCollection 2018 Feb.

Abstract

BACKGROUND

Informed consent is a systematic process for obtaining permission before conducting a healthcare intervention. In a developing country, gaining informed consent is generally perceived to be a ritual only to comply with legal requirements. The present study examined this by assessing the process of informed consent in patients undergoing gastrointestinal surgery or living donor liver transplantation (LDLT) and their relatives, based on their comprehension and overall satisfaction, in India.

METHODS

All patients undergoing any gastrointestinal surgery or LDLT procedure between August 2015 and July 2016 and their relatives were included, and were administered a structured questionnaire 5 days after the procedure.

RESULTS

The majority of patients (94·2 per cent) could recall the nature of their disease, the surgery performed (81·6 per cent) and anticipated complications (55·6 per cent). Among their relatives, these proportions were 97·8, 87·3 and 58·5 per cent respectively. Recall was associated with age, occupation and education among both patients and relatives. Patients undergoing LDLT, their donors and their relatives had better recall than those who had other gastrointestinal procedures (P < 0·001). Many patients found the process of informed consent useful and reassuring.

CONCLUSION

The details and risks of an operation were understood by most of the patients, especially those undergoing liver transplantation. Patients from developing countries can generally understand 'informed consent', and value it.

摘要

背景

知情同意是在进行医疗干预前获得许可的系统过程。在发展中国家,人们普遍认为获得知情同意只是为了遵守法律要求的一种例行程序。本研究通过评估印度接受胃肠手术或活体肝移植(LDLT)患者及其亲属的知情同意过程,基于他们的理解程度和总体满意度对此进行了研究。

方法

纳入2015年8月至2016年7月期间接受任何胃肠手术或LDLT手术的所有患者及其亲属,并在术后5天对他们进行结构化问卷调查。

结果

大多数患者(94.2%)能够回忆起自己疾病的性质、所进行的手术(81.6%)以及预期并发症(55.6%)。在他们的亲属中,这些比例分别为97.8%、87.3%和58.5%。患者及其亲属的回忆情况与年龄、职业和教育程度有关。接受LDLT的患者、其供体及其亲属的回忆情况比接受其他胃肠手术的患者更好(P<0.001)。许多患者认为知情同意过程有用且令人安心。

结论

大多数患者,尤其是接受肝移植的患者,了解手术的细节和风险。发展中国家的患者通常能够理解“知情同意”并重视它。

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