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关于患者信息手册在获得知情同意方面作用的前瞻性随机对照试验。

Prospective randomised controlled trial on the role of patient information leaflets in obtaining informed consent.

作者信息

Ashraff Seemab, Malawa Gideon, Dolan Trevor, Khanduja Vikas

机构信息

Department of Trauma and Orthopaedics, Newham University Hospital, Plaistow, London, UK.

出版信息

ANZ J Surg. 2006 Mar;76(3):139-41. doi: 10.1111/j.1445-2197.2006.03671.x.

DOI:10.1111/j.1445-2197.2006.03671.x
PMID:16626351
Abstract

BACKGROUND

The aim of this study was to determine whether patient information leaflets help to improve patient recall during the process of informed consent.

METHODS

A prospective randomized controlled trial that compared a group of patients who were posted a patient information leaflet with those given verbal consent only was carried out. The study was conducted at the orthopaedic unit of a district general hospital. A total of 110 patients were selected, of whom 57 were randomly allocated to receive patient information leaflets by post and 53 were given verbal consent only. The outcome measure was the recall of information given to the patient. This was tested on admission by using a questionnaire. Each patient was allocated a score out of 10.

RESULTS

There was a significant difference between the patients in the group that received patient information leaflets and those in the group that did not (P < 0.0001; confidence interval, 2.0-3.1).

CONCLUSION

Patient information leaflets are a useful tool for the surgeon to improve the recall of the information given to the patient, in order to facilitate informed consent.

摘要

背景

本研究的目的是确定患者信息手册在知情同意过程中是否有助于提高患者的记忆。

方法

开展了一项前瞻性随机对照试验,将一组收到患者信息手册的患者与另一组仅接受口头同意的患者进行比较。该研究在一家地区综合医院的骨科进行。共选取了110名患者,其中57名被随机分配通过邮寄方式接收患者信息手册,53名仅接受口头同意。结果指标是患者对所提供信息的记忆。入院时通过问卷调查进行测试。每位患者的得分满分为10分。

结果

收到患者信息手册的组与未收到的组之间存在显著差异(P < 0.0001;置信区间为2.0 - 3.1)。

结论

患者信息手册是外科医生提高患者对所提供信息的记忆的有用工具,以便促进知情同意。

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