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希腊雅典地区患者对术前知情同意质量的感知:一项初步研究。

Patients' perception of quality of pre-operative informed consent in athens, Greece: a pilot study.

机构信息

Alfa Institute of Biomedical Sciences, Athens, Greece.

出版信息

PLoS One. 2009 Nov 26;4(11):e8073. doi: 10.1371/journal.pone.0008073.

Abstract

BACKGROUND

We sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC) in Greece.

METHODOLOGY/PRINCIPAL FINDINGS: A prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman's rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC.

CONCLUSIONS

Despite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant's comprehension of the right to IC and the provision of information regarding other possible therapeutic options.

摘要

背景

我们旨在进行一项研究,以记录和评估希腊患者对外科医生在沟通知情同意(IC)方面的看法。

方法/主要发现:2007 年 9 月至 2008 年 4 月在雅典进行了一项前瞻性试点研究。该研究样本来自八位不同外科医生手术的患者,他们自愿填写手术后关于 IC 的自我报告问卷。为了分析的目的,构建了综合传递信息指数和医患关系指数。共有 77 名患者(42 名男性)自愿回答问卷。传递信息指数的评分范围为 3 至 10,平均得分为 8,标准差(SD)为 1.9。所有患者均了解其潜在诊断和手术原因。然而,相当一部分(14.3%)受访者的得分低于或等于 5。医患关系评分范围为 0 至 20,平均得分为 16,标准差(SD)为 4.3。医患关系越好,医生最终向患者传递的信息就越多(Spearman 等级相关系数为 0.4,p<0.001)。与未理解知情同意权的参与者相比,理解知情同意权的参与者的传递信息指数更高(p<0.001),并且与获得其他可能治疗方案信息的参与者相比,传递信息指数更高(p=0.001)。43%的受访者回答说,同意过程花费的时间少于 10 分钟,58.4%的患者表示他们没有被告知其他可能的治疗选择,28.6%的患者并不真正理解他们的合法知情同意权。

结论

尽管存在固有局限性和小样本量,无法得出任何确凿的结论,但结果表明,成功的 IC 过程可能与特定因素相关,例如医患关系、医生告知患者的时间、参与者对知情同意权的理解以及提供有关其他可能治疗选择的信息。

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