Alfa Institute of Biomedical Sciences, Athens, Greece.
PLoS One. 2009 Nov 26;4(11):e8073. doi: 10.1371/journal.pone.0008073.
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.
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.
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。
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。