Hammami Muhammad M, Al-Jawarneh Yussuf, Hammami Muhammad B, Al Qadire Mohammad
Clinical Studies and Empirical Ethics Department, King Faisal Specialist Hospital and Research Centre, P O Box # 3354 (MBC 03), Riyadh 11211, Saudi Arabia.
BMC Med Ethics. 2014 Jan 10;15:3. doi: 10.1186/1472-6939-15-3.
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures.
We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues.
Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009).
当前临床护理知情同意原则是在以低语境沟通和监控式应对为特征的文化中发展起来的。关于其他文化中患者对信息披露规范认知的实证数据很少。
我们对沙特阿拉伯一家三级医疗保健医院中计划接受或最近接受了需要书面知情同意程序的470名成年人进行了调查。使用5点李克特量表(1 = 强烈同意披露)和7个领域的30项信息来探究规范认知和当前实践:从业者详细信息、益处、风险、并发症管理、可用替代方案、程序描述和术后问题。
受访者的平均(标准差)年龄为38.4(12.5)岁;50.2%为男性,57.2%拥有大专及以上学历,37.9%接受过手术。根据规范认知,强烈同意/同意的回答比例从98.0%(主要益处)到50.5%(助理/实习生姓名)不等。总体而言,与益处和术后问题相关的项目排名优于与风险和可用替代方案相关的项目。术后受访者中有4项(13.3%)的排名得分更高(p < 0.001至0.001),男性中有8项(26.7%)的排名得分更高(p = 0.008至<0.001)。年龄较大与3项(10.0%)项目的排名得分较好相关,与1项项目的排名得分较差相关(p < 0.001至0.006)。根据当前实践认知,强烈同意/同意的回答比例从93.3%(程序名称披露)到13.9%(主刀医生的培训地点)不等,所有项目的排名得分均低于规范认知(p < 0.001),术后状态、较年轻的年龄和较低的教育水平分别与15项(50.0%)、12项(40.0%)和4项(13.3%)项目的排名得分较好相关(p < 0.001至0.009)。
1)即使在总体上高语境沟通的文化中,人们认为应披露比目前更多、更广泛的信息才符合规范;2)期望信息的重点更接近益处和术后问题,而非风险和可用替代方案;3)男性、术后患者和老年患者更倾向于更多的信息披露;4)男性、老年和受教育程度较高的患者可能对当前的信息披露特别不满意。如果要满足“合理”患者的标准,临床知情同意信息披露的重点和范围可能需要调整。