Ibrahim Nagmeldin Hassan , Mohamed Ibrahim , Siddig Yaqub , Muhsin Ibrahim , Haythem Abdalla , Ghada Aljaili , Wafa Osman , Nagmeldin Abuassa
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引用次数: 0
Abstract
Background
Informed consent is a cornerstone of ethical surgical practice, yet significant challenges persist in ensuring patients' comprehension, particularly in low-resource settings. Cultural norms, literacy barriers, and limited institutional support often hinder truly informed decision-making.
Methods
A hospital-based cross-sectional study was conducted from September to December 2024 at a rural surgical center in Omdurman, Sudan. A total of 422 adult patients undergoing elective surgery were interviewed postoperatively using a validated, culturally adapted questionnaire. Descriptive and inferential statistics were applied to assess patient demographics, perceptions of the informed consent process, and associated barriers.
Results
The mean age of participants was 42.0 ± 14.3 years, with a near-equal gender distribution. Only 17.1% of patients signed their own surgical consent forms, with 80.6% of these self-signers being male. Among those whose consent was signed by relatives (82.9%), females were overrepresented (56.6%). While 91.5% recognized the importance of informed consent, only 33.6% understood its medico-legal significance. Consent explanations were predominantly delivered by residents or house officers (62.1%), and just 20.1% of patients felt that the discussion influenced their surgical decision. Self-signers were more likely to recall discussion of surgical complications (75.0% vs. 51.4%; p < 0.001), less likely to recall expected benefits (61.1% vs. 78.9%; p = 0.001), and showed no significant difference for consequences if surgery was not performed (80.6% vs. 82.9%; p = 1.0). Overall satisfaction with the consent process was high (87.7%), though this did not correlate with comprehension. Educational status significantly influenced autonomy, with illiterate participants disproportionately less likely to sign their own forms and more likely to cite language barriers and lack of information (p < 0.05).
Conclusion
Despite high reported satisfaction, substantial deficiencies exist in patients’ comprehension and autonomy in the informed consent process in Sudan. Gender disparities, literacy limitations, and systemic reliance on junior staff compromise the ethical validity of consent. Interventions tailored to cultural and educational contexts—such as provider training, simplified materials, and patient-centered communication—are urgently needed to enhance informed surgical decision-making in low-resource environments.
知情同意是外科伦理实践的基石,但在确保患者理解方面仍然存在重大挑战,特别是在资源匮乏的环境中。文化规范、识字障碍和有限的制度支持往往阻碍真正知情的决策。方法于2024年9月至12月在苏丹恩图曼的一家农村外科中心进行以医院为基础的横断面研究。共有422名接受择期手术的成年患者在术后接受了一份经过验证的、适应文化的问卷调查。描述性和推断性统计应用于评估患者人口统计学,知情同意过程的看法,以及相关的障碍。结果参与者的平均年龄为42.0±14.3岁,性别分布基本相等。只有17.1%的患者自己签署了手术同意书,其中80.6%的患者是男性。在亲属签署同意书的患者中(82.9%),女性比例过高(56.6%)。虽然91.5%的人认识到知情同意的重要性,但只有33.6%的人了解其医学-法律意义。同意解释主要由住院医生或住院医生(62.1%)提供,只有20.1%的患者认为讨论影响了他们的手术决定。自签名者更有可能回忆起手术并发症的讨论(75.0% vs. 51.4%; p < 0.001),不太可能回忆起预期的益处(61.1% vs. 78.9%; p = 0.001),如果不进行手术,其后果没有显着差异(80.6% vs. 82.9%; p = 1.0)。对同意过程的总体满意度很高(87.7%),尽管这与理解程度无关。教育程度显著影响自主性,不识字的参与者不太可能在自己的表格上签名,更有可能提到语言障碍和缺乏信息(p < 0.05)。结论尽管报告的满意度很高,但苏丹患者在知情同意过程中的理解和自主权存在实质性缺陷。性别差异、读写能力的限制以及对初级员工的系统性依赖损害了同意的道德有效性。在资源匮乏的环境中,迫切需要针对文化和教育背景的干预措施,如提供者培训、简化材料和以患者为中心的沟通,以提高知情的手术决策。