沙特阿拉伯中部地区侵入性操作的知情同意书质量。
Quality of informed consent for invasive procedures in central Saudi Arabia.
机构信息
King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
出版信息
Int J Gen Med. 2012;5:269-75. doi: 10.2147/IJGM.S29599. Epub 2012 Mar 20.
BACKGROUND
Informed consent is considered the most important step in clinical interventions. The aims of this study were (1) to assess the quality of informed consent for invasive procedures with regard to consent process and information given about risks and alternative treatments, and (2) to determine patients' attitude toward informed consent at King Abdulaziz Medical City, Riyadh, Saudi Arabia.
METHODS
A cross-sectional study was conducted of 162 adult patients in different wards after undergoing surgery or invasive procedures within 1-2 days of signing the informed consent, using a previously validated interview questionnaire. Data on patients' characteristics, type of invasive procedure, and some informed consent-related issues were collected. Multiple linear regression analysis was used to identify the predictors of the percentage mean score of quality of informed consent, and significance was considered at P ≤ 0.05.
RESULTS
The quality of informed consent was generally poor (% mean score = 50.98 ± 17.49). About two-thirds of patients were told during the informed consent process that they have to sign merely as routine, 48% thought that if they refused the treatment plan they would lose the interest of the treating physician to help them, 42% thought that by saying no they would lose the good relationship with their physician, and 42.6% were not interested in having a copy of the informed consent document. Significantly higher quality was predicted when the physicians were the ones who explained the informed consent (t = 4.15, P < 0.001) and when informed consent was explained to younger patients (t = 2.754, P = 0.007). The overall attitude of the patients toward the process of informed consent was satisfactory (% mean score = 76.31 ± 7.63).
CONCLUSION
The results suggest either that patients are not aware of their rights or that physician paternalism is practiced in Saudi Arabia. Cultural barriers should not be an argument to diminish the role of informed consent. Further studies should focus on how the value of autonomy can be appreciated in the Saudi culture.
背景
知情同意被认为是临床干预中最重要的步骤。本研究的目的是（1）评估侵入性手术知情同意的质量，包括同意过程和有关风险及替代治疗的信息；（2）了解沙特阿拉伯利雅得阿卜杜勒阿齐兹国王医疗城的患者对知情同意的态度。
方法
对 162 名在签署知情同意书后 1-2 天内接受手术或侵入性操作的不同病房的成年患者进行横断面研究，使用预先验证的访谈问卷。收集患者特征、侵入性操作类型和一些知情同意相关问题的数据。采用多元线性回归分析确定影响知情同意质量平均得分百分比的预测因素，P≤0.05 为差异有统计学意义。
结果
知情同意的质量普遍较差（%平均得分=50.98±17.49）。大约三分之二的患者在知情同意过程中被告知只需签字作为例行程序，48%的患者认为如果拒绝治疗方案，他们会失去主治医生帮助他们的兴趣，42%的患者认为如果拒绝，他们会失去与医生的良好关系，42.6%的患者对获得知情同意文件的副本不感兴趣。当医生解释知情同意（t=4.15，P<0.001）或向年轻患者解释知情同意（t=2.754，P=0.007）时，质量更高。患者对知情同意过程的总体态度令人满意（%平均得分=76.31±7.63）。
结论
结果表明，在沙特阿拉伯，患者要么不知道自己的权利，要么医生实行家长式作风。文化障碍不应成为削弱知情同意作用的理由。进一步的研究应集中在如何在沙特文化中重视自主权的价值。
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