Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Spine (Phila Pa 1976). 2020 Dec 1;45(23):1661-1667. doi: 10.1097/BRS.0000000000003641.
Prospective study.
To determine the parents'/patients' perception on the informed consent process prior to posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) patients.
Understanding parents/patients perspective on the process is important in order to achieve the goal of consent and prevent medico-legal implications.
Fifty AIS patients operated between August 2019 and November 2019 were prospectively recruited. Parents'/patients' perceptions on three sections were evaluated: the process of the informed consent, specific operative risk which they were most concerned with and the accountability of surgeons for the surgical risks. These data were ranked and scored using a 5-point Likert Scale. Preferences were reported in mean and standard deviation. Differences in terms of preferences were studied using One-way analysis of variance (ANOVA) analysis and deemed significant when P < 0.05.
There were 30 females (60.0%) and 20 males (40.0%) with a mean age of 41.8 ± 10.6 years. Majority of parents/patients preferred the inform consent to be explained more than once (P = 0.021), once during clinic consultation and once during admission (4.2 ± 1.0). Consent taking by both attending surgeons was preferred (4.5 ± 0.6) compared with other healthcare providers, P < 0.001. Death (60.0%) and neurological deficit (30.0%) were the two most concerned surgical risks. Parents/patients would still hold the surgeon accountable for any complications despite signing the informed consent and they felt that surgeons were directly responsible for screw-related injuries (3.9 ± 0.9), neurological injury (3.8 ± 0.9), and intraoperative bleeding (3.7 ± 0.9).
Parents/patients preferred the attending surgeons to personally explain the informed consent, more than once with the use of visual aid. They would still hold the surgeons accountable when complications occur despite acceptance of the informed consent.
前瞻性研究。
确定青少年特发性脊柱侧凸（AIS）患者接受后路脊柱融合术（PSF）前，家长/患者对知情同意过程的看法。
了解家长/患者对该过程的看法对于实现同意的目标和预防医疗法律纠纷至关重要。
2019 年 8 月至 11 月期间，前瞻性招募了 50 名 AIS 患者。评估家长/患者对三个部分的看法：知情同意过程、他们最关注的具体手术风险以及外科医生对手术风险的责任。这些数据使用 5 分李克特量表进行评分和排名。偏好以平均值和标准差报告。使用单向方差分析（ANOVA）分析研究偏好差异，当 P<0.05 时认为差异具有统计学意义。
有 30 名女性（60.0%）和 20 名男性（40.0%），平均年龄为 41.8±10.6 岁。大多数家长/患者更希望知情同意被多次解释（P=0.021），一次在诊所咨询时，一次在入院时，（4.2±1.0）。家长/患者更喜欢由两位主治外科医生共同获取知情同意（4.5±0.6），而不是其他医疗保健提供者，P<0.001。死亡（60.0%）和神经功能缺损（30.0%）是他们最关注的两种手术风险。尽管已签署知情同意书，但家长/患者仍会追究外科医生的责任，如果出现任何并发症，他们认为外科医生直接负责螺钉相关损伤（3.9±0.9）、神经损伤（3.8±0.9）和术中出血（3.7±0.9）。
家长/患者希望主治外科医生亲自解释知情同意书，最好使用视觉辅助工具，多次进行解释。尽管已经接受了知情同意书，但当出现并发症时，他们仍会追究外科医生的责任。
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