Chia Clement L K, Chan Kai Siang, Ng Marcus J M, Rao Anil D, Singaporewalla Reyaz
Department of General Surgery, Khoo Teck Puat Hospital, Singapore.
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.
ANZ J Surg. 2019 Jun;89(6):677-682. doi: 10.1111/ans.15214. Epub 2019 May 14.
Studies show that patients often sign consent documents without fully comprehending the risks, benefits and potential complications. There is currently no Asian study performed analysing adequacy of informed consent. This study aims to assess adequacy of informed consent by evaluating patient understanding and retention of key information and complications pertaining to surgery via medical student-administered interview.
A prospective study was performed on 48 patients undergoing groin hernia surgery, laparoscopic cholecystectomy and total thyroidectomy from 2017 to 2018 in a teaching hospital. Standardized assessment forms including major common complications and key details of the surgery were prepared. Structured one-to-one interviews between students and patients were performed and recorded on the morning of surgery.
Although 93.8% of the patients claimed to have understood the information regarding their surgery, only 19.4%, 44.4% and 62.5% of the patients could actually recall the serious complications of groin hernia surgery, laparoscopic cholecystectomy and thyroidectomy, respectively. Elderly patients (>65 years) had poorer understanding of surgical procedure compared to the young (80% versus 100%, respectively, P = 0.008) with 26.7% of elderly patients claiming that they did not understand the indication for surgery. High satisfaction rates with this preoperative interview were reported by both patients and students (95.8% and 97.9%, respectively). Time interval from informed consent to surgery did not make any difference.
Understanding of information and key complications was generally low, especially in the elderly population. The structured preoperative interview achieved the dual goal of reinforcing patient gaps in knowledge and improving student communication skills.
研究表明，患者在签署同意书时往往并未充分理解其中的风险、益处及潜在并发症。目前尚无针对知情同意充分性的亚洲研究。本研究旨在通过医学生进行的访谈来评估患者对手术相关关键信息及并发症的理解和记忆情况，从而评估知情同意的充分性。
2017年至2018年，在一家教学医院对48例行腹股沟疝修补术、腹腔镜胆囊切除术和全甲状腺切除术的患者进行了一项前瞻性研究。准备了包括主要常见并发症和手术关键细节的标准化评估表。在手术当天上午，学生与患者进行了一对一的结构化访谈并录音。
尽管93.8%的患者声称理解了关于其手术的信息，但实际上只有19.4%、44.4%和62.5%的患者能分别回忆起腹股沟疝修补术、腹腔镜胆囊切除术和甲状腺切除术的严重并发症。老年患者（>65岁）与年轻患者相比，对手术过程的理解较差（分别为80%对100%，P = 0.008），26.7%的老年患者声称不理解手术适应症。患者和学生对术前访谈的满意度都很高（分别为95.8%和97.9%）。从签署知情同意书到手术的时间间隔没有产生任何影响。
对信息和关键并发症的理解普遍较低，尤其是在老年人群中。结构化的术前访谈实现了弥补患者知识差距和提高学生沟通技巧这两个双重目标。
