Zizzo Claudia, Henriques Maria, Wooding James, Kennedy-Dalby Andrew
Emergency, Great Western Hospital, Swindon, GBR.
Medicine and Surgery, Whiston Hospital, Whiston, GBR.
Cureus. 2025 Jul 24;17(7):e88660. doi: 10.7759/cureus.88660. eCollection 2025 Jul.
Introduction Informed consent is a crucial component of surgical practice, ensuring that patients understand the risks and benefits associated with procedures. However, handwritten consent forms are often incomplete, illegible, and inconsistent. This quality improvement project aimed to review the informed consent process for emergency laparoscopic cholecystectomy and appendicectomy at a district general hospital in the United Kingdom and subsequently introduce pre-filled, procedure-specific consent forms for these procedures. Methods A retrospective review of 20 handwritten consent forms compared the documented risks to a standardized set (SS) of risks developed from multiple resources. This demonstrated the inadequate documentation of the risks of handwritten consent forms. In response to this, two pre-filled consent forms were developed, which incorporated the SS of risks. Layman's explanations were included, and space for additional risks was provided to cater to patient-specific needs. These new forms aimed to enhance patient-surgeon communication, facilitate patient understanding, and improve documentation. Post-intervention, a second retrospective analysis of 74 consent forms was then performed. Results Pre-intervention, a mean of 64.00% (n = 10) of risks was mentioned for appendicectomy and 55.79% (n = 10) for cholecystectomy. The most commonly documented risks were bleeding, bruising, and infection, while less frequent risks such as infertility were often omitted. Post-intervention, the mean documentation of risks increased to a mean of 81.82% (n = 45) for appendicectomy and 79.69% (n = 29) for cholecystectomy. Conclusion This quality improvement project demonstrates that pre-filled, procedure-specific consent forms are a valuable tool in improving the consenting process, acting as aids for structured discussion of risks, improving risk documentation, and reducing human errors in documentation. As such, a set of recommendations was developed for the future development of consent forms. Additionally, these consent forms may aid the transition to digital-based systems, helping reduce paper waste. Future recommendations also include the implementation of teaching sessions on informed consent to improve the consent process.
引言
知情同意是外科手术实践的关键组成部分,可确保患者了解与手术相关的风险和益处。然而,手写同意书往往不完整、难以辨认且不一致。本质量改进项目旨在审查英国一家地区综合医院急诊腹腔镜胆囊切除术和阑尾切除术的知情同意流程,并随后引入针对这些手术的预先填写好的、特定手术的同意书。
方法
对20份手写同意书进行回顾性审查,将记录的风险与从多种资源中制定的标准化风险集(SS)进行比较。这表明手写同意书对风险的记录不充分。对此,制定了两份预先填写好的同意书,其中纳入了标准化风险集。包含了通俗易懂的解释,并提供了填写额外风险的空间,以满足患者的特定需求。这些新表格旨在加强医患沟通,促进患者理解,并改善记录。干预后,对74份同意书进行了第二次回顾性分析。
结果
干预前,阑尾切除术提及的风险平均为64.00%(n = 10),胆囊切除术为55.79%(n = 10)。最常记录的风险是出血、瘀伤和感染,而诸如不孕等不太常见的风险往往被遗漏。干预后,阑尾切除术风险的平均记录增加到81.82%(n = 45),胆囊切除术为79.69%(n = 29)。
结论
本质量改进项目表明,预先填写好的、特定手术的同意书是改善同意流程的宝贵工具,可作为风险结构化讨论的辅助工具,改善风险记录,并减少记录中的人为错误。因此,针对同意书的未来发展制定了一系列建议。此外,这些同意书可能有助于向数字化系统过渡,有助于减少纸张浪费。未来的建议还包括开展关于知情同意的教学课程,以改善同意流程。