The Role of Pre-filled Procedure-Specific Consent Forms in Emergency General Surgery: A Quality Improvement Study

预填式手术特定知情同意书在急诊普通外科手术中的作用:一项质量改进研究

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Abstract

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.

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