Verma Vandna, Lucena Hayser Medina, Pandeva Ivilina, Pradhan Ashish
Department of Urogynaecology, Bedford Hospital NHS Trust, Kempston Road, Bedford, MK42 9DJ, UK.
Department of Urogynaecology, Cambridge University Hospitals NHS Foundation Trust, Biomedical Campus, Hills Road, Cambridge, CB2 0QQ, UK.
Int Urogynecol J. 2025 Apr;36(4):813-819. doi: 10.1007/s00192-025-06055-8. Epub 2025 Jan 31.
Obtaining informed consent to surgery is essential for ethical, legal, and quality-care reasons. This study evaluates patients' understanding, experience, and satisfaction with the informed consent process prior to pelvic reconstructive surgery.
A prospective study was conducted from April 2021 to April 2022, registered as a service evaluation project. It included all consenting women undergoing pelvic reconstructive surgery. A standardised questionnaire with closed and open-ended questions assessed patients' experiences and decision-making evaluated using the Decisional Conflict Scale (DCS). Satisfaction was evaluated through a five-point Likert scale and a ten-point visual analogue scale (VAS) for response reliability.
The study included 87 patients with a mean age of 61.4 years (SD 11.4). A significant 96.6% read the consent form thoroughly, 98% affirmed detailed explanations by staff, and 88.5% found the explanation clear. Although 83.9% considered the surgery details sufficient, 16.1% found the information overly detailed or too brief. Most patients (91.9%) felt that they had ample time to think before signing, and 75.9% deemed both oral and written information helpful. Only 13.8% preferred medical staff to decide for them, whereas 55.2% valued being included in decision making. Key factors influencing satisfaction were detailed procedure information (72.4%) and reading the consent form (51.7%). The mean DCS score was 7, indicating a high level of satisfaction. Overall, 85% were very satisfied or satisfied with the consent process, with 89.7% scoring 8-10 on the VAS scale.
A thorough consent process is associated with high patient satisfaction and facilitates shared decision making.
出于伦理、法律和优质医疗护理的原因，获得手术知情同意至关重要。本研究评估了患者在盆腔重建手术前对知情同意过程的理解、体验和满意度。
2021年4月至2022年4月进行了一项前瞻性研究，该研究注册为一项服务评估项目。研究对象包括所有接受盆腔重建手术并签署知情同意书的女性。使用一份包含封闭式和开放式问题的标准化问卷评估患者的体验，并采用决策冲突量表（DCS）评估决策情况。通过五点李克特量表和十点视觉模拟量表（VAS）评估满意度，以确保回答的可靠性。
该研究纳入了87例患者，平均年龄为61.4岁（标准差11.4）。显著比例的患者中，96.6%彻底阅读了同意书，98%认可工作人员的详细解释，88.5%认为解释清晰。尽管83.9%认为手术细节充分，但16.1%觉得信息过于详细或过于简略。大多数患者（91.9%）觉得在签字前有足够的时间思考，75.9%认为口头和书面信息都有帮助。只有13.8%的患者希望医护人员为他们做决定，而55.2%重视参与决策过程。影响满意度的关键因素是详细的手术信息（72.4%）和阅读同意书（51.7%）。DCS平均得分为7分，表明满意度较高。总体而言，85%的患者对同意过程非常满意或满意，89.7%在VAS量表上的得分在8至10分之间。
全面的同意过程与患者的高满意度相关，并有助于共同决策。
