J Med Ethics. 2011 Mar;37(3):187-9. doi: 10.1136/jme.2010.039644. Epub 2010 Nov 17.
OJECTIVES: Low energy hip fractures are one of the greatest causes of morbidity and mortality in orthopaedics. This study aims to evaluate written consent forms with respect to basic standards as set out in the Good Practice in Consent Initiative. In particular the stated risks and benefits of each procedure were assessed.
100 consecutive consent forms were reviewed prospectively. The stated procedure, side and complications were recorded. Appropriate signature and legibility was assessed. 13 consultant orthopaedic surgeons were surveyed to identify what risks and benefits they thought should be stated.
Of 100 consent forms, 31 were for patients who are unable to consent. All 100 consent forms were correctly filled in with patient details and signed. 98% were legible. All stated the side of the operation. The number of complications listed per form ranged from 4 to 11. Infection, bleeding and thromboembolic complications were stated in the majority of consent forms. In total, 30 different complications were recorded; some were only stated once.
This work suggests consent forms are completed well with respect to patient identifiers, legibility and procedure. The variability of complications stated is vast. We suggest standard pre-printed consent forms containing risks and benefits should be used as this may improve standards of informed consent. This has also been recently supported by the British Orthopaedic Association.
目的:低能量髋部骨折是矫形外科发病率和死亡率的最大原因之一。本研究旨在评估书面知情同意书是否符合“知情同意良好实践倡议”规定的基本标准。特别是,评估了每种手术的规定风险和收益。
方法:前瞻性地审查了 100 份连续的知情同意书。记录了规定的手术、手术侧和并发症。评估了适当的签名和清晰度。对 13 名顾问矫形外科医生进行了调查,以确定他们认为应陈述哪些风险和收益。
结果:100 份知情同意书中,有 31 份是为无法同意的患者准备的。所有 100 份知情同意书均正确填写了患者详细信息并签名。98%的知情同意书清晰易读。所有知情同意书均注明了手术侧。每份知情同意书列出的并发症数量从 4 到 11 不等。感染、出血和血栓栓塞并发症在大多数知情同意书中都有说明。总共记录了 30 种不同的并发症,有些仅说明过一次。
讨论和结论:这项工作表明,在患者识别码、清晰度和手术方面,知情同意书的填写情况良好。所陈述的并发症的变化范围很大。我们建议使用包含风险和收益的标准预印知情同意书,因为这可能会提高知情同意的标准。这也得到了英国矫形外科协会的最新支持。