Department of Neurosurgery, Queen Elizabeth Hospital, Birmingham, Birmingham, UK.
Academic Neurosurgery Unit, St George's, University of London, London, UK.
Eur Spine J. 2017 Nov;26(11):2789-2796. doi: 10.1007/s00586-017-5107-6. Epub 2017 May 20.
Prospective, multi-centre, multi-specialty medical notes review and patient interview.
The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall.
Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall.
The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade.
Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.
前瞻性、多中心、多专业的医疗记录回顾和患者访谈。
知情同意过程是一种重要的沟通工具,也具有医学法律意义。虽然在英国进行脊柱手术前需要书面同意,但之前尚未评估该过程的标准和效果。本研究评估了英国不同地区和专业的退行性椎间盘疾病选择性腰椎减压手术的书面同意标准;患者对同意内容的回忆程度;并确定了影响患者回忆的因素。
对来自 4 个中心 a、b、c、d 的 153 名住院患者的同意书进行了回顾。评估了预期益处、替代治疗和手术风险的书面记录。其中,108 名患者在手术前 24 小时内或手术后接受了访谈,以评估其回忆。
术中出血和括约肌功能障碍的手术风险书面记录在各中心之间存在显著差异(P=0.000),但其他风险则没有。汇总数据分析显示,风险的书面记录存在差异(P<0.0005),感染的记录最高(96.1%),复发的记录最低(52.3%)。对于这些风险,患者的回忆在各中心之间没有差异。患者对瘫痪作为风险的回忆最高(50.9%),对复发的回忆最低(6.5%)。年龄<65 岁的患者比年龄≥65 岁的患者对风险的回忆更好,感染的差异具有统计学意义(29.9%比 9.7%,P=0.027)。与手术前<2 天相比,手术前>14 天同意手术的患者对瘫痪(65.2%比 43.7%)和复发(17.4%比 2.8%)的回忆更高。患者的回忆与同意者的级别无关。
总体而言,选择性腰椎减压手术的书面同意标准不理想,这在一定程度上反映了患者回忆的不佳。虽然同意者的级别不会影响患者的回忆,但年龄较轻和同意手术的时间较长可以提高回忆。