成人脊柱畸形患者术前能回忆起的知情同意过程中讨论的风险不到50%，且术后回忆率显著下降。
Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period.
作者信息
Saigal Rajiv, Clark Aaron J, Scheer Justin K, Smith Justin S, Bess Shay, Mummaneni Praveen V, McCarthy Ian M, Hart Robert A, Kebaish Khaled M, Klineberg Eric O, Deviren Vedat, Schwab Frank, Shaffrey Christopher I, Ames Christopher P
机构信息
*Department of Neurological Surgery, University of California San Francisco, San Francisco, CA †University of California San Diego, School of Medicine, San Diego, CA ‡Department of Neurosurgery, University of Virginia Health System, Charlottesville, VA §Rocky Mountain Hospital for Children, Denver, CO ¶Department of Orthopaedic Surgery, Baylor Scoliosis Center, Plano, TX ‖Department of Orthopaedic Surgery, Oregon Health & Science University, Portland, OR **Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD ††Department of Orthopaedic Surgery, University of California, Davis, CA ‡‡Department of Orthopedic Surgery, University of California San Francisco, San Francisco, CA; and §§Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, NY.
出版信息
Spine (Phila Pa 1976). 2015 Jul 15;40(14):1079-85. doi: 10.1097/BRS.0000000000000964.
STUDY DESIGN
Recall of the informed consent process in patients undergoing adult spinal deformity surgery and their family members was investigated prospectively.
OBJECTIVE
To quantify the percentage recall of the most common complications discussed during the informed consent process in adult spinal deformity surgery, assess for differences between patients and family members, and correlate with mental status.
SUMMARY OF BACKGROUND DATA
Given high rates of complications in adult spinal deformity surgery, it is critical to shared decision making that patients are adequately informed about risks and are able to recall preoperative discussion of possible complications to mitigate medical legal risk.
METHODS
Patients undergoing adult spinal deformity surgery underwent an augmented informed consent process involving both verbal and video explanations. Recall of the 11 most common complications was scored. Mental status was assessed with the mini-mental status examination-brief version. Patients subjectively scored the informed consent process and video. After surgery, the recall test and mini-mental status examination-brief version were readministered at 5 additional time points: hospital discharge, 6 to 8 weeks, 3 months, 6 months, and 1 year postoperatively. Family members were assessed at the first 3 time points for comparison.
RESULTS
Fifty-six patients enrolled. Despite ranking the consent process as important (median overall score: 10/10; video score: 9/10), median patient recall was only 45% immediately after discussion and video re-enforcement and subsequently declined to 18% at 6 to 8 weeks and 1 year postoperatively. Median family recall trended higher at 55% immediately and 36% at 6 to 8 weeks postoperatively. The perception of the severity of complications significantly differs between patient and surgeon. Mental status scores showed a transient, significant decrease from preoperation to discharge but were significantly higher at 1 year.
CONCLUSION
Despite being well-informed in an optimized informed consent process, patients cannot recall most surgical risks discussed and recall declines over time. Significant progress remains to improve informed consent retention.
LEVEL OF EVIDENCE
研究设计
对接受成人脊柱畸形手术的患者及其家属对知情同意过程的回忆情况进行前瞻性调查。
目的
量化成人脊柱畸形手术知情同意过程中讨论的最常见并发症的回忆百分比，评估患者与家属之间的差异，并与精神状态相关联。
背景数据总结
鉴于成人脊柱畸形手术并发症发生率较高，患者充分了解风险并能够回忆术前对可能并发症的讨论以降低医疗法律风险对于共同决策至关重要。
方法
接受成人脊柱畸形手术的患者接受了强化的知情同意过程，包括口头和视频解释。对11种最常见并发症的回忆情况进行评分。使用简易精神状态检查表简版评估精神状态。患者对知情同意过程和视频进行主观评分。术后，在另外5个时间点再次进行回忆测试和简易精神状态检查表简版：出院时、术后6至8周、3个月、6个月和1年。对家属在前3个时间点进行评估以作比较。
结果
纳入56例患者。尽管患者将同意过程评为重要（总体中位数评分：10/10；视频评分：9/10），但讨论和视频强化后患者的回忆中位数立即仅为45%，随后在术后6至8周和1年降至18%。家属回忆中位数在术后立即较高，为55%，在6至8周时为36%。患者和外科医生对并发症严重程度的认知存在显著差异。精神状态评分从术前到出院时出现短暂显著下降，但在1年时显著更高。
结论
尽管在优化的知情同意过程中得到了充分告知，但患者无法回忆讨论的大多数手术风险，且回忆随时间下降。在提高知情同意保留率方面仍有很大进展空间。
证据级别
3级。
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