A Patient Registry to Improve Patient Safety: Recording General Neurosurgery Complications

Background
To improve the transparency of the local health care system, treatment cost was recently referenced to disease related groups. Treatment quality must be legally documented in a patient registry, in particular for the highly specialized treatments provided by neurosurgery departments.
Methods
In 2013 we have installed a patient registry focused on cranial neurosurgery. Surgeries are characterized by indication, treatment, location and other specific neurosurgical parameters. Preoperative state and postoperative outcome are recorded prospectively using neurological and sociological scales. Complications are graded by their severity in a therapy-oriented complication score system (Clavien-Dindo-Grading system, CDG). Results are presented at the monthly clinical staff meeting.
Results
Data acquisition compatible with the clinic workflow permitted to include all eligible patients into the registry. Until December 2015, we have registered 2880 patients that were treated in 3959 surgeries and 8528 consultations. Since the registry is fully operational (August 2014), we have registered 325 complications on 1341 patient discharge forms (24%). In 64% of these complications, no or only pharmacological treatment was required. At discharge, there was a clear correlation of the severity of the complication and the Karnofsky Performance Status (KPS, ρ = -0.3, slope -6 KPS percentage points per increment of CDG) and the length of stay (ρ = 0.4, slope 1.5 days per increment of CDG).
Conclusions
While the therapy-oriented complication scores correlate reasonably well with outcome and length of stay, they do not account for new deficits that cannot be treated. Outcome grading and complication severity grading thus serve a complimentary purpose. Overall, the registry serves to streamline and to complete information flow in the clinic, to identify complication rates and trends early for the internal quality monitoring and communication with patients. Conversely, the registry influences clinical practice in that it demands rigorous documentation and standard operating procedures.

### 背景
为提升本地医疗体系的透明度，近期已将治疗费用与疾病相关组别挂钩。治疗质量必须通过患者登记系统（patient registry）进行合规记录，对于神经外科科室开展的高专业化治疗，这一要求尤为突出。

### 方法
2013年，我们搭建了针对颅脑神经外科的患者登记系统。手术信息通过手术指征、治疗方式、病变部位及其他神经外科专属参数进行表征。研究团队采用神经学与社会学量表，前瞻性记录患者术前状态与术后转归。并发症则基于治疗导向的并发症评分系统（Clavien-Dindo分级系统，CDG）按严重程度进行分级。相关结果会在每月临床科室会议上汇报。

### 结果
适配临床工作流程的数据采集方案可将所有符合入组标准的患者纳入登记系统。截至2015年12月，我们共登记了2880例患者，涉及3959台手术与8528次门诊咨询。自2014年8月系统正式上线运行以来，我们在1341份患者出院表单中记录了325例并发症（占比24%），其中64%的并发症仅需药物治疗或无需额外干预。出院时可见，并发症严重程度与卡诺夫斯基体能状态评分（Karnofsky Performance Status, KPS，相关系数ρ = -0.3，每增加1级CDG分级，KPS评分下降6个百分点）及住院时长（相关系数ρ = 0.4，每增加1级CDG分级，住院时长增加1.5天）均存在显著相关性。

### 结论
尽管治疗导向的并发症评分系统与患者转归及住院时长具有较好的相关性，但该系统无法涵盖无法干预的新发功能缺损。因此，转归分级与并发症严重程度分级二者互为补充。总体而言，本登记系统可优化并完善临床信息流转流程，助力内部质量监控以及与患者沟通时早期识别并发症发生率与变化趋势。与此同时，登记系统也对临床实践提出了规范要求，推动了严格的文档记录与标准操作流程的落地。