Design, Development, Funding, and Implementation of the CSRS Registry: A Prospective Multicenter Clinical Cervical Spine Registry.

IF 1.7 4区 医学 Q3 CLINICAL NEUROLOGY
Julie M Witham, Rick C Sasso, Praveen V Mummaneni, K Daniel Riew, Zeeshan M Sardar, Wilson Z Ray, James S Harrop, Themistocles Protopsaltis, Samuel K Cho, Ahmad Nassr, Aditya Vedentam, Addisu Mesfin, John M Rhee, Brandon D Lawrence, Steven C Ludwig, Zoher Ghogawala
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Abstract

Study design: A national prospective cervical spine surgery registry was developed to archive radiographic studies, patient-reported outcome measures (PROMs), and surgical implant data to assess long-term safety.

Objective: To describe the design, development, funding, and implementation of a cervical spine data registry for 1000 patients with myelopathy and radiculopathy.

Summary of background data: While surgery for cervical radiculopathy and myelopathy is safe and effective, there is significant practice variation among spine surgeons. While randomized clinical trials (RCTs) can provide high-quality comparative effectiveness data, RCTs lack the ability to evaluate the safety and effectiveness of various surgical procedures and implants among heterogenous real-world patient populations. The CSRS Registry was designed to collect patient demographics, outcomes, radiographic imaging, surgical approach, and implant data for the purpose of conducting high-quality research.

Methods: Patients with cervical myelopathy or radiculopathy were enrolled in the CSRS National Registry. De-identified patient data, validated PROMs, radiographic data, and implant data were collected from multiple clinical sites across the United States.

Results: One thousand patients [mean age, 58 y; 456 (46%) women] were enrolled, with 31% follow-up at 1 year. Five hundred ninety-two patients were diagnosed with radiculopathy, 252 with myelopathy, and 156 with radiculopathy and myelopathy. Patients had significant improvements in their PROMs after surgery. At 1 year, the mean NDI score improved from 37.2 to 20.9 (P<0.001). The mean self-reported P-mJOA score at baseline was 14.2 and improved to 15.2 by 1 year (P<0.001). Baseline CSDI score was 23.6 and improved with a 1-year decrease to an average score of 13.6 (P<0.001). There was significant improvement in PROMIS-10 Physical Health score from 41.0 to 45.9 (n=311; P<0.001) at 1-year follow-up.

Conclusions: The CSRS Registry has successfully collected clinical outcomes data that is being leveraged for comparative effectiveness research and evaluations of the long-term safety and effectiveness of spinal implants.

CSRS登记的设计、发展、资助和实施:前瞻性多中心临床颈椎登记。
研究设计:建立了一项全国前瞻性颈椎手术登记,以存档放射学研究、患者报告的结果测量(PROMs)和手术植入物数据,以评估长期安全性。目的:描述1000名脊髓病和神经根病患者颈椎数据登记的设计、发展、资助和实施。背景资料总结:虽然颈椎神经根病和脊髓病的手术是安全有效的,但脊柱外科医生的实践差异很大。虽然随机临床试验(rct)可以提供高质量的比较有效性数据,但rct缺乏在异质性现实世界患者群体中评估各种外科手术和植入物的安全性和有效性的能力。为了开展高质量的研究,CSRS注册的目的是收集患者的人口统计资料、结果、放射成像、手术入路和植入物数据。方法:颈椎病或神经根病患者被纳入CSRS国家登记处。从美国各地的多个临床站点收集了去识别的患者数据、验证的prom、放射学数据和植入物数据。结果:1000例患者[平均年龄58岁;456名(46%)女性入组,31%随访1年。592名患者被诊断为神经根病,252名患者被诊断为脊髓病,156名患者被诊断为神经根病和脊髓病。手术后患者的PROMs有显著改善。1年后,平均NDI评分从37.2提高到20.9。结论:CSRS Registry成功收集了临床结果数据,用于比较有效性研究和评估脊柱植入物的长期安全性和有效性。
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来源期刊
Clinical Spine Surgery
Clinical Spine Surgery Medicine-Surgery
CiteScore
3.00
自引率
5.30%
发文量
236
期刊介绍: Clinical Spine Surgery is the ideal journal for the busy practicing spine surgeon or trainee, as it is the only journal necessary to keep up to date with new clinical research and surgical techniques. Readers get to watch leaders in the field debate controversial topics in a new controversies section, and gain access to evidence-based reviews of important pathologies in the systematic reviews section. The journal features a surgical technique complete with a video, and a tips and tricks section that allows surgeons to review the important steps prior to a complex procedure. Clinical Spine Surgery provides readers with primary research studies, specifically level 1, 2 and 3 studies, ensuring that articles that may actually change a surgeon’s practice will be read and published. Each issue includes a brief article that will help a surgeon better understand the business of healthcare, as well as an article that will help a surgeon understand how to interpret increasingly complex research methodology. Clinical Spine Surgery is your single source for up-to-date, evidence-based recommendations for spine care.
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