Harbaugh Robert E, Devin Clinton, Leavy Michelle B, Ghogawala Zoher, Archer Kristin R, Bydon Mohamad, Goertz Christine, Dinstein Doron, Nerenz David R, Eakin Guy S, Lavelle William, Shaffer William O, Arnold Paul M, Washabaugh Charles H, Gliklich Richard E
1Department of Neurosurgery, Penn State Hershey Medical Center, Hershey, Pennsylvania.
2Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
J Neurosurg Spine. 2021 Mar 19;34(6):888-896. doi: 10.3171/2020.9.SPINE20437. Print 2021 Jun 1.
The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice.
Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process.
The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization.
This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.
退行性腰椎滑脱症（DLS）新治疗方法的发展引发了许多关于比较疗效和长期预后的问题。患者登记处收集了强大的纵向数据，这些数据可以合并或汇总，以形成一个国家乃至潜在的国际研究数据基础设施，以解决这些及其他研究问题。然而，跨登记处链接数据具有挑战性，因为登记处通常定义和捕获不同的结局指标。结局指标的差异在临床实践和其他类型的研究中也会出现，这限制了现有数据源用于解决新研究问题的效用。本项目的目的是制定一套最少的、与患者和临床医生相关的标准化结局指标，这些指标在DLS登记处和临床实践中收集是可行的。
邀请了19个DLS登记处、观察性研究和质量改进项目参与并提交结局指标。组织了一个利益相关者小组，成员包括医学专业协会、卫生系统、政府机构、支付方、行业、卫生信息技术组织和患者权益倡导组织的代表。该小组使用医疗保健研究与质量局的结局指标框架（OMF）对指标进行分类，确定了一套最少的结局指标，并通过基于共识的过程制定了标准化定义。
该小组将57项结局指标进行了识别和统一，形成了一套最少的10个核心结局指标领域和6个补充结局指标领域。这些指标被组织到OMF的生存、临床反应、感兴趣事件、患者报告结局和资源利用类别中。
这项工作确定了一套最少的标准化指标，这些指标与患者和临床医生相关，适用于DLS登记处、其他研究工作和临床实践。在登记处和临床实践中收集这些指标是构建研究数据基础设施、创建学习型医疗系统以及改善DLS患者管理和预后的重要一步。
