Understanding Non response in Spine Fusion Surgery

了解脊柱融合手术中的无反应

• 批准号: 9102903
• 负责人: David R Flum
• 金额: $ 14.27万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9102903
• 关键词: Address; American; Anxiety; Area; Benchmarking; Blinded; Caring; Case Series; Characteristics; Cicatrix; Clinical; Clinical Data; Cohort Studies; Control Locus; Data Collection; Decision Making; Disease; Effectiveness; Evaluation; Failure; Future; Grant; Health; Health Status; Healthcare; Heterogeneity; Hospitals; Image; Inpatients; Intervention; Link; Lordosis; Magnetic Resonance Imaging; Measures; Medical Records; Mental Health; Minority; Nerve compression syndrome; Operative Surgical Procedures; Opioid; Outcome; Outcome Assessment; Outcome Measure; Pain; Patient Outcomes Assessments; Patients; Perceived quality of life; Personality Character; Personality Traits; Pharmaceutical Preparations; Population; Prevalence; Procedures; Process; Randomized Controlled Trials; Reporting; Research; Risk Factors; Roentgen Rays; Scanning; Selection Criteria; Self Perception; Sleep; Social support; Spine surgery; State Hospitals; Surveys; Symptoms; Translations; Vertebral column; Washington; Work; X-Ray Computed Tomography; base; case control; cigarette smoking; clinical care; comparative effectiveness; cost; design; disability; effectiveness research; evidence base; expectation; follow-up; high risk; improved; improved functioning; improved outcome; intervertebral disk degeneration; modifiable risk; novel; operation; prediction algorithm; predictive modeling; programs; prospective; response; satisfaction; standardize measure; symptomatic improvement; trait; treatment effect

 DESCRIPTION (provided by applicant): Each year more than 800,000 Americans undergo spine surgery. There is considerable debate about the effectiveness of one of the more commonly performed procedures-spine fusion for pain and functional limitations related to degenerative disc disease (DDD). Randomized controlled trials (RCTs) and case series from centers of excellence highlight the potential benefits, but other RCTs and assessments of patient reported outcomes (PROs) after spine fusion from broader populations, indicate heterogeneity of treatment effect. Failure to improve on PRO measures (i.e., non-response) after spine fusion may occur in as many as 1 in 3 patients, but has not been systematically evaluated. While many clinicians have opinions about which patients are likely to have a good outcome based on personality traits or other characteristics, there are no evidence- based selection criteria. In fact, only a handful of modifiable characteristics (e.g., cigarette smoking) and non- modifiable factors (e.g., work-related disability) have been identified as predictors of non-response. Similarly, radiographic features at baseline that may be associated with non-response have not been systematically evaluated, but these too have been suspected. Addressing these gaps in evidence should help inform decision making about spine surgery. Identifying and addressing modifiable factors may improve outcomes. To accomplish this, we propose leveraging ongoing medical record-based clinical data collection and survey- based PRO data collection being performed at Washington (WA) State hospitals participating in the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP). The proposed aims include the addition of surveys related to personality traits, mental health and relationships and adding standardized evaluations of preoperative radiographic images used in the course of clinical care. Specifically, among patients with DDD undergoing fusion we aim to: (1) Determine patient characteristics associated with non-response; and (2) Determine radiographic features at baseline that are associated with non-response. Addressing these evidence gaps should help inform decision makers about the likely impact of spine operations on the outcomes that matter most to patients. The findings of this study will also be used to create predictive models that support patient and clinician decision making. Spine SCOAP is linked to the Comparative Effectiveness Research Translation Network (CERTAIN) which performs implementation activities related to evidence that emerges from the statewide network. Once validated, these predictive models can be widely disseminated and used to support decision makers.

 描述（由适用提供）：每年有80万美国人接受脊柱手术。关于与退行性椎间盘疾病（DDD）相关的疼痛和功能局限性，更常见的程序融合的有效性之一是有很大争议的。卓越中心的随机对照试验（RCT）和病例系列强调了潜在的好处，但在较广泛的人群脊柱融合后，其他RCT和对患者报告的结果（PRO）的评估表明治疗效果的异质性。在脊柱融合后未能改善PRO措施（即无响应）可能会发生多达3例患者，但尚未进行系统评估。尽管许多临床医生对哪些患者可能会根据人格特征或其他特征有良好的结果有意见，但没有基于证据的选择标准。实际上，只有少数可修改的特征（例如，吸烟） 和不可修改的因素（例如，与工作相关的残疾）已被确定为无响应的预测指标。同样，基线上可能与无响应有关的射线照相特征尚未系统地评估，但也怀疑这些。解决这些差距的证据应有助于告知有关脊柱手术的决策。识别和解决可修改因素可能会改善结果。为此，我们建议在华盛顿州（WA）州医院进行基于病历的临床数据收集和基于调查的PRO数据收集，该医院参加了脊柱外科护理和成果评估计划（脊柱scoap）。拟议的目的包括添加与人格特征，心理健康和关系有关的调查，并添加对临床护理过程中使用的术前放射线图像的标准评估。具体而言，在接受融合的DDD患者中，我们的目的是：（1）确定与无反应相关的患者特征； （2）确定与无响应相关的基线上的X线照相特征。解决这些证据差距应有助于告知决策者脊柱操作对患者最重要的结果的可能影响。这项研究的发现还将用于创建支持患者和临床决策的预测模型。脊柱SCOAP与比较有效性研究翻译网络（某些）有关，该网络（某些）执行与从全州范围内出现的证据相关的实施活动。一旦得到验证，这些预测模型就可以被广泛传播并用于支持决策者。