Understanding Non response in Spine Fusion Surgery

 描述（由申请人提供）：每年有超过80万美国人接受脊柱手术。对于一种更常用的手术-脊柱融合术治疗与退行性椎间盘疾病（DDD）相关的疼痛和功能限制的有效性，存在相当大的争议。来自卓越中心的随机对照试验（RCT）和病例系列突出了潜在受益，但其他RCT和来自更广泛人群的脊柱融合术后患者报告结局（PRO）评估表明治疗效果存在异质性。未能改善PRO措施（即，无反应）可能发生在多达1/3的患者中，但尚未进行系统评价。虽然许多临床医生对哪些患者可能会有基于人格特质或其他特征的良好结果有意见，但没有基于证据的选择标准。事实上，只有少数可修改的特性（例如，吸烟） 以及不可修改的因素（例如，与工作有关的残疾）被确定为无应答的预测因素。同样，可能与无应答相关的基线放射学特征尚未进行系统评价，但这些特征也被怀疑。解决这些证据上的差距应该有助于为脊柱手术的决策提供信息。确定和解决可改变的因素可能会改善结果。为了实现这一点，我们建议利用正在进行的基于病历的临床数据收集和基于调查的PRO数据收集，这些数据收集在参与脊柱外科护理和结局评估计划（脊柱SCOAP）的华盛顿（WA）州立医院进行。拟议的目标包括增加与人格特征、心理健康和人际关系有关的调查，并增加对临床护理过程中使用的术前放射影像的标准化评估。具体而言，在接受融合术的DDD患者中，我们的目标是：（1）确定与无应答相关的患者特征;（2）确定与无应答相关的基线影像学特征。解决这些证据缺口应该有助于告知决策者脊柱手术对患者最重要的结果可能产生的影响。这项研究的结果也将用于创建支持患者和临床医生决策的预测模型。Spine SCOAP与比较有效性研究翻译网络（CERTAIN）相联系，该网络执行与全州网络中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广泛传播并用于支持决策者。

 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.