Lumbar Imaging With Reporting Of Epidemiology (LIRE)-Protocol for a pragmatic cluster randomized trial
Lumbar Imaging With Reporting Of Epidemiology (LIRE)-Protocol for a pragmatic cluster randomized trial
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DOI：
10.1016/j.cct.2015.10.003
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发表时间：
2015-11-01
影响因子：
2.2
通讯作者：
Heagerty, Patrick J.
中科院分区：
文献类型：
--
作者：
Jarvik, Jeffrey G.;Comstock, Bryan A.;Heagerty, Patrick J.
背景：诊断成像通常是评估背痛患者的第一步，可能是后续一系列干预措施的“门户”。然而，腰椎成像经常在正常、无痛的个体中显示偶然发现，这表明治疗这些“异常”可能是不合理的。我们之前的研究表明，将无背痛患者的影像学发现纳入脊柱影像学报告可能会减少后续干预。我们目前正在进行一项实用的集群随机临床试验，以验证以下假设：在初级保健提供者要求的研究中，将患病率数据插入腰椎影像学报告将减少随后的脊柱相关干预。方法/设计：我们采用阶梯式楔形设计，顺序随机选取4个卫生系统的100个初级保健诊所，接收标准腰椎影像学报告或包含无背痛患者常见影像学发现的患病率数据的报告。我们通过电子病历被动地获取所有结果。我们的主要结果是在接下来的一年中基于相对价值单位（RVUs）的脊柱相关干预强度。次要结果包括随后的阿片类镇痛药处方和腰椎横断面重新成像。讨论：如果我们的研究表明，在脊柱影像学报告中添加患病率数据可以减少随后的背部相关rvu，那么这种干预措施可以很容易地推广并应用于其他类型的检查，以及其他偶然发现可能很常见的情况。我们的研究也为风险最小且高度实用的集群随机试验提供了一个模型。(C) 2015爱思唯尔公司版权所有。
Background: Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions.Methods/design: We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging.Discussion: If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic. (C) 2015 Elsevier Inc. All rights reserved.