A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE)

描述（由申请人提供）：腰痛是医学研究所比较有效性研究的优先条件，具有重要的公共卫生重要性。这是就诊最常见的原因之一，也是造成功能限制和残疾的重要原因。成像经常作为诊断评估的一部分进行，并且是背部疼痛护理成本的重要贡献者，2005年总计超过860亿美元。众所周知，即使没有背痛，腰椎的磁共振（MR）成像也经常显示椎间盘干燥或突出。这些发现往往与年龄有关，患者和他们的医生可能认为这些发现比他们应该的更重要，因为他们没有一个适当的参考框架来解释这些发现。这些“偶然”的发现可能引发一连串的事件，甚至可能导致手术，而不会改善患者的预后。我们建议进行一项实用的随机对照试验（RCT），以确定在影像学报告中插入流行病学基准在减少后续检查和治疗方面的有效性。我们的基本原理是，为医生和患者更好地解释影像学发现提供一个背景，可以减少对偶然发现的担忧，减少不必要的进一步诊断测试和治疗。我们的干预措施简单、廉价且易于部署。我们提出了一种高效、新颖的聚类随机设计，称为“阶梯形”设计，允许纵向比较，同时控制时间趋势。根据申请请求的要求，我们计划在我们参与的站点使用可靠的电子医疗记录，被动地收集干预前和干预后医疗保健利用的主要结果测量。我们假设，对于初级保健提供者的患者，在腰椎影像学报告中插入流行病学基准将减少随后的诊断和治疗干预，包括MR和CT、阿片类药物处方、脊柱注射和手术。其基本原理是，流行病学数据可以为医生和患者更好地解释影像学结果提供一个背景。长期公共卫生意义重大。这种简单、廉价的干预措施不仅可以大大减少不必要和昂贵的背部疼痛治疗；三干预可以很容易地推广到所有的诊断测试，并可能成为沟通诊断信息的主要范例。

DESCRIPTION (provided by applicant): Low back pain, an Institute of Medicine priority condition for comparative effectiveness research, is of major public health importance. It is one of the most common reasons for physician visits and an important cause of functional limitation and disability. Imaging is frequently performed as part of the diagnostic evaluation and is an important contributor to the cost of back pain care, which totaled more than $86 billion in 2005. It is well known that, even without back pain, magnetic resonance (MR) imaging of the lumbar spine frequently reveals findings such as disc desiccation or bulging. Patients and their providers may attribute greater importance to these findings, which are often age-related, than they should, because they do not have an appropriate frame of reference in which to interpret the findings. These "incidental" findings may initiate a cascade of events leading possibly even to surgery, without improving patient outcomes. We propose a pragmatic, randomized controlled trial (RCT) to determine the effectiveness of inserting epidemiological benchmarks into imaging reports at reducing subsequent tests and treatments. Our rationale is that providing a context for both physicians and patients to better interpret imaging findings may reduce concern about incidental findings and reduce unnecessary further diagnostic tests and treatments. Our intervention is simple, inexpensive and easy to deploy. We propose an efficient, novel, cluster randomized design referred to as a "stepped wedge" design, permitting longitudinal comparisons while controlling for temporal trends. As called for in the Request for Applications, we plan to passively collect primary outcome measures of healthcare utilization both pre- and post-intervention, using robust electronic medical records at our participating sites. We hypothesize that for patients of primary care providers, inserting epidemiological benchmarks in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including MR and CT, opioid prescriptions, spinal injections and surgery. The rationale is that the epidemiologic data may provide a context for both physicians and patients to better interpret imaging findings. The long-term public health significance is high. Not only may this simple, inexpensive intervention substantially reduce unnecessary and expensive care for back pain; thee intervention can easily be generalized to all diagnostic tests, and could become the dominant paradigm for communicating diagnostic information. PUBLIC HEALTH RELEVANCE: The overall goal of our Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE) is to perform a large, pragmatic, randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention - of inserting epidemiological benchmarks into lumbar spine imaging reports - at reducing subsequent tests and treatments. The long-term public health significance is that our simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care not only for back pain, but also for a wide range of other conditions, since it could easily b applied to other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). If our study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information.