RCT of US versus CT for Patients in the ED with Suspected Renal Colic

描述（由申请人提供）：医学成像是美国医疗支出中增长最快的组成部分，增长速度是医疗保健总成本的两倍。值得注意的是，很少有研究比较昂贵的成像技术的有效性。比较诊断成像测试的研究必须不仅包括诊断准确性的评估，还包括一系列结果，包括患者健康、功能状态、发病率和死亡率、近期和长期安全性以及成本。然而，很少有研究超越了诊断准确性的评估，只有少数研究使用随机对照试验设计来比较不同成像技术的患者结果。尽管该应用程序并不关注AHRQ强调的临床领域之一，但它解决了一种非常常见的情况，即在急诊科（ED）中，支持在计算机断层扫描（CT）（尿石症最常用的检查）和超声检查（一种不需要辐射的较便宜的检查）之间进行选择的科学数据有限。这将为CT与其他替代方法的比较建立一个模型。事实上，急诊科的订单占所有CT扫描订单的41%。因此，该提案与AHRQ的目标高度相关，即定义如何更有效地利用医疗保健资源来改善患者健康。目前的应用侧重于尿石症（尿石病），这是一种非常常见的疾病，终生风险为10-15%。尿石症占所有急诊科就诊的1%，美国急诊科每年约有110万人次就诊。1995年，CT作为超声检查的替代方案被引入，在美国，它已迅速成为疑似尿石症患者诊断成像的金标准。CT取代超声可能有几个原因，包括检查的速度，执行或解释研究所需的技能较少（使放射科更容易提供这种检查），过剩的CT容量使其广泛使用，以及与超声相比，CT的报销更多，导致使用CT而不是超声的经济激励。然而，有几个理由质疑CT的广泛使用与安全性和成本有关。首先，CT给病人提供了大量的辐射剂量，这些剂量在致癌的范围内。其次，计算机断层扫描识别出许多偶然发现，导致进一步的测试，临床随访和治疗可能是不必要的。最后，CT很昂贵，大大增加了尿石症的治疗费用。另一方面，使用超声作为疑似尿路结石患者的初始影像学检查有几个潜在的优点，包括它没有辐射暴露（更安全）、广泛可用、假阳性诊断较少和成本较低。根据医学研究所的数据，急诊科人满为患已经到了危机的边缘，而解决方案之一就是提高急诊科的病人护理效率。如果在急诊科可以准确地进行超声检查（而不是放射检查），那么这也将大大减少评估时间和患者管理效率。此外，这种过度拥挤的危机在为服务不足的人提供护理的设施中尤为严重，在那里，有限的放射资源进一步加剧了延误，因此，ed提供的护理点超声可能对患者吞吐量产生更大的影响。我们建议进行一项多中心随机对照试验，比较超声检查与CT检查对疑似尿石症患者的评价。这项研究将在10个大型城市急诊科进行，反映了地理、社会经济、种族和民族的多样性，并将包括学术医疗中心和安全网医院。患者将被随机分为三组：1)急诊科超声组，2)放射科超声组，或3)放射科CT组。然后，我们将收集关于全面结果的精确和无偏见的数据，以便评估随机分配到三组之一的患者的有效性、安全性、准确性和成本。综上所述，这些措施旨在为在急诊科看到的疑似尿石症患者的有效影像比较提供基础。该试验的结果可能导致临床实践的改变，这与改善患者预后和降低成本有关。已经寻求来自放射学、急诊医学和几个亚专业社区的广泛利益相关者的参与，以确保研究目标的战略完成，并帮助将研究结果迅速传播到临床实践中。这将创建一个愿意充当实验室的诊疗室的协作网络，以研究诊断测试的相对有效性。因此，拟议的试验将证明进行成像随机对照试验的可行性，其中包括可在未来扩展到其他成像测试的结果测量。

DESCRIPTION (provided by applicant): Medical imaging is the fastest growing component of medical spending in the United States, growing twice as fast as total health care costs. Remarkably few studies have compared the effectiveness of expensive imaging technologies. Studies comparing diagnostic imaging tests must include not only an assessment of diagnostic accuracy, but also a range of outcomes including patient health, functional status, morbidity and mortality, immediate and long-term safety, and cost. However, extremely few studies have gone beyond an assessment of diagnostic accuracy, and only a handful of studies have used a randomized controlled trial design to compare patient outcomes across imaging techniques. Although this application does not focus on one of the clinical areas highlighted by the AHRQ, it addresses a very common condition, where there is limited scientific data to support the choice in the Emergency Department (ED) between computerized tomography (CT) - the most common test used for urolithiasis -- and ultrasonography - a less expensive test that entails no radiation. This will establish a model for comparisons of CT with other alternatives. Indeed, emergency department orders account for 41% of all CT scans ordered. Thus, the proposal is highly relevant to the goal of AHRQ to define how to use health care resources more effectively to improve patient health. The current application focuses on urolithiasis (urinary stone disease), a very common condition with a lifetime risk of 10-15%. Urolithiasis accounts for 1% of all ED visits, approximately 1.1 million visits annually to U.S. EDs. CT was introduced as an alternative to ultrasonography in 1995, and in the United States has been rapidly embraced as the gold standard for diagnostic imaging in patients with suspected urolithiasis. There are several reasons CT likely has replaced ultrasonography, including the speed of the examination, less skill required to perform or interpret studies (making it easier for radiology departments to provide this examination), excess CT capacity making it widely available, and greater reimbursement for CT compared with ultrasonography, resulting in financial incentives to use CT rather than ultrasonography. However, there are several reasons to question the widespread use of CT related to safety and cost. First, CT delivers substantial radiation doses to patients, and these doses are in the range where carcinogenesis has been documented. Second, computed tomography identifies many incidental findings that result in further testing, clinical follow up, and treatment that may be unnecessary. Lastly, CT is expensive and substantially increases the cost of care for urolithiasis. On the other hand, there are several potential advantages of using ultrasound as the initial imaging test in patients with suspected urinary stone disease, including its lack of radiation exposure (greater safety), widespread availability, fewer false positive diagnoses and lower cost. ED overcrowding is on the verge of crisis according to the Institute of Medicine, and one of the solutions identified is to increase the efficiency of patient care in the ED setting. If ultrasonography can be accurately performed in the ED (rather than radiology), then this will also substantially reduce the time for assessment and efficiency of patient management. Further, this overcrowding crisis is particularly dire at facilities that provide care for the underserved, where limited radiology resources further compound delays, and thus where ED-provided point of care ultrasound could have an even greater impact on patient throughput. We propose a multicenter, randomized controlled trial of ultrasonography compared with CT for the evaluation of patients with suspected urolithiasis. The study will be conducted at 10 large urban EDs, reflecting geographic, socioeconomic, racial and ethnic diversity, and will include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the ED, 2) ultrasound in radiology, or 3) CT in radiology. We will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one of the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting RCT of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future. PUBLIC HEALTH RELEVANCE: This study compares different imaging strategies for patients seen in large emergency departments with symptoms concerning for urolithiasis (kidney stones). The study proposes a multicenter, randomized controlled trial of ultrasonography compared with computed tomography for the evaluation of patients with suspected kidney stones. The study will enroll patients at 10 large urban Emergency Departments (ED) and patients will be randomized to one of three arms: 1) ultrasonography in the ED, 2) ultrasonography in radiology, or 3) computed tomography in radiology. The study will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one of the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost.