Abstract
BackgroundChest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years. Recently, ultra-low-dose chest computed tomography (ULD chest CT) has been introduced, which provides substantially more detailed information on pulmonary conditions that may cause pulmonary disease, with a dose in the order of chest X-ray (0.1 vs. 0.05 mSv). The OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or CT (OPTIMACT) study is a randomized trial designed to evaluate the effectiveness of replacing chest X-ray for ULD chest CT in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED.MethodsTwo thousand four hundred patients presenting at the ED with pulmonary complaints and suspected of non-traumatic pulmonary disease will be enrolled in this multicenter, pragmatic, randomized trial. During randomly assigned periods of one calendar month, either conventional chest X-ray or ULD chest CT scan will be used as the imaging strategy. Randomization will rely on computer-generated blocks of 2 months to control for seasonal effects. Chest X-ray and ULD chest CT will be performed in a standardized way, after obtaining the clinical history and performing physical examination and initial laboratory tests. The primary outcome measure is functional health at 28 days. Secondary outcome measures are mental health, length of hospital stay, mortality within 28 days, quality-adjusted life years (QALYs) during the first 28 days, correct diagnoses at ED discharge as compared to the final post hoc diagnosis, and number of patients in follow-up because of incidental findings on chest X-ray or ULD chest CT. In an economic evaluation, we will estimate total health care costs during the first 28 days.DiscussionThis pragmatic trial will clarify the effects of replacing chest X-ray by ULD chest CT in daily practice, in terms of patient-related health outcomes and costs, in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED.Trial registrationThe OPTIMACT trial is registered in the Netherlands National Trial Register under number NTR6163. The date of registration is December 6, 2016.
Highlights
Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years
* Correspondence: i.a.vandenberk@amc.uva.nl 1Radiology and Nuclear Medicine, Amsterdam Gastroenterology and Metabolism, Cancer Center Amsterdam, Amsterdam Amsterdam University Medical Centers (UMC), location Academic Medical Center (AMC), University of Amsterdam, Amsterdam, Netherlands Full list of author information is available at the end of the article van den Berk et al Diagnostic and Prognostic Research (2018) 2:20 (Continued from previous page). This pragmatic trial will clarify the effects of replacing chest X-ray by ULD chest computed tomography (CT) in daily practice, in terms of patient-related health outcomes and costs, in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED
The purpose of this study, the OPTIMACT trial (OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT), is to evaluate the effectiveness of replacing chest X-ray for ULD chest CT on patient outcomes in the diagnostic work-up of patients suspected of non-traumatic pulmonary disease at the ED
Summary
Chest X-ray has been the standard imaging method for patients suspected of non-traumatic pulmonary disease at the emergency department (ED) for years. Dyspnea-related chief complaints (cough, chest discomfort) contributed to 8.2% of ED visits [1] These patients are suspected of non-traumatic pulmonary disease, and chest X-ray is a standard diagnostic procedure. Chest X-ray helps to elucidate important causes for pulmonary complaints, such as pneumonia, congestion, and pneumothorax, at a very low ionizing radiation dose (0.05 mSv). In the USA, the average radiation dose per person is 6.2 mSv, of which 48% is caused by medical imaging, mainly CT [15] For this reason, current guidelines do not recommend CT scanning as a standard imaging technique in patients suspected of non-traumatic pulmonary disease [16, 17]
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