212 Chapter 9 Methods Studydesign In this pragmatic, multicentre, non-inferiority randomised clinical trial we compared patient outcomes and short-term health process parameters after ULDCT to those after CXR in ED patients suspected of non-traumatic pulmonary disease. The protocol and statistical analysis plan for this trial on the OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the ED: chest X-ray or CT (OPTIMACT) have been published earlier [17, 18]. In short, during randomly assigned periods of one calendar month between January 31, 2017 and May 31, 2018, either ULDCT or conventional CXR was used in two participating Dutch hospitals: one university hospital (Amsterdam UMC) and one large teaching hospital (Spaarne Gasthuis). The Medical Ethics Committee approved the study protocol. The trial was performed according to General Data Protection Regulation and Good Clinical Practice standards. Written informed consent was provided by all study participants. This study report was prepared following the CONsolidated Standards Of Reporting Trials (CONSORT) reporting guidelines, using the extension for non-inferiority and equivalence randomised trials [19]. Setting and Participants Eligible for inclusion were ED patients aged 18 years and older, suspected of nontraumatic pulmonary disease and requiring CXR according to the attending physician. Patients could be either self-referred or referred by a general practitioner or their treating physician at the hospital. Excluded were patients unable to undergo ULDCT or CXR, incapacitated patients, pregnant women, and patients with a life expectancy less than one month or with other anticipated barriers to 28-days follow-up data collection; subjects could only participate once. Study Procedures History taking, physical examination and laboratory tests were initiated by the attending physician. After setting the indication for chest imaging and acquiring informed consent, the attending physician provided a working diagnosis on the structured and standardized radiology request form. This was followed by either ULDCT or CXR, according to the imaging method allocated to the month of presentation. If the clinical question was not adequately answered after obtaining the CXR or ULDCT, standard additional imaging (e.g., chest CT with intravenous contrast medium, CT pulmonary angiography) was performed. If there was a high suspicion of pulmonary emboli at ED admission, patients directly underwent a CT pulmonary angiography, in accordance with regular clinical practice. The technical aspects of the imaging methods can be found in the study protocol paper and Supplementary text S1 [17]. Radiologists used a structured standardized report to optimise and standardize reading. Reading and reporting was performed or supervised by the radiologist on call at the time of clinical management, also outside office hours. The ULDCT and CXR were read with prior imaging if available. To increase inter-reader consistency, the residents and radiologist less experienced in the field of chest imaging were supervised by a group of seven radiologists with a subspecialty in chest imaging. The attending physician subsequently formulated an ED discharge diagnosis. Decisions on additional imaging,
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