Search results for "Diagnostic Trial"
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Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale
2020
The diagnostic strategy for chronic thromboembolic pulmonary hypertension (CTEPH) is composed of two components required for a diagnosis of CTEPH: the presence of chronic pulmonary embolism and an elevated pulmonary artery pressure. The current guidelines require that ventilation–perfusion single-photon emission computed tomography (VQ-SPECT) is used for the first step diagnosis of chronic pulmonary embolism. However, VQ-SPECT exposes patients to ionizing radiation in a radiation sensitive population. The prospective, multicenter, comparative phase III diagnostic trial CTEPH diagnosis Europe - MRI (CHANGE-MRI, ClinicalTrials.gov identifier NCT02791282) aims to demonstrate whether functional…
Fallzahlplanung in referenzkontrollierten Diagnosestudien
2002
Purpose: A tutorial illustration of a flexible approach to determine the sample size in reference-controlled diagnostic trials. Materials and Methods: Assuming the usual setting of a new diagnostic method to be compared with a reference method, the emphasis is on the sensitivity of the new method in comparison with the reference method, using a binary outcome (positive versus negative) for both methods. Based on the confidence interval of the sensitivity, a simple but flexible procedure for determining the sample size is described, which incorporates clinically interpretable information. The procedure is illustrated by the fictious planning of a trial to assess the diagnostic value of MRI v…