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Sci Rep ; 11(1): 10678, 2021 05 21.
Article in English | MEDLINE | ID: covidwho-1238016


With an urgent need for bedside imaging of coronavirus disease 2019 (COVID-19), this study's main goal was to assess inter- and intraobserver agreement in lung ultrasound (LUS) of COVID-19 patients. In this single-center study we prospectively acquired and evaluated 100 recorded ten-second cine-loops in confirmed COVID-19 intensive care unit (ICU) patients. All loops were rated by ten observers with different subspeciality backgrounds for four times by each observer (400 loops overall) in a random sequence using a web-based rating tool. We analyzed inter- and intraobserver variability for specific pathologies and a semiquantitative LUS score. Interobserver agreement for both, identification of specific pathologies and assignment of LUS scores was fair to moderate (e.g., LUS score 1 Fleiss' κ = 0.27; subpleural consolidations Fleiss' κ = 0.59). Intraobserver agreement was mostly moderate to substantial with generally higher agreement for more distinct findings (e.g., lowest LUS score 0 vs. highest LUS score 3 (median Fleiss' κ = 0.71 vs. 0.79) or air bronchograms (median Fleiss' κ = 0.72)). Intraobserver consistency was relatively low for intermediate LUS scores (e.g. LUS Score 1 median Fleiss' κ = 0.52). We therefore conclude that more distinct LUS findings (e.g., air bronchograms, subpleural consolidations) may be more suitable for disease monitoring, especially with more than one investigator and that training material used for LUS in point-of-care ultrasound (POCUS) should pay refined attention to areas such as B-line quantification and differentiation of intermediate LUS scores.

COVID-19/diagnostic imaging , Lung/diagnostic imaging , Point-of-Care Systems , SARS-CoV-2 , COVID-19/therapy , Female , Humans , Male , Middle Aged , Monitoring, Physiologic , Observer Variation , Prospective Studies , Ultrasonography
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz ; 63(12): 1511-1518, 2020 Dec.
Article in German | MEDLINE | ID: covidwho-746457


BACKGROUND: The classic randomized and controlled clinical trial is facing new challenges with complex study designs and disease interception concepts. For this reason, data monitoring committees (DMCs) can take on a central function if professionally integrated into the methodical procedure of clinical trials. On this basis, the responsible competent authority and the responsible ethics committee have to verify the substantial charter document in the implicit/explicit approval procedure reflecting the working process of the independent committee. OBJECTIVES: The frequencies and conditions under which DMCs are used in clinical trials was investigated. METHODS: The database of the Federal Institute for Drugs and Medical Devices (BfArM) was the basis for statistical analysis concerning the frequency of implementation of data monitoring committees with different criteria over an observation period of more than 15 years. RESULTS: In total, 4152 DMCs have been used in 14,135 clinical trials with drugs. The independent expert committee was mostly integrated by commercial sponsors in phase III of the clinical development. The ethics committees were involved with different absolute frequencies. DISCUSSION: Sponsors demonstrate an increasing willingness to integrate DMCs in the methodical conduct of clinical trials especially in the case of new study designs. DMCs could be an important scientific aid in order to assess the implications of coronavirus SARS-CoV­2 on clinical trials.

Clinical Trials Data Monitoring Committees , Coronavirus Infections , Pandemics , Pneumonia, Viral , Betacoronavirus , COVID-19 , Germany , Humans , SARS-CoV-2