ABSTRACT
Objectives: Developing a control group of a clinical trial using real world data is desirable and ethically sound despite challenges pertaining to internal validity. To examine the internal validity, we reproduced the control group in a Randomized Controlled Trial (RCT) using Electric Health Record (EHR) data and evaluated the difference between the outcome of the original trial and that of the reproduced analysis. Method(s): We selected an RCT, REMDACTA trial, that was performed to evaluate the efficacy of tocilizumab plus remdesivir against placebo plus remdesivir in patients with severe COVID-19 pneumonia. We reproduced its control group (patients with severe COVID-19 pneumonia taking only remdesivir), using Japanese EHR data, Millennial Medical Record provided by Life Data Initiative. Target patients for the main analysis were those prescribed remdesivir within 2 days after admission and diagnosed with COVID-19 (defined by ICD-10 code, U07.1) and/or with COVID-19 pneumonia (defined by diagnosis name). Patients in the sub analysis included only those with COVID-19 pneumonia diagnosis. Among the target patients, those undergoing image inspection, oxygen administration, and not taking any medicines for pneumonia before the first remdesivir prescription were eligible for the analyses. Median length of stay was compared in the reproduced group and in REMDACTA trial. Result(s): The database included 676 and 110 target patients for the main and sub analyses, respectively. However, only 57 and 14 patients met the eligibility criteria for the main and sub analyses, respectively. The reduction in the number of patients is attributed to the criteria of image inspection and oxygen administration. Median length of stay in the reproduced group were 13 and 11 days in the main and sub analyses, respectively. In REMDACTA trial, 95% CI of median time was 11.0-16.0. Conclusion(s): We successfully reproduced the median time of the control group by EHR data.Copyright © 2023
ABSTRACT
Background: The aim of this study was to investigate the effect of the coronavirus disease (COVID-19) pandemic restrictions on the change in muscle mass in older patients with type 2 diabetes (T2D), who were not infected with COVID-19. Methods: In this retrospective cohort study, data were obtained from outpatients who underwent bioelectrical impedance analysis at least twice before April 2020 and at least once thereafter. Skeletal muscle mass index (SMI, kg/m<sup>2</sup>) was calculated as appendicular muscle mass (kg) divided by height squared (m<sup>2</sup>). Change in SMI (kg/m<sup>2</sup>/year) was calculated as (follow-up SMI-baseline SMI/follow-up period). The differences between the changes in SMI before and after the start of the COVID-19 pandemic were evaluated using paired t test.
ABSTRACT
Background: Previous reports have documented ground-glass opacities (GGOs), followed by appearance of the crazy pavement pattern and consolidation as the typical findings on chest computed tomography (CT) in patients with Coronavirus Disease-2019 (COVID-19). Case: A 69-year-old man with chronic renal failure and diabetes mellitus presented with a 2-day history of fever and fatigue, without cough or sputum production. Chest auscultation revealed coarse crackles at the right base. Laboratory findings included a normal leukocyte count, normal serum procalcitonin level, and a slightly elevated serum C-reactive protein level. Chest CT performed on day 2 after symptom onset revealed consolidation in the right lower lobe with an air bronchogram. The patient was tentatively diagnosed as having bacterial pneumonia, however, antibiotic treatment with ampicillin/sulbactam yielded no improvement of the symptoms, respiratory status, or laboratory findings. A repeat chest CT revealed changes in the findings of the right lower lobe from areas of focal consolidation to GGOs. GGOs and areas of consolidation were also detected in the other lung lobes. A polymerase chain reaction test for Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) returned a positive result. Discussion: Focal areas of lung consolidation is an atypical radiological presentation of coronavirus pneumonia. It is possible that the initial findings of CT represented those of bacterial pneumonia which responded to the antibiotic therapy, and that the GGOs that developed subsequently reflected new-onset SARS-CoV-2 pneumonia. However, the symptom of fatigue without cough or sputum, a normal leukocyte count, and a poor response to antibiotics are not typical findings of bacterial pneumonia. Our experience suggests that it is important to consider other or concomitant diseases when the initial treatment is followed by a deteriorating clinical course in patients with pneumonia. Moreover, it is essential to prevent the spread of hospital-acquired infection, especially if epidemic diseases need to be included in the initial differential diagnosis.