Exploring Opportunities for Clinical Data Warehouse Enhancement Through Data Catalog Integration.

Secondary use of clinical health data implies a prior integration of mostly heterogenous and multidimensional data sets. A clinical data warehouse addresses the technological and organizational framework conditions required for this, by making any data available for analysis. However, users of a data warehouse often do not have a comprehensive overview of all available data and only know about their own data in their own systems - a situation which is also referred to as 'data siloed state'. This problem can be addressed and ultimately solved by implementation of a data catalog. Its core function is a search engine, which allows for searching the metadata collected from different data sources and thereby accessing all data there is. With this in mind, we conducted an explorative online market survey followed by vendor comparison as a pre-requisite for system selection of a data catalog. Assessment of vendor performance was based on seven predetermined and weighted selection criteria. Although three vendors achieved the highest score, results were lying closely together. Detailed investigations and test installations are needed for further narrowing down the selection process.

Disease Course and Pulmonary Involvement of COVID-19 during the Delta Variant Period in Germany: A Comparative Study of Vaccinated and Unvaccinated Patients at a Tertiary Hospital.

Background: Despite the availability of vaccines, there is an increasing number of SARS-CoV-2-breakthrough-infections. OBJECTIVE: The aim of this study was to determine whether there is a radiological difference in lung parenchymal involvement between infected vaccinated and unvaccinated patients. Additionally, we aimed to investigate whether vaccination has an impact on the course of illness and the need for intensive care. METHODS: This study includes all patients undergoing chest computed tomography (CT) or x-ray imaging in case of a proven SARS-CoV-2 infection between September and November 2021. Anonymized CT and x-ray images were reviewed retrospectively and in consensus by two radiologists, applying an internal severity score scheme for CT and x-ray as well as CARE and BRIXIA scores for x-ray. Radiological findings were compared to vaccination status, comorbidities, inpatient course of the patient's illness and the subjective onset of symptoms. RESULTS: In total, 38 patients with acute SARS-CoV-2 infection underwent a CT scan, and 168 patients underwent an x-ray examination during the study period. Of these, 32% were vaccinated in the CT group, and 45% in the x-ray group. For the latter, vaccinated patients exhibited significantly more comorbidities (cardiovascular (p=0.002), haemato-oncological diseases (p=0.016), immunosuppression (p=0.004)), and a higher age (p<0.001). Vaccinated groups showed significantly lower extent of lung involvement (severity scores in CT cohort and x-ray cohort both p≤0.020; ARDS 42% in unvaccinated CT cohort vs. 8% in vaccinated CT cohort). Furthermore, vaccinated patients in the CT cohort had significantly less need for intensive care treatment (p=0.040). CONCLUSION: Our data suggest that vaccination, in the case of breakthrough infection, favours a milder course of illness concerning lung parenchymal involvement and the need for intensive care, despite negative predictors, such as immunosuppression or other pre-existing conditions.

Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA.

Quantification of hepatitis C virus (HCV)-RNA in serum or plasma samples is an essential parameter in HCV diagnostics. Here, the NeuMoDx™Molecular System (Qiagen) was tested for the most common HCV genotypes and compared to the cobas c6800 system (Roche). HCV-RNA from 131 plasma/serum samples from chronically infected patients was determined in parallel on the NeuMoDx and c6800 systems. Linearity was analysed using the four most common HCV genotypes (1-4) in our cohort. The coefficient of variation (CV) within (intra-assay) and between (inter-assay) runs was calculated based on HCV-RNA concentration. Quantitative HCV-RNA results were highly correlated on both test systems (R2 = 0.7947; y = 0.94 x + 0.37). On average, the NeuMoDx and c6800 HCV RNA levels showed a mean difference of only 0.05 log10 IU/mL but with a broad distribution (±1.2 2 x SD). The NeuMoDx demonstrated very good linearity across all HCV genotypes tested at concentrations between 1.7 and 6.2 log10 IU/mL (R2 range: 0.9257-0.9991) with the highest mean coefficient of determination for genotype 1 (R2 = 0.9909). The mean intra- and inter-assay CV for both serum and plasma samples was <5 %. The NeuMoDx HCV-RNA Assay demonstrates high subtype-independent comparability, linearity, and reproducibility for the quantification of HCV-RNA in serum and plasma samples from chronically infected patients.

Dynamics of Virological and Clinical Response Parameters of Bulevirtide Treatment for Hepatitis D: Real-World Data.

Background and Aims: The entry inhibitor bulevirtide represents the first specific treatment for hepatitis-D virus (HDV)-infected patients. In clinical trials, around 80% of patients achieve normalization of alanine aminotransferase (ALT) with about 60% virological response after 1 year, but little is known about the dynamics of responses and clinical predictors of treatment outcomes. We report our single-center data from 15 patients and describe response dynamics, clinical outcomes, and predictive factors for treatment response. Methods: Retrospective data from 15 patients have been analyzed at our department who started treatment with bulevirtide between 10/2020 and 08/2022. According to our standard procedures, laboratory parameters were controlled monthly; transient elastography was performed every 3 months, and the treatment duration was 12 months. Results: Treatment response rates after 1 year of treatment were similar to published data from clinical trials. ALT normalization usually occurs between months 2-6 of treatment, followed by a virological response after ≥6 months. Patients with more severe hepatitis at the start of treatment were less likely to respond in the first year of treatment. Loss of HDV-RNA was observed in one-third of patients after ≥1 year of treatment. Low body mass index and high alpha-fetoprotein at baseline were possible predictors of a delayed treatment response. Conclusion: Bulevirtide is a safe treatment option for HDV, leading to a fast hepatological response. Of note, decrease in transaminases precedes virological response. Patients with high viral load and ALT levels respond slower, but nonresponders (as classified by Food and Drug Administration criteria) still show a reduction in viremia. Longer observation periods are required to determine the optimal duration of bulevirtide monotherapy.