Development and Application of Global Health Events-Mental Stress Scale for Assessment of Medical Staff?s Acute Mental Stress Responses

Background: Medical workers have been increasingly involved in emergent public health events, which can lead to severe stress. However, no standardized, officially recognized, unified tool exists for mental distress measurement in medical workers who experienced the public health events. Purpose: In the present study, we propose the Global Health Events-Mental Stress Scale (GHE-MSS), as a revised version of the Impact of Event Scale-Revision (IES-R), for assessment of medical workers' acute mental stress responses within one month and their chronic mental stress responses within six months after major health events. Patients and methods: The IES-R was slightly modified, developed, and its reliability and validity were tested using the Delphi survey, primary survey with 115 participants, formal survey with 300 participants, and clinical evaluation with 566 participants. Results: Exploratory factor analysis and confirmatory factor analysis confirmed a promising validity of the scale. The values of Cronbach's alpha coefficient, the Spearman-Brown coefficient, and the retested Cronbach's alpha coefficient of the scale applied for the clinical evaluation were 0.88, 0.87, and 0.98, respectively, which confirmed a good internal consistency and stability. The results of the goodness-of-fit test indicated a good adaptation of the model. A correlation analysis was conducted to assess the correlation between the GHE-MSS and the PCL-C, which had a correlation coefficient of 0.68 (P < 0.01). Conclusion: GHE-MSS can be applied with a promising reliability and validity for the assessment of the acute mental stress response of medical workers experiencing public health events. This method can also be used for the screening of mental stress-associated disorders.

Safety and Efficacy of Isavuconazole in Patients Aged 65 Years or Older with Invasive Fungal Disease: A Post-Hoc Analysis from the VITAL and Secure Studies

Background: Invasive fungal diseases (IFDs), such as invasive mucormycosis (IM) and invasive aspergillosis (IA), are life-threatening infections that remain a major cause of morbidity and mortality in a wide range of immunocompromised patients, including older individuals. During the COVID-19 pandemic, a rise in the proportion of older patients with IFDs was observed. Isavuconazole is a broad-spectrum triazole, approved for the treatment of IM and IA in adults. Here, we conducted a post-hoc analysis of two phase 3 studies to evaluate the safety and efficacy of isavuconazole specifically in patients ≥65 years with IFDs. Methods: Data from two prospective clinical trials, VITAL (NCT00634049) and SECURE (NCT00412893), were included. VITAL was a single-arm, open-label study evaluating isavuconazole for rare IFDs (mainly IM) and IA in renally-impaired patients. SECURE was a randomized, double-blind, non-inferiority study comparing isavuconazole with voriconazole for IA. Safety (adverse events [AEs] by system organ class) and efficacy (all-cause mortality through day 42 and overall responses at end of treatment [EOT]) were assessed for the ≥65 and <65 years subgroups. Results: At enrollment, 116/146 patients were <65 years and 30/146 patients were ≥65 years in VITAL, and 391/516 patients were <65 years and 125/516 patients were ≥65 years in SECURE. Baseline characteristics were mostly comparable for both subgroups across both studies and between the isavuconazole and voriconazole treatment arms in SECURE (Table 1). Safety In VITAL, AEs were reported in similar proportions in both subgroups (≥65 years: 100.0%;<65 years: 94.0%);with infections and infestations (≥65 years: 63.3%;<65 years: 62.1%) being the most common. Serious AEs (SAEs) were higher in the ≥65 years (76.7%) compared to the <65 years (56.9%) subgroup, although drug-related AEs had a reverse trend (≥65 years: 33.3%, <65 years: 43.1%). The most common drug-related AEs were gastrointestinal disorders (≥65 years: 13.3%;<65 years: 16.4%). In SECURE, a similar proportion of AEs was reported in both subgroups of the isavuconazole arm (≥65 years: 98.4%;<65 years: 95.4%), with gastrointestinal disorders (≥65 years: 73.0% <65 years: 66.0%) being the most common. SAEs were reported at higher rates (61.9% vs 49.0%) in the ≥65 years than the <65 years subgroup in the isavuconazole arm. Drug-related AEs were reported more frequently in both subgroups of the voriconazole arm (≥65 years: 54.8%;<65 years: 61.4%) than the isavuconazole arm (≥65 years: 44.4%;<65 years: 41.8%). Additionally, in the ≥65 years subgroup, a higher proportion of patients (cut-off difference: ≥5%) experienced drug-related cardiac disorders (isavuconazole: 6.3%;voriconazole: 0) and general disorders and administrative site conditions (9.5% vs 1.6%) in the isavuconazole arm;and drug-related psychiatric disorders (isavuconazole: 3.2%;voriconazole: 21.0%), eye disorders (3.2% vs 19.4%), and investigation abnormalities (7.9% vs 14.5%) in the voriconazole arm. In the <65 years subgroup, higher proportions of patients (cut-off difference: ≥5%) with drug-related AEs were observed only in the voriconazole arm: investigation abnormalities (isavuconazole: 10.3%;voriconazole: 19.3%), hepatobiliary disorders (2.6% vs 11.7%), psychiatric disorders (2.1% vs 8.1%), and eye disorders (3.1% vs 8.1%). Efficacy In VITAL, all-cause mortality through day 42 was higher (30.0% vs 13.8%) and the overall response at EOT was lower (27.6% vs 46.8%) in the ≥65 years than the <65 years subgroup (Table 2). In SECURE, all-cause mortality through day 42 was similar between both subgroups and both the isavuconazole (20.6% vs 17.9%) and voriconazole (22.6% vs 19.4%) treatment arms. Overall response at EOT was lower in the ≥65 years subgroup of the isavuconazole arm (23.7% vs 39.0%) as compared to the voriconazole arm (32.0% vs 37.5%) (Table 2). Conclusions: As expected, overall, the safety and efficacy outcomes were more favorable in the <65 years compared to the ≥65 years subgroup in both studies, although, the number of patients was relatively low in the ≥65 years subgroup. In SECURE, all-cause mortality through day 42 was similar between both subgroups and treatment arms, and the safety profile favored isavuconazole in both age subgroups. [Formula presented] Disclosures: Hamed: Basilea Pharmaceutica International Ltd.: Consultancy. Engelhardt: Basilea Pharmaceutica International Ltd.: Current Employment. Kovanda: Astellas Pharma Global Development, Inc.: Current Employment. Huang: Pfizer Inc: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Yan: Pfizer Inc: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Aram: Pfizer Inc: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company.

[Establishment of index system for population based SARS-CoV-2 nucleic acid screening].

Objective: To establish an index system of population based SARS-CoV-2 nucleic acid screening, and provide reference to determine the screening coverage appropriately. Methods: The literature review and brain storming sessions were used to develop the basic frame and index system of population based SARS-CoV-2 nucleic acid screening. Based on Delphi method and Analytic Hierarchy Process, 21 domestic experts were selected for two rounds of consultation to determine the index system of population based SARS-CoV-2 nucleic acid screening and its weight. Results: The positive indexes of experts in two rounds of consultations were both 100%. The experts' authority coefficients (Cr) were 0.88±0.08 and 0.89±0.07, respectively. And the range of coefficient of variation (CV) were (0.08, 0.24), (0.09, 0.25). The Kendall's W coordination coefficients were 0.34 and 0.22 respectively, which were statistically significant. The index system of population based SARS-CoV-2 nucleic acid screening was established, which had 4 first-level indexes, 11 second-level indexes and 58 third-level indexes. Besides, the weight of each index was determined. Conclusion: The index system of population based SARS-CoV-2 nucleic acid screening has been established, which can provide scientific reference for the health administration to determine the coverage of population based SARS-CoV-2 nucleic acid screening when local COVID-19 epidemic occurs.

Efficient and Privacy-Preserving Medical Research Support Platform Against COVID-19: A Blockchain-Based Approach

COVID-19 is a major global public health challenge and difficult to control in a short time completely. To prevent the COVID-19 epidemic from continuing to worsen, global scientific research institutions have actively carried out studies on COVID-19, thereby effectively improving the prevention, monitoring, tracking, control, and treatment of the epidemic. However, the COVID-19 electronic medical records (CEMRs) among hospitals worldwide are managed independently. With privacy consideration, CEMRs cannot be made public or shared, which is not conducive to in-depth and extensive research on COVID-19 by medical research institutions. In addition, even if new research results are developed, the disclosure and sharing process is slow. To address this issue, we propose a blockchain-based medical research support platform, which can provide efficient and privacy-preserving data sharing against COVID-19. First, hospitals and medical research institutions are treated as nodes on the alliance chain, so consensus and data sharing among the nodes is achieved. Then, COVID-19 patients, doctors, and researchers need to be authenticated in various institutes. Moreover, doctors and researchers need to be registered with the Fabric certificate authority. The CEMRs for COVID-19 patients uses the blockchain's pseudonym mechanism to protect privacy. After that, doctors upload CEMRs on the alliance chain, and researchers can obtain CEMRs from the alliance chain for research. Finally, the research results will be published on the blockchain for doctors to use. The experimental results show that the read and write performance and security performance on the alliance chain meet the requirements, which can promote the wide application of scientific research results against COVID-19.