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eISSN: 1643-3750


This Week Editorial

#933554

Editorial: Registries and Population Databases in Clinical Research and Practice

Dinah V. Parums

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, USA

Med Sci Monit 2021; 27:e933554

DOI: 10.12659/MSM.933554


ABSTRACT: Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems. Patient registries include mainly local, regional, and national patient data on general or specific patient groups. Global registries currently exist mainly for rare diseases. Some of the most studied registries include the national Surveillance, Epidemiology, and End Results (SEER) program and the hospital-based Medical Information Mart for Intensive Care (MIMIC-III) dataset. The limitations of registry databases have included lack of feedback from clinical studies to the clinical center, the lack of patient involvement, and limited findings on patient-reported outcomes (PROs). In September 2020, the European Medicines Agency (EMA) published its draft guidelines on registry-based clinical studies. Guidelines for the development and analysis of registry data will improve the quality and registry-based studies and increase the role of registry data to support clinical trials. This Editorial aims to present the current status of registries and population databases in clinical research and practice.

Keywords: Editorial, Registries, Population, Guidelines as Topic, Epidemiology



Published: 2021-06-14

#929701

#929701

A Cluster Transmission of Coronavirus Disease 2019 and the Prevention and Control Measures in the Early Stage of the Epidemic in Xi’an, China, 2020

Hui Zhang, Shuxuan Song, Zhijun Chen, Miao Bai, Zhen He, Ting Fu, Kun Liu, Zhongjun Shao

Department of Prevention of Infectious Diseases, Xi’an Center for Disease Control and Prevention, Xi’an, Shaanxi, China (mainland)

Med Sci Monit 2021; 27:e929701

DOI: 10.12659/MSM.929701


BACKGROUND: At the beginning of the COVID-19 pandemic, a cluster outbreak caused by an imported case from Hubei Province was reported in Xi’an City, Shaanxi Province, China. Ten patients from 2 families and 1 hospital were involved in the transmission.
MATERIAL AND METHODS: We conducted an epidemiological investigation to identify the cluster transmission of COVID-19. The demographic, epidemiological, clinical, laboratory, and cluster characteristics were described and analyzed.
RESULTS: From January 27 to February 13, 2020, a total of 10 individuals were confirmed to be infected with SARS-CoV-2 by the nucleic acid testing of nasopharyngeal swabs from 2 families and 1 hospital. Among the confirmed cases, 7 had atypical clinical symptoms and 3 were asymptomatic. The median times from onset to diagnosis and to discharge were 3.5 days (range, 1-5 days) and 19.5 days (range, 16-38 days), respectively. There were 4 patients whose exposure dates were 1, 3, 3, and 2 days earlier than the onset dates of their previous-generation cases, respectively. Four prevention and control measures were effectively used to interrupt the disease transmission.
CONCLUSIONS: SARS-CoV-2 can be easily transmitted within families and in hospitals, and asymptomatic patients could act as a source of disease transmission. The results of this outbreak at the early epidemic stage support the recommendation that individuals with confirmed COVID-19 and all their close contacts should be subjected to medical quarantined observation and nucleic acid screening as early as possible, even if they do not have any symptoms. Meanwhile, people in high-risk areas should improve their protective measures.

Keywords: asymptomatic infections, Coronavirus Infections, Disease Outbreaks



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