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1.
BMJ Open ; 12(7): e059092, 2022 07 18.
Article in English | MEDLINE | ID: covidwho-1997240

ABSTRACT

OBJECTIVE: To clarify the impact of Japan's Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data. DESIGN: Retrospective database study. SETTING: We extracted information on clinical intervention studies registered between 1 April 2018 and 30 September 2020 in the conventional University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) and the new Japan Registry of Clinical Trials (jRCT). We collected and analysed information on registration dates, intervention types, funding, secondary sponsors and use of designated staff in multidisciplinary roles (research planning support, research administration, data management, statistical analysis, monitoring and auditing). The temporal trends in clinical trial activity after CTA enactment were examined. RESULTS: A total of 577 CTA-compliant specified clinical trials (ie, studies funded by pharmaceutical companies or studies evaluating the efficacy and safety of off-label drugs or devices in humans) were registered in the jRCT. During the same period, 5068 clinical trials were registered in the UMIN-CTR. The number of specific clinical trials increased immediately after the implementation of the CTA and stabilised in late 2019, whereas the number of clinical trials registered in the UMIN-CTR generally declined over time. Specified clinical trials that received industry funding and public grants were more likely to use designated staff in multidisciplinary roles. CONCLUSIONS: The implementation of the CTA has not reduced the number of specified clinical trials, but has reduced the total number of intervention trials. The use of designated staff in multidisciplinary roles is associated with funding, secondary sponsors and multicentre studies. It was inferred that funding was needed to establish research infrastructure systems that support high-quality research.


Subject(s)
Clinical Trials as Topic , Data Management , Clinical Trials as Topic/legislation & jurisprudence , Databases, Factual , Humans , Japan , Registries , Retrospective Studies
2.
Int J Environ Res Public Health ; 19(15)2022 07 23.
Article in English | MEDLINE | ID: covidwho-1994026

ABSTRACT

Today, the world population is aging at a fast rate. This scenario of the accelerated aging of human populations entails increased concern for healthy aging that is associated with a rise in scientific production related to the topic. In this study, the Scopus database from Elsevier was used, with a final search carried out on 5 January 2022, and various bibliometric indicators were obtained from SciVal. The study was fundamentally intended to characterize, determine trends, and understand the evolution and current state of research on the concept of "healthy aging" in the last decade. We found that there has been proportionally greater and more accelerated growth in the subject with respect to the general productivity of the world and that countries with high life expectancies tend to have made more effort to investigate this topic. The "hottest" research areas were found to be related to the cognitive aspect and the biological mechanisms involved in aging.


Subject(s)
Bibliometrics , Data Management , Aging , Databases, Factual , Humans , Publications
3.
Philos Trans A Math Phys Eng Sci ; 380(2233): 20210300, 2022 Oct 03.
Article in English | MEDLINE | ID: covidwho-1992458

ABSTRACT

Modern epidemiological analyses to understand and combat the spread of disease depend critically on access to, and use of, data. Rapidly evolving data, such as data streams changing during a disease outbreak, are particularly challenging. Data management is further complicated by data being imprecisely identified when used. Public trust in policy decisions resulting from such analyses is easily damaged and is often low, with cynicism arising where claims of 'following the science' are made without accompanying evidence. Tracing the provenance of such decisions back through open software to primary data would clarify this evidence, enhancing the transparency of the decision-making process. Here, we demonstrate a Findable, Accessible, Interoperable and Reusable (FAIR) data pipeline. Although developed during the COVID-19 pandemic, it allows easy annotation of any data as they are consumed by analyses, or conversely traces the provenance of scientific outputs back through the analytical or modelling source code to primary data. Such a tool provides a mechanism for the public, and fellow scientists, to better assess scientific evidence by inspecting its provenance, while allowing scientists to support policymakers in openly justifying their decisions. We believe that such tools should be promoted for use across all areas of policy-facing research. This article is part of the theme issue 'Technical challenges of modelling real-life epidemics and examples of overcoming these'.


Subject(s)
COVID-19 , Data Management , Humans , Pandemics , Software , Workflow
4.
Int J Environ Res Public Health ; 19(16)2022 08 17.
Article in English | MEDLINE | ID: covidwho-1987819

ABSTRACT

Increasing evidence relate anti-SARS-CoV-2 vaccinations to orofacial adverse reactions, therefore, the present systematic review aimed to evaluate primary oral lesions diagnosed in adult subjects, following the WHO Emergency Use Listing approved and EMA authorized vaccines, also in relation to cases' age, gender, comorbidities, and history of COVID-19, and in relation to vaccine type and doses. The study protocol, registered on PROSPERO (CRD42022339032) and compliant with the PRISMA statement, included an electronic search across Scopus, MEDLINE/PubMed, BioMed Central databases, and PROSPERO, ended on 18 June 2022 and succeeded by a manual search, an independent data extraction, and arisk of bias evaluation through ROBINS-I tool. Qualitatively synthesized data from the 13studies included showed an overall low prevalence (16 cases), though higher in females (68.8%), of oral lesions, mainly erosions and ulcers (34.5%). Nine cases were diagnosed following Pfizer-BioNTech, two Moderna, and one AstraZeneca, Serum Institute of India, Sinopharm, and Johnson&Johnson vaccines, respectively; specifically, eight after the first dose and seven after the second. In one case, vaccine type and dose were not specified. Considering newly developing vaccines, presented findings may be updated and further studies needed to highlight factors affecting oral lesion occurrence and specific macro-microscopic phenotypes in relation to cases' and vaccines' characteristics.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Data Management , Female , Humans , India , Vaccination/adverse effects , Vaccines/adverse effects
5.
Stud Health Technol Inform ; 290: 278-281, 2022 Jun 06.
Article in English | MEDLINE | ID: covidwho-1933556

ABSTRACT

We present a work-in-progress software project which aims to assist cross-database medical research and knowledge acquisition from heterogeneous sources. Using a Natural Language Processing (NLP) model based on deep learning algorithms, topical similarities are detected, going beyond measures of connectivity via citation or database suggestion algorithms. A network is generated based on the NLP-similarities between them, and then presented within an explorable 3D environment. Our software will then generate a list of publications and datasets which pertain to a certain topic of interest, based on their level of similarity in terms of knowledge representation.


Subject(s)
COVID-19 , Algorithms , Data Management , Humans , Natural Language Processing , Software
6.
Prehosp Disaster Med ; 37(4): 451-454, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1931262

ABSTRACT

BACKGROUND: Violence against primary care providers (PCPs) has increased during the current pandemic. While some of these violent acts are not defined as terrorist events, they are intentional events with an aim to disrupt, kill, or injure. Despite their pivotal role in health care, little is known about the risk for PCPs as targets of terrorism. METHODS: Data collection was performed using a retrospective database search through the Global Terrorism Database (GTD). The GTD was searched using the internal database search functions for all terrorist attacks against PCPs and their offices from January 1, 1970 - December 31, 2019. Years 2020 and 2021 were not yet available at the time of the study. Primary attack and weapon type, location (country, world region), and number of deaths and injuries were collated. Results were exported into an Excel spreadsheet (Microsoft Corp.; Redmond, Washington USA) for analysis. RESULTS: There were 29 terrorist attacks against PCPs and their offices from 1970-2019. The majority of attacks occurred during or after 2010. There were 58 fatalities, 52 injured, and 13 hostages. Most documented attacks took place in Pakistan, the United States, and Sri Lanka. Bombings concerned 55% of cases and 21% were hostage-takings. CONCLUSION: Although less common than attacks on other health care related targets, terrorist attacks against PCPs have occurred. The majority of attacks occurred during the last decade. Future studies are warranted to further assess the risk of terrorist attacks against PCPs: before, during, and beyond the current pandemic.


Subject(s)
Terrorism , Data Management , Humans , Primary Health Care , Retrospective Studies , United States , Violence
7.
Am J Emerg Med ; 58: 281-285, 2022 08.
Article in English | MEDLINE | ID: covidwho-1906653

ABSTRACT

OBJECTIVE: This study aimed to evaluate whether there was a significant relationship between anemia and the risk for mortality among coronavirus disease 2019 (COVID-19) patients by a quantitative meta-analysis based on the adjusted effect estimates. METHODS: A systematic search was conducted in electronic databases to identify all published literature. A random-effects meta-analysis model was used to estimate the pooled effect size and 95% confidence interval (CI). Heterogeneity test, Begg's test, subgroup analysis and meta-regression were performed. RESULTS: Twenty-three articles with 573,928 COVID-19 patients were included in the quantitative meta-analysis. There was a significant association between anemia and an elevated risk of COVID-19 mortality (pooled effect size = 1.47, 95% CI [1.30-1.67]). We observed this significant association in the further subgroup analyses by age, proportion of males, sample size, study design, region and setting. Sensitivity analysis exhibited that our results were reliable. Begg's test showed that there was no publication bias. Meta-regression indicated that the tested variables might not be the source of heterogeneity. CONCLUSION: Our meta-analysis based on risk factors-adjusted effect estimates indicated that anemia was independently associated with a significantly elevated risk for mortality among COVID-19 patients.


Subject(s)
Anemia , COVID-19 , Anemia/complications , Anemia/epidemiology , Data Management , Humans , Male , Risk Factors
8.
Medicine (Baltimore) ; 101(25): e29508, 2022 Jun 24.
Article in English | MEDLINE | ID: covidwho-1909032

ABSTRACT

BACKGROUND: In recent years, many countries around the world have been threatened by COVs. The aim of this study was to better grasp developments and trends in research on coronavirus around the world and to promote theoretical research into their prevention and control. METHODS: Research on coronavirus was reviewed and analyzed using bibliometrics based on a total of 4860 publications collected from the Web of Science Core Collection database. Yearly quantitative distribution of literature, country/region distribution, organization distribution, main source journal distribution, subject category distribution, research knowledge bases, and research hotspots and frontiers were all analyzed, and CiteSpace and VOSviewer were used to plot knowledge domain maps, Excel was used to plot keyword strategy diagram. RESULTS: Coronavirus research could be roughly divided into 4 stages: preliminary development stage (before 2000), rapid growth stage (2000-2005), slow decline stage (2006-2011) and sustained growth stage (since 2012). America had taken the leading position in this field. The study of COVs involves many subject categories, mainly includes virology, veterinary sciences, biology, and immunology. At present, the key words in the field of coronavirus research were mainly divided into 6 major hot clusters, namely, the introduction and structure analysis of coronavirus, the research on the outbreak source and transmission of coronavirus, the research on the infection pathway of coronavirus in human body, the research on the pathogenesis of coronavirus, the research on the diagnosis and symptoms of coronavirus infection, and the research on the treatment of coronavirus. CONCLUSION: Coronavirus, which occurs all over the world, often causes huge casualties and economic losses, and poses a serious threat to the safe and stable operation of the social and economic system. Objective literature review and analysis can help scholars in related fields to deepen their overall understanding. And, there are several key issues that should be further explored in future research.


Subject(s)
Biomedical Research , Coronavirus Infections , Coronavirus , Bibliometrics , Coronavirus Infections/epidemiology , Data Management , Humans , Publications
9.
JMIR Mhealth Uhealth ; 10(7): e35195, 2022 07 12.
Article in English | MEDLINE | ID: covidwho-1902832

ABSTRACT

BACKGROUND: COVID-19 digital contact-tracing apps were created to assist public health authorities in curbing the pandemic. These apps require users' permission to access specific functions on their mobile phones, such as geolocation, Bluetooth or Wi-Fi connections, or personal data, to work correctly. As these functions have privacy repercussions, it is essential to establish how contact-tracing apps respect users' privacy. OBJECTIVE: This study aimed to systematically map existing contact-tracing apps and evaluate the permissions required and their privacy policies. Specifically, we evaluated the type of permissions, the privacy policies' readability, and the information included in them. METHODS: We used custom Google searches and existing lists of contact-tracing apps to identify potentially eligible apps between May 2020 and November 2021. We included contact-tracing or exposure notification apps with a Google Play webpage from which we extracted app characteristics (eg, sponsor, number of installs, and ratings). We used Exodus Privacy to systematically extract the number of permissions and classify them as dangerous or normal. We computed a Permission Accumulated Risk Score representing the threat level to the user's privacy. We assessed the privacy policies' readability and evaluated their content using a 13-item checklist, which generated a Privacy Transparency Index. We explored the relationships between app characteristics, Permission Accumulated Risk Score, and Privacy Transparency Index using correlations, chi-square tests, or ANOVAs. RESULTS: We identified 180 contact-tracing apps across 152 countries, states, or territories. We included 85.6% (154/180) of apps with a working Google Play page, most of which (132/154, 85.7%) had a privacy policy document. Most apps were developed by governments (116/154, 75.3%) and totaled 264.5 million installs. The average rating on Google Play was 3.5 (SD 0.7). Across the 154 apps, we identified 94 unique permissions, 18% (17/94) of which were dangerous, and 30 trackers. The average Permission Accumulated Risk Score was 22.7 (SD 17.7; range 4-74, median 16) and the average Privacy Transparency Index was 55.8 (SD 21.7; range 5-95, median 55). Overall, the privacy documents were difficult to read (median grade level 12, range 7-23); 67% (88/132) of these mentioned that the apps collected personal identifiers. The Permission Accumulated Risk Score was negatively associated with the average App Store ratings (r=-0.20; P=.03; 120/154, 77.9%) and Privacy Transparency Index (r=-0.25; P<.001; 132/154, 85.7%), suggesting that the higher the risk to one's data, the lower the apps' ratings and transparency index. CONCLUSIONS: Many contact-tracing apps were developed covering most of the planet but with a relatively low number of installs. Privacy-preserving apps scored high in transparency and App Store ratings, suggesting that some users appreciate these apps. Nevertheless, privacy policy documents were difficult to read for an average audience. Therefore, we recommend following privacy-preserving and transparency principles to improve contact-tracing uptake while making privacy documents more readable for a wider public.


Subject(s)
COVID-19 , Mobile Applications , Contact Tracing/methods , Data Management , Humans , Policy , Privacy
10.
Sci Data ; 9(1): 330, 2022 06 20.
Article in English | MEDLINE | ID: covidwho-1900518

ABSTRACT

A pandemic, like other disasters, changes how systems work. In order to support research on how the COVID-19 pandemic impacted the dynamics of a single metropolitan area and the communities therein, we developed and made publicly available a "data-support system" for the city of Boston. We actively gathered data from multiple administrative (e.g., 911 and 311 dispatches, building permits) and internet sources (e.g., Yelp, Craigslist), capturing aspects of housing and land use, crime and disorder, and commercial activity and institutions. All the data were linked spatially through BARI's Geographical Infrastructure, enabling conjoint analysis. We curated the base records and aggregated them to construct ecometric measures (i.e., descriptors of a place) at various geographic scales, all of which were also published as part of the database. The datasets were published in an open repository, each accompanied by a detailed documentation of methods and variables. We anticipate updating the database annually to maintain the tracking of the records and associated measures.


Subject(s)
COVID-19 , Databases, Factual , Boston/epidemiology , COVID-19/epidemiology , Data Management , Humans , Pandemics
12.
Prehosp Disaster Med ; 37(4): 468-473, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1873377

ABSTRACT

INTRODUCTION: Over the past five decades, Eastern Europe has seen relatively little in terms of terrorist attacks. The recent escalation of the Russo-Ukrainian conflict has, however, placed a new spotlight on the region, and new questions and concerns around war, conflict, insurgency, and terrorism are being posed. The Russian invasion and extensive combat operations, the largest in Europe since World War II, are occurring across Ukraine where there are 15 active nuclear reactors, not including the Chernobyl site, that are vulnerable to attack or sabotage. In addition, Eastern Europe has been heavily affected by COVID-19, exposing broad vulnerabilities in an otherwise fragile health care system. This raises concerns over the ability of Eastern European health care institutions to absorb surge and manage terrorist attacks or acts of violent extremism. This study provides an epidemiological description of all terrorism-related fatalities and injuries in Eastern Europe sustained from 1970 - 2019. METHOD: Data collection was performed using a retrospective database search through the Global Terrorism Database (GTD). The GTD was searched using the internal database functions for all terrorism events which occurred in Eastern Europe from January 1, 1970 - December 31, 2019. Years 2020 and 2021 were not yet available at the time of this study. Primary weapon type, country where the incident occurred, and number of deaths and injured were collated. Results were exported into an Excel spreadsheet (Microsoft Corp.; Redmond, Washington USA) for analysis. RESULTS: There were 3,901 terrorism-related events in Eastern Europe between the years 1970 and 2019, inclusive. In total, the attacks resulted in 5,391 deaths and 9,538 persons injured. Explosives were the most commonly used weapon type in 59.2% of all attacks in the region, followed by firearms in 27.6%. CONCLUSION: From 1970 through 2019, a total of 3,901 terrorist attacks occurred in Eastern Europe, inflicting 5,391 deaths and 9,538 injuries. Of those, 72.3% occurred in Russia and Ukraine. Terrorist attacks sharply declined since the peak in 2014, but there is an overall uptrend in attacks since the 1970s.


Subject(s)
COVID-19 , Terrorism , COVID-19/epidemiology , Data Management , Europe, Eastern/epidemiology , Humans , Retrospective Studies
13.
Stud Health Technol Inform ; 294: 659-663, 2022 May 25.
Article in English | MEDLINE | ID: covidwho-1865430

ABSTRACT

The scientific community, having turned its interest, almost entirely, to the treatment and understanding of COVID-19, is constantly striving to collect and use data from the countless available sources. That data, however, is scattered, not designed to be combined, collected in different time periods and their volume is constantly increasing. In this paper, we present an automated methodology that collects, refines, groups and combines data for a large number of countries. Most of these data resources are directly related to COVID-19 but we also choose to include other types of variables for each country, which may be of particular interest for researchers working in understanding the COVID-19 pandemic. The presented methodology unifies critical information regarding the pandemic. It is implemented in Python, provided as a simple script that extracts data, in the form of a daily time series, in a short period of time, directly available to be incorporated for analysis.


Subject(s)
COVID-19 , COVID-19/epidemiology , Data Management , Humans , Pandemics
14.
Stud Health Technol Inform ; 294: 490-494, 2022 May 25.
Article in English | MEDLINE | ID: covidwho-1865424

ABSTRACT

The Robert Koch Institute (RKI) monitors the actual number of COVID-19 patients requiring intensive care from aggregated data reported by hospitals in Germany. So far, there is no infrastructure to make use of individual patient-level data from intensive care units for public health surveillance. Adopting concepts and components of the already established AKTIN Emergency Department Data registry, we implemented the prototype of a federated and distributed research infrastructure giving the RKI access to patient-level intensive care data.


Subject(s)
COVID-19 , COVID-19/epidemiology , Data Management , Germany/epidemiology , Humans , Intensive Care Units , Public Health Surveillance
15.
Int J Environ Res Public Health ; 19(8)2022 04 12.
Article in English | MEDLINE | ID: covidwho-1785704

ABSTRACT

Several studies have attempted to identify how people's risk perceptions differ in regard to containing COVID-19 infections. The aim of the present review was to illustrate how risk awareness towards COVID-19 predicts people's preventive behaviors and to understand which features are associated with it. For the review, 77 articles found in six different databases (ProQuest, PsycInfo, PubMed, Science Direct, SCOPUS, and Web of Science) were considered, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was followed, and data synthesis was conducted using a mixed-methods approach. The results indicate that a high-risk perception towards COVID-19 predicts, in general, compliance with preventive behaviors and social distancing measures. Additionally, risk awareness was found to be associated with four other key themes: demographic factors, individual factors, geographical factors, and timing. Therefore, gaining a greater understanding of individual and cultural differences as well as how people behave could be the basis of an effective strategy for raising public risk awareness and for countering COVID-19.


Subject(s)
COVID-19 , COVID-19/epidemiology , Data Management , Humans , Perception
16.
Front Public Health ; 9: 665584, 2021.
Article in English | MEDLINE | ID: covidwho-1771099

ABSTRACT

Background: ODK provides software and standards that are popular solutions for off-grid electronic data collection and has substantial code overlap and interoperability with a number of related software products including CommCare, Enketo, Ona, SurveyCTO, and KoBoToolbox. These tools provide open-source options for off-grid use in public health data collection, management, analysis, and reporting. During the 2018-2020 Ebola epidemic in the North Kivu and Ituri regions of Democratic Republic of Congo, we used these tools to support the DRC Ministère de la Santé RDC and World Health Organization in their efforts to administer an experimental vaccine (VSV-Zebov-GP) as part of their strategy to control the transmission of infection. Method: New functions were developed to facilitate the use of ODK, Enketo and R in large scale data collection, aggregation, monitoring, and near-real-time analysis during clinical research in health emergencies. We present enhancements to ODK that include a built-in audit-trail, a framework and companion app for biometric registration of ISO/IEC 19794-2 fingerprint templates, enhanced performance features, better scalability for studies featuring millions of data form submissions, increased options for parallelization of research projects, and pipelines for automated management and analysis of data. We also developed novel encryption protocols for enhanced web-form security in Enketo. Results: Against the backdrop of a complex and challenging epidemic response, our enhanced platform of open tools was used to collect and manage data from more than 280,000 eligible study participants who received VSV-Zebov-GP under informed consent. These data were used to determine whether the VSV-Zebov-GP was safe and effective and to guide daily field operations. Conclusions: We present open-source developments that make electronic data management during clinical research and health emergencies more viable and robust. These developments will also enhance and expand the functionality of a diverse range of data collection platforms that are based on the ODK software and standards.


Subject(s)
Epidemics , Hemorrhagic Fever, Ebola , Data Management , Electronics , Epidemics/prevention & control , Hemorrhagic Fever, Ebola/epidemiology , Hemorrhagic Fever, Ebola/prevention & control , Humans
18.
BMJ Open ; 12(3): e055615, 2022 03 10.
Article in English | MEDLINE | ID: covidwho-1741633

ABSTRACT

BACKGROUND: For medical conditions with numerous interventions worthy of investigation, there are many advantages of a multi-arm multi-stage (MAMS) platform trial approach. However, there is currently limited knowledge on uptake of the MAMS design, especially in the late-phase setting. We sought to examine uptake and characteristics of late-phase MAMS platform trials, to enable better planning for teams considering future use of this approach. DESIGN: We examined uptake of registered, late-phase MAMS platforms in the EU clinical trials register, Australian New Zealand Clinical Trials Registry, International Standard Randomised Controlled Trial Number registry, Pan African Clinical Trials Registry, WHO International Clinical Trial Registry Platform and databases: PubMed, Medline, Cochrane Library, Global Health Library and EMBASE. Searching was performed and review data frozen on 1 April 2021. MAMS platforms were defined as requiring two or more comparison arms, with two or more trial stages, with an interim analysis allowing for stopping of recruitment to arms and typically the ability to add new intervention arms. RESULTS: 62 late-phase clinical trials using an MAMS approach were included. Overall, the number of late-phase trials using the MAMS design has been increasing since 2001 and been accelerated by COVID-19. The majority of current MAMS platforms were either targeting infectious diseases (52%) or cancers (29%) and all identified trials were for treatment interventions. 89% (55/62) of MAMS platforms were evaluating medications, with 45% (28/62) of the MAMS platforms having at least one or more repurposed medication as a comparison arm. CONCLUSIONS: Historically, late-phase trials have adhered to long-established standard (two-arm) designs. However, the number of late-phase MAMS platform trials is increasing, across a range of different disease areas. This study highlights the potential scope of MAMS platform trials and may assist research teams considering use of this approach in the late-phase randomised clinical trial setting. PROSPERO REGISTRATION NUMBER: CRD42019153910.


Subject(s)
COVID-19 , Australia , Data Management , Humans , Registries , Research Design
20.
PLoS One ; 16(3): e0248128, 2021.
Article in English | MEDLINE | ID: covidwho-1575679

ABSTRACT

BACKGROUND: The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments. METHODS: Electronic health record (EHR) and claims data were extracted from seven separate databases. Parallel analyses were undertaken on data extracted from each source. Each analysis examined time to mortality in hospitalized patients treated with hydroxychloroquine, azithromycin, and the two in combination as compared to patients not treated with either drug. Cox proportional hazards models were used, and propensity score methods were undertaken to adjust for confounding. Frequencies of adverse events in each treatment group were also examined. RESULTS: Neither hydroxychloroquine nor azithromycin, alone or in combination, were significantly associated with time to mortality among hospitalized COVID-19 patients. No treatment groups appeared to have an elevated risk of adverse events. CONCLUSION: Administration of hydroxychloroquine, azithromycin, and their combination appeared to have no effect on time to mortality in hospitalized COVID-19 patients. Continued research is needed to clarify best practices surrounding treatment of COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , Azithromycin/therapeutic use , COVID-19/drug therapy , Hydroxychloroquine/therapeutic use , Pandemics/prevention & control , Data Management/methods , Drug Therapy, Combination/methods , Female , Hospitalization , Humans , Male , SARS-CoV-2/drug effects
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