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1.
BMC Med Res Methodol ; 22(1): 35, 2022 01 30.
Article in English | MEDLINE | ID: covidwho-1699687

ABSTRACT

BACKGROUND: We investigated whether we could use influenza data to develop prediction models for COVID-19 to increase the speed at which prediction models can reliably be developed and validated early in a pandemic. We developed COVID-19 Estimated Risk (COVER) scores that quantify a patient's risk of hospital admission with pneumonia (COVER-H), hospitalization with pneumonia requiring intensive services or death (COVER-I), or fatality (COVER-F) in the 30-days following COVID-19 diagnosis using historical data from patients with influenza or flu-like symptoms and tested this in COVID-19 patients. METHODS: We analyzed a federated network of electronic medical records and administrative claims data from 14 data sources and 6 countries containing data collected on or before 4/27/2020. We used a 2-step process to develop 3 scores using historical data from patients with influenza or flu-like symptoms any time prior to 2020. The first step was to create a data-driven model using LASSO regularized logistic regression, the covariates of which were used to develop aggregate covariates for the second step where the COVER scores were developed using a smaller set of features. These 3 COVER scores were then externally validated on patients with 1) influenza or flu-like symptoms and 2) confirmed or suspected COVID-19 diagnosis across 5 databases from South Korea, Spain, and the United States. Outcomes included i) hospitalization with pneumonia, ii) hospitalization with pneumonia requiring intensive services or death, and iii) death in the 30 days after index date. RESULTS: Overall, 44,507 COVID-19 patients were included for model validation. We identified 7 predictors (history of cancer, chronic obstructive pulmonary disease, diabetes, heart disease, hypertension, hyperlipidemia, kidney disease) which combined with age and sex discriminated which patients would experience any of our three outcomes. The models achieved good performance in influenza and COVID-19 cohorts. For COVID-19 the AUC ranges were, COVER-H: 0.69-0.81, COVER-I: 0.73-0.91, and COVER-F: 0.72-0.90. Calibration varied across the validations with some of the COVID-19 validations being less well calibrated than the influenza validations. CONCLUSIONS: This research demonstrated the utility of using a proxy disease to develop a prediction model. The 3 COVER models with 9-predictors that were developed using influenza data perform well for COVID-19 patients for predicting hospitalization, intensive services, and fatality. The scores showed good discriminatory performance which transferred well to the COVID-19 population. There was some miscalibration in the COVID-19 validations, which is potentially due to the difference in symptom severity between the two diseases. A possible solution for this is to recalibrate the models in each location before use.


Subject(s)
COVID-19 , Influenza, Human , Pneumonia , COVID-19 Testing , Humans , Influenza, Human/epidemiology , SARS-CoV-2 , United States
2.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-315007

ABSTRACT

Limited data describing the effect of sex hormone on coronavirus disease (COVID-19) is available. We evaluated the effect of sex hormone on prevalence and clinical outcomes of COVID-19. Retrospective cohort study was performed using the nationwide claims data of 5061 adult patients with laboratory-confirmed COVID-19 in South Korea, from January 20 to April 8, 2020. COVID-19 was most prevalent in women of the 20-39 age group (1250 [44.14%]). Men were more likely to receive oxygen therapy (144 [6.46%] vs 131 [4.63%], P=0.004), be admitted to the intensive care unit (60 [2.69%] vs 53 [1.87%], P=0.049), and stay longer after admission to the intensive care unit (19.70±11.80 vs 14.75±9.23, P=0.016). However, there was no significant difference in mortality rates between men and women. In multivariable Cox analysis, independent risk factors for mortality were older age and underlying co-morbidities, rather than sex. To evaluate the effect of HRT among women, subgroup analysis was implemented using age-matched case-control data with a 1:3 ratio of females receiving HRT to those who did not. HRT did not have statistically significant association with clinical outcomes. This study suggests that sex hormone may not affect prevalence and clinical outcome of COVID-19 in South Korea.

3.
BMC Pharmacol Toxicol ; 23(1): 9, 2022 01 17.
Article in English | MEDLINE | ID: covidwho-1636310

ABSTRACT

BACKGROUND: This study aimed to evaluate incidence risk and adverse clinical outcomes in COVID-19 disease among short-term users of acid-suppressants in South Korea. METHODS: This retrospective cohort study, conducted using a nationwide claims database for South Korea, used data from patients with COVID-19 tested between January 1 and May 15, 2020. Patients aged over 18 years and prescribed proton pump inhibitors (PPI) or histamine-2 receptor antagonist (H2RA) for more than 7 days were identified. Primary outcome was COVID-19 while secondary outcomes were all-cause mortality, hospitalization with respiratory disease, or intensive respiratory intervention. Large-scale propensity scores were used to match patients, while the Cox proportional hazard model was utilized to evaluate any association between exposure and outcome(s). The risk estimates were calibrated by using 123 negative control outcomes. RESULTS: We identified 26,166 PPI users and 62,117 H2RA users. After propensity score matching, compared to H2RA use, PPI use was not significantly associated with lower risk of COVID-19 (calibrated hazard ratio [HR], 0.81 [95% confidence interval (CI), 0.30-2.19]); moreover, PPI use was not associated with adverse clinical outcomes in COVID-19, namely, hospitalization with respiratory disease (calibrated HR, 0.88 [95% CI, 0.72-1.08]), intensive respiratory interventions (calibrated HR, 0.92 [95% CI, 0.46-1.82]), except for all-cause mortality (calibrated HR, 0.54 [95% CI, 0.31-0.95]). CONCLUSIONS: In this study, we found that the PPI user was not associated with risk of COVID-19 compared to H2RA users. There was no significant relationship between severe clinical outcomes of COVID-19 and exposure to PPI compared with H2RA, except for all-cause mortality.


Subject(s)
COVID-19/epidemiology , Histamine H2 Antagonists/therapeutic use , Proton Pump Inhibitors/therapeutic use , SARS-CoV-2 , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/therapy , Female , Hospitalization/statistics & numerical data , Humans , Incidence , Male , Middle Aged , Republic of Korea/epidemiology , Retrospective Studies , Risk Factors , Treatment Outcome , Young Adult
4.
BMJ Open ; 11(12): e057632, 2021 12 22.
Article in English | MEDLINE | ID: covidwho-1583090

ABSTRACT

OBJECTIVE: To characterise patients with and without prevalent hypertension and COVID-19 and to assess adverse outcomes in both inpatients and outpatients. DESIGN AND SETTING: This is a retrospective cohort study using 15 healthcare databases (primary and secondary electronic healthcare records, insurance and national claims data) from the USA, Europe and South Korea, standardised to the Observational Medical Outcomes Partnership common data model. Data were gathered from 1 March to 31 October 2020. PARTICIPANTS: Two non-mutually exclusive cohorts were defined: (1) individuals diagnosed with COVID-19 (diagnosed cohort) and (2) individuals hospitalised with COVID-19 (hospitalised cohort), and stratified by hypertension status. Follow-up was from COVID-19 diagnosis/hospitalisation to death, end of the study period or 30 days. OUTCOMES: Demographics, comorbidities and 30-day outcomes (hospitalisation and death for the 'diagnosed' cohort and adverse events and death for the 'hospitalised' cohort) were reported. RESULTS: We identified 2 851 035 diagnosed and 563 708 hospitalised patients with COVID-19. Hypertension was more prevalent in the latter (ranging across databases from 17.4% (95% CI 17.2 to 17.6) to 61.4% (95% CI 61.0 to 61.8) and from 25.6% (95% CI 24.6 to 26.6) to 85.9% (95% CI 85.2 to 86.6)). Patients in both cohorts with hypertension were predominantly >50 years old and female. Patients with hypertension were frequently diagnosed with obesity, heart disease, dyslipidaemia and diabetes. Compared with patients without hypertension, patients with hypertension in the COVID-19 diagnosed cohort had more hospitalisations (ranging from 1.3% (95% CI 0.4 to 2.2) to 41.1% (95% CI 39.5 to 42.7) vs from 1.4% (95% CI 0.9 to 1.9) to 15.9% (95% CI 14.9 to 16.9)) and increased mortality (ranging from 0.3% (95% CI 0.1 to 0.5) to 18.5% (95% CI 15.7 to 21.3) vs from 0.2% (95% CI 0.2 to 0.2) to 11.8% (95% CI 10.8 to 12.8)). Patients in the COVID-19 hospitalised cohort with hypertension were more likely to have acute respiratory distress syndrome (ranging from 0.1% (95% CI 0.0 to 0.2) to 65.6% (95% CI 62.5 to 68.7) vs from 0.1% (95% CI 0.0 to 0.2) to 54.7% (95% CI 50.5 to 58.9)), arrhythmia (ranging from 0.5% (95% CI 0.3 to 0.7) to 45.8% (95% CI 42.6 to 49.0) vs from 0.4% (95% CI 0.3 to 0.5) to 36.8% (95% CI 32.7 to 40.9)) and increased mortality (ranging from 1.8% (95% CI 0.4 to 3.2) to 25.1% (95% CI 23.0 to 27.2) vs from 0.7% (95% CI 0.5 to 0.9) to 10.9% (95% CI 10.4 to 11.4)) than patients without hypertension. CONCLUSIONS: COVID-19 patients with hypertension were more likely to suffer severe outcomes, hospitalisations and deaths compared with those without hypertension.


Subject(s)
COVID-19 , Hypertension , COVID-19 Testing , Cohort Studies , Comorbidity , Female , Hospitalization , Humans , Hypertension/epidemiology , Middle Aged , Retrospective Studies , SARS-CoV-2
5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-295691

ABSTRACT

Background: This study aimed to evaluate incidence risk and severe clinical outcomes in COVID-19 disease among short-term users of acid-suppressants in South Korea. Methods: : This retrospective cohort study, conducted using a nationwide claims database for South Korea, used data from patients with COVID-19 tested between January 1 and May 15, 2020. Patients aged over 18 years and prescribed proton pump inhibitors (PPI) or histamine-2 receptor antagonist (H 2 RA) for more than 7 days were identified. Primary outcome was COVID-19 while secondary outcomes were all-cause mortality, hospitalization with respiratory disease, or intensive respiratory intervention. Large-scale propensity scores were used to match patients, while the Cox proportional hazard model was utilized to evaluate any association between exposure and outcome(s). The risk estimates were calibrated by using 123 falsification endpoints. Results: We identified 26,166 PPI users and 62,117 H 2 RA users. After propensity score matching, compared to H 2 RA use, PPI use was not significantly associated with lower risk of COVID-19 (calibrated hazard ratio [HR], 0.81 [95% confidence interval (CI), 0.30–2.19]);moreover, PPI use was not associated with adverse clinical outcomes in COVID-19, namely, hospitalization with respiratory disease (calibrated HR, 0.88 [95% CI, 0.72–1.08]), intensive respiratory interventions (calibrated HR, 0.92 [95% CI, 0.46–1.82]), except for all-cause mortality (calibrated HR, 0.54 [95% CI, 0.31–0.95]). Conclusions: In this study, we found that the PPI user was not associated with risk of COVID-19 compared to H 2 RA users. There was no significant relationship between severe clinical outcomes of COVID-19 and exposure to PPI compared with H 2 RA, except for all-cause mortality.

6.
2021.
Preprint in English | Other preprints | ID: ppcovidwho-295136

ABSTRACT

Background and Objective As a response to the ongoing COVID-19 pandemic, several prediction models have been rapidly developed, with the aim of providing evidence-based guidance. However, no COVID-19 prediction model in the existing literature has been found to be reliable. Models are commonly assessed to have a risk of bias, often due to insufficient reporting, use of non-representative data, and lack of large-scale external validation. In this paper, we present the Observational Health Data Sciences and Informatics (OHDSI) analytics pipeline for patient-level prediction as a standardized approach for rapid yet reliable development and validation of prediction models. We demonstrate how our analytics pipeline and open-source software can be used to answer important prediction questions while limiting potential causes of bias (e.g., by validating phenotypes, specifying the target population, performing large-scale external validation and publicly providing all analytical source code). Methods We show step-by-step how to implement the pipeline for the question: ‘In patients hospitalized with COVID-19, what is the risk of death 0 to 30 days after hospitalization’. We develop models using six different machine learning methods in a US claims database containing over 20,000 COVID-19 hospitalizations and externally validate the models using data containing over 45,000 COVID-19 hospitalizations from South Korea, Spain, and the US. Results Our open-source tools enabled us to efficiently go end-to-end from problem design to reliable model development and evaluation. When predicting death in patients hospitalized for COVID-19 adaBoost, random forest, gradient boosting machine, and decision tree yielded similar or lower internal and external validation discrimination performance compared to L1-regularized logistic regression, whereas the MLP neural network consistently resulted in lower discrimination. L1-regularized logistic regression models were well calibrated. Conclusion Our results show that following the OHDSI analytics pipeline for patient-level prediction can enable the rapid development towards reliable prediction models. The OHDSI tools and pipeline are open source and available to researchers around the world.

7.
Comput Methods Programs Biomed ; 211: 106394, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1437413

ABSTRACT

BACKGROUND AND OBJECTIVE: As a response to the ongoing COVID-19 pandemic, several prediction models in the existing literature were rapidly developed, with the aim of providing evidence-based guidance. However, none of these COVID-19 prediction models have been found to be reliable. Models are commonly assessed to have a risk of bias, often due to insufficient reporting, use of non-representative data, and lack of large-scale external validation. In this paper, we present the Observational Health Data Sciences and Informatics (OHDSI) analytics pipeline for patient-level prediction modeling as a standardized approach for rapid yet reliable development and validation of prediction models. We demonstrate how our analytics pipeline and open-source software tools can be used to answer important prediction questions while limiting potential causes of bias (e.g., by validating phenotypes, specifying the target population, performing large-scale external validation, and publicly providing all analytical source code). METHODS: We show step-by-step how to implement the analytics pipeline for the question: 'In patients hospitalized with COVID-19, what is the risk of death 0 to 30 days after hospitalization?'. We develop models using six different machine learning methods in a USA claims database containing over 20,000 COVID-19 hospitalizations and externally validate the models using data containing over 45,000 COVID-19 hospitalizations from South Korea, Spain, and the USA. RESULTS: Our open-source software tools enabled us to efficiently go end-to-end from problem design to reliable Model Development and evaluation. When predicting death in patients hospitalized with COVID-19, AdaBoost, random forest, gradient boosting machine, and decision tree yielded similar or lower internal and external validation discrimination performance compared to L1-regularized logistic regression, whereas the MLP neural network consistently resulted in lower discrimination. L1-regularized logistic regression models were well calibrated. CONCLUSION: Our results show that following the OHDSI analytics pipeline for patient-level prediction modelling can enable the rapid development towards reliable prediction models. The OHDSI software tools and pipeline are open source and available to researchers from all around the world.


Subject(s)
COVID-19 , Pandemics , Humans , Logistic Models , Machine Learning , SARS-CoV-2
8.
Pediatrics ; 148(3)2021 09.
Article in English | MEDLINE | ID: covidwho-1394618

ABSTRACT

OBJECTIVES: To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in secondary analyses with patients diagnosed with previous seasonal influenza in 2017-2018. METHODS: International network cohort using real-world data from European primary care records (France, Germany, and Spain), South Korean claims and US claims, and hospital databases. We included children and adolescents diagnosed and/or hospitalized with COVID-19 at age <18 between January and June 2020. We described baseline demographics, comorbidities, symptoms, 30-day in-hospital treatments, and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome, multisystem inflammatory syndrome in children, and death. RESULTS: A total of 242 158 children and adolescents diagnosed and 9769 hospitalized with COVID-19 and 2 084 180 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were more common among those hospitalized with versus diagnosed with COVID-19. Dyspnea, bronchiolitis, anosmia, and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital prevalent treatments for COVID-19 included repurposed medications (<10%) and adjunctive therapies: systemic corticosteroids (6.8%-7.6%), famotidine (9.0%-28.1%), and antithrombotics such as aspirin (2.0%-21.4%), heparin (2.2%-18.1%), and enoxaparin (2.8%-14.8%). Hospitalization was observed in 0.3% to 1.3% of the cohort diagnosed with COVID-19, with undetectable (n < 5 per database) 30-day fatality. Thirty-day outcomes including pneumonia and hypoxemia were more frequent in COVID-19 than influenza. CONCLUSIONS: Despite negligible fatality, complications including hospitalization, hypoxemia, and pneumonia were more frequent in children and adolescents with COVID-19 than with influenza. Dyspnea, anosmia, and gastrointestinal symptoms could help differentiate diagnoses. A wide range of medications was used for the inpatient management of pediatric COVID-19.


Subject(s)
COVID-19 , Adolescent , Age Distribution , COVID-19/complications , COVID-19/diagnosis , COVID-19/drug therapy , COVID-19/epidemiology , Child , Child, Preschool , Cohort Studies , Comorbidity , Databases, Factual , Diagnosis, Differential , Female , France/epidemiology , Germany/epidemiology , Hospitalization/statistics & numerical data , Humans , Infant , Infant, Newborn , Influenza, Human/complications , Influenza, Human/diagnosis , Influenza, Human/epidemiology , Male , Republic of Korea/epidemiology , Spain/epidemiology , Symptom Assessment , Time Factors , Treatment Outcome , United States/epidemiology
9.
BMJ ; 373: n1038, 2021 05 11.
Article in English | MEDLINE | ID: covidwho-1223582

ABSTRACT

OBJECTIVE: To investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents. DESIGN: Multinational network cohort study. SETTING: Hospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea. PARTICIPANTS: 303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020. MAIN OUTCOME MEASURES: Prescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19. RESULTS: Of the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from <5 (<2%) patients in China to 2165 (85.1%) in Spain), azithromycin (from 15 (4.9%) in China to 1473 (57.9%) in Spain), combined lopinavir and ritonavir (from 156 (<2%) in the VA-OMOP US to 2,652 (34.9%) in South Korea and 1285 (50.5%) in Spain), and umifenovir (0% in the US, South Korea, and Spain and 238 (78.3%) in China). Use of adjunctive drugs varied greatly, with the five most used treatments being enoxaparin, fluoroquinolones, ceftriaxone, vitamin D, and corticosteroids. Hydroxychloroquine use increased rapidly from March to April 2020 but declined steeply in May to June and remained low for the rest of the year. The use of dexamethasone and corticosteroids increased steadily during 2020. CONCLUSIONS: Multiple drugs were used in the first few months of the covid-19 pandemic, with substantial geographical and temporal variation. Hydroxychloroquine, azithromycin, lopinavir-ritonavir, and umifenovir (in China only) were the most prescribed repurposed drugs. Antithrombotics, antibiotics, H2 receptor antagonists, and corticosteroids were often used as adjunctive treatments. Research is needed on the comparative risk and benefit of these treatments in the management of covid-19.


Subject(s)
COVID-19/drug therapy , Chemotherapy, Adjuvant/methods , Drug Repositioning/methods , Administrative Claims, Healthcare/statistics & numerical data , Adolescent , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Azithromycin/therapeutic use , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , Ceftriaxone/therapeutic use , Child , Child, Preschool , China/epidemiology , Cohort Studies , Drug Combinations , Electronic Health Records/statistics & numerical data , Enoxaparin/therapeutic use , Female , Fluoroquinolones/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Infant , Infant, Newborn , Inpatients , Lopinavir/therapeutic use , Male , Middle Aged , Republic of Korea/epidemiology , Ritonavir/therapeutic use , SARS-CoV-2/drug effects , SARS-CoV-2/genetics , Safety , Spain/epidemiology , Treatment Outcome , United States/epidemiology , Vitamin D/therapeutic use , Young Adult
10.
JMIR Med Inform ; 9(4): e21547, 2021 Apr 05.
Article in English | MEDLINE | ID: covidwho-1195972

ABSTRACT

BACKGROUND: SARS-CoV-2 is straining health care systems globally. The burden on hospitals during the pandemic could be reduced by implementing prediction models that can discriminate patients who require hospitalization from those who do not. The COVID-19 vulnerability (C-19) index, a model that predicts which patients will be admitted to hospital for treatment of pneumonia or pneumonia proxies, has been developed and proposed as a valuable tool for decision-making during the pandemic. However, the model is at high risk of bias according to the "prediction model risk of bias assessment" criteria, and it has not been externally validated. OBJECTIVE: The aim of this study was to externally validate the C-19 index across a range of health care settings to determine how well it broadly predicts hospitalization due to pneumonia in COVID-19 cases. METHODS: We followed the Observational Health Data Sciences and Informatics (OHDSI) framework for external validation to assess the reliability of the C-19 index. We evaluated the model on two different target populations, 41,381 patients who presented with SARS-CoV-2 at an outpatient or emergency department visit and 9,429,285 patients who presented with influenza or related symptoms during an outpatient or emergency department visit, to predict their risk of hospitalization with pneumonia during the following 0-30 days. In total, we validated the model across a network of 14 databases spanning the United States, Europe, Australia, and Asia. RESULTS: The internal validation performance of the C-19 index had a C statistic of 0.73, and the calibration was not reported by the authors. When we externally validated it by transporting it to SARS-CoV-2 data, the model obtained C statistics of 0.36, 0.53 (0.473-0.584) and 0.56 (0.488-0.636) on Spanish, US, and South Korean data sets, respectively. The calibration was poor, with the model underestimating risk. When validated on 12 data sets containing influenza patients across the OHDSI network, the C statistics ranged between 0.40 and 0.68. CONCLUSIONS: Our results show that the discriminative performance of the C-19 index model is low for influenza cohorts and even worse among patients with COVID-19 in the United States, Spain, and South Korea. These results suggest that C-19 should not be used to aid decision-making during the COVID-19 pandemic. Our findings highlight the importance of performing external validation across a range of settings, especially when a prediction model is being extrapolated to a different population. In the field of prediction, extensive validation is required to create appropriate trust in a model.

11.
Rheumatology (Oxford) ; 60(SI): SI37-SI50, 2021 10 09.
Article in English | MEDLINE | ID: covidwho-1135892

ABSTRACT

OBJECTIVE: Patients with autoimmune diseases were advised to shield to avoid coronavirus disease 2019 (COVID-19), but information on their prognosis is lacking. We characterized 30-day outcomes and mortality after hospitalization with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza. METHODS: A multinational network cohort study was conducted using electronic health records data from Columbia University Irving Medical Center [USA, Optum (USA), Department of Veterans Affairs (USA), Information System for Research in Primary Care-Hospitalization Linked Data (Spain) and claims data from IQVIA Open Claims (USA) and Health Insurance and Review Assessment (South Korea). All patients with prevalent autoimmune diseases, diagnosed and/or hospitalized between January and June 2020 with COVID-19, and similar patients hospitalized with influenza in 2017-18 were included. Outcomes were death and complications within 30 days of hospitalization. RESULTS: We studied 133 589 patients diagnosed and 48 418 hospitalized with COVID-19 with prevalent autoimmune diseases. Most patients were female, aged ≥50 years with previous comorbidities. The prevalence of hypertension (45.5-93.2%), chronic kidney disease (14.0-52.7%) and heart disease (29.0-83.8%) was higher in hospitalized vs diagnosed patients with COVID-19. Compared with 70 660 hospitalized with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2-4.3% vs 6.32-24.6%). CONCLUSION: Compared with influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality.


Subject(s)
Autoimmune Diseases/mortality , Autoimmune Diseases/virology , COVID-19/mortality , Hospitalization/statistics & numerical data , Influenza, Human/mortality , Adult , Aged , Aged, 80 and over , COVID-19/immunology , Cohort Studies , Female , Humans , Influenza, Human/immunology , Male , Middle Aged , Prevalence , Prognosis , Republic of Korea/epidemiology , SARS-CoV-2 , Spain/epidemiology , United States/epidemiology , Young Adult
12.
JMIR Med Inform ; 9(4): e25035, 2021 Apr 06.
Article in English | MEDLINE | ID: covidwho-1133823

ABSTRACT

BACKGROUND: Accurate and rapid clinical decisions based on real-world evidence are essential for patients with cancer. However, the complexity of chemotherapy regimens for cancer impedes retrospective research that uses observational health databases. OBJECTIVE: The aim of this study is to compare the anticancer treatment trajectories and patterns of clinical events according to regimen type using the chemotherapy episodes determined by an algorithm. METHODS: We developed an algorithm to extract the regimen-level abstracted chemotherapy episodes from medication records in a conventional Observational Medical Outcomes Partnership (OMOP) common data model (CDM) database. The algorithm was validated on the Ajou University School Of Medicine (AUSOM) database by manual review of clinical notes. Using the algorithm, we extracted episodes of chemotherapy from patients in the EHR database and the claims database. We also developed an application software for visualizing the chemotherapy treatment patterns based on the treatment episodes in the OMOP-CDM database. Using this software, we generated the trends in the types of regimen used in the institutions, the patterns of the iterative chemotherapy use, and the trajectories of cancer treatment in two EHR-based OMOP-CDM databases. As a pilot study, the time of onset of chemotherapy-induced neutropenia according to regimen was measured using the AUSOM database. The anticancer treatment trajectories for patients with COVID-19 were also visualized based on the nationwide claims database. RESULTS: We generated 178,360 treatment episodes for patients with colorectal, breast, and lung cancer for 85 different regimens. The algorithm precisely identified the type of chemotherapy regimen in 400 patients (average positive predictive value >98%). The trends in the use of routine clinical chemotherapy regimens from 2008-2018 were identified for 8236 patients. For a total of 12 regimens (those administered to the largest proportion of patients), the number of repeated treatments was concordant with the protocols for standard chemotherapy regimens for certain cases. In addition, the anticancer treatment trajectories for 8315 patients were shown, including 62 patients with COVID-19. A comparative analysis of neutropenia showed that its onset in colorectal cancer regimens tended to cluster between days 9-15, whereas it tended to cluster between days 2-8 for certain regimens for breast cancer or lung cancer. CONCLUSIONS: We propose a method for generating chemotherapy episodes for introduction into the oncology extension module of the OMOP-CDM databases. These proof-of-concept studies demonstrated the usability, scalability, and interoperability of the proposed framework through a distributed research network.

13.
PLoS One ; 16(3): e0248058, 2021.
Article in English | MEDLINE | ID: covidwho-1127792

ABSTRACT

BACKGROUND: The effect of renin-angiotensin-aldosterone system (RAAS) inhibitors in coronavirus disease 19 (Covid-19) patients has not been fully investigated. We evaluated the association between RAAS inhibitor use and outcomes of Covid-19. METHODS: This study was a retrospective observational cohort study that used data based on insurance benefit claims sent to the Health Insurance Review and Assessment Service of Korea by May 15, 2020. These claims comprised all Covid-19 tested cases and the history of medical service use in these patients for the past five years. The primary outcome was all-cause mortality, and the rate of ventilator care was compared between the groups. RESULTS: From a total of 7,590 patients diagnosed with Covid-19, two distinct cohorts were generated based on RAAS inhibitors prescribed within 6 months before Covid-19 diagnosis. A total of 1,111 patients was prescribed RAAS inhibitors, and 794 patients were prescribed antihypertensive drugs, excluding RAAS inhibitors. In propensity-score matched analysis, 666 pairs of data set were generated, and all-cause mortality of the RAAS inhibitor group showed no significant difference compared with the non-RAAS inhibitor group (14.6% vs. 11.1%; hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.54-1.15; p = 0.22). The rate of ventilator care was not significantly different between the two groups (4.4% vs. 4.1%; HR, 1.04; 95%CI, 0.60-1.79; p = 0.89). CONCLUSIONS: RAAS inhibitor treatment did not appear to increase the mortality of Covid-19 patients compared with other antihypertensive drugs, suggesting that they may be safely continued in Covid-19 patients.


Subject(s)
Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Antihypertensive Agents/therapeutic use , COVID-19/complications , Hypertension/complications , Hypertension/drug therapy , Renin-Angiotensin System/drug effects , Adolescent , Adult , Aged , COVID-19/mortality , COVID-19/therapy , Female , Humans , Male , Middle Aged , Republic of Korea/epidemiology , Respiration, Artificial , Retrospective Studies , Young Adult
14.
Sci Rep ; 11(1): 5087, 2021 03 03.
Article in English | MEDLINE | ID: covidwho-1117657

ABSTRACT

Non-steroidal anti-inflammatory drugs (NSAIDs) have been widely used in patients with respiratory infection, but their safety in coronavirus disease 19 (Covid-19) patients has not been fully investigated. We evaluated an association between NSAID use and outcomes of Covid-19. This study was a retrospective observational cohort study based on insurance benefit claims sent to the Health Insurance Review and Assessment Service of Korea by May 15, 2020. These claims comprised all Covid-19-tested cases and history of medical service use for the past 3 years in these patients. The primary outcome was all-cause mortality, and the secondary outcome was need for ventilator care. Among 7590 patients diagnosed with Covid-19, two distinct cohorts were generated based on NSAID or acetaminophen prescription within 2 weeks before Covid-19 diagnosis. A total of 398 patients was prescribed NSAIDs, and 2365 patients were prescribed acetaminophen. After propensity score matching, 397 pairs of data set were generated, and all-cause mortality of the NSAIDs group showed no significant difference compared with the acetaminophen group (4.0% vs. 3.0%; hazard ratio [HR], 1.33; 95% confidence interval [CI], 0.63-2.88; P = 0.46). The rate of ventilator care also did not show significantly different results between the two groups (2.0% vs. 1.3%; HR, 1.60; 95% CI 0.53-5.30; P = 0.42). Use of NSAIDs was not associated with mortality or ventilator care in Covid-19 patients. NSAIDs may be safely used to relieve symptoms in patients with suspicion of Covid-19.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , Acetaminophen/adverse effects , Acetaminophen/therapeutic use , Administration, Oral , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Cohort Studies , Female , Humans , Male , Middle Aged , Odds Ratio , Propensity Score , Republic of Korea/epidemiology , Retrospective Studies , SARS-CoV-2/pathogenicity
15.
J Prev Med Public Health ; 54(1): 8-16, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1097326

ABSTRACT

This article aims to introduce the inception and operation of the COVID-19 International Collaborative Research Project, the world's first coronavirus disease 2019 (COVID-19) open data project for research, along with its dataset and research method, and to discuss relevant considerations for collaborative research using nationwide real-world data (RWD). COVID-19 has spread across the world since early 2020, becoming a serious global health threat to life, safety, and social and economic activities. However, insufficient RWD from patients was available to help clinicians efficiently diagnose and treat patients with COVID-19, or to provide necessary information to the government for policy-making. Countries that saw a rapid surge of infections had to focus on leveraging medical professionals to treat patients, and the circumstances made it even more difficult to promptly use COVID-19 RWD. Against this backdrop, the Health Insurance Review and Assessment Service (HIRA) of Korea decided to open its COVID-19 RWD collected through Korea's universal health insurance program, under the title of the COVID-19 International Collaborative Research Project. The dataset, consisting of 476 508 claim statements from 234 427 patients (7590 confirmed cases) and 18 691 318 claim statements of the same patients for the previous 3 years, was established and hosted on HIRA's in-house server. Researchers who applied to participate in the project uploaded analysis code on the platform prepared by HIRA, and HIRA conducted the analysis and provided outcome values. As of November 2020, analyses have been completed for 129 research projects, which have been published or are in the process of being published in prestigious journals.


Subject(s)
COVID-19/prevention & control , Insurance Carriers/statistics & numerical data , Internationality , COVID-19/transmission , Databases, Factual/statistics & numerical data , Humans , Outcome Assessment, Health Care/standards , Outcome Assessment, Health Care/statistics & numerical data , Quality of Health Care/standards , Quality of Health Care/statistics & numerical data , Republic of Korea
16.
JMIR Med Inform ; 9(1): e25435, 2021 Jan 08.
Article in English | MEDLINE | ID: covidwho-1067578

ABSTRACT

BACKGROUND: Although telehealth is considered a key component in combating the worldwide crisis caused by COVID-19, the factors that influence its acceptance by the general population after the flattening of the COVID-19 curve remain unclear. OBJECTIVE: We aimed to identify factors affecting telehealth acceptance, including anxiety related to COVID-19, after the initial rapid spread of the disease in South Korea. METHODS: We proposed an extended technology acceptance model (TAM) and performed a cross-sectional survey of individuals aged ≥30 years. In total, 471 usable responses were collected. Confirmatory factor analysis was used to examine the validity of measurements, and the partial least squares (PLS) method was used to investigate factors influencing telehealth acceptance and the impacts of COVID-19. RESULTS: PLS analysis showed that increased accessibility, enhanced care, and ease of telehealth use had positive effects on its perceived usefulness (P=.002, P<.001, and P<.001, respectively). Furthermore, perceived usefulness, ease, and privacy/discomfort significantly impacted the acceptance of telehealth (P<.001, P<.001, and P<.001, respectively). However, anxiety toward COVID-19 was not associated with telehealth acceptance (P=.112), and this insignificant relationship was consistent in the cluster (n=216, 46%) of respondents with chronic diseases (P=.185). CONCLUSIONS: Increased accessibility, enhanced care, usefulness, ease of use, and privacy/discomfort are decisive variables affecting telehealth acceptance in the Korean general population, whereas anxiety about COVID-19 is not. This study may lead to a tailored promotion of telehealth after the pandemic subsides.

17.
Lancet Digit Health ; 3(2): e98-e114, 2021 02.
Article in English | MEDLINE | ID: covidwho-1065706

ABSTRACT

BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been postulated to affect susceptibility to COVID-19. Observational studies so far have lacked rigorous ascertainment adjustment and international generalisability. We aimed to determine whether use of ACEIs or ARBs is associated with an increased susceptibility to COVID-19 in patients with hypertension. METHODS: In this international, open science, cohort analysis, we used electronic health records from Spain (Information Systems for Research in Primary Care [SIDIAP]) and the USA (Columbia University Irving Medical Center data warehouse [CUIMC] and Department of Veterans Affairs Observational Medical Outcomes Partnership [VA-OMOP]) to identify patients aged 18 years or older with at least one prescription for ACEIs and ARBs (target cohort) or calcium channel blockers (CCBs) and thiazide or thiazide-like diuretics (THZs; comparator cohort) between Nov 1, 2019, and Jan 31, 2020. Users were defined separately as receiving either monotherapy with these four drug classes, or monotherapy or combination therapy (combination use) with other antihypertensive medications. We assessed four outcomes: COVID-19 diagnosis; hospital admission with COVID-19; hospital admission with pneumonia; and hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis. We built large-scale propensity score methods derived through a data-driven approach and negative control experiments across ten pairwise comparisons, with results meta-analysed to generate 1280 study effects. For each study effect, we did negative control outcome experiments using a possible 123 controls identified through a data-rich algorithm. This process used a set of predefined baseline patient characteristics to provide the most accurate prediction of treatment and balance among patient cohorts across characteristics. The study is registered with the EU Post-Authorisation Studies register, EUPAS35296. FINDINGS: Among 1 355 349 antihypertensive users (363 785 ACEI or ARB monotherapy users, 248 915 CCB or THZ monotherapy users, 711 799 ACEI or ARB combination users, and 473 076 CCB or THZ combination users) included in analyses, no association was observed between COVID-19 diagnosis and exposure to ACEI or ARB monotherapy versus CCB or THZ monotherapy (calibrated hazard ratio [HR] 0·98, 95% CI 0·84-1·14) or combination use exposure (1·01, 0·90-1·15). ACEIs alone similarly showed no relative risk difference when compared with CCB or THZ monotherapy (HR 0·91, 95% CI 0·68-1·21; with heterogeneity of >40%) or combination use (0·95, 0·83-1·07). Directly comparing ACEIs with ARBs demonstrated a moderately lower risk with ACEIs, which was significant with combination use (HR 0·88, 95% CI 0·79-0·99) and non-significant for monotherapy (0·85, 0·69-1·05). We observed no significant difference between drug classes for risk of hospital admission with COVID-19, hospital admission with pneumonia, or hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis across all comparisons. INTERPRETATION: No clinically significant increased risk of COVID-19 diagnosis or hospital admission-related outcomes associated with ACEI or ARB use was observed, suggesting users should not discontinue or change their treatment to decrease their risk of COVID-19. FUNDING: Wellcome Trust, UK National Institute for Health Research, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, South Korean Ministry of Health and Welfare Republic, Australian National Health and Medical Research Council, and European Health Data and Evidence Network.

18.
Lancet Digit Health ; 3(2): e98-e114, 2021 02.
Article in English | MEDLINE | ID: covidwho-989557

ABSTRACT

BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been postulated to affect susceptibility to COVID-19. Observational studies so far have lacked rigorous ascertainment adjustment and international generalisability. We aimed to determine whether use of ACEIs or ARBs is associated with an increased susceptibility to COVID-19 in patients with hypertension. METHODS: In this international, open science, cohort analysis, we used electronic health records from Spain (Information Systems for Research in Primary Care [SIDIAP]) and the USA (Columbia University Irving Medical Center data warehouse [CUIMC] and Department of Veterans Affairs Observational Medical Outcomes Partnership [VA-OMOP]) to identify patients aged 18 years or older with at least one prescription for ACEIs and ARBs (target cohort) or calcium channel blockers (CCBs) and thiazide or thiazide-like diuretics (THZs; comparator cohort) between Nov 1, 2019, and Jan 31, 2020. Users were defined separately as receiving either monotherapy with these four drug classes, or monotherapy or combination therapy (combination use) with other antihypertensive medications. We assessed four outcomes: COVID-19 diagnosis; hospital admission with COVID-19; hospital admission with pneumonia; and hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis. We built large-scale propensity score methods derived through a data-driven approach and negative control experiments across ten pairwise comparisons, with results meta-analysed to generate 1280 study effects. For each study effect, we did negative control outcome experiments using a possible 123 controls identified through a data-rich algorithm. This process used a set of predefined baseline patient characteristics to provide the most accurate prediction of treatment and balance among patient cohorts across characteristics. The study is registered with the EU Post-Authorisation Studies register, EUPAS35296. FINDINGS: Among 1 355 349 antihypertensive users (363 785 ACEI or ARB monotherapy users, 248 915 CCB or THZ monotherapy users, 711 799 ACEI or ARB combination users, and 473 076 CCB or THZ combination users) included in analyses, no association was observed between COVID-19 diagnosis and exposure to ACEI or ARB monotherapy versus CCB or THZ monotherapy (calibrated hazard ratio [HR] 0·98, 95% CI 0·84-1·14) or combination use exposure (1·01, 0·90-1·15). ACEIs alone similarly showed no relative risk difference when compared with CCB or THZ monotherapy (HR 0·91, 95% CI 0·68-1·21; with heterogeneity of >40%) or combination use (0·95, 0·83-1·07). Directly comparing ACEIs with ARBs demonstrated a moderately lower risk with ACEIs, which was significant with combination use (HR 0·88, 95% CI 0·79-0·99) and non-significant for monotherapy (0·85, 0·69-1·05). We observed no significant difference between drug classes for risk of hospital admission with COVID-19, hospital admission with pneumonia, or hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis across all comparisons. INTERPRETATION: No clinically significant increased risk of COVID-19 diagnosis or hospital admission-related outcomes associated with ACEI or ARB use was observed, suggesting users should not discontinue or change their treatment to decrease their risk of COVID-19. FUNDING: Wellcome Trust, UK National Institute for Health Research, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, South Korean Ministry of Health and Welfare Republic, Australian National Health and Medical Research Council, and European Health Data and Evidence Network.

19.
medRxiv ; 2020 Nov 27.
Article in English | MEDLINE | ID: covidwho-955714

ABSTRACT

OBJECTIVE: Patients with autoimmune diseases were advised to shield to avoid COVID-19, but information on their prognosis is lacking. We characterised 30-day outcomes and mortality after hospitalisation with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza. DESIGN: Multinational network cohort study. SETTING: Electronic health records data from Columbia University Irving Medical Center (CUIMC) (NYC, United States [US]), Optum [US], Department of Veterans Affairs (VA) (US), Information System for Research in Primary Care-Hospitalisation Linked Data (SIDIAP-H) (Spain), and claims data from IQVIA Open Claims (US) and Health Insurance and Review Assessment (HIRA) (South Korea). PARTICIPANTS: All patients with prevalent autoimmune diseases, diagnosed and/or hospitalised between January and June 2020 with COVID-19, and similar patients hospitalised with influenza in 2017-2018 were included. MAIN OUTCOME MEASURES: 30-day complications during hospitalisation and death. RESULTS: We studied 133,589 patients diagnosed and 48,418 hospitalised with COVID-19 with prevalent autoimmune diseases. The majority of participants were female (60.5% to 65.9%) and aged ≥50 years. The most prevalent autoimmune conditions were psoriasis (3.5 to 32.5%), rheumatoid arthritis (3.9 to 18.9%), and vasculitis (3.3 to 17.6%). Amongst hospitalised patients, Type 1 diabetes was the most common autoimmune condition (4.8% to 7.5%) in US databases, rheumatoid arthritis in HIRA (18.9%), and psoriasis in SIDIAP-H (26.4%).Compared to 70,660 hospitalised with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2% to 4.3% versus 6.3% to 24.6%). CONCLUSIONS: Patients with autoimmune diseases had high rates of respiratory complications and 30-day mortality following a hospitalization with COVID-19. Compared to influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality. Future studies should investigate predictors of poor outcomes in COVID-19 patients with autoimmune diseases. WHAT IS ALREADY KNOWN ABOUT THIS TOPIC: Patients with autoimmune conditions may be at increased risk of COVID-19 infection andcomplications.There is a paucity of evidence characterising the outcomes of hospitalised COVID-19 patients with prevalent autoimmune conditions. WHAT THIS STUDY ADDS: Most people with autoimmune diseases who required hospitalisation for COVID-19 were women, aged 50 years or older, and had substantial previous comorbidities.Patients who were hospitalised with COVID-19 and had prevalent autoimmune diseases had higher prevalence of hypertension, chronic kidney disease, heart disease, and Type 2 diabetes as compared to those with prevalent autoimmune diseases who were diagnosed with COVID-19.A variable proportion of 6% to 25% across data sources died within one month of hospitalisation with COVID-19 and prevalent autoimmune diseases.For people with autoimmune diseases, COVID-19 hospitalisation was associated with worse outcomes and 30-day mortality compared to admission with influenza in the 2017-2018 season.

20.
medRxiv ; 2020 Oct 30.
Article in English | MEDLINE | ID: covidwho-915986

ABSTRACT

Objectives To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children/adolescents diagnosed or hospitalized with COVID-19. Secondly, to describe health outcomes amongst children/adolescents diagnosed with previous seasonal influenza. Design International network cohort. Setting Real-world data from European primary care records (France/Germany/Spain), South Korean claims and US claims and hospital databases. Participants Diagnosed and/or hospitalized children/adolescents with COVID-19 at age <18 between January and June 2020; diagnosed with influenza in 2017-2018. Main outcome measures Baseline demographics and comorbidities, symptoms, 30-day in-hospital treatments and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome (ARDS), multi-system inflammatory syndrome (MIS-C), and death. Results A total of 55,270 children/adolescents diagnosed and 3,693 hospitalized with COVID-19 and 1,952,693 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were all more common among those hospitalized vs diagnosed with COVID-19. The most common COVID-19 symptom was fever. Dyspnea, bronchiolitis, anosmia and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital treatments for COVID-19 included repurposed medications (<10%), and adjunctive therapies: systemic corticosteroids (6.8% to 37.6%), famotidine (9.0% to 28.1%), and antithrombotics such as aspirin (2.0% to 21.4%), heparin (2.2% to 18.1%), and enoxaparin (2.8% to 14.8%). Hospitalization was observed in 0.3% to 1.3% of the COVID-19 diagnosed cohort, with undetectable (N<5 per database) 30-day fatality. Thirty-day outcomes including pneumonia, ARDS, and MIS-C were more frequent in COVID-19 than influenza. Conclusions Despite negligible fatality, complications including pneumonia, ARDS and MIS-C were more frequent in children/adolescents with COVID-19 than with influenza. Dyspnea, anosmia and gastrointestinal symptoms could help differential diagnosis. A wide range of medications were used for the inpatient management of pediatric COVID-19.

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