Author: "Casajust, Paula" - Searchworks@Jio Institute Digital Library Search Results

Your search keyword '"Casajust, Paula"' showing total 36 results

Start Over Author "Casajust, Paula"

36 results on '"Casajust, Paula"'

1. Implementation of the COVID-19 Vulnerability Index Across an International Network of Health Care Data Sets: Collaborative External Validation Study

Author: Reps, Jenna M, Kim, Chungsoo, Williams, Ross D, Markus, Aniek F, Yang, Cynthia, Duarte-Salles, Talita, Falconer, Thomas, Jonnagaddala, Jitendra, Williams, Andrew, Fernández-Bertolín, Sergio, DuVall, Scott L, Kostka, Kristin, Rao, Gowtham, Shoaibi, Azza, Ostropolets, Anna, Spotnitz, Matthew E, Zhang, Lin, Casajust, Paula, Steyerberg, Ewout W, Nyberg, Fredrik, Kaas-Hansen, Benjamin Skov, Choi, Young Hwa, Morales, Daniel, Liaw, Siaw-Teng, Abrahão, Maria Tereza Fernandes, Areia, Carlos, Matheny, Michael E, Lynch, Kristine E, Aragón, María, Park, Rae Woong, Hripcsak, George, Reich, Christian G, Suchard, Marc A, You, Seng Chan, Ryan, Patrick B, Prieto-Alhambra, Daniel, and Rijnbeek, Peter R
Subjects: Computer applications to medicine. Medical informatics, R858-859.7
Abstract: BackgroundSARS-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. ObjectiveThe 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. MethodsWe 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. ResultsThe 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. ConclusionsOur 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.
Published: 2021
Full Text: View/download PDF

2. Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

Author: Lai, Lana YH, Arshad, Faaizah, Areia, Carlos, Alshammari, Thamir M, Alghoul, Heba, Casajust, Paula, Li, Xintong, Dawoud, Dalia, Nyberg, Fredrik, Pratt, Nicole, Hripcsak, George, Suchard, Marc A, Prieto-Alhambra, Dani, Ryan, Patrick, and Schuemie, Martijn J
Subjects: Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Patient Safety, Infectious Diseases, Vaccine Related, Immunization, Prevention, 8.4 Research design and methodologies (health services), Health and social care services research, Generic health relevance, Good Health and Well Being, vaccine safety surveillance, methods evaluation, real-world data, study design, bias, Pharmacology and pharmaceutical sciences
Abstract: Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance-for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance.
Published: 2022

3. Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS

Author: Kostka, Kristin, Duarte-Salles, Talita, Prats-Uribe, Albert, Sena, Anthony G, Pistillo, Andrea, Khalid, Sara, Lai, Lana YH, Golozar, Asieh, Alshammari, Thamir M, Dawoud, Dalia M, Nyberg, Fredrik, Wilcox, Adam B, Andryc, Alan, Williams, Andrew, Ostropolets, Anna, Areia, Carlos, Jung, Chi Young, Harle, Christopher A, Reich, Christian G, Blacketer, Clair, Morales, Daniel R, Dorr, David A, Burn, Edward, Roel, Elena, Tan, Eng Hooi, Minty, Evan, DeFalco, Frank, de Maeztu, Gabriel, Lipori, Gigi, Alghoul, Hiba, Zhu, Hong, Thomas, Jason A, Bian, Jiang, Park, Jimyung, Roldán, Jordi Martínez, Posada, Jose D, Banda, Juan M, Horcajada, Juan P, Kohler, Julianna, Shah, Karishma, Natarajan, Karthik, Lynch, Kristine E, Liu, Li, Schilling, Lisa M, Recalde, Martina, Spotnitz, Matthew, Gong, Mengchun, Matheny, Michael E, Valveny, Neus, Weiskopf, Nicole G, Shah, Nigam, Alser, Osaid, Casajust, Paula, Park, Rae Woong, Schuff, Robert, Seager, Sarah, DuVall, Scott L, You, Seng Chan, Song, Seokyoung, Fernández-Bertolín, Sergio, Fortin, Stephen, Magoc, Tanja, Falconer, Thomas, Subbian, Vignesh, Huser, Vojtech, Ahmed, Waheed-Ul-Rahman, Carter, William, Guan, Yin, Galvan, Yankuic, He, Xing, Rijnbeek, Peter R, Hripcsak, George, Ryan, Patrick B, Suchard, Marc A, and Prieto-Alhambra, Daniel
Subjects: Clinical Research, Infectious Diseases, Prevention, 2.4 Surveillance and distribution, Aetiology, Good Health and Well Being, OHDSI, OMOP CDM, descriptive epidemiology, real world data, real world evidence, open science, Clinical Sciences, Public Health and Health Services
Abstract: PurposeRoutinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) Characterizing Health Associated Risks and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD.Patients and methodsWe conducted a descriptive retrospective database study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11th June 2020 and are iteratively updated via GitHub. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical COVID-19 diagnosis or positive test, 886,193 hospitalized with COVID-19, and 113,627 hospitalized with COVID-19 requiring intensive services.ResultsWe aggregated over 22,000 unique characteristics describing patients with COVID-19. All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts and are readily available online. Globally, we observed similarities in the USA and Europe: more women diagnosed than men but more men hospitalized than women, most diagnosed cases between 25 and 60 years of age versus most hospitalized cases between 60 and 80 years of age. South Korea differed with more women than men hospitalized. Common comorbidities included type 2 diabetes, hypertension, chronic kidney disease and heart disease. Common presenting symptoms were dyspnea, cough and fever. Symptom data availability was more common in hospitalized cohorts than diagnosed.ConclusionWe constructed a global, multi-centre view to describe trends in COVID-19 progression, management and evolution over time. By characterising baseline variability in patients and geography, our work provides critical context that may otherwise be misconstrued as data quality issues. This is important as we perform studies on adverse events of special interest in COVID-19 vaccine surveillance.
Published: 2022

4. COVID-19 in patients with autoimmune diseases: characteristics and outcomes in a multinational network of cohorts across three countries

Author: Tan, Eng Hooi, Sena, Anthony G, Prats-Uribe, Albert, You, Seng Chan, Ahmed, Waheed-Ul-Rahman, Kostka, Kristin, Reich, Christian, Duvall, Scott L, Lynch, Kristine E, Matheny, Michael E, Duarte-Salles, Talita, Bertolin, Sergio Fernandez, Hripcsak, George, Natarajan, Karthik, Falconer, Thomas, Spotnitz, Matthew, Ostropolets, Anna, Blacketer, Clair, Alshammari, Thamir M, Alghoul, Heba, Alser, Osaid, Lane, Jennifer CE, Dawoud, Dalia M, Shah, Karishma, Yang, Yue, Zhang, Lin, Areia, Carlos, Golozar, Asieh, Recalde, Martina, Casajust, Paula, Jonnagaddala, Jitendra, Subbian, Vignesh, Vizcaya, David, Lai, Lana YH, Nyberg, Fredrik, Morales, Daniel R, Posada, Jose D, Shah, Nigam H, Gong, Mengchun, Vivekanantham, Arani, Abend, Aaron, Minty, Evan P, Suchard, Marc, Rijnbeek, Peter, Ryan, Patrick B, and Prieto-Alhambra, Daniel
Subjects: Infectious Diseases, Lung, Emerging Infectious Diseases, Pneumonia & Influenza, Clinical Research, Influenza, Autoimmune Disease, Cardiovascular, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Autoimmune Diseases, COVID-19, Cohort Studies, Female, Hospitalization, Humans, Influenza, Human, Male, Middle Aged, Prevalence, Prognosis, Republic of Korea, SARS-CoV-2, Spain, United States, Young Adult, autoimmune condition, mortality, hospitalization, open science, Observational Health Data Sciences and Informatics, Observational Medical Outcomes Partnership, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract: ObjectivePatients 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.MethodsA 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.ResultsWe 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%).ConclusionCompared with influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality.
Published: 2021

5. Characteristics and Outcomes of Over 300,000 Patients with COVID-19 and History of Cancer in the United States and SpainCharacteristics of 300,000 COVID-19 Individuals with Cancer

Author: Roel, Elena, Pistillo, Andrea, Recalde, Martina, Sena, Anthony G, Fernández-Bertolín, Sergio, Aragón, Maria, Puente, Diana, Ahmed, Waheed-Ul-Rahman, Alghoul, Heba, Alser, Osaid, Alshammari, Thamir M, Areia, Carlos, Blacketer, Clair, Carter, William, Casajust, Paula, Culhane, Aedin C, Dawoud, Dalia, DeFalco, Frank, DuVall, Scott L, Falconer, Thomas, Golozar, Asieh, Gong, Mengchun, Hester, Laura, Hripcsak, George, Tan, Eng Hooi, Jeon, Hokyun, Jonnagaddala, Jitendra, Lai, Lana YH, Lynch, Kristine E, Matheny, Michael E, Morales, Daniel R, Natarajan, Karthik, Nyberg, Fredrik, Ostropolets, Anna, Posada, José D, Prats-Uribe, Albert, Reich, Christian G, Rivera, Donna R, Schilling, Lisa M, Soerjomataram, Isabelle, Shah, Karishma, Shah, Nigam H, Shen, Yang, Spotniz, Matthew, Subbian, Vignesh, Suchard, Marc A, Trama, Annalisa, Zhang, Lin, Zhang, Ying, Ryan, Patrick B, Prieto-Alhambra, Daniel, Kostka, Kristin, and Duarte-Salles, Talita
Subjects: Biomedical and Clinical Sciences, Health Services and Systems, Health Sciences, Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Patient Safety, Infectious Diseases, Rare Diseases, Hematology, Cancer, Urologic Diseases, Prevention, Clinical Research, Aetiology, 2.4 Surveillance and distribution, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, COVID-19, Child, Cohort Studies, Comorbidity, Databases, Factual, Female, Hospitalization, Humans, Immunosuppression Therapy, Influenza, Human, Male, Middle Aged, Neoplasms, Outcome Assessment, Health Care, Pandemics, Prevalence, Risk Factors, SARS-CoV-2, Spain, United States, Young Adult, Medical and Health Sciences, Epidemiology, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundWe described the demographics, cancer subtypes, comorbidities, and outcomes of patients with a history of cancer and coronavirus disease 2019 (COVID-19). Second, we compared patients hospitalized with COVID-19 to patients diagnosed with COVID-19 and patients hospitalized with influenza.MethodsWe conducted a cohort study using eight routinely collected health care databases from Spain and the United States, standardized to the Observational Medical Outcome Partnership common data model. Three cohorts of patients with a history of cancer were included: (i) diagnosed with COVID-19, (ii) hospitalized with COVID-19, and (iii) hospitalized with influenza in 2017 to 2018. Patients were followed from index date to 30 days or death. We reported demographics, cancer subtypes, comorbidities, and 30-day outcomes.ResultsWe included 366,050 and 119,597 patients diagnosed and hospitalized with COVID-19, respectively. Prostate and breast cancers were the most frequent cancers (range: 5%-18% and 1%-14% in the diagnosed cohort, respectively). Hematologic malignancies were also frequent, with non-Hodgkin's lymphoma being among the five most common cancer subtypes in the diagnosed cohort. Overall, patients were aged above 65 years and had multiple comorbidities. Occurrence of death ranged from 2% to 14% and from 6% to 26% in the diagnosed and hospitalized COVID-19 cohorts, respectively. Patients hospitalized with influenza (n = 67,743) had a similar distribution of cancer subtypes, sex, age, and comorbidities but lower occurrence of adverse events.ConclusionsPatients with a history of cancer and COVID-19 had multiple comorbidities and a high occurrence of COVID-19-related events. Hematologic malignancies were frequent.ImpactThis study provides epidemiologic characteristics that can inform clinical care and etiologic studies.
Published: 2021

6. Risk of depression, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multinational network cohort study

Author: Lane, Jennifer CE, Weaver, James, Kostka, Kristin, Duarte-Salles, Talita, Abrahao, Maria Tereza F, Alghoul, Heba, Alser, Osaid, Alshammari, Thamir M, Areia, Carlos, Biedermann, Patricia, Banda, Juan M, Burn, Edward, Casajust, Paula, Fister, Kristina, Hardin, Jill, Hester, Laura, Hripcsak, George, Kaas-Hansen, Benjamin Skov, Khosla, Sajan, Kolovos, Spyros, Lynch, Kristine E, Makadia, Rupa, Mehta, Paras P, Morales, Daniel R, Morgan-Stewart, Henry, Mosseveld, Mees, Newby, Danielle, Nyberg, Fredrik, Ostropolets, Anna, Park, Rae Woong, Prats-Uribe, Albert, Rao, Gowtham A, Reich, Christian, Rijnbeek, Peter, Sena, Anthony G, Shoaibi, Azza, Spotnitz, Matthew, Subbian, Vignesh, Suchard, Marc A, Vizcaya, David, Wen, Haini, de Wilde, Marcel, Xie, Junqing, You, Seng Chan, Zhang, Lin, Lovestone, Simon, Ryan, Patrick, Prieto-Alhambra, Daniel, and consortium, for the OHDSI-COVID-19
Subjects: Brain Disorders, Autoimmune Disease, Serious Mental Illness, Mental Health, Suicide, Depression, Behavioral and Social Science, Arthritis, Clinical Research, Prevention, Suicide Prevention, Mental health, Good Health and Well Being, Adolescent, Adult, Aged, Antirheumatic Agents, Arthritis, Rheumatoid, Cohort Studies, Female, Germany, Humans, Hydroxychloroquine, Male, Middle Aged, Psychoses, Substance-Induced, Risk Assessment, Suicidal Ideation, United Kingdom, United States, Young Adult, COVID-19 Drug Treatment, HCQ, safety, epidemiology, RA, psychosis, depression, OHDSI-COVID-19 consortium, epidemiology, RA, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract: ObjectivesConcern has been raised in the rheumatology community regarding recent regulatory warnings that HCQ used in the coronavirus disease 2019 pandemic could cause acute psychiatric events. We aimed to study whether there is risk of incident depression, suicidal ideation or psychosis associated with HCQ as used for RA.MethodsWe performed a new-user cohort study using claims and electronic medical records from 10 sources and 3 countries (Germany, UK and USA). RA patients ≥18 years of age and initiating HCQ were compared with those initiating SSZ (active comparator) and followed up in the short (30 days) and long term (on treatment). Study outcomes included depression, suicide/suicidal ideation and hospitalization for psychosis. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate database-specific calibrated hazard ratios (HRs), with estimates pooled where I2
Published: 2021

7. Use of repurposed and adjuvant drugs in hospital patients with covid-19: multinational network cohort study.

Author: Prats-Uribe, Albert, Sena, Anthony G, Lai, Lana Yin Hui, Ahmed, Waheed-Ul-Rahman, Alghoul, Heba, Alser, Osaid, Alshammari, Thamir M, Areia, Carlos, Carter, William, Casajust, Paula, Dawoud, Dalia, Golozar, Asieh, Jonnagaddala, Jitendra, Mehta, Paras P, Gong, Mengchun, Morales, Daniel R, Nyberg, Fredrik, Posada, Jose D, Recalde, Martina, Roel, Elena, Shah, Karishma, Shah, Nigam H, Schilling, Lisa M, Subbian, Vignesh, Vizcaya, David, Zhang, Lin, Zhang, Ying, Zhu, Hong, Liu, Li, Cho, Jaehyeong, Lynch, Kristine E, Matheny, Michael E, You, Seng Chan, Rijnbeek, Peter R, Hripcsak, George, Lane, Jennifer Ce, Burn, Edward, Reich, Christian, Suchard, Marc A, Duarte-Salles, Talita, Kostka, Kristin, Ryan, Patrick B, and Prieto-Alhambra, Daniel
Subjects: Humans, Ceftriaxone, Azithromycin, Ritonavir, Hydroxychloroquine, Fluoroquinolones, Adrenal Cortex Hormones, Enoxaparin, Vitamin D, Drug Combinations, Treatment Outcome, Chemotherapy, Adjuvant, Cohort Studies, Safety, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Child, Child, Preschool, Infant, Infant, Newborn, Inpatients, United States, China, Spain, Female, Male, Young Adult, Republic of Korea, Electronic Health Records, Drug Repositioning, Lopinavir, Administrative Claims, Healthcare, COVID-19, SARS-CoV-2, Administrative Claims, Healthcare, and over, Chemotherapy, Adjuvant, Preschool, Newborn, General & Internal Medicine, Clinical Sciences, Public Health and Health Services
Abstract: ObjectiveTo investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents.DesignMultinational network cohort study.SettingHospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea.Participants303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020.Main outcome measuresPrescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19.ResultsOf 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
Published: 2021

8. Bias, Precision and Timeliness of Historical (Background) Rate Comparison Methods for Vaccine Safety Monitoring: An Empirical Multi-Database Analysis

Author: Li, Xintong, Lai, Lana YH, Ostropolets, Anna, Arshad, Faaizah, Tan, Eng Hooi, Casajust, Paula, Alshammari, Thamir M, Duarte-Salles, Talita, Minty, Evan P, Areia, Carlos, Pratt, Nicole, Ryan, Patrick B, Hripcsak, George, Suchard, Marc A, Schuemie, Martijn J, and Prieto-Alhambra, Daniel
Subjects: Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Vaccine Related, Prevention, Immunization, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Good Health and Well Being, incidence rate, vaccine safety, real world data, empirical, comparison, background rate, empirical - comparison, Pharmacology and pharmaceutical sciences
Abstract: Using real-world data and past vaccination data, we conducted a large-scale experiment to quantify bias, precision and timeliness of different study designs to estimate historical background (expected) compared to post-vaccination (observed) rates of safety events for several vaccines. We used negative (not causally related) and positive control outcomes. The latter were synthetically generated true safety signals with incident rate ratios ranging from 1.5 to 4. Observed vs. expected analysis using within-database historical background rates is a sensitive but unspecific method for the identification of potential vaccine safety signals. Despite good discrimination, most analyses showed a tendency to overestimate risks, with 20%-100% type 1 error, but low (0% to 20%) type 2 error in the large databases included in our study. Efforts to improve the comparability of background and post-vaccine rates, including age-sex adjustment and anchoring background rates around a visit, reduced type 1 error and improved precision but residual systematic error persisted. Additionally, empirical calibration dramatically reduced type 1 to nominal but came at the cost of increasing type 2 error.
Published: 2021

9. Characteristics and outcomes of 627 044 COVID-19 patients living with and without obesity in the United States, Spain, and the United Kingdom

Author: Recalde, Martina, Roel, Elena, Pistillo, Andrea, Sena, Anthony G., Prats-Uribe, Albert, Ahmed, Waheed-Ul-Rahman, Alghoul, Heba, Alshammari, Thamir M., Alser, Osaid, Areia, Carlos, Burn, Edward, Casajust, Paula, Dawoud, Dalia, DuVall, Scott L., Falconer, Thomas, Fernández-Bertolín, Sergio, Golozar, Asieh, Gong, Mengchun, Lai, Lana Yin Hui, Lane, Jennifer C. E., Lynch, Kristine E., Matheny, Michael E., Mehta, Paras P., Morales, Daniel R., Natarjan, Karthik, Nyberg, Fredrik, Posada, Jose D., Reich, Christian G., Rijnbeek, Peter R., Schilling, Lisa M., Shah, Karishma, Shah, Nigam H., Subbian, Vignesh, Zhang, Lin, Zhu, Hong, Ryan, Patrick, Prieto-Alhambra, Daniel, Kostka, Kristin, and Duarte-Salles, Talita
Published: 2021
Full Text: View/download PDF

10. Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study

Author: Lane, Jennifer C E, Weaver, James, Kostka, Kristin, Duarte-Salles, Talita, Abrahao, Maria Tereza F, Alghoul, Heba, Alser, Osaid, Alshammari, Thamir M, Biedermann, Patricia, Banda, Juan M, Burn, Edward, Casajust, Paula, Conover, Mitchell M, Culhane, Aedin C, Davydov, Alexander, DuVall, Scott L, Dymshyts, Dmitry, Fernandez-Bertolin, Sergio, Fišter, Kristina, Hardin, Jill, Hester, Laura, Hripcsak, George, Kaas-Hansen, Benjamin Skov, Kent, Seamus, Khosla, Sajan, Kolovos, Spyros, Lambert, Christophe G, van der Lei, Johan, Lynch, Kristine E, Makadia, Rupa, Margulis, Andrea V, Matheny, Michael E, Mehta, Paras, Morales, Daniel R, Morgan-Stewart, Henry, Mosseveld, Mees, Newby, Danielle, Nyberg, Fredrik, Ostropolets, Anna, Park, Rae Woong, Prats-Uribe, Albert, Rao, Gowtham A, Reich, Christian, Reps, Jenna, Rijnbeek, Peter, Sathappan, Selva Muthu Kumaran, Schuemie, Martijn, Seager, Sarah, Sena, Anthony G, Shoaibi, Azza, Spotnitz, Matthew, Suchard, Marc A, Torre, Carmen O, Vizcaya, David, Wen, Haini, de Wilde, Marcel, Xie, Junqing, You, Seng Chan, Zhang, Lin, Zhuk, Oleg, Ryan, Patrick, and Prieto-Alhambra, Daniel
Published: 2020
Full Text: View/download PDF

11. Empagliflozin reduces cardiorenal events, healthcare resource use and mortality in Sweden compared to dipeptidyl peptidase‐4 inhibitors: Real world evidence from the Nordic EMPRISE study.

Author: Nyström, Thomas, Toresson Grip, Emilie, Gunnarsson, Joel, Casajust, Paula, Karlsdotter, Kristina, Skogsberg, Josefin, and Ustyugova, Anastasia
Subjects: CD26 antigen, EMPAGLIFLOZIN, CHRONIC kidney failure, GLOMERULAR filtration rate, POISSON regression
Abstract: Aims: To evaluate effectiveness and healthcare resource utilization (HCRU) of empagliflozin versus dipeptidyl peptidase‐4 inhibitors (DPP‐4i) in Swedish clinical practice, as part of the EMPRISE EU study (EUPAS27606, NCT03817463). Materials and Methods: A non‐interventional, cohort study using retrospectively collected data from Swedish national registries. Adults with type 2 diabetes newly initiated on empagliflozin or DPP‐4i from May 2014 to December 2018 were matched 1:1 using propensity scores based on >180 covariates. Cardiovascular outcomes included hospitalization for heart failure (HHF), all‐cause mortality (ACM), myocardial infarction (MI), stroke and cardiovascular mortality (CVM), as well as their composite outcomes. Renal outcomes included end‐stage renal disease (ESRD), estimated glomerular filtration rate (eGFR) decline to <60 ml/min/1.73 m2 and progression to micro/macroalbuminuria. HCRU outcomes were also assessed. Comparisons were done using Cox proportional hazards and Poisson regression models. Results: Overall, 15,785 matched‐pairs were identified, with a mean follow‐up of 6.4 and 9.7 months for patients initiating empagliflozin versus DPP‐4i, respectively. Empagliflozin was associated with significant reduction in rates of HHF (hazard ratio [HR] = 0.67; 95% confidence interval: 0.49‐0.91), ACM (HR = 0.53; 0.41‐0.68), HHF + ACM (HR = 0.59; 0.48‐0.73), MI + stroke + ACM (HR = 0.68; 0.57‐0.81), CVM (HR = 0.46; 0.29‐0.73), HHF + CVM (HR = 0.61; 0.47‐0.79) and MI + stroke + CVM (HR = 0.79; 0.63‐0.98) versus DPP‐4i. Empagliflozin also reduced the rates of ESRD (HR = 0.13; 0.03‐0.57) and eGFR decline (HR = 0.83; 0.70‐0.99). Regarding HCRU, empagliflozin was associated with lower risk of first inpatient stay (HR = 0.87; 0.81‐0.93), and lower rate of inpatient and outpatient visits (rate ratio [RR] = 0.85; 0.80‐0.89 and RR = 0.96; 0.94‐0.98) than DPP‐4i. Conclusions: Empagliflozin treatment compared to DPP‐4i reduced cardiorenal events and overall mortality, which may explain lower HCRU among empagliflozin users in Sweden. [ABSTRACT FROM AUTHOR]
Published: 2023
Full Text: View/download PDF

12. Characteristics and outcomes of COVID-19 patients with and without asthma from the United States, South Korea, and Europe.

Author: Morales, Daniel R., Ostropolets, Anna, Lai, Lana, Sena, Anthony, Duvall, Scott, Suchard, Marc, Verhamme, Katia, Rjinbeek, Peter, Posada, Joe, Ahmed, Waheed, Alshammary, Thamer, Alghoul, Heba, Alser, Osaid, Areia, Carlos, Blacketer, Clair, Burn, Edward, Casajust, Paula, You, Seng Chan, Dawoud, Dalia, and Golozar, Asieh
Subjects: COVID-19, ASTHMATICS, ADULT respiratory distress syndrome, COUGH
Abstract: Objective: Large international comparisons describing the clinical characteristics of patients with COVID-19 are limited. The aim of the study was to perform a large-scale descriptive characterization of COVID-19 patients with asthma. Methods: We included nine databases contributing data from January to June 2020 from the US, South Korea (KR), Spain, UK and the Netherlands. We defined two cohorts of COVID-19 patients ('diagnosed' and 'hospitalized') based on COVID-19 disease codes. We followed patients from COVID-19 index date to 30 days or death. We performed descriptive analysis and reported the frequency of characteristics and outcomes in people with asthma defined by codes and prescriptions. Results: The diagnosed and hospitalized cohorts contained 666,933 and 159,552 COVID-19 patients respectively. Exacerbation in people with asthma was recorded in 1.6–8.6% of patients at presentation. Asthma prevalence ranged from 6.2% (95% CI 5.7–6.8) to 18.5% (95% CI 18.2–18.8) in the diagnosed cohort and 5.2% (95% CI 4.0–6.8) to 20.5% (95% CI 18.6–22.6) in the hospitalized cohort. Asthma patients with COVID-19 had high prevalence of comorbidity including hypertension, heart disease, diabetes and obesity. Mortality ranged from 2.1% (95% CI 1.8–2.4) to 16.9% (95% CI 13.8–20.5) and similar or lower compared to COVID-19 patients without asthma. Acute respiratory distress syndrome occurred in 15–30% of hospitalized COVID-19 asthma patients. Conclusion: The prevalence of asthma among COVID-19 patients varies internationally. Asthma patients with COVID-19 have high comorbidity. The prevalence of asthma exacerbation at presentation was low. Whilst mortality was similar among COVID-19 patients with and without asthma, this could be confounded by differences in clinical characteristics. Further research could help identify high-risk asthma patients. KEY MESSAGES Asthma prevalence in COVID-19 patients varied internationally (5.2–20.5%).The prevalence of asthma exacerbation at presentation with COVID-19 in diagnosed and hospitalized patients was low.Comorbidities were common in COVID-19 patients with asthma. Supplemental data for this article is available online at https://doi.org/10.1080/02770903.2021.2025392. [ABSTRACT FROM AUTHOR]
Published: 2023
Full Text: View/download PDF

13. Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

Author: Lai, Lana YH, primary, Arshad, Faaizah, additional, Areia, Carlos, additional, Alshammari, Thamir M., additional, Alghoul, Heba, additional, Casajust, Paula, additional, Li, Xintong, additional, Dawoud, Dalia, additional, Nyberg, Fredrik, additional, Pratt, Nicole, additional, Hripcsak, George, additional, Suchard, Marc A., additional, Prieto-Alhambra, Dani, additional, Ryan, Patrick, additional, and Schuemie, Martijn J., additional
Published: 2022
Full Text: View/download PDF

14. Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS

Author: Kostka, Kristin, primary, Duarte-Salles, Talita, additional, Prats-Uribe, Albert, additional, Sena, Anthony G, additional, Pistillo, Andrea, additional, Khalid, Sara, additional, Lai, Lana YH, additional, Golozar, Asieh, additional, Alshammari, Thamir M, additional, Dawoud, Dalia M, additional, Nyberg, Fredrik, additional, Wilcox, Adam B, additional, Andryc, Alan, additional, Williams, Andrew, additional, Ostropolets, Anna, additional, Areia, Carlos, additional, Jung, Chi Young, additional, Harle, Christopher A, additional, Reich, Christian G, additional, Blacketer, Clair, additional, Morales, Daniel R, additional, Dorr, David A, additional, Burn, Edward, additional, Roel, Elena, additional, Tan, Eng Hooi, additional, Minty, Evan, additional, DeFalco, Frank, additional, de Maeztu, Gabriel, additional, Lipori, Gigi, additional, Alghoul, Heba, additional, Zhu, Hong, additional, Thomas, Jason A, additional, Bian, Jiang, additional, Park, Jimyung, additional, Martínez Roldán, Jordi, additional, Posada, Jose D, additional, Banda, Juan M, additional, Horcajada, Juan P, additional, Kohler, Julianna, additional, Shah, Karishma, additional, Natarajan, Karthik, additional, Lynch, Kristine E, additional, Liu, Li, additional, Schilling, Lisa M, additional, Recalde, Martina, additional, Spotnitz, Matthew, additional, Gong, Mengchun, additional, Matheny, Michael E, additional, Valveny, Neus, additional, Weiskopf, Nicole G, additional, Shah, Nigam, additional, Alser, Osaid, additional, Casajust, Paula, additional, Park, Rae Woong, additional, Schuff, Robert, additional, Seager, Sarah, additional, DuVall, Scott L, additional, You, Seng Chan, additional, Song, Seokyoung, additional, Fernández-Bertolín, Sergio, additional, Fortin, Stephen, additional, Magoc, Tanja, additional, Falconer, Thomas, additional, Subbian, Vignesh, additional, Huser, Vojtech, additional, Ahmed, Waheed-Ul-Rahman, additional, Carter, William, additional, Guan, Yin, additional, Galvan, Yankuic, additional, He, Xing, additional, Rijnbeek, Peter R, additional, Hripcsak, George, additional, Ryan, Patrick B, additional, Suchard, Marc A, additional, and Prieto-Alhambra, Daniel, additional
Published: 2022
Full Text: View/download PDF

15. Characteristics and outcomes of COVID-19 patients with and without asthma from the United States, South Korea, and Europe

Author: Morales, Daniel R., primary, Ostropolets, Anna, additional, Lai, Lana, additional, Sena, Anthony, additional, Duvall, Scott, additional, Suchard, Marc, additional, Verhamme, Katia, additional, Rjinbeek, Peter, additional, Posada, Joe, additional, Ahmed, Waheed, additional, Alshammary, Thamer, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Areia, Carlos, additional, Blacketer, Clair, additional, Burn, Edward, additional, Casajust, Paula, additional, You, Seng Chan, additional, Dawoud, Dalia, additional, Golozar, Asieh, additional, Gong, Menchung, additional, Jonnagaddala, Jitendra, additional, Lynch, Kristine, additional, Matheny, Michael, additional, Minty, Evan, additional, Nyberg, Fredrik, additional, Uribe, Albert, additional, Recalde, Martina, additional, Reich, Christian, additional, Scheumie, Martijn, additional, Shah, Karishma, additional, Shah, Nigam, additional, Schilling, Lisa, additional, Vizcaya, David, additional, Zhang, Lin, additional, Hripcsak, George, additional, Ryan, Patrick, additional, Prieto-Alhambra, Daniel, additional, Durate-Salles, Talita, additional, and Kostka, Kristin, additional
Published: 2022
Full Text: View/download PDF

16. Bias, Precision and Timeliness of Historical (Background) Rate Comparison Methods for Vaccine Safety Monitoring: An Empirical Multi-Database Analysis

Author: Li, Xintong, primary, Lai, Lana YH, additional, Ostropolets, Anna, additional, Arshad, Faaizah, additional, Tan, Eng Hooi, additional, Casajust, Paula, additional, Alshammari, Thamir M., additional, Duarte-Salles, Talita, additional, Minty, Evan P., additional, Areia, Carlos, additional, Pratt, Nicole, additional, Ryan, Patrick B., additional, Hripcsak, George, additional, Suchard, Marc A., additional, Schuemie, Martijn J., additional, and Prieto-Alhambra, Daniel, additional
Published: 2021
Full Text: View/download PDF

17. Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience

Author: Duarte-Salles, Talita, primary, Vizcaya, David, additional, Pistillo, Andrea, additional, Casajust, Paula, additional, Sena, Anthony G., additional, Lai, Lana Yin Hui, additional, Prats-Uribe, Albert, additional, Ahmed, Waheed-Ul-Rahman, additional, Alshammari, Thamir M., additional, Alghoul, Heba, additional, Alser, Osaid, additional, Burn, Edward, additional, You, Seng Chan, additional, Areia, Carlos, additional, Blacketer, Clair, additional, DuVall, Scott, additional, Falconer, Thomas, additional, Fernandez-Bertolin, Sergio, additional, Fortin, Stephen, additional, Golozar, Asieh, additional, Gong, Mengchun, additional, Tan, Eng Hooi, additional, Huser, Vojtech, additional, Iveli, Pablo, additional, Morales, Daniel R., additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Recalde, Martina, additional, Roel, Elena, additional, Schilling, Lisa M., additional, Shah, Nigam H., additional, Shah, Karishma, additional, Suchard, Marc A., additional, Zhang, Lin, additional, Zhang, Ying, additional, Williams, Andrew E., additional, Reich, Christian G., additional, Hripcsak, George, additional, Rijnbeek, Peter, additional, Ryan, Patrick, additional, Kostka, Kristin, additional, and Prieto-Alhambra, Daniel, additional
Published: 2021
Full Text: View/download PDF

18. Use of repurposed and adjuvant drugs in hospital patients with covid-19: multinational network cohort study

Author: Prats-Uribe, Albert, primary, Sena, Anthony G, additional, Lai, Lana Yin Hui, additional, Ahmed, Waheed-Ul-Rahman, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Alshammari, Thamir M, additional, Areia, Carlos, additional, Carter, William, additional, Casajust, Paula, additional, Dawoud, Dalia, additional, Golozar, Asieh, additional, Jonnagaddala, Jitendra, additional, Mehta, Paras P, additional, Gong, Mengchun, additional, Morales, Daniel R, additional, Nyberg, Fredrik, additional, Posada, Jose D, additional, Recalde, Martina, additional, Roel, Elena, additional, Shah, Karishma, additional, Shah, Nigam H, additional, Schilling, Lisa M, additional, Subbian, Vignesh, additional, Vizcaya, David, additional, Zhang, Lin, additional, Zhang, Ying, additional, Zhu, Hong, additional, Liu, Li, additional, Cho, Jaehyeong, additional, Lynch, Kristine E, additional, Matheny, Michael E, additional, You, Seng Chan, additional, Rijnbeek, Peter R, additional, Hripcsak, George, additional, Lane, Jennifer CE, additional, Burn, Edward, additional, Reich, Christian, additional, Suchard, Marc A, additional, Duarte-Salles, Talita, additional, Kostka, Kristin, additional, Ryan, Patrick B, additional, and Prieto-Alhambra, Daniel, additional
Published: 2021
Full Text: View/download PDF

19. Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS

Author: Prieto-Alhambra, Daniel, primary, Kostka, Kristin, additional, Duarte-Salles, Talita, additional, Prats-Uribe, Albert, additional, Sena, Anthony, additional, Pistillo, Andrea, additional, Khalid, Sara, additional, Lai, Lana, additional, Golozar, Asieh, additional, Alshammari, Thamir M, additional, Dawoud, Dalia, additional, Nyberg, Fredrik, additional, Wilcox, Adam, additional, Andryc, Alan, additional, Williams, Andrew, additional, Ostropolets, Anna, additional, Areia, Carlos, additional, Jung, Chi Young, additional, Harle, Christopher, additional, Reich, Christian, additional, Blacketer, Clair, additional, Morales, Daniel, additional, Dorr, David A., additional, Burn, Edward, additional, Roel, Elena, additional, Tan, Eng Hooi, additional, Minty, Evan, additional, DeFalco, Frank, additional, de Maeztu, Gabriel, additional, Lipori, Gigi, additional, Alghoul, Heba, additional, Zhu, Hong, additional, Thomas, Jason, additional, Bian, Jiang, additional, Park, Jimyung, additional, Roldán, Jordi Martínez, additional, Posada, Jose, additional, Banda, Juan M, additional, Horcajada, Juan P, additional, Kohler, Julianna, additional, Shah, Karishma, additional, Natarajan, Karthik, additional, Lynch, Kristine, additional, Liu, Li, additional, Schilling, Lisa, additional, Recalde, Martina, additional, Spotnitz, Matthew, additional, Gong, Mengchun, additional, Matheny, Michael, additional, Valveny, Neus, additional, Weiskopf, Nicole, additional, Shah, Nigam, additional, Alser, Osaid, additional, Casajust, Paula, additional, Park, Rae Woong, additional, Schuff, Robert, additional, Seager, Sarah, additional, DuVall, Scott, additional, You, Seng Chan, additional, Song, Seokyoung, additional, Fernández-Bertolín, Sergio, additional, Fortin, Stephen, additional, Magoc, Tanja, additional, Falconer, Thomas, additional, Subbian, Vignesh, additional, Huser, Vojtech, additional, Ahmed, Waheed-Ul-Rahman, additional, Carter, William, additional, Guan, Yin, additional, Galvan, Yankuic, additional, He, Xing, additional, Rijnbeek, Peter, additional, Hripcsak, George, additional, Ryan, Patrick, additional, and Suchard, Marc, additional
Published: 2021
Full Text: View/download PDF

20. Use of dialysis, tracheostomy, and extracorporeal membrane oxygenation among 842,928 patients hospitalized with COVID-19 in the United States

Author: Burn, Edward, primary, Sena, Anthony G., additional, Prats-Uribe, Albert, additional, Spotnitz, Matthew, additional, DuVall, Scott, additional, Lynch, Kristine E., additional, Matheny, Michael E., additional, Nyberg, Fredrik, additional, Ahmed, Waheed-Ul-Rahman, additional, Alser, Osaid, additional, Alghoul, Heba, additional, Alshammari, Thamir, additional, Zhang, Lin, additional, Casajust, Paula, additional, Areia, Carlos, additional, Shah, Karishma, additional, Reich, Christian, additional, Blacketer, Clair, additional, Andryc, Alan, additional, Fortin, Stephen, additional, Natarajan, Karthik, additional, Gong, Mengchun, additional, Golozar, Asieh, additional, Morales, Daniel, additional, Rijnbeek, Peter, additional, Subbian, Vignesh, additional, Roel, Elena, additional, Recalde, Martina, additional, Lane, Jennifer C.E., additional, Vizcaya, David, additional, Posada, Jose D., additional, Shah, Nigam H., additional, Jonnagaddala, Jitendra, additional, Lai, Lana Yin Hui, additional, Avilés-Jurado, Francesc Xavier, additional, Hripcsak, George, additional, Suchard, Marc A., additional, Ranzani, Otavio T., additional, Ryan, Patrick, additional, Prieto-Alhambra, Daniel, additional, Kostka, Kristin, additional, and Duarte-Salles, Talita, additional
Published: 2020
Full Text: View/download PDF

21. Characteristics, outcomes, and mortality amongst 133,589 patients with prevalent autoimmune diseases diagnosed with, and 48,418 hospitalised for COVID-19: a multinational distributed network cohort analysis

Author: Tan, Eng Hooi, primary, Sena, Anthony G., additional, Prats-Uribe, Albert, additional, You, Seng Chan, additional, Ahmed, Waheed-Ul-Rahman, additional, Kostka, Kristin, additional, Reich, Christian, additional, Duvall, Scott L., additional, Lynch, Kristine E., additional, Matheny, Michael E., additional, Duarte-Salles, Talita, additional, Bertolin, Sergio Fernandez, additional, Hripcsak, George, additional, Natarajan, Karthik, additional, Falconer, Thomas, additional, Spotnitz, Matthew, additional, Ostropolets, Anna, additional, Blacketer, Clair, additional, Alshammari, Thamir M, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Lane, Jennifer C.E., additional, Dawoud, Dalia M, additional, Shah, Karishma, additional, Yang, Yue, additional, Zhang, Lin, additional, Areia, Carlos, additional, Golozar, Asieh, additional, Relcade, Martina, additional, Casajust, Paula, additional, Jonnagaddala, Jitendra, additional, Subbian, Vignesh, additional, Vizcaya, David, additional, Lai, Lana YH, additional, Nyberg, Fredrik, additional, Morales, Daniel R, additional, Posada, Jose D., additional, Shah, Nigam H., additional, Gong, Mengchun, additional, Vivekanantham, Arani, additional, Abend, Aaron, additional, Minty, Evan P, additional, Suchard, Marc, additional, Rijnbeek, Peter, additional, Ryan, Patrick B, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

22. Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study

Author: Duarte-Salles, Talita, primary, Vizcaya, David, additional, Pistillo, Andrea, additional, Casajust, Paula, additional, Sena, Anthony G., additional, Lai, Lana Yin Hui, additional, Prats-Uribe, Albert, additional, Ahmed, Waheed-Ul-Rahman, additional, Alshammari, Thamir M, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Burn, Edward, additional, You, Seng Chan, additional, Areia, Carlos, additional, Blacketer, Clair, additional, DuVall, Scott, additional, Falconer, Thomas, additional, Fernandez-Bertolin, Sergio, additional, Fortin, Stephen, additional, Golozar, Asieh, additional, Gong, Mengchun, additional, Tan, Eng Hooi, additional, Huser, Vojtech, additional, Iveli, Pablo, additional, Morales, Daniel R., additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Recalde, Martina, additional, Roel, Elena, additional, Schilling, Lisa M., additional, Shah, Nigam H., additional, Shah, Karishma, additional, Suchard, Marc A., additional, Zhang, Lin, additional, Zhang, Ying, additional, Williams, Andrew E., additional, Reich, Christian G., additional, Hripcsak, George, additional, Rijnbeek, Peter, additional, Ryan, Patrick, additional, Kostka, Kristin, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

23. Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States

Author: Golozar, Asieh, primary, Lai, Lana YH, additional, Sena, Anthony G., additional, Vizcaya, David, additional, Schilling, Lisa M., additional, Huser, Vojtech, additional, Nyberg, Fredrik, additional, Duvall, Scott L., additional, Morales, Daniel R., additional, Alshammari, Thamir M, additional, Abedtash, Hamed, additional, Ahmed, Waheed-Ul-Rahman, additional, Alser, Osaid, additional, Alghoul, Heba, additional, Zhang, Ying, additional, Gong, Mengchun, additional, Guan, Yin, additional, Areia, Carlos, additional, Jonnagaddala, Jitendra, additional, Shah, Karishma, additional, Lane, Jennifer C.E., additional, Prats-Uribe, Albert, additional, Posada, Jose D., additional, Shah, Nigam H., additional, Subbian, Vignesh, additional, Zhang, Lin, additional, Fernandes Abrahão, Maria Tereza, additional, Rijnbeek, Peter R., additional, You, Seng Chan, additional, Casajust, Paula, additional, Roel, Elena, additional, Recalde, Martina, additional, Fernández-Bertolín, Sergio, additional, Andryc, Alan, additional, Thomas, Jason A., additional, Wilcox, Adam B., additional, Fortin, Stephen, additional, Blacketer, Clair, additional, DeFalco, Frank, additional, Natarajan, Karthik, additional, Falconer, Thomas, additional, Spotnitz, Matthew, additional, Ostropolets, Anna, additional, Hripcsak, George, additional, Suchard, Marc, additional, Lynch, Kristine E., additional, Matheny, Michael E., additional, Williams, Andrew, additional, Reich, Christian, additional, Duarte-Salles, Talita, additional, Kostka, Kristin, additional, Ryan, Patrick B., additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

24. “Clinical characteristics, symptoms, management and health outcomes in 8,598 pregnant women diagnosed with COVID-19 compared to 27,510 with seasonal influenza in France, Spain and the US: a network cohort analysis”

Author: Lai, Lana Yin Hui, primary, Golozar, Asieh, additional, Sena, Anthony, additional, Margulis, Andrea V., additional, Haro, Nuria, additional, Casajust, Paula, additional, Valveny, Neus, additional, Prats-Uribe, Albert, additional, Minty, Evan P., additional, Ahmed, Waheed-Ul-Rahman, additional, Alshammari, Thamir M, additional, Morales, Daniel R., additional, Alghoul, Heba, additional, Alser, Osaid, additional, Dawoud, Dalia, additional, Zhang, Lin, additional, Posada, Jose D., additional, Shah, Nigam H., additional, Blacketer, Clair, additional, Areia, Carlos, additional, Subbian, Vignesh, additional, Nyberg, Fredrik, additional, Lane, Jennifer C E, additional, Suchard, Marc A, additional, Gong, Mengchun, additional, Recalde, Martina, additional, Jonnagaddala, Jitendra, additional, Shah, Karishma, additional, Roel, Elena, additional, Vizcaya, David, additional, Fortin, Stephen, additional, Joanne Cheng, Ru-fong, additional, Reich, Christian, additional, Hripcsak, George, additional, Rijnbeek, Peter, additional, Ryan, Patrick, additional, Kostka, Kristin, additional, Duarte-Salles, Talita, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

25. Heterogeneity and temporal variation in the management of COVID-19: a multinational drug utilization study including 71,921 hospitalized patients from China, South Korea, Spain, and the United States of America

Author: Prats-Uribe, Albert, primary, Sena, Anthony G., additional, Hui Lai, Lana Yin, additional, Ahmed, Waheed-Ul-Rahman, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Alshammari, Thamir M, additional, Areia, Carlos, additional, Carter, William, additional, Casajust, Paula, additional, Dawoud, Dalia, additional, Golozar, Asieh, additional, Jonnagaddala, Jitendra, additional, Mehta, Paras P., additional, Gong, Mengchun, additional, Morales, Daniel R., additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Recalde, Martina, additional, Roel, Elena, additional, Shah, Karishma, additional, H. Shah, Nigam, additional, Schilling, Lisa M., additional, Subbian, Vignesh, additional, Vizcaya, David, additional, Williams, Andrew, additional, Zhang, Lin, additional, Zhang, Ying, additional, Zhu, Hong, additional, Liu, Li, additional, Rijnbeek, Peter, additional, Hripcsak, George, additional, Lane, Jennifer CE, additional, Burn, Edward, additional, Reich, Christian, additional, Suchard, Marc A., additional, Duarte-Salles, Talita, additional, Kostka, Kristin, additional, Ryan, Patrick, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

26. Characteristics and outcomes of 627 044 COVID-19 patients with and without obesity in the United States, Spain, and the United Kingdom

Author: Recalde, Martina, primary, Roel, Elena, additional, Pistillo, Andrea, additional, Sena, Anthony G., additional, Prats-Uribe, Albert, additional, Ahmed, Waheed-Ul-Rahman, additional, Alghoul, Heba, additional, Alshammari, Thamir M, additional, Alser, Osaid, additional, Areia, Carlos, additional, Burn, Edward, additional, Casajust, Paula, additional, Dawoud, Dalia, additional, DuVall, Scott L., additional, Falconer, Thomas, additional, Fernández-Bertolín, Sergio, additional, Golozar, Asieh, additional, Gong, Mengchun, additional, Lai, Lana Yin Hui, additional, Lane, Jennifer C.E., additional, Lynch, Kristine E., additional, Matheny, Michael E., additional, Mehta, Paras P, additional, Morales, Daniel R., additional, Natarjan, Karthik, additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Reich, Christian G., additional, Schilling, Lisa M., additional, Shah, Karishma, additional, Shah, Nigam H., additional, Subbian, Vignesh, additional, Zhang, Lin, additional, Zhu, Hong, additional, Ryan, Patrick, additional, Prieto-Alhambra, Daniel, additional, Kostka, Kristin, additional, and Duarte-Salles, Talita, additional
Published: 2020
Full Text: View/download PDF

27. Risk of depression, suicidal ideation, suicide and psychosis with hydroxychloroquine treatment for rheumatoid arthritis: a multi-national network cohort study

Author: Lane, Jennifer C.E., primary, Weaver, James, additional, Kostka, Kristin, additional, Duarte-Salles, Talita, additional, Abrahao, Maria Tereza F., additional, Alghoul, Heba, additional, Alser, Osaid, additional, Alshammari, Thamir M, additional, Areia, Carlos, additional, Biedermann, Patricia, additional, Banda, Juan M., additional, Burn, Edward, additional, Casajust, Paula, additional, Fišer, Kristina, additional, Hardin, Jill, additional, Hester, Laura, additional, Hripcsak, George, additional, Kaas-Hansen, Benjamin Skov, additional, Khosla, Sajan, additional, Kolovos, Spyros, additional, Lynch, Kristine E., additional, Makadia, Rupa, additional, Mehta, Paras P., additional, Morales, Daniel R., additional, Morgan-Stewart, Henry, additional, Mosseveld, Mees, additional, Newby, Danielle, additional, Nyberg, Fredrik, additional, Ostropolets, Anna, additional, Park, Rae Woong, additional, Prats-Uribe, Albert, additional, Rao, Gowtham A., additional, Reich, Christian, additional, Rijnbeek, Peter, additional, Sena, Anthony G., additional, Shoaibi, Azza, additional, Spotnitz, Matthew, additional, Subbian, Vignesh, additional, Suchard, Marc A., additional, Vizcaya, David, additional, Wen, Haini, additional, de Wilde, Marcel, additional, Xie, Junqing, additional, You, Seng Chan, additional, Zhang, Lin, additional, Lovestone, Simon, additional, Ryan, Patrick, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

28. Implementation of the COVID-19 Vulnerability Index Across an International Network of Health Care Data Sets: Collaborative External Validation Study (Preprint)

Author: Reps, Jenna M, primary, Kim, Chungsoo, additional, Williams, Ross D, additional, Markus, Aniek F, additional, Yang, Cynthia, additional, Duarte-Salles, Talita, additional, Falconer, Thomas, additional, Jonnagaddala, Jitendra, additional, Williams, Andrew, additional, Fernández-Bertolín, Sergio, additional, DuVall, Scott L, additional, Kostka, Kristin, additional, Rao, Gowtham, additional, Shoaibi, Azza, additional, Ostropolets, Anna, additional, Spotnitz, Matthew E, additional, Zhang, Lin, additional, Casajust, Paula, additional, Steyerberg, Ewout W, additional, Nyberg, Fredrik, additional, Kaas-Hansen, Benjamin Skov, additional, Choi, Young Hwa, additional, Morales, Daniel, additional, Liaw, Siaw-Teng, additional, Abrahão, Maria Tereza Fernandes, additional, Areia, Carlos, additional, Matheny, Michael E, additional, Lynch, Kristine E, additional, Aragón, María, additional, Park, Rae Woong, additional, Hripcsak, George, additional, Reich, Christian G, additional, Suchard, Marc A, additional, You, Seng Chan, additional, Ryan, Patrick B, additional, Prieto-Alhambra, Daniel, additional, and Rijnbeek, Peter R, additional
Published: 2020
Full Text: View/download PDF

29. Can we trust the prediction model? Demonstrating the importance of external validation by investigating the COVID-19 Vulnerability (C-19) Index across an international network of observational healthcare datasets

Author: Reps, Jenna M., primary, Kim, Chungsoo, additional, Williams, Ross D., additional, Markus, Aniek F., additional, Yang, Cynthia, additional, Salles, Talita Duarte, additional, Falconer, Thomas, additional, Jonnagaddala, Jitendra, additional, Williams, Andrew, additional, Fernández-Bertolín, Sergio, additional, DuVall, Scott L., additional, Kostka, Kristin, additional, Rao, Gowtham, additional, Shoaibi, Azza, additional, Ostropolets, Anna, additional, Spotnitz, Matthew E, additional, Zhang, Lin, additional, Casajust, Paula, additional, Steyerberg, Ewout W., additional, Nyberg, Fredrik, additional, Kaas-Hansen, Benjamin Skov, additional, Choi, Young Hwa, additional, Morales, Daniel, additional, Liaw, Siaw-Teng, additional, Fernandes Abrahão, Maria Tereza, additional, Areia, Carlos, additional, Matheny, Michael E., additional, Aragón, María, additional, Park, Rae Woong, additional, Hripcsak, George, additional, Reich, Christian G., additional, Suchard, Marc A., additional, You, Seng Chan, additional, Ryan, Patrick B., additional, Prieto-Alhambra, Daniel, additional, and Rijnbeek, Peter R., additional
Published: 2020
Full Text: View/download PDF

30. Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid wide-spread use for COVID-19: a multinational, network cohort and self-controlled case series study

Author: C.E.Lane, Jennifer, primary, Weaver, James, additional, Kostka, Kristin, additional, Duarte-Salles, Talita, additional, Abrahao, Maria Tereza F., additional, Alghoul, Heba, additional, Alser, Osaid, additional, Alshammari, Thamir M, additional, Biedermann, Patricia, additional, Burn, Edward, additional, Casajust, Paula, additional, Conover, Mitch, additional, Culhane, Aedin C., additional, Davydov, Alexander, additional, DuVall, Scott L., additional, Dymshyts, Dmitry, additional, Fernandez-Bertolin, Sergio, additional, Fišter, Kristina, additional, Hardin, Jill, additional, Hester, Laura, additional, Hripcsak, George, additional, Kent, Seamus, additional, Khosla, Sajan, additional, Kolovos, Spyros, additional, Lambert, Christophe G., additional, van der Lei, Johan, additional, Londhe, Ajit A., additional, Lynch, Kristine E., additional, Makadia, Rupa, additional, Margulis, Andrea V., additional, Matheny, Michael E., additional, Mehta, Paras, additional, Morales, Daniel R., additional, Morgan-Stewart, Henry, additional, Mosseveld, Mees, additional, Newby, Danielle, additional, Nyberg, Fredrik, additional, Ostropolets, Anna, additional, Park, Rae Woong, additional, Prats-Uribe, Albert, additional, Rao, Gowtham A., additional, Reich, Christian, additional, Reps, Jenna, additional, Rijnbeek, Peter, additional, Kumaran Sathappan, Selva Muthu, additional, Schuemie, Martijn, additional, Seager, Sarah, additional, Sena, Anthony, additional, Shoaibi, Azza, additional, Spotnitz, Matthew, additional, Suchard, Marc A., additional, Swerdel, Joel, additional, Torre, Carmen O., additional, Vizcaya, David, additional, Wen, Haini, additional, de Wilde, Marcel, additional, You, Seng Chan, additional, Zhang, Lin, additional, Zhuk, Oleg, additional, Ryan, Patrick, additional, and Prieto-Alhambra, Daniel, additional
Published: 2020
Full Text: View/download PDF

31. Bias, Precision and Timeliness of Historical (Background) Rate Comparison Methods for Vaccine Safety Monitoring: An Empirical Multi-Database Analysis

Author: Xintong Li, Lana YH Lai, Anna Ostropolets, Faaizah Arshad, Eng Hooi Tan, Paula Casajust, Thamir M. Alshammari, Talita Duarte-Salles, Evan P. Minty, Carlos Areia, Nicole Pratt, Patrick B. Ryan, George Hripcsak, Marc A. Suchard, Martijn J. Schuemie, Daniel Prieto-Alhambra, Li, Xintong, Lai, Lana Y H, Ostropolets, Anna, Arshad, Faaizah, Tan, Eng Hooi, Casajust, Paula, Alshammari, Thamir M, Duarte-Salles, Talita, Minty, Evan P, Areia, Carlos, Pratt, Nicole, Ryan, Patrick B, Hripcsak, George, Suchard, Marc A, Schuemie, Martijn J, Prieto-Alhambra, Daniel, and Medical Informatics
Subjects: Vaccine safety, and promotion of well-being, Computer science, Calibration (statistics), RM1-950, empirical - comparison, Residual, Vaccine Related, SDG 3 - Good Health and Well-being, background rate, Statistics, Pharmacology (medical), vaccine safety, Original Research, Pharmacology, Prevention, Clinical study design, Comparability, incidence rate, Pharmacology and Pharmaceutical Sciences, Prevention of disease and conditions, Identification (information), real world data, Good Health and Well Being, 3.4 Vaccines, Method comparison, comparison, Immunization, Therapeutics. Pharmacology, empirical, Type I and type II errors
Abstract: Refereed/Peer-reviewed Using real-world data and past vaccination data, we conducted a large-scale experiment to quantify bias, precision and timeliness of different study designs to estimate historical background (expected) compared to post-vaccination (observed) rates of safety events for several vaccines. We used negative (not causally related) and positive control outcomes. The latter were synthetically generated true safety signals with incident rate ratios ranging from 1.5 to 4. Observed vs. expected analysis using within-database historical background rates is a sensitive but unspecific method for the identification of potential vaccine safety signals. Despite good discrimination, most analyses showed a tendency to overestimate risks, with 20%-100% type 1 error, but low (0% to 20%) type 2 error in the large databases included in our study. Efforts to improve the comparability of background and post-vaccine rates, including age-sex adjustment and anchoring background rates around a visit, reduced type 1 error and improved precision but residual systematic error persisted. Additionally, empirical calibration dramatically reduced type 1 to nominal but came at the cost of increasing type 2 error.
Published: 2021

32. Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS.

Author: Prieto-Alhambra D, Kostka K, Duarte-Salles T, Prats-Uribe A, Sena A, Pistillo A, Khalid S, Lai L, Golozar A, Alshammari TM, Dawoud D, Nyberg F, Wilcox A, Andryc A, Williams A, Ostropolets A, Areia C, Jung CY, Harle C, Reich C, Blacketer C, Morales D, Dorr DA, Burn E, Roel E, Tan EH, Minty E, DeFalco F, de Maeztu G, Lipori G, Alghoul H, Zhu H, Thomas J, Bian J, Park J, Roldán JM, Posada J, Banda JM, Horcajada JP, Kohler J, Shah K, Natarajan K, Lynch K, Liu L, Schilling L, Recalde M, Spotnitz M, Gong M, Matheny M, Valveny N, Weiskopf N, Shah N, Alser O, Casajust P, Park RW, Schuff R, Seager S, DuVall S, You SC, Song S, Fernández-Bertolín S, Fortin S, Magoc T, Falconer T, Subbian V, Huser V, Ahmed WU, Carter W, Guan Y, Galvan Y, He X, Rijnbeek P, Hripcsak G, Ryan P, and Suchard M
Abstract: Background: Routinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response [1,2]. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) [3] Characterizing Health Associated Risks, and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD. Methods: We conducted a descriptive cohort study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11 th June 2020 and are iteratively updated via GitHub [4]. Findings: We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical COVID-19 diagnosis or positive test, 886,193 hospitalized with COVID-19 , and 113,627 hospitalized with COVID-19 requiring intensive services . All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts, and are available in an interactive website: https://data.ohdsi.org/Covid19CharacterizationCharybdis/. Interpretation: CHARYBDIS findings provide benchmarks that contribute to our understanding of COVID-19 progression, management and evolution over time. This can enable timely assessment of real-world outcomes of preventative and therapeutic options as they are introduced in clinical practice.
Published: 2021
Full Text: View/download PDF

33. Use of dialysis, tracheostomy, and extracorporeal membrane oxygenation among 842,928 patients hospitalized with COVID-19 in the United States.

Author: Burn E, Sena AG, Prats-Uribe A, Spotnitz M, DuVall S, Lynch KE, Matheny ME, Nyberg F, Ahmed WU, Alser O, Alghoul H, Alshammari T, Zhang L, Casajust P, Areia C, Shah K, Reich C, Blacketer C, Andryc A, Fortin S, Natarajan K, Gong M, Golozar A, Morales D, Rijnbeek P, Subbian V, Roel E, Recalde M, Lane JCE, Vizcaya D, Posada JD, Shah NH, Jonnagaddala J, Lai LYH, Avilés-Jurado FX, Hripcsak G, Suchard MA, Ranzani OT, Ryan P, Prieto-Alhambra D, Kostka K, and Duarte-Salles T
Abstract: Objective: To estimate the proportion of patients hospitalized with COVID-19 who undergo dialysis, tracheostomy, and extracorporeal membrane oxygenation (ECMO)., Design: A network cohort study., Setting: Seven databases from the United States containing routinely-collected patient data: HealthVerity, Premier, IQVIA Hospital CDM, IQVIA Open Claims, Optum EHR, Optum SES, and VA-OMOP., Patients: Patients hospitalized with a clinical diagnosis or a positive test result for COVID-19., Interventions: Dialysis, tracheostomy, and ECMO., Measurements and Main Results: 842,928 patients hospitalized with COVID-19 were included (22,887 from HealthVerity, 77,853 from IQVIA Hospital CDM, 533,997 from IQVIA Open Claims, 36,717 from Optum EHR, 4,336 from OPTUM SES, 156,187 from Premier, and 10,951 from VA-OMOP). Across the six databases, 35,192 (4.17% [95% CI: 4.13% to 4.22%]) patients received dialysis, 6,950 (0.82% [0.81% to 0.84%]) had a tracheostomy, and 1,568 (0.19% [95% CI: 0.18% to 0.20%]) patients underwent ECMO over the 30 days following hospitalization. Use of ECMO was more common among patients who were younger, male, and with fewer comorbidities. Tracheostomy was broadly used for a similar proportion of patients regardless of age, sex, or comorbidity. While dialysis was generally used for a similar proportion among younger and older patients, it was more frequent among male patients and among those with chronic kidney disease., Conclusion: Use of dialysis among those hospitalized with COVID-19 is high at around 4%. Although less than one percent of patients undergo tracheostomy and ECMO, the absolute numbers of patients who have undergone these interventions is substantial., Competing Interests: Competing interests All authors have completed the ICMJE uniform disclosure form, with the following declarations made: AS reports personal fees from Janssen Research & Development, during the conduct of the study; personal fees from Janssen Research & Development, outside the submitted work. AS is a full time employee of Janssen and shareholder of Johnson & Johnson. SDV reports grants from Anolinx, LLC, grants from Astellas Pharma, Inc, grants from AstraZeneca Pharmaceuticals LP, grants from Boehringer Ingelheim International GmbH, grants from Celgene Corporation, grants from Eli Lilly and Company, grants from Genentech Inc., , grants from Genomic Health, Inc., grants from Gilead Sciences Inc., grants from GlaxoSmithKline PLC, grants from Innocrin Pharmaceuticals Inc., grants from Janssen Pharmaceuticals, Inc., grants from Kantar Health, grants from Myriad Genetic Laboratories, Inc., grants from Novartis International AG, grants from Parexel International Corporation through the University of Utah or Western Institute for Biomedical Research outside the submitted work. MEM has nothing to disclose. CR is an employee of IQVIA. CB reports other from Janssen, Research and Development, outside the submitted work; and full time employee of Janssen R&D and Johnson & Johnson shareholder. AA reports other from Janssen, Research and Development, outside the submitted work; and full time employee of Janssen R&D and Johnson & Johnson shareholder. SF reports other from Janssen, outside the submitted work. AG reports personal fees from Regeneron Pharmaceuticals, outside the submitted work. She is a full-time employee at Regeneron Pharmaceuticals. This work was not conducted at Regeneron Pharmaceuticals. DM is supported by a Wellcome Trust Clinical Research Development Fellowship (Grant 214588/Z/18/Z) and reports grants from Chief Scientist Office (CSO), grants from Health Data Research UK (HDR-UK), grants from Tenovus, grants from National Institute of Health Research (NIHR), outside the submitted work. PR reports grants from Innovative Medicines Initiative, grants from Janssen Research and Development, during the conduct of the study. VS reports grants from National Science Foundation, grants from State of Arizona; Arizona Board of Regents, grants from Agency for Healthcare Research and Quality, outside the submitted work. DV reports personal fees from Bayer, outside the submitted work; and he is a full-time employee at a pharmaceutical company. GH reports grants from US NIH National Library of Medicine, during the conduct of the study; grants from Janssen Research, outside the submitted work. MAS reports grants from US National Science Foundation, grants from US National Institutes of Health, grants from IQVIA, personal fees from Janssen Research and Development, during the conduct of the study .PR reports and is employee of Janssen Research and Development and shareholder of Johnson & Johnson. DPA reports grants and other from AMGEN, grants, non-financial support and other from UCB Biopharma, grants from Les Laboratoires Servier, outside the submitted work; and Janssen, on behalf of IMI-funded EHDEN and EMIF consortiums, and Synapse Management Partners have supported training programmes organised by DPA’s department and open for external participants. KK reports she is an employee of IQVIA. All other authors declare no competing interests.
Published: 2021
Full Text: View/download PDF

34. Characteristics, outcomes, and mortality amongst 133,589 patients with prevalent autoimmune diseases diagnosed with, and 48,418 hospitalised for COVID-19: a multinational distributed network cohort analysis.

Author: Tan EH, Sena AG, Prats-Uribe A, You SC, Ahmed WU, Kostka K, Reich C, Duvall SL, Lynch KE, Matheny ME, Duarte-Salles T, Bertolin SF, Hripcsak G, Natarajan K, Falconer T, Spotnitz M, Ostropolets A, Blacketer C, Alshammari TM, Alghoul H, Alser O, Lane JCE, Dawoud DM, Shah K, Yang Y, Zhang L, Areia C, Golozar A, Relcade M, Casajust P, Jonnagaddala J, Subbian V, Vizcaya D, Lai LY, Nyberg F, Morales DR, Posada JD, Shah NH, Gong M, Vivekanantham A, Abend A, Minty EP, Suchard M, Rijnbeek P, Ryan PB, and Prieto-Alhambra D
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.
Published: 2020
Full Text: View/download PDF

35. Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study.

Author: Duarte-Salles T, Vizcaya D, Pistillo A, Casajust P, Sena AG, Lai LYH, Prats-Uribe A, Ahmed WU, Alshammari TM, Alghoul H, Alser O, Burn E, You SC, Areia C, Blacketer C, DuVall S, Falconer T, Fernandez-Bertolin S, Fortin S, Golozar A, Gong M, Tan EH, Huser V, Iveli P, Morales DR, Nyberg F, Posada JD, Recalde M, Roel E, Schilling LM, Shah NH, Shah K, Suchard MA, Zhang L, Zhang Y, Williams AE, Reich CG, Hripcsak G, Rijnbeek P, Ryan P, Kostka K, and Prieto-Alhambra D
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.
Published: 2020
Full Text: View/download PDF

36. Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States.

Author: Golozar A, Lai LY, Sena AG, Vizcaya D, Schilling LM, Huser V, Nyberg F, Duvall SL, Morales DR, Alshammari TM, Abedtash H, Ahmed WU, Alser O, Alghoul H, Zhang Y, Gong M, Guan Y, Areia C, Jonnagaddala J, Shah K, Lane JCE, Prats-Uribe A, Posada JD, Shah NH, Subbian V, Zhang L, Abrahão MTF, Rijnbeek PR, You SC, Casajust P, Roel E, Recalde M, Fernández-Bertolín S, Andryc A, Thomas JA, Wilcox AB, Fortin S, Blacketer C, DeFalco F, Natarajan K, Falconer T, Spotnitz M, Ostropolets A, Hripcsak G, Suchard M, Lynch KE, Matheny ME, Williams A, Reich C, Duarte-Salles T, Kostka K, Ryan PB, and Prieto-Alhambra D
Abstract: Early identification of symptoms and comorbidities most predictive of COVID-19 is critical to identify infection, guide policies to effectively contain the pandemic, and improve health systems' response. Here, we characterised socio-demographics and comorbidity in 3,316,107persons tested and 219,072 persons tested positive for SARS-CoV-2 since January 2020, and their key health outcomes in the month following the first positive test. Routine care data from primary care electronic health records (EHR) from Spain, hospital EHR from the United States (US), and claims data from South Korea and the US were used. The majority of study participants were women aged 18-65 years old. Positive/tested ratio varied greatly geographically (2.2:100 to 31.2:100) and over time (from 50:100 in February-April to 6.8:100 in May-June). Fever, cough and dyspnoea were the most common symptoms at presentation. Between 4%-38% required admission and 1-10.5% died within a month from their first positive test. Observed disparity in testing practices led to variable baseline characteristics and outcomes, both nationally (US) and internationally. Our findings highlight the importance of large scale characterization of COVID-19 international cohorts to inform planning and resource allocation including testing as countries face a second wave., Competing Interests: COMPETING INTEREST STATEMENT All authors have completed the ICMJE uniform disclosure form, with the following declarations made: DPA reports grants from Amgen, grants and other from UCB Biopharma, grants from Johnson and Johnson, outside the submitted work. DM is supported by a Wellcome Trust Clinical Research Development Fellowship (Grant 214588/Z/18/Z) and reports grants from Chief Scientist Office (CSO), grants from Health Data Research UK (HDR-UK), grants from National Institute of Health Research (NIHR), and Tenovus outside the submitted work. SCY reports grants from Korean Ministry of Health & Welfare, grants from Korean Ministry of Trade, Industry & Energy, during the conduct of the study. AG reports personal fees from Regeneron Pharmaceuticals, outside the submitted work; and she is a full-time employee at Regeneron Pharmaceuticals. This work was not conducted at Regeneron Pharmaceuticals. Dr. Lane reports grants from Versus Arthritis, grants from Medical Research Council, outside the submitted work. MS reports grants from US National Science Foundation, grants from US National Institutes of Health, grants from IQVIA, personal fees from Janssen Research and Development, during the conduct of the study. HA reports personal fees from Eli Lilly and Company, outside the submitted work. AS reports personal fees from Janssen Research & Development, during the conduct of the study; personal fees from Janssen Research & Development, outside the submitted work. AS is a full-time employee of Janssen and shareholder of Johnson & Johnson. FD reports personal fees from Janssen Research & Development, during the conduct of the study; personal fees from Janssen Research & Development, outside the submitted work. KK reports she is an employee of IQVIA. CR reports he is an employee of IQVIA. FN was an employee of AstraZeneca until 2019 and holds some AstraZeneca shares. SF is an employee of Janssen Research and Development, a subsidiary of Johnson and Johnson. VS reports grant funding from the National Science Foundation, Agency for Healthcare Research and Quality, and the Arizona Board of Regents outside of the submitted work. The views expressed are those of the authors and do not necessarily represent the views or policy of the Department of Veterans Affairs or the United States Government. PR reports and is employee of Janssen Research and Development and shareholder of Johnson & Johnson. No other relationships or activities that could appear to have influenced the submitted work.
Published: 2020
Full Text: View/download PDF

Catalog

Books, media, physical & digital resources

See catalog results

Searchworks

Select search scope, currently: Articles Catalog books, media & more in Jio Institute collections Articles journal articles & other e-resources

Search

Search Constraints

Refine your results

Search Limiters

Topic

Publication Year Range

Language

Publication Type

Journal

Region

Database

Publisher

36 results on '"Casajust, Paula"'

Search Results

Catalog

Select search scope, currently: Articles

Catalog

books, media & more in Jio Institute collections

Articles

journal articles & other e-resources