Publications by authors named "Talita Duarte-Salles"

74 Publications

Alpha-1 blockers and susceptibility to COVID-19 in benign prostate hyperplasia patients : an international cohort study.

medRxiv 2021 Mar 24. Epub 2021 Mar 24.

Alpha-1 blockers, often used to treat benign prostate hyperplasia (BPH), have been hypothesized to prevent COVID-19 complications by minimising cytokine storms release. We conducted a prevalent-user active-comparator cohort study to assess association between alpha-1 blocker use and risks of three COVID-19 outcomes: diagnosis, hospitalization, and hospitalization requiring intensive services. Our study included 2.6 and 0.46 million users of alpha-1 blockers and of alternative BPH therapy during the period between November 2019 and January 2020, found in electronic health records from Spain (SIDIAP) and the United States (Department of Veterans Affairs, Columbia University Irving Medical Center, IQVIA OpenClaims, Optum DOD, Optum EHR). We estimated hazard ratios using state-of-the-art techniques to minimize potential confounding, including large-scale propensity score matching/stratification and negative control calibration. We found no differential risk for any of COVID-19 outcome, pointing to the need for further research on potential COVID-19 therapies.
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http://dx.doi.org/10.1101/2021.03.18.21253778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010772PMC
March 2021

Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study.

medRxiv 2021 Mar 28. Epub 2021 Mar 28.

Background: As large-scale immunization programs against COVID-19 proceed around the world, safety signals will emerge that need rapid evaluation. We report population-based, age- and sex- specific background incidence rates of potential adverse events of special interest (AESI) in eight countries using thirteen databases.

Methods: This multi-national network cohort study included eight electronic medical record and five administrative claims databases from Australia, France, Germany, Japan, Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. People observed for at least 365 days before 1 January 2017, 2018, or 2019 were included. We based study outcomes on lists published by regulators: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain-Barre syndrome, hemorrhagic and non-hemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, and transverse myelitis. We calculated incidence rates stratified by age, sex, and database. We pooled rates across databases using random effects meta-analyses. We classified meta-analytic estimates into Council of International Organizations of Medical Sciences categories: very common, common, uncommon, rare, or very rare.

Findings: We analysed 126,661,070 people. Rates varied greatly between databases and by age and sex. Some AESI (e.g., myocardial infarction, Guillain-Barre syndrome) increased with age, while others (e.g., anaphylaxis, appendicitis) were more common in young people. As a result, AESI were classified differently according to age. For example, myocardial infarction was very rare in children, rare in women aged 35-54 years, uncommon in men and women aged 55-84 years, and common in those aged ≥85 years.

Interpretation: We report robust baseline rates of prioritised AESI across 13 databases. Age, sex, and variation between databases should be considered if background AESI rates are compared to event rates observed with COVID-19 vaccines.
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http://dx.doi.org/10.1101/2021.03.25.21254315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010764PMC
March 2021

Use of health services among long-term breast cancer survivors in Spain: longitudinal study based on real-world data.

J Cancer Surviv 2021 Mar 23. Epub 2021 Mar 23.

Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim, 25-29, 08003, Barcelona, Spain.

Purpose: This study aimed to evaluate health service utilization in Spain among long-term breast cancer survivors and to compare it with that among women with no history of breast cancer.

Methods: Study based on the SURBCAN cohort includes a sample of long-term breast cancer survivors and a sample of women without breast cancer from 5 Spanish regions. Healthcare utilization was assessed through primary care, hospital visits, and tests during the follow-up period (2012 to 2016) by using electronic health records. Annual contact rates to healthcare services were calculated, and crude and multivariate count models were fitted to estimate the adjusted relative risk of healthcare services use.

Results: Data were obtained from 19,328 women, including 6512 long-term breast cancer survivors. Healthcare use was higher among breast cancer survivors (20.9 vs 16.6; p < 0.0001) and decreased from >10 years of survival. Breast cancer survivors who underwent a mastectomy were more likely to have a primary care visit (RR = 3.10 95% CI 3.08-3.11). Five to ten years survivors were more likely to have hospital inpatient visits and imaging test compared to women without breast cancer (RRa = 1.35 95% CI 1.30-1.39 and RRa = 1.27 95% CI 1.25-1.29 respectively).

Conclusion: This study shows higher use of health services in long-term breast cancer survivors than in women without breast cancer regardless of survival time.

Implications For Cancer Survivors: These results help to estimate the health resources needed for the growing group of breast cancer survivors and to identify risk factors that drive higher use of health services.
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http://dx.doi.org/10.1007/s11764-021-01011-zDOI Listing
March 2021

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

Rheumatology (Oxford) 2021 Mar 16. Epub 2021 Mar 16.

Real-World Evidence, Trial, Barcelona, Spain, Form Support.

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.

Methods: A multinational network cohort study was conducted using electronic health records data from Columbia University Irving Medical Center (CUIMC) (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). 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. Outcomes were death and complications within 30 days of hospitalisation.

Results: We studied 133 589 patients diagnosed and 48 418 hospitalised 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 hospitalised vs diagnosed patients with COVID-19. Compared with 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% vs 6.3% to 24.6%).

Conclusions: Compared with influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality.
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http://dx.doi.org/10.1093/rheumatology/keab250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989171PMC
March 2021

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

Res Sq 2021 Mar 1. Epub 2021 Mar 1.

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. 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 June 2020 and are iteratively updated via GitHub [4]. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical 886,193 , and 113,627 . 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/. 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.
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http://dx.doi.org/10.21203/rs.3.rs-279400/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941629PMC
March 2021

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

JMIR Med Inform 2021 Apr 5;9(4):e21547. Epub 2021 Apr 5.

Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea.

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.
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http://dx.doi.org/10.2196/21547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023380PMC
April 2021

Ambient air pollution and the development of overweight and obesity in children: a large longitudinal study.

Int J Obes (Lond) 2021 May 24;45(5):1124-1132. Epub 2021 Feb 24.

ISGlobal, Barcelona, Spain.

Background: Ambient air pollution may play a role in childhood obesity development, but evidence is scarce, and the modifying role of socioeconomic status (SES) is unclear. We aimed to examine the association between exposure to air pollution during early childhood and subsequent risk of developing overweight and obesity, and to evaluate whether SES is a modifier of this association.

Methods: This longitudinal study included 416,955 children identified as normal weight between 2-5 years old and registered in an electronic primary healthcare record between 2006 and 2016 in Catalonia (Spain). Children were followed-up until they developed overweight or obesity, reached 15 years of age, died, transferred out, or end of study period (31/12/2018). Overweight and obesity were defined following the WHO reference obtained from height and weight measures. We estimated annual residential census levels of nitrogen dioxide (NO) and particulate matter <10 μm (PM), <2.5 μm (PM), and 2.5-10 μm (PM) at study entry. We estimated the risk of developing overweight and obesity per interquartile range increase in air pollution exposure with Cox proportional hazard models.

Results: A total of 142,590 (34.2%) children developed overweight or obesity. Increased exposure to NO, PM, and PM was associated with a 2-3% increased risk of developing overweight and obesity (hazard ratio [HR] per 21.8 μg/m NO = 1.03 [95% CI: 1.02-1.04]; HR per 6.4 μg/m PM = 1.02 [95% CI: 1.02-1.03]; HR per 4.6 µg/m PM = 1.02, [95% CI: 1.01-1.02]). For all air pollutants, associations were stronger among children living in most compared to least deprived areas.

Conclusions: This study suggests that early life exposure to air pollution may be associated with a small increase in the risk of developing overweight and obesity in childhood, and that this association may be exacerbated in the most deprived areas. Even these small associations are of potential global health importance because air pollution exposure is widespread and the long-term health consequences of childhood obesity are clear.
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http://dx.doi.org/10.1038/s41366-021-00783-9DOI Listing
May 2021

The natural history of symptomatic COVID-19 during the first wave in Catalonia.

Nat Commun 2021 02 3;12(1):777. Epub 2021 Feb 3.

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.

The natural history of coronavirus disease 2019 (COVID-19) has yet to be fully described. Here, we use patient-level data from the Information System for Research in Primary Care (SIDIAP) to summarise COVID-19 outcomes in Catalonia, Spain. We included 5,586,521 individuals from the general population. Of these, 102,002 had an outpatient diagnosis of COVID-19, 16,901 were hospitalised with COVID-19, and 5273 died after either being diagnosed or hospitalised with COVID-19 between 1st March and 6th May 2020. Older age, being male, and having comorbidities were all generally associated with worse outcomes. These findings demonstrate the continued need to protect those at high risk of poor outcomes, particularly older people, from COVID-19 and provide appropriate care for those who develop symptomatic disease. While risks of hospitalisation and death were lower for younger populations, there is a need to limit their role in community transmission.
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http://dx.doi.org/10.1038/s41467-021-21100-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7858639PMC
February 2021

Body mass index and waist circumference in relation to the risk of 26 types of cancer: a prospective cohort study of 3.5 million adults in Spain.

BMC Med 2021 Jan 14;19(1):10. Epub 2021 Jan 14.

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Gran Via Corts Catalanes, 587 àtic, 08007, Barcelona, Spain.

Background: A high body mass index (BMI) has been associated with increased risk of several cancers; however, whether BMI is related to a larger number of cancers than currently recognized is unclear. Moreover, whether waist circumference (WC) is more strongly associated with specific cancers than BMI is not well established. We aimed to investigate the associations between BMI and 26 cancers accounting for non-linearity and residual confounding by smoking status as well as to compare cancer risk estimates between BMI and WC.

Methods: Prospective cohort study with population-based electronic health records from Catalonia, Spain. We included 3,658,417 adults aged ≥ 18 years and free of cancer at baseline between 2006 and 2017. Our main outcome measures were cause-specific hazard ratios (HRs) with 99% confidence intervals (CIs) for incident cancer at 26 anatomical sites.

Results: After a median follow-up time of 8.3 years, 202,837 participants were diagnosed with cancer. A higher BMI was positively associated with risk of nine cancers (corpus uteri, kidney, gallbladder, thyroid, colorectal, breast post-menopausal, multiple myeloma, leukemia, non-Hodgkin lymphoma) and was positively associated with three additional cancers among never smokers (head and neck, brain and central nervous system, Hodgkin lymphoma). The respective HRs (per 5 kg/m increment) ranged from 1.04 (99%CI 1.01 to 1.08) for non-Hodgkin lymphoma to 1.49 (1.45 to 1.53) for corpus uteri cancer. While BMI was negatively associated to five cancer types in the linear analyses of the overall population, accounting for non-linearity revealed that BMI was associated to prostate cancer in a U-shaped manner and to head and neck, esophagus, larynx, and trachea, bronchus and lung cancers in an L-shaped fashion, suggesting that low BMIs are an approximation of heavy smoking. Of the 291,305 participants with a WC measurement, 27,837 were diagnosed with cancer. The 99%CIs of the BMI and WC point estimates (per 1 standard deviation increment) overlapped for all cancers.

Conclusions: In this large Southern European study, a higher BMI was associated with increased risk of twelve cancers, including four hematological and head and neck (only among never smokers) cancers. Furthermore, BMI and WC showed comparable estimates of cancer risk associated with adiposity.
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http://dx.doi.org/10.1186/s12916-020-01877-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807518PMC
January 2021

Body mass index and waist circumference in relation to the risk of 26 types of cancer: a prospective cohort study of 3.5 million adults in Spain.

BMC Med 2021 Jan 14;19(1):10. Epub 2021 Jan 14.

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Gran Via Corts Catalanes, 587 àtic, 08007, Barcelona, Spain.

Background: A high body mass index (BMI) has been associated with increased risk of several cancers; however, whether BMI is related to a larger number of cancers than currently recognized is unclear. Moreover, whether waist circumference (WC) is more strongly associated with specific cancers than BMI is not well established. We aimed to investigate the associations between BMI and 26 cancers accounting for non-linearity and residual confounding by smoking status as well as to compare cancer risk estimates between BMI and WC.

Methods: Prospective cohort study with population-based electronic health records from Catalonia, Spain. We included 3,658,417 adults aged ≥ 18 years and free of cancer at baseline between 2006 and 2017. Our main outcome measures were cause-specific hazard ratios (HRs) with 99% confidence intervals (CIs) for incident cancer at 26 anatomical sites.

Results: After a median follow-up time of 8.3 years, 202,837 participants were diagnosed with cancer. A higher BMI was positively associated with risk of nine cancers (corpus uteri, kidney, gallbladder, thyroid, colorectal, breast post-menopausal, multiple myeloma, leukemia, non-Hodgkin lymphoma) and was positively associated with three additional cancers among never smokers (head and neck, brain and central nervous system, Hodgkin lymphoma). The respective HRs (per 5 kg/m increment) ranged from 1.04 (99%CI 1.01 to 1.08) for non-Hodgkin lymphoma to 1.49 (1.45 to 1.53) for corpus uteri cancer. While BMI was negatively associated to five cancer types in the linear analyses of the overall population, accounting for non-linearity revealed that BMI was associated to prostate cancer in a U-shaped manner and to head and neck, esophagus, larynx, and trachea, bronchus and lung cancers in an L-shaped fashion, suggesting that low BMIs are an approximation of heavy smoking. Of the 291,305 participants with a WC measurement, 27,837 were diagnosed with cancer. The 99%CIs of the BMI and WC point estimates (per 1 standard deviation increment) overlapped for all cancers.

Conclusions: In this large Southern European study, a higher BMI was associated with increased risk of twelve cancers, including four hematological and head and neck (only among never smokers) cancers. Furthermore, BMI and WC showed comparable estimates of cancer risk associated with adiposity.
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http://dx.doi.org/10.1186/s12916-020-01877-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807518PMC
January 2021

Renin-angiotensin system blockers and susceptibility to COVID-19: an international, open science, cohort analysis.

Lancet Digit Health 2021 02 17;3(2):e98-e114. Epub 2020 Dec 17.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

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.
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http://dx.doi.org/10.1016/S2589-7500(20)30289-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834915PMC
February 2021

Use of dialysis, tracheostomy, and extracorporeal membrane oxygenation among 240,392 patients hospitalized with COVID-19 in the United States.

medRxiv 2020 Nov 27. Epub 2020 Nov 27.

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: Six databases from the United States containing routinely-collected patient data: HealthVerity, Premier, 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: 240,392 patients hospitalized with COVID-19 were included (22,887 from HealthVerity, 139,971 from IQVIA Open Claims, 29,061 from Optum EHR, 4,336 from OPTUM SES, 36,019 from Premier, and 8,118 from VA-OMOP). Across the six databases, 9,703 (4.04% [95% CI: 3.96% to 4.11%]) patients received dialysis, 1,681 (0.70% [0.67% to 0.73%]) had a tracheostomy, and 398 (0.17% [95% CI: 0.15% to 0.18%]) patients underwent ECMO over the 30 days following hospitalization. Use of ECMO was generally concentrated among patients who were younger, male, and with fewer comorbidities except for obesity. Tracheostomy was used for a similar proportion of patients regardless of age, sex, or comorbidity. While dialysis was 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 and can be expected to continue grow given the continuing spread of the COVID-19.
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http://dx.doi.org/10.1101/2020.11.25.20229088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709172PMC
November 2020

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.

medRxiv 2020 Nov 27. Epub 2020 Nov 27.

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.
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http://dx.doi.org/10.1101/2020.11.24.20236802DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709171PMC
November 2020

Gender-based approach on the social impact and mental health in Spain during COVID-19 lockdown: a cross-sectional study.

BMJ Open 2020 11 24;10(11):e044617. Epub 2020 Nov 24.

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.

Objective: Lockdown has impacts on people's living conditions and mental health. The study aims to assess the relations between social impact and mental health among adults living in Spain during COVID-19 lockdown measures, taking a gender-based approach into account.

Design, Setting And Participants: We conducted a cross-sectional study among adults living in Spain during the lockdown of COVID-19 with an online survey from 8 April to 28 May 2020. The main variable was mental health measured by Generalized Anxiety Disorder Scale for anxiety and the Patient Health Questionnaire for depression. Sex-stratified multivariate ordinal logistic regression models were constructed to assess the association between social impact variables, anxiety and depression.

Results: A total of 7053 people completed this survey. A total of 31.2% of women and 17.7% of men reported anxiety. Depression levels were reported in 28.5% of women and 16.7% of men. A higher proportion of anxiety and depression levels was found in the younger population (18-35 years), especially in women. Poorer mental health was mainly related to fear of COVID-19 infection, with higher anxiety levels especially in women (adjusted ordinal OR (aOR): 4.23, 95% CI 3.68 to 4.87) and worsened economy with higher levels of depression in women (aOR: 1.51, 95% CI 1.24 to 1.84), and perceived inadequate housing to cope with lockdown was especially associated with anxiety in men (aOR: 2.53, 95% CI 1.93 to 3.44).

Conclusion: The social impact of the lockdown is related to gender, age and socioeconomic conditions. Women and young people had worse mental health outcomes during lockdown. It is urgent to establish strategies for public health emergencies that include mental health and its determinants, taking a gender-based approach into account, in order to reduce health inequities.
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http://dx.doi.org/10.1136/bmjopen-2020-044617DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688440PMC
November 2020

Vascular and metabolic risk factor differences prior to dementia diagnosis: a multidatabase case-control study using European electronic health records.

BMJ Open 2020 11 14;10(11):e038753. Epub 2020 Nov 14.

Psychological Medicine, King's College London (Institute of Psychiatry, Psychology and Neuroscience), London, UK

Objective: The objective of the study is to compare body mass index (BMI), systolic/diastolic blood pressure (SBP/DBP) and serum total cholesterol levels between dementia cases and controls at multiple time intervals prior to dementia onset, and to test time interval as a modifying factor for these associations.

Design: Case-control study.

Setting: Six European electronic health records databases.

Participants: 291 780 cases at the date of first-recorded dementia diagnosis, compared with 29 170 549 controls randomly selected from the same databases, age matched and sex matched at this index date.

Exposure: The following measures were extracted whenever recorded within each dataset: BMI (kg/m), SBP and DBP (mm Hg) and serum total cholesterol (mmol/L). Levels for each of these variables were defined within six 2-year time intervals over the 12 years prior to the index date.

Main Outcomes: Case-control differences in exposures of interest were modelled for each time period and adjusted for demographic and clinical factors (ischaemic/unspecified stroke, type 2 diabetes mellitus, acute myocardial infarction, hypertension diagnosis, antihypertensive medication, cholesterol-lowering medication). Coefficients and interactions with time period were meta-analysed across the six databases.

Results: Mean BMI (coefficient -1.16 kg/m; 95% CI -1.38 to 0.93) and SBP (-2.83 mm Hg; 95% CI -4.49 to -1.16) were lower in cases at diagnosis, and case-control differences were greater in more recent time periods, as indicated by significant case-x-time interaction and case-x-time-squared interaction terms. Time variations in coefficients for cholesterol levels were less consistent between databases and those for DBP were largely not significant.

Conclusion: Routine clinical data show emerging divergence in levels of BMI and SBP prior to the diagnosis of dementia but less evidence for DBP or total cholesterol levels. These divergences should receive at least some consideration in routine dementia risk screening, although underlying mechanisms still require further investigation.
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http://dx.doi.org/10.1136/bmjopen-2020-038753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668358PMC
November 2020

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.

medRxiv 2020 Oct 30. Epub 2020 Oct 30.

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. International network cohort. Real-world data from European primary care records (France/Germany/Spain), South Korean claims and US claims and hospital databases. Diagnosed and/or hospitalized children/adolescents with COVID-19 at age <18 between January and June 2020; diagnosed with influenza in 2017-2018. 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. 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. 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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http://dx.doi.org/10.1101/2020.10.29.20222083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605587PMC
October 2020

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.

medRxiv 2020 Oct 27. Epub 2020 Oct 27.

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.
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http://dx.doi.org/10.1101/2020.10.25.20218875DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605581PMC
October 2020

Filling the gaps in the characterization of the clinical management of COVID-19: 30-day hospital admission and fatality rates in a cohort of 118 150 cases diagnosed in outpatient settings in Spain.

Int J Epidemiol 2021 01;49(6):1930-1939

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.

Background: Currently, there is a missing link in the natural history of COVID-19, from first (usually milder) symptoms to hospitalization and/or death. To fill in this gap, we characterized COVID-19 patients at the time at which they were diagnosed in outpatient settings and estimated 30-day hospital admission and fatality rates.

Methods: This was a population-based cohort study.

Data were obtained from Information System for Research in Primary Care (SIDIAP)-a primary-care records database covering >6 million people (>80% of the population of Catalonia), linked to COVID-19 reverse transcriptase polymerase chain reaction (RT-PCR) tests and hospital emergency, inpatient and mortality registers. We included all patients in the database who were ≥15 years old and diagnosed with COVID-19 in outpatient settings between 15 March and 24 April 2020 (10 April for outcome studies). Baseline characteristics included socio-demographics, co-morbidity and previous drug use at the time of diagnosis, and polymerase chain reaction (PCR) testing and results.

Study outcomes included 30-day hospitalization for COVID-19 and all-cause fatality.

Results: We identified 118 150 and 95 467 COVID-19 patients for characterization and outcome studies, respectively. Most were women (58.7%) and young-to-middle-aged (e.g. 21.1% were 45-54 years old). Of the 44 575 who were tested with PCR, 32 723 (73.4%) tested positive. In the month after diagnosis, 14.8% (14.6-15.0) were hospitalized, with a greater proportion of men and older people, peaking at age 75-84 years. Thirty-day fatality was 3.5% (95% confidence interval: 3.4% to 3.6%), higher in men, increasing with age and highest in those residing in nursing homes [24.5% (23.4% to 25.6%)].

Conclusion: COVID-19 infections were widespread in the community, including all age-sex strata. However, severe forms of the disease clustered in older men and nursing-home residents. Although initially managed in outpatient settings, 15% of cases required hospitalization and 4% died within a month of first symptoms. These data are instrumental for designing deconfinement strategies and will inform healthcare planning and hospital-bed allocation in current and future COVID-19 outbreaks.
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http://dx.doi.org/10.1093/ije/dyaa190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665572PMC
January 2021

Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study.

Nat Commun 2020 10 6;11(1):5009. Epub 2020 Oct 6.

Clinical Pharmacology Unit, Zealand University Hospital, Køge, Denmark.

Comorbid conditions appear to be common among individuals hospitalised with coronavirus disease 2019 (COVID-19) but estimates of prevalence vary and little is known about the prior medication use of patients. Here, we describe the characteristics of adults hospitalised with COVID-19 and compare them with influenza patients. We include 34,128 (US: 8362, South Korea: 7341, Spain: 18,425) COVID-19 patients, summarising between 4811 and 11,643 unique aggregate characteristics. COVID-19 patients have been majority male in the US and Spain, but predominantly female in South Korea. Age profiles vary across data sources. Compared to 84,585 individuals hospitalised with influenza in 2014-19, COVID-19 patients have more typically been male, younger, and with fewer comorbidities and lower medication use. While protecting groups vulnerable to influenza is likely a useful starting point in the response to COVID-19, strategies will likely need to be broadened to reflect the particular characteristics of individuals being hospitalised with COVID-19.
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http://dx.doi.org/10.1038/s41467-020-18849-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538555PMC
October 2020

Childhood overweight and obesity and back pain risk: a cohort study of 466 997 children.

BMJ Open 2020 09 17;10(9):e036023. Epub 2020 Sep 17.

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objectives: To assess the association between age, sex, socioeconomic group, weight status and back pain risk in a large general population cohort of children.

Design And Setting: A dynamic cohort of children aged 4 years in the Information System for Research in Primary Care (SIDIAP) electronic primary care records data in Catalonia. Multivariable Cox models were fitted to explore the association between back pain and weight status categories according to the WHO 2007 growth reference groups (body mass index for age z-score). Models were adjusted for age, sex, socioeconomic status and nationality.

Participants: Children seen at age 4 years at paediatric primary care clinics between 1 January 2006 and 31 December 2013 and followed up until 31 December 2016 or age 15 years.

Outcome Measures: Incident back pain registered by paediatricians at primary care using the International Statistical Classification of Diseases and Health Related Problems, 10th Edition code M54.

Results: 466 997 children were followed for a median 5.0 years (IQR 5.1). In multivariable models, overweight and obesity increased back pain risk, with adjusted HRs of 1.18 (95% CI 1.09 to 1.27) and 1.34 (95%CI 1.19 to 1.51) for overweight and obesity, respectively. Females were at greater risk of back pain than males with adjusted HR 1.40 (95%CI 1.35 to 1.46). Adjusted HR was 1.43 (95%CI 1.33 to 1.55) for back pain in children from the most deprived socioeconomic groups compared with the least deprived socioeconomic groups.

Conclusions: Maintaining a healthy weight from an early age may reduce the prevalence of back pain in both children and adults. Overweight female children from deprived socioeconomic groups are at greatest risk of back pain and represent a target population for intervention.
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http://dx.doi.org/10.1136/bmjopen-2019-036023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7500301PMC
September 2020

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

Lancet Rheumatol 2020 Nov 21;2(11):e698-e711. Epub 2020 Aug 21.

Janssen Research and Development, Titusville, NJ, USA.

Background: Hydroxychloroquine, a drug commonly used in the treatment of rheumatoid arthritis, has received much negative publicity for adverse events associated with its authorisation for emergency use to treat patients with COVID-19 pneumonia. We studied the safety of hydroxychloroquine, alone and in combination with azithromycin, to determine the risk associated with its use in routine care in patients with rheumatoid arthritis.

Methods: In this multinational, retrospective study, new user cohort studies in patients with rheumatoid arthritis aged 18 years or older and initiating hydroxychloroquine were compared with those initiating sulfasalazine and followed up over 30 days, with 16 severe adverse events studied. Self-controlled case series were done to further establish safety in wider populations, and included all users of hydroxychloroquine regardless of rheumatoid arthritis status or indication. Separately, severe adverse events associated with hydroxychloroquine plus azithromycin (compared with hydroxychloroquine plus amoxicillin) were studied. Data comprised 14 sources of claims data or electronic medical records from Germany, Japan, the Netherlands, Spain, the UK, and the USA. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate calibrated hazard ratios (HRs) according to drug use. Estimates were pooled where the value was less than 0·4.

Findings: The study included 956 374 users of hydroxychloroquine, 310 350 users of sulfasalazine, 323 122 users of hydroxychloroquine plus azithromycin, and 351 956 users of hydroxychloroquine plus amoxicillin. No excess risk of severe adverse events was identified when 30-day hydroxychloroquine and sulfasalazine use were compared. Self-controlled case series confirmed these findings. However, long-term use of hydroxychloroquine appeared to be associated with increased cardiovascular mortality (calibrated HR 1·65 [95% CI 1·12-2·44]). Addition of azithromycin appeared to be associated with an increased risk of 30-day cardiovascular mortality (calibrated HR 2·19 [95% CI 1·22-3·95]), chest pain or angina (1·15 [1·05-1·26]), and heart failure (1·22 [1·02-1·45]).

Interpretation: Hydroxychloroquine treatment appears to have no increased risk in the short term among patients with rheumatoid arthritis, but in the long term it appears to be associated with excess cardiovascular mortality. The addition of azithromycin increases the risk of heart failure and cardiovascular mortality even in the short term. We call for careful consideration of the benefit-risk trade-off when counselling those on hydroxychloroquine treatment.

Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, NIHR Senior Research Fellowship programme, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research and Development, IQVIA, Korea Health Industry Development Institute through the Ministry of Health and Welfare Republic of Korea, Versus Arthritis, UK Medical Research Council Doctoral Training Partnership, Foundation Alfonso Martin Escudero, Innovation Fund Denmark, Novo Nordisk Foundation, Singapore Ministry of Health's National Medical Research Council Open Fund Large Collaborative Grant, VINCI, Innovative Medicines Initiative 2 Joint Undertaking, EU's Horizon 2020 research and innovation programme, and European Federation of Pharmaceutical Industries and Associations.
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http://dx.doi.org/10.1016/S2665-9913(20)30276-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442425PMC
November 2020

Early life exposure to air pollution, green spaces and built environment, and body mass index growth trajectories during the first 5 years of life: A large longitudinal study.

Environ Pollut 2020 Nov 28;266(Pt 3):115266. Epub 2020 Jul 28.

ISGlobal, Barcelona, Spain; Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Spain; Universitat Pompeu Fabra, Barcelona, Spain. Electronic address:

Urban environments are characterized by multiple exposures that may influence body mass index (BMI) growth in early life. Previous studies are few, with inconsistent results and no evaluation of simultaneous exposures. Thus, this study aimed to assess the associations between exposure to air pollution, green spaces and built environment characteristics, and BMI growth trajectories from 0 to 5 years. This longitudinal study used data from an electronic primary care health record database in Catalonia (Spain), including 79,992 children born between January 01, 2011 and December 31, 2012 in urban areas and followed until 5 years of age. Height and weight were measured frequently during childhood and BMI (kg/m) was calculated. Urban exposures were estimated at census tract level and included: air pollution (nitrogen dioxide (NO), particulate matter <10 μm (PM) and <2.5 μm (PM), green spaces (Normalized Difference Vegetation Index (NDVI) and % green space) and built environment (population density, street connectivity, land use mix, walkability index). Individual BMI trajectories were estimated using linear spline multilevel models with several knot points. In single exposure models, NO PM PM and population density were associated with small increases in BMI growth (e.g. β per IQR PM increase = 0.023 kg/m, 95%CI: 0.013, 0.033), and NDVI, % of green spaces and land use mix with small reductions in BMI growth (e.g. β per IQR % green spaces increase = -0.015 kg/m 95%CI: -0.026, -0.005). These associations were strongest during the first two months of life. In multiple exposure models, most associations were attenuated, with only those for PM and land use mix remaining statistically significant. This large longitudinal study suggests that early life exposure to air pollution, green space and built environment characteristics may be associated with small changes in BMI growth trajectories during the first years of life, and that it is important to account for multiple exposures in urban settings.
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http://dx.doi.org/10.1016/j.envpol.2020.115266DOI Listing
November 2020

Metabolic perturbations prior to hepatocellular carcinoma diagnosis: Findings from a prospective observational cohort study.

Int J Cancer 2021 Feb 28;148(3):609-625. Epub 2020 Aug 28.

Public Health Directorate, Asturias, Spain.

Hepatocellular carcinoma (HCC) development entails changes in liver metabolism. Current knowledge on metabolic perturbations in HCC is derived mostly from case-control designs, with sparse information from prospective cohorts. Our objective was to apply comprehensive metabolite profiling to detect metabolites whose serum concentrations are associated with HCC development, using biological samples from within the prospective European Prospective Investigation into Cancer and Nutrition (EPIC) cohort (>520 000 participants), where we identified 129 HCC cases matched 1:1 to controls. We conducted high-resolution untargeted liquid chromatography-mass spectrometry-based metabolomics on serum samples collected at recruitment prior to cancer diagnosis. Multivariable conditional logistic regression was applied controlling for dietary habits, alcohol consumption, smoking, body size, hepatitis infection and liver dysfunction. Corrections for multiple comparisons were applied. Of 9206 molecular features detected, 220 discriminated HCC cases from controls. Detailed feature annotation revealed 92 metabolites associated with HCC risk, of which 14 were unambiguously identified using pure reference standards. Positive HCC-risk associations were observed for N1-acetylspermidine, isatin, p-hydroxyphenyllactic acid, tyrosine, sphingosine, l,l-cyclo(leucylprolyl), glycochenodeoxycholic acid, glycocholic acid and 7-methylguanine. Inverse risk associations were observed for retinol, dehydroepiandrosterone sulfate, glycerophosphocholine, γ-carboxyethyl hydroxychroman and creatine. Discernible differences for these metabolites were observed between cases and controls up to 10 years prior to diagnosis. Our observations highlight the diversity of metabolic perturbations involved in HCC development and replicate previous observations (metabolism of bile acids, amino acids and phospholipids) made in Asian and Scandinavian populations. These findings emphasize the role of metabolic pathways associated with steroid metabolism and immunity and specific dietary and environmental exposures in HCC development.
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http://dx.doi.org/10.1002/ijc.33236DOI Listing
February 2021

Renin-angiotensin system blockers and susceptibility to COVID-19: a multinational open science cohort study.

medRxiv 2020 Jun 12. Epub 2020 Jun 12.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UK.

Introduction: Angiotensin converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs) could influence infection risk of coronavirus disease (COVID-19). Observational studies to date lack pre-specification, transparency, rigorous ascertainment adjustment and international generalizability, with contradictory results.

Methods: Using electronic health records from Spain (SIDIAP) and the United States (Columbia University Irving Medical Center and Department of Veterans Affairs), we conducted a systematic cohort study with prevalent ACE, ARB, calcium channel blocker (CCB) and thiazide diuretic (THZ) use to determine relative risk of COVID-19 diagnosis and related hospitalization outcomes. The study addressed confounding through large-scale propensity score adjustment and negative control experiments.

Results: Following over 1.1 million antihypertensive users identified between November 2019 and January 2020, we observed no significant difference in relative COVID-19 diagnosis risk comparing ACE/ARB vs CCB/THZ monotherapy (hazard ratio: 0.98; 95% CI 0.84 - 1.14), nor any difference for mono/combination use (1.01; 0.90 - 1.15). ACE alone and ARB alone similarly showed no relative risk difference when compared to CCB/THZ monotherapy or mono/combination use. Directly comparing ACE vs. ARB demonstrated a moderately lower risk with ACE, non-significant for monotherapy (0.85; 0.69 - 1.05) and marginally significant for mono/combination users (0.88; 0.79 - 0.99). We observed, however, no significant difference between drug- classes for COVID-19 hospitalization or pneumonia risk across all comparisons.

Conclusion: There is no clinically significant increased risk of COVID-19 diagnosis or hospitalization with ACE or ARB use. Users should not discontinue or change their treatment to avoid COVID-19.
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http://dx.doi.org/10.1101/2020.06.11.20125849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7310640PMC
June 2020

Impact of a single-age cohort human papillomavirus vaccination strategy in Catalonia, Spain: Population-based analysis of anogenital warts in men and women.

Prev Med 2020 09 18;138:106166. Epub 2020 Jun 18.

Unit of Infections and Cancer - Information and Interventions, Cancer Epidemiology Research Programme, Catalan Institute of Oncology (ICO) - IDIBELL, l'Hospitalet de Llobregat, Spain. Electronic address:

Extensive multiple-age cohort human papillomavirus (HPV) vaccination has proved to be highly effective. We aimed to determine the 8-year population impact of a female single-age cohort HPV vaccination programme on the incidence of anogenital warts (AGW). In 2008, Catalonia initiated a school-based quadrivalent HPV vaccination programme targeting 11-year-old girls, achieving coverage over 80%. Data on diagnoses of AGW and genital herpes were obtained from a population-based database of electronic health records covering 74% of the population. The annual incidence rates from 2009 to 2016 were calculated, stratified by age and sex using Joinpoint regression to estimate trends and annual percentage changes (APC). Among women aged 16-19 years, the AGW incidence decreased by 61% from 2012 to 2016 (APC -19.4%; 95% CI: -30.0 to -7.3). In contrast, the incidence of genital herpes in same-aged women increased throughout the study period (APC 11.1%; 95% CI: 7.2-15.2). Among men aged 20-22 years, the increasing incidence of AGW shifted to a downward trend in 2013 (APC 2009-2013: 17.0%; 95% CI: 8.2-26.5; and APC 2013-2016: -4.5%; 95% CI: -14.6 to 6.9). A similar pattern was observed among men aged 23-25 years (APC 2009-2014: 16.0%; 95% CI: 12.0-20.2; and APC 2014-2016: -6.0%; 95% CI: -18.4 to 8.3). In contrast to AGW, among men aged 20-25 years, the incidence of genital herpes increased over this period. Our study strongly suggests that a single-cohort HPV vaccination strategy with high vaccine uptake not only provides direct benefit in the vaccinated cohorts but also extends protection through a herd effect to unvaccinated men.
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http://dx.doi.org/10.1016/j.ypmed.2020.106166DOI Listing
September 2020

An international characterisation of patients hospitalised with COVID-19 and a comparison with those previously hospitalised with influenza.

medRxiv 2020 Apr 25. Epub 2020 Apr 25.

Science Policy and Research, National Institute for Health and Care Excellence, UK.

Background: To better understand the profile of individuals with severe coronavirus disease 2019 (COVID-19), we characterised individuals hospitalised with COVID-19 and compared them to individuals previously hospitalised with influenza.

Methods: We report the characteristics (demographics, prior conditions and medication use) of patients hospitalised with COVID-19 between December 2019 and April 2020 in the US (Columbia University Irving Medical Center [CUIMC], STAnford Medicine Research data Repository [STARR-OMOP], and the Department of Veterans Affairs [VA OMOP]) and Health Insurance Review & Assessment [HIRA] of South Korea. Patients hospitalised with COVID-19 were compared with patients previously hospitalised with influenza in 2014-19.

Results: 6,806 (US: 1,634, South Korea: 5,172) individuals hospitalised with COVID-19 were included. Patients in the US were majority male (VA OMOP: 94%, STARR-OMOP: 57%, CUIMC: 52%), but were majority female in HIRA (56%). Age profiles varied across data sources. Prevalence of asthma ranged from 7% to 14%, diabetes from 18% to 43%, and hypertensive disorder from 22% to 70% across data sources, while between 9% and 39% were taking drugs acting on the renin-angiotensin system in the 30 days prior to their hospitalisation. Compared to 52,422 individuals hospitalised with influenza, patients admitted with COVID-19 were more likely male, younger, and, in the US, had fewer comorbidities and lower medication use.

Conclusions: Rates of comorbidities and medication use are high among individuals hospitalised with COVID-19. However, COVID-19 patients are more likely to be male and appear to be younger and, in the US, generally healthier than those typically admitted with influenza.
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http://dx.doi.org/10.1101/2020.04.22.20074336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239064PMC
April 2020

ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data.

Vaccine 2020 12 9;38 Suppl 2:B47-B55. Epub 2020 Apr 9.

Julius Global Health, University Medical Center, Utrecht, Heidelberglaan 100, The Netherlands; VACCINE.GRID Foundation, Spitalstrasse 33, Basel, Switzerland; P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address:

The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid vaccine benefit-risk monitoring using existing European healthcare databases. Incidence rate (IR) estimates of vaccination-associated adverse events that are needed to model vaccination risks can be calculated from existing healthcare databases when vaccination (exposure) data are available. We assessed different methods to derive IRs in risk periods following vaccination when exposure data are missing in one database, using estimated IRs and IRRs from other databases for febrile seizures, fever and persistent crying. IRs were estimated for children aged 0-5 years in outcome-specific risk and non-risk periods following the first dose of acellular pertussis (aP) vaccination in four primary care databases and one hospital database. We compared derived and observed IRs in each database using three methods: 1) multiplication of non-risk period IR for database i by IR ratio (IRR) obtained from meta-analysis of IRRs estimated using the self-controlled case-series method, from databases other than i; 2) same method as 1, but multiplying with background IR; and 3) meta-analyses of observed IRs from databases other than i. IRs for febrile seizures were lower in primary care databases than the hospital database. The derived IR for febrile seizures using data from primary care databases was lower than that observed in the hospital database, and using data from the hospital database gave a higher derived IR than that observed in the primary care database. For fever and persistent crying the opposite was observed. We demonstrated that missing IRs for a post-vaccination period can be derived but that the type of database and the method of event data capture can have an impact on potential bias. We recommend IRs are derived using data from similar database types (hospital or primary care) with caution as even this can give heterogeneous results.
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http://dx.doi.org/10.1016/j.vaccine.2020.03.050DOI Listing
December 2020

Preschool Obesity Is Associated With an Increased Risk of Childhood Fracture: A Longitudinal Cohort Study of 466,997 Children and Up to 11 Years of Follow-up in Catalonia, Spain.

J Bone Miner Res 2020 06 7;35(6):1022-1030. Epub 2020 Apr 7.

NIHR BRC, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.

This study aimed to determine if having an overweight or obese range body mass index (BMI) at time of beginning school is associated with increased fracture incidence in childhood. A dynamic cohort was created from children presenting for routine preschool primary care screening, collected in the Information System for Research in Primary Care (SIDIAP) platform in Catalonia, Spain. Data were collected from 296 primary care centers representing 74% of the regional pediatric population. A total of 466,997 children (48.6% female) with a validated weight and height measurement within routine health care screening at age 4 years (±6 months) between 2006 and 2013 were included, and followed up to the age of 15, migration out of region, death, or until December 31, 2016. BMI was calculated at age 4 years and classified using WHO growth tables, and fractures were identified using previously validated ICD10 codes in electronic primary care records, divided by anatomical location. Actuarial lifetables were used to calculate cumulative incidence. Cox regression was used to investigate the association of BMI category and fracture risk with adjustment for socioeconomic status, age, sex, and nationality. Median follow-up was 4.90 years (interquartile range [IQR] 2.50 to 7.61). Cumulative incidence of any fracture during childhood was 9.20% (95% confidence interval [CI] 3.79% to 14.61%) for underweight, 10.06% (9.82% to 10.29%) for normal weight, 11.28% (10.22% to 12.35%) for overweight children, and 13.05% (10.69% to 15.41%) for children with obesity. Compared with children of normal range weight, having an overweight and obese range BMI was associated with an excess risk of lower limb fracture (adjusted hazard ratio [HR] = 1.42 [1.26 to 1.59]; 1.74 [1.46 to 2.06], respectively) and upper limb fracture (adjusted HR = 1.10 [1.03 to 1.17]; 1.19 [1.07 to 1.31]). Overall, preschool children with an overweight or obese range BMI had increased incidence of upper and lower limb fractures in childhood compared with contemporaries of normal weight. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
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http://dx.doi.org/10.1002/jbmr.3984DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7116071PMC
June 2020

Methotrexate and relative risk of dementia amongst patients with rheumatoid arthritis: a multi-national multi-database case-control study.

Alzheimers Res Ther 2020 04 6;12(1):38. Epub 2020 Apr 6.

Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.

Background: Inflammatory processes have been shown to play a role in dementia. To understand this role, we selected two anti-inflammatory drugs (methotrexate and sulfasalazine) to study their association with dementia risk.

Methods: A retrospective matched case-control study of patients over 50 with rheumatoid arthritis (486 dementia cases and 641 controls) who were identified from electronic health records in the UK, Spain, Denmark and the Netherlands. Conditional logistic regression models were fitted to estimate the risk of dementia.

Results: Prior methotrexate use was associated with a lower risk of dementia (OR 0.71, 95% CI 0.52-0.98). Furthermore, methotrexate use with therapy longer than 4 years had the lowest risk of dementia (odds ratio 0.37, 95% CI 0.17-0.79). Sulfasalazine use was not associated with dementia (odds ratio 0.88, 95% CI 0.57-1.37).

Conclusions: Further studies are still required to clarify the relationship between prior methotrexate use and duration as well as biological treatments with dementia risk.
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http://dx.doi.org/10.1186/s13195-020-00606-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137292PMC
April 2020

Time Trends and Sociodemographic Factors Associated With Overweight and Obesity in Children and Adolescents in Spain.

JAMA Netw Open 2020 03 2;3(3):e201171. Epub 2020 Mar 2.

Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.

Importance: Time-trend studies of overweight and obesity in childhood by sociodemographic factors are important for prioritizing public health initiatives. However, little is known about these trends in Spain, where high levels of obesity are found and where important demographic changes have occurred during the last 2 decades.

Objective: To examine how time trends in the prevalence and incidence of overweight and obesity among children and adolescents differ by age, sex, socioeconomic status, urban/rural residence, and nationality.

Design, Setting, And Participants: This cohort study included 1.1 million children and adolescents (aged 2-17 years) with at least 1 measure of height and weight in Catalonia, Spain, from 2006 to 2016. Electronic health records were accessed from the Information System for Research in Primary Care. Data analysis was conducted from January to December 2018.

Main Outcomes And Measures: Prevalence and incidence rates and trends of overweight/obesity and obesity (overweight/obesity defined as having of BMI z score greater than 2.0 among children aged <5 years and greater than 1.0 among children aged ≥5 years; obesity defined as having of BMI z score greater than 3.0 among children aged <5 years and greater than 2.0 among children aged ≥5 years) between 2006 and 2016 were calculated and stratified by sociodemographic characteristics (ie, age, sex, deprivation index, urban/rural residence, and nationality).

Results: The study population included 1 166 609 children and adolescents (570 982 [48.9%] girls; median [interquartile range] age at entry to electronic health record system, 2.4 [0-7.7] years; 1 006 892 [86.3%] with Spanish nationality). Of 941 041 children (80.7%) who lived in urban areas, 197 427 (20.7%) lived in the most deprived areas. Overall, the prevalence of overweight/obesity and obesity decreased between 2006 and 2016 in all sex and age groups; for example, among boys and girls aged 6 to 11 years, overweight/obesity prevalence decreased from 41.9% (95% CI, 41.5%-42.2%) to 39.9% (95% CI, 39.6%-40.3%) and from 39.7% (95% CI, 39.3%-40.2%) to 37.6% (95% CI, 37.3%-38.0%), respectively. Incidence rates of overweight/obesity and obesity were highest among children aged 6 to 7 years (overweight/obesity among boys: 11.9 [95% CI, 11.8-12.0] new cases per 100 person-years; obesity among boys: 4.9 [95% CI, 4.8-4.9] new cases per 100 person-years). Prevalence and incidence rates were highest in the most deprived areas, in urban areas, and among children with North, Central, or South American nationalities. Between 2006 and 2016, prevalence increased in the most deprived areas in almost all sex and age groups. Among girls aged 6 to 11 years living in the most deprived areas, the obesity prevalence ratio increased from 1.59 (95% CI, 1.46-1.74) to 2.03 (95% CI, 1.88-2.19) compared with those living in the least deprived areas. Furthermore, during this period, prevalence increased among children with non-Spanish nationalities, especially in the African and Asian nationality groups (eg, boys aged 6-11 years with Asian nationality compared with Spanish nationality, 2006: prevalence rate, 0.78 [95% CI, 0.60-1.01]; 2016: prevalence rate, 1.27 [95% CI, 1.15-1.39]). Incidence rates decreased among younger groups (eg, ≤7 years: incidence rate ratio for January 1, 2006, to June 30, 2011, vs July 1, 2011, to December 31, 2016: 0.94; 95% CI, 0.91-0.98) but remained stable in older groups.

Conclusions And Relevance: In this study, the overall prevalence and incidence rates of childhood overweight/obesity and obesity slightly decreased during the last decade. However, increased deprivation disparities in childhood obesity were found, given that the prevalence increased among children living in deprived areas and with non-Spanish nationalities.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.1171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081120PMC
March 2020