Publications by authors named "Kristine E Lynch"

43 Publications

Characteristics and outcomes of over 300,000 COVID-19 individuals with history of cancer in the United States and Spain.

Cancer Epidemiol Biomarkers Prev 2021 Jul 16. Epub 2021 Jul 16.

Tennessee Valley Healthcare System, Veterans Affairs Medical Center, Nashville, TN, USA.

Background: We described the demographics, cancer subtypes, comorbidities, and outcomes of patients with a history of cancer and COVID-19. Secondly, we compared patients hospitalized with COVID-19 to patients diagnosed with COVID-19 and patients hospitalized with influenza.

Methods: We conducted a cohort study using eight routinely-collected healthcare databases from Spain and the US, 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 2017-2018. Patients were followed from index date to 30 days or death. We reported demographics, cancer subtypes, comorbidities, and 30-day outcomes.

Results: We included 366,050 and 119,597 patients diagnosed and hospitalized with COVID-19, respectively. Prostate and breast cancers were the most frequent cancers (range: 5-19% and 1-14% in the diagnosed cohort, respectively). Hematological malignancies were also frequent, with non-Hodgkin's lymphoma being among the 5 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.

Conclusions: Patients with a history of cancer and COVID-19 had multiple comorbidities and a high occurrence of COVID-19-related events. Hematological malignancies were frequent.

Impact: This study provides epidemiologic characteristics that can inform clinical care and etiological studies.
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http://dx.doi.org/10.1158/1055-9965.EPI-21-0266DOI Listing
July 2021

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

Int J Obes (Lond) 2021 Jul 15. Epub 2021 Jul 15.

Data Science to Patient Value Program, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Background: A detailed characterization of patients with COVID-19 living with obesity has not yet been undertaken. We aimed to describe and compare the demographics, medical conditions, and outcomes of COVID-19 patients living with obesity (PLWO) to those of patients living without obesity.

Methods: We conducted a cohort study based on outpatient/inpatient care and claims data from January to June 2020 from Spain, the UK, and the US. We used six databases standardized to the OMOP common data model. We defined two non-mutually exclusive cohorts of patients diagnosed and/or hospitalized with COVID-19; patients were followed from index date to 30 days or death. We report the frequency of demographics, prior medical conditions, and 30-days outcomes (hospitalization, events, and death) by obesity status.

Results: We included 627 044 (Spain: 122 058, UK: 2336, and US: 502 650) diagnosed and 160 013 (Spain: 18 197, US: 141 816) hospitalized patients with COVID-19. The prevalence of obesity was higher among patients hospitalized (39.9%, 95%CI: 39.8-40.0) than among those diagnosed with COVID-19 (33.1%; 95%CI: 33.0-33.2). In both cohorts, PLWO were more often female. Hospitalized PLWO were younger than patients without obesity. Overall, COVID-19 PLWO were more likely to have prior medical conditions, present with cardiovascular and respiratory events during hospitalization, or require intensive services compared to COVID-19 patients without obesity.

Conclusion: We show that PLWO differ from patients without obesity in a wide range of medical conditions and present with more severe forms of COVID-19, with higher hospitalization rates and intensive services requirements. These findings can help guiding preventive strategies of COVID-19 infection and complications and generating hypotheses for causal inference studies.
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http://dx.doi.org/10.1038/s41366-021-00893-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8281807PMC
July 2021

Uptake of KRAS Testing and Anti-EGFR Antibody Use for Colorectal Cancer in the VA.

JCO Precis Oncol 2021 13;5. Epub 2021 Apr 13.

VA Salt Lake City Healthcare System, Salt Lake City, UT.

Advances in precision oncology, including testing to predict response to epidermal growth factor receptor monoclonal antibodies (EGFR mAbs) in colorectal cancer (CRC), can extend patients' lives. We evaluated uptake and clinical use of molecular testing, guideline recommended since 2010, in the Veterans Affairs Healthcare System (VA).

Materials And Methods: We conducted a retrospective cohort study of patients with stage IV CRC diagnosed in the VA 2006-2015. We gathered clinical, demographic, molecular, and treatment data from the VA Corporate Data Warehouse and 29 commercial laboratories. We performed multivariable analyses of associations between patient characteristics, testing, and EGFR mAb treatment.

Results: Among 5,943 patients diagnosed with stage IV CRC, only 1,053 (17.7%) had testing. Testing rates increased from 2.3% in 2006 to 28.4% in 2013. In multivariable regression, older patients (odds ratio, 0.17; 95% CI, 0.09 to 0.32 for ≥ age 85 < 45 years) and those treated in the Northeast and South regions were less likely, and those treated at high-volume CRC centers were more likely to have testing (odds ratio, 2.32; 95% CI, 1.48 to 3.63). Rates of potentially guideline discordant care were high: 64.3% (321/499) of wild-type (WT) went untreated with EGFR mAb and 8.8% (401/4,570) with no testing received EGFR mAb. Among -WT patients, survival was better for patients who received EGFR mAb treatment (29.6 18.8 months; < .001).

Conclusion: We found underuse of testing in advanced CRC, especially among older patients and those treated at lower-volume CRC centers. We found high rates of potentially guideline discordant underuse of EGFR mAb in patients with -WT tumors. Efforts to understand barriers to precision oncology are needed to maximize patient benefit.
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http://dx.doi.org/10.1200/PO.20.00359DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8232805PMC
April 2021

Healthcare service utilization for formerly homeless veterans in permanent supportive housing: Do neighborhoods matter?

Psychol Serv 2021 Jun 3. Epub 2021 Jun 3.

HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP).

Neighborhood characteristics are associated with residents' healthcare use. However, we understand less about these relationships among formerly homeless persons, who often have complex healthcare needs, including mental health and substance use disorders. Among formerly homeless Veterans, we examined: (a) how neighborhood characteristics are associated with Veteran Health Administration (VHA) healthcare use and, (b) if these relationships varied by Veterans' level of healthcare need. We obtained data on our cohort of 711 Veterans housed through VHA's permanent supportive housing program (HUD-VASH) in 2016-2017 from VHA's Homeless Registry, VHA's electronic health records, and the U.S. Census. We studied the relationships between neighborhood characteristics (% Veteran, % in poverty, % unemployed, % using public transportation, and % vacant properties) and VA healthcare use (primary care visits, outpatient mental health visits, and "high use" of emergency departments [> 4 visits]) using mixed-effects logistic and negative binomial regression models, controlling for patient demographics. We further examined moderation by patient healthcare need (calculated from cost and clinical data). We found that veterans in neighborhoods with higher percentages of residents who (a) were Veterans or (b) used public transportation were more likely to have high emergency department use. Those in neighborhoods with higher public transportation use had more primary care visits while those in neighborhoods with more property vacancies had more outpatient mental health visits. Among those with high healthcare needs, residents of areas with more Veterans had higher emergency department use. Promoting public transportation use and social engagement with other Veterans in residential neighborhoods may influence HUD-VASH Veterans' VA healthcare use. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/ser0000561DOI Listing
June 2021

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

BMJ 2021 05 11;373:n1038. Epub 2021 May 11.

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

Objective: To investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents.

Design: Multinational network cohort study.

Setting: Hospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea.

Participants: 303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020.

Main Outcome Measures: Prescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19.

Results: Of the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from <5 (<2%) patients in China to 2165 (85.1%) in Spain), azithromycin (from 15 (4.9%) in China to 1473 (57.9%) in Spain), combined lopinavir and ritonavir (from 156 (<2%) in the VA-OMOP US to 2,652 (34.9%) in South Korea and 1285 (50.5%) in Spain), and umifenovir (0% in the US, South Korea, and Spain and 238 (78.3%) in China). Use of adjunctive drugs varied greatly, with the five most used treatments being enoxaparin, fluoroquinolones, ceftriaxone, vitamin D, and corticosteroids. Hydroxychloroquine use increased rapidly from March to April 2020 but declined steeply in May to June and remained low for the rest of the year. The use of dexamethasone and corticosteroids increased steadily during 2020.

Conclusions: Multiple drugs were used in the first few months of the covid-19 pandemic, with substantial geographical and temporal variation. Hydroxychloroquine, azithromycin, lopinavir-ritonavir, and umifenovir (in China only) were the most prescribed repurposed drugs. Antithrombotics, antibiotics, H2 receptor antagonists, and corticosteroids were often used as adjunctive treatments. Research is needed on the comparative risk and benefit of these treatments in the management of covid-19.
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http://dx.doi.org/10.1136/bmj.n1038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111167PMC
May 2021

Actionable druggable genome-wide Mendelian randomization identifies repurposing opportunities for COVID-19.

Nat Med 2021 04 9;27(4):668-676. Epub 2021 Apr 9.

Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA.

Drug repurposing provides a rapid approach to meet the urgent need for therapeutics to address COVID-19. To identify therapeutic targets relevant to COVID-19, we conducted Mendelian randomization analyses, deriving genetic instruments based on transcriptomic and proteomic data for 1,263 actionable proteins that are targeted by approved drugs or in clinical phase of drug development. Using summary statistics from the Host Genetics Initiative and the Million Veteran Program, we studied 7,554 patients hospitalized with COVID-19 and >1 million controls. We found significant Mendelian randomization results for three proteins (ACE2, P = 1.6 × 10; IFNAR2, P = 9.8 × 10 and IL-10RB, P = 2.3 × 10) using cis-expression quantitative trait loci genetic instruments that also had strong evidence for colocalization with COVID-19 hospitalization. To disentangle the shared expression quantitative trait loci signal for IL10RB and IFNAR2, we conducted phenome-wide association scans and pathway enrichment analysis, which suggested that IFNAR2 is more likely to play a role in COVID-19 hospitalization. Our findings prioritize trials of drugs targeting IFNAR2 and ACE2 for early management of COVID-19.
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http://dx.doi.org/10.1038/s41591-021-01310-zDOI Listing
April 2021

Association of Posttraumatic Stress Disorder and Incident Ischemic Heart Disease in Women Veterans.

JAMA Cardiol 2021 Jun;6(6):642-651

Department of Psychology, UCLA.

Importance: Posttraumatic stress disorder (PTSD) is associated with greater risk of ischemic heart disease (IHD) in predominantly male populations or limited community samples. Women veterans represent a growing, yet understudied, population with high levels of trauma exposure and unique cardiovascular risks, but research on PTSD and IHD in this group is lacking.

Objective: To determine whether PTSD is associated with incident IHD in women veterans.

Design, Setting, And Participants: In this retrospective, longitudinal cohort study of the national Veterans Health Administration (VHA) electronic medical records, the a priori hypothesis that PTSD would be associated with greater risk of IHD onset was tested. Women veterans 18 years or older with and without PTSD who were patients in the VHA from January 1, 2000, to December 31, 2017, were assessed for study eligibility. Exclusion criteria consisted of no VHA clinical encounters after the index visit, IHD diagnosis at or before the index visit, and IHD diagnosis within 90 days of the index visit. Propensity score matching on age at index visit, number of prior visits, and presence of traditional and female-specific cardiovascular risk factors and mental and physical health conditions was conducted to identify women veterans ever diagnosed with PTSD, who were matched in a 1:2 ratio to those never diagnosed with PTSD. Data were analyzed from October 1, 2018, to October 30, 2020.

Exposures: PTSD, defined by International Classification of Diseases, Ninth Revision (ICD-9), or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10), diagnosis codes from inpatient or outpatient encounters.

Main Outcomes And Measures: Incident IHD, defined as new-onset coronary artery disease, angina, or myocardial infarction, based on ICD-9 and ICD-10 diagnosis codes from inpatient or outpatient encounters, and/or coronary interventions based on Current Procedural Terminology codes.

Results: A total of 398 769 women veterans, 132 923 with PTSD and 265 846 never diagnosed with PTSD, were included in the analysis. Baseline mean (SD) age was 40.1 (12.2) years. During median follow-up of 4.9 (interquartile range, 2.1-9.2) years, 4381 women with PTSD (3.3%) and 5559 control individuals (2.1%) developed incident IHD. In a Cox proportional hazards model, PTSD was significantly associated with greater risk of developing IHD (hazard ratio [HR], 1.44; 95% CI, 1.38-1.50). Secondary stratified analyses indicated that younger age identified women veterans with PTSD who were at greater risk of incident IHD. Effect sizes were largest for those younger than 40 years at baseline (HR, 1.72; 95% CI, 1.55-1.93) and decreased monotonically with increasing age (HR for ≥60 years, 1.24; 95% CI, 1.12-1.38).

Conclusions And Relevance: This cohort study found that PTSD was associated with increased risk of IHD in women veterans and may have implications for IHD risk assessment in vulnerable individuals.
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http://dx.doi.org/10.1001/jamacardio.2021.0227DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970390PMC
June 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

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

Variation in Sexual Orientation Documentation in a National Electronic Health Record System.

LGBT Health 2021 04 24;8(3):201-208. Epub 2021 Feb 24.

Suzanne Dworak-Peck School of Social Work, University of Southern California, Los Angeles, California, USA.

The purpose of this study was to determine variation in sexual minority (SM) sexual orientation documentation within the electronic medical records of the Veterans Health Administration (VHA). Documentation of SM sexual orientation was retrospectively extracted from clinical notes and administrative data in the VHA from October 1, 1999 to July 1, 2019. The rate of documentation overall and by calendar year was calculated, and differences across patient, provider, and clinic characteristics were evaluated. Approximately 1.4% of all VHA Veterans ( = 115,911) had at least one documentation of SM sexual orientation, including 79,455 men and 36,456 women. The rate of documentation increased from 81.01/100,000 in 2000 to 568.84/100,000 in 2018. The majority of documentations (58.7%) occurred in mental health settings by non-MD mental health/social work counselors, whereas only 9.6% occurred in primary care settings. Although 99% of these Veterans had a primary care visit, only 19% had SM status recorded in that setting. Documentation patterns of SM sexual orientation varied considerably in the VHA with notable gaps in primary care. Diverse approaches to culturally competent training for primary care clinicians and patient-facing collection strategies could facilitate documentation of sexual orientation.
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http://dx.doi.org/10.1089/lgbt.2020.0333DOI Listing
April 2021

International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study.

medRxiv 2021 Feb 5. Epub 2021 Feb 5.

BIOMERIS (BIOMedical Research Informatics Solutions).

Objectives: To perform an international comparison of the trajectory of laboratory values among hospitalized patients with COVID-19 who develop severe disease and identify optimal timing of laboratory value collection to predict severity across hospitals and regions.

Design: Retrospective cohort study.

Setting: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE), an international multi-site data-sharing collaborative of 342 hospitals in the US and in Europe.

Participants: Patients hospitalized with COVID-19, admitted before or after PCR-confirmed result for SARS-CoV-2. Primary and secondary outcome measures: Patients were categorized as ″ever-severe″ or ″never-severe″ using the validated 4CE severity criteria. Eighteen laboratory tests associated with poor COVID-19-related outcomes were evaluated for predictive accuracy by area under the curve (AUC), compared between the severity categories. Subgroup analysis was performed to validate a subset of laboratory values as predictive of severity against a published algorithm. A subset of laboratory values (CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin) was compared between North American and European sites for severity prediction.

Results: Of 36,447 patients with COVID-19, 19,953 (43.7%) were categorized as ever-severe. Most patients (78.7%) were 50 years of age or older and male (60.5%). Longitudinal trajectories of CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin showed association with disease severity. Significant differences of laboratory values at admission were found between the two groups. With the exception of D-dimer, predictive discrimination of laboratory values did not improve after admission. Sub-group analysis using age, D-dimer, CRP, and lymphocyte count as predictive of severity at admission showed similar discrimination to a published algorithm (AUC=0.88 and 0.91, respectively). Both models deteriorated in predictive accuracy as the disease progressed. On average, no difference in severity prediction was found between North American and European sites.

Conclusions: Laboratory test values at admission can be used to predict severity in patients with COVID-19. Prediction models show consistency across international sites highlighting the potential generalizability of these models.
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http://dx.doi.org/10.1101/2020.12.16.20247684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872369PMC
February 2021

International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study.

medRxiv 2021 Feb 5. Epub 2021 Feb 5.

BIOMERIS (BIOMedical Research Informatics Solutions).

Objectives: To perform an international comparison of the trajectory of laboratory values among hospitalized patients with COVID-19 who develop severe disease and identify optimal timing of laboratory value collection to predict severity across hospitals and regions.

Design: Retrospective cohort study.

Setting: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE), an international multi-site data-sharing collaborative of 342 hospitals in the US and in Europe.

Participants: Patients hospitalized with COVID-19, admitted before or after PCR-confirmed result for SARS-CoV-2. Primary and secondary outcome measures: Patients were categorized as ″ever-severe″ or ″never-severe″ using the validated 4CE severity criteria. Eighteen laboratory tests associated with poor COVID-19-related outcomes were evaluated for predictive accuracy by area under the curve (AUC), compared between the severity categories. Subgroup analysis was performed to validate a subset of laboratory values as predictive of severity against a published algorithm. A subset of laboratory values (CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin) was compared between North American and European sites for severity prediction.

Results: Of 36,447 patients with COVID-19, 19,953 (43.7%) were categorized as ever-severe. Most patients (78.7%) were 50 years of age or older and male (60.5%). Longitudinal trajectories of CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin showed association with disease severity. Significant differences of laboratory values at admission were found between the two groups. With the exception of D-dimer, predictive discrimination of laboratory values did not improve after admission. Sub-group analysis using age, D-dimer, CRP, and lymphocyte count as predictive of severity at admission showed similar discrimination to a published algorithm (AUC=0.88 and 0.91, respectively). Both models deteriorated in predictive accuracy as the disease progressed. On average, no difference in severity prediction was found between North American and European sites.

Conclusions: Laboratory test values at admission can be used to predict severity in patients with COVID-19. Prediction models show consistency across international sites highlighting the potential generalizability of these models.
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http://dx.doi.org/10.1101/2020.12.16.20247684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872369PMC
February 2021

International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study.

medRxiv 2021 Feb 5. Epub 2021 Feb 5.

BIOMERIS (BIOMedical Research Informatics Solutions).

Objectives: To perform an international comparison of the trajectory of laboratory values among hospitalized patients with COVID-19 who develop severe disease and identify optimal timing of laboratory value collection to predict severity across hospitals and regions.

Design: Retrospective cohort study.

Setting: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE), an international multi-site data-sharing collaborative of 342 hospitals in the US and in Europe.

Participants: Patients hospitalized with COVID-19, admitted before or after PCR-confirmed result for SARS-CoV-2. Primary and secondary outcome measures: Patients were categorized as ″ever-severe″ or ″never-severe″ using the validated 4CE severity criteria. Eighteen laboratory tests associated with poor COVID-19-related outcomes were evaluated for predictive accuracy by area under the curve (AUC), compared between the severity categories. Subgroup analysis was performed to validate a subset of laboratory values as predictive of severity against a published algorithm. A subset of laboratory values (CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin) was compared between North American and European sites for severity prediction.

Results: Of 36,447 patients with COVID-19, 19,953 (43.7%) were categorized as ever-severe. Most patients (78.7%) were 50 years of age or older and male (60.5%). Longitudinal trajectories of CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin showed association with disease severity. Significant differences of laboratory values at admission were found between the two groups. With the exception of D-dimer, predictive discrimination of laboratory values did not improve after admission. Sub-group analysis using age, D-dimer, CRP, and lymphocyte count as predictive of severity at admission showed similar discrimination to a published algorithm (AUC=0.88 and 0.91, respectively). Both models deteriorated in predictive accuracy as the disease progressed. On average, no difference in severity prediction was found between North American and European sites.

Conclusions: Laboratory test values at admission can be used to predict severity in patients with COVID-19. Prediction models show consistency across international sites highlighting the potential generalizability of these models.
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http://dx.doi.org/10.1101/2020.12.16.20247684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872369PMC
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.

Bayer Pharmaceuticals, Sant Joan Despi, Spain.

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.

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

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

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

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

The Utility of Clinical Notes for Sexual Minority Health Research.

Am J Prev Med 2020 11 1;59(5):755-763. Epub 2020 Oct 1.

VA Informatics and Computing Infrastructure, VA Salt Lake City Health Care System, Salt Lake City, Utah; Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah.

Introduction: Despite improvements in electronic medical record capability to collect data on sexual orientation, not all healthcare systems have adopted this practice. This can limit the usability of systemwide electronic medical record data for sexual minority research. One viable resource might be the documentation of sexual orientation within clinical notes. The authors developed an approach to identify sexual orientation documentation and subsequently derived a cohort of sexual minority patients using clinical notes from the Veterans Health Administration electronic medical record.

Methods: A hybrid natural language processing approach was developed and used to identify and categorize instances of terms and phrases related to sexual orientation in Veterans Health Administration clinical notes from 2000 to 2019. System performance was assessed with positive predictive value and sensitivity. Data were analyzed in 2019.

Results: A total of 2,413,584 sexual minority terms/phrases were found within clinical notes, of which 439,039 (18%) were found to be related to patient sexual orientation with a positive predictive value of 85.9%. Documentation of sexual orientation was found for 115,312 patients. When compared with 2,262 patients with a record of administrative coding for homosexuality, the system found mentions of sexual orientation for 1,808 patients (79.9% sensitivity).

Conclusions: When systemwide structured data are unavailable or inconsistent, deriving a cohort of sexual minority patients in electronic medical records for research is possible and permits longitudinal analysis across multiple clinical domains. Although limitations and challenges to the approach were identified, this study makes an important step forward for the Veterans Health Administration sexual minority research, and the methodology can be applied in other healthcare organizations.
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http://dx.doi.org/10.1016/j.amepre.2020.05.026DOI Listing
November 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

Association of Depression and Post-Traumatic Stress Disorder with Receipt of Minimally Invasive Hysterectomy for Uterine Fibroids: Findings from the U.S. Department of Veterans Affairs.

Womens Health Issues 2020 Sep - Oct;30(5):359-365. Epub 2020 Jul 22.

U.S. Department of Veterans Affairs (VA) Puget Sound Health Care System, Health Services Research and Development Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, Washington; Department of Health Services, University of Washington, Seattle, Washington.

Background: When hysterectomy is used to treat uterine fibroids, a minimally invasive versus open abdominal approach is preferred. Depression and post-traumatic stress disorder (PTSD) may be associated with surgical mode. We sought to examine whether depression and PTSD are associated with minimally invasive hysterectomy (MIH).

Methods: This was a cross-sectional study of veterans with uterine fibroids undergoing hysterectomy in the Department of Veterans Affairs between 2012 and 2014. Diagnoses and procedures were identified by International Classification of Disease, Ninth Revision, codes. MIH was defined as laparoscopic, vaginal, or robotic-assisted versus open abdominal. A dichotomous variable indicated presence of depression or PTSD. Clinical variables, including uterine size, were abstracted from the medical record. We employed generalized linear models to estimate adjusted percentages and 95% confidence intervals (CIs) of MIH by presence of depression or PTSD and sequentially adjusted for sociodemographic variables and health indicators (model 1), and then gynecologic and reproductive history variables, including uterine size (model 2).

Results: We included 770 veterans in our analytic sample. Veterans with depression or PTSD were more likely than those without such diagnoses to have a MIH (49% vs. 42%). Differences were attenuated in model 1 (47% [95% CI, 37%-57%] vs. 43% [95% CI, 34%-52%]) and no longer detectable in model 2 (45% [95% CI, 36%-54%] vs. 44% [95% CI, 36%-52%]).

Conclusions: Veterans with depression or PTSD were more likely that those without to have a MIH, possibly owing to smaller uterine size, suggesting that they may be undergoing hysterectomy earlier in the disease process. Further research is needed to understand whether this reflects high-quality, patient-centered care.
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http://dx.doi.org/10.1016/j.whi.2020.06.005DOI Listing
October 2020

COVID-19 TestNorm: A tool to normalize COVID-19 testing names to LOINC codes.

J Am Med Inform Assoc 2020 07;27(9):1437-1442

School of Biomedical Informatics, University of Texas, Houston, Texas, USA.

Large observational data networks that leverage routine clinical practice data in electronic health records (EHRs) are critical resources for research on coronavirus disease 2019 (COVID-19). Data normalization is a key challenge for the secondary use of EHRs for COVID-19 research across institutions. In this study, we addressed the challenge of automating the normalization of COVID-19 diagnostic tests, which are critical data elements, but for which controlled terminology terms were published after clinical implementation. We developed a simple but effective rule-based tool called COVID-19 TestNorm to automatically normalize local COVID-19 testing names to standard LOINC (Logical Observation Identifiers Names and Codes) codes. COVID-19 TestNorm was developed and evaluated using 568 test names collected from 8 healthcare systems. Our results show that it could achieve an accuracy of 97.4% on an independent test set. COVID-19 TestNorm is available as an open-source package for developers and as an online Web application for end users (https://clamp.uth.edu/covid/loinc.php). We believe that it will be a useful tool to support secondary use of EHRs for research on COVID-19.
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http://dx.doi.org/10.1093/jamia/ocaa145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7337837PMC
July 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.

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

The impact of low- versus high-intensity surveillance cystoscopy on surgical care and cancer outcomes in patients with high-risk non-muscle-invasive bladder cancer (NMIBC).

PLoS One 2020 23;15(3):e0230417. Epub 2020 Mar 23.

White River Junction VA Medical Center, White River Junction, VT, United States of America.

Purpose: To assess the association of low- vs. guideline-recommended high-intensity cystoscopic surveillance with outcomes among patients with high-risk non-muscle invasive bladder cancer (NMIBC).

Materials & Methods: A retrospective cohort study of Veterans Affairs patients diagnosed with high-risk NMIBC between 2005 and 2011 with follow-up through 2014. Patients were categorized by number of surveillance cystoscopies over two years following diagnosis: low- (1-5) vs. high-intensity (6 or more) surveillance. Propensity score adjusted regression models were used to assess the association of low-intensity cystoscopic surveillance with frequency of transurethral resections, and risk of progression to invasive disease and bladder cancer death.

Results: Among 1,542 patients, 520 (33.7%) underwent low-intensity cystoscopic surveillance. Patients undergoing low-intensity surveillance had fewer transurethral resections (37 vs. 99 per 100 person-years; p<0.001). Risk of death from bladder cancer did not differ significantly by low (cumulative incidence [CIn] 8.4% [95% CI 6.5-10.9) at 5 years) vs. high-intensity surveillance (CIn 9.1% [95% CI 7.4-11.2) at 5 years, p = 0.61). Low vs. high-intensity surveillance was not associated with increased risk of bladder cancer death among patients with Ta (CIn 5.7% vs. 8.2% at 5 years p = 0.24) or T1 disease at diagnosis (CIn 10.2% vs. 9.1% at 5 years, p = 0.58). Among patients with Ta disease, low-intensity surveillance was associated with decreased risk of progression to invasive disease (T1 or T2) or bladder cancer death (CIn 19.3% vs. 31.3% at 5 years, p = 0.002).

Conclusions: Patients with high-risk NMIBC undergoing low- vs. high-intensity cystoscopic surveillance underwent fewer transurethral resections, but did not experience an increased risk of progression or bladder cancer death. These findings provide a strong rationale for a clinical trial to determine whether low-intensity surveillance is comparable to high-intensity surveillance for cancer control in high-risk NMIBC.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230417PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7089561PMC
June 2020

Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility.

Pharmacoepidemiol Drug Saf 2020 01;29(1):18-29

Duke University, Durham, North Carolina.

Purpose: To provide guidance on data linkage appropriateness and feasibility to plan purposeful and sustainable new linkages that advance pharmacoepidemiology and healthcare research. Planning a new data linkage requires careful evaluation to weigh the resources required with the potential overall benefits.

Methods: In response to an International Society for Pharmacoepidemiology (ISPE) call for manuscripts, a working group comprised of members from academic, industry, and government determined priority content areas; appropriateness and feasibility of data linkage was selected. Within this topic, scientific and operational considerations were determined, reviewed, and formulated into key areas, and translated into 12 consensus recommendations.

Results: Guidance for feasibility assessment was categorized into five key areas: (1) research objectives and justification; (2) data quality and completeness; (3) the linkage process; (4) data ownership and governance; and (5) overall value added by linkage. Within these key areas, recommendations to consider prior to initiation were developed to evaluate suitability of the linkage to meet research objectives, assess source data completeness and population coverage, and ensure well-defined data governance standards and protections. When creating novel linked datasets, researchers must assess the feasibility of both scientific (data quality and linkage methods) and operational (access, data use and transfer, governance, and cost) aspects.

Conclusions: The data linkage feasibility assessment considerations outlined can be used as a guide when designing sustainable linked data resources to generate actionable evidence in healthcare research. These recommendations were constructed for wide applicability and can be adapted depending on the geographic, structural, and data components of the linkage.
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http://dx.doi.org/10.1002/pds.4918DOI Listing
January 2020

Sex and the Diagnostic Pathway to Bladder Cancer among Veterans: No Evidence of Disparity.

Womens Health Issues 2020 Mar - Apr;30(2):128-135. Epub 2019 Dec 24.

The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, Lebanon, New Hampshire; White River Junction VA Medical Center, White River Junction, Vermont; Section of Urology and Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.

Background: Longer time intervals from presentation with hematuria to bladder cancer diagnosis have been reported among women compared with men. Despite women being the fastest growing cohort within the Department of Veterans Affairs, little is known about women veterans with bladder cancer. Our objectives were to quantify the time from hematuria to bladder cancer diagnosis in Department of Veterans Affairs and assess differences between sexes.

Methods: This was a retrospective cohort study of patients diagnosed with bladder cancer from 2001 to 2016. Included were patients with hematuria for fewer than 365 days before a bladder cancer diagnosis and who had a record of diagnostic cystoscopy after hematuria but before diagnosis. We evaluated the number of days from hematuria to diagnostic cystoscopy (clinical appraisal), cystoscopy to bladder cancer diagnosis (surgical appraisal), and hematuria to bladder cancer diagnosis (total diagnostic appraisal). We used quantile regression models to separately evaluate the effect of sex on the three appraisal intervals.

Results: Data from 213 women and 24,295 men were analyzed. The median clinical appraisal time was 78 days for women and 72 for men (p = .49). The median surgical appraisal time was 32 days for women and 33 for men (p = .74). The median total diagnostic appraisal time was 135 days for women and 130 for men (p = .71). Multivariable analyses showed no differences between men and women for any of the three appraisal intervals.

Conclusions: The majority of time from hematuria to bladder cancer diagnosis is spent in clinical appraisal, but little difference was observed between men and women in Department of Veterans Affairs.
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http://dx.doi.org/10.1016/j.whi.2019.11.001DOI Listing
August 2020

Contributors to Racial Disparities in Minimally Invasive Hysterectomy in the US Department of Veterans Affairs.

Med Care 2019 12;57(12):930-936

Health Services Research and Development (HSR&D), Center of Innovation for Veteran-Centered and Value-Driven Care, US Department of Veterans Affairs (VA) Puget Sound Health Care System.

Background: Minimally invasive hysterectomy for fibroids decreases recovery time and risk of postoperative complications compared with abdominal hysterectomy. Within Veterans Affair (VA), black women with uterine fibroids are less likely to receive a minimally invasive hysterectomy than white women.

Objective: To quantify the contributions of patient, facility, temporal and geographic factors to VA black-white disparity in minimally invasive hysterectomy.

Research Design: A cross-sectional study.

Subjects: Veterans with fibroids and hysterectomy performed in VA between October 1, 2012 and September 30, 2015.

Measures: Hysterectomy mode was defined using ICD-9 codes as minimally invasive (laparoscopic, vaginal, or robotic-assisted) versus abdominal. The authors estimated a logistic regression model with minimally invasive hysterectomy modeled as a function of 4 sets of factors: sociodemographic characteristics other than race, health risk factors, facility, and temporal and geographic factors. Using decomposition techniques, systematically substituting each white woman's characteristics for each black woman's characteristics, then recalculating the predicted probability of minimally invasive hysterectomy for black women for each possible combination of factors, we quantified the contribution of each set of factors to observed disparities in minimally invasive hysterectomy.

Results: Among 1255 veterans with fibroids who had a hysterectomy at a VA, 61% of black women and 39% of white women had an abdominal hysterectomy. Our models indicated there were 99 excess abdominal hysterectomies among black women. The majority (n=77) of excess abdominal hysterectomies were unexplained by measured sociodemographic factors beyond race, health risk factors, facility, and temporal or geographic trends.

Conclusion: Closer examination of the equity of VA gynecology care and ways in which the VA can work to ensure equitable care for all women veterans is necessary.
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http://dx.doi.org/10.1097/MLR.0000000000001200DOI Listing
December 2019

Incrementally Transforming Electronic Medical Records into the Observational Medical Outcomes Partnership Common Data Model: A Multidimensional Quality Assurance Approach.

Appl Clin Inform 2019 10 23;10(5):794-803. Epub 2019 Oct 23.

Vanderbilt University Medical Center, Nashville, Tennessee, United States.

Background: The development and adoption of health care common data models (CDMs) has addressed some of the logistical challenges of performing research on data generated from disparate health care systems by standardizing data representations and leveraging standardized terminology to express clinical information consistently. However, transforming a data system into a CDM is not a trivial task, and maintaining an operational, enterprise capable CDM that is incrementally updated within a data warehouse is challenging.

Objectives: To develop a quality assurance (QA) process and code base to accompany our incremental transformation of the Department of Veterans Affairs Corporate Data Warehouse health care database into the Observational Medical Outcomes Partnership (OMOP) CDM to prevent incremental load errors.

Methods: We designed and implemented a multistage QA) approach centered on completeness, value conformance, and relational conformance data-quality elements. For each element we describe key incremental load challenges, our extract, transform, and load (ETL) solution of data to overcome those challenges, and potential impacts of incremental load failure.

Results: Completeness and value conformance data-quality elements are most affected by incremental changes to the CDW, while updates to source identifiers impact relational conformance. ETL failures surrounding these elements lead to incomplete and inaccurate capture of clinical concepts as well as data fragmentation across patients, providers, and locations.

Conclusion: Development of robust QA processes supporting accurate transformation of OMOP and other CDMs from source data is still in evolution, and opportunities exist to extend the existing QA framework and tools used for incremental ETL QA processes.
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http://dx.doi.org/10.1055/s-0039-1697598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811349PMC
October 2019

Characterizing VA Users with the OMOP Common Data Model.

Stud Health Technol Inform 2019 Aug;264:1614-1615

VA Informatics and Computing Infrastructure, Department of Veterans Affairs, Salt Lake City, UT, USA.

In 2015, the VA Informatics and Computing Infrastructure, a resource center of the Department of Veterans Affairs, began to transform parts of its Corporate Data Warehouse (CDW) into the Observational Medical Outcomes Partnership) Common Data Model for use by its research and operations communities. Using the hierarchical relationships within the clinical vocabularies in OMOP we found differences in visits, disease prevalence, and medications prescribed between male and female veterans seen between VA fiscal years 2000-17.
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http://dx.doi.org/10.3233/SHTI190561DOI Listing
August 2019

Using Enriched Samples for Semi-Automated Vocabulary Expansion to Identify Rare Events in Clinical Text: Sexual Orientation as a Use Case.

Stud Health Technol Inform 2019 Aug;264:1532-1533

VA Informatics and Computing Infrastructure, Department of Veterans Affairs, Salt Lake City, UT, USA.

We demonstrate the utility of concept lexicon expansion and evaluation using enriched samples of patients and documents with sexual orientation as a use case for rare event detection in electronic medical records. Using this approach, we found 7 additional words and 21 misspellings beyond our initial set of five seed words. We can use the expanded vocabulary to further develop a full natural language processing system to identify instances where sexual orientation is documented.
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http://dx.doi.org/10.3233/SHTI190520DOI Listing
August 2019

Overuse of Cystoscopic Surveillance Among Patients With Low-risk Non-Muscle-invasive Bladder Cancer - A National Study of Patient, Provider, and Facility Factors.

Urology 2019 Sep 28;131:112-119. Epub 2019 May 28.

The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, Lebanon, NH; The White River Junction VA Medical Center, White River Junction, VT; Section of Urology, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

Objective: To understand cystoscopic surveillance practices among patients with low-risk non-muscle-invasive bladder cancer (NMIBC) within the Department of Veterans Affairs (VA).

Methods: Using a validated natural language processing algorithm, we included patients newly diagnosed with low-risk (ie low-grade Ta) NMIBC from 2005 to 2011 in the VA. Patients were followed until cancer recurrence, death, last contact, or 2 years after diagnosis. Based on guidelines, surveillance overuse was defined as >1 cystoscopy if followed <1 year, >2 cystoscopies if followed 1 to <2 years, or >3 cystoscopies if followed for 2 years. We identified patient, provider, and facility factors associated with overuse using multilevel logistic regression.

Results: Overuse occurred in 75% of patients (852/1135) - with an excess of 1846 more cystoscopies performed than recommended. Adjusting for 14 factors, overuse was associated with patient race (odds ratio [OR] 0.49, 95% confidence interval [CI]: 0.28, 0.85 unlisted race vs White), having 2 comorbidities (OR 1.60, 95% CI: 1.00, 2.55 vs no comorbidities), and earlier year of diagnosis (OR 2.50, 95% CI: 1.29, 4.83 for 2005 vs 2011, and OR 2.03, 95% CI: 1.11, 3.69 for 2006 vs 2011). On sensitivity analyses assuming all patients were diagnosed with multifocal or large low-grade tumors (ie, intermediate-risk), overuse would have still occurred in 45% of patients.

Conclusion: Overuse of cystoscopy among patients with low-risk NMIBC was common, raising concerns about bladder cancer surveillance cost and quality. However, few factors were associated with overuse. Further qualitative research is needed to identify other determinants of overuse not readily captured in administrative data.
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http://dx.doi.org/10.1016/j.urology.2019.04.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6711796PMC
September 2019