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1.
Am J Gastroenterol ; 2024 Sep 04.
Article in English | MEDLINE | ID: mdl-39235290

ABSTRACT

BACKGROUND: Spontaneous bacterial peritonitis (SBP) bacteriology has changed over time. Reappraisal of primary SBP prophylaxis showed an increased rate of resistance in patients on primary prophylaxis with resultant discontinuation of this prophylaxis throughout the VA. We aimed to re-evaluate the risk-benefit ratio of secondary SBP prophylaxis (SecSBPPr). METHODS: Using validated ICD 9/10 codes, we utilized the VA Corporate Data Warehouse and the Non-VA National TriNetX database to identify patients in two different large US systems who survived their first SBP diagnosis (with chart review from two VA centers) between 2009-2019. We evaluated the prevalence of SecSBPPr and compared outcomes between those started on SecSBPPr versus not. RESULTS: We identified 4673 Veterans who survived their index SBP episode; 54.3% of whom were prescribed SecSBPPr. Multivariable analysis showed higher SBP recurrence risk in those on vs. off SecSBPPr(HR-1.63[1.40-1.91], p<0.001). This was accompanied by higher fluroquinolone-resistance odds in SecSBPPr patients (OR=4.32[1.36-15.83], p=0.03). In TriNetX we identified 6708 patients who survived their index SBP episode; 48.6% were on SecSBPPr. Multivariable analysis similarly showed SecSBPPr increased SBP recurrence risk (HR-1.68[1.33-1.80], p<0.001). Both datasets showed higher SBP recurrence trends over time in SecSBPPr patients. Results remained consistent at 6-month and 2-year timepoints. CONCLUSION: In two national data sets of >11,000 patients with SBP we found that SecSBPPr was prescribed in roughly half of patients. When initiated, SecSBPPr, compared to no prophylaxis after SBP, increased the risk of SBP recurrence in multivariable analysis by 63-68%, and this trend worsened over time. SecSBPPr should be reconsidered in cirrhosis.

3.
Transpl Infect Dis ; : e14333, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38980969

ABSTRACT

BACKGROUND: While coronavirus disease 2019 (COVID-19) is no longer a public health emergency, certain patients remain at risk of severe outcomes. To better understand changing risk profiles, we studied the risk factors for patients with and without solid organ transplantation (SOT) through the various waves of the pandemic. METHODS: Using the National COVID Cohort Collaborative we studied a cohort of adult patients testing positive for COVID-19 between January 1, 2020, and May 2, 2022. We separated the data into waves of COVID-19 as defined by the Centers for Disease Control. In our primary outcome, we used multivariable survival analysis to look at various risk factors for hospitalization in those with and without SOT. RESULTS: A total of 3,570,032 patients were captured. We found an overall risk attenuation of adverse COVID-19-associated outcomes over time. In both non-SOT and SOT populations, diabetes, chronic kidney disease, and congestive heart failure were risk factors for hospitalization. For SOT specifically, longer time periods between transplant and COVID-19 were protective and age was a risk factor. Notably, asthma was not a risk factor for major adverse renal cardiovascular events, hospitalization, or mortality in either group. CONCLUSIONS: Our study provides a longitudinal view of the risks associated with adverse COVID-related outcomes amongst SOT and non-SOT patients, and how these risk factors evolved over time. Our work will help inform providers and policymakers to better target high-risk patients.

4.
Laryngoscope ; 2024 Jul 30.
Article in English | MEDLINE | ID: mdl-39077963

ABSTRACT

OBJECTIVE: Although olfactory dysfunction is one of the most common presenting signs of COVID-19 infection, little is known about which populations are most susceptible. The aim of this study is to evaluate the risk of COVID-19-induced chemosensory dysfunction in malnourished individuals. METHODS: The N3C database was queried for adults having positive COVID-19 test result, diagnosis of chemosensory dysfunction within 2 weeks of positive test date, and overnutrition or undernutrition (i.e., deficiency or excess of micro- and macronutrients) related diagnoses prior to COVID-19 infection. Individuals previously diagnosed with chemosensory dysfunction were excluded. COVID-19-positive adults without olfactory dysfunction were similarly analyzed. Statistical analysis was performed using odds ratio calculations (95% confidence interval [CI]). RESULTS: Of 3,971,536 patients with COVID-19, 73,211 adults were identified with a diagnosis of undernutrition and 428,747 adults were identified with a diagnosis of overnutrition prior to infection. Of those with undernutrition, 264 (0.36%) individuals were identified with a diagnosis of olfactory dysfunction within 2 weeks of infection. Of those with overnutrition, 2851 (0.66%) individuals were identified with a diagnosis of olfactory dysfunction within 2 weeks of infection. The calculated odds ratio for undernutrition and olfactory dysfunction was 0.731 (p < 0.0001, 95% CI [0.0647, 0.0825]). The calculated odds ratio for overnutrition and olfactory dysfunction was 1.419 (p < 0.0001, 95% CI [1.3359, 1.5081]). CONCLUSION: Overnutrition may increase the risk of COVID-19-related olfactory dysfunction, while undernutrition may slightly protect. While reasons are unclear, baseline differences in metabolic, inflammatory, and structural biochemistry deserve closer inspection. LEVEL OF EVIDENCE: 3 Laryngoscope, 2024.

5.
medRxiv ; 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38947087

ABSTRACT

Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long-COVID, encompasses a variety of complex and varied outcomes following COVID-19 infection that are still poorly understood. We clustered over 600 million condition diagnoses from 14 million patients available through the National COVID Cohort Collaborative (N3C), generating hundreds of highly detailed clinical phenotypes. Assessing patient clinical trajectories using these clusters allowed us to identify individual conditions and phenotypes strongly increased after acute infection. We found many conditions increased in COVID-19 patients compared to controls, and using a novel method to associate patients with clusters over time, we additionally found phenotypes specific to patient sex, age, wave of infection, and PASC diagnosis status. While many of these results reflect known PASC symptoms, the resolution provided by this unprecedented data scale suggests avenues for improved diagnostics and mechanistic understanding of this multifaceted disease.

6.
Am J Transplant ; 24(9): 1675-1689, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38857785

ABSTRACT

Postacute sequelae after the coronavirus disease (COVID) of 2019 (PASC) is increasingly recognized, although data on solid organ transplant (SOT) recipients (SOTRs) are limited. Using the National COVID Cohort Collaborative, we performed 1:1 propensity score matching (PSM) of all adult SOTR and nonimmunosuppressed/immunocompromised (ISC) patients with acute COVID infection (August 1, 2021 to January 13, 2023) for a subsequent PASC diagnosis using International Classification of Diseases, 10th Revision, Clinical Modification codes. Multivariable logistic regression was used to examine not only the association of SOT status with PASC, but also other patient factors after stratifying by SOT status. Prior to PSM, there were 8769 SOT and 1 576 769 non-ISC patients with acute COVID infection. After PSM, 8756 SOTR and 8756 non-ISC patients were included; 2.2% of SOTR (n = 192) and 1.4% (n = 122) of non-ISC patients developed PASC (P value < .001). In the overall matched cohort, SOT was independently associated with PASC (adjusted odds ratio [aOR], 1.48; 95% confidence interval [CI], 1.09-2.01). Among SOTR, COVID infection severity (aOR, 11.6; 95% CI, 3.93-30.0 for severe vs mild disease), older age (aOR, 1.02; 95% CI, 1.01-1.03 per year), and mycophenolate mofetil use (aOR, 2.04; 95% CI, 1.38-3.05) were each independently associated with PASC. In non-ISC patients, only depression (aOR, 1.96; 95% CI, 1.24-3.07) and COVID infection severity were. In conclusion, PASC occurs more commonly in SOTR than in non-ISC patients, with differences in risk profiles based on SOT status.


Subject(s)
COVID-19 , Organ Transplantation , SARS-CoV-2 , Transplant Recipients , Humans , COVID-19/epidemiology , Male , Female , Middle Aged , Organ Transplantation/adverse effects , Transplant Recipients/statistics & numerical data , Aged , Adult , Prevalence , Risk Factors , Post-Acute COVID-19 Syndrome , Cohort Studies , United States/epidemiology , Retrospective Studies , Immunocompromised Host , Propensity Score
7.
Otol Neurotol Open ; 4(2): e051, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38919767

ABSTRACT

Objective: Determine the incidence of vestibular disorders in patients with SARS-CoV-2 compared to the control population. Study Design: Retrospective. Setting: Clinical data in the National COVID Cohort Collaborative database (N3C). Methods: Deidentified patient data from the National COVID Cohort Collaborative database (N3C) were queried based on variant peak prevalence (untyped, alpha, delta, omicron 21K, and omicron 23A) from covariants.org to retrospectively analyze the incidence of vestibular disorders in patients with SARS-CoV-2 compared to control population, consisting of patients without documented evidence of COVID infection during the same period. Results: Patients testing positive for COVID-19 were significantly more likely to have a vestibular disorder compared to the control population. Compared to control patients, the odds ratio of vestibular disorders was significantly elevated in patients with untyped (odds ratio [OR], 2.39; confidence intervals [CI], 2.29-2.50; P < 0.001), alpha (OR, 3.63; CI, 3.48-3.78; P < 0.001), delta (OR, 3.03; CI, 2.94-3.12; P < 0.001), omicron 21K variant (OR, 2.97; CI, 2.90-3.04; P < 0.001), and omicron 23A variant (OR, 8.80; CI, 8.35-9.27; P < 0.001). Conclusions: The incidence of vestibular disorders differed between COVID-19 variants and was significantly elevated in COVID-19-positive patients compared to the control population. These findings have implications for patient counseling and further research is needed to discern the long-term effects of these findings.

8.
Am J Med ; 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38942345

ABSTRACT

BACKGROUND: Dementia and hepatic encephalopathy (HE) have symptom overlap and are challenging to differentiate. The presence of undiagnosed cirrhosis may lead to missed opportunities to treat HE, which was found in a veterans database. This needs validation in a non-veteran cohort. METHODS: A retrospective cohort study was conducted between 2009 and 2019 using national non-Veteran patient data from the multi-center TriNetX database. Participants included 68,807 patients with a dementia diagnosis at ≥2 visits, no prior diagnosis of cirrhosis, and with sufficient laboratory test results to calculate the Fibrosis-4 (FIB-4) index, which indicates liver disease. Prevalences of high FIB-4 scores (>2.67 and >3.25) were measured within the cohort, and associations between high FIB-4 and comorbidities/demographics were examined. RESULTS: Within the cohort (44.7% male, 78.0% White, mean age 72.73 years (±11.09), 7.6% (n = 5815) had a FIB-4 index > 3.25 and 12.8% (n = 8683) had FIB-4 > 2.67. In multivariable logistic regression models, FIB-4 > 3.25 was associated with male gender (OR: 1.42 [1.33-1.51]), congestive heart failure (OR: 1.73 [1.59-1.87]), viral hepatitis (OR: 2.23 [1.84-2.68]), alcohol use disorder (OR: 1.39 [1.22-1.58]), and chronic kidney disease (OR: 1.38 [1.28-1.48]), and inversely associated with White race (OR: 0.76 [0.71-0.82]) and diabetes (OR: 0.82 [0.77-0.88]). Similar findings were associated with the FIB-4 > 2.67 threshold. CONCLUSION: The findings of this national cohort suggest that the FIB-4 index could be utilized to screen for potential undiagnosed cirrhosis in patients with dementia, and that hepatic encephalopathy might be misdiagnosed as dementia or cause worsening of cognitive function in patients with dementia.

9.
J Clin Transl Sci ; 7(1): e213, 2023.
Article in English | MEDLINE | ID: mdl-38028347

ABSTRACT

Background: The Fibrosis-4 (FIB-4) index, a simple index that includes age, liver enzymes, and platelet count has been studied as a tool to identify patients at a risk of requiring mechanical ventilation due to its high negative predictive value. It is unknown if FIB-4 remains useful to predict the severity of respiratory disease requiring mechanical ventilation amongst new Coronavirus disease 2019 (COVID-19) variants and whether a relationship also exists between FIB-4 and 30-day mortality. The main objective was to determine if FIB-4 can predict mechanical ventilation requirements and 30-day mortality from COVID-19 across variants including Alpha, Delta, and Omicron. Methods: This was a population-based, retrospective cohort analysis of 232,364 hospitalized patients in the National COVID-19 Cohort Collaborative between the age of 18-90 who tested positive for COVID-19 between April 27, 2020 and June 25, 2022. The primary outcome was association between FIB-4 and need for mechanical ventilation. Secondary measures included the association of FIB-4 with 30-day mortality. Results: A FIB-4 > 2.67 had 1.8 times higher odds of requiring mechanical ventilation across all variants of COVID-19 (OR 1.81; 95% CI: [1.76, 1.86]). The area under the ROC curve showed high diagnostic accuracy with values ranging between 0.79 (Omicron wave) and 0.97 (delta wave). Increased FIB-4 was associated with 30-day mortality across the variates. Conclusion: The FIB-4 was consistently associated with both increased utilization of mechanical ventilation and 30-day mortality among COVID-19 patients across all waves in both adjusted and unadjusted models. This provides a simple tool for risk-stratification for front-line health care professionals.

10.
Otolaryngol Head Neck Surg ; 169(5): 1386-1389, 2023 11.
Article in English | MEDLINE | ID: mdl-37232470

ABSTRACT

Chemosensory losses have long been considered a cardinal symptom of COVID-19 infection. Recent studies have shown changing symptom profiles with COVID-19, including decreasing incidence of olfactory losses. We accessed the National COVID Cohort Collaborative database to identify patients with and without smell and taste loss within 2 weeks of COVID-19 diagnosis. Peak prevalence time intervals for variants were determined from Covariants.org. Using rates of chemosensory loss during the peak time interval for "Untyped" variants as baseline (4/27/2020-6/18/2020), odds ratios for COVID-19-associated smell or taste disturbance fell for each of the Alpha (0.744), Delta (0.637), Omicron K (0.139), Omicron L (0.079), Omicron C (0.061), and Omicron B (0.070) peak intervals. These data suggest that during the recent Omicron waves and potentially moving forward, the presence or absence of smell and taste disturbances may no longer have predictive value in the diagnosis of COVID-19 infection.


Subject(s)
COVID-19 , Olfaction Disorders , Humans , COVID-19/complications , SARS-CoV-2 , COVID-19 Testing , Taste Disorders/epidemiology , Olfaction Disorders/epidemiology , Olfaction Disorders/etiology , Olfaction Disorders/diagnosis , Smell
11.
Am J Transplant ; 23(7): 1035-1047, 2023 07.
Article in English | MEDLINE | ID: mdl-37105315

ABSTRACT

Exogenous estrogen is associated with reduced coronavirus disease (COVID) mortality in nonimmunosuppressed/immunocompromised (non-ISC) postmenopausal females. Here, we examined the association of estrogen or testosterone hormone replacement therapy (HRT) with COVID outcomes in solid organ transplant recipients (SOTRs) compared to non-ISC individuals, given known differences in sex-based risk in these populations. SOTRs ≥45 years old with COVID-19 between April 1, 2020 and July 31, 2022 were identified using the National COVID Cohort Collaborative. The association of HRT use in the last 24 months (exogenous systemic estrogens for females; testosterone for males) with major adverse renal or cardiac events in the 90 days post-COVID diagnosis and other secondary outcomes were examined using multivariable Cox proportional hazards models and logistic regression. We repeated these analyses in a non-ISC control group for comparison. Our study included 1135 SOTRs and 43 383 immunocompetent patients on HRT with COVID-19. In non-ISC, HRT use was associated with lower risk of major adverse renal or cardiac events (adjusted hazard ratio [aHR], 0.61; 95% confidence interval [CI], 0.57-0.65 for females; aHR, 0.70; 95% CI, 0.65-0.77 for males) and all secondary outcomes. In SOTR, HRT reduced the risk of acute kidney injury (aHR, 0.79; 95% CI, 0.63-0.98) and mortality (aHR, 0.49; 95% CI, 0.28-0.85) in males with COVID but not in females. The potentially modifying effects of immunosuppression on the benefits of HRT requires further investigation.


Subject(s)
COVID-19 , Cardiovascular Diseases , Organ Transplantation , Male , Female , Humans , Middle Aged , COVID-19/epidemiology , COVID-19/etiology , Hormone Replacement Therapy/adverse effects , Organ Transplantation/adverse effects , Cardiovascular Diseases/etiology , Estrogens , Transplant Recipients
13.
J Biomed Inform ; 137: 104252, 2023 01.
Article in English | MEDLINE | ID: mdl-36464228

ABSTRACT

Biomedical Entity Linking (BEL) is the task of mapping of spans of text within biomedical documents to normalized, unique identifiers within an ontology. This is an important task in natural language processing for both translational information extraction applications and providing context for downstream tasks like relationship extraction. In this paper, we will survey the progression of BEL from its inception in the late 80s to present day state of the art systems, provide a comprehensive list of datasets available for training BEL systems, reference shared tasks focused on BEL, discuss the technical components that comprise BEL systems, and discuss possible directions for the future of the field.


Subject(s)
Data Mining , Text Messaging , Natural Language Processing
14.
Otolaryngol Head Neck Surg ; 168(4): 704-706, 2023 04.
Article in English | MEDLINE | ID: mdl-35503739

ABSTRACT

Anecdotal clinical observation suggests that rates of chemosensory dysfunction associated with COVID-19 infection may be decreasing. To investigate, the National COVID Cohort Collaborative database was queried for all patients with and without smell and taste loss within 2 weeks of COVID-19 diagnosis. Six-week periods of peak variant prevalence were selected by using CoVariants.org for analysis. Of 3,678,214 patients with COVID-19 in the database, 616,318 met inclusion criteria during the time intervals of interest, with 3431 having an associated smell or taste disturbance diagnosis. With the initial/untyped variant set as the baseline, the odds ratios for alpha, delta, and omicron (December 27, 2021-February 7, 2022) were 0.50 (95% CI, 0.45-0.55; P < .0001), 0.44 (95% CI, 0.41-0.48; P < .0001), and 0.17 (95% CI, 0.15-0.18; P < .0001), respectively. These data strongly support the clinical observation that patients infected with more recent variants are at a significantly lower risk of developing associated chemosensory loss.


Subject(s)
COVID-19 , Olfaction Disorders , Humans , COVID-19/epidemiology , COVID-19/complications , SARS-CoV-2 , Incidence , COVID-19 Testing , Olfaction Disorders/epidemiology , Olfaction Disorders/etiology , Olfaction Disorders/diagnosis
15.
Database (Oxford) ; 20222022 08 11.
Article in English | MEDLINE | ID: mdl-35951425

ABSTRACT

TopEx is a natural language processing application developed to facilitate the exploration of topics and key words in a set of texts through a user interface that requires no programming or natural language processing knowledge, thus enhancing the ability of nontechnical researchers to explore and analyze textual data. The underlying algorithm groups semantically similar sentences together followed by a topic analysis on each group to identify the key topics discussed in a collection of texts. Implementation is achieved via a Python library back end and a web application front end built with React and D3.js for visualizations. TopEx has been successfully used to identify themes, topics and key words in a variety of corpora, including Coronavirus disease 2019 (COVID-19) discharge summaries and tweets. Feedback from the BioCreative VII Challenge Track 4 concludes that TopEx is a useful tool for text exploration for a variety of users and tasks. DATABSE URL: http://topex.cctr.vcu.edu.


Subject(s)
COVID-19 , Algorithms , Data Mining/methods , Humans , Natural Language Processing , Software
16.
Am J Transplant ; 22(10): 2418-2432, 2022 10.
Article in English | MEDLINE | ID: mdl-35674237

ABSTRACT

Clinical outcomes in solid organ transplant (SOT) recipients with breakthrough COVID (BTCo) after two doses of mRNA vaccination compared to the non-immunocompromised/immunosuppressed (ISC) general population, are not well described. In a cohort of adult patients testing positive for COVID-19 between December 10, 2020 and April 4, 2022, we compared the cumulative incidence of BTCo in a non-ISC population to SOT recipients (overall and by organ type) using the National COVID Cohort Collaborative (N3C) including data from 36 sites across the United States. We assessed the risk of complications post-BTCo in vaccinated SOT recipients versus SOT with unconfirmed vaccination status (UVS) using multivariable Cox proportional hazards and logistic regression. BTCo occurred in 4776 vaccinated SOT recipients over a median of 149 days (IQR 99-233), with the highest cumulative incidence in heart recipients. The relative risk of BTCo was greatest in SOT recipients (relative to non-ISC) during the pre-Delta period (HR 2.35, 95% CI 1.80-3.08). The greatest relative benefit with vaccination for both non-ISC and SOT cohorts was in BTCo mortality (HR 0.37, 95% CI 0.36-0.39 for non-ISC; HR 0.67, 95% 0.57-0.78 for SOT relative to UVS). While the relative benefit of vaccine was less in SOT than non-ISC, SOT patients still exhibited significant benefit with vaccination.


Subject(s)
COVID-19 , Organ Transplantation , Adult , COVID-19/epidemiology , Humans , Organ Transplantation/adverse effects , RNA, Messenger , SARS-CoV-2 , Transplant Recipients
17.
Proc Int World Wide Web Conf ; 2022: 823-832, 2022 Apr.
Article in English | MEDLINE | ID: mdl-37465200

ABSTRACT

Since the rise of the COVID-19 pandemic, peer-reviewed biomedical repositories have experienced a surge in chemical and disease related queries. These queries have a wide variety of naming conventions and nomenclatures from trademark and generic, to chemical composition mentions. Normalizing or disambiguating these mentions within texts provides researchers and data-curators with more relevant articles returned by their search query. Named entity normalization aims to automate this disambiguation process by linking entity mentions onto their appropriate candidate concepts within a biomedical knowledge base or ontology. We explore several term embedding aggregation techniques in addition to how the term's context affects evaluation performance. We also evaluate our embedding approaches for normalizing term instances containing one or many relations within unstructured texts.

18.
Am J Transplant ; 22(1): 245-259, 2022 01.
Article in English | MEDLINE | ID: mdl-34637599

ABSTRACT

While older males are at the highest risk for poor coronavirus disease 2019 (COVID-19) outcomes, it is not known if this applies to the immunosuppressed recipient of a solid organ transplant (SOT), nor how the type of allograft transplanted may impact outcomes. In a cohort study of adult (>18 years) patients testing positive for COVID-19 (January 1, 2020-June 21, 2021) from 56 sites across the United States identified using the National COVID Cohort Collaborative (N3C) Enclave, we used multivariable Cox proportional hazards models to assess time to MARCE after COVID-19 diagnosis in those with and without SOT. We examined the exposure of age-stratified recipient sex overall and separately in kidney, liver, lung, and heart transplant recipients. 3996 (36.4%) SOT and 91 646 (4.8%) non-SOT patients developed MARCE. Risk of post-COVID outcomes differed by transplant allograft type with heart and kidney recipients at highest risk. Males with SOT were at increased risk of MARCE, but to a lesser degree than the non-SOT cohort (HR 0.89, 95% CI 0.81-0.98 for SOT and HR 0.61, 95% CI 0.60-0.62 for non-SOT [females vs. males]). This represents the largest COVID-19 SOT cohort to date and the first-time sex-age-stratified and allograft-specific COVID-19 outcomes have been explored in those with SOT.


Subject(s)
COVID-19 , Organ Transplantation , Adult , COVID-19 Testing , Cohort Studies , Female , Humans , Kidney , Male , Organ Transplantation/adverse effects , SARS-CoV-2 , Transplant Recipients , United States
19.
JAMA Intern Med ; 182(2): 153-162, 2022 02 01.
Article in English | MEDLINE | ID: mdl-34962505

ABSTRACT

Importance: Persons with immune dysfunction have a higher risk for severe COVID-19 outcomes. However, these patients were largely excluded from SARS-CoV-2 vaccine clinical trials, creating a large evidence gap. Objective: To identify the incidence rate and incidence rate ratio (IRR) for COVID-19 breakthrough infection after SARS-CoV-2 vaccination among persons with or without immune dysfunction. Design, Setting, and Participants: This retrospective cohort study analyzed data from the National COVID Cohort Collaborative (N3C), a partnership that developed a secure, centralized electronic medical record-based repository of COVID-19 clinical data from academic medical centers across the US. Persons who received at least 1 dose of a SARS-CoV-2 vaccine between December 10, 2020, and September 16, 2021, were included in the sample. Main Outcomes and Measures: Vaccination, COVID-19 diagnosis, immune dysfunction diagnoses (ie, HIV infection, multiple sclerosis, rheumatoid arthritis, solid organ transplant, and bone marrow transplantation), other comorbid conditions, and demographic data were accessed through the N3C Data Enclave. Breakthrough infection was defined as a COVID-19 infection that was contracted on or after the 14th day of vaccination, and the risk after full or partial vaccination was assessed for patients with or without immune dysfunction using Poisson regression with robust SEs. Poisson regression models were controlled for a study period (before or after [pre- or post-Delta variant] June 20, 2021), full vaccination status, COVID-19 infection before vaccination, demographic characteristics, geographic location, and comorbidity burden. Results: A total of 664 722 patients in the N3C sample were included. These patients had a median (IQR) age of 51 (34-66) years and were predominantly women (n = 378 307 [56.9%]). Overall, the incidence rate for COVID-19 breakthrough infection was 5.0 per 1000 person-months among fully vaccinated persons but was higher after the Delta variant became the dominant SARS-CoV-2 strain (incidence rate before vs after June 20, 2021, 2.2 [95% CI, 2.2-2.2] vs 7.3 [95% CI, 7.3-7.4] per 1000 person-months). Compared with partial vaccination, full vaccination was associated with a 28% reduced risk for breakthrough infection (adjusted IRR [AIRR], 0.72; 95% CI, 0.68-0.76). People with a breakthrough infection after full vaccination were more likely to be older and women. People with HIV infection (AIRR, 1.33; 95% CI, 1.18-1.49), rheumatoid arthritis (AIRR, 1.20; 95% CI, 1.09-1.32), and solid organ transplant (AIRR, 2.16; 95% CI, 1.96-2.38) had a higher rate of breakthrough infection. Conclusions and Relevance: This cohort study found that full vaccination was associated with reduced risk of COVID-19 breakthrough infection, regardless of the immune status of patients. Despite full vaccination, persons with immune dysfunction had substantially higher risk for COVID-19 breakthrough infection than those without such a condition. For persons with immune dysfunction, continued use of nonpharmaceutical interventions (eg, mask wearing) and alternative vaccine strategies (eg, additional doses or immunogenicity testing) are recommended even after full vaccination.


Subject(s)
COVID-19 Testing/statistics & numerical data , COVID-19/diagnosis , COVID-19/epidemiology , Health Status , Vaccination/statistics & numerical data , Adult , Aged , COVID-19 Vaccines , Cohort Studies , Female , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Sex Distribution
20.
Transplant Direct ; 7(11): e775, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34646938

ABSTRACT

Coronavirus disease 2019 (COVID-19) has resulted in significant morbidity and mortality in solid organ transplant (SOT) recipients. The National COVID Cohort Collaborative was developed to facilitate analysis of patient-level data for those tested for COVID-19 across the United States. METHODS: In this study, we identified a cohort of SOT recipients testing positive or negative for COVID-19 (COVID+ and COVID-, respectively) between January 1, 2020, and November 20, 2020. Univariable and multivariable logistic regression were used to determine predictors of a positive result among those tested. Outcomes following COVID-19 diagnosis were also explored. RESULTS: Of 18 121 SOT patients tested, 1925 were positive (10.6%). COVID+ SOT patients were more likely to have a kidney transplant and be non-White race. Comorbidities were common in all SOT patients but significantly more common in those who were COVID+. Of COVID+ SOT, 42.9% required hospital admission. COVID+ status was the strongest predictor of acute kidney injury (AKI), rejection, and graft failure in the 90 d after testing. A total of 40.9% of COVID+ SOT experienced a major adverse renal or cardiac event, 16.3% experienced a major adverse cardiac event, 35.3% experienced AKI, and 1.5% experienced graft loss. CONCLUSIONS: In the largest US cohort of COVID+ SOT recipients to date, we identified patient factors associated with the diagnosis of COVID-19 and outcomes following infection, including a high incidence of major adverse renal or cardiac event and AKI.

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