COVID-19 Registry Research Articles

Population differences in completeness and reliability of Dutch COVID-19 registry data: The influence of testing policy, test readiness, and registration policy from an epidemiological perspective.

During the COVID-19 pandemic, the bidirectional relationship between policy and data reliability has been achallenge for researchers of the local municipal health services. Policy decisions on population specific test locations and selective registration of negative test results led to population differences in data quality. This hampered the calculation of reliable population specific infection rates needed to develop proper data driven public health policy.

Serum Lactate Dehydrogenase Level One Week after Admission Is the Strongest Predictor of Prognosis of COVID-19: A Large Observational Study Using the COVID-19 Registry Japan.

Clinical features of COVID-19 are diverse, and a useful tool for predicting clinical outcomes based on clinical characteristics of COVID-19 is needed. This study examined the laboratory values and trends that influence mortality in hospitalised COVID-19 patients. Data on hospitalised patients enrolled in a registry study in Japan (COVID-19 Registry Japan) were obtained. Patients with records on basic information, outcomes, and laboratory data on the day of admission (day 1) and day 8 were included. In-hospital mortality was set as the outcome, and associated factors were identified by multivariate analysis using the stepwise method. A total of 8860 hospitalised patients were included. The group with lactate dehydrogenase (LDH) levels >222 IU/L on day 8 had a higher mortality rate compared to the group with LDH levels ≤222 IU/L. Similar results were observed in subgroups formed by age, body mass index (BMI), underlying disease, and mutation type, except for those aged <50 years. When age, sex, BMI, underlying disease, and laboratory values on days 1 and 8 were tested for factors strongly associated with in-hospital mortality, LDH on day 8 was most strongly associated with mortality. LDH level on day 8 was the strongest predictor of in-hospital mortality in hospitalised COVID-19 patients, indicating its potential usefulness in post-treatment decision-making in severe COVID-19 cases.

Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study

ObjectiveTo investigate the influence of COVID-19 vaccination on disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients under targeted therapies.Patients and methods1765 vaccinated patients COVID-19, 1178 (66.7%) with...

Hospital Outcomes of Community-Acquired SARS-CoV-2 Omicron Variant Infection Compared With Influenza Infection in Switzerland

With the ongoing COVID-19 pandemic, it is crucial to assess the current burden of disease of community-acquired SARS-CoV-2 Omicron variant in hospitalized patients to tailor appropriate public health policies. Comparisons with better-known seasonal influenza infections may facilitate such decisions. To compare the in-hospital outcomes of patients hospitalized with the SARS-CoV-2 Omicron variant with patients with influenza. This cohort study was based on a national COVID-19 and influenza registry. Hospitalized patients aged 18 years and older with community-acquired SARS-CoV-2 Omicron variant infection who were admitted between January 15 and March 15, 2022 (when B.1.1.529 Omicron predominance was >95%), and hospitalized patients with influenza A or B infection from January 1, 2018, to March 15, 2022, where included. Patients without a study outcome by August 30, 2022, were censored. The study was conducted at 15 hospitals in Switzerland. Community-acquired SARS-CoV-2 Omicron variant vs community-acquired seasonal influenza A or B. Primary and secondary outcomes were defined as in-hospital mortality and admission to the intensive care unit (ICU) for patients with the SARS-CoV-2 Omicron variant or influenza. Cox regression (cause-specific and Fine-Gray subdistribution hazard models) was used to account for time-dependency and competing events, with inverse probability weighting to adjust for confounders with right-censoring at day 30. Of 5212 patients included from 15 hospitals, 3066 (58.8%) had SARS-CoV-2 Omicron variant infection in 14 centers and 2146 patients (41.2%) had influenza A or B in 14 centers. Of patients with the SARS-CoV-2 Omicron variant, 1485 (48.4%) were female, while 1113 patients with influenza (51.9%) were female (P = .02). Patients with the SARS-CoV-2 Omicron variant were younger (median [IQR] age, 71 [53-82] years) than those with influenza (median [IQR] age, 74 [59-83] years; P < .001). Overall, 214 patients with the SARS-CoV-2 Omicron variant (7.0%) died during hospitalization vs 95 patients with influenza (4.4%; P < .001). The final adjusted subdistribution hazard ratio (sdHR) for in-hospital death for SARS-CoV-2 Omicron variant vs influenza was 1.54 (95% CI, 1.18-2.01; P = .002). Overall, 250 patients with the SARS-CoV-2 Omicron variant (8.6%) vs 169 patients with influenza (8.3%) were admitted to the ICU (P = .79). After adjustment, the SARS-CoV-2 Omicron variant was not significantly associated with increased ICU admission vs influenza (sdHR, 1.08; 95% CI, 0.88-1.32; P = .50). The data from this prospective, multicenter cohort study suggest a significantly increased risk of in-hospital mortality for patients with the SARS-CoV-2 Omicron variant vs those with influenza, while ICU admission rates were similar.

Myocardial Injury and Prognosis in Hospitalized COVID-19 Patients in Brazil: Results From The Brazilian COVID-19 Registry.

Cardiovascular complications of COVID-19 are important aspects of the disease's pathogenesis and prognosis. Evidence on the prognostic role of troponin and myocardial injury in Latin American hospitalized COVID-19 patients is still scarce. To evaluate myocardial injury as independent predictor of in-hospital mortality and invasive mechanical ventilation support in hospitalized patients, from the Brazilian COVID-19 Registry. This cohort study is a substudy of the Brazilian COVID-19 Registry, conducted in 31 Brazilian hospitals of 17 cities, March-September 2020. Primary outcomes included in-hospital mortality and invasive mechanical ventilation support. Models for the primary outcomes were estimated by Poisson regression with robust variance, with statistical significance of p<0.05. Of 2,925 patients (median age of 60 years [48-71], 57.1% men), 27.3% presented myocardial injury. The proportion of patients with comorbidities was higher among patients with cardiac injury (median 2 [1-2] vs. 1 [0-2]). Patients with myocardial injury had higher median levels of brain natriuretic peptide, lactate dehydrogenase, creatine phosphokinase, N-terminal pro-brain natriuretic peptide, and C-reactive protein than patients without myocardial injury. As independent predictors, C-reactive protein and platelet counts were related to the risk of death, and neutrophils and platelet counts were related to the risk of invasive mechanical ventilation support. Patients with high troponin levels presented a higher risk of death (RR 2.03, 95% CI 1.60-2.58) and invasive mechanical ventilation support (RR 1.87, 95% CI 1.57-2.23), when compared to those with normal troponin levels. Cardiac injury was an independent predictor of in-hospital mortality and the need for invasive mechanical ventilation support in hospitalized COVID-19 patients.

Site-level variability in the processes of care and outcomes over time among patients with COVID-19 and myocardial injury: Insights from the American Heart Association's COVID-19 Cardiovascular Disease Registry

BackgroundElevated cardiac troponin (cTn) levels in patients with COVID-19 has been associated with worse outcomes. Guidelines on best practices of those patients remain uncertain. MethodsWe included patients with COVID-19 and cTn above the assay-specific upper limit of normal (ULN) enrolled in the American Heart Association's COVID-19 registry between March 2020–January 2021. Site-level variability in invasive coronary angiography, LVEF assessment, ICU utilization, and inpatient mortality were determined by calculating adjusted median odds ratio (MOR) using hierarchical logistic regression models. Temporal trends were assessed with Cochran-Armitage trend test. ResultsAmong 32,636 patients, we included 6234 (19.4 %) with cTn above ULN (age 68.7 ± 16.0 years, 56.5 % male, 51.5 % Caucasian), of whom 1365 (21.6 %) had ≥5-fold elevations. Across 55 sites, the median rate of invasive coronary angiography was 0.1 % with adjusted MOR 1.5(1.0,2.3), median LVEF assessment was 25.5 %, MOR 3.0(2.2,3.9), ICU utilization was 41.7 %, MOR 2.2(1.8,2.6), and mortality was 20.9 %, MOR 1.7(1.5,2.0). Over time, we noted a significant increase in invasive coronary angiography (p-trend = 0.001), and LVEF assessment (p-trend<0.001), and reduction in mortality (p-trend<0.001), without significant change in ICU admissions (p-trend = 0.08). Similar variability and temporal trends were seen among patients with ≥5-fold cTn elevation. ConclusionsThe use of invasive coronary angiography among patients with COVID-19 and myocardial injury was very low during the early pandemic. We found moderate institutional variability in processes of care with an uptrend in invasive catheterization and LVEF assessment, and downtrend in mortality. Comparative effectiveness studies are needed to examine whether variability in care is associated with differences in outcomes.

The Association Between Pediatric COVID-19 Vaccination and Socioeconomic Position: Nested Case-Control Study From the Pedianet Veneto Cohort

The success of pediatric COVID-19 vaccination strongly depends on parents' willingness to vaccinate their children. To date, the role of socioeconomic position (SEP) in pediatric COVID-19 vaccination has not been thoroughly examined. We evaluated the association between COVID-19 vaccination and SEP in a large pediatric cohort. A case-control study design nested into a pediatric cohort of children born between 2007 and 2017, living in the Veneto Region and followed up to at least January 1, 2022, was adopted. Data on children were collected from the Pedianet database and linked with the regional COVID-19 registry. Each child vaccinated with at least one dose of any COVID-19 vaccine between July 1, 2021, and March 31, 2022, was matched by sex, year of birth, and family pediatrician to up to 5 unvaccinated children. Unvaccinated children with a positive outcome on the swab test within 180 days before the index date were excluded from the analyses. Children were geo-referenced to determine their area deprivation index (ADI)-a social and material deprivation measure calculated at the census block level and consisting of 5 socioeconomic items. The index was then categorized in quintiles based on the regional ADI level. The association between ADI quintiles and vaccination status was measured using conditioned logistic regression models to estimate odds ratios and the corresponding 95% CIs. Quantile-g-computation regression models were applied to develop a weighted combination of the individual items to estimate how much each component influenced the likelihood of vaccination. All analyses were stratified by age at vaccination (5-11 and 12-14 years). The study population consisted of 6475 vaccinated children, who were matched with 32,124 unvaccinated children. Increasing area deprivation was associated with a lower probability of being vaccinated, with approximately a linear dose-response relationship. Children in the highest deprivation quintile were 36% less likely to receive a COVID-19 vaccine than those with the lowest area deprivation (95% CI 0.59-0.70). The results were similar in the 2 age groups, with a slightly stronger association in 5-11-year-old children. When assessing the effects of the weighted combination of the individual items, a quintile increase was associated with a 17% decrease in the probability of being vaccinated (95% CI 0.80-0.86). The conditions that influenced the probability of vaccination the most were living on rent, being unemployed, and being born in single-parent families. This study has shown a significant reduction in the likelihood of receiving a COVID-19 vaccine among children living in areas characterized by a lower SEP. Findings were robust among multiple analyses and definitions of the deprivation index. These findings suggest that SEP plays an important role in vaccination coverage, emphasizing the need to promote targeted public health efforts to ensure global vaccine equity.

Gender Difference in the Effects of COVID-19 Pandemic on Mechanical Reperfusion and 30-Day Mortality for STEMI: Results of the ISACS-STEMI COVID-19 Registry.

Several reports have demonstrated the impact of the COVID-19 pandemic on the management and outcome of patients with ST-segment elevation myocardial infarction (STEMI). The aim of the current analysis is to investigate the potential gender difference in the effects of the COVID-19 pandemic on mechanical reperfusion and 30-day mortality for STEMI patients within the ISACS-STEMI COVID-19 Registry. This retrospective multicenter registry was performed in high-volume primary percutaneous coronary intervention (PPCI) centers on four continents and included STEMI patients undergoing PPCIs in March-June 2019 and 2020. Patients were divided according to gender. The main outcomes were the incidence and timing of the PPCI, (ischemia time ≥ 12 h and door-to-balloon ≥ 30 min) and in-hospital or 30-day mortality. We included 16683 STEMI patients undergoing PPCIs in 109 centers. In 2020 during the pandemic, there was a significant reduction in PPCIs compared to 2019 (IRR 0.843 (95% CI: 0.825-0.861, p < 0.0001). We did not find a significant gender difference in the effects of the COVID-19 pandemic on the numbers of STEMI patients, which were similarly reduced from 2019 to 2020 in both groups, or in the mortality rates. Compared to prepandemia, 30-day mortality was significantly higher during the pandemic period among female (12.1% vs. 8.7%; adjusted HR [95% CI] = 1.66 [1.31-2.11], p < 0.001) but not male patients (5.8% vs. 6.7%; adjusted HR [95% CI] = 1.14 [0.96-1.34], p = 0.12). The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a 16% reduction in PPCI procedures similarly observed in both genders. Furthermore, we observed significantly increased in-hospital and 30-day mortality rates during the pandemic only among females. Trial registration number: NCT 04412655.

Evaluation of Inequities in Cancer Treatment Delay or Discontinuation Following SARS-CoV-2 Infection

There is a disproportionately greater burden of COVID-19 among Hispanic and non-Hispanic Black individuals, who also experience poorer cancer outcomes. Understanding individual-level and area-level factors contributing to inequities at the intersection of COVID-19 and cancer is critical. To evaluate associations of individual-level and area-level social determinants of health (SDOH) with delayed or discontinued cancer treatment following SARS-CoV-2 infection. This retrospective, registry-based cohort study used data from 4768 patients receiving cancer care who had positive test results for SARS-CoV-2 and were enrolled in the American Society for Clinical Oncology COVID-19 Registry. Data were collected from April 1, 2020, to September 26, 2022. Race and ethnicity, sex, age, and area-level SDOH based on zip codes of residence at the time of cancer diagnosis. Delayed (≥14 days) or discontinued cancer treatment (any cancer treatment, surgery, pharmacotherapy, or radiotherapy) and time (in days) to restart pharmacotherapy. A total of 4768 patients (2756 women [57.8%]; 1558 [32.7%] aged ≥70 years at diagnosis) were included in the analysis. There were 630 Hispanic (13.2%), 196 non-Hispanic Asian American or Pacific Islander (4.1%), 568 non-Hispanic Black (11.9%), and 3173 non-Hispanic White individuals (66.5%). Compared with non-Hispanic White individuals, Hispanic and non-Hispanic Black individuals were more likely to experience a delay of at least 14 days or discontinuation of any treatment and drug-based treatment; only estimates for non-Hispanic Black individuals were statistically significant, with correction for multiple comparisons (risk ratios [RRs], 1.35 [95% CI, 1.22-1.49] and 1.37 [95% CI, 1.23-1.52], respectively). Area-level SDOH (eg, geography, proportion of residents without health insurance or with only a high school education, lower median household income) were associated with delayed or discontinued treatment. In multivariable Cox proportinal hazards regression models, estimates suggested that Hispanic (hazard ratio [HR], 0.87 [95% CI, 0.71-1.05]), non-Hispanic Asian American or Pacific Islander (HR, 0.79 [95% CI, 0.46-1.35]), and non-Hispanic Black individuals (HR, 0.81 [95% CI, 0.67-0.97]) experienced longer delays to restarting pharmacotherapy compared with non-Hispanic White individuals. The findings of this cohort study suggest that race and ethnicity and area-level SDOH were associated with delayed or discontinued cancer treatment and longer delays to the restart of drug-based therapies following SARS-CoV-2 infection. Such treatment delays could exacerbate persistent cancer survival inequities in the United States.

Mechanical ventilation and death in pregnant patients admitted for COVID-19: a prognostic analysis from the Brazilian COVID-19 registry score

BackgroundThe assessment of clinical prognosis of pregnant COVID-19 patients at hospital presentation is challenging, due to physiological adaptations during pregnancy. Our aim was to assess the performance of the ABC2-SPH score to predict in-hospital mortality and mechanical ventilation support in pregnant patients with COVID-19, to assess the frequency of adverse pregnancy outcomes, and characteristics of pregnant women who died.MethodsThis multicenter cohort included consecutive pregnant patients with COVID-19 admitted to the participating hospitals, from April/2020 to March/2022. Primary outcomes were in-hospital mortality and the composite outcome of mechanical ventilation support and in-hospital mortality. Secondary endpoints were pregnancy outcomes. The overall discrimination of the model was presented as the area under the receiver operating characteristic curve (AUROC). Overall performance was assessed using the Brier score.ResultsFrom 350 pregnant patients (median age 30 [interquartile range (25.2, 35.0)] years-old]), 11.1% had hypertensive disorders, 19.7% required mechanical ventilation support and 6.0% died. The AUROC for in-hospital mortality and for the composite outcome were 0.809 (95% IC: 0.641–0.944) and 0.704 (95% IC: 0.617–0.792), respectively, with good overall performance (Brier = 0.0384 and 0.1610, respectively). Calibration was good for the prediction of in-hospital mortality, but poor for the composite outcome. Women who died had a median age 4 years-old higher, higher frequency of hypertensive disorders (38.1% vs. 9.4%, p < 0.001) and obesity (28.6% vs. 10.6%, p = 0.025) than those who were discharged alive, and their newborns had lower birth weight (2000 vs. 2813, p = 0.001) and five-minute Apgar score (3.0 vs. 8.0, p < 0.001).ConclusionsThe ABC2-SPH score had good overall performance for in-hospital mortality and the composite outcome mechanical ventilation and in-hospital mortality. Calibration was good for the prediction of in-hospital mortality, but it was poor for the composite outcome. Therefore, the score may be useful to predict in-hospital mortality in pregnant patients with COVID-19, in addition to clinical judgment. Newborns from women who died had lower birth weight and Apgar score than those who were discharged alive.

Differential Effects of COVID-19 Hospitalization on the Trajectory of Liver Disease Progression.

Patients with chronic liver disease (CLD) were significantly affected by COVID-19. Despite evidence of acute hepatic injury and increased mortality, the long-term effects of COVID-19 hospitalization on the natural history of CLD patients are unknown. The Massachusetts General Hospital COVID-19 registry was used to obtain a cohort of CLD patients hospitalized between March 8 and June 3, 2020. The Partners Research Patient Data Registry was used to develop a matched CLD patient control list without COVID-19. Fibrosis-4 index (FIB-4), nonalcoholic fatty liver disease fibrosis score (NFS), and model for end-stage liver disease/Na (MELD-Na) scores were calculated pre-, day of, and 1-year post-discharge from admission. Unpaired t-test was used to compare continuous variables. Fifty-two COVID-19 patients and 92 control patients with CLD were included. Patients with non-cirrhotic CLD who were hospitalized for COVID-19 had an acute rise in FIB-4 on admission with subsequent improvement on one-year follow-up demonstrating no difference in progression of liver disease compared to the controls (P= .87, confidence interval [CI]-0.088 to 0.048). Similar trends were observed in nonalcoholic fatty liver disease patients using NFS (P= .48, CI-0.016 to 0.023). In contrast, patients with cirrhosis experienced rise in MELD-Na postadmission compared to the control cirrhosis group (0.35 vs-0.076/month; P= .04, CI-0.827 to-0.025), suggesting a potential for long-term consequences of COVID-19. Non-cirrhotic CLD patients who survive COVID-19 hospitalization do not appear to have change in FIB-4, NFS scores at one year. However, patients with cirrhosis exhibit increasing MELD-Na one-year post-COVID suggesting a differential effect of acute COVID-19 on the trajectory of established cirrhosis.

Using a Claims-Based Frailty Index to Investigate Frailty, Survival, and Healthcare Expenditures among Older Adults Hospitalized for COVID-19 at an Academic Medical Center

Frailty is associated with mortality in older adults hospitalized with COVID-19, yet few studies have quantified healthcare utilization and spending following COVID-19 hospitalization. To evaluate whether survival and follow-up healthcare utilization and expenditures varied as a function of claims-based frailty status for older adults hospitalized with COVID-19. Retrospective cohort study. 136 patients aged 65 and older enrolled in an Accountable Care Organization (ACO) risk contract at an academic medical center and hospitalized for COVID-19 between March 11, 2020 - June 3, 2020. We linked a COVID-19 Registry with administrative claims data to quantify a frailty index and its relationship to mortality, healthcare utilization, and expenditures over 6 months following hospital discharge. Kaplan Meier curves and Cox Proportional Hazards models were used to evaluate survival by frailty. Kruskal-Wallis tests were used to compare utilization. A generalized linear model with a gamma distribution was used to evaluate differences in monthly Medicare expenditures. Much of the cohort was classified as moderate to severely frail (65.4%), 24.3% mildly frail, and 10.3% robust or pre-frail. Overall, 27.2% (n=37) of the cohort died (n=26 during hospitalization, n=11 after discharge) and survival did not significantly differ by frailty. Among survivors, inpatient hospitalizations during the 6-month follow-up period varied significantly by frailty (p=0.02). Mean cost over follow-up was $856.37 for the mild and $4914.16 for the moderate to severe frailty group, and monthly expenditures increased with higher frailty classification (p <.001). In this cohort, claims-based frailty was not significantly associated with survival but was associated with follow-up hospitalizations and Medicare expenditures.

Abstract C103: Inequities in timely cancer treatment after testing positive for COVID-19: Findings from the ASCO Survey on COVID-19 in Oncology (ASCO) Registry

Abstract Introduction: There is a disproportionately greater burden of COVID-19 among non-Hispanic Black (NHB) and Hispanic individuals, who also shoulder an inordinate burden of poor cancer outcomes. Understanding patient- and area-level factors contributing to these inequities at the intersection of COVID-19 and cancer is critical. As such, the objective of this study was to evaluate inequities in receipt of timely cancer treatment following a confirmed positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)—the virus that causes COVID-19. Methods: This retrospective cohort study is comprised of 2,686 non-Hispanic White (NHW), non-Hispanic Black (NHB), and Hispanic cancer patients from the American Society for Clinical Oncology COVID-19 Registry (ASCO Registry), for whom relatively complete data were available at entry into the registry (at the date of confirmed positive SARS-CoV-2 test) up to the end of the follow-up period (~6-9 months post confirmed positive SARS-CoV-2 test). Data were collected from April 2020 to November 2021. Relative risk (RR) estimates (generated using the generalized linear model procedure with a Poisson distribution, log link, and robust error variances) were used to examine multivariable-adjusted associations between patient-level sociodemographic and clinical factors and area-level social determinants of health (SDOH), separately, with timely (on schedule or within 14 days of schedule) and delayed (≥14-day delay) receipt of cancer treatment. Kaplan-Meier curves were plotted to investigate the time (in days) to restart cancer treatment post-COVID-19 infection. Results: After correction for multiple comparisons, for drug-based therapy, NHB race (RR, 0.69 [95% CI, 0.55-0.87]; P=.002) and male sex (RR, 0.82 [95% CI, 0.71-0.95]; P=.009) were associated with 31% and 18% reductions in timely treatment receipt. NHB race (RR, 1.41 [95% CI, 1.17-1.71]; P&amp;lt;.001) was also associated with a 41% increased risk of ≥14-day delays in treatment receipt. NHB patients further experienced longer delays, on average, in restarting drug-based therapy relative to NHW and Hispanic patients (mean days: 54.7 vs. 36.6 and 36.7, P=.001). Hispanic ethnicity was marginally associated with a lower likelihood of timely drug-based therapy receipt (RR, 0.79 [95% CI, 0.61-1.02]; P=.075) and a greater risk of delayed receipt of drug-based therapy (RR, 1.31 [95% CI, 1.04-1.67]; P=.024). Residents of areas with higher proportions of NHWs (≥77.4% vs. &amp;lt;77.4%) had a 31% higher likelihood of timely drug-based therapy receipt (RR, 1.31 [95% CI, 1.18-1.47]; P&amp;lt;.001) and 21% significantly lower risk of delayed drug-based therapy (RR, 0.79 [95% CI, 0.69-0.90]; P=.001). Conclusions: NHB cancer patients, males, and residents of areas that are more racially and ethnically diverse experienced delayed drug-based cancer treatment following COVID-19 infection. These delays will likely exacerbate persistent cancer survival inequities in the United States. Citation Format: Adana A.M. Llanos, Adiba Ashrafi, Nabarun Ghosh, Jennifer Tsui, Yong Lin, Angela J. Fong, Shridar Ganesan, Carolyn J. Heckman. Inequities in timely cancer treatment after testing positive for COVID-19: Findings from the ASCO Survey on COVID-19 in Oncology (ASCO) Registry [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr C103.

Hospital-based COVID-19 registry: Design and implementation. Colombian experience

Registries are essential to providing valuable clinical and epidemiological decisions. Designing a registry is challenging because it is time-consuming and resource-intensive, particularly in low- and middle-income countries. Here, we described our experience with the rationale, design, and implementation of a hospital-based COVID-19 registry in Cali, Colombia. We designed and implemented a hospital-based registry over a dynamic web-based structure to record all sociodemographic, clinical, and laboratory tests, imaging, treatment, and outcomes of SARS-CoV-2. We included 4458 confirmed COVID-19 cases of 18 years and older from March 2020 to March 2021. The median age was 48 years. The most frequent comorbidities were hypertension, obesity, and diabetes. The ICU admission rate was 19%, and the in-hospital mortality rate was 20%. The implemented strategies provided rapid and reliable information collection for the registry of emerging studies from the different clinical areas. Regular data quality and feedback are essential to ensure the reliability of the information. The integration of automatic data extraction reduces time consumption in information gathering and resources.

One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry.

The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored. This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days). A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001). At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death. URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

Biologic Therapy Is Not Associated with Increased COVID-19 Severity in Patients with Hidradenitis Suppurativa: Updated Findings from the Global Hidradenitis Suppurativa COVID-19 Registry

Biologic Therapy Is Not Associated with Increased COVID-19 Severity in Patients with Hidradenitis Suppurativa: Updated Findings from the Global Hidradenitis Suppurativa COVID-19 Registry

Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study.

Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites. None. For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16-50 d), with differences not significantly different by country (United States: 30 [17-50] vs non-United States: 23 d [8-46 d]; p = 0.08) or previous "multisite trial experience" (experienced: 27 [15-51] vs not experienced: 29 d [13-47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1-28) versus 3 days (1-6 d) (p = 0.02). In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.

7: ASSESSMENT OF READMISSION RISK FACTORS AFTER INDEX HOSPITAL DISCHARGE FOR COVID-19 PATIENTS

Introduction: During the COVID-19 pandemic, the burden on the healthcare system makes it critical to examine readmission patterns. In this study, we evaluated the readmission rates and risk factors associated with COVID-19 from the large SCCM Discovery VIRUS: COVID-19 Registry. Methods: This was a retrospective, cohort study including hospitalized adult patients from 181 hospitals in 24 countries within the VIRUS: COVID-19 Registry. Demographic, clinical, and outcome data were extracted and divided into two groups: Patients with readmission with COVID-19 in 30 days from discharge and those who were not. A univariate analysis is done using chi-square and t-test as appropriate. Multivariable logistic regression was used to measure risk factor associations with 30-day readmission. Results: Among 20,283 patients, 1,195 (5.9%) were readmitted within 30 days from discharge. The median (IQR) age of readmitted patients was 66 (55-78) years and 45.2% were female, 60.2% were white, and 78.9% non-Hispanic. Higher odds of readmission were observed in patients aged >60 vs 18–40 years (OR 2.76; 95% CI, 2.23–3.41), moderate COVID-19 disease (WHO Ordinal scale 4-5) vs Severe COVID-19 (WHO Ordinal scale 6-9) (OR 1.23; 95% CI, 1.10–1.39), no ICU admission at index hospitalization (OR 1.70; 95% CI, 1.32–1.80), and Hospital length of stay ≤14 vs >14 days (OR 1.53; 95% CI, 1.32–1.80) vs those not readmitted (p= < 0.001). Comorbidities including coronary artery disease (OR 2.14; 95% CI 1.84–2.48), hypertension (OR 1.58; 95% CI 1.40–1.78), congestive Heart Failure (OR 2.54; 95% CI 2.16–2.98), chronic pulmonary disease (OR 2.26; 95% CI 1.94–2.63), diabetes (OR 1.32; 95% CI 1.17–1.49) or chronic kidney disease (CKD) (OR 2.41; 95% CI 1.2.09–2.78) were associated with higher odds of readmission. In multivariate logistic regression adjusted for age group, hospital length of stay ≤14 days and, highest WHO COVID-19 ordinal scale and index ICU admission coronary artery disease, congestive heart failure, chronic pulmonary disease, chronic kidney disease, hospital length of stay ≤14 days and age >60 years remained independent risk factors for readmission within 30 days. Conclusions: Among hospitalized patients with COVID-19, those readmitted had a higher burden of comorbidities compared to those non-readmitted.

1895. SingHealth COVID-19 Disease Registry

Abstract Background One of Singapore’s national strategies for the COVID-19 pandemic was containment. Efforts included a fourteen-day quarantine of close contacts, were subjected to an entry and exit SARS-CoV-2 PCR test, the latter being done between 11-14 days post exposure. Additionally, symptomatic contacts were tested for SARS-CoV-2. We aim to determine the trend in COVID-19 incubation periods during three distinct pandemic waves corresponding to different SARS-CoV-2 variants. Incubation Period Incubation period of the prevalent SARS-CoV-2 variant in circulation Methods This is an ecological study and information collected from the SingHealth COVID-19 Registry, a database of all inpatients admitted to any of the SingHealth hospitals. For patients under quarantine, the start date of the quarantine period was assumed to be the last date of exposure to the index case. Incubation period was determined by the duration between date of exposure and date of the first positive SARS-CoV-2 PCR test. The prevalent strain in circulation was identified from the Singapore database in the GISAID collection. Only variants of concern, as categorized by WHO, Alpha (23rd Jan 2020 – 1st Mar 2021), Delta (5th May 2021 – 31st Oct 2021) and Omicron (1st Jan 2022 – Present) were considered. For the Omicron variant, quarantine was discontinued, hence the last date of arrival from international travel was assumed to be the date of exposure. Results From January 2020 to March 2022, there were 19,905 patients in the COVID-19 registry, of whom 11,235 were under quarantine and 8,612 had preceding international travel. Of the 11,235 patients under quarantine, 8,189 patients were infected when SARS-CoV-2 Alpha variant and 3,046 patients were infected when SARS-CoV-2 Delta variant were in circulation. Of the 8,612 patients with preceding travel, 6,503 patients were infected when SARS-CoV-2 Omicron variant was in circulation. The median incubation period for the Alpha variant was 11 days (IQR: 7-14 days) versus 3 days (IQR: 2-4 days) for the Delta variant versus 3 days (IQR: 0-5 days) for the Omicron variant. Pairwise comparisons between the variants were (p-value = &amp;lt; .001) Conclusion The significant differences between incubation periods of the SARS-CoV-2 variants in circulation poses a challenge to containment efforts and has emphasize the importance of dynamic national strategies. Disclosures All Authors: No reported disclosures.

1811. Use of Procalcitonin and Antimicrobial Stewardship Intervention to Limit Antibiotic Utilization in Patients Admitted to a Community Hospital with SARS-CoV-2 Infection

Abstract Background Patients admitted to the hospital with SARS-CoV-2 infection are often treated with antibacterial agents in addition to antivirals, although bacterial co-infection in this population is uncommon. Overuse of unnecessary antibiotics can lead to suboptimal outcomes, including increased bacterial resistance, adverse events, and costs. Our Antimicrobial Stewardship (AS) Program routinely provides recommendations for appropriate therapy based on molecular/microbiologic tests, clinical findings, and procalcitonin (PCT). PCT can assist in differentiating bacterial from viral respiratory infections, and can be useful in the decision to discontinue antibiotic therapy if viral monomicrobial infection is suspected. The purpose of our quality improvement project was to review the appropriateness of antibiotics utilized for patients admitted with SARS-CoV-2 and to promote optimal patient care and AS at our institution. Methods We performed a retrospective review of SARS-CoV-2 patients from our institution’s COVID-19 registry for patients hospitalized from March 2020-April 2021. We compared patients with PCT &amp;lt; 0.25 ng/mL to those with PCT &amp;gt; 0.25 ng/mL and assessed differences in patient characteristics and disease presentation, including: age, gender, WBC, serum creatinine, culture results, disease severity, patient location, duration of antibiotics, length of stay, 30 day readmission and mortality. Characteristics were compared using descriptive statistics and appropriate inferential statistics. Results Shown in Table 1. If prescribed antibiotics, median duration of antibiotic therapy was significantly reduced in the PCT &amp;lt; 0.25 group vs. the PCT &amp;gt; 0.25 group (2 days vs. 4.1 days). Median WBC, SOFA score, serum creatinine, and length of stay were significantly lower in the PCT &amp;lt; 0.25 group compared to the PCT &amp;gt; 0.25 group. Severity adjusted models showed significantly decreased duration and overall likelihood of antibiotic use for PCT &amp;lt; 0.25 vs. PCT &amp;gt; 0.25. 30 day readmission and 30 day mortality were significantly lower in the PCT &amp;lt; 0.25 group vs. the PCT &amp;gt; 0.25 group. Conclusion Antibiotic utilization was reduced in patients admitted with SARS-CoV-2 infection and PCT &amp;lt; 0.25, and if prescribed antibiotics, duration was significantly shorter vs. those in the PCT &amp;gt; 0.25 group. Disclosures Michael J. Tan, MD, FACP, FIDSA, Pfizer: Honoraria|Thermo Fisher Scientific: Honoraria Thomas M. File, Jr., MD, MSc, MACP, FIDSA, Nabriva Therapeutics: Advisor/Consultant|Nabriva Therapeutics: Honoraria.