Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection.

BACKGROUND: Reports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection. METHODS: INSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses. RESULTS: Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing. CONCLUSIONS: This study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.

Clinical Course and Factors Associated With Hospitalization and Critical Illness Among COVID-19 Patients in Chicago, Illinois.

BACKGROUND: SARS-CoV-2 is a global pandemic associated with significant morbidity and mortality. However, information from United States cohorts is limited. Understanding predictors of admission and critical illness in these patients is essential to guide prevention and risk stratification strategies. METHODS: This was a retrospective, registry-based cohort study including all patients presenting to Rush University Medical Center in Chicago, Illinois, with COVID-19 from March 4, 2020 to June 21, 2020. Demographic, clinical, laboratory, and treatment data were obtained from the registry and compared between hospitalized and nonhospitalized patients as well as those with critical illness. We used logistic regression modeling to explore risk factors associated with hospitalization and critical illness. RESULTS: A total of 8,673 COVID-19 patients were included in the study, of whom 1,483 (17.1%) were admitted to the hospital and 528 (6.1%) were admitted to the intensive care unit. Risk factors for hospital admission included advanced age, male sex (odds ratio [OR] = 1.69, 95% confidence interval [CI] = 1.44 to 1.98), Hispanic/Latino ethnicity (OR = 1.52, 95% CI = 1.18 to 1.92), hypertension (OR = 1.77, 95% CI = 1.46 to 2.16), diabetes mellitus (OR = 1.84, 95% CI = 1.53 to 2.22), prior CVA (OR = 3.20, 95% CI = 1.99 to 5.14), coronary artery disease (OR = 1.45, 95% CI = 1.03 to 2.06), heart failure (OR = 1.79, 95% CI = 1.23 to 2.61), chronic kidney disease (OR = 2.60, 95% CI = 1.77 to 3.83), end-stage renal disease (OR = 2.22, 95% CI = 1.12 to 4.41), cirrhosis (OR = 2.03, 95% CI = 1.42 to 2.91), fever (OR = 1.43, 95% CI = 1.19 to 1.71), and dyspnea (OR = 4.53, 95% CI = 3.75 to 5.47). Factors associated with critical illness included male sex (OR = 1.45, 95% CI = 1.12 to 1.88), congestive heart failure (OR = 1.45, 95% CI = 1.00 to 2.12), obstructive sleep apnea (OR = 1.58, 95% CI = 1.07 to 2.33), blood-borne cancer (OR = 3.53, 95% CI = 1.26 to 9.86), leukocytosis (OR = 1.53, 95% CI = 1.15 to 2.17), elevated neutrophil-to-lymphocyte ratio (OR = 1.61, 95% CI = 1.20 to 2.17), hypoalbuminemia (OR = 1.80, 95% CI = 1.39 to 2.32), elevated AST (OR = 1.66, 95% CI = 1.20 to 2.29), elevated lactate (OR = 1.95, 95% CI = 1.40 to 2.73), elevated D-Dimer (OR = 1.44, 95% CI = 1.05 to 1.97), and elevated troponin (OR = 3.65, 95% CI = 2.03 to 6.57). CONCLUSION: There are a number of factors associated with hospitalization and critical illness. Clinicians should consider these factors when evaluating patients with COVID-19.

Prognostic significance of ischemic electrocardiographic changes with regadenoson stress myocardial perfusion imaging.

BACKGROUND: In patients undergoing regadenoson SPECT myocardial perfusion imaging (MPI), the prognostic value of ischemic ST-segment depression (ST↓) and the optimal ST↓ threshold have not been studied. METHODS: A retrospective cohort study of consecutive patients referred for regadenoson stress MPI was conducted. Patients with uninterpretable ECG were excluded. Two diagnostic thresholds of horizontal or downsloping ST↓ were studied, ≥ 0.5 mm and ≥ 1.0 mm. The primary endpoint was the composite major adverse cardiac events (MACE) of cardiac death, myocardial infarction, or coronary revascularization. RESULTS: Among 8615 subjects (mean age 62 ± 13 years; 55% women), 89 (1.0%) had ST↓ ≥ 1.0 mm and 133 (1.5%) had ST↓ ≥ 0.5 mm. Regadenoson-induced ST↓ was more common in women (P < .001). Mean follow-up was 2.5 ± 2.2 years. After multivariate adjustment, ST↓ ≥ 1.0 mm was associated with a non-significant increase in MACE risk (P = .069), irrespective to whether MPI was abnormal (P = .162) or normal (P = .214). Ischemic ST↓ ≥ 0.5 mm was independently associated with MACE in the entire cohort (HR 2.14; CI 1.38-3.32; P = .001), whether MPI is normal (HR 2.07; CI 1.07-4.04; P = .032) or abnormal (HR 2.24; CI 1.23-4.00; P = .007), after adjusting for clinical and imaging covariates. An ST↓ threshold of ≥ 0.5 mm provided greater incremental prognostic value beyond clinical and imaging parameters (Δχ2 = 12.78; P < .001) than ≥ 1.0 mm threshold (Δχ2 = 3.72; P = .093). CONCLUSION: Regadenoson-induced ischemic ST↓ is more common in women and it provides a modest independent prognostic value beyond MPI and clinical parameters. ST↓ ≥ 0.5 mm is a better threshold than ≥ 1.0 mm to define ECG evidence for regadenoson-induced myocardial ischemia.

Reconstructive valve surgery within 10 days of stroke in endocarditis.

BACKGROUND: The optimal timing of surgical treatment for infective endocarditis complicated by cerebrovascular events is controversial, largely due to the perceived risk of perioperative intracranial bleeding. Current guidelines suggest waiting 2 weeks between the diagnosis of stroke and surgery. The aim of this study was to investigate the clinical and neurological outcomes of early surgery following a stroke. METHODS: This was a single-center retrospective analysis of 12 consecutive patients requiring surgery for infective endocarditis between 2011 and 2014 at Rush University Medical Center, with either ischemic (n = 6) and/or hemorrhagic (n = 6) cerebrovascular complications. All underwent computed tomographic angiography prior to early valve reconstructive surgery to identify potentially actionable neurological findings. Early valve surgery was performed for ongoing sepsis or persistent emboli. Neurologic risk and outcome were assessed pre- and postoperatively using the National Institutes of Health Stroke Scale and the Glasgow Outcome Scale, respectively. RESULTS: All 12 patients underwent surgical treatment within 10 days of the diagnosis of stroke. Mortality in the immediate postoperative period was 8%. Eleven of the 12 patients exhibited good neurological recovery in the immediate postoperative period, with a Glasgow Outcome Scale score ≥ 3. There was no correlation between duration of cardiopulmonary bypass and neurological outcomes. CONCLUSION: Early cardiac surgery in patients with infective endocarditis and stroke maybe lifesaving with a low neurological risk. Comprehensive neurovascular imaging may help in identifying patient-related risk factors.

Community-associated methicillin-resistant Staphylococcus aureus colonization in high-risk groups of HIV-infected patients.

BACKGROUND: We examined the epidemiology of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) nasal colonization among 3 groups of human immunodeficiency virus (HIV)-infected and 1 group of HIV-negative outpatients. METHODS: We determined prevalence and risk factors associated with MRSA colonization among women, recently incarcerated, and Hispanic HIV-infected patients and HIV-negative patients; isolates were typed by pulsed-field gel electrophoresis. Relative prevalence was calculated using Poisson regression, and logistic regression was used for multivariate analysis. RESULTS: Of 601 patients, 9.3% were colonized with MRSA; 11% of HIV-infected and 4.2% of HIV-negative patients were colonized (relative prevalence, 2.6; 95% confidence interval [CI], 1.12-6.07; P = .03). Among HIV-infected patients, recently incarcerated patients had the highest colonization prevalence (15.6%) followed by women (12%); Hispanic patients had the lowest (2.8%). Eighty percent of confirmed MRSA isolates were identified as USA300. On multivariate analysis, history of incarceration or residence in alternative housing (odds ratio [OR], 2.3; 95% CI, 1.1-4.7; P = .03) was associated with MRSA colonization; Hispanic ethnicity was negatively associated (OR, 0.3; 95% CI, .11-.98; P = .045). There was a trend (OR, 1.6; 95% CI, .9-3.0; P = .097) toward geographic location of residence being associated with colonization. After controlling for incarceration, residence, and geography, HIV status was no longer significantly associated with colonization. CONCLUSIONS: The CA-MRSA and HIV epidemics have intersected. Examination of networks of individuals released from incarceration, both HIV positive and negative, is needed to assess the role of social networks in spread of CA-MRSA and inform prevention strategies.

Staphylococcus aureus bacteriuria as a prognosticator for outcome of Staphylococcus aureus bacteremia: a case-control study.

BACKGROUND: When Staphylococcus aureus is isolated in urine, it is thought to usually represent hematogenous spread. Because such spread might have special clinical significance, we evaluated predictors and outcomes of S. aureus bacteriuria among patients with S. aureus bacteremia. METHODS: A case-control study was performed at John H. Stroger Jr. Hospital of Cook County among adult inpatients during January 2002-December 2006. Cases and controls had positive and negative urine cultures, respectively, for S. aureus, within 72 hours of positive blood culture for S. aureus. Controls were sampled randomly in a 1:4 ratio. Univariate and multivariable logistic regression analyses were done. RESULTS: Overall, 59% of patients were African-American, 12% died, 56% of infections had community-onset infections, and 58% were infected with methicillin-susceptible S. aureus (MSSA). Among 61 cases and 247 controls, predictors of S. aureus bacteriuria on multivariate analysis were urological surgery (OR = 3.4, p = 0.06) and genitourinary infection (OR = 9.2, p = 0.002). Among patients who died, there were significantly more patients with bacteriuria than among patients who survived (39% vs. 17%; p = 0.002). In multiple Cox regression analysis, death risks in bacteremic patients were bacteriuria (hazard ratio 2.9, CI 1.4-5.9, p = 0.004), bladder catheter use (2.0, 1.0-4.0, p = 0.06), and Charlson score (1.1, 1.1-1.3, p = 0.02). Neither length of stay nor methicillin-resistant Staphylococcus aureus (MRSA) infection was a predictor of S. aureus bacteriuria or death. CONCLUSIONS: Among patients with S. aureus bacteremia, those with S. aureus bacteriuria had 3-fold higher mortality than those without bacteriuria, even after adjustment for comorbidities. Bacteriuria may identify patients with more severe bacteremia, who are at risk of worse outcomes.

Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship.

BACKGROUND: Organisms resistant to antimicrobials continue to emerge and spread. This study was performed to measure the medical and societal cost attributable to antimicrobial-resistant infection (ARI). METHODS: A sample of high-risk hospitalized adult patients was selected. Measurements included ARI, total cost, duration of stay, comorbidities, acute pathophysiology, Acute Physiology and Chronic Health Evaluation III score, intensive care unit stay, surgery, health care-acquired infection, and mortality. Hospital services used and outcomes were abstracted from electronic and written medical records. Medical costs were measured from the hospital perspective. A sensitivity analysis including 3 study designs was conducted. Regression was used to adjust for potential confounding in the random sample and in the sample expanded with additional patients with ARI. Propensity scores were used to select matched control subjects for each patient with ARI for a comparison of mean cost for patients with and without ARI. RESULTS: In a sample of 1391 patients, 188 (13.5%) had ARI. The medical costs attributable to ARI ranged from $18,588 to $29,069 per patient in the sensitivity analysis. Excess duration of hospital stay was 6.4-12.7 days, and attributable mortality was 6.5%. The societal costs were $10.7-$15.0 million. Using the lowest estimates from the sensitivity analysis resulted in a total cost of $13.35 million in 2008 dollars in this patient cohort. CONCLUSIONS: The attributable medical and societal costs of ARI are considerable. Data from this analysis could form the basis for a more comprehensive evaluation of the cost of resistance and the potential economic benefits of prevention programs.

The role of rapid vs conventional human immunodeficiency virus testing for inpatients: effects on quality of care.

BACKGROUND: Rapid testing for human immunodeficiency virus (HIV) has improved HIV screening in the outpatient and perinatal settings, but few data report how it may be used to improve the quality of inpatient care. We compared quality of care for inpatients diagnosed in the emergency department via rapid testing vs patients whose conditions were diagnosed via conventional testing during their hospital admission. METHODS: We reviewed medical records to identify patients with first-time positive HIV tests and concurrent hospital admission who were tested via either rapid testing in the emergency department or conventional testing during their hospital admission. We compared quality-of-care end points for these patients. RESULTS: We identified 103 HIV-infected inpatients with no previous HIV diagnosis; the conditions of 48 patients (47%) were diagnosed by rapid testing and 55 (53%) by conventional testing. Mean length of stay was 6 days for the rapid test group vs 13 days for the conventional test group (P<.001); multivariate regression analysis showed that testing modality had an independent, statistically significant effect on length of stay. Nine (16%) of the patients in the conventional test group vs none in the rapid test group were discharged without receiving their HIV test results (P = .002). Patients in the rapid test group attended the outpatient HIV clinic in a mean of 22 days vs 50 days for the conventional test group patients (P = .05). CONCLUSIONS: Rapid HIV testing in the emergency department preceding admission may shorten hospital stay, increase the number of newly diagnosed patients with HIV who are discharged from the hospital aware of their HIV status, and improve entry into outpatient care for patients admitted at the time of their initial HIV diagnosis.