Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group.

BACKGROUND: Long-term symptoms following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are a major concern, yet their prevalence is poorly understood. METHODS: We conducted a prospective cohort study comparing adults with SARS-CoV-2 infection (coronavirus disease-positive [COVID+]) with adults who tested negative (COVID-), enrolled within 28 days of a Food and Drug Administration (FDA)-approved SARS-CoV-2 test result for active symptoms. Sociodemographic characteristics, symptoms of SARS-CoV-2 infection (assessed with the Centers for Disease Control and Prevention [CDC] Person Under Investigation Symptom List), and symptoms of post-infectious syndromes (ie, fatigue, sleep quality, muscle/joint pains, unrefreshing sleep, and dizziness/fainting, assessed with CDC Short Symptom Screener for myalgic encephalomyelitis/chronic fatigue syndrome) were assessed at baseline and 3 months via electronic surveys sent via text or email. RESULTS: Among the first 1000 participants, 722 were COVID+ and 278 were COVID-. Mean age was 41.5 (SD 15.2); 66.3% were female, 13.4% were Black, and 15.3% were Hispanic. At baseline, SARS-CoV-2 symptoms were more common in the COVID+ group than the COVID- group. At 3 months, SARS-CoV-2 symptoms declined in both groups, although were more prevalent in the COVID+ group: upper respiratory symptoms/head/eyes/ears/nose/throat (HEENT; 37.3% vs 20.9%), constitutional (28.8% vs 19.4%), musculoskeletal (19.5% vs 14.7%), pulmonary (17.6% vs 12.2%), cardiovascular (10.0% vs 7.2%), and gastrointestinal (8.7% vs 8.3%); only 50.2% and 73.3% reported no symptoms at all. Symptoms of post-infectious syndromes were similarly prevalent among the COVID+ and COVID- groups at 3 months. CONCLUSIONS: Approximately half of COVID+ participants, as compared with one-quarter of COVID- participants, had at least 1 SARS-CoV-2 symptom at 3 months, highlighting the need for future work to distinguish long COVID. CLINICAL TRIALS REGISTRATION: NCT04610515.

Frequent Methicillin-Resistant Staphylococcus aureus Introductions Into an Inner-city Jail: Indications of Community Transmission Networks.

BACKGROUND: Jails may facilitate spread of methicillin-resistant Staphylococcus aureus (MRSA) in urban areas. We examined MRSA colonization upon entrance to a large urban jail to determine if there are MRSA transmission networks preceding incarceration. METHODS: Males incarcerated in Cook County Jail (Chicago) were enrolled, with enrichment for people living with human immunodeficiency virus (PLHIV), within 72 hours of intake. Surveillance cultures assessed prevalence of MRSA colonization. Whole-genome sequencing (WGS) identified preincarceration transmission networks.We examined methicillin-resistant Staphylococcus aureus (MRSA) isolates to determine if there are transmission networks that precede incarceration. A large proportion of individuals enter jail colonized with MRSA. Molecular epidemiology and colonization risk factors provide clues to community reservoirs for MRSA. RESULTS: There were 718 individuals (800 incarcerations) enrolled; 58% were PLHIV. The prevalence of MRSA colonization at intake was 19%. In multivariate analysis, methamphetamine use, unstable housing, current/recent skin infection, and recent injection drug use were predictors of MRSA. Among PLHIV, recent injection drug use, current skin infection, and HIV care at outpatient clinic A that emphasizes comprehensive care to the lesbian, gay, bisexual, transgender community were predictors of MRSA. Fourteen (45%) of 31 detainees with care at clinic A had colonization. WGS revealed that this prevalence was not due to clonal spread in clinic but rather to an intermingling of distinct community transmission networks. In contrast, genomic analysis supported spread of USA500 strains within a network. Members of this USA500 network were more likely to be PLHIV (P < .01), men who have sex with men (P < .001), and methamphetamine users (P < .001). CONCLUSIONS: A large proportion of individuals enter jail colonized with MRSA. Molecular epidemiology and colonization risk factors provide clues to identify colonized detainees entering jail and potential community reservoirs of MRSA.

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.

Genomic and Epidemiological Evidence for Community Origins of Hospital-Onset Methicillin-Resistant Staphylococcus aureus Bloodstream Infections.

Background: We examined whether disparities existed in hospital-onset (HO) Staphylococcus aureus bloodstream infections (BSIs) and used whole-genome sequencing (WGS) to identify factors associated with USA300 transmission networks. Methods: We evaluated HO methicillin-susceptible S. aureus (MSSA) and HO methicillin-resistant S. aureus (MRSA) BSIs for 2009-2013 at 2 hospitals and used an adjusted incidence for modeling. WGS and phylogenetic analyses were performed on a sample of USA300 BSI isolates. Epidemiologic data were analyzed in the context of phylogenetic reconstructions. Results: On multivariate analysis, male sex, African-American race, and non-Hispanic white race/ethnicity were significantly associated with HO-MRSA BSIs whereas Hispanic ethnicity was negatively associated (rate ratio, 0.41; P = .002). Intermixing of community-onset and HO-USA300 strains on the phylogenetic tree indicates that these strains derive from a common pool. African-American race was the only factor associated with genomic clustering of isolates. Conclusions: In a multicenter assessment of HO-S. aureus BSIs, African-American race was significantly associated with HO-MRSA but not MSSA BSIs. There appears to be a nexus of USA300 community and hospital transmission networks, with a community factor being the primary driver. Our data suggest that HO-USA300 BSIs likely are due to colonizing strains acquired in the community before hospitalization. Therefore, prevention efforts may need to extend to the community for maximal benefit.

Genomic Epidemiology of USA300 Methicillin-Resistant Staphylococcus aureus in an Urban Community.

BACKGROUND: In a community, it is unknown what factors account for transmission of methicillin-resistant Staphylococcus aureus (MRSA). We integrated whole genome sequencing (WGS) and epidemiologic data to identify factors associated with MRSA transmission networks in an urban community. METHODS: WGS was performed on colonizing USA300 MRSA isolates from 74 individuals within 72 hours of admission to a public hospital in Chicago, IL. Single nucleotide variants (SNVs) were used to reconstruct the phylogeny of sequenced isolates, and epidemiologic data was overlaid to identify factors associated with transmission networks. RESULTS: The maximum within-patient SNV difference for an individual with multisite colonization was 41 SNVs, with no systematic divergence among body sites. We observed a minimum of 7 SNVs and maximum of 153 SNVs between isolates from different individuals. We identified 4 pairs of individuals whose isolates were within 40 SNVs of each other. Putting our isolates in the context of previously sequenced USA300 isolates from other communities, we identified a 13-member group and two 4-member groups that represent samples from putative local transmission networks. Individuals in these groups were more likely to be African American, to be human immunodeficiency virus-infected, to reside in high detainee release areas, and to be current users of illicit drugs. CONCLUSIONS: Using WGS, we observed potential transmission networks in an urban community and that certain epidemiologic factors were associated with inclusion in these networks. Future work with contact tracing and advanced molecular diagnostics may allow for identification of MRSA "epicenters" in the community where interventions can be targeted.

Consumer Rankings and Health Care: Toward Validation and Transparency.

BACKGROUND: Differences between the Centers for Medicare & Medicaid Services (CMS)-measured rates of safety events for Rush University Medical Center (RUMC; Chicago) and the U. S. News & World Report (USNWR)-deter mined patient safety score were evaluated in an attempt to validate the USNWR patient safety score-based ranking. METHODS: The USNWR findings for Patient Safety Indicators (PSIs) were compared with findings derived from RUMC internal billing data, and sensitivity analyses were conducted using a simulated data set derived from the Healthcare Cost and Utilization Project (HCUP) state inpatient data sets. RESULTS: Discrepancies were found for PSIs 3 (Pressure Ulcer Rate), 9 (Perioperative Hemorrhage or Hematoma Rate), and 11 (Postoperative Respiratory Failure Rate)-an excess of 0.72, 0.63, and 0.26 cases/1,000 admissions, in USNWR versus RUMC, respectively). The sensitivity analysis, which included missing present on admission (POA) flags and dates, resulted in an increase of rates by 1.83 (95% confidence interval [CI] = 1.10-2.56) cases/1,000 hospital- izations, 2.72 (CI = 0.00-5.90) cases/1,000 hospitalizations, and 3.89 (CI = 1.60-6.20) cases/1,000 hospitalizations for PSI 3, 9, and 11, respectively. Regression modeling showed that each 1% increase in transfers was associated with an in- crease of 0.06 cases of PSI 3/1,000 admissions; each 1,000 increase in admissions was associated with an increase of 0.04 cases of PSI 9/1,000 admissions. CONCLUSION: The USNWR data set produced inaccurate PSI rates for RUMC, and false-positive event rates were more common among high-transfer and high-volume hos- pitals. More transparency and validation is needed for con- sumer-based benchmarking methods. In response to these findings and concerns raised by others, in 2016 USNWR made changes to its methodology and data sources and reported them in announcing its 2016-17 Best Hospitals.

Chicago Ebola Response Network (CERN): A Citywide Cross-hospital Collaborative for Infectious Disease Preparedness.

The 2014-2015 Ebola virus disease (EVD) epidemic and international public health emergency has been referred to as a "black swan" event, or an event that is unlikely, hard to predict, and highly impactful once it occurs. The Chicago Ebola Response Network (CERN) was formed in response to EVD and is capable of receiving and managing new cases of EVD, while also laying the foundation for a public health network that can anticipate, manage, and prevent the next black swan public health event. By sharing expertise, risk, and resources among 4 major academic centers, Chicago created a sustainable network to respond to the latest in a series of public health emergencies. In this respect, CERN is a roadmap for how a region can prepare to respond to public health emergencies, thereby preventing negative impacts through planning and implementation.

Corticosteroid Monotherapy Is Usually Insufficient Treatment for Idiopathic Inflammatory Myopathy.

Idiopathic inflammatory myopathies (IIM) are a rare group of autoimmune diseases characterized by muscle inflammation. High-dose corticosteroids are conventionally used as the first-line therapy for IIM, but early introduction of noncorticosteroid immunosuppressive agents has become increasingly common in recent years despite a paucity of compelling evidence to support this. Here, we systematically analyze therapeutic practice patterns of IIM in a large municipal safety net medical center. We conducted a retrospective chart review of all adult patients attending rheumatology clinics at the Cook County Health and Hospital Systems from 2006 to 2011 with a diagnosis of IIM. Data collected included patient demographics, diagnosis, immunosuppressive therapies, serial serum creatine kinase (CK) measurements, and serial muscle strength testing. One hundred eight patients fulfilled eligibility criteria. The mean duration of follow-up was 62 months (range, 1-351 months). At presentation, the mean strength in the weakest muscle group was rated as 3.6 out of 5 (range, 1-5; SD 0.9), the mean initial CK was 4720 U/L (range, 23-38, 461; SD 6, 795), and initial mean prednisone dosage was 48 mg/d (range, 0-100, SD 22). At the end of the follow-up period, mean strength in the weakest muscle group was 4.6 out of 5 (range, 2-5; SD 0.7), mean peak CK was 412 (24-7533; SD 875), and the mean prednisone dosage was 12.7 mg (0-80; SD 17.5). Only 15 patients (14%) received exclusively corticosteroid monotherapy during the follow-up period. Ninety-three patients (86%) received additional immunosuppressive agents. Over the course of their illness, only a minority of patients in our cohort of IIM patients was treated with corticosteroids alone. It is unlikely we will determine optimal therapy in the absence of a large controlled study comparing corticosteroids versus a combination regimen, but it seems that rheumatologists favor addition of second-line immunosuppressive agents.

Serum transaminases are frequently elevated at time of diagnosis of idiopathic inflammatory myopathy and normalize with creatine kinase.

INTRODUCTION: Despite multiple reports of elevated transaminases in muscle injury, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are not always considered indicators of muscle damage. The purpose of this study was to examine the relationship between serum AST, ALT, and creatine kinase (CK) levels at time of diagnosis of idiopathic inflammatory myopathy (IIM) and at the time of CK normalization. METHODS: We conducted a retrospective chart review of all adult patients attending rheumatology clinics at a county hospital with a diagnosis of IIM. Data collected included patient demographics, serial CK measurements, and serial serum transaminase measurements. RESULTS: We identified 85 patients with IIM. At myositis presentation, 75 (88%) had CK above the upper limit of normal (ULN), 72 (85%) had AST above the ULN, and 68 (80%) had ALT above the ULN. The average CK was 5302 U/L (range, 23-38,461 U/L [SD, 7096]), average AST 215 U/L (range, 16-1270 [SD, 227]), and average ALT 137 U/L (range, 10-621 [SD, 137]). The average AST and ALT at first available normalized CK was 26 U/L (range, 9-139 [SD, 18]) and 26 U/L (range, 5-96 [SD, 19]). We found a strong correlation between CK and AST (r= 0.832; P < 0.001) and ALT (r = 0.775; P < 0.001) at initial presentation and also at the time of peak CK levels (r = 0.874 [P < 0.001] and r = 0.842 [P < 0.001], respectively). CONCLUSIONS: In our series, we found a strong correlation between CK and serum transaminases. Serum transaminases were elevated in 80% of patients at the time of presentation and normalized in 85% of the patients at the time of CK normalization. Appropriate recognition of these laboratory changes in IIM may help reduce unnecessary hepatic evaluation, delayed diagnosis, unnecessary avoidance of second line immunosuppressants, and misdiagnosis of primary liver disease.

The Pandemic Response Commons.

Objectives: A data commons is a software platform for managing, curating, analyzing, and sharing data with a community. The Pandemic Response Commons (PRC) is a data commons designed to provide a data platform for researchers studying an epidemic or pandemic. Methods: The PRC was developed using the open source Gen3 data platform and is based upon consortium, data, and platform agreements developed by the not-for-profit Open Commons Consortium. A formal consortium of Chicagoland area organizations was formed to develop and operate the PRC. Results: The consortium developed a general PRC and an instance of it for the Chicagoland region called the Chicagoland COVID-19 Commons. A Gen3 data platform was set up and operated with policies, procedures, and controls for a NIST SP 800-53 revision 4 Moderate system. A consensus data model for the commons was developed, and a variety of datasets were curated, harmonized and ingested, including statistical summary data about COVID cases, patient level clinical data, and SARS-CoV-2 viral variant data. Discussion and conclusions: Given the various legal and data agreements required to operate a data commons, a PRC is designed to be in place and operating at a low level prior to the occurrence of an epidemic, with the activities increasing as required during an epidemic. A regional instance of a PRC can also be part of a broader data ecosystem or data mesh consisting of multiple regional commons supporting pandemic response through sharing regional data.

Community-associated methicillin-resistant Staphylococcus aureus colonization burden in HIV-infected patients.

BACKGROUND: The epidemic of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has had a disproportionate impact on patients with human immunodeficiency virus (HIV). METHODS: We evaluated CA-MRSA colonization burden (number of colonized sites per total number sampled) among HIV-infected and HIV-negative inpatients within 72 hours of hospitalization. From March 2011 through April 2012, we obtained cultures from nasal and extranasal sites (throat, axilla, inguinal, perirectal, and chronic wound if present) and collected risk factor data. RESULTS: Of 745 patients (374 HIV-infected, 371 HIV-negative), 15.7% were colonized with CA-MRSA at any site: 20% of HIV and 11% of HIV-negative patients (relative prevalence=1.8, P=.002). HIV-infected patients had a higher prevalence of nasal, extranasal, and exclusive extranasal colonization as well as higher colonization burden. Perirectal and inguinal areas were the extranasal sites most frequently colonized, and 38.5% of colonized patients had exclusive extranasal colonization. Seventy-three percent of isolates were identified as USA300. Among HIV-infected patients, male sex, younger age, and recent incarceration were positively associated whereas Hispanic ethnicity was negatively associated with higher colonization burden. Among HIV-negative patients, temporary housing (homeless, shelter, or substance abuse center) was the only factor associated with higher colonization burden. Predictors of USA300 included HIV, younger age, illicit drug use, and male sex; all but 1 colonized individual with current or recent incarceration carried USA300. CONCLUSIONS: HIV-infected patients were more likely to have a higher CA-MRSA colonization burden and carry USA300. In certain populations, enhanced community and outpatient-based infection control strategies may be needed to prevent CA-MRSA cross-transmission and infection.

Random variation drives a critical bias in the comparison of healthcare-associated infections.

OBJECTIVE: To evaluate random effects of volume (patient days or device days) on healthcare-associated infections (HAIs) and the standardized infection ratio (SIR) used to compare hospitals. DESIGN: A longitudinal comparison between publicly reported quarterly data (2014-2020) and volume-based random sampling using 4 HAI types: central-line-associated bloodstream infections, catheter-associated urinary tract infections, Clostridioides difficile infections, methicillin-resistant Staphylococcus aureus infections. METHODS: Using 4,268 hospitals with reported SIRs, we examined relationships of SIRs to volume and compared distributions of SIRs and numbers of reported HAIs to the outcomes of simulated random sampling. We included random expectations into SIR calculations to produce a standardized infection score (SIS). RESULTS: Among hospitals with volumes less than the median, 20%-33% had SIRs of 0, compared to 0.3%-5% for hospitals with volumes higher than the median. Distributions of SIRs were 86%-92% similar to those based on random sampling. Random expectations explained 54%-84% of variation in numbers of HAIs. The use of SIRs led hundreds of hospitals with more infections than either expected at random or predicted by risk-adjusted models to rank better than other hospitals. The SIS mitigated this effect and allowed hospitals of disparate volumes to achieve better scores while decreasing the number of hospitals tied for the best score. CONCLUSIONS: SIRs and numbers of HAIs are strongly influenced by random effects of volume. Mitigating these effects drastically alters rankings for HAI types and may further alter penalty assignments in programs that aim to reduce HAIs and improve quality of care.

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.

Economical Utilization of Health Information with Learning Healthcare System Data Commons.

Finding, accessing, sharing, and analyzing patient data from a clinical setting for collaborative research has continually proven to be a challenge in healthcare organizations. The human and technological architecture required to perform these services exist at the largest academic institutions but are usually under-funded. At smaller, less academically focused healthcare organizations across the United States, where the majority of care is delivered, they are generally absent. Here we propose a solution called the Learning Healthcare System Data Commons where cost is usage-based and the most basic elements are designed to be extensible, allowing it to evolve with the changing landscape of healthcare. Herein we also discuss our reference implementation of this platform tailored specifically for operational sustainability and governance using the data generated in a hospital setting for research, quality, and educational purposes.

Variation in the Reporting of Elective Surgeries and Its Influence on Patient Safety Indicators.

BACKGROUND: US hospital safety is routinely measured via Patient Safety Indicators (PSIs). Receiving a score for most PSIs requires a minimum number of qualifying cases to meet specific criteria; for example, whether an admission was elective. Because admission type is determined by hospitals' internal policies, the study team suspected that hospitals may be exempted from elective-based PSI scores as a result of their internal admission classification policies. METHODS: Multiple regression was combined with machine learning to analyze Medicare inpatient claims data reported by 3,484 hospitals during the 2015-2017 PSI measurement period. The researchers examined the average percentage of elective admissions across surgical diagnosis-related groups (DRGs) (average percent elective [APE]) in relation to hospital characteristics, surgical claims volumes, and numbers and types of surgical DRGs. This study asked whether hospitals with exceptionally low APE shared particular characteristics, reported claims for similar DRGs, or were disproportionately exempted from elective-based PSIs. RESULTS: Cross-validated multiple regression explained 73.9% of variation in APE among hospitals and identified surgical claims volume and 16 surgical DRGs as consistently important variables. However, the exceptionally low APE of 96 hospitals could not be explained by surgical claims volume, surgical DRGs among claims, or hospital characteristics. These outliers were disproportionately exempt from elective-based PSI scores. CONCLUSION: Some hospitals may have classified admissions in a way that exempted them from elective-based PSI scores. Transparency into admission classification policies is needed to ensure fair and reliable use of PSIs when ranking hospitals and adjusting payments. Alternatively, PSIs may need modifications to rely on externally validated criteria.

A Standard-Based Citywide Health Information Exchange for Public Health in Response to COVID-19: Development Study.

BACKGROUND: Disease surveillance is a critical function of public health, provides essential information about the disease burden and the clinical and epidemiologic parameters of disease, and is an important element of effective and timely case and contact tracing. The COVID-19 pandemic demonstrates the essential role of disease surveillance in preserving public health. In theory, the standard data formats and exchange methods provided by electronic health record (EHR) meaningful use should enable rapid health care data exchange in the setting of disruptive health care events, such as a pandemic. In reality, access to data remains challenging and, even if available, often lacks conformity to regulated standards. OBJECTIVE: We sought to use regulated interoperability standards already in production to generate awareness of regional bed capacity and enhance the capture of epidemiological risk factors and clinical variables among patients tested for SARS-CoV-2. We described the technical and operational components, governance model, and timelines required to implement the public health order that mandated electronic reporting of data from EHRs among hospitals in the Chicago jurisdiction. We also evaluated the data sources, infrastructure requirements, and the completeness of data supplied to the platform and the capacity to link these sources. METHODS: Following a public health order mandating data submission by all acute care hospitals in Chicago, we developed the technical infrastructure to combine multiple data feeds from those EHR systems-a regional data hub to enhance public health surveillance. A cloud-based environment was created that received ELR, consolidated clinical data architecture, and bed capacity data feeds from sites. Data governance was planned from the project initiation to aid in consensus and principles for data use. We measured the completeness of each feed and the match rate between feeds. RESULTS: Data from 88,906 persons from CCDA records among 14 facilities and 408,741 persons from ELR records among 88 facilities were submitted. Most (n=448,380, 90.1%) records could be matched between CCDA and ELR feeds. Data fields absent from ELR feeds included travel histories, clinical symptoms, and comorbidities. Less than 5% of CCDA data fields were empty. Merging CCDA with ELR data improved race, ethnicity, comorbidity, and hospitalization information data availability. CONCLUSIONS: We described the development of a citywide public health data hub for the surveillance of SARS-CoV-2 infection. We were able to assess the completeness of existing ELR feeds, augment those feeds with CCDA documents, establish secure transfer methods for data exchange, develop a cloud-based architecture to enable secure data storage and analytics, and produce dashboards for monitoring of capacity and the disease burden. We consider this public health and clinical data registry as an informative example of the power of common standards across EHRs and a potential template for future use of standards to improve public health surveillance.

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.

Association of Initial SARS-CoV-2 Test Positivity With Patient-Reported Well-being 3 Months After a Symptomatic Illness.

Importance: Long-term sequelae after symptomatic SARS-CoV-2 infection may impact well-being, yet existing data primarily focus on discrete symptoms and/or health care use. Objective: To compare patient-reported outcomes of physical, mental, and social well-being among adults with symptomatic illness who received a positive vs negative test result for SARS-CoV-2 infection. Design, Setting, and Participants: This cohort study was a planned interim analysis of an ongoing multicenter prospective longitudinal registry study (the Innovative Support for Patients With SARS-CoV-2 Infections Registry [INSPIRE]). Participants were enrolled from December 11, 2020, to September 10, 2021, and comprised adults (aged ≥18 years) with acute symptoms suggestive of SARS-CoV-2 infection at the time of receipt of a SARS-CoV-2 test approved by the US Food and Drug Administration. The analysis included the first 1000 participants who completed baseline and 3-month follow-up surveys consisting of questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29; 7 subscales, including physical function, anxiety, depression, fatigue, social participation, sleep disturbance, and pain interference) and the PROMIS Short Form-Cognitive Function 8a scale, for which population-normed T scores were reported. Exposures: SARS-CoV-2 status (positive or negative test result) at enrollment. Main Outcomes and Measures: Mean PROMIS scores for participants with positive COVID-19 tests vs negative COVID-19 tests were compared descriptively and using multivariable regression analysis. Results: Among 1000 participants, 722 (72.2%) received a positive COVID-19 result and 278 (27.8%) received a negative result; 406 of 998 participants (40.7%) were aged 18 to 34 years, 644 of 972 (66.3%) were female, 833 of 984 (84.7%) were non-Hispanic, and 685 of 974 (70.3%) were White. A total of 282 of 712 participants (39.6%) in the COVID-19-positive group and 147 of 275 participants (53.5%) in the COVID-19-negative group reported persistently poor physical, mental, or social well-being at 3-month follow-up. After adjustment, improvements in well-being were statistically and clinically greater for participants in the COVID-19-positive group vs the COVID-19-negative group only for social participation (ß = 3.32; 95% CI, 1.84-4.80; P < .001); changes in other well-being domains were not clinically different between groups. Improvements in well-being in the COVID-19-positive group were concentrated among participants aged 18 to 34 years (eg, social participation: ß = 3.90; 95% CI, 1.75-6.05; P < .001) and those who presented for COVID-19 testing in an ambulatory setting (eg, social participation: ß = 4.16; 95% CI, 2.12-6.20; P < .001). Conclusions and Relevance: In this study, participants in both the COVID-19-positive and COVID-19-negative groups reported persistently poor physical, mental, or social well-being at 3-month follow-up. Although some individuals had clinically meaningful improvements over time, many reported moderate to severe impairments in well-being 3 months later. These results highlight the importance of including a control group of participants with negative COVID-19 results for comparison when examining the sequelae of COVID-19.

Predictors of clinical virulence in community-onset methicillin-resistant Staphylococcus aureus infections: the importance of USA300 and pneumonia.

BACKGROUND: Though USA300 community-onset methicillin-resistant Staphylococcus aureus (CO-MRSA) has emerged as a major public health concern in the United States, its relative virulence is unknown. We sought to evaluate if the USA300 strain of CO-MRSA causes more severe infections than other MRSA (ie, USA100, -500, -800, and others) strains. METHODS: An epidemiologic study was conducted from 2000 to 2007 to measure rates of severe infection. A matched case-control study was conducted from 2004 to 2006 to assess the relationship of strain type, syndrome, and severity of infection. Severe illness was defined as CO-MRSA infections with medical intensive care unit (MICU) admission or death within 1 week of admission. Controls were those with CO-MRSA infection without MICU admission. RESULTS: We found an incidence of 75 cases per 100000 people of CO-MRSA infection in 2000, which increased to a rate of 396 per 100000 in 2007 (relative risk [RR], 5.3; 95% confidence interval [CI], 4.47-6.27). The incidence of severe infections increased from 5 cases per 100000 in 2000 to 17 per 100000 in 2007 (RR, 3.4; 95% CI; 1.67-6.43). USA300 strains were negatively associated with severe clinical courses or death as compared with other MRSA strain types. The highest risk of severe infection was found in those with pulmonary embolic infiltrates and bacteremia in the setting of USA300 infection (odds ratio, 31.41; 95% CI, 6.40-154.23). CONCLUSIONS: Our findings suggest that USA300 infections are negatively associated with severe clinical courses, suggesting less virulence than other MRSA strains, except in the setting of pneumonia with septic pulmonary emboli.

Emergence and rapid regional spread of Klebsiella pneumoniae carbapenemase-producing Enterobacteriaceae.

UNLABELLED: Exposure network analysis and molecular epidemiologic methods were used to analyze the emergence and regional spread of Klebsiella pneumoniae carbapenemase-producing Enterobacteriaceae over a 1-year period. Although 40 patients and 26 health care facilities were affected, 1 long-term acute care hospital played a critical role in the convergence of patients at high risk, amplification by cross-infection, and dissemination of these multidrug-resistant bacteria. BACKGROUND: Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae are an emerging antibiotic resistance threat with demonstrated epidemic potential. METHODS: We conducted an outbreak investigation of KPC-producing Enterobacteriaceae among patients of acute and long-term acute care hospitals (LTACHs) in 4 adjacent counties in Indiana and Illinois from 1 January 2008 through 31 December 2008 (cases). The study used traditional and molecular epidemiologic methods and an adaptation of social network analysis ("exposure network analysis"). RESULTS: Clinical records for 40 (95%) of 42 patients were available. Patients were mostly older with multiple comorbid conditions. Eleven patients (27.5%) died during the index hospitalization or were discharged to hospice; 23 (57.5%) were discharged to a nursing home, and 4 (10.0%) were discharged to home. One LTACH (LTACH-A) was central to the regional outbreak: 24 (60%) of 40 cases were linked to LTACH-A, and at least 10 patients (25%) acquired KPC there. Of 16 cases not linked to LTACH-A, 12 (75%) were linked to 3 nursing homes. Only 4 patients (10%) definitely acquired KPC during an acute care hospital stay. Molecular typing revealed the 31 available KPC-positive K. pneumoniae isolates to be similar and to cluster with epidemic multilocus sequence type 258; 2 KPC-positive Escherichia coli isolates were unique. CONCLUSIONS: We observed extensive transfer of KPC-positive patients throughout the exposure network of 14 acute care hospitals, 2 LTACHs, and 10 nursing homes. Although few cases were identified at most institutions, many facilities were affected. Successful control of KPC-producing Enterobacteriaceae will require a coordinated, regional effort among acute and long-term health care facilities and public health departments.