The Impact of the COVID-19 Pandemic on Racial Disparities in Patients Undergoing Total Shoulder Arthroplasty in the United States.

Introduction: The purpose of this study was to assess racial disparities in total shoulder arthroplasty (TSA) in the US and to determine whether these disparities were affected by the COVID-19 pandemic. Methods: Centers for Medicare and Medicaid Services (CMS) 100% sample was used to examine primary TSA volume from April-December from 2019-2020. Utilization was assessed for White/Black/Hispanic/Asian populations to determine if COVID-19 affected these groups differently. A regression model adjusted for age/sex/CMS-Hierarchical Condition Categories (HCC) score, dual enrollment (proxy for socioeconomic status), time fixed effects, and Core-based Statistical Area (CBSA) fixed effects was used to study difference across groups. Results: In 2019, TSA volume/1000 beneficiaries was 1.51 for White and 0.57 for non-White, a 2.6-fold difference. In 2020, the rate of TSA in White patients (1.30/1000) was 2.9 times higher than non-White (0.45/1000) during the COVID-19 pandemic (P<0.01). There was an overall 14% decrease in TSA volume/1000 Medicare beneficiaries in 2020; non-White patients had a larger percentage decrease in TSA volume than White (21% vs. 14%, estimated difference;8.7%,p = 0.02). Black patients experienced the most pronounced disparity with estimated difference of 10.1%,p = 0.05, compared with White patients. Similar disparities were observed when categorizing procedures into anatomic and reverse TSA, but not proximal humerus fracture. Conclusions: During the COVID-19 pandemic, overall TSA utilization decreased by 14% with White patients experiencing a decrease of 14%, and non-White patients experiencing a decrease of 21%. This trend was observed for elective TSA while disparities were less apparent for proximal humerus fracture.

Impact of the COVID-19 pandemic on shoulder arthroplasty: surgical trends and postoperative care pathway analysis.

BACKGROUND: COVID-19 triggered disruption in the conventional care pathways for many orthopedic procedures. The current study aims to quantify the impact of the COVID-19 pandemic on shoulder arthroplasty hospital surgical volume, trends in surgical case distribution, length of hospitalization, posthospital disposition, and 30-day readmission rates. METHODS: This study queried all Medicare (100% sample) fee-for-service beneficiaries who underwent a shoulder arthroplasty procedure (Diagnosis-Related Group code 483, Current Procedural Terminology code 23472) from January 1, 2019, to December 18, 2020. Fracture cases were separated from nonfracture cases, which were further subdivided into anatomic or reverse arthroplasty. Volume per 1000 Medicare beneficiaries was calculated from April to December 2020 and compared to the same months in 2019. Length of stay (LOS), discharged-home rate, and 30-day readmission for the same period were obtained. The yearly difference adjusted for age, sex, race (white vs. nonwhite), Centers for Medicare & Medicaid Services Hierarchical Condition Category risk score, month fixed effects, and Core-Based Statistical Area fixed effects, with standard errors clustered at the provider level, was calculated using a multivariate analysis (P < .05). RESULTS: A total of 49,412 and 41,554 total shoulder arthroplasty (TSA) cases were observed April through December for 2019 and 2020, respectively. There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% (19% reduction in anatomic TSA, 13% reduction in reverse shoulder arthroplasty, and 3% reduction in fracture cases). LOS for all shoulder arthroplasty cases decreased by 16% (-0.27 days, P < .001) when adjusted for confounders. There was a 5% increase in the discharged-home rate (88.0% to 92.7%, P < .001), which was most prominent in fracture cases, with a 20% increase in discharged-home cases (65.0% to 73.4%, P < .001). There was no significant change in 30-day hospital readmission rates overall (P = .20) or when broken down by individual procedures. CONCLUSIONS: There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% during the COVID-19 pandemic. A decrease in LOS and increase in the discharged-home rates was also observed with no significant change in 30-day hospital readmission, indicating that a shift toward an outpatient surgical model can be performed safely and efficiently and has the potential to provide value.

Populism unrestrained: Policy responses of the Orbán regime to the pandemic in 2020–2021

The paper provides a case study on how the Orbán regime in Hungary has dealt with coronavirus disease 2019 (COVID-19) in 2020–2021. Despite having led worldwide rankings in pandemic-related death rates since the second part of 2020, the government was not politically shaken by COVID-19. Institutionally unrestrained, the governing majority periodically renewed emergency legal regimes to control public discourses and curtail the financial resources of opposition-led local governments. The policy conduct of the regime is discussed in the context of authoritarian populism, which is conceptualized along a strategy-based approach to populism. In this, authoritarian populism is seen to generate democratic legitimacy for dismantling the institutional foundations of liberal democracy and the rule of law. This had been happening in Hungary well before COVID-19 kicked in, but the pandemic provided enhanced opportunities for this strategy. Meanwhile, fiscal policies became increasingly expansionary, signalling a partial return to the practice of preelection overspending. © 2022 The Authors. European Policy Analysis published by Wiley Periodicals LLC on behalf of Policy Studies Organization.

Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.

The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline with Emergency Use Authorization (EUA) of LDTs and the US Food and Drug Administration (FDA)-orchestrated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) labeling update study. The initial EUA adoption by LDT developers shows that the FDA can have oversight over LDTs. We used efficiency-corrected microcosting of our EUA PCR assay to estimate the national cost of the labeling update study to $0.3 to $1.4 million US dollars. Labeling update study performance data showed lower average detection limits in commercial in vitro diagnostic (IVD) assays versus LDTs (32,000 ± 75,000 versus 71,000 ± 147,000 nucleic acid amplification tests/mL; P = 0.04); however, comparison also shows that FDA review of IVD assays and LDTs did not prevent differences between initial and labeling update performance (IVD assay, P < 0.0001; LDT, P = 0.003). The regulatory shifts re-emphasized that both commercial tests and LDTs rely heavily on laboratory competence and procedures; however, lack of performance data on authorized tests, when clinically implemented, precludes assessment of the benefit related to regulatory review. Temporary regulatory deviations during the pandemic and regulatory science tools (ie, reference material) have generated valuable real-world evidence to inform pending legislation regarding LDT regulation.

Better clinical outcomes in hospitalized COVID-19 minority patients with accompanying gastrointestinal symptoms.

BACKGROUND AND AIMS: The novel coronavirus (SARS-CoV-2) is highly contagious pathogen that primarily causes respiratory illnesses. Howerver, multiple gastrointestinal (GI) symptoms have been reported in Coronavirus Disease of 2019 (COVID-19). We conducted a retrospective cohort study of inpatients with COVID-19 at the George Washington University Hospital (GWUH) to assess the prevalence of GI symptoms and their association with clinical outcomes. METHODS: We reviewed the charts of 401 adults admitted to GWUH with positive SARS-CoV-2 tests from February 24 to May 21, 2020, ultimately including 382 inpatients. RESULTS: 87% of our cohort was African American or Latinx. 59% of patients reported at least one GI symptom, with diarrhea being the most common (29%). Patients with GI symptoms were slightly younger (58 +/- 15.8 vs. 65 +/- 16.9, p = 0.0005), have higher body mass index (31.5 +/- Standard Deviation of 8.7 vs. 28 +/- 8.2, p = 0.0001), and more likely to be Latinx (34 vs. 27, p = 0.01). Patients who presented with abdominal pain, nausea, vomiting, or diarrhea had significantly lower rates of death during hospitalization compared to those who did not present those symptoms (Odds Ratio 0.48, 95% Confidence Interval 0.28-0.8, p = 0.004). CONCLUSIONS: Our study suggests that GI symptoms portend a less-severe clinical course of COVID-19 which may reflect a different disease phenotype and lower overall immune response. Additional research should focus on more robust symptom reporting and longer follow-up.

Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital.

The diagnosis of COVID-19 requires integration of clinical and laboratory data. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic assays play a central role in diagnosis and have fixed technical performance metrics. Interpretation becomes challenging because the clinical sensitivity changes as the virus clears and the immune response emerges. Our goal was to examine the clinical sensitivity of two most common SARS-CoV-2 diagnostic test modalities, polymerase chain reaction (PCR) and serology, over the disease course to provide insight into their clinical interpretation in patients presenting to the hospital. We conducted a single-center, retrospective study. To derive clinical sensitivity of PCR, we identified 209 PCR-positive SARS-CoV-2 patients with multiple PCR test results (624 total PCR tests) and calculated daily sensitivity from date of symptom onset or first positive test. Clinical sensitivity of PCR decreased with days post symptom onset with >90% clinical sensitivity during the first 5 days after symptom onset, 70%-71% from Days 9 to 11, and 30% at Day 21. To calculate daily clinical sensitivity by serology, we utilized 157 PCR-positive patients with a total of 197 specimens tested by enzyme-linked immunosorbent assay for IgM, IgG, and IgA anti-SARS-CoV-2 antibodies. In contrast to PCR, serological sensitivity increased with days post symptom onset with >50% of patients seropositive by at least one antibody isotype after Day 7, >80% after Day 12, and 100% by Day 21. Taken together, PCR and serology are complimentary modalities that require time-dependent interpretation. Superimposition of sensitivities over time indicate that serology can function as a reliable diagnostic aid indicating recent or prior infection.

A Multidisciplinary Intubation Algorithm for Suspected COVID-19 Patients in the Emergency Department.

INTRODUCTION: Intubation of patients suspected of having coronavirus disease 2019 (COVID-19) is considered to be a high-risk procedure due to the aerosolization of viral particles. In an effort to minimize the risk of exposure and optimize patient care, we sought to develop, test, provide training, and implement a standardized algorithm for intubating these high-risk patients at our institution. METHODS: We developed an initial intubation algorithm, incorporating strategic use of equipment and incorporating emerging best practices. By combining simulation-based training sessions and rapid-cycle improvement methodology with physicians, nurses, and respiratory therapists, and incorporating their feedback into the development, we were able to optimize the process prior to implementation. Training sessions also enabled the participants to practice the algorithm as a team. Upon completion of each training session, participants were invited to complete a brief online survey about their overall experience. RESULTS: An algorithm and training system vetted by simulation and actual practice were developed. A training video and dissemination package were made available for other emergency departments to adopt. Survey results were overall positive, with 97.92% of participants feeling confident in their role in the intubation process, and many participants citing the usefulness of the multidisciplinary approach to the training. CONCLUSION: A multidisciplinary, team-based approach to the development and training of a standardized intubation algorithm combining simulation and rapid-cycle improvement methodology is a useful, effective process to respond to rapidly evolving clinical information and experiences during a global pandemic.

Clinical Sensitivity and Interpretation of PCR and Serological COVID-19 Diagnostics for Patients Presenting to the Hospital (preprint)

Introduction: The diagnosis of COVID-19 requires integration of clinical and laboratory data. SARS-CoV-2 diagnostic assays play a central role in diagnosis and have fixed technical performance metrics. Interpretation becomes challenging because the clinical sensitivity changes as the virus clears and the immune response emerges. Our goal was to examine the clinical sensitivity of two most common SARS-CoV-2 diagnostic test modalities, polymerase chain reaction (PCR) and serology, over the disease course to provide insight into their clinical interpretation in patients presenting to the hospital. Methods: A single-center, retrospective study. To derive clinical sensitivity of PCR, we identified 209 PCR-positive SARS-CoV-2 patients with multiple PCR test results (624 total PCR tests) and calculated daily sensitivity from date of symptom onset or first positive test. To calculate daily clinical sensitivity by serology, we utilized 157 PCR-positive patients with a total of 197 specimens tested by enzyme-linked immunosorbent assay for IgM, IgG, and IgA anti-SARS-CoV-2 antibodies. Results: Clinical sensitivity of PCR decreased with days post symptom onset with >90% clinical sensitivity during the first 5 days after symptom onset, 70-71% from days 9-11, and 30% at day 21. In contrast, serological sensitivity increased with days post symptom onset with >50% of patients seropositive by at least one antibody isotype after day 7, >80% after day 12, and 100% by day 21. Conclusion: PCR and serology are complimentary modalities that require time-dependent interpretation. Superimposition of sensitivities over time indicate that serology can function as a reliable diagnostic aid indicating recent or prior infection.