Prescription Opioid Use Among Cancer Patients before and after the Onset of COVID-19: Evidence from Real-World Data

Objectives: Opioids play a significant role in the effective management of cancer-related pain. The COVID-19 lock down may have reduced access to opioids and caused a decline in the use of prescription of opioids among cancer survivors. This study compared opioid prescription rates among cancer survivors before and after the onset of COVID-19 pandemic using real-world electronic health records (EHR). Method(s): Cohort analyses of cancer patients using data from EHR database from the TriNetX, a global federated health research network across 76 healthcare organizations. We analyzed changes in prescription opioid use before (March 1, 2018, through March 1, 2019) and after onset of COVID-19 (April 01, 2020, through March 2021) among cancer survivors. The key outcome variable was any opioid prescription within 1 year of cancer diagnosis. One-to-one propensity score matching was used to balance the characteristics (age, sex, race, diagnoses including diabetes, hypertensive diseases, overweight, mood disorders, and visual disturbances) of the two cohorts. Data were analyzed using the TriNetX platform. Result(s): There were 1,502,143 cancer survivors before COVID-19 and 1,412,599 cancer survivors after the onset of COVID-19. The one-to-one propensity-score match yielded 1,382,561 cancer patients, mean age 64 at cancer diagnosis, and 73% were white. Percentage of opioid use among cancer patients declined from 35.6% before the COVID-19 to 35.1% after the onset of the pandemic (OR=0.976, 95% CI 0.971-0.981). Average number of opioid prescriptions within 1 year of cancer diagnosis declined from 5.7 before to 5.3 after the COVID-19 onset (p<0.001). Conclusion(s): Among cancer survivors, a small decline in prescription opioid use was observed after the onset of COVID-19 pandemic. Future studies are needed to distinguish the impact of revised guidelines, opioid prescription policy changes, and COVID-19 lock down on lower rates of prescription opioid use among cancer survivors.Copyright © 2023

Literature Review of Statistical Methods Comparisons through Simulations When Using External Control Arm for Regulatory or HTA Submissions

Objectives: Using a historical control or external control arm (ECA) to augment or replace a concurrent control arm in a randomized trial is a hot topic given the challenge of patient recruitment in rare diseases or during COVID-19 pandemic. The FDA released draft guidance in 2021 on effectiveness and safety submissions using real-world evidence. While the guidance focuses mainly on elements of study design and data source selection, there is a lack of consensus in the selection of appropriate statistical methods when constructing an ECA. This study discusses rigorous statistical methodology for ECA-supported trials in regulatory or HTA submissions. Method(s): Targeted literature reviews of statistical simulations comparing methods for ECA in statistical journals were performed. The articles compared commonly used ECA-construction and analysis methods were selected and summarized, including but not limited to propensity score (PS)-based matching, weighting, and stratification, and PS plus Bayesian integrated approaches. Result(s): Type I error, power, bias, and coverage probability are common criteria used to compare different methods. When imbalances only exist in known baseline covariates and the outcome distributions are the same between the trial concurrent control and ECA, the PS method alone or paired with commensurate prior yield almost unbiased estimates, good Type I errors, and coverage probability. PS plus Bayesian approaches have wider interval width and lower power compared with PS-only methods. When there is a change in the outcome distribution over time, the PS (matching or IPTW) and commensurate prior integrated methods yield the smallest biases among all methods. Conclusion(s): PS and Bayesian integrated methods outperformed the PS-only methods in terms of bias and Type I error when outcome distribution changed with current trial control. A "sweet spot" that balances all criteria through trial-specific simulations could provide the ideal setting of trial analyses plan based on specific trial design and scenarios.Copyright © 2023

Perioperative Outcomes of Emergency Surgeries Before and During the Covid-19 Pandemic: A Philippine Tertiary Hospital Experience

Introduction: The COVID-19 pandemic has imposed a large burden on our global medical systems, particularly in patients that would require emergency surgery. Method(s): This single centre study determined the perioperative outcomes of patients who underwent emergency surgery before and during the COVID-19 pandemic after using a propensity score matching analysis. Result(s): A decrease in the number of emergency surgeries performed during the pandemic was noted at 47.9%. Data showed that severe complications arose more frequently during the pandemic (pvalue<0.05). Furthermore, it arose more frequently in patients who had a concomitant COVID-19 infection. Age was directly proportional to the likelihood of developing of severe postoperative complications (pvalue<0.05). Undergoing cancer surgery and being classified as ASA IV increased the likelihood of developing severe postoperative complications (pvalue<0.05). Preoperative time was a significant factor for patients who underwent trauma and can- cer surgery during the pandemic since it was noted to be directly proportional to the likelihood of developing severe postoperative complications (pvalue<0.05). The mortality rate was significantly pronounced during the pandemic for patients who underwent benign and trauma surgeries (pvalue<0.05). Conclusion(s): Severe complications arose more frequently during the pandemic. Undergoing cancer surgery and being classified as ASA IV increased the likelihood of developing of severe postoperative complications. Age and Preoperative time were noted to be directly proportional to the development of severe postoperative complications particularly in trauma and cancer surgeries. The mortality rate was significantly more pronounced during the pandemic for patients who underwent benign and trauma surgeries especially with longer preoperative time.

Nasal spray of an IgM-like ACE2 fusion protein HH-120 accelerates SARS-CoV-2 clearance: A single-center propensity score-matched cohort study.

HH-120, a recently developed IgM-like ACE2 fusion protein with broad-spectrum neutralizing activity against all ACE2-utilizing coronaviruses, has been developed as a nasal spray for use as an early treatment agent to reduce disease progression and airborne transmission. The objective of this study was to evaluate the safety and efficacy of the HH-120 nasal spray in SARS-CoV-2-infected subjects. Eligible symptomatic or asymptomatic SARS-CoV-2-infected participants were enrolled in a single-arm trial to receive the HH-120 nasal spray for no longer than 6 days or until viral clearance at a single hospital between August 3 and October 7, 2022. An external control was built from real-world data of SARS-CoV-2-infected subjects contemporaneously hospitalized in the same hospital using a propensity score matching (PSM) method. After PSM, 65 participants in the HH-120 group and 103 subjects with comparable baseline characteristics in the external control group were identified. The viral clearance time was significantly shorter in participants receiving the HH-120 nasal spray than that in subjects of the control group (median 8 days vs. 10 days, p < 0.001); the difference was more prominent in those subgroup subjects with higher baseline viral load (median 7.5 days vs. 10.5 days, p < 0.001). The incidence of treatment-emergent adverse events and treatment-related adverse events of HH-120 group were 35.1% (27/77) and 3.9% (3/77), respectively. All the adverse events observed were mild, being of CTCAE grade 1 or 2, and transient. The HH-120 nasal spray showed a favorable safety profile and promising antiviral efficacy in SARS-CoV-2-infected subjects. The results from this study warrant further assessment of the efficacy and safety of the HH-120 nasal spray in large-scale randomized controlled clinical trials.

Impact of corticosteroids use on midterm sequelae in survivors of COVID-19 admitted to hospital: A prospective cohort study.

An understanding of the midterm sequelae in COVID-19 and their association with corticosteroids use are needed. Between March and July 2020, we evaluated 1227 survivors of COVID-19, 3 months posthospitalization, of whom 213 had received corticosteroids within 7 days of admission. Main outcome was any midterm sequelae (oxygen therapy, shortness of breath, one major clinical sign, two minor clinical signs or three minor symptoms). Association between corticosteroids use and midterm sequelae was assessed using inverse propensity-score weighting models. Our sample included 753 (61%) male patients, and 512 (42%) were older than 65 years. We found a higher rate of sequelae among users than nonusers of corticosteroids (42% vs. 35%, odds ratio [OR] 1.40 [1.16-1.69]). Midterm sequelae were more frequent in users of low-dose corticosteroids than nonusers (64% vs. 51%, OR 1.60 [1.10-2.32]), whereas no association between higher doses (≥20 mg/day equivalent of dexamethasone) and sequelae was evidenced (OR 0.95 [0.56-1.61]). Higher risk of sequelae with corticosteroids use was observed among subjects with propensity score below the 90th percentile. Our study suggest that corticosteroids use during hospitalization for COVID-19 is associated with higher risk of midterm sequelae.

Reemployment premium effect of furlough programs: evaluating Spain's scheme during the COVID-19 crisis.

This paper presents an average treatment effect analysis of Spain's furlough program during the onset of the COVID-19 pandemic. Using 2020 labour force quarterly microdata, we construct a counterfactual made of comparable nonfurloughed individuals who lost their jobs and apply propensity score matching based on their pretreatment characteristics. Our findings show that the probability of being re-employed in the next quarter significantly increased for the treated (furlough granted group). These results appear robust across models, after testing a wide range of matching specifications that reveal a reemployment probability premium of near 30 percentage points in the group of workers who had been furloughed for a single quarter. Nevertheless, a different time arrangement affected the magnitude of the effect, suggesting that it may decrease with the furlough duration. Thus, an analogous analysis for a longer (two quarter) scheme estimated a still positive but smaller effect, approximately 12 percentage points. Although this finding might alert against long lasting schemes under persistent recessions, this policy still stands as a useful strategy to face essentially transitory adverse shocks.

Reducedhumoral response against variants of concern in childhood solid cancer patients compared to adult patients and healthy children after SARS-CoV-2 vaccination.

Introduction: Although there is extended research on the response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in adult cancer patients (ACP), the immunogenicity to the variants of concern (VOCs) in childhood cancer patients (CCP) and safety profiles are now little known. Methods: A prospective, multi-center cohort study was performed by recruiting children with a solid cancer diagnosis and childhood healthy control (CHC) to receive standard two-dose SARS-CoV-2 vaccines. An independent ACP group was included to match CCP in treatment history. Humoral response to six variants was performed and adverse events were followed up 3 months after vaccination. Responses to variants were compared with ACP and CHC by means of propensity score-matched (PSM) analysis. Results: The analysis included 111 CCP (27.2%, median age of 8, quartile 5.5-15 years), 134 CHC (32.8%), and 163 ACP (40.0%), for a total 408 patients. Pathology included carcinoma, neural tumors, sarcoma, and germ cell tumors. Median chemotherapy time was 7 (quartile, 5-11) months. In PSM sample pairs, the humoral response of CCP against variants was significantly decreased, and serology titers (281.8 ± 315.5 U/ml) were reduced, as compared to ACP (p< 0.01 for the rate of neutralization rate against each variant) and CHC (p< 0.01 for the rate of neutralization against each variant) groups. Chemotherapy time and age (Pearson r ≥ 0.8 for all variants) were associated with the humoral response against VOCs of the CHC group. In the CCP group, less than grade II adverse events were observed, including 32 patients with local reactions, and 29 patients had systemic adverse events, including fever (n = 9), rash (n = 20), headache (n = 3), fatigue (n = 11), and myalgia (n = 15). All reactions were well-managed medically. Conclusions: The humoral response against VOCs after the CoronaVac vaccination in CCP was moderately impaired although the vaccine was safe. Age and chemotherapy time seem to be the primary reason for poor response and low serology levels.

Impact of economic shocks on mental health during COVID-19: A longitudinal study of adult residents of Indian metropolitan cities.

Background: The causal impact of income shocks on mental well-being in developing countries is an under-researched area. The COVID-19 pandemic, along with the economic recession caused by the lockdowns to reduce transmission, provides a natural experimental setting to examine the causal impact of a decline in monthly per capita expenditure (MPCE) on mental health of the general population in India during the pandemic. Aim: To evaluate the impact of income shocks on mental health of adults in metro cities during the COVID-19 pandemic. Materials and Methods: The data were collected using the abridged version of the Depression Anxiety Stress Schedule administered through a telephonic survey on adult residents of six metropolitan cities in September-August 2020 and July-August 2021. Results: In the present study, 994 adults participated from six metropolitan cities. Average treatment effects were estimated using Propensity Score Matching. The mean normalized scores are significantly higher for respondents whose MPCE had fallen (treated) vis-à-vis respondents whose MPCE had remained same or increased (control): anxiety (0.21 for treated vs -0.19 for control), stress (0.16 vs -0.14), and depression (0.04 vs -0.19). Propensity score matching reveals that the normalized scores for anxiety, stress, and depression were 33 (95% confidence intervals, CI: 20.0-46.7), 25 (95% CI: 12.9-36.9), and 36 (95% CI: 18.6-53.1) higher among the treated group vis-a-vis control group. The ATET was 34 (95% CI: 18.9-48.9), 26 (95% CI: 10.1-42.9), and 32 (955 CI: 12.3-50.7) for these three outcomes, respectively. The post-estimation tests indicated that the results are valid. Conclusions: The study advocates that policies to ensure income security should be made an integral part of the response packages to tackle pandemics like COVID-19.

Impact of HIV on COVID-19 Outcomes: A Propensity Score Matching Analysis with Varying Age Differences.

To exploratorily test (1) the impact of HIV and aging process among PLWH on COVID-19 outcomes; and (2) whether the effects of HIV on COVID-19 outcomes differed by immunity level. The data used in this study was retrieved from the COVID-19 positive cohort in National COVID Cohort Collaborative (N3C). Multivariable logistic regression models were conducted on populations that were matched using either exact matching or propensity score matching (PSM) with varying age difference between PLWH and non-PLWH to examine the impact of HIV and aging process on all-cause mortality and hospitalization among COVID-19 patients. Subgroup analyses by CD4 counts and viral load (VL) levels were conducted using similar approaches. Among the 2,422,864 adults with a COVID-19 diagnosis, 15,188 were PLWH. PLWH had a significantly higher odds of death compared to non-PLWH until age difference reached 6 years or more, while PLWH were still at an elevated risk of hospitalization across all matched cohorts. The odds of both severe outcomes were persistently higher among PLWH with CD4 < 200 cells/mm3. VL ≥ 200 copies/ml was only associated with higher hospitalization, regardless of the predefined age differences. Age advancement in HIV might significantly contribute to the higher risk of COVID-19 mortality and HIV infection may still impact COVID-19 hospitalization independent of the age advancement in HIV.

Long-Term Hydroxychloroquine and Its Association with Covid-19 Infection, a Cohort Study from a South American Hospital

Objectives: We aimed at examining whether patients with rheumatological conditions receiving chronic hydroxychloroquine therapy are at a lower risk of developing SARS-CoV-2 infection than those not receiving hydroxychloroquine. Method(s): This historical cohort study included information of all patients aged 18 years or older with rheumatoid arthritis, systemic lupus erythematosus, or associated rheumatological conditions (based on International Classification of Diseases, 10th edition, diagnostic codes). A propensity score was calculated for each patient, and each patientwho was receiving hydroxychloroquine was matched to two patients who were not receiving hydroxychloroquine (controls). The primary endpoint was the proportion of patients with PCR-confirmed SARS-CoV-2 infection among those receiving chronic hydroxychloroquine versus the propensity-matched patients not receiving chronic hydroxychloroquine in 2021. Result(s): 322 patients receiving hydroxychloroquine and 645 patients not receiving hydroxychloroquine were included in the primary analysis. The incidence of active SARS-CoV-2 infections during the study period did not differ between patients receiving hydroxychloroquine and patients not receiving hydroxychloroquine ( [0 3%] vs 78 [0 4%] of 21406;odds ratio 0 79, 95% CI 0 52-1 20, p = 0 27). There were no significant differences in secondary outcomes between the two groups of patients who developed active SARS-CoV-2 infection. For all patients in the study, overall mortality was lower in the hydroxychloroquine group than in the group of patients who did not receive hydroxychloroquine (odds ratio hydroxychloroquine was not associated with the development of active SARS-CoV-2 infection (odds ratio 0 79, 95% CI 0 51-1 42) Conclusion(s): Hydroxychloroquine was not associated with a protective effect against SARS-CoV-2 infection in a large group of patients with rheumatological conditions.

Adapting to the new normal: The impact of remote work on firm performance in Jordan and Morocco

Businesses have been impacted particularly hard by the COVID-19 pandemic, resulting in a decline in productivity. Whether a remote work policy boosts the firm's productivity is still debatable. We use the COVID-19 World Bank Enterprise Survey, a cross-sectional dataset that covers Jordan and Morocco, to empirically examine this question. We use the propensity score matching technique to estimate the causal effect between remote work and firm performance. Results suggest the existence of a positive impact, suggesting that remote work policies cause an increase in productivity. In a further investigation, we perform our regression by country and firm size. Coefficients are found to remain positive in both countries but statistically significant only in Morocco. Regarding firm size, coefficients are found to be positive and statistically significant across all models. The paper offers some recommendations for policymakers in both countries to mitigate the ongoing crisis on firm performance.

Protective effect of ursodeoxycholic acid on COVID-19 in patients with chronic liver disease.

Objective: Ursodeoxycholic acid (UDCA) may reduce susceptibility to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection by downregulating angiotensin-converting enzyme 2 (ACE2), based on recent experimental investigation. This study aimed to determine the potential protective effect of UDCA against SARS-CoV-2 infection in patients with chronic liver disease. Methods: Patients with chronic liver disease receiving UDCA (taking UDCA ≥1 month) at Beijing Ditan Hospital between January 2022 and December 2022 were consecutively enrolled. These patients were matched in a 1:1 ratio to those with liver disease not receiving UDCA during the same period by using a propensity score matching analysis with nearest neighbor matching algorithm. We conducted a phone survey of coronavirus disease 2019 (COVID-19) infection during the early phase of the pandemic liberation (from 15 December 2022 to 15 January 2023). The risk of COVID-19 was compared in two matched cohorts of 225 UDCA users and 225 non-UDCA users based on patient self-report. Results: In the adjusted analysis, the control group was superior to the UDCA group in COVID-19 vaccination rates and liver function indicators, including γ-glutamyl transpeptidase and alkaline phosphatase (p < 0.05). UDCA was associated with a lower incidence of SARS-CoV-2 infection (UDCA 85.3% vs. control 94.2%, p = 0.002), more mild cases (80.0% vs. 72.0%, p = 0.047), and shorter median time from infection to recovery (5 vs. 7 days, p < 0.001). Logistic regression analysis showed that UDCA was a significant protective factor against COVID-19 infection (OR: 0.32, 95%CI: 0.16-0.64, p = 0.001). Furthermore, diabetes mellitus (OR: 2.48, 95%CI: 1.11-5.54, p = 0.027) and moderate/severe infection (OR: 8.94, 95%CI: 1.07-74.61, p = 0.043) were more likely to prolong the time from infection to recovery. Conclusion: UDCA therapy may be beneficial in reducing COVID-19 infection risk, alleviating symptoms, and shortening the recovery time in patients with chronic liver disease. However, it should be emphasized that the conclusions were based on patient self-report rather than classical COVID-19 detection by experimental investigations. Further large clinical and experimental studies are needed to validate these findings.

Diabetes as a risk factor of death in hospitalized COVID-19 patients - an analysis of a National Hospitalization Database from Poland, 2020.

Introduction: Diabetes is one of the comorbidities associated with poor prognosis in hospitalized COVID-19 patients. In this nationwide retrospective study, we evaluated the risk of in-hospital death attributed to diabetes. Methods: We analyzed data from discharge reports of patients hospitalized with COVID-19 in 2020 as submitted to the Polish National Health Fund. Several multivariate logistic regression models were used. In each model, in-hospital death was estimated with explanatory variables. Models were built either on the whole cohorts or cohorts matched with propensity score matching (PSM). The models examined either the main effects of diabetes itself or the interaction of diabetes with other variables. Results: We included 174,621 patients with COVID-19 who were hospitalized in the year 2020. Among them, there were 40,168 diabetic patients (DPs), and the proportion of DPs in this group was higher than in the general population (23.0% vs. 9.5%, p<0.001). In this group of COVID-19 hospitalizations, 17,438 in-hospital deaths were recorded, and the mortality was higher among DPs than non-diabetics (16.3% vs. 8.1%, p<0.001). Multivariate logistic regressions showed that diabetes was a risk factor of death, regardless of sex and age. In the main effect analysis, odds of in-hospital death were higher by 28.3% for DPs than for non-diabetic patients. Similarly, PSM analysis including 101,578 patients, of whom 19,050 had diabetes, showed that the risk of death was higher in DPs regardless of sex with odds higher by 34.9%. The impact of diabetes differed among age groups and was the highest for patients aged 60-69. Conclusions: This nationwide study confirmed that diabetes was an independent risk factor of in-hospital death in the course of COVID-19 infection. However, the relative risk differed across the age groups.

Convalescent Plasma Treatment of Severe Covid-19 Cases in the Bronx, Ny

Junior Physician Investigator Award Recipient Purpose of study Severe acute respiratory syndrome coronavirus- 2 (SARS-CoV-2) is the causative agent of the Coronavirus disease 2019 (COVID-19) pandemic. Convalescent plasma obtained from recovered persons was used for previous respiratory pandemics. Convalescent plasma with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) antibodies (CCP) was proposed as an option that may hold promise as treatment for COVID-19. Our aim was to retrospectively evaluate the efficacy of CCP treatment of patients with severe to life-threatening COVID-19 hospitalized at Montefiore Medical Center (MMC) in the Bronx, NY between April 13 to May 4, 2020. Methods used We administered CCP as part of the Mayo Clinic expanded access investigational new drug (IND) program for hospitalized patients. We compared the mortality and clinical outcome of 73 patients with COVID-19 who received 200 mL of CCP with a Spike protein IgG titer >=1:2,430 (median 1:47,385) within 72 hours of admission to 1:1 propensity score-matched controls. Matching criteria for controls were age, sex, body mass index, race, ethnicity, comorbidities, week of admission, oxygen requirement, D-dimer, lymphocyte counts, corticosteroids, and anticoagulation use (figure 1). We additionally measured Spike protein IgG and neutralizing antibody titer in CCP and pre- and post-transfusion Spike protein IgG, IgM and IgA titer in CCP recipients. The primary outcome was all-cause mortality at day 28 post-CCP. The secondary outcomes were improvement in oxygenation status or mortality at day 28 post-CCP. Exploratory outcomes were associations between pre-CCP SARS-CoV-2 antibody titers and mortality at day 28. Summary of results There was no difference in mortality or oxygenation between CCP recipients and controls at day 28. When stratified by age, compared to matched controls, CCP recipients < 65 years had 4-fold lower mortality and 4-fold lower deterioration in oxygenation or mortality at day 28 (figure 2, 3). There was no association between CCP IgG or neutralizing antibody titer and clinical outcome. For CCP recipients, pre-transfusion Spike protein IgG, IgM and IgA titers were associated with mortality at day 28 in univariate analyses but not in multivariable analyses. Pre-transfusion Spike protein IgG titer was significantly correlated with Ddimer and detected viral load measured by cycle threshold (Ct) value of nasopharyngeal SARS-CoV-2 reverse-transcriptase- polymerase-chain-reaction (figure 4). No adverse effects of CCP were observed. Conclusions We report that CCP administration within 72 hours of hospitalization demonstrated a possible signal of reduced mortality in patients < 65 years. Pre-transfusion IgG titer may be a proxy for disease severity that may be useful in identifying those who are more likely to respond to CCP. Data from controlled trials is needed to validate this finding and establish the effect of ageing on CCP efficacy. (Figure Presented).

Effectiveness of CoronaVac vaccine against severe acute respiratory infections (SARI) hospitalizations in Sibu District, Malaysia: A retrospective test-negative design

Introduction: The COVID-19 vaccination campaign was implemented in Sibu, Malaysia in February 2021. We assessed the effectiveness of the CoronaVac vaccine against severe acute respiratory infections (SARI) hospitalisation associated with laboratory-confirmed SARS-CoV-2 by time since vaccination. Method(s): A test-negative case-control design was employed using a web-based national information system for PCR results of SARS-CoV-2 infection and COVID-19 vaccination, and the hospitalisation dataset in Sibu Hospital. Eligible SARI cases with SARS-CoV-2 RT-PCR positive were matched to those SARI cases with negative RT-PCR tests by age and workplace. Vaccine effectiveness was measured by conditional logistic regression with adjustment for gender, comorbidity, smoking and education level. Result(s): Between 15 March and 30 September 2021, in the dominance of lineages B.1.466.2 and B.1.617.2 (Delta variant), a total of 838 eligible SARI patients were identified. Vaccine effectiveness was 42.4% (95% confidence interval [CI]: -28.3, 74.1), and 76.5% (95% CI: 45.6, 89.8) for partial vaccination (after the first dose through 14 days after the second dose) and complete vaccination (at 15 days or more after receipt of the second dose), respectively. Sensitivity analysis using propensity score matching yielded a conservative estimate of 57.4% (95% CI: 9.2, 80.1) for complete vaccination. Conclusion(s): Primary immunisation with two doses of CoronaVac vaccine provided satisfactory protection against SARI caused by SARS-CoV-2 in the short term. However, the duration of protection, incremental effectiveness induced by boosting, as well as performance against new variants need to be studied continuously.

Hiv Infection Increases Risk of Pasc While Covid-19 Vaccination Is Protective

Background: People with HIV (PWH) are at a higher risk of severe acute COVID-19;however, their risk of subsequently developing post-acute sequelae of SARS-CoV2 (PASC) remains unclear. Furthermore, although vaccination has been shown to be protective against PASC in the general population, few studies have evaluated its effectiveness in PWH. Method(s): We used the TriNetX health research database to source data from 69 healthcare organizations within the US. We included any adults aged >= 18 years with positive SARS-CoV-2 between January 1, 2020 and September 16, 2022 and categorized them based on their HIV status, baseline sociodemographic characteristics, comorbidities and COVID-19 vaccination status. The primary outcome was risk of PASC, compared by HIV and vaccination status after 1:1 propensity score matching. PASC was defined as either the persistence of COVID-attributable symptoms or the occurrence of new-onset health conditions at least 28 days following COVID-19 diagnosis. For all analysis, statistical significance was set at p < 0.05. Result(s): Of 3,048,792 people with confirmed SARS-CoV-2 infection, 1% (n=28,904) were PWH, with 9% of PWH (n=2592) vaccinated. At 28 days post-COVID-19 diagnosis, PWH had lower mortality compared with their non-HIV counterparts (OR 0.78, 95% CI 0.70-0.87), but higher risk of developing new-onset diabetes (DM) (OR 1.26, 95% CI 1.11-1.42), heart disease (OR 1.27, 95% 1.14-1.41), malignancy (OR 1.66, 95% CI 1.45-1.89), thrombosis (OR 1.25, 95% CI 1.12-1.39) and mental health disorders (OR 1.70 (95% CI 1.53-1.90). Furthermore, vaccinated PWH had significantly lower odds of death (OR 0.63, 95% CI 0.42- 0.93) and each new-onset PASC outcome, as follows: DM (OR 0.51, 95% CI 0.32- 0.82), heart disease (OR 0.44, 95% CI 0.29-0.67), malignancy (OR 0.43 (95% CI 0.25-0.74), thrombosis (OR 0.51, 95% CI 0.33-0.78) and mental health disorders (OR 0.49, 95% CI 0.30-0.79). The risk of PASC was higher during the pre-Delta variant period but did not vary based on CD4 count or HIV viremia. Conclusion(s): HIV infection confers a higher risk of PASC. Importantly, COVID-19 vaccination significantly lowered mortality and was protective against PASC among PWH. With the increase in the number of COVID-19 survivors, vaccination offers an effective preventive strategy to address a burgeoning public health problem. (Table Presented).

Sexual Health Implications Associated with Psychotropic Medication Usage in Adolescents during the Covid-19 Pandemic: Analysis of a Federated Research Network

INTRODUCTION AND OBJECTIVE: Psychotropic medications have a significant impact on sexual health. Long-term usage is strongly associated with dyspareunia, decreased libido, hypogonadism and erectile dysfunction. We hypothesized that the prescription rates for psychotropic medications increased in adolescent patients during the COVID-19 pandemic because of the unprecedented stress levels on youth in isolation. Therefore, we evaluated the prescription rates of psychotropic medications as well as concurrent use of PDE5i in adolescent patients during the COVID-19 pandemic compared to the pre-pandemic era. METHOD(S): We utilized data generated from TriNetX Research Network to conduct a retrospective matched cohort study. Adolescent patients aged 10-19 presenting for outpatient evaluation were placed into two cohorts: 1) outpatient evaluation before and 2) during the COVID-19 pandemic. Patients with prior psychiatric diagnoses and those with prior use of psychotropic medications were excluded. The outcomes of interest were new prescriptions within 90 days of outpatient evaluation. Propensity score matching was performed using logistic regression to build cohorts of equal size. RESULT(S): A total of 1,612,283 adolescents pre-COVID-19 and 1,008,161 adolescents presenting during the COVID-19 pandemic for outpatient evaluations were identified. After propensity matching, a total of 1,005,408 adolescents were included in each cohort each withan average age of 14.7 +/- 2.84 and 52% female and 48% male. Prescribing of antipsychotics and benzodiazepines were more frequent during the pandemic for adolescents (RR: 1.58, 95% CI 1.01-2.2). However, they were less likely to receive antidepressants (Risk Ratio (RR): 0.6, 95% Confidence Interval (CI) 0.57-0.63), anxiolytics (RR: 0.78, 95% CI 0.75-0.81), stimulants (RR: 0.26, 95% CI 0.25-0.27), as well as mood stabilizers (RR: 0.44, 95% CI 0.39-0.49). Erectile dysfunction requiring oral PDE5i in this cohort was more frequent during the pandemic for adolescents (RR: 1.53, 95% CI 1.05-2.01). CONCLUSION(S): The rates of antipsychotic and benzodiazepine prescriptions increased during the COVID-19 global pandemic compared to preceding years. This coincided with a statistically significant increase in the prescription of PDE5i for erectile dysfunction. Adolescents may face an increased risk of sexual dysfunction as both their illness and the medications they are prescribed both have a positive association with sexual dysfunction. Clinicians must be cognizant of the fact that adolescents may face an increased risk of medication related sexual dysfunction.

Covid-19 Outcome in Patients with and without Cirrhosis

Background: Severe outcomes of COVID-19 are associated with advancing age, and multiple medical comorbidities. The impact of COVID-19 on the clinical course of patients with cirrhosis has not been well studied. We determined the effect of SARS-CoV-2 infection on the hospitalization and survival rates of patients with cirrhosis. Method(s): Using ICD-10-CM codes, we identified all Veterans with a diagnosis of cirrhosis in the VA Corporate Data Warehouse and COVID-19 Shared Data Resource. Study cohort included Veterans who were tested for SARS-CoV-2 and had no history of organ transplantation or malignancies. Each SARS-CoV-2 positive case was propensity-score matched by demographics and comorbidities with up to two SARS-CoV-2 negative controls. The primary endpoints were acute care hospitalization, admission to intensive care, respiratory support, or death. Result(s): Of 1,115,037 individuals tested for SARS-CoV-2, 31,680 were noted to have cirrhosis and among them 5,047 (16%) were SARS-CoV-2 positive. After exclusions and propensity-score matching, 5,047 SARS-CoV-2 positive and 9,913 propensity score matched SARS-CoV-2 negative individuals were included in the analysis cohort. Median age was 67 years, 95% were men and 25% were of black race. Median BMI was 30 and history of hypertension, diabetes, cardiovascular and chronic pulmonary disease was noted among 81%, 54%, 56% and 32% respectively. Among all cirrhotic individuals, SARS-CoV-2 positive individuals less frequently progressed to hepatic decompensation (3.1% vs 4.8%, P< 0.0001) or hospitalization (35.7% vs 38.2%, P=0.002), but more frequently required ICU admission 15% vs 12.2%, P< 0.0001) or respiratory support (7.3% vs 8.4%, P=0.01). Among those admitted, length of hospital stay was longer among SARS-CoV-2 positive individuals (7 vs 4 days, P< 0.0001). In Cox regression analysis, SARS-CoV-2 positivity was associated with a higher risk of all-cause mortality (HR 1.37, 95% CI 1.19,1.56). Conclusion(s): Although patients with cirrhosis and COVID-19 were less often hospitalized, they had longer duration of hospitalization and were at higher risk of severe or critical illness and death. (Figure Presented).

Serum-calprotectin for identification of severe COVID-19 in hospitalized patients

Introduction: The disease severity of COVID-19 varies from mild upper respiratory tract infection to life-threatening lower respiratory tract infection. Biomarkers can support severity assessment. We aimed to compare scalprotectin with routine biomarkers to study if s-calprotectin could identify patients with risk for severe COVID-19. We also aimed to study if ongoing corticosteroid therapy would alter levels of s-calprotectin. Method(s): We collected serum samples within 8 days from admission from 162 adult patients hospitalized for COVID-19 from April to October 2020. The serum tubes were centrifuged within 2 h and serum was aspirated and frozen in aliquots at -80 degreeC. scalprotectin was measured according to the routine method at Karolinska University Laboratory. Study endpoint was severe COVID-19 any time during the hospital stay. Severe COVID-19 was defined as treatment with either low-flow oxygen >= 10 l/min, high-flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation. For patients hospitalized before the results of the RECOVERY Dexamethasone study were presented, a propensity score matched sub-study was performed, comparing patients treated and not treated with corticosteroids prior to study sample. Result(s): Median s-calprotectin was, 2.7 ml/L (IQR, 1.6-4.2) for nonsevere COVID-19 cases (n = 59) and 5.0 ml/l (IQR, 3.5-9.1) for severe COVID-19 (n = 103) (p < 0.001). ROC-curve analysis compering s-calprotectin, C-reactive protein (CRP), neutrophils, 1/lymphocytes, and D-dimer, showed the highest AUC for s-calprotectin, 0.775 (Fig. 1). In the sub-study of with corticosteroid treated (n = 35) and non-treated patients (n = 26), the median s-calprotectin was 4.0 (IQR, 2.5-5.6) and 3.8 (IQR, 2.7-3.8), respectively (p = 1.0). Conclusion(s): The study showed a good performance of s-calprotectin for identification of severe COVID-19, in agreement with previous studies. It also indicated that s-calprotectin results are not affected by ongoing corticosteroid treatment.

A COST ANALYSIS of TELEHEALTH-INTEGRATED ANTENATAL CARE

Background: Monash Health implemented a new telehealth-integrated antenatal care schedule in March 2020, in response to the COVID-19 pandemic. Given ever-increasing healthcare costs, new interventions must be evaluated to ensure value for money. Method(s): We conducted a retrospective comparative cost analysis from the health service and patient perspective. Women with a singleton pregnancy who received antenatal care and gave birth at Monash Health from 1 January 2018 to 22 March 2020 (pre-telehealth) and 20 April 2020 to 31 December 2021 (post-telehealth) were included. We generated propensity score matched pre- and post-telehealth cohorts, balancing baseline characteristics and comorbidities. We assigned costs for all episodes of care at Monash Health and calculated the average cost per birth in each cohort. Travel costs were estimated using the average travel distance and time. Result(s): Matched pre- and post-telehealth cohorts (both n = 13 534) were generated from the pre-telehealth ( n = 18 628) and post-telehealth ( n = 14 137) populations. We found an AU$122 increase per birth, for a total cost of AU$12 069 per birth post-telehealth. This was mainly driven by an AU$188 per birth increase in outpatient costs, associated with an extra half an appointment per birth, but offset by an AU$99 per birth decrease in patient travel costs. Differences in clinical outcomes are described in Table 1. Conclusion(s): Telehealth-integrated antenatal care enabled the health service to provide safe, ongoing care for more complex pregnancies during the pandemic for only a minimal cost increase. The results highlight the need for more research into obstetric telehealth, including more comprehensive valuations of benefits and costs to all stakeholders.