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1.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.04.10.24305549

ABSTRACT

Background/ObjectivesCOVID-19 continues to pose a significant burden that impacts public health and the healthcare system as the SARS-CoV-2 virus continues to evolve. Regularly updated vaccines are anticipated to boost waning immunity and provide protection against circulating variants. This study evaluated vaccine effectiveness (VE) of mRNA-1273.815, a 2023-2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine, at preventing COVID-19-related hospitalizations and any medically attended COVID-19 in adults [≥]18 years, overall, and by age and underlying medical conditions. MethodsThis retrospective cohort study used the Veradigm Network EHR linked to claims data to identify US adults [≥]18 years of age who received the mRNA-1273.815 vaccine (exposed) matched 1:1 to individuals who did not receive a 2023-2024 updated COVID-19 vaccine (unexposed). Patients in the unexposed cohort were randomly matched to eligible mRNA-1273.815 recipients. Inverse probability of treatment weighting was used to adjust for differences between the two cohorts. The exposed cohort was vaccinated between September 12, 2023, and December 15, 2023, and individuals in both cohorts were followed up for COVID-19-related hospitalizations and medically attended COVID-19 until December 31, 2023. A Cox regression model was used to estimate the hazard ratio (HR). VE of the mRNA-1273.815 vaccine in preventing COVID-19-related hospitalizations and any medically attended COVID-19 was estimated as 100*(1-HR). Subgroup analyses were performed for adults [≥]50, adults [≥]65, and individuals with underlying medical conditions associated with severe COVID-19 outcomes. ResultsOverall, 859,335 matched pairs of mRNA-1273.815 recipients and unexposed adults were identified. The mean age was 63 years, and 80% of the study population was [≥]50 years old. 61.5% of the mRNA-1273.815 cohort and 66.4% of the unexposed cohort had an underlying medical condition. Among the overall adult population ([≥]18 years), VE was 60.2% (53.4-66.0%) against COVID-19-related hospitalization and 33.1% (30.2%-35.9%) against medically attended COVID-19 over a median follow-up of 63 (IQR: 44-78) days. VE estimates by age and underlying medical conditions were similar. ConclusionsThese results demonstrate the significant protection provided by mRNA-1273.815 against COVID-19-related hospitalizations and any medically attended COVID-19 in adults 18 years and older, regardless of their vaccination history, and support CDC recommendations for vaccination with the 2023-2024 Omicron XBB.1.5-containing COVID-19 vaccine to prevent COVID-19-related outcomes, including hospitalizations.


Subject(s)
COVID-19
2.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.20.24302892

ABSTRACT

Maternal stress and viral illness during pregnancy are associated with neurodevelopmental conditions in offspring. Children born during the COVID-19 pandemic, including those exposed prenatally to maternal SARS-CoV-2 infections, are reaching the developmental age for the assessment of risk for neurodevelopmental conditions. We examined associations between birth during the COVID-19 pandemic, prenatal exposure to maternal SARS-CoV-2 infection, and rates of positive screenings on the Modified Checklist for Autism in Toddlers-Revised (M-CHAT-R). Data were drawn from the COVID-19 Mother Baby Outcomes (COMBO) Initiative. Participants completed the M-CHAT-R as part of routine clinical care (COMBO-EHR cohort) or for research purposes (COMBO-RSCH cohort). Maternal SARS-CoV-2 status during pregnancy was determined through electronic health records. The COMBO-EHR cohort includes n=1664 children (n=442 historical cohort, n=1222 pandemic cohort; n=997 SARS-CoV-2 unexposed prenatally, n=130 SARS-CoV-2 exposed prenatally) who were born at affiliated hospitals between 2018-2023 and who had a valid M-CHAT-R score in their health record. The COMBO-RSCH cohort consists of n=359 children (n=268 SARS-CoV-2 unexposed prenatally, n=91 SARS-CoV-2 exposed prenatally) born at the same hospitals who enrolled into a prospective cohort study that included administration of the M-CHAT-R at 18-months. Birth during the pandemic was not associated with greater likelihood of a positive M-CHAT-R screen in the COMBO-EHR cohort. Maternal SARS-CoV-2 was associated with lower likelihood of a positive M-CHAT-R screening in adjusted models in the COMBO-EHR cohort (OR=0.40, 95% CI=0.22 - 0.68, p=0.001), while analyses in the COMBO-RSCH cohort yielded similar but non-significant results (OR=0.67, 95% CI=0.31-1.37, p=0.29).These results suggest that children born during the first 18 months of the COVID-19 pandemic and those exposed prenatally to a maternal SARS-CoV-2 infection are not at greater risk for screening positive on the M-CHAT-R.


Subject(s)
Severe Acute Respiratory Syndrome , Autistic Disorder , COVID-19 , Abnormalities, Drug-Induced , Developmental Disabilities
3.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.12.11.23299663

ABSTRACT

Background: Emerging SARS-CoV-2 sublineages continue to cause serious COVID-19 disease, but most individuals have not received COVID-19 vaccine for >1 year. Assessment of long-term effectiveness of bivalent COVID-19 vaccines against circulating sublineages is important to inform the potential need for vaccination with updated vaccines. Methods: In this test-negative study at Kaiser Permanente Southern California, sequencing-confirmed BA.4/BA.5- or XBB-related SARS-CoV-2-positive cases during 9/1/2022-6/30/2023 were matched 1:3 to SARS-CoV-2-negative controls. We assessed mRNA-1273 bivalent relative (rVE) and absolute vaccine effectiveness (VE) compared to [≥]2 or 0 doses of original monovalent vaccine, respectively. Outcomes were BA.4/BA.5- or XBB-related infection, emergency department/urgent care (ED/UC) encounters, and hospitalization. Results: The rVE analysis included 20,966 cases and 62,898 controls. rVE (95%CI) against BA.4/BA.5 at 14-60 days and 121-180 days was 52.7% (46.9-57.8%) and 35.5% (-2.8%-59.5%) for infection, and 59.3% (49.7-67.0%) and 33.2% (-28.2-68.0%) for ED/UC encounters. For BA.4/BA.5-related hospitalizations, rVE was 71.3% (44.9-85.1%) and 52.0% (-1.2-77.3%) at 14-60 days and 61-120 days, respectively. rVE against XBB at 14-60 days and 121-180 days, was 48.8% (33.4-60.7%) and -3.9% (-18.1-11.3%) for infection, 70.7% (52.4-82.0%) and 15.7% (-6.0-33.2%) for ED/UC encounters, and 87.9% (43.8-97.4%) and 57.1% (17.0-77.8%) for hospitalization. Results for VE and subgroup analyses (age, immunocompromise, and previous SARS-CoV-2 infection) were similar to rVE analyses. Conclusions: rVE of mRNA-1273 bivalent vaccine against BA.4/BA.5 and XBB infections, ED/UC encounters, and hospitalizations waned over time. Periodic adjustment of vaccines to target emerging variants and revaccination may be important in reducing COVID-19 morbidity and mortality.


Subject(s)
COVID-19
4.
European Journal of Human Genetics ; 31(Supplement 1):706, 2023.
Article in English | EMBASE | ID: covidwho-20243198

ABSTRACT

Background/Objectives: Chemosensory dysfunction is a hallmark of SARS-CoV-2 infection;nevertheless, the genetic factors predisposing to long-term smell and taste loss are still unknown. This study aims to identify candidate genes possibly involved in persistent smell/taste loss through Whole Genome Sequencing (WGS) analysis of a large cohort of 130 fully characterised Italian individuals, previously diagnosed with COVID-19. Method(s): DNA of all analysed patients was used to perform WGS analysis, and a detailed personal anamnesis was collected. Moreover, orthonasal function was assessed through the extended Sniffin' Sticks test, retronasal function was tested with 20 powdered tasteless aromas, and taste was determined with validated Taste Strips. Self-reported smell and taste alterations were assessed via Visual Analog Scales plus questionnaires. Result(s): The clinical evaluation allowed to classify the patients in two groups: 88 cases affected by persistent smell dysfunction (median age, 49) and 42 controls (median age, 51). Among cases, 26.1% (n = 23) were functionally anosmic and 73.9% (n = 65) were hyposmic. Within cases, 77 underwent the taste strip test: 53.2% (n = 41) presented hypogeusia and 46.8% (n = 36) were normogeusic. Preliminary WGS results on a first subset of 76 samples confirmed the important role of UGT2A1 gene, previously described as involved in smell loss. Interestingly, we identified a nonsense variant (rs111696697, MAF 0.046) significantly associated with anosmia in males (p-value: 0.0183). Conclusion(s): Here, for the first time a large cohort of patients, fully characterised through a comprehensive psychophysical evaluation of smell and taste, have been analysed to better define the genetic bases of COVID-19-related persistent chemosensory dysfunction.

5.
Cureus ; 15(5): e38442, 2023 May.
Article in English | MEDLINE | ID: covidwho-20240449

ABSTRACT

Pressure ulcers form when skin is compressed against a bony prominence, often in the context of prolonged supine or prone-based care. Hospitalized, bedridden patients are at the highest risk of this complication, especially when preventative measures like regular rotational bed treatment are not employed. In this case report, we present a rare case of a COVID-19-related facial pressure ulcer that occurred in the context of regular rotational bed treatment. The lesion was managed by wound care and allowed to heal by secondary intention. Ultimately, we hope that this manuscript will raise awareness for this atypical ulcer location, especially as prone-position treatment approaches take hold.

6.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.05.25.23290456

ABSTRACT

The bivalent (original and Omicron BA.4/BA.5) mRNA-1273 COVID-19 vaccine was authorized to offer broader protection against COVID-19. We conducted a matched cohort study to evaluate the effectiveness of the bivalent vaccine in preventing hospitalization for COVID-19 (primary outcome) and medically attended SARS-CoV-2 infection and hospital death (secondary outcomes). Compared to individuals who did not receive bivalent mRNA vaccination but received [≥]2 doses of any monovalent mRNA vaccine, the relative vaccine effectiveness (rVE) against hospitalization for COVID-19 was 70.3% (95% confidence interval, 64.0%-75.4%). rVE was consistent across subgroups and not modified by time since last monovalent dose or number of monovalent doses received. Protection was durable [≥]3 months after the bivalent booster. rVE against SARS-CoV-2 infection requiring emergency department/urgent care and against COVID-19 hospital death was 55.0% (50.8%-58.8%) and 82.7% (63.7%-91.7%), respectively. The mRNA-1273 bivalent booster provides additional protection against hospitalization for COVID-19, medically attended SARS-CoV-2 infection, and COVID-19 hospital death.


Subject(s)
Severe Acute Respiratory Syndrome , Death , COVID-19
7.
J Pediatric Infect Dis Soc ; 2023 May 05.
Article in English | MEDLINE | ID: covidwho-2318839

ABSTRACT

BACKGROUND: Outbreaks of healthcare-associated respiratory syncytial virus (HA-RSV) infections in children are well described, but less is known about sporadic HA-RSV infections. We assessed the epidemiology and clinical outcomes associated with sporadic HA-RSV infections. METHODS: We retrospectively identified hospitalized children <18 years old with HA-RSV infections in six children's hospitals in the United States during the respiratory viral seasons October-April in 2016-2017, 2017-2018, and 2018-2019 and prospectively from October 2020 through November 2021. We evaluated outcomes temporally associated with HA-RSV infections including escalation of respiratory support, transfer to the pediatric intensive care unit (PICU), and in-hospital mortality. We assessed demographic characteristics and comorbid conditions associated with escalation of respiratory support. RESULTS: We identified 122 children (median age 16.0 months [IQR 6, 60 months]) with HA-RSV. The median onset of HA-RSV infections was hospital day 14 (IQR 7, 34 days). Overall, 78 (63.9%) children had two or more comorbid conditions; cardiovascular, gastrointestinal, neurologic/neuromuscular, respiratory, and premature/ neonatal comorbidities were most common. Fifty-five (45.1%) children required escalation of respiratory support and 18 (14.8%) were transferred to the PICU. Five (4.1%) died during hospitalization. In the multivariable analysis, respiratory comorbidities (aOR: 3.36 [CI95 1.41, 8.01]) were associated with increased odds of escalation of respiratory support. CONCLUSIONS: HA-RSV infections cause preventable morbidity and increase healthcare resource utilization. Further study of effective mitigation strategies for HA-respiratory viral infections should be prioritized; this priority is further supported by the impact of the COVID-19 pandemic on seasonal viral infections.

8.
Cancer Research Conference ; 83(5 Supplement), 2022.
Article in English | EMBASE | ID: covidwho-2282509

ABSTRACT

Background: Multi-parameter tumor gene expression assays (MPAs) are used to estimate individual patient risk and guide chemotherapy use in hormone-sensitive, HER2-negative early breast cancer. The TAILORx trial supports MPA use in a node-negative population. Evidence for MPA use in postmenopausal node-positive breast cancer has been provided by the RxPONDER trial interim analysis but this relies on the absence of superiority in an analysis where >50% of events were unrelated to breast cancer. There is much uncertainty about MPA use for premenopausal patients. OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis) (ISRCTN42400492) is a prospective international randomized controlled trial designed to validate MPAs as predictors of chemotherapy sensitivity in a largely node-positive breast cancer population. Method(s): OPTIMA is a partially blinded study with an adaptive two-stage design. The trial recruits women and men age 40 or older with resected ER-positive, HER2-negative invasive breast cancer and up to 9 involved axillary lymph nodes. Randomization is to standard management (chemotherapy and endocrine therapy) or to MPA-directed treatment using the Prosigna (PAM50) test. Those with a Prosigna tumor Score (ROR-PT) >60 receive standard management whilst those with a low score (<=60) tumor are treated with endocrine therapy alone. Endocrine therapy for premenopausal women includes ovarian suppression for all participants unless they experience a chemotherapy-induced menopause. Adjuvant abemaciclib is permitted. The trial will be analyzed for (1) non-inferiority of recurrence according to randomization and (2) cost-effectiveness. The key secondary outcome is non-inferiority of recurrence for patients with low ROR-PT score tumors. The efficacy analyses will be performed Per Protocol using Invasive Breast Cancer Free Survival (IBCFS) as the primary outcome measure to limit the risk of a false non-inferiority conclusion. Recruitment of 4500 patients over 8 years will permit demonstration of up to 3% non-inferiority of test-directed treatment with at least 83% power, assuming 5-year IBCFS is 87% with standard management. An integrated qualitative recruitment study addresses challenges to consent and recruitment, building on experience from the feasibility study which found that a multidisciplinary approach is important for recruitment success. OPTIMA is strongly supported by a patient group which has helped design all patient documents and which is represented on the TMG. Result(s): The OPTIMA main trial opened in January 2017 and has continued to recruit throughout the COVID-19 pandemic. Overall recruitment as of 1 July 2022 was 2814 (2593 from UK, 221 from Norway). Patient characteristics are well balanced between the trial arms. Currently 95% of randomized participants are eligible for inclusion in the PP analysis. 66% of the MPA-directed arm participants have been allocated to endocrine therapy only. The test failure rate is < 1%. Conclusion(s): OPTIMA will provide robust unbiased evidence on test-directed chemotherapy safety for both postmenopausal and premenopausal women with 1-3 involved nodes as well as for patients with 4-9 involved nodes and for patients treated with abemaciclib.

9.
Clin Exp Dent Res ; 9(3): 500-508, 2023 06.
Article in English | MEDLINE | ID: covidwho-2258224

ABSTRACT

OBJECTIVES: The rapid spread of severe acute respiratory syndrome coronavirus 2 and the ensuing rise of the COVID-19 pandemic have impacted healthcare unprecedentedly. With the scarcity of available resources, including healthcare providers themselves, novel methods for tracking aerosol and splatter in real time are required to alleviate demand and increase safety. This study evaluates the utility of riboflavin (vitamin B2 ) as a tracer for splatter/aerosol distribution from ultrasonic scaling in an open operatory clinic. MATERIAL AND METHODS: In two experimental designs, ultrasonic scaling was performed on 18 volunteers or simulated on a manikin. Riboflavin was introduced into the irrigation system, and aerosol and splatter dissemination were evaluated for both experimental designs. RESULTS: Ultrasonic scaling utilizing riboflavin solution, in volunteers and manikins, leads to observable particle fluorescence under UV light. Contamination distribution varied across the different suction methods and between the volunteer and manikin trials. Nearly all observed incidences of contamination occurred within the operatory in use. CONCLUSIONS: Riboflavin can be used with minimal risk during dental procedures and allows for the detection of droplet spread in clinical settings in real time.


Subject(s)
COVID-19 , Humans , Pandemics , Dental Clinics , Respiratory Aerosols and Droplets , Coloring Agents
10.
Sci Adv ; 9(13): eade8778, 2023 03 29.
Article in English | MEDLINE | ID: covidwho-2272466

ABSTRACT

Vaccines and drugs have helped reduce disease severity and blunt the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, ongoing virus transmission, continuous evolution, and increasing selective pressures have the potential to yield viral variants capable of resisting these interventions. Here, we investigate the susceptibility of natural variants of the main protease [Mpro; 3C-like protease (3CLpro)] of SARS-CoV-2 to protease inhibitors. Multiple single amino acid changes in Mpro confer resistance to nirmatrelvir (the active component of Paxlovid). An additional clinical-stage inhibitor, ensitrelvir (Xocova), shows a different resistance mutation profile. Importantly, phylogenetic analyses indicate that several of these resistant variants have pre-existed the introduction of these drugs into the human population and are capable of spreading. These results encourage the monitoring of resistance variants and the development of additional protease inhibitors and other antiviral drugs with different mechanisms of action and resistance profiles for combinatorial therapy.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , SARS-CoV-2/genetics , SARS-CoV-2/metabolism , Protease Inhibitors/chemistry , Phylogeny , Peptide Hydrolases
11.
Biophys J ; 122(3S1): 39a, 2023 Feb 10.
Article in English | MEDLINE | ID: covidwho-2229802
12.
SAGE Open Med ; 11: 20503121221147851, 2023.
Article in English | MEDLINE | ID: covidwho-2195576

ABSTRACT

Objective: To examine trends in child sleep, physical activity, and screen use during the COVID-19 pandemic in New York City with a prospective, longitudinal online survey of parents recruited from a large medical center. Methods: Data was collected Spring 2020 ("Complete Shutdown") and Fall 2020 ("Partial Shutdown"). Outcomes were parental perceptions about changes in child sleep, physical activity, and screen time compared to before COVID-19; and contemporaneous measures of these child behaviors. We report contemporaneous responses and paired analyses to describe longitudinal changes. Results: Two hundred seventy-seven participants were surveyed during Complete Shutdown and 227 (81.9%) filled out a follow-up survey during Partial Shutdown. The largest percentage of parents at both time points perceived no change in child sleep, decreases in child exercise, and increases in child screen time. In paired analyses, perceptions shifted toward less sleep, more physical activity and less screen time from Complete Shutdown to Partial Shutdown. Conclusion: COVID-19 had negative impacts on child health behaviors that did not resolve over a 6-month period despite partial reopenings.

13.
Open Forum Infectious Diseases ; 9(Supplement 2):S474-S475, 2022.
Article in English | EMBASE | ID: covidwho-2189768

ABSTRACT

Background. Currently, therapeutic options for outpatients with COVID-19 are limited, in Mexico Polymerized Collagen type I (PCTI) has been tested as a useful option. Methods. Double-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. To evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. Eighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. Patients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). Results. Of 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis;37 (41.6%) were male and mean age was 48.5+/-14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation >=92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P< 0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation < 92% vs placebo (P< 0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1+/-3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. Conclusion. Treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean SaO2 >=92% and a shorter duration of symptoms as compared with placebo. Serum cytokine and chemokine levels of SARS-CoV2-infected symptomatic outpatients at baseline and day 8 post-treatment with PTIC or placebo. Data are expressed as median with 95% confidence. (A) IP-10, IFN-gamma inducible protein-10;(B) IL-8, Interleukin-8;(C) M-CSF, Macrophage colony-stimulating factor;(D) IL-1Ra, IL-1 receptor antagonist;(E) TRAIL, TNF-related apoptosis inducing ligand;and (F) Forest plot (95% confidence intervals). (A) Probability of oxygen saturation 92% or greater while breathing ambient air. (B) Accelerated time failure model for oxygen saturation 92% or greater while breathing ambient air among polymerised type I collagen and placebo.

14.
J Ambul Care Manage ; 45(4): 343-345, 2022.
Article in English | MEDLINE | ID: covidwho-2018272
15.
Annals of the Rheumatic Diseases ; 81:946-947, 2022.
Article in English | EMBASE | ID: covidwho-2008953

ABSTRACT

Background: In March 2020, as part of the UK's COVID-19 prevention strategy, those identifed as 'clinically extremely vulnerable,' were advised to shield. This included a number of patients prescribed anti-rheumatic drugs, who were asked to continue their current treatment unless they developed symptoms of infection. Suboptimal treatment adherence (16.0%-81.0%) has been reported in patients with arthritic diseases, and is associated with psychological factors, including anxiety (1). Previous literature in non-UK cohorts has highlighted suboptimal adherence levels in immunosuppressed patients during the pandemic, although many were single centre studies (2,3). Objectives: The aim of this multi-centre study is to investigate the impact of the COVID-19 pandemic on adherence to anti-rheumatic medications in patients with established rheumatoid (RA) and psoriatic (PsA) arthritis in the UK who had recently commenced a biologic or targeted synthetic DMARD. Methods: Between September 2020 and May 2021, RA and PsA patients prescribed biologic or targeted synthetic anti-rheumatic drugs from two multi-centre observational studies (BRAGGSS and OUTPASS) were sent a questionnaire on medication usage, adherence, and perceptions to establish the impact of COVID-19 on these parameters. Patients were asked about compliance during the COVID-19 pandemic using a 5-point Likert scale (always, often, sometimes, rarely, and never) and the reason for non-adherence. Adherence was defned as never missing or delaying a dose, unless medically advised. Descriptive summary statistics were calculated, and logistic regression and Pearson's chi-squared tests were employed to investigate variables associated with self-reported non-adherence. Results: In total 159 questionnaires were returned (81.1% RA and 18.9% PsA). Methotrexate (53.5%) was the most frequently prescribed agent, followed by etan-ercept (25.2%), sulfasalazine (22.6%), hydroxychloroquine (21.4%) and adalimumab (19.5%). Furthermore, 68.6% of patients were prescribed ≥2 drugs. During the pandemic, 42.1% of patients reported missing or delaying a treatment dose for any reason. Adherence information was available for 97.5% of patients with 25.8% reporting non-adherence which was not medically advised. Methotrexate non-adherence was 27.1%, with similar levels reported for etanercept (20.0%), sulfasalazine (27.8%), hydroxychloroquine (35.3%) and adalimumab (29.0%). No drugs had signifcantly different adherence compared to methotrexate. Furthermore, there was no association between disease type or perception of disease control and adherence. Of non-adherent patients, 17.5% reported increased anxiety, fear, and increased risk due to the COVID-19 pandemic as an influencing factor. Meanwhile, 37.5% of non-adherent patients listed non-COVID-19 intentional reasons and 45.0% reported non-intentional reasons, with forgetting and running out of treatment listed most frequently. Conclusion: In a UK cohort self-reported non-adherence was reported in 25.8% of patients during the COVID-19 pandemic, despite medical advice, with reasons including increased anxiety due to COVID-19.

16.
Clinical Nutrition ESPEN ; 48:515-516, 2022.
Article in English | EMBASE | ID: covidwho-2003970

ABSTRACT

Critically ill patients often face progressive and rapid losses of body and muscle mass due to hypermetabolism and increased protein catabolism. Certain population groups (such as obese patients or those requiring Continuous Renal Replacement Therapy (CRRT) require a higher protein provision as advised by both ASPEN1 and ESPEN2. Furthermore, critically ill patients often receive significant energy provision from non-nutritional sources such as propofol. As a consequence, calorie provision via enteral feed is commonly restricted to avoid overfeeding, and protein provision to the patient is further compromised. Retrospective data was collected for 58 patients who were either confirmed or suspected of COVID-19 and admitted to the Intensive Care Unit (ICU) during April 2020. 31% (n=18) of patients were unable to meet their protein requirements from the feed formula alone, based on initial dietetic assessment. Recommended protein requirements were not achieved in any patients who were obese (n=10;defined as BMI ≥30 kg/m2) or receiving CRRT (n=6). The maximum protein provision for obese patients was 1.5g/kg IBW and 1.6g/kg for patients receiving CRRT. The situation was exacerbated for patients receiving high dose propofol (defined as >10 ml/hr), where protein provision decreased to 0.8 – 1.2g/kg and 1.1 – 1.3g/kg respectively. [Formula presented] In the non-obese, non-CRRT ICU population, the available enteral feeding regimes were appropriate to meet the majority of patients’ protein requirements (as shown in Figure 1). However the review almost certainly overestimates protein provision, as percentage feed delivery was not assessed and the results assume 100% feed delivery. We know from previous audits on our unit that feed delivery is often <80% of target, and although this review was based on COVID-19 patients, the ‘typical’ patients in ICU often have specific nutrition requirements, which includes high protein. The challenges faced during COVID-19 has raised awareness of the importance of protein delivery in ICU and our review highlights the need to continually monitor and augment protein delivery in critically ill patients. The findings support the need for a high protein supplement in specific population groups;particularly those who may be obese, require CRRT or are receiving high dose propofol in an ICU setting. 1 McClave S A, Taylor B E, Martindale R G et al. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) J Parenter Enteral Nutr 2016;40(2): 159-211. 2 Singer P, Blaser A R, Berger M M et al. ESPEN Guideline on clinical nutrition in the intensive care unit Clin Nut 2019;38: 48-79

17.
Journal of General Internal Medicine ; 37:S318-S319, 2022.
Article in English | EMBASE | ID: covidwho-1995752

ABSTRACT

BACKGROUND: Reports of silent hypoxia in patients with Covid-19 have raised concerns that patients monitored at home should receive pulse oximeters to objectively measure oxygen saturation rather than relying on subjective dyspnea as an indicator of clinical deterioration. METHODS: In this pragmatic randomized control trial, patients with suspected or confirmed Covid-19 were randomly assigned (1:1) to receive a text message based remote monitoring program (“Covid Watch”) or the program supplemented with SpO2 monitoring using a home pulse oximeter (“COVID Watch + Pulse Oximetry”). Covid Watch is a an automated 14-day text program that enquires about patients' symptoms of dyspnea. The primary outcome was days alive and out of hospital (DAOH) at 30 days. RESULTS: A total of 1056 patients (611 Covid-19 positive) were assigned to receive automated remote monitoring of both peripheral oxygen saturation (SpO2) levels and self-reported symptoms of dyspnea and 1041 (606 Covid-19 positive) to receive symptom monitoring alone. Among Covid-19 patients, the addition of SpO2 monitoring provided no significant difference in mean DAOH at 30 days (29.38 vs 29.46;difference -0.08;95% CI, -0.37 to 0.21). Patients in the intervention arm were more likely to use more clinical resources such as telephone calls and telemedicine visits. These finding were consistent across subgroups defined by race, age, and clinical status. CONCLUSIONS: SpO2 monitoring added no clinical value to subjective assessments of dyspnea in an automated text-message remote monitoring program of Covid-19 patients, while simultaneously increasing utilization of clinical resources. These findings reveal that home pulse oximetry may be ineffective and inefficient in supporting the management of Covid-19 patients in outpatient settings relative to remotely monitoring symptoms of dyspnea alone.

18.
Internal Medicine Journal ; 52(SUPPL 1):7, 2022.
Article in English | EMBASE | ID: covidwho-1916177

ABSTRACT

Background: Upper gastrointestinal bleeding (UGIB) is a common gastrointestinal emergency and carries a high morbidity and mortality. There are multiple risk factors for poorer outcomes, including malnutrition. Ascorbic acid is a water-soluble vitamin present in most plant foods. Dietary deficiency leads to scurvy, which may alter the natural history of UGIB through impaired tissue and mucosal integrity. Traditionally thought to be rare in developed countries, Vitamin C deficiency (VCD) is now well described in patients with pneumonia, sepsis and COVID-191, 2. There is a paucity of literature investigating the prevalence and clinical significance of VCD in UGIB;interim findings reported by our group suggested a prevalence of >30%. Aim: The aim of this study was to establish the prevalence of VCD in patients presenting with UGIB and its association with clinical outcomes. Methods: We conducted a prospective cohort study of adult patients presenting with UGIB to two metropolitan tertiary hospitals in Melbourne, Australia over a 12-month period (March 2020 to March 2021). Fasting Vitamin C levels were obtained on admission. Patients were risk stratified using the AIMS65 score and baseline demographic data and outcomes were recorded. The primary outcome was the prevalence of VCD (serum Vitamin C level <23mcmol/L) and severe VCD (<12mcmol/L). Secondary outcomes included a composite endpoint of adverse events (AE), comprising inpatient death, intensive care unit (ICU) admission, rebleeding, surgery, angioembolisation or massive transfusion (≥4 units of red cells). Multivariate logistic regression was used to determine the association between Vitamin C levels and the secondary endpoints. Subgroup analyses were performed in variceal and non-variceal UGIB and high- (AIMS65≥2) and low-risk (AIMS65 0-2) UGIB. Results: 227 patients were included. The mean age was 65±17 years, 145 (63.9%) were male and median AIMS65 score was 1 (IQR 1-2). The aetiology of UGIB was variceal bleeding in 20.3%, peptic ulcer disease (PUD) in 44.1% and other causes in 35.7%. The mean Vitamin C level was 40±26mcmol/L. In terms of patient outcomes, inpatient mortality was 4%, ICU admission occurred in 11.9% and mean length of stay (LOS) was 7.7±9.7 days. Red cell transfusion was required in 63.4% of patients with a mean requirement of 2.2±2.8 units. VCD was identified in 74 patients (32.6%) with severe deficiency in 32 (14.1%). VCD was associated with significantly higher in-hospital mortality (9.5% vs. 1.3%, p=0.01), prolonged LOS (10.8 vs. 6.2 days, p<0.01), rebleeding (17.6% vs. 7.88%, p=0.05) and a higher composite endpoint of AE (77% vs. 54.9%, p<0.01). At multivariate logistic regression, high-risk UGIB (OR 3.24, CI 1.42-7.42), VCD (OR 2.28, CI1.11-4.71) and chronic liver disease (OR 11.66, CI 2.92-46.64) were all independently associated with the composite endpoint of AE. At subgroup analysis, VCD was associated with a significantly increased composite endpoint of AE in patients with non-variceal (74% vs. 51%, p<0.01) and low-risk UGIB (66% vs. 44%, p=0.04). Conclusion: VCD is highly prevalent in patients with UGIB and associated with poorer outcomes, including higher mortality, rebleeding and LOS. Interventional studies are required to determine the impact of early Vitamin C supplementation on clinical outcomes.

20.
Front Microbiol ; 13: 878342, 2022.
Article in English | MEDLINE | ID: covidwho-1879462

ABSTRACT

COVID-19 emerged at varying intervals in different regions of the United States in 2020. This report details the epidemiologic and genetic evolution of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first year of the epidemic in the state of Nebraska using data collected from the Creighton Catholic Health Initiatives (CHI) health system. Statistical modelling identified age, gender, and previous history of diabetes and/or stroke as significant risk factors associated with mortality in COVID-19 patients. In parallel, the viral genomes of over 1,000 samples were sequenced. The overall rate of viral variation in the population was 0.07 mutations/day. Genetically, the first 9 months of the outbreak, which include the initial outbreak, a small surge in August and a major outbreak in November 2020 were primarily characterized by B.1. lineage viruses. In early 2021, the United Kingdom variant (B.1.1.7 or alpha) quickly became the dominant variant. Notably, surveillance of non-consensus variants detected B.1.1.7 defining mutations months earlier in Fall 2020. This work provides insights into the regional variance and evolution of SARS-CoV-2 in the Nebraska region during the first year of the pandemic.

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