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3.
Sci Rep ; 11(1): 23921, 2021 12 14.
Article in English | MEDLINE | ID: covidwho-1585804

ABSTRACT

Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudovirus-based SARS-CoV-2 neutralization assays, with each trial using one of the two assays. Here we describe and compare the nAb titers obtained in the two assays. We observe that one assay consistently yielded higher nAb titers than the other when both assays were performed on the World Health Organization's anti-SARS-CoV-2 immunoglobulin International Standard, COVID-19 convalescent sera, and mRNA-1273 vaccinee sera. To overcome the challenge this difference in readout poses in comparing/combining data from the two assays, we evaluate three calibration approaches and show that readouts from the two assays can be calibrated to a common scale. These results may aid decision-making based on data from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.


Subject(s)
Antibodies, Neutralizing/blood , COVID-19/immunology , Neutralization Tests/standards , SARS-CoV-2/immunology , /immunology , Antibodies, Viral/blood , COVID-19/blood , Clinical Decision-Making , Clinical Trials as Topic , Diagnostic Tests, Routine , Humans , Neutralization Tests/methods , World Health Organization
6.
J Gen Intern Med ; 36(8): 2408-2413, 2021 08.
Article in English | MEDLINE | ID: covidwho-1549541

ABSTRACT

Scholars from a range of disciplines including medicine, sociology, psychology, and philosophy have addressed the concepts of ambiguity and uncertainty in medical practice and training. Most of this scholarship has been descriptive, focusing on defining and measuring ambiguity and uncertainty tolerance or tracking clinicians' responses to ambiguous and uncertain situations. Meanwhile, scholars have neglected some fundamental normative questions: Is tolerance of uncertainty good; if so, to what extent? Using a philosophical approach to these questions, we show that neither tolerance nor intolerance of uncertainty is necessarily a good or bad trait. Rather, both tolerance and intolerance of uncertainty can give physicians advantages while at the same time exposing them to pitfalls in clinical practice. After making this case, we argue that cultivating certain virtues-like courage, diligence, and curiosity-could help clinicians avoid the dangers of excessive tolerance and intolerance of uncertainty. Finally, we suggest that medical educators develop curricula and career counseling beginning with matriculation and proceeding through specialty choice and residency training that explicitly address trainees' responses to clinical uncertainty. These programs should encourage trainees, students and residents, to be mindful of their reactions to uncertainty and help them develop virtues that will allow them to avoid the hazards of extreme tolerance or intolerance of uncertainty.


Subject(s)
Internship and Residency , Physicians , Clinical Decision-Making , Curriculum , Humans , Uncertainty
8.
mSphere ; 6(5): e0075221, 2021 10 27.
Article in English | MEDLINE | ID: covidwho-1526451

ABSTRACT

During the progression of coronavirus disease 2019 (COVID-19), immune response and inflammation reactions are dynamic events that develop rapidly and are associated with the severity of disease. Here, we aimed to develop a predictive model based on the immune and inflammatory response to discriminate patients with severe COVID-19. COVID-19 patients were enrolled, and their demographic and immune inflammatory reaction indicators were collected and analyzed. Logistic regression analysis was performed to identify the independent predictors, which were further used to construct a predictive model. The predictive performance of the model was evaluated by receiver operating characteristic curve, and optimal diagnostic threshold was calculated; these were further validated by 5-fold cross-validation and external validation. We screened three key indicators, including neutrophils, eosinophils, and IgA, for predicting severe COVID-19 and obtained a combined neutrophil, eosinophil, and IgA ratio (NEAR) model (NEU [109/liter] - 150×EOS [109/liter] + 3×IgA [g/liter]). NEAR achieved an area under the curve (AUC) of 0.961, and when a threshold of 9 was applied, the sensitivity and specificity of the predicting model were 100% and 88.89%, respectively. Thus, NEAR is an effective index for predicting the severity of COVID-19 and can be used as a powerful tool for clinicians to make better clinical decisions. IMPORTANCE The immune inflammatory response changes rapidly with the progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and is responsible for clearance of the virus and further recovery from the infection. However, the intensified immune and inflammatory response in the development of the disease may lead to more serious and fatal consequences, which indicates that immune indicators have the potential to predict serious cases. Here, we identified both eosinophils and serum IgA as prognostic markers of COVID-19, which sheds light on new research directions and is worthy of further research in the scientific research field as well as clinical application. In this study, the combination of NEU count, EOS count, and IgA level was included in a new predictive model of the severity of COVID-19, which can be used as a powerful tool for better clinical decision-making.


Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , COVID-19/immunology , Clinical Decision Rules , Severity of Illness Index , Adult , Aged , Biomarkers/blood , COVID-19/blood , Clinical Decision-Making/methods , Disease Progression , Eosinophils/metabolism , Female , Humans , Immunoglobulin A/blood , Inflammation/blood , Inflammation/diagnosis , Inflammation/virology , Logistic Models , Male , Middle Aged , Neutrophils/metabolism , Predictive Value of Tests , Prognosis , Sensitivity and Specificity
9.
Pan Afr Med J ; 40: 41, 2021.
Article in English | MEDLINE | ID: covidwho-1513182

ABSTRACT

Introduction: the coronavirus disease 2019 (COVID-19) pandemic has negatively impacted countries across the globe. Infected individuals will seek aid at various health care facilities. Many patients will recover without requiring specialised treatment. A significant percentage of infected individuals will need critical care management, which will begin in the emergency department, generally staffed by junior doctors. Junior doctors will need to stabilize, triage and manage these patients prior to referral to specialized units. Above and beyond the usual occupational demands that accompany junior doctors in state facilities, this pandemic will thrust further responsibility on them. The objectives were to describe crisis preparedness of junior doctors in the areas of triage decision-making and critical care management, outside the intensive care unit. Methods: this is a descriptive, cross-sectional study, utilizing a web-based survey. Junior doctors in South Africa, being doctors in year one or year two of internship and community service, were invited to participate anonymously via various social media platforms. Results: a total of 210 junior doctors across South Africa answered the survey. Junior doctors expressed confidence with knowledge of intubation drugs, to perform intubation and cardiopulmonary arrest resuscitation without supervision. Only 13.3% of respondents expressed comfort with setting and adjusting ventilator settings independently. 57% of participants expressed discomfort with making critical care triage decisions. Ninety-three percent (93%) of participants expressed benefit from a telemedicine intervention. Conclusion: junior doctors in South Africa indicate that they are prepared to initiate management of the critically ill patient outside the intensive care unit but remain uncertain in their ability to provide ongoing critical care management. The COVID-19 pandemic has highlighted the need to prepare junior doctors with the ability to manage critical care triage and management in emergency rooms. Leveraging of the workforce in South Africa may be potentiated by telemedicine interventions.


Subject(s)
COVID-19 , Critical Care/methods , Medical Staff, Hospital/statistics & numerical data , Triage/methods , Clinical Competence , Clinical Decision-Making , Critical Illness/therapy , Cross-Sectional Studies , Emergency Service, Hospital/organization & administration , Humans , Intensive Care Units , Internship and Residency , South Africa , Surveys and Questionnaires
10.
Infect Dis Clin North Am ; 35(4): 841-856, 2021 12.
Article in English | MEDLINE | ID: covidwho-1506789

ABSTRACT

Despite a large volume of research in prevention, central line-associated bloodstream infections and catheter-related bloodstream infections continue to cause significant morbidity, mortality, and increased health care costs. Strategies in prevention, including decision about catheter placement, insertion bundles, adherence to standard of care guidelines, and technologic innovations, shown to decrease rates of catheter-related bloodstream infections and central line-associated bloodstream infections are described in this update. The coronavirus disease 2019 pandemic has resulted in increased health care-acquired infections, including central line-associated bloodstream infections.


Subject(s)
Bacteremia/prevention & control , Catheter-Related Infections/prevention & control , Catheterization, Central Venous/adverse effects , Bacteremia/epidemiology , Bacteremia/etiology , COVID-19/epidemiology , Catheter-Related Infections/epidemiology , Catheter-Related Infections/etiology , Catheterization, Central Venous/standards , Clinical Decision-Making , Cross Infection/epidemiology , Cross Infection/etiology , Humans , Patient Care Bundles/standards , Practice Guidelines as Topic , SARS-CoV-2
12.
Arch Dis Child Fetal Neonatal Ed ; 106(6): 627-634, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1503592

ABSTRACT

OBJECTIVE: To identify risk factors associated with delivery room respiratory support in at-risk infants who are initially vigorous and received delayed cord clamping (DCC). DESIGN: Prospective cohort study. SETTING: Two perinatal centres in Melbourne, Australia. PATIENTS: At-risk infants born at ≥35+0 weeks gestation with a paediatric doctor in attendance who were initially vigorous and received DCC for >60 s. MAIN OUTCOME MEASURES: Delivery room respiratory support defined as facemask positive pressure ventilation, continuous positive airway pressure and/or supplemental oxygen within 10 min of birth. RESULTS: Two hundred and ninety-eight infants born at a median (IQR) gestational age of 39+3 (38+2-40+2) weeks were included. Cord clamping occurred at a median (IQR) of 128 (123-145) s. Forty-four (15%) infants received respiratory support at a median of 214 (IQR 156-326) s after birth. Neonatal unit admission for respiratory distress occurred in 32% of infants receiving delivery room respiratory support vs 1% of infants who did not receive delivery room respiratory support (p<0.001). Risk factors independently associated with delivery room respiratory support were average heart rate (HR) at 90-120 s after birth (determined using three-lead ECG), mode of birth and time to establish regular cries. Decision tree analysis identified that infants at highest risk had an average HR of <165 beats per minute at 90-120 s after birth following caesarean section (risk of 39%). Infants with an average HR of ≥165 beats per minute at 90-120 s after birth were at low risk (5%). CONCLUSIONS: We present a clinical decision pathway for at-risk infants who may benefit from close observation following DCC. Our findings provide a novel perspective of HR beyond the traditional threshold of 100 beats per minute.


Subject(s)
Critical Pathways/standards , Delivery, Obstetric , Electrocardiography/methods , Oxygen Inhalation Therapy , Umbilical Cord , Australia/epidemiology , Cesarean Section/adverse effects , Cesarean Section/methods , Clinical Decision-Making , Constriction , Continuous Positive Airway Pressure/methods , Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Delivery, Obstetric/statistics & numerical data , Female , Gestational Age , Heart Rate , Humans , Infant, Newborn , Male , Monitoring, Physiologic/methods , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/instrumentation , Oxygen Inhalation Therapy/methods , Risk Assessment/methods , Risk Factors , Time-to-Treatment/standards , Time-to-Treatment/statistics & numerical data
14.
Arch Iran Med ; 24(4): 333-338, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1498430

ABSTRACT

BACKGROUND: Decision-making on allocating scarce medical resources is crucial in the context of a strong health system reaction to the coronavirus disease 2019 (COVID-19) pandemic. Therefore, understanding the risk factors related to a high mortality rate can enable the physicians for a better decision-making process. METHODS: Information was collected regarding clinical, demographic, and epidemiological features of the definite COVID-19 cases. Through Cox regression and statistical analysis, the risk factors related to mortality were determined. The Kaplan-Meier curve was used to estimate survival function and measure the mean length of living time in the patients. RESULTS: Among about 3000 patients admitted in the Taleghani hospital as outpatients with suspicious signs and symptoms of COVID-19 in 2 months, 214 people were confirmed positive for this virus using the polymerase chain reaction (PCR) technique. Median time to death was 30 days. In this population, 24.29% of the patients died and 24.76% of them were admitted to the ICU (intensive care unit) during hospitalization. The results of Multivariate Cox regression Analysis showed that factors including age (HR, 1.031; 95% CI, 1.001-1.062; P value=0.04), and C-reactive protein (CRP) (HR, 1.007; 95% CI, 1.000-1.015; P value=0.04) could independently predict mortality. Furthermore, the results showed that age above 59 years directly increased mortality rate and decreased survival among our study population. CONCLUSION: Predictor factors play an important role in decisions on public health policy-making. Our findings suggested that advanced age and CRP were independent mortality rate predictors in the admitted patients.


Subject(s)
COVID-19/diagnosis , COVID-19/mortality , Adult , Age Factors , Aged , COVID-19/complications , Clinical Decision-Making , Female , Hospital Mortality , Hospitalization , Humans , Iran , Male , Middle Aged , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Factors , Survival Rate
15.
PLoS One ; 16(11): e0258945, 2021.
Article in English | MEDLINE | ID: covidwho-1496519

ABSTRACT

Exposure notification apps have been developed to assist in notifying individuals of recent exposures to SARS-CoV-2. However, in several countries, such apps have had limited uptake. We assessed whether strategies to increase downloads of exposure notification apps should emphasize improving the accuracy of the apps in recording contacts and exposures, strengthening privacy protections and/or offering financial incentives to potential users. In a discrete choice experiment with potential app users in the US, financial incentives were more than twice as important in decision-making about app downloads, than privacy protections, and app accuracy. The probability that a potential user would download an exposure notification app increased by 40% when offered a $100 reward to download (relative to a reference scenario in which the app is free). Financial incentives might help exposure notification apps reach uptake levels that improve the effectiveness of contact tracing programs and ultimately enhance efforts to control SARS-CoV-2. Rapid, pragmatic trials of financial incentives for app downloads in real-life settings are warranted.


Subject(s)
COVID-19 , Mobile Applications , SARS-CoV-2/pathogenicity , Adult , Aged , Clinical Decision-Making , Contact Tracing/methods , Disease Notification , Humans , Middle Aged , Young Adult
16.
J Infect Dis ; 224(8): 1325-1332, 2021 Oct 28.
Article in English | MEDLINE | ID: covidwho-1493826

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse-transcription polymerase chain reaction (RT-PCR) provides a highly variable cycle threshold (Ct) value that cannot distinguish viral infectivity. Subgenomic ribonucleic acid (sgRNA) has been used to monitor active replication. Given the importance of long RT-PCR positivity and the need for work reincorporation and discontinuing isolation, we studied the functionality of normalized viral loads (NVLs) for patient monitoring and sgRNA for viral infectivity detection. METHODS: The NVLs measured through the Nucleocapsid and RNA-dependent-RNA-polymerase genes and sgRNA RT-PCRs were performed in 2 consecutive swabs from 84 healthcare workers. RESULTS: The NVLs provided similar and accurate quantities of both genes of SARS-CoV-2 at 2 different timepoints of infection, overcoming Ct-value and swab collection variability. Among SARS-CoV-2-positive samples, 51.19% were sgRNA-positive in the 1st RT-PCR and 5.95% in the 2nd RT-PCR. All sgRNA-positive samples had >4 log10 RNA copies/1000 cells, whereas samples with ≤1 log10 NVLs were sgRNA-negative. Although NVLs were positive until 29 days after symptom onset, 84.1% of sgRNA-positive samples were from the first 7 days, which correlated with viral culture viability. Multivariate analyses showed that sgRNA, NVLs, and days of symptoms were significantly associated (P < .001). CONCLUSIONS: The NVLs and sgRNA are 2 rapid accessible techniques that could be easily implemented in routine hospital practice providing a useful proxy for viral infectivity and coronavirus disease 2019 patient follow-up.


Subject(s)
COVID-19/diagnosis , SARS-CoV-2/isolation & purification , Viral Load/standards , Adult , Aftercare/standards , COVID-19/therapy , COVID-19/transmission , COVID-19/virology , COVID-19 Nucleic Acid Testing/statistics & numerical data , Clinical Decision-Making/methods , Epidemiological Monitoring , Female , Health Personnel/statistics & numerical data , Humans , Male , Middle Aged , Nasopharynx/pathology , Nasopharynx/virology , RNA, Viral/isolation & purification , SARS-CoV-2/genetics , SARS-CoV-2/pathogenicity
18.
J Med Internet Res ; 23(10): e30491, 2021 10 19.
Article in English | MEDLINE | ID: covidwho-1477708

ABSTRACT

BACKGROUND: The COVID-19 pandemic has increased the demand for youth mental health services in Canada as disruptions to clinical care continue to persist due to the risk of transmission and exposure to the virus. Digital mental health interventions, including web-based resources and mobile apps, have provided opportunities to support youth mental health remotely across Canada. There is a need to better understand how these digital interventions are being selected, recommended, and used in various regions across Canada. OBJECTIVE: A national jurisdictional scan was completed to (1) determine what web-based programs, apps, and websites are promoted and licensed in Canada for youth mental health; (2) identify criteria and decision-making processes that Canadian jurisdictions use to select web-based programs, apps, and websites for youth mental health; and (3) identify upcoming trends, innovations, and digital mental health possibilities that are emerging in the youth sector. METHODS: The aims of the jurisdictional scan were addressed through a review of related academic and grey literature; stakeholder interviews, including individuals involved in various areas of the youth mental health sector; and a social media review of pertinent Twitter content. RESULTS: A total of 66 web-based resources and apps were identified for use by youth in Canada. 16 stakeholder interviews were completed and included discussions with researchers, clinicians, youth organizations, and others involved in digital interventions for youth mental health. These discussions identified a limited use of frameworks used to guide decision-making processes when selecting digital interventions. Many clinicians agreed on a similar set of eligibility requirements for youth mental health apps and digital resources, such as the evidence base and cultural relevance of the intervention. Stakeholders also identified upcoming trends and innovations in the youth digital mental health space, including artificial intelligence, digital phenotyping, and personalized therapy. Over 4 weeks, 2184 tweets were reviewed to identify and compare global and national trends and innovations involving digital mental health and youth. Key trends included the promotion of regional chat services as well as the effects of the COVID-19 pandemic on youth mental health and access to care. CONCLUSIONS: As organizations begin to plan for the delivery of mental health care following the pandemic, there are concerns about the sustainability of these digital mental health interventions as well as a need for services to be more informed by the experiences and preferences of youth.


Subject(s)
COVID-19 , Mental Health , Adolescent , Artificial Intelligence , Canada , Clinical Decision-Making , Humans , Pandemics , SARS-CoV-2
19.
J Manag Care Spec Pharm ; 27(10-a Suppl): S2-S13, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1471241

ABSTRACT

BACKGROUND: Despite therapeutic advances for patients with schizophrenia, improving patient outcomes and reducing the cost of care continue to challenge formulary decision makers. OBJECTIVES: To (1) understand the perspectives of formulary decision makers on challenges to optimal schizophrenia population management and (2) identify best practices and recommendations for mitigating these challenges. METHODS: This mixed-methods study, conducted in a double-blind manner, comprised in-depth telephone interviews with formulary decision makers from February through May 2020, and a web-based follow-on survey that was sent to all participants in October 2020. US-based formulary decision makers were recruited if they were directly involved in schizophrenia drug formulary or coverage decision making for national or regional payers, health systems, or behavioral health centers. Formulary decision makers' perceptions of challenges, policies, and programs related to schizophrenia population health management were assessed generally and in the context of the COVID-19 pandemic. RESULTS: 19 formulary decision makers participated in the interviews and 18 (95%) completed the survey. Participants reported a spectrum of patient- and payer-driven challenges in schizophrenia population health management, including medication nonadherence, high pharmacy and medical costs, and frequent hospitalizations and emergency department visits. Participants noted that COVID-19 had worsened all identified challenges, although patient unemployment (mean score of 2.00 on a scale of 1 [made much worse] to 5 [made much better]) and reduced access to psychiatric care (mean score, 2.12) were most negatively affected. The most common strategies implemented in order to improve schizophrenia population health management included case management (89%), telemedicine (83%), care coordination programs (72%), strategies to mitigate barriers to accessing medication (61%), and providing nonmedical services to address social determinants of health (56%). Participants noted that, ideally, all treatments for schizophrenia would be available on their formularies without utilization management policies in place in order to increase accessibility to medication, but cost to the health plans made that difficult. Whereas 61% of respondents believed that long-acting injectable antipsychotics (LAIs) were currently underused in their organizations, only 28% represented organizations with open access policies for LAIs. Participants believed that among patients with schizophrenia, LAIs were most beneficial for those with a history of poor or uncertain adherence to oral medications (mean score of 4.50 on a scale of 1 [not at all beneficial] to 5 [extremely beneficial]) and those with recurring emergency department visits and inpatient stays (mean score, 3.94). Study participants reported slightly increased use of LAIs (mean score of 3.17 on a scale of 1 [negatively impacted] to 5 [positively impacted]) among their patients with schizophrenia in response to the COVID-19 pandemic; 29% of participants reported easing access restrictions for LAIs. CONCLUSIONS: Participants described persisting challenges and various approaches intended to improve schizophrenia population health management. They also recommended strategies to optimize future health management for this population, including expanding programs to address social determinants of health and mitigating barriers to accessing treatment. DISCLOSURES: This study was funded by Janssen Scientific Affairs, LLC. Roach, Graf, Pednekar, and Chou are employees of PRECISIONheor, which received financial support from Janssen Scientific Affairs, LLC, to conduct this study. Chou owns equity in Precision Medicine Group, the parent company of PRECISIONheor. Lin and Benson are employees of Janssen Scientific Affairs, LLC. Doshi has served as a consultant, advisory board member, or both, for Acadia, Allergan, Boehringer Ingelheim, Janssen, Merck, Otsuka, and Sage Therapeutics and has received research funding from AbbVie, Biogen, Humana, Janssen, Novartis, Merck, Pfizer, PhRMA, Regeneron, Sanofi, and Valeant.


Subject(s)
COVID-19/prevention & control , Clinical Decision-Making/methods , Health Personnel , Population Health Management , Population Health , Schizophrenia/therapy , Antipsychotic Agents/therapeutic use , COVID-19/epidemiology , Double-Blind Method , Female , Follow-Up Studies , Humans , Interviews as Topic/methods , Male , Medication Adherence , Schizophrenia/diagnosis , Schizophrenia/epidemiology
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