key: cord-0935478-r6iz0u2t
authors: Alcayaga, C.; Loor-Sánchez, V.; Oyarce-Hormazábal, N.; Riveros-Riveros, M. P.; Reynaldos-Grandón, K.
title: PRS32 Management Of The Covid-19 Pandemic Around Public Health: Ethical Perspectives
date: 2021-06-30
journal: Value in Health
DOI: 10.1016/j.jval.2021.04.1096
sha: 504e18789b9fc0326e13a71fb50106df6a41aad8
doc_id: 935478
cord_uid: r6iz0u2t

nan

Institute of Health Technology, Andhra Pradesh, India Objectives: To evaluate the clinical effectiveness continuous positive airway pressure (CPAP) with helmet in patients with acute respiratory failure. Methods: A computerized search of PubMed, Google Scholar and Cochrane was done from 1966 through August 2020, followed by analysis of the text words contained in the title and abstract. Secondly search using all identified keywords and index terms was done across all included databases. Thirdly, the reference list of all identified reports and articles was searched for additional studies. Studies in English language, were considered. Quantitative data was pooled in statistical meta-analysis using Cochrane Review Manager (RevMan). Effect sizes expressed as risk ratio with 95% confidence intervals was calculated for analysis. Results: A total of 15 studies were included in this analysis. Use of the helmet was associated with lower hospital mortality, intubation rate, complications, increased oxygenation and reduces average length of stay. Risk Ratio for mortality {0.57, 95% CI (0.42 to 0.78) p=0.0004)}, for intubation {0.43, 95% CI (0.33 to 0.55), p=0.00001)}, for complications {0.79, 95%CI (0.59 to 1.04), p=0.09)}. Conclusions: The application of CPAP with the helmet can represent a valid pulmonary support in the adequate setting and with simple monitoring tools. A careful CPAP titration can optimize the recruitment of unventilated lung regions and improve hypoxemia, making it a suitable bridge to ICU or a supportive treatment to improve patients' outcomes. A better tolerability of the helmet and a reduced room contamination compared with oronasal masks may also improve patients' clinical management, increasing the safety of the healthcare workers involved in the assistance during the COVID-19 pandemic. The use of CPAP with helmet interface, when compared to the other standard therapies in the management of patients with ARDS, reduces intubation rates, mortality, complications, increases oxygenation and reduces and hospital costs. Technologies   PRS30  COVID-19 RAPID ANTIGEN TEST FALSE POSITIVES AND  FALSE NEGATIVES REPORTED TO THE FDA  MANUFACTURER AND USER FACILITY DEVICE  EXPERIENCE DATABASE Zettler M, 1 Gajra A, 2 Feinberg B 2 1 Cardinal Health, Falls Church, VA, USA, 2 Cardinal Health, Dublin, OH, USA Objectives: COVID-19 diagnostic testing has been a critical element of managing risk during the pandemic. Point-of-care rapid antigen tests have been authorized by the Food and Drug Administration (FDA) for use among symptomatic individuals, as an alternative to the gold standard PCR-based tests (which have a much longer turnaround time). Inaccurate test results can detrimentally affect the spread of infection. In this study, we assessed false positives and false negatives reported for COVID-19 rapid antigen tests with Emergency Use Authorizations (EUAs), using FDA's Manufacturer and User Facility Device Experience (MAUDE) database (a repository of deidentified reports of issues associated with authorized medical devices). Methods: The MAUDE database was queried for reports of false positives or false negatives associated with COVID-19 rapid antigen tests, from the date of the first EUA (05/ 08/2020) through 12/31/2020. When noted in the MAUDE report, off-label use of the test was recorded. Results: Five of the 11 authorized rapid antigen tests had false positive or false negative reports in the MAUDE database. Of the total 1816 reports, 1725 (95.0%) were false positives and 91 (5.0%) were false negatives. Off-label use in asymptomatic individuals was noted in 1024 (56.4%) reports. Conclusions: Our study found that nearly all erroneous results with rapid antigen tests reported to MAUDE were false positives, and half involved samples from asymptomatic individuals. These findings suggest that false negatives, which are more consequential for virus transmission, occur infrequently with rapid antigen tests. Limitations of this study include potential under-reporting to MAUDE, the unknown denominator of COVID-19 tests, and the inability to establish device malfunction in relation to aberrant results. This analysis provides important new insights into real-world use of COVID-19 rapid antigen tests and the potential negative ramifications of off-label use. Objectives: IVA/TEZ/ELX is a novel cystic fibrosis transmembrane conductance modulator (CFTRm) therapy approved by the European Medicines Agency to treat the underlying cause of disease for pwCF aged $12 years homozygous for the F508del mutation (F/F) or heterozygous for F508del and a minimal function mutation. A simulation model was used to estimate survival benefit of IVA/TEZ/ELX in F/F pwCF. Methods: A validated, lifetime, patient-level simulation model was used to estimate median survival in a simulated cohort of F/F pwCF aged $12 years in the United Kingdom (UK) treated with: IVA/TEZ/ELX+best supportive care (BSC), tezacaftor/ ivacaftor (TEZ/IVA)+BSC, and BSC-alone. Age-specific mortality hazards from the 2008 UK CF Registry were combined with a Cox proportional hazards model to predict survival based on several risk factors in pwCF. Clinical efficacy inputs for IVA/ TEZ/ELX+BSC and TEZ/IVA+BSC were derived from an indirect treatment comparison conducted using data from the IVA/TEZ/ELX Phase 3b study (NCT04105972) and TEZ/ IVA Phase 3 study (NCT02347657). CFTRm impact on long-term lung function decline was based on TEZ/IVA data. Results: Median projected survival in BSC-treated pwCF was 37.8 years; median projected survival increased to 47.9 years in TEZ/IVA-treated pwCF and 59.1 years in IVA/TEZ/ELX+BSC-treated pwCF, leading to an incremental survival increase with IVA/TEZ/ELX+BSC of 11.2 years versus TEZ/IVA+BSC and 21.3 years versus BSC-alone. Patients initiating IVA/TEZ/ELX+BSC treatment at age 12 years were projected to live 15.6 years more than TEZ/IVA+BSC-treated (74.4 vs 58.8 years) and 37.5 years more than BSC-alone-treated (74.4 vs 36.9 years) pwCF. At 10 years, 83% of IVA/TEZ/ELX+BSC-treated pwCF were alive versus 73% and 57% of TEZ/IVA+BSCtreated and BSC-alone-treated pwCF, respectively. Conclusions: Based on these simulations, treatment with IVA/TEZ/ELX+BSC is projected to substantially increase survival for pwCF aged $12 years with the F/F genotype in the UK. Treatment initiation at the youngest indicated age is projected to provide even greater survival benefit. Objectives: To analyze the ethical perspectives in the management of the COVID-19 pandemic around public health. Methods: A literature review conducted between August and October 2020, using databases: PubMed/MEDLINE, Scielo, Scopus and Cochrane with the search engines: "Ethics", "Pandemic", "COVID-19" and "Public Health", and the Boolean operators "AND" and "OR". Publications made between January and October 2020, in English and Spanish. Theses and conference abstracts were excluded. The analysis and synthesis were made in a descriptive way, using a spreadsheet. Forty-three articles were selected according to the methodological quality. Results: The analysis was made by continent according to the development of the pandemic. In Asia, individual rights, privacy and human dignity were respected, but in African countries, basic needs were affected, generating major ethical dilemmas. In Europe, the principle of charity was violated by not being able to follow up on patients. The principle of autonomy was transgressed due to the mourning process. The principle of non-maleficence is linked to futility. The principle of justice has been questioned in the face of the dilemma of scarcity and allocation of resources. In addition, in North America, aggression against social justice was identified as an exacerbation of social inequalities. In Latin America, all articles mention the vulnerability of all ethical principles Conclusions: It highlights the conflict between individual rights and collective health protection. Worldwide, there have been similarities in ethical conflicts. Social, cultural, political and economic differences have had an impact on the management of the pandemic. It is fundamental to generate global ethical entities in accordance with the culture and health system of each country, which allow for the discussion of measures to preserve the ethical aspects of the population. Objective: Exacerbations of asthma present a significant burden to patients and health-care systems and are common endpoints in clinical studies. Whilst severe exacerbations are well understood, moderate exacerbations of asthma (requiring a temporary change in treatment although not requiring hospitalization) are less so, making their interpretation as endpoints difficult. Concept elicitation interviews were conducted to characterize patient experience of moderate exacerbations and develop a conceptual model. Methods: 20 US patients, with clinician confirmed diagnosis of moderate/severe asthma and experience of a moderate exacerbation =,30 days prior to the interview, participated in 60-minute semi-structured interviews about their experience. Interview transcripts were analyzed using thematic analysis. Results: Conceptual saturation was achieved within 20 interviews. The resulting conceptual model relates exacerbation triggers (similar to those of severe exacerbations) to symptoms of moderate exacerbations and the subsequent impact of these events. The model suggests moderate asthma exacerbations are characterized by increased severity, frequency and duration of symptoms above day-to-day experience. Two key symptoms were reported as most important; shortness of breath and wheezing, as well as coughing, chest tightness, phlegm/mucus and chest pain. Patients increased rescue/maintenance medication use. Night-time awakenings or difficulty falling asleep were also reported. Impacts on health-related quality of life included fatigue and anxiety/fear/panic. Patients stopped or slowed down physical, daily and social activities, missed work or were less productive. Conclusion: Increased frequency, severity and duration of core asthma symptoms, sleep disturbances and increased medication use define a moderate exacerbation from the patient perspective. Symptoms lead to fatigue, emotional distress and avoidance of physical, daily, work, and social activities. Although challenges may exist in identifying moderate exacerbations in clinical practice as patients may not seek healthcare, this conceptual model of moderate asthma exacerbation will be used to plan a patient focused measurement strategy for future clinical development. Objectives: Hospital readmissions for pneumonia are a growing concern in the US. This study evaluated the prediction models for hospital readmission in pneumonia using machine learning (ML) methods. Methods: A retrospective study using the 2016 Healthcare Cost and Utilization Project-National Readmission Database (HCUP-NRD) was conducted. The study included patients aged .=18 years with index admissions for pneumonia identified using ICD-10-CM codes as the principal diagnosis. The ML algorithms, including the Least Absolute Shrinkage and Selection Operator (LASSO), random forest, and RuleFit were used to develop prediction models for 30day all-cause readmissions. Models were trained on randomly partitioned 50% of the data and evaluated using the remaining dataset. Model hyperparameters were tuned using the 10-fold cross-validation on the resampled training dataset. The model performances were evaluated using Area Under the Curve (AUC), accuracy, precision, recall, sensitivity, specificity, and F1 score. Results: There were 400,690 hospital admissions from 372,293 unique patients with a pneumonia diagnosis. The 30-day readmissions rate was 12.97%. Most of the re-admitted patients were .=65 years old (65%), female (52%), and with Medicare (70%). Among the ML methods, the random forest model achieved the best model performance with an AUC of 0.7139 (accuracy 65%, precision 21%, recall 80%, sensitivity 62%, specificity 80% and F1 score 37%), followed by the RuleFit model with an AUC of 0.6119 (accuracy 60%, precision 19%, recall 63%, sensitivity 59%, specificity 63% and F1 score 29%) and the LASSO model with an AUC of 0.6068 (accuracy 62%, precision 19%, recall 59%, sensitivity 63%, specificity 59% and F1 score 29%). Conclusions: The model performance of various ML methods varied, with the random forest model providing the best performance for predicting the risk of 30-day readmission in pneumonia. More research is needed to evaluate ML methods for other diseases of interest.

Frantz RP, 1 Rane D, 2 Nathan SD, 3 Lancaster L, 4 Frost AE, 5 Chakinala MM, 6 Oudiz RJ, 7 Farber HW 8

31/112, BMI $ 30), CVD (24%, 27), and CAD (23%, 26). 59% (51/86) patients completed pulmonary rehab with 16% (8/51) currently in rehab. 50% (56/111) patients use oxygen therapy, 61% (34/56) with continuous use. Conclusions: Compared to other US/European IPF registries, TRIO Health registry patients are older (mean, 74 vs 67-71), more current/former smokers (74% vs. 53%-72%), with more severe baseline DLCO (mean, 31% predicted vs. 36%-50%)