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1.
Frontiers in medicine ; 9, 2022.
Article in English | EuropePMC | ID: covidwho-1733150

ABSTRACT

Background The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and predictors of response. To date, data on the use of subcutaneous sarilumab is limited and no randomized trial results are available. Methods Open label randomized controlled trial at a single center in Spain. We included adult patients admitted with microbiology documented COVID-19 infection, imaging confirmed pneumonia, fever and/or laboratory evidence of inflammatory phenotype, and no need for invasive ventilation. Participants were randomly assigned to receive sarilumab, a single 400 mg dose in two 200 mg subcutaneous injections, added to standard care or standard care, in a 2:1 proportion. Primary endpoints included 30-day mortality, mean change in clinical status at day 7 scored in a 7-category ordinal scale ranging from death (category 1) to discharge (category 7), and duration of hospitalization. The primary efficacy analysis was conducted on the intention-to-treat population. Results A total of 30 patients underwent randomization: 20 to sarilumab and 10 to standard care. Most patients were male (20/30, 67%) with a median (interquartile range) age of 61.5 years (56–72). At day 30, 2/20 (10%) patients died in the sarilumab arm vs. none (0/10) in standard care (Log HR 15.11, SE 22.64;p = 0.54). At day 7, no significant differences were observed in the median change in clinical status (2 [0–3]) vs. 3 [0–3], p = 0.32). Median time to discharge (days) was similar (7 [6–11] vs. 6 [4–12];HR 0.65, SE 0.26;p = 0.27). No significant differences were detected in the rate of progression to invasive and noninvasive mechanical ventilation. Conclusions and Relevance Our pragmatic pilot study has failed to demonstrate the benefit of adding subcutaneous sarilumab to standard care for mortality by 30 days, functional status at day 7, or hospital stay. Findings herein do not exclude a potential effect of sarilumab in severe COVID-19 but adequately powered blinded randomized phase III trials are warranted to assess the impact of the subcutaneous route and a more selected target population. Trial Registration www.ClinicalTrials.gov, Identifier: NCT04357808.

2.
2021.
Preprint in English | Other preprints | ID: ppcovidwho-295743

ABSTRACT

Objective We examine the feasibility of an Artificial Intelligence (AI)-powered clinical decision support system (CDSS), which combines the operationalized 2016 Canadian Network for Mood and Anxiety Treatments guidelines with a neural-network based individualized treatment remission prediction. Methods Due to COVID-19, the study was adapted to be completed entirely at a distance. Seven physicians recruited outpatients diagnosed with major depressive disorder (MDD) as per DSM-V criteria. Patients completed a minimum of one visit without the CDSS (baseline) and two subsequent visits where the CDSS was used by the physician (visit 1 and 2). The primary outcome of interest was change in session length after CDSS introduction, as a proxy for feasibility. Feasibility and acceptability data were collected through self-report questionnaires and semi-structured interviews. Results Seventeen patients enrolled in the study;14 completed. There was no significant difference between appointment length between visits (introduction of the tool did not increase session length). 92.31% of patients and 71.43% of physicians felt that the tool was easy to use. 61.54% of the patients and 71.43% of the physicians rated that they trusted the CDSS. 46.15% of patients felt that the patient-clinician relationship significantly or somewhat improved, while the other 53.85% felt that it did not change. Conclusions Our results confirm the primary hypothesis that the integration of the tool does not increase appointment length. Findings suggest the CDSS is easy to use and may have some positive effects on the patient-physician relationship. The CDSS is feasible and ready for effectiveness studies.

3.
JMIR Form Res ; 5(10): e31862, 2021 Oct 25.
Article in English | MEDLINE | ID: covidwho-1484964

ABSTRACT

BACKGROUND: Approximately two-thirds of patients with major depressive disorder do not achieve remission during their first treatment. There has been increasing interest in the use of digital, artificial intelligence-powered clinical decision support systems (CDSSs) to assist physicians in their treatment selection and management, improving the personalization and use of best practices such as measurement-based care. Previous literature shows that for digital mental health tools to be successful, the tool must be easy for patients and physicians to use and feasible within existing clinical workflows. OBJECTIVE: This study aims to examine the feasibility of an artificial intelligence-powered CDSS, which combines the operationalized 2016 Canadian Network for Mood and Anxiety Treatments guidelines with a neural network-based individualized treatment remission prediction. METHODS: Owing to the COVID-19 pandemic, the study was adapted to be completed entirely remotely. A total of 7 physicians recruited outpatients diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Patients completed a minimum of one visit without the CDSS (baseline) and 2 subsequent visits where the CDSS was used by the physician (visits 1 and 2). The primary outcome of interest was change in appointment length after the introduction of the CDSS as a proxy for feasibility. Feasibility and acceptability data were collected through self-report questionnaires and semistructured interviews. RESULTS: Data were collected between January and November 2020. A total of 17 patients were enrolled in the study; of the 17 patients, 14 (82%) completed the study. There was no significant difference in appointment length between visits (introduction of the tool did not increase appointment length; F2,24=0.805; mean squared error 58.08; P=.46). In total, 92% (12/13) of patients and 71% (5/7) of physicians felt that the tool was easy to use; 62% (8/13) of patients and 71% (5/7) of physicians rated that they trusted the CDSS. Of the 13 patients, 6 (46%) felt that the patient-clinician relationship significantly or somewhat improved, whereas 7 (54%) felt that it did not change. CONCLUSIONS: Our findings confirm that the integration of the tool does not significantly increase appointment length and suggest that the CDSS is easy to use and may have positive effects on the patient-physician relationship for some patients. The CDSS is feasible and ready for effectiveness studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04061642; http://clinicaltrials.gov/ct2/show/NCT04061642.

4.
International Journal of Feminist Approaches to Bioethics ; 14(2):114-143, 2021.
Article in English | Academic Search Complete | ID: covidwho-1412377

ABSTRACT

During the COVID-19 pandemic, several hospitals implemented "birthing alone" policies, banning companions (e.g., partners, family members, doulas) from accompanying individuals giving birth. We offer an ethical analysis of these policies. First, we examine them through a consequentialist framework of risks and benefits. Second, we consider the significance of birth, highlighting the unique ways in which risks, relationships, and rights are understood in the context of obstetrics. We conclude that birthing alone policies are largely unjustified, as the harm they are certain to cause outweighs their possible benefits and because they fail to take into account what matters to mothers. [ABSTRACT FROM AUTHOR] Copyright of International Journal of Feminist Approaches to Bioethics is the property of University of Toronto Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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