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Background and aims: Onboarding of the FreeStyle Libre, an intermittently scanned continuous glucose monitoring (isCGM) device, was pre-dominantly conducted in-person prior to the Covid-19 pandemic. However, onboarding rapidly become virtual due to enforced social distancing restrictions. This audit aimed to determine if onboarding method impacted on glycaemic outcomes and engagement statistics in people living with diabetes (pwD). Method(s): PwD who started FreeStyle Libre between January 2019 and March 2022, had their mode of onboarding recorded and had >=70% data were identified and included within the audit. Glycaemic indices and engagement statistics (previous 90 day averages) were obtained from LibreView (Abbott, USA) three months after the last person was onboarded, and compared using linear models, adjusting for FreeStyle Libre duration, %active (where appropriate), age and sex. Result(s): From 1007 eligible participants (in-person 44% [n = 445];virtual 56% [n = 562]), FreeStyle Libre usage duration was greater for those onboarded in-person vs. virtually (974[891,1101) vs. 420[280,564] days [p < 0.001]). There were no significant differences in glycaemic or engagement indices between in-person and virtual onboarding methods: average glucose (10[9,11]) vs. 10[9,11])mmol/l), %time very-low (<3.0mmol/l, 0[0,1]) vs. 0[0,1]%), %time low (3.0-3.8mmol/ l, 2[1,4] vs. 2[1,4]), %time in range (3.9-10.0mmol/ l, 54[+/-17] vs. 53[+/-19]%), %time high (10.1-13.9mmol/ l, 27[21,31]) vs. 26[21,31]%), %time very-high (>13.9mmol/l, 14[6,24] vs. 15[7,26]%), %active (96[90,100] vs. 94[87,99]%) or scans/day (11[8,15] vs. 10[7,14]). Conclusion(s): There were no differences in glycaemic outcomes or engagement indices between pwD between onboarding methods. Virtual onboarding using online videos for isCGM is as equally effective as face to face.
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The concepts of 'graduateness' and graduate attributes became contested terrain before COVID-19 destabilised even the most assured of shared learning constructions. Indeed, for those of us immersed in the delivery of work-based learning (WBL), this has long been the case. Promotion of reductive notions of 'skills' acquisition to comply neatly with an employability agenda holds little relevance for those students already engaged in full time careers, and with a wealth of professional experience. What can hold influence and interest, however, is the opportunity to engage in meaningful, agentic, professionally-aligned reflective practices as a scaffolded route to promoting self-awareness and developing confidence in mapping competences from the professional domain to the academic (and vice versa).This paper shares an account of taking an embedded approach to supporting the development of academic literacies amongst work-based learners in one UK HEI. In particular, it will consider the use of reflective pedagogical tools and values in supporting work-based learners to become confident and adaptable writers. Discussion considers how work-based pedagogies and approaches may have far-reaching relevance in a post-pandemic landscape, where reskilling and professional agility are likely to become more prolific aspects of education and work. Writing itself is framed as an integrated communication practice that encompasses literature retrieval, reading, evaluation, synthesis and articulation of argument. The paper will describe pre-pandemic academic support activities and share qualitative survey data in which students consider their confidence as both professional and academic writers. It concludes with consideration of how some of the approaches outlined may have relevance for the wider academic community.
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Introduction/Aim: Home spirometry may improve respiratory disease monitoring and management and mitigate the decline in testing exacerbated by COVID-19. Smartphone-connected spirometers could allow patients to conduct spirometry independently without the need to travel to lung function clinics. This study assessed the accuracy of a personal spirometer and the feasibility of unsupervised home spirometry. Method(s): Subjects (19-88 years) with (n = 44) and without (n = 20) respiratory disease, were recruited and supervised to perform spirometry on a standard desktop spirometer (MGC Diagnostics) and a personal ultrasonic spirometer (SpiroHome) in the clinical laboratory. Unsupervised testing was subsequently conducted using the SpiroHome at the subjects' home (2 tests/week for 3 weeks). Subjects returned to the clinic to conduct an exit survey which assessed their willingness to adopt a personal spirometer into their long-term care plan. Comparisons between desktop and personal spirometry, as well as supervised and unsupervised spirometry, were compared by Bland-Altman analysis (%Bias +/- CI) and Pearson's correlation. Result(s): The proportion of tests meeting American Thoracic Society/European Respiratory Society criteria (80%) remained constant across clinic and home spirometry sessions for subjects who completed 3 weeks of home testing (p = 0.73, Fisher's exact test, n = 61). Supervised spirometry on the SpiroHome (n = 56) reliably measured FEV 1 (-3.12+/-27.01%;r=0.98, p < 0.0001) and FVC (-0.38+/-22.91%;r=0.99, p < 0.0001) producing a small underestimation compared to desktop spirometry. Unsupervised home spirometry (when performed <24 hrs from the clinic appointment) on the SpiroHome (n = 51) produced a small underestimation of FEV 1 (-2.41+/-35.57%;r=0.96, p < 0.0001) and a slight overestimation of FVC (0.08+/-24.70%;r=0.98, p < 0.0001) compared with supervised manoeuvres in the clinical laboratory. Conclusion(s): Findings indicate that lung function assessed by SpiroHome compares well with in-clinic standard desktop spirometry across a range of diseases and severities in both the clinic and home settings. A larger cohort of subjects are being recruited to confirm the accuracy and the overall utility of personal spirometry.
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This article explores adaptive capacity as a framework for understanding how South Australian women in midlife (aged 45-64) demonstrated resilience during the early phases of COVID-19. In-depth interviews were undertaken with 40 women mid-2020 as a follow-up study to interviews with the same women undertaken 2018-19 (before COVID-19 emerged). Transcripts were analysed following a critical realist approach using Grothmann and Patt's construct of adaptive capacity as a framework for analysis. This enabled authors to unpack the mechanisms of resilience that shaped women's experiences of appraising, and then showing an intention to adapt to COVID-19 adversity. Findings support the explanatory utility of adaptive capacity to understand resilience processes in the context of person-environment changes - the environment being the COVID-19 context - and women's capability to adapt to social distancing and lockdown conditions. With COVID-19 evoking health, social and economic challenges at incomparable scales, potentially fracturing mental stability, this article provides insight useful to policy makers and health professionals to support resilience as the pandemic continues.Copyright © 2022 The Authors
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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.
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BACKGROUND: Global healthcare systems have been particularly impacted by the COVID-19 pandemic. Healthcare workers (HCWs) are widely reported to have experienced increased levels of baseline psychological distress relative to the general population, and the COVID-19 pandemic may have had an additive effect. However, previous studies are typically restricted to physicians and nurses with limited data available on hospital HCWs. We aimed to conduct a cross-sectional, psychological evaluation of Irish HCWs during COVID-19. METHODS: HCWs across five adult acute level-4 Dublin-based hospitals completed an online survey of wellbeing and COVID-19 experience. RESULTS: There were 1898 HCWs who commenced the survey representing 10% of the total employee base. The sample comprised nurses (33%), doctors (21%), Health and Social Care Professionals (HSCPs) (24%) and 'Other' disciplines (22%), and 81% identified as female. Clinical levels of depression, anxiety and PTSD symptoms were endorsed by 31%, 34% and 28% of respondents, respectively. Professional grouping effects included: nurses reporting significantly greater levels of COVID-19 exposure, infection, COVID-fear, moral injury, and post-traumatic distress; HSCPs were significantly less likely to report mood dysfunction. In terms of gender, males were significantly less likely to report negative pandemic experiences, low resilience, and significantly more likely to endorse 'minimal' depression, anxiety, and traumatic distress. Logistic regression modelling revealed mental health outcomes (depression, anxiety and PTSD symptoms) were associated with increased frontline exposure, fewer career years' experience, elevated pre-pandemic stress, and female gender. DISCUSSION: To our knowledge, this is the largest evaluation of psychological wellbeing amongst HCWs in acute hospitals in the Dublin region. Our findings have implications for healthcare workforce wellbeing and future service delivery.
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Objective: As part of Epilepsy Connections' role in providing support to people affected by epilepsy, we aim to raise awareness of epilepsy at a community/grassroots level, with particular focus on: (1) school communities through our Schools Project/Seizure-Smart Schools;and (2) providing fun activities for families affected by childhood epilepsies (FACE). We recognise that for young people with epilepsy (YPE) to live their lives to the full, their needs go much further than the clinical involvement of their healthcare teams. Our objectives were (1) To promote knowledge of epilepsy, seizures and how to help when a seizure happens'so that YPE can go about their lives, confident that the people around them are informed and respectful;and (2) to provide fun activities for YPE and their families. Method(s): (1) Age-appropriate playground-based activities (message games, story time/roleplay/drama, arts and crafts, using hands-on brain/neuron models) for nursery/primary classes, and workshops for secondary/college students/school staff;(2) large-scale public events (virtual festivals and face-to-face) in collaboration with the Glasgow Science Centre, and EPNA Congress in Glasgow;(3) bespoke, supported days out for individual families;(4) Three residential trips to Ardentinny Outdoor Education Centre since September 2021, for families new to us and those already accessing our services. Result(s): (1) Engagement with thousands of participants;(2) YPE and families took part in fun, adventurous outdoors activities (canoeing, gorge walking, climbing, abseiling, forest and beach walks), got together for meals, informal peer support and family disco! Conclusion(s): Families value having breaks and activities in a supportive, inclusive and bespoke way. We re-modelled how we provide our activities within school communities and with FACE, to reflect COVID-19 protective measures. Nonetheless, the ongoing impact of COVID-19 restricts opportunities to engage.
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INTRODUCTION: Enhanced recovery after surgery (ERAS) is well established in many specialties but has not been widely adopted in renal transplantation. The aim of this survey was to understand current national practices and sentiment concerning ERAS for renal transplant recipients in the UK. METHODOLOGY: A national web-based survey was sent to consultant surgeons at all 23 UK adult renal transplant units. Completed questionnaires were collected between May and July 2020. Data were analysed according to individual responses and grouped according to the existence of formal ERAS pathways within units. RESULTS: All transplant units were represented in this survey. Three units had a formal ERAS pathway for all recipients. Of the remaining units, 65.9% considered implementing an ERAS pathway in the near future. The most commonly perceived barrier to ERAS implementation was 'embedded culture within transplant units' (54.8% of respondents). A fifth of respondents insert surgical drains selectively and 11.7% routinely discontinue patient-controlled analgesia on postoperative day 1. Most respondents routinely remove urinary catheters on day 5 (70%) and ureteric stents 4-6 weeks post-transplantation (81.7%). Median length of stay for deceased donor kidney transplant recipients was lower in units with ERAS programmes (5-7 days versus 8-10 days, respectively). The main cited barriers for discharge were 'suboptimal fluid balance' and 'requirement of treatment for rejection'. CONCLUSIONS: Despite slow uptake of ERAS in kidney transplantation, appetite appears to be increasing, particularly in the post-COVID-19 era. The current practice and opinions of transplant specialists highlighted in this survey may help to establish nationally agreed ERAS guidelines in this field.
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Background Continuous loss of muscle mass and strength are the consequences of the ageing process, which increase the risk of falls among older adults. Falls can lead to severe consequences such as bone fractures and hampered physical and psychological well-being. Regular exercise is the key to reversing muscle atrophy and relieving sarcopenia. However, the frailty of the elderly and the recent COVID-19 pandemic may affect their confidence to leave home to attend classes in the community. A feasible and effective alternative should be explored. Methods The primary objective is to evaluate the effectiveness of tele-exercise (TE) in relation to physical functioning and exercise adherence among the community-dwelling elderly at risk of falls in comparison with a community-based group (CB). The secondary objective includes evaluating the elderly's experience with tele-exercise, emphasizing their psychological welfare, social well-being, and acceptance of the telehealth approach. The design, conduct, and report follow the SPIRIT guidelines (Standard Protocol Items: recommended items to address in a Clinical Trial Protocol and Related Documents). The elderly will be recruited from 10 local community centres in Hong Kong and randomly allocated into two groups. All participants will attend the exercise training 3 days per week for 3 months but the mode of delivery will differ, either online as the tele-exercise group (TE) or face-to-face as the community-based group (CB). The outcome measures include muscle strength, physical function, exercise adherence and dropout rate, psychological and social well-being will be assessed at the baseline, and the 3rd, 6th and 12th month. Some participants will be invited to attend focus group interviews to evaluate their overall experience of the tele-exercise training. Discussion Tele-exercise reduces the barriers to exercise, such as time constraints, inaccessibility to facilities, and the fear of frail elderly persons leaving their home. Promoting an online home-based exercise programme for the elderly can encourage them to engage in regular physical activity and increase their exercise adherence even when remaining at home. The use of telehealth can potentially result in savings in cost and time. The final findings will provide insights on delivering exercise via telehealth to the elderly and propose an exercise delivery and maintenance model for future practice. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx), registration number: ChiCTR2200063370. Registered on 5 September 2022
Subject(s)
Muscular Atrophy , Fractures, Bone , Sarcopenia , COVID-19ABSTRACT
Background. The spread of Carbapenem-resistant Enterobacterales (CRE) continue to be a public health threat. Tennessee has participated in the Multidrug-Resistant Gram-Negative Bacilli Surveillance Initiative (MuGSI) since 2014. We investigated our data to describe the trends of CRE and CP-CRE and their changes during the COVID-19 outbreak. Methods. Population-based surveillance targeting selected CRE organisms was conducted in Davidson County and seven surrounding counties in Tennessee. A CRE case was defined as isolation of Escherichia coli, Klebsiella spp., or Enterobacter spp. resistant to >=1 carbapenem from a normally sterile body site or urine, in a surveillance area resident. A case was identified as incident if it was reported for the first time in the surveillance year or was a subsequent report of a case >=30 days after the last report. The Tennessee state public health laboratory tests for carbapenemase production on CRE isolates received from clinical laboratories. The data analysis was conducted using SAS software version 9.4. Results. 474 incident CRE cases were reported from 2016 to 2021. Females made up 68.63% and the average age was 65 years for both sexes. The incidence rate of CRE cases increased throughout study period and the rate in 2021 was 1.8-fold of 2016 (lowest rate for the study period) (P-value< 0.001). The incidence rate of CP-CRE increased in 2017 and 2018 compared to 2016 (p-value=0.01). The incidence rate for CP-CRE declined to the lowest level in 2020 (0.3 per 100,000 population). In 2021, the CP-CRE rate significantly increased compared to 2020 (p-value=0.02). The carbapenemase production (CP) positivity rate was also significantly higher in 2017(28.8%), 2018 (26.6%), and 2021 (25.8%) compared to the year 2020 where the positivity rate was the lowest (10.0%) (P-value< 0.05). Conclusion. The transmission of CP-CRE cases decreased during the years prior to the COVID-19 outbreak despite the steady increase in CRE cases. The transmission of CP-CRE gained momentum during the COVID outbreak as evidenced by an increased infection rate and CP positivity rate in 2021. Renewed focus on implementing coordinated infection prevention strategies is likely to contribute to reducing the spread of antimicrobial-resistant pathogens. (Figure Presented).
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Background. The Centers for Disease Control and Prevention's Emerging Infections Program (EIP) conducts active laboratory- and population-based surveillance for carbapenem-resistant Enterobacterales (CRE), extended spectrum beta-lactamase-producing Enterobacterales (ESBL-E), and carbapenem-resistant Acinetobacter baumannii (CRAB) in 10 U.S. sites. To describe the impact of the COVID-19 pandemic on the epidemiology of these antibiotic-resistant gram-negative bacteria (AR-GNB), we assessed characteristics of AR-GNB patients with and without a prior SARS-CoV-2 positive (SC2+) viral test. Methods. In 2020 among EIP catchment-area residents, an incident CRAB or CRE case was defined as the first isolation of A. baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella aerogenes, K. oxytoca, K. pneumonia, or K. variicola in a 30-day period resistant to >=1 carbapenem (excluding ertapenem for CRAB) from a normally sterile site or urine. An incident ESBL-E case was defined as the first isolation of E. coli, K. pneumonia, or K. oxytoca in a 30-day period resistant to any third-generation cephalosporin and non-resistant to all carbapenems from a normally sterile site or urine. Patient charts were reviewed. Results. Of 3904 AR-GNB cases with data available, 163 (4%) had a prior SC2+ test (85 ESBL-E, 70 CRE, and 8 CRAB). Median time from the most recent SC2+ test to AR-GNB culture date was 20 days (IQR 1-48 days). AR-GNB cases with a SC2+ test versus those without were more likely to be Black, non-Hispanic than another race/ ethnicity (31% vs 15%;P< 0.0001), aged >=65 years (62% vs 52%;P=0.0139), and to have prior healthcare exposures (63% vs 49%;P=0.0003) and indwelling devices (51% vs 28%;P< 0.0001). They were also more likely to have bacteremia (24% vs 11%;P< 0.0001), pneumonia (6% vs 1%;P< 0.0001) and be hospitalized around the time of their AR-GNB culture (67% vs 36%;P< 0.0001);median time from SC2 + test to hospital admission was 0.5 day (IQR 0-29.5 days). Conclusion. AR-GNB infections preceded by a SC2+ test were rare but more severe and associated with more healthcare risk factors. This underscores the need for continued infection prevention and control practices and monitoring of these infections during the COVID-19 pandemic.
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Background: Continuous loss of muscle mass and strength are the consequences of the ageing process, increasing the risk of falls among older adults. Falls can lead to severe consequences such as bone fractures and hampered physical and psychological well-being. Regular exercise is the key to reversing muscle atrophy and relieving sarcopenia. However, the frailty of the elderly and the recent COVID-19 pandemic may affect their confidence in leaving home to attend classes in the community. A feasible and effective alternative should be explored. Methods: The primary objective is to evaluate the effectiveness of tele-exercise (TE) on physical function and exercise adherence among the community-dwelling elderly at risk of falls in comparison with a community-based group (CB). The secondary objective includes evaluating the elderly's experience with tele-exercise, emphasizing their psychological welfare, social well-being, and acceptance of the telehealth approach. The design, conduct, and report follow the SPIRIT guidelines (Standard Protocol Items: recommended items to address in a Clinical Trial Protocol and Related Documents). The elderly will be recruited from 10 local community centres in Hong Kong and randomly allocated into two groups. All participants will attend the exercise training 3 days per week for 3 months but differ in the mode of delivery, either online as the tele-exercise group (TE) or face-to-face as the community-based group (CB). The outcome measures include muscle strength, physical function, exercise adherence and dropout rate, psychological and social well-being will be assessed at baseline, the 3rd, 6th and 12th month. Some participants will be invited for focus group interviews to evaluate their overall experience of the tele-exercise training. Discussion: Tele-exercise reduces barriers to exercise, such as time constraints, inaccessibility to facilities, and the fear of the frail elderly leaving home. Promoting an online home-based exercise programme for the elderly can encourage them to engage in regular physical activity and increase their exercise adherence even when staying home. The use of telehealth can potentially result in savings in costs and time. The final findings will give insights on delivering exercise via telehealth approach to the elderly and propose exercise delivering and maintenance model for future practices. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx), registration number: ChiCTR2200063370. Registered on 5 September 2022
Subject(s)
Muscular Atrophy , Fractures, Bone , Sarcopenia , COVID-19ABSTRACT
Introduction: WHO declared a pandemic of COVID-19 in March 2020. This study analyses the impact of COVID-19 on beta-cell replacement therapy in the UK. Method(s): Pancreas and islet donation and transplant activity in the period March 2020/2021 was compared with the same period the previous year. Result(s): 2,180 patients had a functioning graft during March 2020/2021. 5.8%(n=126) tested positive for COVID-19 and two died (1%). In this period there was a 43% reduction in solid organ donors n=1,615, compared with the previous year, n=2,840. Of the 625 solid organ donors with a pancreas offered, 32% had the pancreas retrieved compared with 51% the previous period. 97 whole pancreas and islet transplants were performed in the UK down 54% from the prior period. Of the 84 pancreas transplant recipients;four tested positive for COVID-19 but none died, and two grafts failed within the first week from vascular thrombosis (neither were COVID-19 positive). Of the 13 SIK and islet alone transplant recipients, two tested positive for COVID-19 but neither died. Of these SIK transplants, one is known to have failed within a month and this is equivalent to that seen in the previous time period. To our knowledge, no patient receiving beta cell replacement therapy died of COVID during the first year of the pandemic despite immunosuppression. Conclusion(s): In the UK, pancreas, and islet transplantation have continued during the pandemic at a lower rate. Outcomes following transplantation within the COVID era are, so far, similar to those in the period prior. Take-home message: Outcomes following transplantation within the COVID era are, so far, similar to those in the period prior.
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Introduction: High interest in the last two years was globally put by Health Authorities on the recording, coding, and reporting of medication errors to ensure the safety and effectiveness of the use of medicines and to provide reliable information to healthcare professionals and patients. Medical coding is a prerequisite for efficient, effective, and reproducible data outputs. Objective(s): Not applicable. Method(s): A sample of medication error coding results was assessed for accuracy and consistency of MedDRA coding and identification of main types of coding errors. It included 1500 coded reported terms for COVID-19 vaccines medication errors, assigned to MedDRA codes by national regulatory authorities or pharmacovigilance centers and drawn from the Uppsala Monitoring Centre (UMC) VigiBase through August 25, 2021. Result(s): One-third of the records could not be assessed due to incomplete or unclear verbatims. In one-third, code assignments were correct, but another third of the sample was not adequately coded. Most frequent coding errors corresponded to vague PT assignments, while more detailed information was available for a more precise coding. This observation is similar to the EudraVigilance database, where some of the most assigned MedDRA terms for medication errors also represent vague concepts. Conclusion(s): These findings indicate that understanding of medication error documentation and assessment and of MedDRA content and coding guidelines need to be reinforced. The MedDRA Maintenance and Support Services Organization (MSSO) offers several MedDRA coding trainings, including coding of medication errors. The authors provide valuable references to the latter, to the applicable ICHEndorsed Guides for MedDRA Users, and to relevant EMA guidance.
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Introduction: High interest in the last two years was globally put by Health Authorities on the recording, coding, and reporting of medication errors to ensure the safety and effectiveness of the use of medicines and to provide reliable information to healthcare professionals and patients. Medical coding is a prerequisite for efficient, effective, and reproducible data outputs. Objective: Not applicable. Methods: A sample of medication error coding results was assessed for accuracy and consistency of MedDRA coding and identification of main types of coding errors. It included 1500 coded reported terms for COVID-19 vaccines medication errors, assigned to MedDRA codes by national regulatory authorities or pharmacovigilance centers and drawn from the Uppsala Monitoring Centre (UMC) VigiBase through August 25, 2021. Results: One-third of the records could not be assessed due to incomplete or unclear verbatims. In one-third, code assignments were correct, but another third of the sample was not adequately coded. Most frequent coding errors corresponded to vague PT assignments, while more detailed information was available for a more precise coding. This observation is similar to the EudraVigilance database, where some of the most assigned MedDRA terms for medication errors also represent vague concepts. Conclusion: These findings indicate that understanding of medication error documentation and assessment and of MedDRA content and coding guidelines need to be reinforced. The MedDRA Maintenance and Support Services Organization (MSSO) offers several MedDRA coding trainings, including coding of medication errors. The authors provide valuable references to the latter, to the applicable ICHEndorsed Guides for MedDRA Users, and to relevant EMA guidance.
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By December 2021, the COVID-19 caused approximately 6.1 million deaths around the world. Several vaccines have been approved, but there is still a need for non-prophylactic treatments for COVID-19. Remdesivir is an antiviral drug approved for emergency use against COVID-19 in several countries, but one of the first clinical trials was inconclusive about the mortality reduction, although the drug showed a reduction in the recovery time of hospitalized patients. Thus, the present investigation revisits the clinical evidence of using remdesivir for COVID-19 treatment, patent status, pharmacology and chemistry. We found 184 families of patents in the Cortellis database, and concerning the clinical evidence, we retrieved 14 systematic reviews with meta-analysis involving remdesivir as a treatment for COVID-19, discussing the reduction of adverse events, hospitalization days, mortality rate and the mechanical ventilation period.
Subject(s)
COVID-19 Drug Treatment , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/adverse effects , Humans , SARS-CoV-2ABSTRACT
COVID-19 has affected all aspects of life, including how we travel. As faculty members responsible for teaching infrastructure courses across four universities, the authors collaborated on creating a teaching module addressing this critical issue. The module focuses on the impacts of COVID-19 on different transportation systems from various stakeholder perspectives. The module was implemented in two universities (n = 25): Southern Methodist University (SMU) and New Mexico Institute of Mining and Technology (New Mexico Tech, NMT) in fall 2020 and will be implemented again at other schools in fall 2021. This paper presents the results obtained during the first implementation of the COVID-19 teaching module during the fall semester of 2020 and addresses how instructors can enhance the module for future offerings. Findings from the module's implementation demonstrate increased knowledge and understanding of the impacts of COVID-19 on different transportation systems from various stakeholder perspectives. SMU students' mean scores showed high post-evaluation scores, and NMT students' scores increased from pre to post evaluation. Additionally, the reflective writing assignment revealed students' awareness of various issues, including operational and economic impacts on operators and users. This paper offers contributions to our engineering community by focusing on lessons learned from the COVID-19 experience while providing recommendations for improving this co-create module. © American Society for Engineering Education, 2021
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Hybrid models to detect dementia based on Machine Learning can provide accurate diagnoses in individuals with neurological disorders and cognitive complications caused by Human Immunodeficiency Virus (HIV) infection. This study proposes a hybrid approach, using Machine Learning algorithms associated with the multicriteria method of Verbal Decision Analysis (VDA). Dementia, which affects many HIV-infected individuals, refers to neurodevelopmental and mental disorders. Some manuals standardize the information used in the correct detection of neurological disorders with cognitive complications. Among the most common manuals used are the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) of the American Psychiatric Association and the International Classification of Diseases, 10th edition (ICD-10)—both published by World Health Organization (WHO). The model is designed to explore the predictive of specific data. Furthermore, a well-defined database data set improves and optimizes the diagnostic models sought in the research.