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Introduction: Cerebral venous sinus thrombosis (CVST) is a rare but potentially debilitating thrombosis affecting 3-4 cases per million adults in the United States. Risk factors are thought similar to venous thrombosis, but there is little epidemiologic data corroborating this assertion. Concern about a possible association between the Janssen (Johnson and Johnson) and Oxford-AztraZenaca COVID-19 vaccines and cases of CVST resulted in increased global attention to this condition. Thus, large epidemiological assessment of the risk factors, treatment and outcomes of CVST are needed. Objective(s): Estimate the distributions of risk factors antecedent to CVST diagnosis, report CVST treatments in clinical practice, and potential sequelae of CVST in a large retrospective cohort of adults with CVST in the United States. Method(s): MarketScan Commercial and Medicare Supplemental administrative databases were employed to assess CVST diagnosed between 2011 and 2019 in the U.S. Validated International Classification of Disease (ICD) codes and receipt of an outpatient anticoagulant (either oral or subcutaneous anticoagulant) prescription within 30 days of the ICD code identified incident CVST. Antecedent clinical characteristics, treatments, and sequelae of CVST were identified using inpatient, outpatient, and prescription data. For outcomes, proportions and incidence with 95% confidence intervals (CIs) were calculated, stratified by sex. Result(s): We identified 1,869 CVST patients. Of these 1,314 (70%) were female, with 200 (10%) events identified as a pregnancy-related CVST. The average age was 41 years for females and 48 years for men. Among women, 24.7% were on hormonal therapy (oral contraceptive, estrogen, and progestin) prior to diagnosis. Men had a higher prevalence of comorbidities, such as diabetes (15% men vs. 9% women) and cancer (19% men vs. 10% women). Oral anticoagulant (OAC) use was the most common treatment for CVST in both men (88%) and women (85%) and did not vary by sex. Use of procedures to treat CVST, optic nerve fenestration and catheter directed thrombolysis, were 0.5% and 4.1%, respectively. The most common sequela after CVST was incidence of intracranial hypertension (Incidence: 4.2 per 100 person-years;95% CI: 3.3, 5.1) and palliedema was rare. Conclusion(s): Overall, a majority of CVST patients were women of reproductive age. Our findings suggest a potential association with both endogenous (pregnancy) and exogenous (oral contraceptives, HRT) hormones which needs further study. In our sample, CVST was managed with oral anticoagulants, regardless of sex, and intracranial hypertension was elevated following CVST. This large claims-based analysis is a descriptive insight into the risk factors and management of CVST, a rare and debilitating condition.
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BACKGROUND: Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients. METHODS: This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses. DISCUSSION: This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19. TRIAL REGISTRATION: ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019.
Subject(s)
COVID-19 , Deafness , Pressure Ulcer , Adult , Humans , Pressure Ulcer/etiology , Pressure Ulcer/prevention & control , Australia , Bandages , SiliconesABSTRACT
One of the key outcomes of the Covid-19 pandemic has been to move fully online teaching from a niche activity to the mainstream within higher education. This has required a radical rethinking of how higher education institutions support their faculty to develop their online teaching practice. In this introductory chapter, we discuss the reasons why continuing professional learning and development (CPLD) has never been more important in helping instructors who are new to online teaching to develop the requisite competencies and strategies to work effectively in this domain, as well as to support experienced teachers in refreshing and extending their online teaching practice. We acknowledge that there is no universally accepted approach to CPLD for online teaching and that diverse approaches are needed to address wide-ranging development requirements, such as staff capabilities, pedagogies and course design needs related to associated disciplinary and institutional practices. We present a CPLD model to capture these diverse sources of support, which forms the organising framework for this book. This model provides an overview of the different sources of learning development that are available to online instructors – both within and outside the teaching institution – and how they are interrelated and interconnected as part of a wider ecology of CPLD support to staff. We explain how these different sources of support may be combined to support personalised learning development pathways in online teaching practice. © 2022, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.
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Introduction: The MSGo Programme is a patient support platform (PSP) designed for patients commencing on multiple sclerosis disease modifying therapies (DMTs) provided by Novartis. The PSP is delivered through RxMx, a digital health company. The technology aims to connect patients and doctors, improve patient safety and create real-time insights with the support of nurses to assist patient navigation. The patient apps feature tailored functions, including medication reminders, appointment scheduling and educational materials. The nurses work directly with patients to address DMT issues and questions, in order to promote engagement and adherence. The patient app also includes a care partner function, to enable a caretaker to monitor from their own device. Objective(s): The rapidly changing landscape of DMTs, pharmacovigilance and COVID-19 has added challenges to DMT prescreening, onboarding and ongoing support of patients, with many clinics being restricted on physical attendance. The patient app, paired with the HCP and care partner function, aims to keep patients on track with their DMTs and appointments whilst maintaining active communication with their healthcare team. Aim(s): A recent study of MS Nurse care in Australia found that for 5% of participants the PSP services offered across all DMTs was their sole source of support. The aim is to explore the effectiveness of MSGo, a PSP which has evolved since the COVID-19 pandemic as a resource of support, information and communication for both the patient and treating MS team. Method(s): Patients utilising the MSGo app were sent voluntary surveys every 3 months, to ascertain effectiveness of the programme (phone, app or email) since enrolling. Result(s): There are 1200+ patients actively enrolled within the programme. An average patient satisfaction score of 9/10 was recorded for all questions, which covered various aspects of the PSP including DMT initiation, virtual support, at home support and nursing support. The full results of the survey will be presented. Conclusion(s): Patient survey responses indicate that MSGo has been an effective PSP and demonstrates an ongoing need for patients to be supported during their DMT journey, particularly in situations where the PSP nurses are the sole source of support.
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Introduction: Siponimod is approved in Australia for adults with secondary progressive multiple sclerosis (SPMS). Prescreen requirements for siponimod include a CYP2C9 genotype test to determine maintenance dosing. An integrated digital platform, 'MSGo', was developed by Novartis and RxMx to support Healthcare Professionals and their multiple sclerosis patients. Objective(s): Data derived exclusively from MSGo was utilised to explore the onboarding experience of siponimod patients in Australia. Aim(s): To provide real world evidence on siponimod for SPMS patients in Australia. Method(s): The study enrolled >350 adults with SPMS registered in MSGo for siponimod in Australia. Primary endpoint is the average time for onboarding with key secondary endpoints addressing adherence and variables that influence onboarding and adherence. Result(s): Final data extraction on April 20th, 2022 included 368 patients (median age of 59y).CYP2C9 genotype testing took a median of 19 days (95%CI 17-21) from registration and maintenance doses of 2mg (n=166) or 1mg (n=27) were initiated as per label recommendations;1mg was initiated for two rare allele genotypes (*1*5 and*1*11) in the absence of label recommendations. Mixture-cure modelling estimated that 58% of patients will ever initiate siponimod, with a median time to initiation of 56d (95%CI 47-59) from registration. Among those who initiated siponimod the most common reported reason for delayed initiation was 'waiting for vaccination'. Self-reporting of daily treatment, captured under the treatment reminder function in MSGo, had a drop-off of ~25% after the first week of initiation;a continued decline in reporting over time limited assessment of adherence. Continued self-reporting of daily dosing trended lower with older patients with only 28% of those >70y continuing to self-report at day 90 compared to 47-69% with the younger age groups. The study uncovered the important role of care partners, with Cox regression analyses demonstrating that SPMS patients who nominated a care partner were more likely to initiate (HR:2.1, 95%CI 1.5-3.0) and to continue self-reporting their daily medication (HR:2.2, 95%CI 1.3-3.7). A total of 90 patients discontinued the study;48 prior to and 42 after siponimod exposure. Conclusion(s): This study provides insights into siponimod onboarding for adults living with SPMS in Australia and demonstrates the impact of MSGo and care partner support during a period challenged by the COVID-19 pandemic.
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Introduction: Undertaking effective drug safety monitoring can be particularly challenging in low-resource settings due to a lack of infrastructure, weak regulatory systems and poor access to training and education [1]. Given the continued impact the COVID-19 pandemic is having upon health systems globally, it is essential to ensure that pharmacovigilance systems in these vulnerable settings have the capacity to address both the exacerbated pre-existing and novel challenges that they now face [2]. This project seeks to harness the membership of an online pharmacovigilance platform, globalpharmacovigilance. org (GPV) to work together in a 'community of practice' (CoP) on specific challenges facing pharmacovigilance during the pandemic [3, 4]. Objective(s): To gather consensus on pharmacovigilance priorities in low-resource settings during the COVID-19 pandemic and provide resources to address them using a CoP model. Method(s): This project has built on a consensus-gathering methodology developed by The Global Health Network that has been implemented successfully during the pandemic to address wider COVID-19 research priorities. An online survey of GPV members was used to identify highly-ranked areas for pharmacovigilance improvement in low-resource settings during the pandemic. A virtual workshop was then hosted to invite further discussion on the survey results and reach consensus on the highest priorities. Members of the CoP were next invited to form virtual working groups, each focussing on one of the top 3 priorities identified. These groups are being supported by GPV to work together and facilitate the development (or provision, if pre-existing) of pharmacovigilance resources to address the priorities identified. Result(s): Of the 43 pharmacovigilance 'themes' that were presented to the CoP membership in the initial survey, 3 topics were identified as the highest priorities at that point in the COVID-19 pandemic, where support, training and guidance are needed;'The safety of COVID-19 vaccination in pregnancy', 'The safety of COVID-19 vaccination in children/adolescents' and 'Analysis of COVID-19 vaccine safety data'. As of May 2022, the number of GPV members interested in involvement in working groups addressing these themes are 207, 206, and 284 respectively. Initial group meetings took place in April 2022 and discussions are ongoing as to how to take group activities forward and address the priorities identified. Conclusion(s): A CoP model represents an effective method of consensus gathering amongst pharmacovigilance stakeholders at a global level, and allows rapid identification of healthcare priorities during public health emergencies. It is anticipated that working groups outputs will include the provision of resources designed to address the priorities identified.
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Introduction: Undertaking effective drug safety monitoring can be particularly challenging in low-resource settings due to a lack of infrastructure, weak regulatory systems and poor access to training and education [1]. Given the continued impact the COVID-19 pandemic is having upon health systems globally, it is essential to ensure that pharmacovigilance systems in these vulnerable settings have the capacity to address both the exacerbated pre-existing and novel challenges that they now face [2]. This project seeks to harness the membership of an online pharmacovigilance platform, globalpharmacovigilance.org (GPV) to work together in a 'community of practice' (CoP) on specific challenges facing pharmacovigilance during the pandemic [3, 4]. Objective: To gather consensus on pharmacovigilance priorities in low-resource settings during the COVID-19 pandemic and provide resources to address them using a CoP model. Methods: This project has built on a consensus-gathering methodology developed by The Global Health Network that has been implemented successfully during the pandemic to address wider COVID-19 research priorities. An online survey of GPV members was used to identify highly-ranked areas for pharmacovigilance improvement in low-resource settings during the pandemic. A virtual workshop was then hosted to invite further discussion on the survey results and reach consensus on the highest priorities. Members of the CoP were next invited to form virtual working groups, each focussing on one of the top 3 priorities identified. These groups are being supported by GPV to work together and facilitate the development (or provision, if pre-existing) of pharmacovigilance resources to address the priorities identified. Results: Of the 43 pharmacovigilance 'themes' that were presented to the CoP membership in the initial survey, 3 topics were identified as the highest priorities at that point in the COVID-19 pandemic, where support, training and guidance are needed;'The safety of COVID-19 vaccination in pregnancy', 'The safety of COVID-19 vaccination in children/adolescents' and 'Analysis of COVID-19 vaccine safety data'. As of May 2022, the number of GPV members interested in involvement in working groups addressing these themes are 207, 206, and 284 respectively. Initial group meetings took place in April 2022 and discussions are ongoing as to how to take group activities forward and address the priorities identified. Conclusion: A CoP model represents an effective method of consensus gathering amongst pharmacovigilance stakeholders at a global level, and allows rapid identification of healthcare priorities during public health emergencies. It is anticipated that working groups outputs will include the provision of resources designed to address the priorities identified.
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BACKGROUND: As the Covid-19 pandemic has exposed the structural factors which give rise to profound health disparities, additional attention is being paid to examining the intersection of social risk and health outcomes. Recent involvement in the criminal legal system is a known risk factor for poor health outcomes, including among those with diabetes. Mental health functioning is an important predictor of diabetes self-care behavior and diabetesrelated outcomes. We used nationally representative data to examine the association between recent criminal legal exposure and mental-health related functioning among US adults with diabetes. METHODS: Using data from the National Survey of Drug Use and Health, we created a representative sample of U.S. adults with diabetes. We considered three distinct exposures to the criminal legal system: those who reported being arrested or booked, on probation, or on parole in the previous 12 months. Our outcome of interest was World Health Organization disability assessment score 2.0 (WHO-DAS), a validated measure of mental-health related functional impairment. Higher scores indicate higher degree of functional impairment. We compared unadjusted and adjusted WHO-DAS score by criminal legal involvement, controlling for relevant sociodemographic confounders. RESULTS: Of 14,403 respondents with diabetes, 277 (1.1% weighted) reported past year arrest. The mean WHO-DAS score was significantly higher for those with past year arrest compared to no past year arrest (7.42 versus 3.64, p<0.001) and past year probation compared to no probation (5.56 versus 3.66, p=0.003) but not past year parole compared to no parole (4.90 versus 3.68, p=0.08). In adjusted models, past year arrest was significantly associated with higher WHO-DAS score (coefficient, 2.73, 95% CI: 1.57, 3.89), but not past year probation (coefficient, 1.23, 95% CI: -0.11, 2.58) or past year parole (coefficient, 0.38, 95% CI: -1.05, 1.81). CONCLUSIONS: In a sample of US adults with diabetes, past year arrest is associated with decreased mental-health related functional status, even after controlling for demographic and clinical confounders, suggesting a potential pathway by which criminal legal involvement may lead to poor health outcomes. Future research should further evaluate this relationship in addition to testing interventions aimed at improving mental-health related functioning for patients with compounding layers of health and social risk factors.
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BACKGROUND: Healthcare costs in 2020 increased 9.7% from the prior year reaching $4.1 trillion dollars. This increase was much higher than the 4.3% rate increase between 2018 and 2019 and considered to be largely attributed to federal expenditures in response to the COVID-19 pandemic. Limited information exists on costs attributed to the pandemic as response continues. The objective of this study was to understand hospitalization costs attributed to COVID-19 within the Veterans Administration (VA) and Department of Defense (DoD). METHODS: Data on hospitalizations within the VA and DoD with a primary diagnosis of COVID-19 were investigated to understand differences in total cost, cost per day, and length of stay by location, age, sex, and Medicare Severity Diagnosis Related Groups (MS-DRGs). 7,818 hospitalizations occurred at VA facilities, while 773 occurred at DoD facilities. 74.7% of the hospitalizations were attributed to respiratory infections and inflammation with major complication or comorbidity (MS-DRG 177).Generalized linearmodels using a gamma distribution for total cost and cost per day and Poisson distribution for length of stay were run to investigate outcomes of overall and byMS-DRG.RESULTS: In the full sample, cost did not differ by location (VA vs. DoD) or sex, however, those aged 71-76 cost on average $537 more than those ages 19-59 (537.67, 95%CI 34.67,1029.68). Length of stay was nearly 3 days shorter for DoD hospitalizations (-2.99, 95%CI -3.54,-2.34) and length of stay increased as age increased with those 77 years and older staying over 8 days longer than those aged 19-59 (8.70, 95%CI 5.04, 12,35). Total costs per day were lower for hospitalizations at DoD facilities (-521.96, 95%CI -718.40,-325.51) and for those aged 77 and above compared to those aged 19- 59 (-317.41, 95%CI -478.61,-156.21). Similar patterns existed when hospitalizations were stratified by MS- DRG, except that in hospitalizations for respiratory infections and inflammation with major complication or comorbidity total costs were $730 higher at DoD compared to the VA (729.99, 95%CI 296.53,1163.47) despite the cost per day remaining lower for DoD (-574.87, 95%CI -804.07,-345.68). CONCLUSIONS: Overall, total costs for hospitalizations from COVID-19 were similar at VA and DoD locations, however, length of stay and costs per day were lower for DoD. When investigating only hospitalizations with major complications or comorbidity, total costs were higher for the DoD, but length of stay and cost per day remained lower compared to the VA. Differences existed by age but not by sex.
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This article aims at reviewing the practice of 'initiatives' by Intergovernmental Organizations (igo s) when responding to crises or the unforeseen needs of their respective memberships. It forms part of a broader research project on the role of igo s in international law where more than 100 initiatives were identified so far, focusing on 14 igo s. The notion of an igo's initiative, conceptualised as activities of the Executive Heads and the secretariat's staff that enhance the remit of an organization beyond those functions initially or formally envisaged by its constituent instrument, is examined. A descriptive analysis of over 30 initiatives indicate that they may be successful in addressing modern unforeseen challenges, whether they stem from international emergencies, climate change, dynamic technological advancements, or global health crises such as the covid-19 pandemic- especially when such initiatives are accepted and supported by igo s' members. © 2022 Koninklijke Brill NV incorporates the imprints Brill, Brill Nijhoff, Brill Hotei, Brill Schöningh, Brill Fink, Brill mentis, Vandenhoeck Ruprecht, Böhlau Verlag and VR Unipress.
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This is the 84th annual report of the British Trust for Ornithology’s Ringing Scheme, incorporating the report of the Nest Record Scheme and covering work carried out and data processed in 2020. An analysis of Curlew Numenius arquata ringing records was carried out to investigate recent declines. Results showed that survival rates are high, so current population declines are more likely to have been driven by low productivity. To reverse the recent population declines, breeding success would need to increase and effective conservation strategies will be needed to maintain the high levels of survival. We examined the potential opportunities and challenges of using winter ringing records to produce survival estimates, as well as other outputs such as age ratios and recruitment, by analysing 2 641 352 encounter records from the winters of 2007/08 to 2017/18: winter-to-winter survival analyses on adult birds were undertaken, initially on 44 species. Results indicated that fortnightly ringing sessions should yield sufficient data to produce useful survival estimates. This research identified a number of potential analytical and methodological options for future development. Covid-19 restrictions limited the amount of fieldwork carried out in 2020;consequently, only 72 CE sites submitted data for the year. Long-term (1984–2019) declines in abundance were observed for five migrant, one partial migrant and four resident species while long-term increases in abundance were recorded for two short-distance migrants and six resident species. Six species are exhibiting significant long-term declines in productivity while only Chaffinch Fringilla coelebs shows a significant long-term increase. Long-term trends in survival indicate increases for 10 species and declines for nine. Short-term trends, which compare the current year to the five-year mean (2015–19), show that the abundance of 10 species increased significantly in 2020, with three species being recorded in higher numbers than in any previous year since CES monitoring began. Significant decreases in abundance were recorded for only two species. Productivity decreased significantly for one migrant and five resident species in 2020;no species recorded a significant increase. Productivity was lower in 2020 than in any previous CES year for Blue Tit Cyanistes caeruleus and Great Tit Parus major. Significant changes in survival rate were observed in two species in 2020 compared to the five-year mean, with Bullfinch Pyrrhula pyrrhula increasing and Blackbird Turdus merula decreasing. A new habitat was added to the suite of standard CES habitats in 2020 in the first year of a Garden CES trial. Submissions were received from 92 sites. A new winter ringing project was also launched in 2020, following a similar methodology to CES. Submissions were received from 111 sites. The number of Retrapping Adults for Survival projects that were able to run and submit data in 2020 was 146, from 200 that were registered. In total, 60 species were monitored, with Pied Flycatcher Ficedula hypoleuca (20 projects), Starling Sturnus vulgaris (19), House Sparrow Passer domesticus (18), Sand Martin Riparia riparia (10) and Reed Warbler Acrocephalus scirpaceus (eight) the species most studied. A total of 930 091 birds were ringed during the year, comprising 98 500 nestlings, 523 777 first-year birds, 278 157 adults (birds in their second calendar year or older) and 29 657 birds whose age could not be determined. In addition, there were 212 414 recaptures of ringed birds at or near the ringing site. In total, 42 987 recoveries (birds found dead, recaptured or resighted at least 5 km from the place of ringing) of BTO-ringed birds were reported in 2020. The Appendix highlights a selection of recoveries that have extended our knowledge of movements, as well as longevity records established during the year. A total of 23 928 NRS submissions were received in 2020, far fewer than usual due to Covid-19 restrictions being in place during the height of the nesting season. As the seasonality of nest reco ds was biased towards the end of the breeding season, after Covid-19 restrictions had lifted, it was not possible to generate meaningful NRS trends for 2020. Permits or licences to disturb breeding birds on Schedule 1 of the Wildlife and Countryside Act 1981 (as amended) were prepared and issued to 611 ringers and nest recorders in 2020. During 2020, the use of special methods was authorised for 1182 marking projects and 146 trapping projects. © 2022 British Trust for Ornithology.
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At a distance of almost two years since the novel coronavirus first entered the public consciousness and drew media attention, it has become clear how women have been affected in distinct ways by the unfamiliar set of social, economic, and, in many cases, personal circumstances created by the Covid-19 pandemic (Guterres 2020). Though it is a simplification to suggest that women are a uniquely privileged group in this respect, it remains true that the instability of lockdowns and their aftermath, in the UK and elsewhere, has taken a specific toll on women's modes of experiencing and inhabiting the world. In an outwardfacing context, this has impinged upon women's self-perception as writers and artists and as employees in other sectors, including the Academy;in the personal sphere, it has touched upon the problem of being mother, partner, friend, and colleague in challenging circumstances. These new (or perhaps not so new, in some cases) experiences are becoming the focus of critical and reflective work in and beyond academic circles, as women seek not only to respond to their own experiences over the past year but to explore broader opportunities presented by the pandemic for thinking through our life as individuals and in community. In response to these emerging creative and critical conditions, at the end of Institute of Modern Languages Research held a workshop titled 'Covid and the (Bristol) and attended by academics, creators, artists, activists, and translators spread across the globe. Reflecting on their own practice and the practice of others, participants' contributions shifted between scholarship and stories, research and representation - literary or otherwise - to reveal a picture of how Covid-19 and its effects are being progressively reflected and/or refracted in
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Study Objective: Concerns over emerging infectious diseases spread via airborne or respiratory droplet transmission have highlighted the importance of respiratory protection for health care workers. During the current COVID-19 pandemic, widespread use of N95 masks by health care workers helped to prevent transmission and contraction of SARS-CoV2. It is not clear if prolonged continuous use of an N-95 during clinical duties results in any detrimental physiological effects and clinical features from increased carbon dioxide. The primary objective of the study was to evaluate for carbon dioxide retention and/or clinically significant changes in pH with prolonged use of N-95 masks. Secondary objective assessed for changes in vital signs and any unexpected subjective symptoms experienced by the study participants. Methods: 10 healthy emergency medicine residents between the ages of 27 and 31 years old provided written consent. All subjects denied history of structural lung disease (asthma, COPD, interstitial lung disease) and had been previously fit-tested for the correct size of N-95 mask. Each participant was provided a new N-95 mask and instructed to don as if they were about to enter a clinical scenario that would require this degree of respiratory protection. All subjects remained in a seated position and asked to refrain from speaking in order maximize fit of the mask. Venous blood gas samples were obtained prior to donning their mask followed by three additional intervals at, 20, 40, and 60 minutes. In addition, vital signs (heart rate, pulse oximetry, blood pressure and respiratory rate) were recorded at each of those four intervals and subjects were ask to self-record any symptoms they experienced prior to each blood draw. Each sample collected consisted of acquiring 2 ml of venous blood, which were analyzed within 30 minutes at the University of Nebraska Medical Center’s core lab. PCO2 and pH was assessed at each of the time intervals and fit with a linear mixed effect model to determine if statistically significant change over time for these measurements. Mean and standard deviations were used to describe the values at each time point. Pairwise comparisons between time points were adjusted using Tukey’s method. All analysis was done using SAS, Version 9.4 and a p-value < 0.05 was considered statistically significant. Results: The mean carbon dioxide levels at time 0 and 60 minutes were 48.9 (CI, 49.0-56.0) and 48.5 (CI 39.0- 57.0) and there was no statistically significant change across any of the time intervals (p=0.20). There was a small significant increase in the mean pH between the 20-minute assessment and baseline [(7.367, CI 7.350- 7.400) vs (7.381, CI 7.350-7.410) p=0.019], which was not clinically significant. In addition, there were no significant changes in vital signs or report of unexpected clinical symptoms by any the subjects. Conclusion: In this small cohort of subjects, there was no evidence of carbon dioxide retention or clinically significant changes in pH with prolonged use of N-95 masks. [Formula presented]
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Background/Introduction: Undertaking effective drug safety monitoring is particularly challenging in low-resource settings due to a lack of infrastructure, weak regulatory systems and poor access to training and education [1]. Given the impact that the COVID-19 pandemic is having upon health systems globally, it is essential to ensure that pharmacovigilance systems in these vulnerable settings have the capacity to address both the exacerbated pre-existing and novel challenges that they now face [2]. This project will harness the membership of an online pharmacovigilance platform, globalpharmacovigilance.org (GPV) to create a community of practice (CoP) to address the challenges facing pharmacovigilance during the pandemic[3, 4]. This community can use proven approaches to reach strong and highly democratic consensus on pharmacovigilance priorities, and then provide relevant resources (whether existing or new training, guidance, tools, mentoring) to address the gaps. The online platform will be used by the CoP to share best practices, engage more widely and disseminate outputs and guidance. Objective/Aim: To identify priorities for pharmacovigilance in low-resource settings during the COVID-19 pandemic and provide resources to address these within a CoP model. Methods: This project will build on a consensus-gathering methodology developed by The Global Health Network that has been implemented successfully during the pandemic to address wider COVID-19 research priorities. An online survey, distributed via social media, mailing lists and directly on GPV, will be used to identify priority areas for pharmacovigilance improvement in low-resource settings. Participants will then be invited to attend an online open workshop, in which the survey results will be presented and consensus gathered on an area for focus. Attendees will be invited to form a working group(s). Membership will be self-selective to encourage involvement from all experience levels. This working group(s) will then be supported to work together to facilitate the development of (or provision of, if already available elsewhere) pharmacovigilance resources to address the priorities identified. Results: Results will be presented in the form of a knowledge gap analysis for pharmacovigilance in low-resource settings during the COVID-19 pandemic, consisting of qualitative/quantitative results from the survey and qualitative data from the workshop. Qualitative/ quantitative data on the uptake and use of the GPV platform will also be presented. Conclusion: It is anticipated that findings will help to understand whether and how a CoP may be built and engaged with using an online platform during a pandemic, and then contribute to a priority area for improvement or development within pharmacovigilance at that time.