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1.
Haemophilia ; 28(2): 247-253, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1685308

ABSTRACT

INTRODUCTION: The haemophilia community on Twitter is diverse, consisting of advocacy groups, patients, physicians, researchers and other users. However, the scope of this community is uncharacterized, and limited data is available regarding effective participation in this community. AIM: To assess the types of users active in the haemophilia community on Twitter, as well as major themes present in haemophilia-related tweets. METHODS: Forty-nine thousand five hundred and twelve tweets between September 2019 and September 2021 were classified using regular expressions. A subset of the classified tweets was manually analysed to identify prevalent discussion themes. RESULTS: Among the top 250 users by post count, the largest categories of users were support and advocacy groups, people with bleeding disorders and healthcare providers. The largest thematic categories of tweets were gene therapy, contaminated haemophilia blood products, haemophilia research, clinical management of haemophilia and COVID-19. While misinformation was rare, negative and incorrect perceptions of haemophilia were present among the general public. CONCLUSION: Our results demonstrate patterns of effective Twitter usage for patient care, research and advocacy purposes among the haemophilia community.


Subject(s)
COVID-19 , Hemophilia A , Social Media , Communication , Hemophilia A/therapy , Humans , SARS-CoV-2
3.
Vaccine ; 39(51): 7357-7362, 2021 12 17.
Article in English | MEDLINE | ID: covidwho-1525978

ABSTRACT

Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO's R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop. Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.


Subject(s)
COVID-19 , Communicable Diseases, Emerging , Vaccines , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/prevention & control , Female , Humans , Lactation , London , Pregnancy , Referral and Consultation , SARS-CoV-2
4.
PLoS One ; 16(10): e0258866, 2021.
Article in English | MEDLINE | ID: covidwho-1480457

ABSTRACT

AIM: The long-term stress, anxiety and job burnout experienced by healthcare workers (HCWs) are important to consider as the novel coronavirus disease (COVID-19) pandemic stresses healthcare systems globally. The primary objective was to examine the changes in the proportion of HCWs reporting stress, anxiety, and job burnout over six months during the peak of the pandemic in Singapore. The secondary objective was to examine the extent that objective job characteristics, HCW-perceived job factors, and HCW personal resources were associated with stress, anxiety, and job burnout. METHOD: A sample of HCWs (doctors, nurses, allied health professionals, administrative and operations staff; N = 2744) was recruited via invitation to participate in an online survey from four tertiary hospitals. Data were gathered between March-August 2020, which included a 2-month lockdown period. HCWs completed monthly web-based self-reported assessments of stress (Perceived Stress Scale-4), anxiety (Generalized Anxiety Disorder-7), and job burnout (Physician Work Life Scale). RESULTS: The majority of the sample consisted of female HCWs (81%) and nurses (60%). Using random-intercept logistic regression models, elevated perceived stress, anxiety and job burnout were reported by 33%, 13%, and 24% of the overall sample at baseline respectively. The proportion of HCWs reporting stress and job burnout increased by approximately 1·0% and 1·2% respectively per month. Anxiety did not significantly increase. Working long hours was associated with higher odds, while teamwork and feeling appreciated at work were associated with lower odds, of stress, anxiety, and job burnout. CONCLUSIONS: Perceived stress and job burnout showed a mild increase over six months, even after exiting the lockdown. Teamwork and feeling appreciated at work were protective and are targets for developing organizational interventions to mitigate expected poor outcomes among frontline HCWs.


Subject(s)
Anxiety , Burnout, Professional , COVID-19 , Health Personnel/psychology , Pandemics , SARS-CoV-2 , Adult , Aged , Anxiety/epidemiology , Anxiety/psychology , Burnout, Professional/epidemiology , Burnout, Professional/etiology , COVID-19/epidemiology , COVID-19/psychology , Female , Humans , Male , Middle Aged , Prospective Studies , Singapore/epidemiology
6.
Can J Neurol Sci ; : 1-10, 2021 Jun 24.
Article in English | MEDLINE | ID: covidwho-1297279

ABSTRACT

BACKGROUND: Due to lack of data on the epidemiology, cardiac, and neurological complications among Ontario visible minorities (Chinese and South Asians) affected by coronavirus disease (COVID-19), this population-based retrospective study was undertaken to study them systematically. METHODS: From January 1, 2020 to September 30, 2020 using the last name algorithm to identify Ontario Chinese and South Asians who were tested positive by PCR for COVID-19, their demographics, cardiac, and neurological complications including hospitalization and emergency visit rates were analyzed compared to the general population. RESULTS: Chinese (N = 1,186) with COVID-19 were found to be older (mean age 50.7 years) compared to the general population (N = 42,547) (mean age 47.6 years) (p < 0.001), while South Asians (N = 3,459) were younger (age of 42.1 years) (p < 0.001). The 30-day crude rate for cardiac complications among Chinese was 169/10,000 (p = 0.069), while for South Asians, it was 64/10,000 (p = 0.008) and, for the general population, it was 112/10,000. For neurological complications, the 30-day crude rate for Chinese was 160/10,000 (p < 0.001); South Asians was 40/10,000 (p = 0.526), and general population was 48/10,000. The 30-day all-cause mortality rate was significantly higher for Chinese at 8.1% vs 5.0% for the general population (p < 0.001), while it was lower in South Asians at 2.1% (p < 0.001). CONCLUSIONS: Chinese and South Asians in Ontario affected by COVID-19 during the first wave of the pandemic were found to have a significant difference in their demographics, cardiac, and neurological outcomes.

7.
Curr Probl Diagn Radiol ; 2021 Jul 04.
Article in English | MEDLINE | ID: covidwho-1293031

ABSTRACT

In an era of rapidly expanding knowledge and sub-specialization, it is becoming increasingly common to focus on one organ system. However, the human body is intimately linked, and disease processes affecting one region of the body not uncommonly affect the other organ systems as well. Understanding diseases from a macroscopic perspective, rather than a narrow vantage point, enables efficient and accurate diagnosis. This tenet holds true for diseases affecting both the thoracic and neurological systems; in isolation, the radiologic appearance of disease in one organ system may be nonspecific, but viewing the pathophysiologic process in both organ systems may markedly narrow the differential considerations, and potentially lead to a definitive diagnosis. In this article, we discuss a variety of disease entities known to affect both the thoracic and neurological systems, either manifesting simultaneously or at different periods of time. Some of these conditions may show neither thoracic nor neurological manifestations. These diseases have been systematically classified into infectious, immune-mediated / inflammatory, vascular, syndromic / hereditary and neoplastic disorders. The underlying pathophysiological mechanisms linking both regions and radiologic appearances in both organ systems are discussed. When appropriate, brief clinical and diagnostic information is provided. Ultimately, accurate diagnosis will lead to expedited triage and prompt institution of potentially life-saving treatment for these groups of complex disorders.

8.
Vaccine ; 39(19): 2712-2718, 2021 05 06.
Article in English | MEDLINE | ID: covidwho-1118713

ABSTRACT

Beginning in December of 2019, a novel coronavirus, SARS-CoV-2, emerged in China and is now a global pandemic with extensive morbidity and mortality. With the emergence of this threat, an unprecedented effort to develop vaccines against this virus began. As vaccines are now being introduced globally, we face the prospect of millions of people being vaccinated with multiple types of vaccines many of which use new vaccine platforms. Since medical events happen without vaccines, it will be important to know at what rate events occur in the background so that when adverse events are identified one has a frame of reference with which to compare the rates of these events so as to make an initial assessment as to whether there is a potential safety concern or not. Background rates vary over time, by geography, by sex, socioeconomic status and by age group. Here we describe two key steps for post-introduction safety evaluation of COVID-19 vaccines: Defining a dynamic list of Adverse Events of Special Interest (AESI) and establishing background rates for these AESI. We use multiple examples to illustrate use of rates and caveats for their use. In addition we discuss tools available from the Brighton Collaboration that facilitate case evaluation and understanding of AESI.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , China/epidemiology , Humans , SARS-CoV-2 , Vaccines/adverse effects
9.
Pharmacoepidemiol Drug Saf ; 30(7): 843-857, 2021 07.
Article in English | MEDLINE | ID: covidwho-1103356

ABSTRACT

INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Health Information Interoperability , Pharmacoepidemiology/methods , Product Surveillance, Postmarketing/methods , Asia/epidemiology , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Databases, Factual/statistics & numerical data , Electronic Health Records/statistics & numerical data , Geography , Humans , International Cooperation , Pacific Islands/epidemiology , Pharmacoepidemiology/organization & administration , Pharmacovigilance , Product Surveillance, Postmarketing/statistics & numerical data , SARS-CoV-2/immunology
10.
J Med Imaging Radiat Oncol ; 65(2): 139-145, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1085304

ABSTRACT

INTRODUCTION: We aimed to study anxiety and burnout among Division of Radiological Sciences (RADSC) staff during the COVID-19 pandemic and identify potential risk and protective factors. These outcomes were compared with non-RADSC staff. METHODS: A cross-sectional online study was conducted between 12 March and 20 July 2020 in the largest public tertiary hospital receiving COVID-19 cases. Burnout and anxiety were assessed with the Physician Work-Life Scale and the Generalized Anxiety Disorder-7 Scale, respectively. Workplace factors were examined as potential risk and protective factors using multivariable ordinary least squares regression analyses, adjusting for pertinent demographic characteristics. RESULTS: RADSC staff (n = 180) and non-RADSC staff (n = 1458) demonstrated moderate-to-severe anxiety rates of 6.7 and 13.2 % and burnout rates of 17.8 and 23.9 %, respectively. RADSC staff reported significantly lower anxiety (mean ± SD: 4.0 ± 3.7 vs 4.9 ± 4.5; P-value < 0.05), burnout (mean ± SD: 1.9 ± 0.7 vs 2.1 ± 0.8; P-value < 0.01), increased teamwork (82.2% vs 74.1%; P-value < 0.05) and fewer night shifts (36.7% vs 41.1%; P-value < 0.01). Among RADSC staff, higher job dedication was associated with lower anxiety (b (95% CI) = -0.28 (-0.45, -0.11)) and burnout (b (95% CI) = -0.07 (-0.11,-0.04)), while longer than usual working hours was associated with increased anxiety (b (95% CI) = 1.42 (0.36, 2.45)) and burnout (b (95% CI) = 0.28 (0.09, 0.48)). CONCLUSIONS: A proportion of RADSC staff reported significant burnout and anxiety, although less compared to the larger hospital cohort. Measures to prevent longer than usual work hours and increase feelings of enthusiasm and pride in one's job may further reduce the prevalence of anxiety problems and burnout in radiology departments.


Subject(s)
Anxiety Disorders/epidemiology , Burnout, Professional/epidemiology , COVID-19/psychology , Health Workforce/statistics & numerical data , Pandemics , Radiology Department, Hospital , Adult , Anxiety Disorders/psychology , Burnout, Professional/psychology , Cross-Sectional Studies , Female , Humans , Male , SARS-CoV-2 , Singapore
14.
Vaccine ; 38(49): 7702-7707, 2020 11 17.
Article in English | MEDLINE | ID: covidwho-867163

ABSTRACT

Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.


Subject(s)
Drug Evaluation, Preclinical/standards , Vaccines, Attenuated/adverse effects , Viral Vaccines/adverse effects , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/pharmacology , Drug Evaluation, Preclinical/methods , Humans , Risk Assessment , Societies, Scientific , Vaccines, Attenuated/pharmacology , Viral Vaccines/pharmacology
15.
AJR Am J Roentgenol ; 214(6): 1206-1210, 2020 06.
Article in English | MEDLINE | ID: covidwho-823643

ABSTRACT

OBJECTIVE. This article shares the ground operational perspective of how a tertiary hospital radiology department in Singapore is responding to the coronavirus disease (COVID-19) epidemic. This same department was also deeply impacted by the severe acute respiratory syndrome (SARS) outbreak in 2003. CONCLUSION. Though similar to SARS, the COVID-19 outbreak has several differences. We share how lessons from 2003 are applied and modified in our ongoing operational response to this evolving novel pathogen.


Subject(s)
Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Epidemics , Infection Control/standards , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Radiology Department, Hospital/organization & administration , Radiology Department, Hospital/standards , Severe Acute Respiratory Syndrome/epidemiology , Severe Acute Respiratory Syndrome/prevention & control , COVID-19 , Humans , Singapore/epidemiology
16.
Vaccine ; 39(22): 3081-3101, 2021 05 21.
Article in English | MEDLINE | ID: covidwho-813888

ABSTRACT

Replication-incompetent adenoviral vectors have been under investigation as a platform to carry a variety of transgenes, and express them as a basis for vaccine development. A replication-incompetent adenoviral vector based on human adenovirus type 26 (Ad26) has been evaluated in several clinical trials. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety and features of recombinant viral vector vaccines. This paper reviews features of the Ad26 vectors, including tabulation of safety and risk assessment characteristics of Ad26-based vaccines. In the Ad26 vector, deletion of E1 gene rendering the vector replication incompetent is combined with additional genetic engineering for vaccine manufacturability and transgene expression optimization. These vaccines can be manufactured in mammalian cell lines at scale providing an effective, flexible system for high-yield manufacturing. Ad26 vector vaccines have favorable thermostability profiles, compatible with vaccine supply chains. Safety data are compiled in the Ad26 vaccine safety database version 4.0, with unblinded data from 23 ongoing and completed clinical studies for 3912 participants in five different Ad26-based vaccine programs. Overall, Ad26-based vaccines have been well tolerated, with no significant safety issues identified. Evaluation of Ad26-based vaccines is continuing, with >114,000 participants vaccinated as of 4th September 2020. Extensive evaluation of immunogenicity in humans shows strong, durable humoral and cellular immune responses. Clinical trials have not revealed impact of pre-existing immunity to Ad26 on vaccine immunogenicity, even in the presence of Ad26 neutralizing antibody titers or Ad26-targeting T cell responses at baseline. The first Ad26-based vaccine, against Ebola virus, received marketing authorization from EC on 1st July 2020, as part of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen. New developments based on Ad26 vectors are underway, including a COVID-19 vaccine, which is currently in phase 3 of clinical evaluation.


Subject(s)
COVID-19 , Ebolavirus , Viral Vaccines , Animals , COVID-19 Vaccines , Genetic Vectors , Humans , Risk Assessment , SARS-CoV-2 , Viral Vaccines/genetics
17.
Vaccine ; 38(49): 7708-7715, 2020 11 17.
Article in English | MEDLINE | ID: covidwho-745909

ABSTRACT

Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.


Subject(s)
Drug Evaluation, Preclinical/standards , Vaccines, Attenuated/adverse effects , Viral Vaccines/adverse effects , Animals , Genetic Vectors , Humans , Internet , Risk Assessment
18.
Nat Rev Drug Discov ; 19(10): 667-668, 2020 10.
Article in English | MEDLINE | ID: covidwho-744351
19.
Vaccine ; 38(39): 6184-6189, 2020 09 03.
Article in English | MEDLINE | ID: covidwho-701883

ABSTRACT

Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.


Subject(s)
Coronavirus Infections/prevention & control , Drug Approval/legislation & jurisprudence , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Risk Assessment , Viral Vaccines/standards , Betacoronavirus/drug effects , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , COVID-19 Vaccines , Civil Defense , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Coronavirus Infections/virology , Government Regulation , Humans , Immunogenicity, Vaccine , International Cooperation , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , SARS-CoV-2 , Vaccines, Inactivated , Viral Vaccines/administration & dosage , Viral Vaccines/biosynthesis
20.
Vaccine ; 38(35): 5734-5739, 2020 07 31.
Article in English | MEDLINE | ID: covidwho-640754

ABSTRACT

Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.


Subject(s)
Viral Vaccines/adverse effects , Viral Vaccines/immunology , Antigens, Viral/administration & dosage , Antigens, Viral/adverse effects , Antigens, Viral/immunology , COVID-19 Vaccines , Coronavirus Infections/immunology , Coronavirus Infections/prevention & control , Humans , Patient Safety , Risk Assessment , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/immunology , Viral Proteins/administration & dosage , Viral Proteins/adverse effects , Viral Proteins/immunology , Viral Vaccines/administration & dosage
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