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PURPOSE: This study aimed to investigate the impact of the initial wave of the COVID-19 pandemic on HIV services in Taiwan. METHODS: An online, cross-sectional survey was conducted among people living with HIV (PLWH), individuals at risk of HIV infection (IAR), and service prescribers between 20th October and 30th November, 2020. Representatives from patient advocacy groups were interviewed. RESULTS: In total, 66 PLWH, 104 IAR, and 32 prescribers from Taiwan completed the survey. Mild to moderate disruptions to HIV-related services (including medical consultation, HIV-related testing, and medications) were found by the survey, with IAR appearing more affected than PLWH. Nine (13.6%) PLWH and 31 (29.8%) IAR reported disruptions in hospital/clinic visits and two (3.0%) PLWH and 25 (24.0%) IAR reported decreased frequency of HIV testing. Similar observations were also made by four patient advocacy group representatives interviewed. Telehealth services were received by only limited proportions of PLWH and IAR who participated in the survey. CONCLUSION: HIV services in Taiwan were not severely affected by the initial wave of COVID-19, but notable disruptions were still observed in HIV screening and prevention services. Multi-pronged strategies, including telehealth services, are warranted to overcome new challenges in HIV care in the COVID-19 era.
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Background: Access to health care including clinical trials (CT) leading to paradigm-changing cancer treatments are critical for high quality cancer care and equity in society. In this report, we highlight methods in accruing to ETCTN wherein underrepresented rural, low-income, and racial minorities comprise >50% of enrollment. Methods: University of Kansas Cancer Center (KUCC) is one of eight National Cancer Institute (NCI) designated cancer centers awarded CATCH-UP.2020 (CATCH-UP), a congressionally mandated P30 supplement to enhance access for minority/underserved populations to ETCTN precision medicine CT. KUCC catchment area is 23% rural by Rural Urban Continuum Codes (RUCC);almost 90 % of counties are designated primary care HPSA's (Health Professional Shortage Areas). KUCC Early Phase and Masonic Cancer Alliance (rural outreach network) partnered to operationalize CATCH-UP. We engaged disease-focused champion investigators in disease working groups and MCA physicians who selected scientifically sound CT that fit catchment area needs. Patient and Investigator Voices Organizing Together, a patient research advocacy group provided practical feedback. MCA navigator coordinated recruitment. Telehealth was used for rural patients that would have a significant distance to travel just to be screened. Results: CATCH-UP was initiated in September 2020. Twenty-eight CT were activated, many in community sites. Average activation time was 81 days. Delays were mainly from CT amendments. KUCC enrolled the first patient in the CATCH-UP program. In 6 months, we met accrual requirements (24/year, 50% minorities). During first year, we enrolled 47 (>50% minorities), an increase of 680% from our average accrual of 6/year (>50% minorities) in ETCTN through Early Drug Development Opportunity Program (2016-2020). To date, we have enrolled 61, 54% from rural, HPSA, race and other minorities. Although the proportion of minorities did not change but remained high, this funding allowed us to substantially increase the number of patients from a catchment area with high proportion of geographically and socioeconomically underserved minorities given access to early phase CT through ETCTN. Conclusions: Amid COVID-19 pandemic, the NCI CATCH-UP program and methods we used allowed access to novel therapies for rural, medically underserved, and other minority groups.
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Background: Since the COVID-19 vaccination campaign was launched all over Europe, there has been general agreement on how benefts of SARS-CoV2 vaccines outweigh the risks in patients with rare connective tissue diseases (rCTDs). Yet, there is still limited evidence regarding safety and efficacy of such vaccines in these patients, especially in the long-term. For this reason, in the framework of ERN-ReCONNET, an observational long-term study (VACCINATE) was designed in order to explore the long-term outcome of COVID-19 vaccination in rCTDs patients. The consent form was developed thanks to the involvement of the ERN ReCONNET ePAG Advocates (European Patients Advocacy Group). Objectives: To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and the potential impact on disease activity. Primary endpoints were the prevalence of adverse events (AEs) and of disease exacerbations post-vaccination. Secondary endpoints were the proportion of serious adverse events (SAEs) and adverse events of special interest for COVID-19 (adapted from https://bright-oncollaboration.us/wp-content/uploads/2021/01/SO2-D2.1.2-V1.2-COVID-19- AESI-update-23Dec2020-review-fnal.pdf) Methods: The frst ad-interim analysis of the VACCINATE study involved 9 ERN-ReCONNET Network centres. Patients over 18 years of age with a known rCTD and who received vaccine against COVID-19 were eligible for recruitment. Demographic data and diagnoses were collected at the time of enrolment, while the appearance of AEs and potential disease exacerbations were monitored after one week from each vaccination dose, and then after 4, 12 and 24 weeks from the second dose. A disease exacerbation was defned as at least one of the following: new manifestations attributable to disease activity, hospital-ization, increase in PGA from previous evaluation, addition of corticosteroids or immunosuppressants. Results: A cohort of 300 patients (261 females, mean age 52, range 18-85) was recruited. Systemic lupus erythematosus (44%) and systemic sclerosis (16%) were the most frequent diagnoses, followed by Sjogren's syndrome (SS,12%), idiopathic infammatory myositis (IMM,10%), undifferentiated connective tissue disease (UCTD,8%), mixed connective tissue disease (MCTD,4%), Ehlers-Dan-los's syndrome (EDS,4%), antiphospholipid syndrome (APS,2%). AEs appearing 7 days after the frst and second doses were reported in 93 (31%) and 96 (32%) patients respectively, mainly represented by fatigue, injection site reaction, headache, fever and myalgia. Otitis, urticaria, Herpes Simplex-related rash, stomatitis, migraine with aura, vertigo, tinnitus and sleepiness were reported with very low frequency. Less than 2% of patients experienced AEs within 24 weeks from the second dose. No SAEs or AEs of special interest were observed in the study period. There were 25 disease exacerbations (8%), 7 of which severe. The highest number of exacerbations was observed after 4 weeks from the second dose (12 within week 4, 6 within week 12 and 7 within week 24). Disease exacerbation was most frequent in patients with EDS (33%) and MCTD (25%). Conclusion: This preliminary analysis shows that COVID-19 vaccination is safe in rCTDs patients. AEs appear most often early after vaccination and are usually mild. Disease exacerbations are not frequent, but can be potentially severe and tend to occur most frequently within the frst month after vaccination. Exacerbations can also occur 3-6 months after vaccination, although a causal relationship with the vaccination remains to be established. Our present data underline the importance of long-term observational studies.
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Objective: To examine how the COVID-19 pandemic impacts the behavioral health of people with intellectual and/or developmental disabilities (IDD) in the US. Background: The general population has suffered increasing rates of mental health problems during the COVID-19 pandemic. Having an intellectual disability was the most significant independent risk factor for a diagnosis of COVID-19, and the second strongest independent risk factor to COVID-19 mortality. This study investigates how the pandemic uniquely impacted the behavioral health of people with IDD. Design/Methods: Data were collected using a modified version of the Coronavirus Health Impact Survey -Adapted for Autism and Related Neurodevelopmental conditions (CRISISAFAR). The survey was disseminated electronically to a non-probability (i.e., convenience) sample of community and advocacy groups through the authors' networks of IDD-affiliated organizations. Study data were collected and managed using REDCap electronic data capture tools from March to June 2021. Results: 437 individuals with IDD completed the survey. 52.2% listed having an intellectual disability and 48.7% listed autism spectrum disorder, among other diagnoses. 51.6% of the survey population reported that their mental health had worsened during the pandemic. 47.6% said that they were worrying more, 55.6% struggled with changes in routine, and 18.7% reported increased self-injurious behavior. Losing access to services and programs correlated with declining mental health. Loss of or decrease in community support also correlated with increased screen time, worse sleep, and needing more help with activities of daily living. Conclusions: The behavioral health of individuals with IDD was profoundly impacted by the changes caused by COVID-19. Despite pervasive needs for increased mental and physical health resources amongst individuals with IDD, the potential positive impact of physical activity and pandemic safe social supports and opportunities should be regarded as an important and accessible means to mitigate the overall gap in services.
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Objective: To assess the long-term social and health impacts of the COVID-19 pandemic on people with muscular dystrophy (MD). Background: As the COVID-19 pandemic has continued, it has produced lasting impacts on daily life worldwide. People with muscular dystrophy are potentially at a higher risk for complications when infected with COVID-19, but little is known about the continued impact of COVID-19 on the muscular dystrophy population. Design/Methods: We modified our prior COVID-19 Impact Survey (K. Eichinger, et al) to assess impacts from the continuing pandemic using feedback from muscular dystrophy experts, patients, and advocacy group/registry representatives. The survey assessed COVID-19 medical history, and the effects of the pandemic on social aspects, muscle disease, and medical care. We also used the Perceived Stress Scale, a validated 10-item scale. The de-identified, electronic survey was distributed to adults with muscular dystrophy via international patient registries or advocacy group websites from February 8, 2021 to March 22, 2021. Results: Respondents (n=1243: 49% FSHD;43% DM, and 8% LGMD) were slightly more women and middle-aged (range 18-90). COVID-19 infection rates were 8%. Reported recovery times were typically less than 2 weeks with only 9% reporting recovery greater than 8 weeks, and 7% requiring hospitalization. Major challenges reported during the pandemic included stress management (27%) and wearing a mask (24%). The majority reported a slight worsening of their disease. Respondents reported moderate stress levels (average= 15.8;range= 0-39), with higher stress levels reported by women and those under age 30 years. Of the participants who had telemedicine visits, 70% reported satisfaction;however, most preferred in-person visits. Conclusions: People with muscular dystrophy reported moderate stress and challenges during the COVID-19 pandemic. COVID-19 infection rates and medical complications were similar to a general population. Telemedicine visits may have a more permanent role in care, though inperson visits are still preferred.
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PURPOSE: The focus of SPINE20 is to develop evidence-based policy recommendations for the G20 countries to work with governments to reduce the burden of spine disease, and disability. METHODS: On September 17-18, 2021, SPINE20 held its annual meeting in Rome, Italy. Prior to the meeting, the SPINE20 created six proposed recommendations. These recommendations were uploaded to the SPINE20 website 10 days before the meeting and opened to the public for comments. The recommendations were discussed at the meeting allowing the participants to object and provide comments. RESULTS: In total, 27 societies endorsed the following recommendations. SPINE20 calls upon the G20 countries: (1) to expand telehealth for the access to spine care, especially in light of the current situation with COVID-19. (2) To adopt value-based interprofessional spine care as an approach to improve patient outcomes and reduce disability. (3) To facilitate access and invest in the development of a competent rehabilitation workforce to reduce the burden of disability related to spine disorders. (4) To adopt a strategy to promote daily physical activity and exercises among the elderly population to maintain an active and independent life with a healthy spine, particularly after COVID-19 pandemic. (5) To engage in capacity building with emerging countries and underserved communities for the benefit of spine patients. (6) To promote strategies to transfer evidence-based advances into patient benefit through effective implementation processes. CONCLUSIONS: SPINE20's initiatives will make governments and decision makers aware of efforts to reduce needless suffering from disabling spine pain through education that can be instituted across the globe.
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COVID-19 , Spinal Diseases , Aged , Humans , Italy , Pandemics/prevention & control , Spinal Diseases/therapyABSTRACT
Introduction: MENTUPP is a multi-level intervention aimed at promoting mental wellbeing in the workplace, addressing clinical and non-clinical mental health issues and reducing stigma in SMEs. Within the context of MENTUPP, a study has been conducted to explore the impacts of COVID-19 on the mental health of SME employees. Materials and Methods: A researcher-designed, semi-structured, online survey was completed anonymously by key stakeholders across nine countries in Europe and Australia. Key stakeholders (N=65) included representatives from academia, SMEs, occupational health associations, labour and advocacy groups, and representatives from the construction, health and information technology sectors. They were from countries with established mental health provisions (Central and Western Europe) and countries with lower resources (Central and Eastern Europe). Results: An overview of the MENTUPP project will be provided, followed by outcomes of the online survey. Stakeholders across different countries and sectors agreed that COVID-19 pandemic has increased clinical and non-clinical mental health issues in SMEs. Experts in Central and Western Europe reported that the capacity of workplaces to promote wellbeing decreased due to COVID-19, and experts from Eastern and Central Europe thought that this did not change much. Mental health stigma has reportedly remained the same, however, mental health awareness may have increased. Conclusions: This study observed that the COVID-19 pandemic has negatively impacted employee mental health indicating the timeliness to introduce a targeted intervention, such as MENTUPP.
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Background: In the setting of the COVID-19 pandemic, major academic gastroenterology/hepatology conferences (American College of Gastroenterology–ACG, Digestive Diseases Weekly–DDW, The Liver Meeting–TLM, International Liver Congress-ILC, United European Gastroenterology Week-UEG) in 2020 have transitioned to virtual venues, using Twitter© to engage with attendees. The impact of virtual platforms on social media (SoMe) and dissemination of data remains unknown. Aim: To assess SoMe trends using conference-designated hashtags during virtual and in-person gastroenterology and hepatology conferences of ACG, DDW, TLM, ILC, and UEG in 2019 and 2020 Methods: Twitter© activity of hashtags (#ACG19, #ACG2020, #DDW19, #DDW2020, #Livermtg19, #TLMdX, #ILC2019, #ILC2020, #UEGweek) during the pre-defined confer-ence dates were assessed. Data were collected using Symplur Signals®, a social media healthcare analytic platform, accessed on 12/2/2020. Results: Of the 5 conferences in 2020, DDW was the only one without invited speaker sessions. In aggregate, an overall decline in Twitter© engagement was seen from 2019 to 2020, with 56% fewer original tweets (43,735 to 19,168), 54% fewer retweets (26,523 to 12,327), and 21% fewer impressions (176,748,242 to 140,209,657) associated with confer-ence-designated hashtags (Figure 1). Additionally, there were 46% fewer linked articles (6,341 to 3,404) and 58% fewer shared visuals (38,233 to 15,975). Interestingly, despite decreased tweets and retweets in individual conferences, hepatology conferences demon-strated an 87% increase (44,033,855 to 82,266,329) in impressions when moved to a virtual meeting. American-based conferences (DDW, ACG, TLM) had overall decreased Twitter© activity in 2020;European conferences (ILC, UEG) had a 16% increase (31,859,986 to 36,850,986) in impressions, with all other metrics decreasing. Trending disease topics in European hepatology conferences included “liver transplant” and “acute variceal bleeding” whereas American conferences referenced “lean NAFLD” and “alcohol-related liver disease”. Stakeholder analysis showed physicians (38% in 2019, 28% in 2020), advocacy groups (9%in 2019, 15% in 2020), and researchers (11% in 2019, 8% in 2020) were the most influential known users. In evaluation of daily engagement, virtual conferences (45%) showed an increase in tweets during the weekend compared to in-person conferences (42%). Conclusion: The transition to online platforms for academic gastroenterology/hepatology meetings during the COVID-19 pandemic has resulted in decreased active participation in SoMe but an increased passive engagement noted in hepatology and European conferences in 2020, with a trend towards more activity on weekends in all conferences. These changes parallel significant shifts in people’s daily lives, as COVID-19 has dramatically altered the landscape of academic conferences.(figure presented)
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Introduction: Early in the COVID-19 pandemic, human challenge trials with SARS-CoV-2 were proposed as a way to develop a vaccine faster, and thereby save lives. But would such trials in fact speed vaccine development? Is it ethical to infect healthy volunteers with wildtype SARS-CoV-2? And going forward, what should be the role of human challenge trials in the development of SARS-CoV-2 vaccines? This 60-min panel session, chaired by Professor Seema Shah, will explore scientific and ethical issues in SARS-CoV-2 human challenge trials. The panel brings together key stakeholders, including scientists working with a variety of challenge models, research ethicists, and a member of the advocacy group 1Day Sooner who recently participated in a challenge trial. The panel comprises five talks followed by a 10- to 15-min discussion period. Background: The origins of human challenge trials can be traced back to efforts in the 1790s to determine whether cow pox inoculation protected against smallpox. In the last 50 years, human challenge trials have enrolled thousands of healthy volunteers to be exposed to dozens of diseases, from the common cold to cholera. Challenge trials are used to better understand how a pathogen causes disease, how it is transmitted (and how transmission may be mitigated), and whether a vaccine candidate confers protection against it. In vaccine challenge trials, healthy participants are randomized to receive either vaccine or placebo, and they are subsequently exposed to the infectious agent. If less people who received the vaccine, compared to those who received placebo, become infected, this provides evidence that the vaccine is efficacious. Challenge trials have played important roles in developing vaccines for cholera, typhoid, and malaria. To protect volunteers, in the modern era, scientists have generally restricted their use of such trials to diseases that are well-understood, or for which there is curative treatment. In the face of the global COVID-19 pandemic, human challenge trials with SARS-CoV-2 were proposed as a means to speed vaccine development and save lives. But are such trials ethical? There are risks associated with COVID-19, including in young people, such as myocarditis, stroke, long COVID, and death. Proponents argue ethical norms are too conservative and may be set aside in a pandemic, provided informed volunteers are willing to participate. What should be the role of challenge trials in the development of a SARS-CoV-2 vaccine? While challenge trials were initially proposed as a substitute for phase 3 efficacy trials for vaccines, challenge trials take time to set up and did not keep pace with dramatically accelerated vaccine development in the COVID-19 pandemic. They also have limitations, including generalizability to older adults or people with comorbidities, since they test vaccine efficacy in 15-150 healthy young adults. Nevertheless, challenge trials could test the second round of vaccine candidates, which is important if the first vaccine approved is not very efficacious or safe or to ensure widespread global access of vaccines. Our panel comprising a healthy volunteer, scientists working with a variety of challenge models, and research ethicists will explore and discuss these ethical and scientific issues. Talk 1: Human challenge trials with SARS-CoV-2 Meta Roestenberg (Leids Universitair Medisch Centrum, The Netherlands) will introduce human challenge trials and their use in vaccine development. She will discuss the development of a SARS-CoV-2 challenge model, and the role of challenge trials in the development of second-generation SARS-CoV-2 vaccines. Bio: https://www.lumc.nl/org/parasitologie/medewerkers/ metaroestenberg Talk 2: The volunteer experience in a SARS-CoV-2 challenge trial Alastair Fraser-Urquhart (1Day Sooner) participated in the UK SARS-CoV-2 challenge trial in Spring 2021, and he will describe his experience in the trial. 1Day Sooner is a grass roots organization that has gathered over 38,000 people globally who have expressed a willingness to participa e in SARS-CoV-2 challenge trials. Bio: https://1daysooner.org/ Talk 3: Developing ethical guidance for SARS-CoV- 2 challenge trials Seema Shah (Northwestern University Feinberg School of Medicine, USA;session co-chair) will describe the development of ethical guidance for SARS-CoV-2 challenge trials published in Science and Vaccine in 2020 and the World Health Organization's key criteria document. She will outline the main ethical considerations in such trials and explain the most compelling potential social value they could provide. Bio: https://www.feinberg.northwestern.edu/faculty-profiles/ az/profile.html?xid = 42926 Talk 4: A critical perspective on the ethics of SARSCoV- 2 challenge trials Charles Weijer (Western University, Canada;session co-chair) will examine critically the case for SARS-CoV-2 challenge trials. He will focus on the social value of challenge trials, whether benefits are justified by risks to volunteers, the use of high-risk groups in such trials, and their impact on public trust in a SARS-CoV-2 vaccine. Bio: https:// www.charlesweijer.com/about-me Talk 5: The future of challenge trials in SARS-CoV- 2 and future pandemics Gagandeep Kang (Christian Medical College, India) will consider the future of challenge trials in the future of SARS-CoV-2 vaccine development and, indeed, their role in future pandemics. The pace of vaccine development and clinical trials in the COVID-19 pandemic is unprecedented. Does this undermine the need for challenge trials? If not, what ought to be their role in vaccine development? Bio: https://en.wikipedia.org/wiki/Gagandeep-Kang Format: This 60-min panel session will be chaired by Professor Seema Shah. Each of the talks will be 8- to 10-min in duration and they will cover the volunteer experience, the science of challenge trials, and ethical issues. The five talks will be followed by a highly interactive 10- to 15-min discussion period. The discussion will be divided into two sections. The first half of the discussion will explore the ethics of SARS-CoV-2 challenge trials. The second half will discuss the future role of challenge trials in vaccine development.