Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators.
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ABSTRACT:
SUBMITTER: Jairath V
PROVIDER: S-EPMC8244581 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Publications
Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators.
Jairath Vipul V Guizzetti Leonardo L Baker K Adam KA Williamson Lee Anne LA Sedano Rocio R Thompson Hershell H Ma Christopher C
Inflammatory bowel diseases 20210701 8
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| S-EPMC7220169 | biostudies-literature
Project description:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first identified in Wuhan, China, in late 2019. Responsible for the ongoing coronavirus disease 2019 (COVID-19) pandemic, SARS-CoV-2 is one of three structurally similar beta-coronaviruses that can cause a strong upregulation of cytokines referred to as cytokine release syndrome (CRS). Unresolved CRS leads to respiratory symptoms, including pneumonia, and in more severe cases, acute respiratory distress syndrome (ARDS). Although COVID-19 is widely known for these hallmark respiratory symptoms, it also impacts the gut, causing gastrointestinal (GI) tract inflammation and diarrhea. COVID-19's GI symptoms may be due to the high intestinal expression of angiotensin converting enzyme-2 receptors, which are for the binding of SARS-CoV-2 viral particles. Reports have shown that SARS-CoV-2 can be passed through fecal matter, with one study finding that 48.1% of COVID-19 patients expressed viral SARS-CoV-2 mRNA in their stool. Given that the GI tract is a target tissue affected by COVID-19, this causes concern for those with underlying GI pathologies, such as inflammatory bowel disease (IBD). Regrettably, there have been only limited studies on the impact of COVID-19 on gut health, and the impact of COVID-19 on intestinal inflammation among IBD patients remains unclear. In particular, questions regarding susceptibility to SARS-CoV-2 infection, clinical impact of COVID-19 on IBD, and the potential influence of age, sex, and immunosuppressant medications are still poorly understood. An improved understanding of these issues is needed to address the unique risks of COVID-19 among IBD patients, as well as the potential impact of SARS-CoV-2 on the host intestinal microbiota.
| S-EPMC9373928 | biostudies-literature
Project description:Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross-sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions. The participants comprised of 54 respondents, among whom 36 were PIs (physicians) and 18 were clinical research support staff. A self-administered electronic survey was created and evaluated by experts, with 50 knowledge items. Mann-Whitney U tests were used to determine the significance of the differences in knowledge between clinical research support staff and PIs. We compared the correct answer rate of clinical research support staff and PIs for each knowledge category and observed that the clinical research support staff scored significantly higher than the PIs in all aspects of clinical research knowledge sections, including total score. Our findings showed that PIs did not have the same amount of clinical research knowledge as the clinical research support staff. Clinical research knowledge is essential for investigators, especially PIs, to protect patients and promote medical breakthroughs. Thus, more accessible clinical research education and mandatory knowledge testing will allow PIs to lead successful clinical research and further the level of medical research in Japan.
| S-EPMC10014686 | biostudies-literature
Project description: Not available
| S-BSST563 | biostudies-other
Project description:ObjectivesTo gain insights into the impact of the COVID-19 pandemic on ongoing health research projects, using projects from a selected funding programme in Germany as an example.DesignOnline survey and validation workshop.SettingLockdowns and social distancing policies impact on clinical and public health research in various forms, especially if unrelated to COVID-19. Research institutions have reduced onsite activities, data are often collected remotely, and during the height of the crisis, clinical researchers were partially forced to abandon their projects in favour of front-line care.Participants survey120 investigators of health research projects across Germany, performed between 15 and 25 May 2020; workshop: 32 investigators, performed on 28 May 2020.ResultsThe response rate (78%) showed that the survey generated significant interest among investigators. 85 responses were included for analysis, and the majority of investigators (93%) reported that their projects were affected by the pandemic, with many (80%) stating that data collection was not possible as planned, and they could not carry out interventions as intended (67%). Other impacts were caused by staff being unavailable, for example, through child or elder care commitments or because of COVID-19 quarantine or illness. Investigators also reported that publications were delayed or not feasible at all (56%), and some experienced problems with PhD or Masters theses (18%). The majority of investigators had mitigation strategies in place such as adjustment of data collection methods using digital tools (46%) or of project implementation in general (46%), others made changes in research design or research questions (27%).ConclusionsThe COVID-19 pandemic has severely impacted on health research projects. The main challenge is now to mitigate negative effects and to improve long-term resilience in health research. The pandemic has also acted as a driver of innovation and change, for example, by accelerating the use of digital methods.
| S-EPMC8649878 | biostudies-literature
Project description:IntroductionPatients with inflammatory bowel disease (IBD) do not seem to be at increased risk of infection by SARS-CoV-2, but there is a concern whether immunosuppressive therapy may be associated with more severe disease. Several clinical practice recommendations have been published to help guide IBD care during the COVID-19 pandemic. Nonetheless, few studies have addressed patients' perspectives and fears. We aimed to evaluate Portuguese IBD patients' perspectives on the clinical management of their disease during the SARS-CoV-2 pandemic as well as the impact on their professional life.MethodsAn anonymous electronic survey was created using REDCap and was distributed by the Portuguese Association of Inflammatory Bowel Disease (APDI) between May and August 2020. Patients' perspectives on immunosuppressive therapy, disease management, interaction with gastroenterology departments, and the impact of the pandemic in their professional life were assessed. Patients' proposals to improve medical care were also evaluated. Descriptive analysis and logistic regression were performed.ResultsA total of 137 participants answered the survey (79.6% females, mean age 41.7 ± 12.1 years). Although having IBD and receiving treatment with immunosuppressors (thiopurines, steroids, or biologics) were considered promotors of anxiety, most patients (85.4%) agreed that disease remission was a priority and only a minority of patients interrupted their treatment during the pandemic. In multivariate analysis, active disease, biologic treatment, and use of corticosteroids in the last 3 months were perceived by the patients as high-risk features for increased risk of SARS-Cov-2 infection and more severe disease. Fifty-nine patients (44%) believed that their follow-up was influenced by the pandemic and only 58.8% felt that they had the opportunity to discuss their therapeutic options with their doctor. Sixty-three patients (46.0%) were working from home during the pandemic, although this decision was related to IBD and immunosuppressive therapy in only 36.5 and 39.7% of the cases, respectively. Areas where care could have been improved during the pandemic were identified by patients, namely enhancement of the communication with IBD professionals, conciliation of telemedicine with face-to-face appointments, and facilitation of the interaction between patients and employers.ConclusionMost patients agreed that maintaining IBD remission is crucial, and only a minority of the patients stopped their treatment as per their own initiative. IBD status only had a small influence on patients' professional activity during the COVID-19 outbreak, with most changes being related to the pandemic itself.
| S-EPMC8678223 | biostudies-literature
Project description:BackgroundThe World Health Organization (WHO) declared coronavirus disease-19 (COVID-19) as a pandemic on March 11, 2020. The impact of COVID-19 on urological services in different geographical areas is unknown.ObjectiveTo investigate the global impact of COVID-19 on urological providers and the provision of urological patient care.Design, setting, and participantsA cross-sectional, web-based survey was conducted from March 30, 2020 to April 7, 2020. A 55-item questionnaire was developed to investigate the impact of COVID-19 on various aspects of urological services. Target respondents were practising urologists, urology trainees, and urology nurses/advanced practice providers.Outcome measurements and statistical analysisThe primary outcome was the degree of reduction in urological services, which was further stratified by the geographical location, degree of outbreak, and nature and urgency of urological conditions. The secondary outcome was the duration of delay in urological services.Results and limitationsA total of 1004 participants responded to our survey, and they were mostly based in Asia, Europe, North America, and South America. Worldwide, 41% of the respondents reported that their hospital staff members had been diagnosed with COVID-19 infection, 27% reported personnel shortage, and 26% had to be deployed to take care of COVID-19 patients. Globally, only 33% of the respondents felt that they were given adequate personal protective equipment, and many providers expressed fear of going to work (47%). It was of concerning that 13% of the respondents were advised not to wear a surgical face mask for the fear of scaring their patients, and 21% of the respondents were advised not to discuss COVID-19 issues or concerns on media. COVID-19 had a global impact on the cut-down of urological services, including outpatient clinic appointments, outpatient investigations and procedures, and urological surgeries. The degree of cut-down of urological services increased with the degree of COVID-19 outbreak. On average, 28% of outpatient clinics, 30% of outpatient investigations and procedures, and 31% of urological surgeries had a delay of >8 wk. Urological services for benign conditions were more affected than those for malignant conditions. Finally, 47% of the respondents believed that the accumulated workload could be dealt with in a timely manner after the COVID-19 outbreak, but 50% thought the postponement of urological services would affect the treatment and survival outcomes of their patients. One of the limitations of this study is that Africa, Australia, and New Zealand were under-represented.ConclusionsCOVID-19 had a profound global impact on urological care and urology providers. The degree of cut-down of urological services increased with the degree of COVID-19 outbreak and was greater for benign than for malignant conditions. One-fourth of urological providers were deployed to assist with COVID-19 care. Many providers reported insufficient personal protective equipment and support from hospital administration.Patient summaryCoronavirus disease-19 (COVID-19) has led to significant delay in outpatient care and surgery in urology, particularly in regions with the most COVID-19 cases. A considerable proportion of urology health care professionals have been deployed to assist in COVID-19 care, despite the perception of insufficient training and protective equipment.
| S-EPMC7248000 | biostudies-literature
Project description:ObjectiveThe aim was to evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on the clinical experiences, research opportunities and well-being of rheumatology trainees.MethodsA voluntary, anonymous, Web-based survey was administered in English, Spanish or French from 19 August 2020 to 5 October 2020. Adult and paediatric rheumatology trainees were invited to participate via social media and email. Using multiple-choice questions and Likert scales, the perceptions of trainees regarding the impact of the COVID-19 pandemic on patient care and redeployment, learning and supervision, research and well-being were assessed.ResultsThere were 302 respondents from 33 countries, with 83% in adult rheumatology training. An increase in non-rheumatology clinical work was reported by 45%, with 68% of these having been redeployed to COVID-19. Overall, trainees reported a negative impact on their learning opportunities during rheumatology training, including outpatient clinics (79%), inpatient consultations (59%), didactic teaching (55%), procedures (53%), teaching opportunities (52%) and ultrasonography (36%). Impacts on research experiences were reported by 46% of respondents, with 39% of these reporting that COVID-19 negatively affected their ability to continue their pre-pandemic research. Burnout and increases in stress were reported by 50% and 68%, respectively. Physical health was negatively impacted by training programme changes in 25% of respondents.ConclusionThe COVID-19 pandemic has had a substantial impact on rheumatology training and trainee well-being. Our study highlights the extent of this impact on research opportunities and clinical care, which are highly relevant to future curriculum planning and the clinical learning environment.
| S-EPMC8982766 | biostudies-literature
Project description:Vaccines against SARS-CoV-2 are believed to play a key role in the suppression of the COVID-19 pandemic. However, patients suffering from inflammatory bowel diseases (IBD) were excluded from SARS-CoV-2 vaccines trials. Therefore, concerns regarding vaccination efficacy and safety among those patients were raised. Overall, vaccination is well tolerated in the IBD population, and different gastroenterological societies recommend vaccinating patients with IBD at the earliest opportunity to do so. Nevertheless, very little is known about the safety of COVID-19 vaccines in special IBD populations such as pregnant and breastfeeding women or pediatric patients, and further research on this matter is crucial. The available data on vaccine efficacy are promising and show high seroconversion rates in IBD patients on different immune-modifying therapies. However, patients treated with high doses of systemic corticosteroids, infliximab or infliximab and immunomodulators may have a blunted response to the vaccination. The data on COVID-19 vaccination willingness among patients with IBD are conflicting. Nevertheless, vaccine effectiveness and safety are reported to be the most common reasons for hesitancy. This review examines the effectiveness and safety of COVID-19 vaccines and describes vaccination willingness and the reasons for potential hesitancy among patients with IBD.
| S-EPMC9104993 | biostudies-literature
Project description:At the onset of the COVID-19 pandemic in the United States, stay-at-home orders disrupted normal research operations. Principal investigators (PIs) had to make decisions about conducting and staffing essential research under unprecedented, rapidly changing conditions. These decisions also had to be made amid other substantial work and life stressors, like pressures to be productive and staying healthy. Using survey methods, we asked PIs funded by the National Institutes of Health and the National Science Foundation (N = 930) to rate how they prioritized different considerations, such as personal risks, risks to research personnel, and career consequences, when making decisions. They also reported how difficult they found these choices and associated symptoms of stress. Using a checklist, PIs indicated those factors in their research environments that made their decisions easier (i.e., facilitators) or more difficult (i.e., barriers) to make. Finally, PIs also indicated how satisfied they were with their decisions and management of research during the disruption. Descriptive statistics summarize PIs' responses and inferential tests explore whether responses varied by academic rank or gender. PIs overall reported prioritizing the well-being and perspectives of research personnel, and they perceived more facilitators than barriers. Early-career faculty, however, rated concerns about their careers and productivity as higher priorities compared to their senior counterparts. Early-career faculty also perceived greater difficulty and stress, more barriers, fewer facilitators, and had less satisfaction with their decisions. Women rated several interpersonal concerns about their research personnel more highly than men and reported greater stress. The experience and perceptions of researchers during the COVID-19 pandemic can inform policies and practices when planning for future crises and recovering from the pandemic.
| S-EPMC9980856 | biostudies-literature