Impact of the COVID-19 pandemic on recruitment to clinical research studies in rheumatology.
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ABSTRACT:
SUBMITTER: Mirza M
PROVIDER: S-EPMC8242596 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
Publications
Impact of the COVID-19 pandemic on recruitment to clinical research studies in rheumatology.
Mirza Mazin M Siebert Stefan S Pratt Arthur A Insch Elspeth E McIntosh Frances F Paton John J Wright Claire C Buckley Christopher D CD Isaacs John J McInnes Iain B IB Raza Karim K Falahee Marie M
Musculoskeletal care 20210503 1
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Project description:ObjectiveThe COVID-19 pandemic has impacted the careers of trainees and early career investigators (ECIs). We sought to assess how the American College of Rheumatology (ACR) and the Rheumatology Research Foundation (RRF) can address the needs of those pursuing research careers.MethodsThe Committee on Research created a survey to assess the impact of COVID-19 and identify topics for the ACR and the RRF to address. In fall of 2020, we surveyed postdoctoral trainees and ECIs within 9 years of terminal training. Responses were analyzed using descriptive statistics and qualitative content analysis.ResultsTwenty-one percent of invitees responded to the survey (n = 365); of these, 60% were pursuing careers in academic research. Seventy-five percent of respondents in academic research career paths placed their primary projects on hold during the pandemic. The number of individuals pursuing a research career from 2020 to 2021 decreased by 5%. Respondents reported funding, caregiving, and lack of preliminary data as significant challenges. Suggested impactful interventions included increased funding, funding process reform, and expanding mentoring and networking resources.ConclusionMajor stressors identified during the pandemic included increased caregiving responsibilities and difficulty obtaining data and funding, for which respondents suggested increases and changes in funding programs as well as more mentoring and networking opportunities. Based on these, the Committee on Research proposes 3 priorities: 1) flexible funding mechanisms for ECIs and additional support for those impacted by caregiving; 2) virtual and in-person programs for career development and networking; and 3) curated content relevant to building a research career available on demand.
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Project description:PurposeThe coronavirus disease 2019 (COVID-19) pandemic has had unprecedented impact on the provision of medical care for genetic disorders. The purpose of this study was to assess the effects of the pandemic on neurofibromatosis (NF) care and research.MethodsSixty-three United States NF clinics were surveyed to identify the impact of the pandemic on clinician role, patient volume, continuity of guideline-driven surveillance, research protocols, and use of (and satisfaction with) telehealth for the delivery of NF care.ResultsFifty-two clinic directors or their representatives completed the survey (83% response rate). About 2/3 of the clinics reported a greater than 50% decrease in the number of available patient appointments, and modified clinical surveillance and research protocols. Fifty-one clinics (98%) newly instituted telehealth during the pandemic. Barriers to telehealth prior to the pandemic were insurance reimbursement concerns and lack of infrastructure. Since telehealth was initiated, high provider satisfaction was reported with ease of use. The most common area of concern was related to inability to perform a physical examination.ConclusionResults show marked impacts on NF care and research since the beginning of the pandemic, with potential long-term changes related to the introduction (or adoption) of telehealth for clinical care.
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Project description:ObjectiveIn the past few months, a large number of clinical studies on the novel coronavirus disease (COVID-19) have been initiated worldwide to find effective therapeutics, vaccines, and preventive strategies for COVID-19. In this study, we aim to understand the landscape of COVID-19 clinical research and identify the issues that may cause recruitment difficulty or reduce study generalizability.MethodsWe analyzed 3765 COVID-19 studies registered in the largest public registry-ClinicalTrials.gov, leveraging natural language processing (NLP) and using descriptive, association, and clustering analyses. We first characterized COVID-19 studies by study features such as phase and tested intervention. We then took a deep dive and analyzed their eligibility criteria to understand whether these studies: (1) considered the reported underlying health conditions that may lead to severe illnesses, and (2) excluded older adults, either explicitly or implicitly, which may reduce the generalizability of these studies to the older adults population.ResultsOur analysis included 2295 interventional studies and 1470 observational studies. Most trials did not explicitly exclude older adults with common chronic conditions. However, known risk factors such as diabetes and hypertension were considered by less than 5% of trials based on their trial description. Pregnant women were excluded by 34.9% of the studies.ConclusionsMost COVID-19 clinical studies included both genders and older adults. However, risk factors such as diabetes, hypertension, and pregnancy were under-represented, likely skewing the population that was sampled. A careful examination of existing COVID-19 studies can inform future COVID-19 trial design towards balanced internal validity and generalizability.
| S-EPMC8083215 | biostudies-literature
Project description:ObjectiveThe novel coronavirus disease (COVID-19), broke out in December 2019, and is now a global pandemic. In the past few months, a large number of clinical studies have been initiated worldwide to find effective therapeutics, vaccines, and preventive strategies for COVID-19. In this study, we aim to understand the landscape of COVID-19 clinical research and identify the gaps such as the lack of population representativeness and issues that may cause recruitment difficulty.Materials and methodsWe analyzed 3,765 COVID-19 studies registered in the largest public registry - ClinicalTrials.gov, leveraging natural language processing and using descriptive, association, and clustering analyses. We first characterized COVID-19 studies by study features such as phase and tested intervention. We then took a deep dive and analyzed their eligibility criteria to understand whether these studies: (1) considered the reported underlying health conditions that may lead to severe illnesses, and (2) excluded older adults, either explicitly or implicitly, which may reduce the generalizability of these studies to the older adults population.ResultsMost trials did not have an upper age limit and did not exclude patients with common chronic conditions such as hypertension and diabetes that are more prevalent in older adults. However, known risk factors that may lead to severe illnesses have not been adequately considered.ConclusionsA careful examination of existing COVID-19 studies can inform future COVID-19 trial design towards balanced internal validity and generalizability.
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Project description:ObjectiveTo evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on rheumatology practice.MethodA cross-sectional web survey was designed by the members of the Arab League of Associations for Rheumatology (ArLAR), validated by its scientific committee and disseminated through e-mail and social media. It included close-ended questions about the impact of the pandemic on the rheumatology activities, including outpatient visits and hospitalizations (in percentage, 100% corresponds to complete suspension) and open-ended questions about unmet needs. Univariate and multivariable logistic regression analyses were used to evaluate the predictors of impact. Suggestions were developed to improve the practice.ResultsA total of 858 rheumatologists were included in the analysis (27.3% of registered in ArLAR), 37% were 35-44 years old, 60% were females, and 48% worked in the private sector. The impact of COVID-19 was a decrease of 69% in hospitalizations, 65% in outpatient clinic, 56% in infusion centers, and 43% in income. It was associated with the region (highest in the Gulf), use of telemedicine, impact on income and practice sector (lowest in private). There was a hydroxychloroquine shortage in 47%. Telemedicine was mostly based on traditional telephone contacts and e-mails and reimbursed in 12%. Fifteen rheumatologists (1.8%) were infected and 156 cases of COVID-19 were reported among patients. The top-cited unmet needs in rheumatology practice were access to drugs and a telemedicine platform.ConclusionsThe negative impact of the COVID-19 pandemic on rheumatology practice may compromise rheumatic diseases control. Better access to drugs and providing telemedicine platforms are recommended to improve the practice. Key Points • The COVID-19 pandemic had a significant negative impact on the rheumatology practice, including access to outpatient clinic, hospitalization, and to anchor drugs. • The compromised access to rheumatology care may jeopardize the control of chronic rheumatic diseases and the long-term prognosis. • Better access to drugs and providing telemedicine platforms are strongly recommended.
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Project description:Clinical research projects often use traditional methods in which data collection and signing informed consent forms rely on patients' visits to the research institutes. However, during challenging times when the medical community is in dire need of information, such as the current COVID-19 pandemic, it becomes more urgent to use digital platforms that can rapidly collect data on large numbers of patients. In the current manuscript, we describe a novel digital rheumatology research platform, consisting of almost 5000 patients with autoimmune diseases and healthy controls, that was set up rapidly during the COVID-19 pandemic, but which is sustainable for the future. Using this platform, uniform patient data can be collected via questionnaires and stored in a single database readily available for analysis. In addition, the platform facilitates two-way communication between patients and researchers, so patients become true research partners. Furthermore, blood collection via a finger prick for routine and specific laboratory measurements has been implemented in this large cohort of patients, which may not only be applicable for research settings but also for clinical care. Finally, we discuss the challenges and potential future applications of our platform, including supplying tailored information to selected patient groups and facilitation of patient recruitment for clinical trials.
| S-EPMC8338203 | 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.
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Project description:Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015-2018 data and forecasted for 2019-2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic (p = 0.56) whereas trial stoppage increased (p = 0.001). There was a pronounced decrease in trial activation early during the pandemic (p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered.
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Project description:ObjectiveThe purpose of this brief report is to describe lessons learned in recruiting and enrolling midlife Latinas in a pilot study to reduce cardiovascular disease (CVD) risk during the menopause transition. We also discuss strategies implemented to overcome the challenges presented by the novel coronavirus (COVID-19) pandemic.MethodsMenopausia, Salud y Corazo´n is a two-group (intervention, waitlist control), repeated measures study. The intervention consists of CVD risk education, coping skills training, physical activity, and stress management. Eligible participants are peri- and early postmenopausal Latinas age 40 to 60 years, free of CVD. From August 2020 to October 2021, we screened 110 women recruited from cultural events and health fairs (n = 56), local businesses (n = 24), and snowball sampling (n = 30). Of these, 60 were eligible for inclusion and 41 enrolled.ResultsStrategies that contributed to successful recruitment included: a primarily Latina bilingual (English, Spanish) research team; flexibility with location and scheduling of data collection; and multiple modes of communication (ie, mailings, phone calls, and text messages). Additionally, we addressed Latino cultural values such as respeto (respect), familismo (loyalty to family), and confianza (trust). In response to COVID-19, we included virtual recruitment strategies, limited in-person visits, and distributed community resources for COVID-19.ConclusionWe have found that despite the challenges presented by COVID-19, midlife Latinas are receptive to clinical research engagement. Researcher flexibility, multiple recruitment modalities, a bilingual research team, and communication strategies that address cultural values are essential elements for the representation of midlife Latinas in research.
| S-EPMC9256898 | biostudies-literature