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1.
Hepatol Commun ; 7(6)2023 06 01.
Article in English | MEDLINE | ID: covidwho-2326175

ABSTRACT

BACKGROUND: Cirrhosis care and outcomes are improved with access to subspecialty gastroenterology and hepatology care. In qualitative interviews, we investigated clinicians' perceptions of factors that optimize or impede cirrhosis care. METHODS: We conducted 24 telephone interviews with subspecialty clinicians at 7 Veterans Affairs medical centers with high- and low-complexity services. Purposive sampling stratified Veterans Affairs medical centers on timely post-hospitalization follow-up, a quality measure. We asked open-ended questions about facilitators and barriers of care coordination, access to appointments, procedures, transplantation, management of complications, keeping up to date with medical knowledge, and telehealth use. RESULTS: Key themes that facilitated care were structural: multidisciplinary teams, clinical dashboards, mechanisms for appointment tracking and reminders, and local or virtual access to transplant and liver cancer specialists through the "specialty care access network extension for community health care outcomes" program. Coordination and efficient communication between transplant and non-transplant specialists and between transplant and primary care facilitated timely care. Same-day access to laboratory, procedural, and clinical services is an indicator of high-quality care. Barriers included lack of on-site procedural services, clinician turnover, patient social needs related to transportation, costs, and patient forgetfulness due to HE. Telehealth enabled lower complexity sites to obtain recommendations for complex patient cases. Barriers to telehealth included lack of credit (eg, VA billing equivalent), inadequate staff, lack of audiovisual technology support, and patient and staff discomfort with technology. Telehealth was optimal for return visits, cases where physical examination was nonessential, and where distance and transportation precluded in-person care. Rapid telehealth uptake during the COVID-19 pandemic was a positive disruptor and facilitated use. CONCLUSIONS: We identify multi-level factors related to structure, staffing, technology, and care organization to optimize cirrhosis care delivery.


Subject(s)
COVID-19 , Telemedicine , Humans , Pandemics , Liver Cirrhosis , Communication , Patient Care Team
2.
PEC Innov ; 2: 100163, 2023 Dec.
Article in English | MEDLINE | ID: covidwho-2318769

ABSTRACT

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27 - May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

3.
J Intern Med ; 293(5): 636-647, 2023 05.
Article in English | MEDLINE | ID: covidwho-2264836

ABSTRACT

BACKGROUND AND AIMS: Studies have demonstrated that reducing farnesoid X receptor activity with ursodeoxycholic acid (UDCA) downregulates angiotensin-converting enzyme in human lung, intestinal and cholangiocytes organoids in vitro, in human lungs and livers perfused ex situ, reducing internalization of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into the host cell. This offers a potential novel target against coronavirus disease 2019 (COVID-19). The objective of our study was to compare the association between UDCA exposure and SARS-CoV-2 infection, as well as varying severities of COVID-19, in a large national cohort of participants with cirrhosis. METHODS: In this retrospective cohort study among participants with cirrhosis in the Veterans Outcomes and Costs Associated with Liver cohort, we compared participants with exposure to UDCA, with a propensity score (PS) matched group of participants without UDCA exposure, matched for clinical characteristics, and vaccination status. The outcomes included SARS-CoV-2 infection, symptomatic, at least moderate, severe, or critical COVID-19, and COVID-19-related death. RESULTS: We compared 1607 participants with cirrhosis who were on UDCA, with 1607 PS-matched controls. On multivariable logistic regression, UDCA exposure was associated with reduced odds of developing SARS-CoV-2 infection (adjusted odds ratio [aOR] 0.54, 95% confidence interval [CI] 0.41-0.71, p < 0.0001). Among patients who developed COVID-19, UDCA use was associated with reduced disease severity, including symptomatic COVID-19 (aOR 0.54, 95% CI 0.39-0.73, p < 0.0001), at least moderate COVID-19 (aOR 0.51, 95% CI 0.32-0.81, p = 0.005), and severe or critical COVID-19 (aOR 0.48, 95% CI 0.25-0.94, p = 0.03). CONCLUSIONS: In participants with cirrhosis, UDCA exposure was associated with both a decrease in SARS-CoV-2 infection, and reduction in symptomatic, at least moderate, and severe/critical COVID-19.


Subject(s)
COVID-19 , Liver Cirrhosis, Biliary , Humans , Ursodeoxycholic Acid/therapeutic use , COVID-19/complications , Retrospective Studies , SARS-CoV-2 , Liver Cirrhosis/complications , Liver Cirrhosis/drug therapy
4.
Am J Gastroenterol ; 117(7): 1072-1079, 2022 07 01.
Article in English | MEDLINE | ID: covidwho-2259761

ABSTRACT

Telemedicine generally refers to the use of technology to communicate with patients and provide health care from a distance. Advances in technology, specifically computers, cellphones, and other mobile devices, have facilitated healthcare providers' growing ability to virtually monitor and mentor patients. There has been a progressive expansion in the use of telemedicine in the field of gastroenterology (GI), which has been accelerated by the COVID-19 pandemic. In this review, we discuss telemedicine-its history, various forms, and limitations-and its current applications in GI. Specifically, we focus on telemedicine in GI practice in general and specific applications, including the management of inflammatory bowel disease, celiac disease, and colorectal cancer surveillance and its use as an aid in endoscopic procedures.


Subject(s)
COVID-19 , Gastroenterology , Telemedicine , Delivery of Health Care , Gastroenterology/methods , Humans , Pandemics , Telemedicine/methods
5.
Am J Gastroenterol ; 2022 Nov 03.
Article in English | MEDLINE | ID: covidwho-2235420

ABSTRACT

INTRODUCTION: We studied longitudinal trends in mortality, outpatient, and inpatient care for cirrhosis in a national cohort in the first 2 years of the coronavirus disease-2019 pandemic. We evaluated trends in hepatocellular carcinoma (HCC) surveillance and factors associated with completion. METHODS: Within the national cirrhosis cohort in the Veterans Administration from 2020 to 2021, we captured mortality, outpatient primary care provider, gastroenterology/hepatology (GI/HEP) visits, and hospitalizations. HCC surveillance was computed as percentage of time up to date with surveillance every 6 months (PTUDS). Multivariable models for PTUDS were adjusted for patient demographics, clinical factors, and facility-level variables. RESULTS: The total cohort was 68,073; 28,678 were eligible for HCC surveillance. Outpatient primary care provider and GI/HEP appointment rates initially dropped from 30% to 7% with a rebound 1 year into the pandemic and steady subsequent use. Telemedicine monthly visit rates rose from less than 10% to a peak of 20% with a steady gradual decline. Nearly 70% of Veterans were up to date with HCC surveillance before the pandemic with an early pandemic nadir of approximately 50% and 60% PTUDS 2 years into the pandemic. In adjusted models, use of a population-based cirrhosis dashboard (ß 8.5, 95% CI 6.9-10.2) and GI/HEP visits both in-person (ß 3.2, 95% CI 2.9-3.6) and telemedicine (ß 2.1, 95% CI 1.9-2.4) were associated with a higher PTUDS. DISCUSSION: Outpatient utilization and HCC surveillance rates have rebounded but remain below at baseline. Population-based approaches and specialty care for cirrhosis were associated with a higher completion of HCC surveillance.

6.
Ann Intern Med ; 173(2): 100-109, 2020 07 21.
Article in English | MEDLINE | ID: covidwho-1994454

ABSTRACT

BACKGROUND: The evolving outbreak of coronavirus disease 2019 (COVID-19) is requiring social distancing and other measures to protect public health. However, messaging has been inconsistent and unclear. OBJECTIVE: To determine COVID-19 awareness, knowledge, attitudes, and related behaviors among U.S. adults who are more vulnerable to complications of infection because of age and comorbid conditions. DESIGN: Cross-sectional survey linked to 3 active clinical trials and 1 cohort study. SETTING: 5 academic internal medicine practices and 2 federally qualified health centers. PATIENTS: 630 adults aged 23 to 88 years living with 1 or more chronic conditions. MEASUREMENTS: Self-reported knowledge, attitudes, and behaviors related to COVID-19. RESULTS: A fourth (24.6%) of participants were "very worried" about getting the coronavirus. Nearly a third could not correctly identify symptoms (28.3%) or ways to prevent infection (30.2%). One in 4 adults (24.6%) believed that they were "not at all likely" to get the virus, and 21.9% reported that COVID-19 had little or no effect on their daily routine. One in 10 respondents was very confident that the federal government could prevent a nationwide outbreak. In multivariable analyses, participants who were black, were living below the poverty level, and had low health literacy were more likely to be less worried about COVID-19, to not believe that they would become infected, and to feel less prepared for an outbreak. Those with low health literacy had greater confidence in the federal government response. LIMITATION: Cross-sectional study of adults with underlying health conditions in 1 city during the initial week of the COVID-19 U.S. outbreak. CONCLUSION: Many adults with comorbid conditions lacked critical knowledge about COVID-19 and, despite concern, were not changing routines or plans. Noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. PRIMARY FUNDING SOURCE: National Institutes of Health.


Subject(s)
Chronic Disease/epidemiology , Coronavirus Infections/epidemiology , Coronavirus Infections/psychology , Health Knowledge, Attitudes, Practice , Pneumonia, Viral/epidemiology , Pneumonia, Viral/psychology , Vulnerable Populations , Adult , Aged , Aged, 80 and over , Betacoronavirus , COVID-19 , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2 , Self Report , Surveys and Questionnaires , United States/epidemiology
7.
Clin Gastroenterol Hepatol ; 20(7): 1432-1435, 2022 07.
Article in English | MEDLINE | ID: covidwho-1899600
8.
BMJ Open ; 12(1): e052495, 2022 01 07.
Article in English | MEDLINE | ID: covidwho-1613003

ABSTRACT

OBJECTIVES: To examine the prevalence of mental health symptoms during the first surge of COVID-19 in the USA, and their associations with COVID-19-related emotional distress, health self-management and healthcare utilisation. DESIGN: Cross-sectional analysis of wave 3 (1-22 May 2020) survey data from the ongoing Chicago COVID-19 Comorbidities (C3) study. SETTING: Seven academic and community health centres in Chicago, Illinois. PARTICIPANTS: 565 adults aged 23-88 with one or more chronic conditions completing at least one prior C3 study wave. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinically relevant anxiety and depressive symptoms as measured using Patient-Reported Outcomes Measurement Information System short forms. Self-reported emotional and health-related responses to COVID-19 were measured through a combination of single-item questions and validated measures. RESULTS: Rates of anxiety and depressive symptoms were 14% (81/563) and 15% (84/563), respectively. Anxiety and depressive symptoms were then each separately associated with greater worry about contracting COVID-19 (relative risk (RR) 2.32, 95% CI 1.52 to 3.53; RR 1.67, 95% CI 1.10 to 2.54), greater stress (RR 4.93, 95% CI 3.20 to 7.59; RR 3.01, 95% CI 1.96 to 4.61) and loneliness (RR 3.82, 95% CI 2.21 to 6.60; RR 5.37, 95% CI 3.21 to 8.98), greater avoidance of the doctor (RR 1.62, 95% CI 1.06 to 2.49; RR 1.54, 95% CI 1.00 to 2.36) and difficulty managing health (least square means (LS Means) 6.09, 95% CI 5.25 to 6.92 vs 4.23, 95% CI 3.70 to 4.75; LS Means 5.85, 95% CI 5.04 to 6.65 vs 4.22, 95% CI 3.70 to 4.75) and medications (LS Means 3.71, 95% CI 2.98 to 4.43 vs 2.47, 95% CI 2.02 to 2.92) due to the pandemic. CONCLUSIONS: Identifying and addressing mental health concerns may be an important factor to consider in COVID-19 prevention and management among high-risk medical populations.


Subject(s)
COVID-19 , Self-Management , Adult , Anxiety/epidemiology , Chicago/epidemiology , Chronic Disease , Cross-Sectional Studies , Depression/epidemiology , Humans , Pandemics , Prevalence , SARS-CoV-2
9.
Hepatol Commun ; 6(5): 1236-1247, 2022 05.
Article in English | MEDLINE | ID: covidwho-1597604

ABSTRACT

The corona virus disease 2019 (COVID-19) pandemic has had a wide-ranging impact on the clinical practice of medicine and emotional well-being of providers. Our aim was to determine the impact of the COVID-19 pandemic on practice and burnout among hepatology providers. From February to March 2021, we conducted an electronic survey of American Association for the Study of Liver Diseases (AASLD) members who were hepatologists, gastroenterologists, and advanced practice providers (APPs). The survey included 26 questions on clinical practice and emotional well-being derived from validated instruments. A total of 230 eligible members completed the survey as follows: 107 (47%) were adult transplant hepatologists, 43 (19%) were adult general hepatologists, 14 (6%) were adult gastroenterologists, 11 (5%) were pediatric hepatologists, 45 (19%) were APPs, and 9 (4%) were other providers. We found that 69 (30%) experienced a reduction in compensation, 92 (40%) experienced a reduction in staff, and 9 (4%) closed their practice; 100 (43%) respondents reported experiencing burnout. In univariate analysis, burnout was more frequently reported in those ≤55 years old (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.2-4.2), women (OR, 2.2; 95% CI, 1.3-3.7), nontransplant hepatology (OR, 2.0; 95% CI, 1.1-3.3), APPs (OR, 2.7; 95% CI, 1.4-5.1), and those less than 10 years in practice (OR, 1.9; 95% CI, 1.1-3.3). In multivariable analysis, only age ≤55 years was associated with burnout (OR, 2.3; 95% CI, 1.1-4.8). The most common ways the respondents suggested the AASLD could help was through virtual platforms for networking, mentoring, and coping with the changes in practice due to the COVID-19 pandemic. Conclusion: The COVID-19 pandemic has had a substantial impact on the clinical practice of hepatology as well as burnout and emotional well-being. Women, APPs, and early and mid-career clinicians more frequently reported burnout. Identified strategies to cope with burnout include virtual platforms to facilitate networking and mentoring.


Subject(s)
Burnout, Professional , COVID-19 , Gastroenterology , Adult , Burnout, Professional/epidemiology , Burnout, Psychological , COVID-19/epidemiology , Child , Female , Humans , Middle Aged , Pandemics , United States/epidemiology
10.
Transplant Infectious Disease ; n/a(n/a), 2021.
Article in English | Wiley | ID: covidwho-1411012

ABSTRACT

Abstract Background Solid organ transplant recipients (SOTRs) are at increased risk for adverse outcomes with COVID-19. Early data shows a lower SARS-CoV-2 spike antibody immune response among SOTRs leading to patient concerns about vaccine efficacy. Public health messaging has largely left out immunocompromised individuals leading to a higher risk of vaccine misinformation. The American Society of Transplantation recommends COVID-19 vaccination for all SOTRs, however, patient concerns and beliefs about vaccination are largely unknown. Methods We conducted a transplant-center-based, pragmatic pilot trial to encourage COVID-19 vaccination among 103 unvaccinated SOTRs. We assessed vaccine concerns, barriers to vaccination, answered questions about efficacy, side effects, and clinical recommendations. Results A total of 24% (n = 25) of SOTRs reported that they will schedule COVID-19 vaccination after the study call, 46% reported that they will consider vaccination in the future, and 30% said they will not consider vaccination. Older age and White race were associated with lower willingness to schedule the vaccine, whereas Black race and longer time from transplant were associated with higher willingness. Common vaccine concerns included lack of long-term data, inconsistent messaging from providers, scheduling inconvenience, and insufficient resources. Follow-up approximately one month after the initial outreach found 52% (n = 13) of liver transplant recipients (LTRs) and 10% (n = 3) of kidney transplant recipients (KTRs) subsequently received COVID-19 vaccines for a vaccination rate of 29% among respondents. Conclusion Transplant center-based vaccine outreach efforts can decrease misinformation and increase vaccination uptake;however, vaccine-related mistrust remains high. This article is protected by copyright. All rights reserved

12.
Am J Gastroenterol ; 116(6): 1345-1349, 2021 06 01.
Article in English | MEDLINE | ID: covidwho-1194822

ABSTRACT

INTRODUCTION: To assess beliefs about safety, effectiveness, and delivery of the coronavirus disease 2019 (COVID-19) vaccine among chronic Gastroenterology and Hepatology patients at an academic health system. METHODS: We asked about vaccine beliefs, vaccine concerns, and preferred location to receive the COVID-19 vaccine. RESULTS: A total of 1,215 patients responded (response rate: 37%). Most patients believed that vaccines are safe, effective, and that they would take the COVID-19 vaccine at a medical office or pharmacy. However, we identified important sociodemographic factors associated with vaccine hesitancy. DISCUSSION: Patients have high level of trust in the COVID-19 vaccine and are likely to follow their specialist physician recommendations.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Vaccination/psychology , Adult , Aged , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , Chronic Disease , Female , Gastroenterology/statistics & numerical data , Humans , Male , Middle Aged , SARS-CoV-2/immunology , Socioeconomic Factors , Surveys and Questionnaires/statistics & numerical data , Vaccination/adverse effects , Vaccination/statistics & numerical data
14.
Hepatol Commun ; 6(11): 3186-3193, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-897784

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has disrupted health care delivery in the United States, with increased reliance on telemedicine visits as opposed to in-person outpatient appointments. We used national data to evaluate shifts in modes of hepatology outpatient care for patients with cirrhosis during the pandemic. This was a retrospective cohort study among U.S. veterans with cirrhosis. We used linear regression to evaluate absolute and percentage changes from baseline in hepatology in-person visits and telemedicine visits from January 1, 2020, to August 11, 2020. The proportion of in-person and telemedicine visits were plotted geographically to demonstrate state-level shifts in care delivery over time. Patient-level characteristics in the pre-COVID and during-COVID periods were also compared. We identified 5,618 in-person and 6,210 telemedicine hepatology visits among patients with cirrhosis. In-person visits significantly declined (-16.0% per week; 95% confidence interval [CI] -20.7, -11.2; P < 0.001), while telemedicine visits significantly increased (61.3% per week; 95% CI 45.1, 77.5; P < 0.001) in the early during-COVID period. At the U.S. state level, we found that nearly all states experienced a significant shift toward telemedicine over the course of several weeks. Patients over the age of 70 years and Black patients were less likely to receive telemedicine visits in the pre-COVID period (each P < 0.05), although these differences were eliminated in the during-COVID periods. Conclusion: Among patients with cirrhosis, hepatology outpatient care delivery has shifted heavily toward telemedicine due to COVID-19. This occurred across the United States, and changes have been sustained through August 2020. Expanded telemedicine visits among older patients and Black patients may reflect dedicated efforts to increased access to care among these groups.


Subject(s)
COVID-19 , Telemedicine , Humans , United States , Aged , Pandemics , Outpatients , Cohort Studies , Retrospective Studies , Ambulatory Care , Delivery of Health Care , Liver Cirrhosis
16.
Hepatology ; 72(2): 723-728, 2020 08.
Article in English | MEDLINE | ID: covidwho-754841

ABSTRACT

Evidence strongly supports that access to specialty gastroenterology or hepatology care in cirrhosis is associated with higher adherence to guideline-recommended care and improves clinical outcomes. Presently, only about one half of acute care hospitalizations for cirrhosis-related complications result in inpatient specialty care, and the current hepatology workforce cannot meet the demand of patients with liver disease nationwide, particularly in less densely populated areas and in community-based practices not affiliated with academic centers. Telemedicine, defined as the delivery of health care services at a distance using electronic means for diagnosis and treatment, holds tremendous promise to increase access to broadly specialty care. The technology is cheap and easy to use, although it is presently limited in scale by interstate licensing restrictions and reimbursement barriers. The outbreak of severe acute respiratory syndrome coronavirus 2 and coronavirus disease 2019 has, in the short term, accelerated the growth of telemedicine delivery as a public health and social distancing measure. Herein, we examine whether this public health crisis can accelerate the national conversation about broader adoption of telemedicine for routine medical care in non-crisis situations, using a case series from our telehepatology program as a pragmatic example.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Liver Diseases/therapy , Pneumonia, Viral/epidemiology , Telemedicine , Adult , Aged , COVID-19 , Emergencies , Female , Humans , Male , Middle Aged , Pandemics , Patient Acceptance of Health Care , Pilot Projects , SARS-CoV-2
17.
J Gen Intern Med ; 35(11): 3285-3292, 2020 11.
Article in English | MEDLINE | ID: covidwho-739674

ABSTRACT

BACKGROUND: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis. OBJECTIVE: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020). DESIGN: Longitudinal, two-wave telephone survey. PARTICIPANTS: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago. MAIN MEASURES: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness. KEY RESULTS: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.


Subject(s)
COVID-19/psychology , Health Knowledge, Attitudes, Practice , Aged , COVID-19/prevention & control , Chicago , Female , Health Literacy/statistics & numerical data , Humans , Longitudinal Studies , Male , Middle Aged , SARS-CoV-2 , Self Report
18.
Hepatology ; 72(5): 1819-1837, 2020 11.
Article in English | MEDLINE | ID: covidwho-691225

ABSTRACT

The severe acute respiratory syndrome coronavirus 2 pandemic has drastically altered all facets of clinical care and research. Clinical research in hepatology has had a rich tradition in several domains, including the discovery and therapeutic development for diseases such as hepatitis B and C and studying the natural history of many forms of chronic liver disease. National Institutes of Health, foundation, and industry funding have provided important opportunities to advance the academic careers of young investigators while they strived to make contributions to the field. Instantaneously, however, all nonessential research activities were halted when the pandemic started, forcing those involved in clinical research to rethink their research strategy, including a shift to coronavirus disease 2019 research while endeavoring to maintain their preexisting agenda. Strategies to maintain the integrity of ongoing studies, including patient follow-up, safety assessments, and continuation of investigational products, have included a shift to telemedicine, remote safety laboratory monitoring, and shipping of investigational products to study subjects. As a revamp of research is being planned, unique issues that face the research community include maintenance of infrastructure, funding, completion of studies in the predetermined time frame, and the need to reprogram career path timelines. Real-world databases, biomarker and long-term follow up studies, and research involving special groups (children, the homeless, and other marginalized populations) are likely to face unique challenges. The implementation of telemedicine has been dramatically accelerated and will serve as a backbone for the future of clinical research. As we move forward, innovation in clinical trial design will be essential for conducting optimized clinical research.


Subject(s)
Biomedical Research/organization & administration , Coronavirus Infections/prevention & control , Gastroenterology/methods , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Telemedicine/organization & administration , COVID-19 , Coronavirus Infections/epidemiology , Delivery of Health Care , Female , Forecasting , Humans , Male , Needs Assessment , Pandemics/statistics & numerical data , Pneumonia, Viral/epidemiology , Program Development , Program Evaluation , Research Design , United States
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