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Background and Aims: The treatment of chronic hepatitis C (CHC) has evolved from genotype-specific to pan-genotypic direct acting antivirals (DAAs) with high efficacy and safety. However, drug-drug interactions (DDIs) must be avoided when used in combination with other medications, especially with the possible concomitant use of COVID-19 infection antivirals during the COVID-19 pandemic. This study aimed to access the potential DDIs of concomitant drugs with pan-genotypic DAAs and COVID-19 infection antivirals, and actual incidence of DDIs in real-world experience. Method(s): From January 2022 to October 2022, consecutive 116 HCV patients receiving pan-genotypic DAAs were retrospectively enrolled in Taipei Veterans General Hospital. The number of comedications and their potential DDIs with three pan-genotypic DAA regimens and three COVID-19 infection antivirals were analyzed. The actual incidence of DDIs during DAAs treatment were also investigated. Result(s): The mean age was 60.9 years old, with male predominant (55.2%). Of them, 12 (10.3%) patients had cirrhosis, and 24 (20.7%) patients had diabetes mellitus. Most patients were within Child-Pugh class A (109/116, 94.0%). The distribution of HCV genotypes was 8.6% in GT 1a, 36.2% in GT 1b, 39.7% in GT 2, 6.9% in GT 6, and 8.6% in indeterminate genotype, respectively. Of them, 43 (37.1%) patients received GLE/PIB, 69 (59.5%) received SOF/VEL 7plusmn;RBV, and 4 (3.4%) received SOF/VEL/VOX as DAAs regimen. Noteworthy, four patients had COVID-19 infection during DAAs treatment course. The rates of ETVR and SVR12 were 97.6% and 95.3%. The mean number of concomitant medications was 2.01. The distribution of concomitant drugs was 64.7% with no concomitant drug, 11.2% with 1-3 drugs, 11.2% with 4-6 drugs, 9.5% with 7-9 drugs, and 3.4% had more than 9 drugs, respectively. In potential contraindicated (red) DDI class, GLE/PIB was the most prevalent (7.3%), followed by SOF/VEL/VOX (6.4%), and SOF/VEL (1.8%) for non-cirrhosis and compensated cirrhosis patients;and no red DDI occurred in decompensated cirrhosis patients. In addition, the percentage of patients without potential DDIs was higher with SOF/VEL (79.8%) than with the other regimens. The potential red DDIs were predominantly with lipid-lowering agents for DAAs. For potential red DDI class with COVID-19 infection antivirals, Nirmatrelvir/Ritonavir was the most prevalent (6%), followed by Remdesivir (0.9%), and no potential DDIs with Molnupiravir. For COVID-19 antivirals, the potential red DDIs was mainly with central nervous system drugs. Finally, the actual incidence of DDIs during DAAs treatment showed no red DDI occurred for all patients, and GLE/PIB was the most prevalent (93%) of no potential DDIs. Conclusion(s): The potential DDIs between these comedications differed, with the most potential DDIs occurring with GLE/PIB and Nirmatrelvir/Ritonavir. After careful assessment of comedications and their potential DDIs, the actual incidence of DDIs could be reduced, and optimize safety in real-world practice.
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Introduction: Barrett's esophagus (BE) is a metaplastic change in the distal esophagus in which squamous epithelium is replaced by columnar epithelium with goblet cells. Chronic gastroesophageal reflux disease (GERD) is strongly linked to the development of BE, which is a known precursor lesion to esophageal adenocarcinoma (EAC). There is no universal guideline for BE screening, however AJG suggest a single screening endoscopy in patients with chronic GERD symptoms and 3 or more addition risk factors, such as male sex, age > 50 years, white race, tobacco smoking, obesity and family history of BE or EAC. Within the Veteran's Affair (VA) hospital in Northport, New York, many veterans possess multiple risk factors for BE. Residents in VA primary care clinic are diligent in colorectal cancer screening, yet there is concern for limited offerings for BE screening. Our project aims to study the barriers to BE screening within a high-risk veteran population. Method(s): This is a survey-based study. A total of 36 internal medicine residents working in VA primary care clinic were asked to fill out a survey regarding their perspective towards BE screening. The results of the survey are compiled in Table. Result(s): 36 residents within the clinic completed the survey. As shown in Table, 35 out of 36 residents expressed that the primary care clinic does not screen for BE adequately. 30 residents expressed uncertainty regarding referral criteria for BE screening, 24 residents revealed having never referred patients for BE screening. When asked about barriers regarding BE screening, consensus polling showed that there is a lack of resident education surrounding indications for screening. Other common barriers include lack of transportation for veterans to appointments, the COVID 19 pandemic, and lack of health literacy within the veteran population. Conclusion(s): Although there is no established guideline for BE screening, per AJG there is recommendation for a one-time screening endoscopy in susceptible population. VA patients pose a high-risk population that appears to have low screening rates. Patients appear to be placed on long term PPIs without re-assessment and endoscopic screening despite possessing multiple risk factors for BE. Our survey shows that within our resident cohort there is concern for lack of awareness regarding screening criteria for BE. With the initiation of this project, we hope to increase awareness of BE screening within the resident group and improve health outcomes within veteran population. (Table Presented).
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Prison reentry programs attempt to equip justice-involved veterans with life skills necessary for their transition out of prison. This qualitative study addressed the scant understanding of the impact pre-released prison reentry programs have on justice-involved veterans' transition and reintegration back to the community. The purpose of this qualitative study was to describe the perceptions of justice-involved veterans regarding prison reentry programs that have impacted their transition out of prison. The well-being development model and Castro's military-to-civilian transition model provided the conceptual framework for this qualitative study, using semistructured questions to interview 11 justice-involved veterans regarding their participation in prison reentry programs. Directed content analysis was used to categorize, synthesize, and interpret data. The first theme revealed that prison reentry programs helped with transition when there was family support, when one participated in industry reentry training, when there is community support, and housing. The second theme that emerged from the data revealed that prison reentry programs did not help with transition when prison reentry programs were cancelled due to SARS-CoV-2 (COVID-19), prisoners faced difficulty in adjusting, had no knowledge of community resources, received no help from prison, and did not have access to housing, transportation, or healthcare. The research findings may contribute to positive social change by engaging justice-involved veteran stakeholders to review and revise prison reentry policies for justice-involved veterans. (PsycInfo Database Record (c) 2023 APA, all rights reserved)
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Background: Severe outcomes of COVID-19 are associated with advancing age, and multiple medical comorbidities. The impact of COVID-19 on the clinical course of patients with cirrhosis has not been well studied. We determined the effect of SARS-CoV-2 infection on the hospitalization and survival rates of patients with cirrhosis. Method(s): Using ICD-10-CM codes, we identified all Veterans with a diagnosis of cirrhosis in the VA Corporate Data Warehouse and COVID-19 Shared Data Resource. Study cohort included Veterans who were tested for SARS-CoV-2 and had no history of organ transplantation or malignancies. Each SARS-CoV-2 positive case was propensity-score matched by demographics and comorbidities with up to two SARS-CoV-2 negative controls. The primary endpoints were acute care hospitalization, admission to intensive care, respiratory support, or death. Result(s): Of 1,115,037 individuals tested for SARS-CoV-2, 31,680 were noted to have cirrhosis and among them 5,047 (16%) were SARS-CoV-2 positive. After exclusions and propensity-score matching, 5,047 SARS-CoV-2 positive and 9,913 propensity score matched SARS-CoV-2 negative individuals were included in the analysis cohort. Median age was 67 years, 95% were men and 25% were of black race. Median BMI was 30 and history of hypertension, diabetes, cardiovascular and chronic pulmonary disease was noted among 81%, 54%, 56% and 32% respectively. Among all cirrhotic individuals, SARS-CoV-2 positive individuals less frequently progressed to hepatic decompensation (3.1% vs 4.8%, P< 0.0001) or hospitalization (35.7% vs 38.2%, P=0.002), but more frequently required ICU admission 15% vs 12.2%, P< 0.0001) or respiratory support (7.3% vs 8.4%, P=0.01). Among those admitted, length of hospital stay was longer among SARS-CoV-2 positive individuals (7 vs 4 days, P< 0.0001). In Cox regression analysis, SARS-CoV-2 positivity was associated with a higher risk of all-cause mortality (HR 1.37, 95% CI 1.19,1.56). Conclusion(s): Although patients with cirrhosis and COVID-19 were less often hospitalized, they had longer duration of hospitalization and were at higher risk of severe or critical illness and death. (Figure Presented).
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Aim of the study was to evaluate the impact of anti-epidemic measures (CAM) complex on the dynamics of the epidemic process of COVID-19 in a controlled cohort of patients. Material and methods. Patients from 30 social long-term care institutions of the city were included in the study, including neuropsychiatric boarding schools, boarding houses for labor veterans, gerontological centers, and houses for stage veterans. A total of 8303 patients participated in the study, of which 4237 were men (mean age 53.6 years) and 4066 were women (mean age 62.0 years). Vaccination was carried out with Gam-Covid-Vac. Results and discussion. For the entire observation period from March 2020 to August 2021, 1619, cases of COVID-19 or 19.5% of the total number of patients were registered among patients. At the initial epidemic stage (spring-summer 2020), the incidence of COVID-19 among patients was explosive. At the same time, in the autumn-winter period of 2020, an increase in the incidence of COVID-19 was also observed. However, much less pronounced than in April 2020. Despite the progress, it was decided to strengthen the sanitary and anti-epidemic regime in institutions with the introduction of additional preventive measures. One of the most effective long-term algorithms for reducing the infectious disease incidence was vaccination. In this regard, the Moscow Department of Healthcare suggested the need for voluntary vaccination of 100% of patients in all institutions at the beginning of 2021. In the spring of 2021, the number of cases began to increase in the city. The increase in the incidence of COVID-19 was insignificant among the patients of institutions: the maximum number of cases detected in one month during this period was 13 people (in April), or 60.5 times less than in April 2020, and 2.5 times less than in October 2020. The incidence of COVID-19 has become sporadic rather than epidemic. Conclusion. The introduction of CAM in long-term care social institutions in the early stages of the epidemic contributed to a decrease in the incidence of COVID 19. 100% vaccination of patients in combination with other prevention measures reduced the incidence of COVID-19 by more than 28 times. At the same time, it was found that there is a trend of increasing incidence depending on the increase in the level of independent activity of patients.Copyright © 2023 The authors.
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Background: COVID-19 vaccination is effective at preventing symptomatic infection, hospitalization, and death from COVID-19, but many people have experienced barriers to receiving this life preserving intervention. A study examining COVID-19 vaccination in New York state found that persons with HIV (PWH) were less likely to be vaccinated than the general population. We examined whether PWH are less likely to be vaccinated than persons without HIV (PWoH) in the Veterans Affairs (VA) Healthcare System. Method(s): We examined COVID-19 vaccination receipt by HIV status in the Veterans Aging Cohort Study (VACS), an open cohort of PWH and 1:2 age-, race/ethnicity-, sex-, and site-matched PWoH. Among participants with a VA encounter from 10 December 2020 to 12 September 2022, we calculated the proportion of individuals who were fully vaccinated and boosted. Fully vaccinated was defined as: 14 days after second dose of mRNA vaccine (either Pfizer BNT162b2 or Moderna mRNA-1273) or single dose of a viral vector vaccine (Janssen Ad26.COV2.S). Boosted was defined as an additional vaccination at least 180 days after full vaccination. We assessed differences using chi-square tests. Result(s): Among 109,421 participants, PWH (n=31,337) were more likely than PWoH (n=78,084) to be fully vaccinated (77.6% vs 68.7%, p< 0.001) and boosted (71.1% vs 63.0%, p< 0.001) (Table). Most people received an mRNA vaccine with 6.9% of fully vaccinated PWH and 7.5% of fully vaccinated PWoH receiving the Janssen vaccine. Among PWH, having an undetectable HIV viral load was more common in those fully vaccinated than those not fully vaccinated (79.4% vs 72.0%, p< 0.001). Conclusion(s): In a matched cohort of veterans with and without HIV in VA care, we found that PWH were more likely than PWoH to be fully vaccinated and boosted. These findings contrast with a New York state study which found lower COVID-19 vaccination rates in PWH, possibly due to differential healthcare access;all patients in our cohort have access to VA care. Further studies are needed to understand differences in vaccine acceptance and receipt to prevent COVID-19 hospitalizations and deaths. COVID-19 Vaccination in People with HIV (PWH) and People without HIV (PWoH) - Veterans Aging Cohort Study, as of 12 September 2022.
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Background: The role of remdesivir in hospitalized patients with COVID-19 is not clear. Some studies have demonstrated improved clinical outcomes and reduced mortality, while others have failed to show a benefit. Method(s): We used the Department of Veterans Affairs' (VA) national COVID-19 Shared Data Resource database to identify confirmed SARS-CoV-2 infected Veterans between July 1, 2020 and December 31, 2021 who were hospitalized and received remdesivir and propensity-score matched controls who had not received remdesivir. Variables for propensity-score matching included demographics, comorbidities, time and location of diagnosis/admission, severity of illness, and use of other potential COVID-19 therapeutics. Primary outcome of interest was 28-day mortality in the entire matched cohort, and among subgroups stratified by use of supplemental oxygen. Result(s): Among 238,298 SARS-CoV-2 infected Veterans, 31,632 were hospitalized, and 13,147 received remdesivir. Our final dataset included 3,583 remdesivir recipients and 3,583 propensity-score matched controls. Probability of survival at 28 days overall was higher in those who had received remdesivir (P=0.032). Remdesivir recipients had better survival among the group who received supplemental oxygen but did not require mechanical ventilation (P=0.005). Conclusion(s): Remdesivir demonstrated a survival benefit among hospitalized patients with COVID-19 which was limited to those who received supplemental oxygen but did not require mechanical ventilation.
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BACKGROUND: Increasing the adoption of digital care tools, including video visits, is a long-term goal for the US Department of Veterans Affairs (VA). While previous work has highlighted patient-specific barriers to the use of video visits, few have examined how clinicians view such barriers and how they have overcome them during the rapid uptake of web-based care. OBJECTIVE: This study sought input from providers, given their role as critical participants in video visit implementation, to qualitatively describe successful strategies providers used to adapt their practices to a web-based care setting. METHODS: We conducted interviews with 28 VA providers (physicians and nurse practitioners) from 4 specialties that represent diverse clinical services: primary care (n=11), cardiology (n=7), palliative care (n=5), and spinal cord injury (n=5). All interviews were audio recorded and transcribed, and transcripts were reviewed and coded according to an iteratively created codebook. To identify themes, codes were grouped together into categories, and participant comments were reviewed for repetition and emphasis on specific points. Finally, themes were mapped to Expert Recommendations for Implementing Change (ERIC) strategies to identify evidence-based opportunities to support video visit uptake in the VA. RESULTS: Interviewees were mostly female (57%, 16/28), with an average age of 49 years and with 2-20 years of experience working in the VA across 16 unique VA facilities. Most providers (82%, 23/28) worked in urban facilities. Many interviewees (78%, 22/28) had some experience with video visits prior to the COVID-19 pandemic, though a majority (61%, 17/28) had conducted fewer than 50 video visits in the quarter prior to recruitment. We identified four primary themes related to how providers adapt their practices to a web-based care setting: (1) peer-based learning and support improved providers' perceived value of and confidence in video visits, (2) providers developed new and refined existing communication and clinical skills to optimize video visits, (3) providers saw opportunities to revisit and refine team roles to optimize the value of video visits for their care teams, and (4) implementing and sustaining web-based care requires institutional and organizational support. We identified several ERIC implementation strategies to support the use of video visits across the individual-, clinic-, and system-levels that correspond to these themes: (1) individual-level strategies include the development of educational materials and conducting education meetings, (2) clinic-level strategies include identifying champions and revising workflows and professional roles, and (3) system-level strategies include altering incentive structures, preparing implementation blueprints, developing and implementing tools for quality monitoring, and involving executive leadership to encourage adoption. CONCLUSIONS: This work highlights strategies to support video visits that align with established ERIC implementation constructs, which can be used by health care systems to improve video visit implementation.
Subject(s)
COVID-19 , Delivery of Health Care , Telemedicine , Veterans , Female , Humans , Male , Middle Aged , Pandemics , Qualitative Research , United States , United States Department of Veterans AffairsABSTRACT
Suicide rates among veterans are higher than those of the general US population. Although veterans compose only 7.6% of the US population, nearly 14% of American adult suicides are among veterans. The rate of suicide is 1.5 times higher among all veterans and 2.1 times higher among female veterans compared with the general population. Only 47% of all veterans are enrolled in the US Department of Veterans Affairs (VA) Healthcare System, leaving a large number either not receiving health care or receiving it outside the VA. Recent legislation has improved access to care for veterans outside the VA, highlighting the need for a broad public health approach to address veteran suicide and the need for all health care institutions and clinicians to be familiar with the unique health concerns in this population. The purpose of this narrative review was to summarize the risk factors contributing to veteran suicide and to provide guidance on how to assess and mitigate these risks. Suicide is preventable through recognition of risk and prompt intervention. Health care providers both inside and outside the VA system are uniquely situated at the intersection of the many contributing factors to veteran suicide and should have a structured, proactive approach to address the problem.
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BACKGROUND: The COVID-19 pandemic has brought many challenges including barriers to delivering high-quality surgical care and follow-up while minimizing the risk of infection. Telehealth has been increasingly utilized for post-operative visits, yet little data exists to guide surgeons in its use. We sought to determine safety and efficacy of telehealth follow-up in patients undergoing cholecystectomy during the global pandemic at a VA Medical Center (VAMC). METHODS: This was a retrospective review of patients undergoing cholecystectomy at a level 1A VAMC over a 2-year period from August 2019 to August 2021. Baseline demographics, post-operative complications, readmissions, emergency department (ED) visits and need for additional procedures were reviewed. Patients who experienced a complication prior to discharge, underwent a concomitant procedure, had non-absorbable skin closure, had new diagnosis of malignancy or were discharged home with drain(s) were ineligible for telehealth follow-up and excluded. RESULTS: Over the study period, 179 patients underwent cholecystectomy; 30 (17%) were excluded as above. 20 (13%) missed their follow-up, 52 (35%) were seen via telehealth and 77 (52%) followed-up in person. There was no difference between the two groups regarding baseline demographics or intra-operative variables. There was no significant difference in post-operative complications [4 (8%) vs 6 (8%), p > 0.99], ED utilization [5 (10%) vs 7 (9%), p = 0.78], 30-day readmission [3 (6%) vs 6 (8%), p = 0.74] or need for additional procedures [2 (4%) vs 4 (5%), p = 0.41] between telehealth and in-person follow-up. CONCLUSION: Telehealth follow-up after cholecystectomy is safe and effective in Veterans. There were no differences in outcomes between patients that followed up in-person vs those that were seen via phone or video. Routine telehealth follow-up after uncomplicated cholecystectomy should be considered for all patients.
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Background Acute coronary syndrome (ACS) hospital admissions decreased during the start of the COVID-19 outbreak. There is limited information on how Google searches related to patients behavior during this time. Methods We examined de-identified data from 2019 through 2020 regarding monthly: 1) admissions for ACS from the Veterans Affairs Healthcare System;2) out of hospital cardiac arrest (OHCA) from NEMSIS public dataset;and 3) Google searches for "chest pain", "coronavirus", "chest pressure", and "hospital safe" from Google Trends. We analyzed the trends for ACS admissions, OHCA, and Google searches. Results During the early months of the first COVID-19 outbreak: 1)Veterans Affairs data showed a significant reduction in ACS admissions at a national and regional (Florida) level (Figure 1);2) NEMSIS database showed a marked increase in OHCA at a national level;and 3) Google Trends showed a significant increase in the before mentioned Google searches at a national and regional level. Conclusion ACS hospital admissions decreased during the beginning of the pandemic likely due to delayed healthcare utilization secondary to patients fear of acquiring COVID-19 infection. Concordantly, Google searches for hospital safety and ACS symptoms increased along with OHCA events during this time. Our results suggest that Google Trends may be a useful tool to predict patients behavior and increase preparedness for future events, however, statistical strategies to establish association are needed. [Formula presented]Copyright © 2023 American College of Cardiology Foundation
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Background: With the ongoing SARS-CoV-2 pandemic there is concern for development of Long COVID in patients with immune-mediated diseases treated with immunosuppressive agents. We aimed to determine the incidence of Long COVID among Inflammatory Bowel Disease (IBD) patients and to identify associated risk factors. Our study also aimed at studying the differences in risk of Long COVID among different IBD medication exposures. Method(s): We conducted a retrospective cohort study utilizing a nationwide cohort of patients with IBD in the Veteran Affairs Healthcare System (VAHS). Patients diagnosed with SARS-COV-2 between March 10th, 2020, and January 24th, 2021, were included. All charts were reviewed to determine recent IBD hospitalization, hospitalization for SARS-CoV-2 infection, and stability of IBD control pre and post infection. COVID-19 hospitalizations were also reviewed for intensive care unit requirement (ICU). COVID-19 treatments including remdesivir, monoclonal antibody infusions, and corticosteroids were also ascertained. Primary outcome was development of Long COVID. Cox regression analysis was used to identify variables associated with Long COVID. Result(s): A total of 677 patients with SARS-CoV-2 infection were included, of which 49 (7.3%) were diagnosed with Long COVID (Table 1). No significant differences in IBD medication class between patients with and without Long COVID diagnoses were noted. In multivariable regression analysis, COVID-19 hospitalization (HR 3.56, 95% CI 1.80-7.09, p<0.001), ICU requirement (HR 2.20, 95% CI 1.18-4.08, p=0.01), and COPD (HR 2.41, 95% CI 1.03-5.64, p=0.04) were significantly associated with Long COVID (Table 2). Adjusted survival curves showed that relative to patients who were not hospitalized, patients hospitalized in the ICU had an 8.61-fold increased hazard of Long COVID (HR 8.61, 95% CI 3.98-18.65, p<0.001) (Figure 1). Conclusion(s): Hospitalization and ICU care for COVID-19, as well as pre-existing COPD, were associated with increased risk of developing Long COVID, suggesting that severity of infection with a vulnerable substrate are key drivers of risk. Medications used in the treatment of IBD did not impact the risk of Long COVID. These findings should help reassure and inform IBD patients about the risk of Long COVID.
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Over the course of a clinical trial, changes in the practice environment have the potential to reduce internal and external validity and impact change in patient outcomes. Such ''history effects''1 can take the form of changes in standard of care, clinical guidelines and recommendations, new drug/device availability in the marketplace, testing and screening procedures, and, as recently experienced, a global pandemic. Clinical trials conducted over many years are particularly susceptible to history effects. Such effects can impact foundational ability to continue a trial, including clinician equipoise and ability to implement trial interventions, necessitating awareness and action planning. For example, Curtis et al.2 acknowledged challenges with clinical guideline history effects and issued recommendations for addressing them such as consideration of participant wellbeing, stakeholder engagement, safety monitoring, review of guideline and policy changes, and development of rules for protocol changes. This session will explore how four multisite clinical trials conducted with VA Cooperative Studies Program sponsorship and coordination have weathered history effects during prolonged periods of enrollment. Topics to be covered include the implementation of pragmatic designs, monitoring of clinical guidelines, assessing control group treatment conditions, modifying protocols, adjusting quality assurance procedures, refining recruitment pathways, and training site investigators. The speakers, Study Chairs, will describe best practices and provide recommendations for navigating history effects in prolonged multisite clinical trials that can ensure outcomes remain relevant and compelling to inform public health at trial commencement. The CSP 2008/PTXRx study is a pragmatic, randomized, double-blind, placebo-controlled, multicenter clinical trial of Veteran patients with diabetic kidney disease (DKD) examining whether pentoxifylline (PTX), when added to usual care, can delay time to end-stage renal disease or death. Enrollment for the study began in 2019, and it is anticipated that 9 years of follow-up will be required to observe the required number of primary events. Given the long duration of the study, changes in clinical guidelines were anticipated and have occurred, including the approval of new DKD therapies and introduction of a new formula for estimated glomerular filtration rate (eGFR) calculation. In anticipation of these changes, the study design allows for whatever standard of care is extant at any time during the course of the study. PTXR's pragmatic trial design and protocol leverage the VA's research infrastructure and remote platforms allowing the study to be responsive to external changes and to safely continue during a global pandemic. The CSP 596/OPTION study is a randomized, double- blind, multicenter trial of Veteran patients with a first or second recurrent Clostridium difficile infection (CDI) comparing (1) fidaxomicin and (2) vancomycin, followed by a taper and pulse to (3) a standard vancomycin regimen. Since enrollment began in 2016, significant changes in CDI epidemiology and clinical management have impacted the study. The COVID-19 pandemic also resulted in an administrative hold on all trial activity followed by staggered reopening of sites due to variable COVID-19 activity and clinical priorities. Many clinical laboratories switched to algorithms that included free toxin assays in addition to polymerase chain reaction (PCR) tests out of concern for overdiagnosis based on PCR testing alone, reducing the number of potentially enrollable cases. There has been increased empirical vancomycin treatment for recurrent CDI without confirmation by stool testing, a requirement for enrollment, and a recruitment strategy for identifying potential cases. Finally, conflicting clinical guidelines for recurrent CDI has created potential equipoise when considering enrollment. Ongoing educational efforts have been made to clarify the protocol and emphasize the validity of the research question as well as protoco changes to allow safe enrollment and follow-up of participants in the face of the ongoing COVID-19 pandemic. The CSP 2005/VALOR is a phase III randomized, open label, multicenter clinical trial of Veteran patients with operable stage I non-small cell lung cancer that compares stereotactic radiotherapy and anatomic pulmonary resection with a primary outcome measure of overall survival. The study was activated in 2017 and recruitment to the trial has been affected by ongoing changes in public and clinician perceptions about stereotactic radiotherapy and surgery that have interfered with equipoise and willingness of participants to enroll. The study team perpetually addresses this challenge through group conversations with local site investigators, study coordinators, and other research personnel to preserve group equipoise across the study. Since the study's activation, new safety information about stereotactic radiotherapy has emerged necessitating protocol modifications while aiming to preserve internal and external validity. The includes modifying standard operating procedures for the study's centralized quality assurance program that has had to adapt its process to remain contemporary. STARPORT, funded by VA CSRD with CSP collaboration, is a randomized, open label, multicenter clinical trial of Veteran patients with oligorecurrent prostate cancer comparing the effects of standard systemic therapy (SST) alone or with PET-directed local therapy using surgery or radiation. Although enrollment was initiated in 2021, changes are already evident in clinical practice guidelines regarding the use of imaging in workup in this patient population. Shortly before the start of accrual, 18F-DCFPyL PSMA PET/CT received FDA-approval. Consequently, it is being rapidly adopted at the STARPORT VA medical centers and the use of conventional imaging using CT or bone scan prior to PET/CT imaging-part of the original eligibility criteria-quickly is falling out of favor. Furthermore, shortly after the start of enrollment, NCCN guidelines adopted the stance that conventional imaging was no longer required in the setting of PSMA PET/CT imaging, solidifying the transition away from conventional imaging. Thus, the protocol is being amended to remove the requirement for conventional imaging as part of workup for oligorecurrence. In addition, to be generalizable, the study is designed to integrate future PSMA radiotracers that are incorporated into practice as well as changes in SST regimens over the time of the study.
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The Veterans Affairs (VA) Cooperative Studies Program (CSP) and Clinical Science Research and Development (CSRD) are both divisions of the VA Office of Research and Development (ORD) that is responsible for the planning and conduct of clinical trials and epidemiological studies within the VA's learning healthcare system. Since the outbreak of the COVID-19 pandemic in the United States, the VA has been facing some new and evolving challenges in clinical research, especially in planning, prioritizing, and conducting new clinical research projects aimed at preventing and/or treating SARS CoV-2 infection/ COVID-19 disease. In considering clinical research projects, different stakeholders of the VA research enterprise assess needs using numerous parameters: (1) CSP and CSRD leadership: VAMC network infrastructure, financial support, available funding, and enterprise-wide impact. (2) Clinical researchers: clinical perspectives and needs, as they relate to study design and operations, in the context of an ever-evolving epidemiological picture and disease knowledgebase. (3) VA research Coordinating Center(s): the challenges that reside in aspects of trial design and planning, in an effort to account for frequent changes in the COVID-19 epidemiology, and its impact on project feasibility/participant recruitment, choice of study endpoints, safety of healthcare providers, research personnel, and study participants. Notwithstanding these evolving challenges, the VA ORD stood up the VA CoronavirUs Research and Efficacy Studies (VA CURES) network in a coordinated effort to develop a master protocol framework that could efficiently utilize the VA's clinical research infrastructure to address the COVID-19 pandemic. The VA CURES framework has been serving as the umbrella structure encompassing numerous COVID-19 clinical research activities. Both CSP and CSRD have an established clinical research infrastructure, including Coordinating Centers, a Network Of Enrollment Dedicated Sites (NODES) and over 150 VA Medical Centers across the United States, with a clear and streamlined process of submission and review of research proposals (Letters of Intent;LOI), subsequent trial planning leading up to scientific review and, once approved, conduct of research projects. In this session, we will present the VA clinical research infrastructure and share its mobilization in this pandemic. Furthermore, we will share lessons learned in conducting research in emergency situations and how the research infrastructure pivoted and adapted to fulfill its mission of providing the best healthcare to Veterans. The following four areas will be the focus of this session: the VA ORD leadership perspective: Infrastructure/support/funding/priorities;clinical research perspectives: Study design in the face of evolving epidemiological picture;trial design and planning: Protocol drafting/timelines/shifting priorities/feasibility/ VAMC networks;organizing and operationalizing the VA CURES umbrella/platform: CURES-1, and CURES-2.
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Purpose: To explore how families respond to the death and dying of their loved ones in a hospital setting, archival research was conducted using eight qualitative articles describing next-of-kins' perceptions of end-of-life care in Veterans Affairs Medical Centers (VAMCs). The articles were based on the qualitative arm of the VA Health Services Research and Development (HSR&D) study entitled, "Best Practices for End-of-life Care and Comfort Care Order Sets for our Nation's Veterans" (BEACON). Design: The archival research consisted of an interactive methodological process of data immersion, analysis, and interpretation which resulted in the emergence of two overarching thematic frameworks called "losing control" and "holding on." Findings: "Losing control" is the process that occurs when the patient experiences a cascading sequence of deleterious biological events and situations rendering the caregiver no longer able to direct the timing or setting of the dying trajectory. The notion of "holding on" captures family member's responses to the need to maintain control after relinquishing the patient's care to the institutional setting. During the patient's hospitalization, the dual dynamics of "losing control" and "holding on" unfolded in the spatial, temporal, and life narrative domains. Originality: The findings not only contribute to better overall understanding of family members' responses to death in the pre-COVID-19 hospital setting but also heighten the awareness of the complex spatial, temporal, and narrative issues faced by family members who lost a hospitalized loved one during the COVID-19 pandemic. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
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The International Classification of Diseases-11 th Revision (ICD-11) includes the diagnosis of complex posttraumatic stress disorder (CPTSD). Clinical practice guidelines support the use of phased care for individuals with CPTSD. This case study illustrates the use of synchronous telehealth to deliver phased treatment to a rural woman veteran with CPTSD. Mrs. A experienced sexual, physical, and emotional abuse throughout her life, perpetrated by family members, intimate partners, and military authority figures. She sought treatment for posttraumatic nightmares and body image issues;she also had pain related to fibromyalgia and chronic migraine headaches. Mrs. A participated in 19 sessions of Skills Training in Affective and Interpersonal Regulation (STAIR) Narrative therapy via synchronous telehealth. Trauma and eating disorder symptoms were assessed before and after treatment and the patient demonstrated clinically significant improvement on measures of these disorders. Patient-provider working alliance and quality of life were assessed post-treatment. Synchronous telehealth use drastically increased with the onset of COVID-19;however, little information on treating CPTSD via synchronous video teleconferencing is available. This case study illustrates an evidence-based, phased therapy for CPTSD while highlighting the feasibility and value of in-home delivery of psychotherapy for CPTSD via synchronous telehealth.Copyright © The Author(s) 2023.
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Background The impact of COVID-19 on major adverse lower extremity (MALE) and cardiovascular events (MACE) in patients with peripheral artery disease (PAD) is unknown. Methods Using the VA Corporate Data Warehouse, Veterans with PAD were identified. Rates of MALE (amputation or lower extremity revascularization [LER]), and MACE (death, MI, or coronary revascularization) were assessed in pre-pandemic (3/11/2019-3/10/2020), early-pandemic (3/11/2020-3/10/2021), and late-pandemic (3/11/2021-3/10/2022) periods. Outcomes were compared using Kaplan-Meier method. Results Of 418,042 Veterans (mean age 72 yrs) with PAD, 76.7% were white and 96.8% male. Furthermore, 89.2% had HTN, 60.4% diabetes, 49.3% CAD, 21.6% heart failure, and 20.5% atrial fibrillation. From 3/11/2019 to 3/10/2022, 3,100 had amputation, 8,187 had LER, & 2,229 had MACE. Amputation rates declined and continued to decline in early- and late-pandemic period (306 to 268 to 235;p<0.001;rates per 100k). Rates of LER declined initially and stabilized in late-pandemic period (951 to 587 to 609;p < 0.001;rates per 100k). MACE did not change significantly. (215 to 168 to 202;p<0.001;rates per 100k). Conclusion Amputation rates in Veterans with PAD did not increase despite a clinically significant decline in LER. Given the known efficacy of noninvasive therapies in PAD, these data suggest that there is a need to re-evaluate appropriate indications for LER and amputation. [Formula presented]Copyright © 2023 American College of Cardiology Foundation
ABSTRACT
BACKGROUND: The coronavirus disease-2019 (COVID-19) pandemic has caused myriad health, social, and economic stressors. To date, however, no known study has examined changes in mental health during the pandemic in the U.S. military veteran population. METHODS: Data were analyzed from the 2019-2020 National Health and Resilience in Veterans Study, a nationally representative, prospective cohort survey of 3078 veterans. Pre-to-peri-pandemic changes in psychiatric symptoms were evaluated, as well as pre-pandemic risk and protective factors and pandemic-related correlates of increased psychiatric distress. RESULTS: The prevalence of generalized anxiety disorder (GAD) positive screens increased from pre- to peri-pandemic (7.1% to 9.4%; p < 0.001) and was driven by an increase among veterans aged 45-64 years (8.2% to 13.5%; p < 0.001), but the prevalence of major depressive disorder and posttraumatic stress disorder positive screens remained stable. Using a continuous measure of psychiatric distress, an estimated 13.2% of veterans reported a clinically meaningful pre-to-peri-pandemic increase in distress (mean = 1.1 standard deviation). Veterans with a larger pre-pandemic social network size and secure attachment style were less likely to experience increased distress, whereas veterans reporting more pre-pandemic loneliness were more likely to experience increased distress. Concerns about pandemic-related social losses, mental health COVID-19 effects, and housing stability during the pandemic were associated with increased distress, over-and-above pre-pandemic factors. CONCLUSIONS: Although most U.S. veterans showed resilience to mental health problems nearly 1 year into the pandemic, the prevalence of GAD positive screens increased, particularly among middle-aged veterans, and one of seven veterans experienced increased distress. Clinical implications of these findings are discussed.
ABSTRACT
In the summer of 2020, there were multiple efforts to establish safe and effective vaccines that would combat the spread of COVID-19. Efforts to eradicate the virus in the United States included Operation Warp Speed (OWS) which was a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. As the nation's largest integrated healthcare system, the US Department of Veterans Affairs (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines in development. Given the national (and global) importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these OWS COVID-19 vaccine trials. To accomplish this mission, two groups within the VA Office of Research and Development (ORD) partnered to manage and provide support to these sites and facilitate their execution of these trials. The Partnered Research Program (PRP) is a division of VA ORD that is dedicated to developing partnerships that enhance Veterans' access to high-quality, multi-site clinical trials. PRP has an overall goal of establishing long-term relationships with external organizations that are committed to Veterans' health and VA's clinical research mission. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure embedded within the VA healthcare system. CSP is also a division of the VA ORD and was established to provide coordination for, and enable cooperation on, multi-site clinical trials and epidemiological studies that fall within the purview of VA. Its infrastructure comprises a number of Coordinating Centers that are responsible for the planning and conduct of large multi-site clinical trials in the VA healthcare system. CSP also established a consortium of 10 VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES) that have teams (nodes) to provide site-level expertise and innovative approaches in addressing challenges to clinical trial execution. This (poster) outlines the partnership and activities undertaken by VA's PRP and CSP NODES groups to manage and support a large-scale OWS Phase III multi-site clinical trial. It focuses specifically on the determination to designate clinical trial facilitators to study sites, the important role that they played in getting this trial initiated at those sites in a timely fashion, and their work to ensure successful study enrollment.
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic rendered congregate shelter settings high risk, creating vulnerability for people experiencing homelessness (PEH). This study employed participant observation and interviews over 16 months in two Veteran encampments, one located on the grounds of the West Los Angeles Veteran Affairs Medical Center (WLAVA) serving as an emergency COVID-19 mitigation measure, and the other outside the WLAVA gates protesting the lack of onsite VA housing. Study participants included Veterans and VA personnel. Data were analyzed using grounded theory, accompanied by social theories of syndemics, purity, danger, and home. The study reveals that Veterans conceptualized home not merely as physical shelter but as encompassing a sense of inclusion and belonging. They sought a Veteran-run collective with a harm reduction approach to substance use, onsite healthcare, and inclusive terms (e.g., no sobriety requirements, curfews, mandatory treatment, or limited lengths of stay). The twin encampments created distinct forms of community and care that protected Veterans from COVID-19 infection and bolstered collective survival. The study concludes that PEH constitute and belong to communities that provide substantial benefits even while amplifying certain harms. Housing interventions must consider how unhoused individuals become, or fail to become, integrate into various communities, and foster therapeutic community connections.