Veterans Affairs System Research Articles

Bridging the Racial, Ethnic, and Gender Gap in Gastroenterology

Bridging the Racial, Ethnic, and Gender Gap in Gastroenterology

Comparing VA and Non-VA Medical Centers: Informing Veteran Health Care Choice at the MISSION Act Watershed

This study compared clinical quality and patient experience in US Department of Veterans Affairs (VA) and non-VA hospitals. One hospital was identified for each full-service VA hospital (<em>n</em> = 125 pairs). Hospitals were compared on four Agency for Healthcare Research and Quality (AHRQ) clinical indicators: Influenza immunization (IMM-2), Patient Safety Indicator 04 (PSI 04), Catheter-associated Urinary Tract Infection (CAUTI), Methicillin-resistant Staphylococcus aureus infection (MRSA); and three patient experience indicators: the three-item care transition measure (CTM-3) and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) #18 and #19. In aggregate, VA hospitals fared significantly better than non-VA hospitals for PSI 04 and CTM-3. Non-VA hospitals fared significantly better for IMM-2 and HCAHPS #18. No differences were found for CAUTI, MRSA, and HCAHPS #19. At the pairwise level, VA hospitals performed the same as or better than the grand mean for each measure except for IMM-2. This study reinforces previous findings in that the data do not mirror public perception of a universally troubled VA system. This study will be helpful as it is one of the last studies published with the latest pre-MISSION Act data.

Consensus Quality Measures and Dose Constraints for Breast Cancer From the Veterans Affairs Radiation Oncology Quality Surveillance Program and American Society for Radiation Oncology Expert Panel

Using evidence-based radiation therapy to direct care for patients with breast cancer is critical to standardize practice, improve safety, and optimize outcomes. To address this need, the Veterans Affairs (VA) National Radiation Oncology Program (NROP) established the VA Radiation Oncology Quality Surveillance Program to develop clinical quality measures (QMs). The VA NROP contracted with the American Society for Radiation Oncology to commission 5 Blue Ribbon Panels for breast, lung, prostate, rectal, and head and neck cancers. The Breast Cancer Blue Ribbon Panel experts worked collaboratively with the NROP to develop consensus QMs for use throughout the VA system, establishing a set of QMs for patients in several areas, including consultation and work-up; simulation, treatment planning, and treatment; and follow-up care. As part of this initiative, consensus dose-volume histogram (DVH) constraints were outlined. In total, 36 QMs were established. Herein, we review the process used to develop QMs and final consensus QMs pertaining to all aspects of radiation patient care, as well as DVH constraints. The QMs and expert consensus DVH constraints are intended for ongoing quality surveillance within the VA system and centers providing community care for Veterans. They are also available for use by greater non-VA community measures of quality care for patients with breast cancer receiving radiation.

Building a Comprehensive Biopsychosocial Database to Identify Underlying Causes of Suicide and Improve Suicide Prevention.

In June, 2022, the United States Department of Veterans Affairs (VA) announced an initiative to reduce death due to suicide in US Veterans. This column is based on a proposal written for that initiative, as well as on an earlier psychopharmacology column in this journal that reviewed the statistics and the genetics of suicide, and the US medicolegal death investigation system. This system is composed of 3137 county coroner or medical examiner offices across the country that are responsible under state and local law for investigating deaths that are not explained by natural causes and are suspicious and/or unattended. Thus, this system gathers data concerning all deaths due to suicide. Currently this death investigation system costs US taxpayers ∼$660 million per year, and it has determined that ∼45,000 Americans die from suicide each year. In the conduct of these investigations, a large amount of data is collected, including biological samples. While the demographic data are reported to the Centers for Disease Control (CDC), little-if anything-is done with the collected biological material beyond its use in determining the cause of death of the individual. The earlier column on this topic advocated for the establishment of a central database to retain and utilize this information to further understand the biopsychosocial causes of suicide, with the goal of preventing suicides. This column describes a proposal submitted to the VA system for how such a system could initially be piloted in a small group of VA medical centers and then expanded to the entire system. This initial effort could then, in turn, serve as a model for expanding such data gathering to the entire US medicolegal death investigation system.

Increasing volume but declining resident autonomy in laparoscopic inguinal hernia repair: an inverse relationship.

With improved technology and technique, laparoscopic inguinal hernia repair (LIHR) has become a valid option for repairing both initial and recurrent inguinal hernia. Surgical residents must learn both techniques to prepare for future practice. We examined resident operative autonomy between LIHR and open inguinal hernia repair (OIHR) across the Veterans Affairs (VA) system. Utilizing the VA Surgical Quality Improvement Program database, we examined inguinal hernia repairs based on the principal procedure code at all teaching VA hospitals from July 2004 to September 2019. All VA cases are codedforlevel of supervision at the time of surgery: attending primary surgeon (AP); attending scrubbed but resident is a primary surgeon (AR), and resident primarywith attending supervising but not scrubbed (RP). Primary outcomes were the proportion of LIHR versus OIHR and resident autonomy over time. A total of 127,497 hernia repair cases were examined (106,892 OIHR and 20,605 LIHR). There was a higher proportion of RP (8.7% vs 2.2%) and lower proportion of AP (23.9% vs 28.4%) within OIHR compared to LIHR (p < 0.001). The overall proportion of LIHR repairs increased from 9 to 28% (p < 0.001). RP cases decreased for LIHR from 9 to 1% and for OIHR from 17 to 4%, while AP cases increased for LIHR from 16 to 42% and for OIHR from 18 to 30% (all p < 0.001). For RP cases, mortality (0 vs 0.2%, p > 0.99) and complication rates (1.1% vs. 1.7%, p = 0.35) were no different. LIHR at VA hospitals has tripled over the past 15years, now compromising nearly one-third of all inguinal hernia repairs; the majority are initial hernias. Despite this increase, resident autonomy in LIHR cases declined alarmingly. The results demonstrate an urgent need to integrate enhanced minimally invasive training into a general surgery curriculum to prepare residents for future independent practice.

Current use, training, and barriers in point-of-care ultrasound in hospital medicine: A national survey of VA hospitals.

Point-of-care ultrasound (POCUS) can reduce procedural complications and improve the diagnostic accuracy of hospitalists. Currently, it is unknown how many practicing hospitalists use POCUS, which applications are used most often, and what barriers to POCUS use exist. This study aimed to characterize current POCUS use, training needs, and barriers to use among hospital medicine groups (HMGs). A prospective observational study of all Veterans Affairs (VA) medical centers was conducted between August 2019 and March 2020 using a web-based survey sent to all chiefs of HMGs. These data were compared to a similar survey conducted in 2015. Chiefs from 117 HMGs were surveyed, with a 90% response rate. There was ongoing POCUS use in 64% of HMGs. From 2015 to 2020, procedural POCUS use decreased by 19%, but diagnostic POCUS use increased for cardiac (8%), pulmonary (7%), and abdominal (8%) applications. The most common barrier to POCUS use was lack of training (89%), and only 34% of HMGs had access to POCUS training. Access to ultrasound equipment was the least common barrier (57%). The proportion of HMGs with ≥1 ultrasound machine increased from 29% to 71% from 2015 to 2020. An average of 3.6 ultrasound devices per HMG was available, and 45% were handheld devices. From 2015 to 2020, diagnostic POCUS use increased, while procedural use decreased among hospitalists in the VA system. Lack of POCUS training is currently the most common barrier to POCUS use among hospitalists.

Hospital Operative Volume and Esophagectomy Outcomes in the Veterans Affairs System.

Previous studies reported that increased hospital case volume improves outcomes after esophagectomy. Yet, the standard for high and low-volume hospitals varies in the literature. This study attempts to define the relationship between hospital operative volume and 30-day post-operative outcomes of esophagectomy in the Veterans Affairs (VA) system. This is a retrospective review of patients that underwent esophagectomy from 2008 to 2019 utilizing the Veterans Affairs Surgical Quality Improvement Program Database. Receiver operating characteristic (ROC) analysis quantified an inflection point of optimal association between 30-day morbidity and mortality by facility volume. This point was used to separate cohorts for comparison of outcomes using 1:1 propensity score matching (PSM) to account for confounding covariates. Two thousand two hundred and twelve esophagectomies were performed from 2008 to 2019 and ROC analysis identified an inflection point at 43 cases (4 cases/y) where bidirectional operative volume significantly affected outcomes. Subsequent PSM resulted in 1718 cases utilized for analysis (n=859 per cohort). Facility volume ≥4 cases/y was significantly associated with decreased odds of 30-day mortality (odds ratio(OR)=0.57; P=0.03), shorter length of stay (median 13 versus 14d; P=0.04) and longer operative times (6.5 versus 6.0h; P<0.001). VA hospitals that averaged ≥4 esophagectomies/y had significantly lower rates of mortality and length of stay. This volume threshold may serve as a benchmark to determine the optimal setting for esophageal resection. However, our findings also may reflect the benefits of cumulative operating room and multidisciplinary team experience at VA centers in conjunction with dedicated surgeons. Future studies should focus on long-term outcomes after esophagectomy in relation to hospital operative volume.

PCR173 A Call to Action: In Search of Standardized Measures of Whole Health in Eight Nationally Representative Datasets in the United States

The Whole Health (WH) Model is an innovative holistic model that centers around “what is important to the person” rather than the disease-driven approach that focuses more on the disease than the person. The WH model identifies several dimensions to personalized whole health including sleep, nutrition, movement, emotional health, and mind-body therapies. The U.S. Department of Veterans Affairs (VA) has been a pioneer in implementing the WH model with studies on Veterans within the VA system showing promise of improved outcomes.

De-escalating adjuvant durvalumab treatment duration in stage III non-small cell lung cancer

BackgroundOne year of adjuvant durvalumab following concurrent chemoradiotherapy significantly improves progression-free survival (PFS) and overall survival (OS) for patients with stage III non-small cell lung cancer (NSCLC). However, the optimal length of adjuvant therapy has not been determined. MethodsWe identified patients with stage III NSCLC treated with definitive chemoradiation and adjuvant durvalumab from November 2017 to April 2021 from the United States Veterans Affairs system. Predictors of early durvalumab discontinuation were evaluated with Cox proportional hazards regression. The effect of differing durations of durvalumab treatment (up to 6, 9, and 12 months) on PFS and OS were compared with a marginal structural model and time-dependent Cox modelling. ResultsWe included 1006 patients with stage III non-small cell lung cancer who received concurrent chemoradiotherapy and at least one dose of adjuvant durvalumab. The median duration of durvalumab treatment was 7 months (interquartile range 2.8–11.5) and 31% completed the intended durvalumab course. The most common reasons for early discontinuation were tumour progression (22%), immune-related adverse events (15%), and non-immune-related toxicity (6.0%), Marginal structural models suggested similar PFS for 9 months versus 12 months of durvalumab treatment and inferior PFS for 6 months versus 12 months. ConclusionsA substantial proportion of patients undergoing adjuvant durvalumab discontinue therapy early due to toxicity, and shorter durvalumab treatment durations may provide similar disease control to 12 months of therapy. Prospective randomised controlled studies are needed to characterise the optimal durvalumab treatment duration in locally advanced NSCLC patients.

Consensus Quality Measures and Dose Constraints for Rectal Cancer From the Veterans Affairs Radiation Oncology Quality Surveillance Program and American Society for Radiation Oncology (ASTRO) Expert Panel

PurposeEnsuring high quality, evidence-based radiation therapy for patients with cancer is of the upmost importance. To address this need, the Veterans Affairs (VA) Radiation Oncology Program partnered with the American Society for Radiation Oncology and established the VA Radiation Oncology Quality Surveillance program. As part of this ongoing effort to provide the highest quality of care for patients with rectal cancer, a blue-ribbon panel comprised of rectal cancer experts was formed to develop clinical quality measures. Methods and MaterialsThe Rectal Cancer Blue Ribbon panel developed quality, surveillance, and aspirational measures for (a) initial consultation and workup, (b) simulation, treatment planning, and treatment, and (c) follow-up. Twenty-two rectal cancer specific measures were developed (19 quality, 1 aspirational, and 2 surveillance). In addition, dose-volume histogram constraints for conventional and hypofractionated radiation therapy were created. ConclusionsThe quality measures and dose-volume histogram for rectal cancer serves as a guideline to assess the quality of care for patients with rectal cancer receiving radiation therapy. These quality measures will be used for quality surveillance for veterans receiving care both inside and outside the VA system to improve the quality of care for these patients.

Implications of Cross-System Use Among US Veterans With Advanced Kidney Disease in the Era of the MISSION Act

Since 2014, when Congress passed the Veterans Access Choice and Accountability (Choice) Act (replaced in 2018 with the more comprehensive Maintaining Internal Systems and Strengthening Integrated Outside Networks [MISSION] Act), the Department of Veterans Affairs (VA) has been paying for US veterans to receive increasing amounts of care in the private sector (non-VA care or VA community care). However, little is known about the implications of these legislative changes for the VA system. To describe the implications for the VA system of recent increases in VA-financed non-VA care. This qualitative study was a thematic analysis of documentation in the electronic health records (EHRs) of a random sample of US veterans with advanced kidney disease between June 6, 2019, and February 5, 2021. Mentions of community care in participant EHRs. Dominant themes pertaining to VA-financed non-VA care. Among 1000 study participants, the mean (SD) age was 73.8 (11.4) years, and 957 participants (95.7%) were male. Three interrelated themes pertaining to VA-financed non-VA care emerged from qualitative analysis of documentation in cohort member EHRs: (1) VA as mothership, which describes extensive care coordination by VA staff members and clinicians to facilitate care outside the VA and the tendency of veterans and their non-VA clinicians to rely on the VA to fill gaps in this care; (2) hidden work of veterans, which describes the efforts of veterans and their family members to navigate the referral process, and to serve as intermediaries between VA and non-VA clinicians; and (3) strain on the VA system, which describes a challenging referral process and the ways in which cross-system care has stretched the traditional roles of VA staff and clinicians and interfered with VA care processes. The findings of this qualitative study describing VA-financed non-VA care for veterans with advanced kidney disease spotlight the substantial challenges of cross-system use and the strain placed on the VA system, VA staff and clinicians, and veterans and their families in recent years. These difficult-to-measure consequences of cross-system care should be considered when budgeting, evaluating, and planning the provision of VA-financed non-VA care in the private sector.

A Practical Review of Suicide Among Veterans: Preventive and Proactive Measures for Health Care Institutions and Providers.

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.

Association of Use of Electronic Appointment Reminders With Waiting Times in the Veterans Affairs Health System

Electronic appointment reminder systems are increasingly used across health systems. However, their association with patients' waiting times for their appointments, a measure of timely access to care, has yet to be assessed. To assess the associations between the introduction of an electronic appointment reminder system and the number of days patients had to wait from appointment booking to appointment completion in patients in the Veterans Affairs Health System. Cohort study of patients who completed appointments from January 1, 2018, to October 13, 2018, inclusive in all 130 Veterans Affairs (VA) health centers in the US. The study population comprised a census of all patients who received care at any VA health center during the period of the study for outpatient, procedural, rehabilitation, or radiology services. Data were analyzed from May 15, 2021, to December 15, 2021. Phased introduction of an electronic appointment reminder system (VEText) in 6 waves spread across the study period. The unit of observation in this study was a completed appointment made by any such patients. Observations were excluded if the appointment was booked before but completed after the exposure, or if data were duplicated, missing, or incomplete. For each completed appointment, the number of days between which the appointment was booked and when it was completed. The number of observations after exclusion comprised 39.5 million completed appointments from 5.1 million patients (91.1% male) with a mean (SD) age of 62.57 (16.24) years. The adoption of VEText was associated with an estimated reduction in patient waiting time by a mean of 6.51 days (95% CI, 5.51-7.52 days). Adoption of VEText was also associated with an increase of 8.54 (95% CI, 7.65-9.44) days of additional waiting per incomplete booking. Results of this study suggest that appointment reminder systems may be associated with decreases in the mean number of days patients in the VA system have to wait for their appointments but can potentially lengthen waiting times for patients who miss their bookings. Further study is warranted to assess whether these findings may be generalizable to other populations.

Clinical features of dementia cases ascertained by ICD coding in LIMBIC-CENC multicenter study of mild traumatic brain injury

ABSTRACT Objective Describe dementia cases identified through International Classification of Diseases (ICD) coding in the Long-term Impact of Military-relevant Brain Injury Consortium – Chronic Effects of Neurotrauma Consortium (LIMBIC-CENC) multicenter prospective longitudinal study (PLS) of mild traumatic brain injury (mTBI). Design Descriptive case series using cross-sectional data. Methods Veterans Affairs (VA) health system data including ICD codes were obtained for 1563 PLS participants through the VA Informatics and Computing Infrastructure (VINCI). Demographic, injury, and clinical characteristics of Dementia positive and negative cases are described. Results Five cases of dementia were identified, all under 65 years old. The dementia cases all had a history of blast-related mTBI and all had self-reported functional problems and four had PTSD symptomatology at the clinical disorder range. Cognitive testing revealed some deficits especially in the visual memory and verbal learning and memory domains, and that two of the cases might be false positives. Conclusions ICD codes for early dementia in the VA system have specificity concerns, but could be indicative of cognitive performance and self-reported cognitive function. Further research is needed to better determine links to blast exposure, blast-related mTBI, and PTSD to early dementia in the military population.

My Life, My Story: Integrating a Life Story Narrative Component Into Medical Student Curricula.

IntroductionMedical students experience burnout, depersonalization, and decreases in empathy throughout medical training. My Life, My Story (MLMS) is a narrative medicine project that aims to combat these adverse outcomes by teaching students to interview patients about their life story, with the goal of improving patient-centered care competencies, such as empathy.MethodsThe MLMS project was started in the Veterans Affairs (VA) system and has since spread to dozens of VA sites. We adapted and integrated this project into the Warren Alpert Medical School of Brown University curriculum. As part of the required curriculum, first- and third-year medical students participated in a life story interview with a community-based volunteer or a patient in the inpatient hospital setting, transcribed the story, and reviewed the written story with the patient. We assessed student perceptions of the project, changes in empathy, and changes in burnout symptoms.ResultsA total of 240 students participated in this project. Students spent an average of 70.7 minutes interviewing patients. A majority of the students believed MLMS was a good use of time (77%), fostered connection with patients (79%), and was effective in recognizing patients’ thoughts and feelings (69%).DiscussionTo our knowledge, this is one of the first life story interview interventions to be implemented into a required medical school curriculum and outside the VA setting. MLMS may assist students in improving clinical empathy skills and create a structure for medical trainees to better understand their patients.

The Utilization and Impact of Live Interactive and Store-and-Forward Teledermatology in a Veterans Affairs Medical Center During the COVID-19 Pandemic

Introduction: Teledermatology has emerged as a promising method of continuing dermatologic care during the coronavirus 2019 (COVID-19) pandemic, including in the Department of Veterans Affairs (VA). Analysis of the utilization and impact of teledermatology within the San Francisco Veterans Affairs Health Care System (SFVAHCS) may elucidate the ways that teledermatology programs can continue to be optimized. Methods: We conducted a retrospective analysis of live interactive encounters, Veterans Affairs Video Connect (VVC), store-and-forward telehealth (SFT), and face-to-face (FTF) consultations, performed within the SFVAHCS from March 2020 to December 2020. To assess utilization, we analyzed numbers of encounters throughout 2020. To assess impact, we analyzed primary diagnoses for each encounter and rates of recommendations for medications and lesion biopsies. Additionally, we assessed diagnostic accuracy associated with each teledermatology type by measuring concordance between teledermatologists' clinical diagnoses and histopathological diagnoses. Results: Two thousand two hundred fifty FTF, 347 VVC, and 470 SFT encounters were conducted from March to December 2020. More female patients utilized VVC, and patients who utilized VVC were younger than SFT and FTF users (p < 0.01). SFT was utilized more by patients from rural areas (p < 0.01). Diagnoses addressed were significantly different between VVC and SFT. A majority of VVC encounters involved referrals for inflammatory conditions; primary diagnoses associated with SFT consultations were most frequently neoplasms. Comparison of VVC and SFT outcomes showed that more VVC visits resulted in a medication recommendation, while more SFT consultations resulted in a biopsy recommendation. Conclusions: Teledermatology contributed to meeting patient needs throughout 2020 and created an impact on clinical management. Patient characteristics, diagnoses, and type of impact associated with encounters varied between SFT and VVC. This analysis provides insight into teledermatology utilization within the VA system and can contribute to efforts to improve the quality of teledermatology care for veterans.

706. Effect of the Covid-19 Pandemic on Rates of Recurrent Clostridiodes difficile Infection in the Veterans Affairs System

Background Clostridiodes difficile infection (CDI) is common and classified as an urgent threat by the US Centers for Disease Control and Prevention. Recurrence (rCDI) occurs in 30% of cases and increases with subsequent episodes. As part of a trial of fecal microbiota transplantation vs. placebo for the prevention of rCDI, rCDI is identified using a case-finding algorithm that screens for potential cases across all Veterans Affairs facilities, a key component of which is a stool test confirming the presence of C. difficile. With the emergence of Covid-19 in the Unites States in early 2020, study personnel observed a decreasing number of rCDI cases. We hypothesized that Covid restrictions and fear of transmission prevented patients from coming to a VA facility to submit a confirmatory stool sample, the standard method of diagnosing rCDI. Accordingly, the algorithm was modified to also identify cases where rCDI was empirically treated, without confirmatory testing. Here we report on the prevalence of empiric treatment of rCDI during the Covid pandemic and changes in lab-conformed cases over time.MethodsCases of potentially rCDI are identified by a weekly query of VA data, using an algorithm that includes laboratory testing results, diagnostic codes, and prescriptions. The ource database is updated daily from every VA facility, encompassing over 8 million Veterans. Potential cases are reviewed by research coordinators using the medical record to determine study eligibility. Beginning June 2020, the algorithm was adjusted to also identify patients with lab confirmation of their first CDI episode but none for their recurrence and identified those who were prescribed treatment for rCDI.ResultsWe observed a reduction in both the number of weekly cases (22.2 vs. 17.4; P < 0.001) which is a 22% decrease after the Covid-19 emergency declaration (figure). Post-declaration, empiric treatment was prescribed to 159 Veterans (mean, 3.3/week).Potential cases of rCDI/week pre- and post Covid-19 pandemic declaration ConclusionThere was a significant drop in laboratory-confirmed rCDI associated with Covid-19. Recurrent CDI was frequently empirically treated during the Covid-19 pandemic, potentially exposing many patients with non-CDI diarrhea to unnecessary antimicrobial use and its attendant risks.Disclosures All Authors: No reported disclosures

Prognostic and predictive value of neutrophil-to-lymphocyte ratio with adjuvant immunotherapy in stage III non-small-cell lung cancer

BackgroundElevated pre-treatment neutrophil-to-lymphocyte ratio (NLR) may reflect immune dysfunction and is negatively prognostic in cancer patients treated with immunotherapy, but it is unclear if NLR is predictive of immunotherapy benefit. MethodsWe identified stage III non-small-cell lung cancer (NSCLC) patients treated with definitive chemoradiation and adjuvant durvalumab within the national Veterans Affairs system from 2017 to 2021. We compared the prognostic value of NLR measured before durvalumab start to a control group of stage III NSCLC patients treated with definitive chemoradiation alone from 2015 to 2016 (no-durvalumab group) before the approval of adjuvant durvalumab. We estimated the predictive value of NLR through the statistical interaction of durvalumab group by NLR level. Outcomes included progression-free survival (PFS) and overall survival (OS). ResultsThe primary analysis for NLR included 821 durvalumab patients and 445 no-durvalumab patients. Higher NLR was associated with inferior PFS in both groups (no-durvalumab: adjusted HR [aHR] 1.14 per 7.43 unit increase in NLR, 95% confidence interval [CI] 1.06–1.23; durvalumab: aHR 1.42, 95% CI 1.23–1.64), though this effect was greater in durvalumab patients (p for interaction = 0.009). Similar results were found for OS (no-durvalumab: aHR 1.16, 95% CI 1.09–1.24; durvalumab: aHR 1.48, 95% CI 1.25–1.76; p for interaction = 0.010). Absolute lymphocytes, eosinophils, and basophils were not prognostic in either group. Estimates of durvalumab treatment efficacy suggested declining efficacy with higher NLR. ConclusionPre-treatment NLR is especially prognostic among stage III NSCLC patients treated with adjuvant immunotherapy compared to control patients treated without immunotherapy and may be a predictive biomarker of immunotherapy benefit.

The PRagmatic EValuation of evENTs And Benefits of Lipid‐lowering in oldEr adults (PREVENTABLE) trial: Study design and procedures for cognitive assessment and adjudication

AbstractBackgroundNo existing therapies for Alzheimer’s disease and related dementias fundamentally alter the trajectory of the disease. While observational data suggests statins may reduce cognitive and functional decline in older adults, randomized evidence is lacking.MethodThe PRagmatic EValuation of evENTs And Benefits of Lipid‐lowering in oldEr adults (PREVENTABLE) trial is funded by the National Institute on Aging, National Heart, Lung, and Blood Institute, and supported by the Alzheimer’s Association. The trial will test the primary hypothesis that randomization to atorvastatin 40 mg versus placebo results in superior survival free of incident dementia or persistent physical disability over 5 years. The development of mild cognitive impairment (MCI) is a secondary endpoint. The target sample size is 20,000 participants ≥75 years without dementia recruited from 90 sites across the US from the National Patient‐Centered Clinical Research Network and the Veterans Affairs system. The trial will use a pragmatic, standardized telephone‐based cognitive battery, centrally administered annually, which includes a cognitive screener, the Telephone Interview for Cognitive Status‐modified (TICSm). Based on TICSm scoring, an extended phone cognitive battery will be performed that includes measures of attention/executive function, verbal memory, language, and mood. In addition, the Functional Activities Questionnaire will be administered to a trusted contact. A telephone assessment of physical and functional status will also be administered annually. Cognitive and functional data will be adjudicated by a panel of experts, blinded to treatment assignment, to determine the occurrence of MCI (and subtype) or probable dementia.ResultPREVENTABLE will utilize pragmatic data sources (electronic health records and administrative claims) to obtain relevant medical data; however, these mechanisms are unreliable at identifying incident dementia and MCI. The pandemic required modification of cognitive testing, embracing a purely telephonic approach at baseline, which will nonetheless permit cognitive adjudication of participants. Recruitment will be ongoing through April 2023 with results available in 2026.ConclusionPREVENTABLE represents the largest randomized pragmatic trial examining cognitive outcomes associated with statin use in older adults. Launching during the pandemic required adaptation to remote assessment, which will facilitate progress towards efficient and novel methods for pragmatic clinical trials aimed at preventing dementia.

Preventive Cardiology in the Digital and COVID-19 Era: A Brave New World within the Veterans Health Administration.

The past year challenged patients, health care providers, and health systems alike to adapt and recalibrate to meet healthcare needs within pandemic constraints. The coronavirus 2019 (COVID-19) pandemic has radically interfered with the accessibility and delivery of cardiovascular care in the United States. With an emphasis on social distancing and stay-at-home orders in effect, many Americans delayed seeking routine medical care and treatment for acute cardiac symptoms due to fear of contracting the coronavirus. The COVID-19 pandemic compelled a rapid shift toward virtual care solutions across cardiovascular domains. The U.S Department of Veterans Affairs (VA) expanded virtual modalities, notably in specialty care and rehabilitation, which offered secure solutions to maintain treatment continuity. Within the VA and other health systems, virtual cardiac rehabilitation (CR) was embraced as an efficacious alternative to on-site cardiac rehabilitation that enabled patients to receive cardiac care remotely. Leveraging the infrastructure and lessons learned from the pandemic-induced expansion of virtual care carries enormous potential to refine virtual CR and revitalize future treatment paradigms for cardiovascular disease patients.