Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?

We conducted a multi-center pragmatic trial of a low-risk intervention focused on medication adherence using an opt-out consent approach, where patients could opt out by letter and then electronically. We focus on the cohort after opt-out by mail. Here, we describe that 8% of patients opted out electronically, resulting in a 92% participation rate. Patients who self-identify as Black or Hispanic were less likely to opt out in the study, and half the study cohort was female. This demographic data is useful for planning future trials employing this approach.

De-implementation of Axillary Dissection in Women With Breast Cancer is Largely Driven By Site-level Contextual Effects.

OBJECTIVE: To assess the contribution of unknown institutional factors (contextual effects) in the de-implementation of cALND in women with breast cancer. SUMMARY OF BACKGROUND DATA: Women included in the National Cancer Database with invasive breast carcinoma from 2012 to 2016 that underwent upfront lumpectomy and were found to have a positive sentinel node. METHODS: A multivariable mixed effects logistic regression model with a random intercept for site was used to determine the effect of patient, tumor, and institutional variables on the risk of cALND. Reference effect measureswere used to describe and compare the contribution of contextual effects to the variation in cALND use to that of measured variables. RESULTS: By 2016, cALND was still performed in at least 50% of the patients in a quarter of the institutions. Black race, younger women and those with larger or hormone negative tumors were more likely to undergo cALND. However, the width of the 90% reference effect measures range for the contextual effects exceeded that of the measured site, tumor, time, and patient demographics, suggesting institutional contextual effects were the major drivers of cALND de-implementation. For instance, a woman at an institution with low-risk of performing cALND would have 74% reduced odds of havinga cALND than if she was treated at a median-risk institution, while a patient at a high-risk institution had 3.91 times the odds. CONCLUSION: Compared to known patient, tumor, and institutional factors, contextual effects had a higher contribution to the variation in cALND use.

Pre-endoscopy coronavirus disease 2019 screening and severe acute respiratory syndrome coronavirus-2 nucleic acid amplification testing in the Veterans Affairs healthcare system: clinical practice patterns, outcomes, and relationship to procedure volume.

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic has had profound impacts worldwide, including on the performance of GI endoscopy. We aimed to describe the performance and outcomes of pre-endoscopy COVID-19 symptom and exposure screening and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) nucleic acid amplification testing (NAAT) across the national Veterans Affairs healthcare system and describe the relationship of SARS-CoV-2 NAAT use and resumption of endoscopy services. METHODS: COVID-19 screening and NAAT results from March 2020 to April 2021 were analyzed to determine use, performance characteristics of screening, and association between testing and endoscopic volume trends. RESULTS: Of 220,891 completed endoscopies identified, 115,890 (52.5%) had documented preprocedure COVID-19 symptom and exposure screenings and 154,127 (69.8%) had preprocedure NAAT results within 7 days before scheduled endoscopy. Of 131,894 total canceled endoscopies, 26,475 (20.1%) had screening data and 28,505 (21.6%) had SARS-CoV-2 NAAT results. Overall, positive NAAT results were reported in 1.8% of all individuals tested and in 1.3% of those who screened negative. Among completed and canceled endoscopies, COVID-19 screening had a 34.6% sensitivity (95% confidence interval [CI], 32.4%-36.8%) and 96.4% specificity (95% CI, 96.2%-96.5%) when compared with NAAT. COVID-19 screening had a positive predictive value of 15.0% (95% CI, 14.0%-16.1%) and a negative predictive value of 98.7% (95% CI, 98.7%-98.8%). There was a very weak correlation between monthly testing and monthly endoscopy volume by site (Spearman rank correlation coefficient = .09). CONCLUSIONS: These findings have important implications for decisions about preprocedure testing, especially given breakthrough infections among vaccinated individuals during the SARS-CoV-2 delta and omicron variant surge.

Impact of Longitudinal Virtual Primary Care on Diabetes Quality of Care.

BACKGROUND: Lack of healthcare access to due to physician shortages is a significant driver of telemedicine expansion in rural areas. Telemedicine is effective for management of chronic conditions such as diabetes but its effectiveness in primary care settings is unknown. OBJECTIVE: To evaluate differences in diabetes care before and after implementation of a longitudinal virtual primary care program. DESIGN: Propensity score-matched cohort study utilizing difference-in-differences analysis. PARTICIPANTS: Patients with diabetes who received care at VA primary care clinics between January 2018 and December 2019 where the Virtual Integrated Multisite Patient Aligned Care Teams (V-IMPACT) program was implemented. EXPOSURE: Patient participation in at least one V-IMPACT visit while usual care patients did not participate in V-IMPACT. MAIN MEASURES: The primary outcome was change in hemoglobin A1C (HbA1C) and secondary outcomes included change in the proportion of patients meeting diabetes quality indicators: blood pressure control, statin use, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (ACEi/ARB) use, and annual microalbuminuria testing. KEY RESULTS: Our propensity-matched cohort included 9010 patients split evenly between those who participated in V-IMPACT and those who remained in usual in-person care. Among individuals with diabetes who participated in V-IMPACT, the change in mean HbA1C was - 0.055% (95% CI - 0.088 to - 0.022%) while those in usual care had a - 0.047% (95% CI - 0.080 to - 0.014%) change before and after program implementation. We observed a 5.1% (95% CI 2.4 to 7.7%) absolute increase in the proportion prescribed statins in the V-IMPACT group, a 5.3% (95% CI 2.5 to 8.2%) increase prescribed ACE/ARBs, and a 4.6% (95% 1.7 to 7.5%) increase in completed yearly microalbuminuria testing. V-IMPACT was not associated with a significant difference in the proportion with controlled blood pressure at < 140/90 or < 130/90 mmHg thresholds. CONCLUSIONS: Quality of diabetes care delivered by a longitudinal virtual primary care model was similar if not better than traditional in-person care.

Variability in Transitional Care Outcomes Across Hospitals Discharging Veterans to Skilled Nursing Facilities.

BACKGROUND: The period after transition from hospital to skilled nursing facility (SNF) is high-risk, but variability in outcomes related to transitions across hospitals is not well-known. OBJECTIVES: Evaluate variability in transitional care outcomes across Veterans Health Administration (VHA) and non-VHA hospitals for Veterans, and identify characteristics of high-performing and low-performing hospitals. RESEARCH DESIGN: Retrospective observational study using the 2012-2014 Residential History File, which concatenates VHA, Medicare, and Medicaid data into longitudinal episodes of care for Veterans. SUBJECTS: Veterans aged 65 or older who were acutely hospitalized in a VHA or non-VHA hospital and discharged to SNF; 1 transition was randomly selected per patient. MEASURES: Adverse "transitional care" outcomes were a composite of hospital readmission, emergency department visit, or mortality within 7 days of hospital discharge. RESULTS: Among the 365,942 Veteran transitions from hospital to SNF across 1310 hospitals, the composite outcome rate ranged from 3.3% to 23.2%. In multivariable analysis adjusting for patient characteristics, hospital discharge diagnosis and SNF category, no single hospital characteristic was significantly associated with the 7-day adverse outcomes in either VHA or non-VHA hospitals. Very few high or low-performing hospitals remained in this category across all 3 years. The increased odds of having a 7-day event due to being treated in a low versus high-performing hospital was similar to the odds carried by having an intensive care unit stay during the index admission. CONCLUSIONS: While variability in hospital outcomes is significant, unmeasured care processes may play a larger role than currently measured hospital characteristics in explaining outcomes.

Risk of obstructive coronary artery disease and major adverse cardiac events in patients with noncoronary atherosclerosis: Insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program.

We sought to determine the risk of obstructive coronary artery disease (oCAD) associated with noncoronary atherosclerosis (cerebrovascular disease [CVD] or peripheral arterial disease [PAD]) and major adverse cardiac events following percutaneous coronary intervention (PCI). METHODS: Rates of the angiographic end point of oCAD were compared among patients with and without noncoronary atherosclerosis undergoing coronary angiography within the Veterans Health Administration between October 2007 and August 2015. The primary angiographic end point of oCAD was defined as left main stenosis ≥50% or any stenosis ≥70% in 1, 2, or 3 vessels. In patients who proceeded to PCI, the rate of the composite clinical end point of death, myocardial infarction, or stroke was compared among those with concomitant noncoronary atherosclerosis (CVD, PAD, or CVD + PAD) versus isolated CAD. RESULTS: Among 233,353 patients undergoing angiography, 9.6% had CVD, 12.4% had PAD, and 6.1% had CVD + PAD. Rates of oCAD were 57.9% for neither CVD nor PAD, 66.4% for CVD, 73.6% for PAD, and 80.9% for CVD + PAD. Compared with patients without noncoronary atherosclerosis, the adjusted risk of oCAD with CVD, PAD, or CVD + PAD was 1.03 (95% CI 1.02-1.04), 1.10 (95% CI 1.09-1.11), and 1.12 (95% CI 1.11-1.13), respectively. In patients who underwent PCI, the adjusted hazard for death, myocardial infarction, or stroke among those with CVD, PAD, or CVD + PAD was 1.36 (95% CI 1.26-1.45), 1.53 (95% CI 1.45-1.62), and 1.72 (95% CI 1.59-1.86), respectively. CONCLUSIONS: In patients undergoing coronary angiography, noncoronary atherosclerosis was associated with increased burden of oCAD and adverse events post-PCI.

Influence of Nonindex Hospital Readmission on Length of Stay and Mortality.

IMPORTANCE: Hospitals and health care systems face increasing accountability for postdischarge outcomes of patients, but it is unclear how frequently hospital readmissions in particular occur at a different hospital than the index hospitalization and whether this is associated with worse outcomes. OBJECTIVE: Describe the prevalence of nonindex 30-day readmissions in a nationally representative sample of all payers and associations with outcomes. DESIGN: Secondary retrospective analysis of the 2013 Nationwide Readmissions Database. SETTING: Nonfederal hospitals from 21 states representing half of hospitalizations in the United States annually. PARTICIPANTS: Our overall sample included all adults discharged alive from an inpatient stay with 30 days of follow-up; we also created 3 additional cohorts: patients with Medicare as the payer (Medicare cohort), patients discharged to home health or skilled nursing facilities after discharge (postacute care cohort), and Medicare patients with any of the current Hospital Readmission Reduction Program's penalized conditions (readmission penalty cohort). EXPOSURE: Readmission within 30 days to "index" hospital (where index stay occurred) or "nonindex" hospital. MAIN OUTCOME(S) AND MEASURE(S): In-hospital mortality and length of stay during the readmission. RESULTS: The weighted overall sample included 22,884,505 hospital discharges from 2004 unique hospitals. The overall 30-day readmission rate was 11.9%, of these, 22.5% occurred at a nonindex hospital. Readmissions to nonindex facilities were associated with increased odds of in-hospital mortality (odds ratio, 1.21; 95% confidence interval, 1.17-1.25) and longer hospital length of stay (hazard ratio for hospital discharge, 0.87; 95% confidence interval, 0.86-0.88) in the overall sample and in the 3 cohorts. CONCLUSIONS AND RELEVANCE: Nonindex readmissions are common and associated with worse outcomes; the common findings across cohorts highlight the importance for hospitals and care systems participating in value-based payment models. Hospitals and care systems should invest in improved methods for real-time identification and intervention for these patients.

Reference effect measures for quantifying, comparing and visualizing variation from random and fixed effects in non-normal multilevel models, with applications to site variation in medical procedure use and outcomes.

BACKGROUND: Multilevel models for non-normal outcomes are widely used in medical and health sciences research. While methods for interpreting fixed effects are well-developed, methods to quantify and interpret random cluster variation and compare it with other sources of variation are less established. Random cluster variation, sometimes referred to as general contextual effects (GCE), may be the main focus of a study; therefore, easily interpretable methods are needed to quantify GCE. We propose a Reference Effect Measure (REM) approach to 1) quantify GCE and compare it to individual subject and cluster covariate effects, and 2) quantify relative magnitudes of GCE and variation from sets of measured factors. METHODS: To illustrate REM, we consider a two-level mixed logistic model with patients clustered within hospitals and a random intercept for hospitals. We compare patients at hospitals at given percentiles of the estimated random effect distribution to patients at a median or 'reference' hospital. These estimates are then compared numerically and graphically to individual fixed effects to quantify GCE in the context of effects of other measured variables (aim 1). We then extend this approach by comparing variation from the random effect distribution to variation from sets of fixed effects to understand their magnitudes relative to overall outcome variation (aim 2). RESULTS: Using an example of initiation of rhythm control treatment in atrial fibrillation (AF) patients within the Veterans Affairs (VA), we use REM to demonstrate that random variation across hospitals (GCE) in initiation of treatment is substantially greater than that due to most individual patient factors, and explains at least as much variation in treatment initiation as do all patient factors combined. These results are contrasted with a relatively small GCE compared with patient factors in 1 year mortality following hospitalization for AF patients. CONCLUSIONS: REM provides a means of quantifying random effect variation (GCE) with multilevel data and can be used to explore drivers of outcome variation. This method is easily interpretable and can be presented visually. REM offers a simple, interpretable approach for evaluating questions of growing importance in the study of health care systems.

Factors associated with rhythm control treatment decisions in patients with atrial fibrillation-Insights from the NCDR PINNACLE registry.

BACKGROUND: Decisions to use rhythm control in atrial fibrillation (AF) should generally be dictated by patient factors, such as quality of life, heart failure, and other comorbidities. Whether or not other factors affect decisions about the use of rhythm control, and catheter ablation in particular, is unknown. METHODS: A cohort of all patients diagnosed with nonvalvular AF were identified from the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence (PINNACLE) AF registry of US outpatient cardiology practices during the study period from May 1, 2008, to December 31, 2014. Overall and practice-specific rates of rhythm control (cardioversion, antiarrhythmic drug therapy, or catheter ablation) were assessed. We assessed patient and practice factors associated with rhythm control and determined the relative contribution of patient, practice, and unmeasured practice factors with its use. RESULTS: Among 511,958 PINNACLE AF patients, 22.3% were treated with rhythm control and 2.9% underwent catheter ablation. Significant practice variation in rhythm control was present (median rate of rhythm control across practices 22.8%, range 0.2%-62.9%). Significant patient factors associated with rhythm control therapy included white (vs nonwhite) race (odds ratio [OR] 2.43, P<.001), private (vs nonprivate) insurance (OR 1.04, P<.001), and whether a patient was seen by an electrophysiologist (OR 1.77, P<.001). In an analysis of the relative contribution of patient, practice, and unmeasured practice factors with rhythm control, the contribution of unmeasured practice factors (95% range OR 0.29-3.44) exceeded that of either patient (95% range OR 0.46-2.30) or practice (95% range OR 0.15-2.77) factors. CONCLUSIONS: One in 5 AF patients in the PINNACLE registry received rhythm control, and 1 in 50 received catheter ablation, suggesting that rhythm control may be underused. A variety of measured and unmeasured practice factors unrelated to patient characteristics play a disproportionate role in the use of rhythm control treatment decisions. Understanding the drivers of these decisions may identify inappropriate treatment variation and better inform optimal use of these therapies.

Site-level variation in and practices associated with dabigatran adherence.

IMPORTANCE: Unlike warfarin, which requires routine laboratory testing and dose adjustment, target-specific oral anticoagulants like dabigatran do not. However, optimal follow-up infrastructure and modifiable site-level factors associated with improved adherence to dabigatran are unknown. OBJECTIVES: To assess site-level variation in dabigatran adherence and to identify site-level practices associated with higher dabigatran adherence. DESIGN, SETTING, AND PARTICIPANTS: Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data. A total of 67 Veterans Health Administration sites with 20 or more patients filling dabigatran prescriptions between 2010 and 2012 for nonvalvular atrial fibrillation were sampled (4863 total patients; median, 51 patients per site). Forty-seven pharmacists from 41 eligible sites participated in the qualitative inquiry. EXPOSURE: Site-level practices identified included appropriate patient selection, pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring. MAIN OUTCOMES AND MEASURES: Dabigatran adherence (intensity of drug use during therapy) defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more. RESULTS: The median proportion of patients adherent to dabigatran was 74% (interquartile range [IQR], 66%-80%). After multivariable adjustment, dabigatran adherence across sites varied by a median odds ratio of 1.57. Review of practices across participating sites showed that appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. The proportion of adherent patients was higher at sites performing appropriate selection (75% vs 69%), education (76% vs 66%), and monitoring (77% vs 65%). Following multivariable adjustment, association between pharmacist-led education and dabigatran adherence was not statistically significant (relative risk [RR], 0.94; 95% CI, 0.83-1.06). Appropriate patient selection (RR, 1.14; 95% CI, 1.05-1.25), and provision of pharmacist-led monitoring (RR, 1.25; 95% CI, 1.11-1.41) were associated with better patient adherence. Additionally, longer duration of monitoring and providing more intensive care to nonadherent patients in collaboration with the clinician improved adherence. CONCLUSIONS AND RELEVANCE: Among nonvalvular atrial fibrillation patients treated with dabigatran, there was variability in patient medication adherence across Veterans Health Administration sites. Specific pharmacist-based activities were associated with greater patient adherence to dabigatran.

Association of Cardiopulmonary Hemodynamics and Mortality in Veterans With Liver Cirrhosis: A Retrospective Cohort Study.

BACKGROUND: Portopulmonary hypertension (PoPH), associated with increased mortality, can limit treatment options for liver diseases. Data on the continuum of clinical risk related to cardiopulmonary hemodynamics in PoPH are lacking. METHODS AND RESULTS: As part of the United States national Veterans Affairs Clinical Assessment, Reporting, and Tracking database, we performed a retrospective cohort study of adults with cirrhosis undergoing right heart catheterization between October 1, 2017, and September 30, 2022. Pulmonary hypertension (mean pulmonary arterial pressure [mPAP] >20 mm Hg without PoPH) and PoPH (mPAP >20 mm Hg+pulmonary artery wedge pressure ≤15 mm Hg+pulmonary vascular resistance ≥3 WU) were defined by right heart catheterization hemodynamics. Multivariable Cox proportional hazards using natural splines for hemodynamic variables were used to evaluate the association between cardiopulmonary hemodynamics and mortality following right heart catheterization. A total of 4409 patients were included in the final analysis, predominantly men (96.3%), with a mean age of 68.5 years. Pulmonary hypertension and PoPH were observed in 71.6% and 10.2% of the cohort, respectively. Compared with a reference cardiac index of 2.5 L/min per m2, the hazard for mortality increased progressively with decreasing cardiac index, even after adjustment for mPAP and pulmonary vascular resistance. The minority of patients with PoPH (N=65, 14.5%) were prescribed pulmonary vasodilator therapy. CONCLUSIONS: These data suggest that pulmonary hypertension and PoPH are prevalent in veterans with chronic liver disease, but low use of targeted PoPH therapy persists. Cardiac function discriminated mortality risk across a wide range of mPAP and pulmonary vascular resistance values and may diagnose and clarify prognosis in this patient population.

Projected Outcomes of Optimized Statin and Ezetimibe Therapy in US Military Veterans with Coronary Artery Disease.

Importance: Many patients with coronary artery disease (CAD) do not achieve the guideline-directed goals for low-density lipoprotein cholesterol (LDL-C) levels. Objective: To estimate reductions in the rates of adverse events associated with CAD in a large US military veteran population that may be achieved through use of optimized statin therapy alone or with ezetimibe compared with the prevailing lipid-lowering therapy (LLT). Design, Setting, and Participants: In this observational cohort study, US military veterans with CAD were identified by coronary angiography between June 2015 and September 2020 across 82 US Department of Veterans Affairs health care facilities. Exposures: The exposures were observed LLT, LLT with an optimized statin regimen, and LLT with optimized statin and ezetimibe. Main Outcomes and Measures: Observed rates of death, myocardial infarction, stroke, and coronary revascularization, and potential reductions in those outcomes with optimized LLT based on expected further reductions in LDL-C levels and application of formulas from The Cholesterol Treatment Trialists' Collaboration. Results: The analysis cohort comprised 111 954 veterans (mean [SD] age, 68.4 [8.8] years; 109 390 men [97.7%]; 91 589 White patients [81.8%]; 17 592 Black patients [15.7%]). The median (IQR) observation period for this study was 3.4 (2.1-4.0) years. At the time of index angiography, 66 877 patients (59.7%) were treated with statin therapy, and 623 patients (0.6%) were treated with ezetimibe. At 6 months, the number of patients with statin prescriptions increased to 74 400 (68.7%), but the number of patients with high-intensity statin prescriptions was only 57 297 (52.9%). At 6 months, ezetimibe use remained low (n = 1168 [1.1%]), and LDL-C levels were 70 mg/dL or more in 56 405 patients (52.1%). At 4 years, observed incidences of death, myocardial infarction, stroke, and coronary revascularization were 21.6% (95% CI, 21.3%-21.8%), 5.0% (95% CI, 4.9%-5.2%), 2.2% (95% CI, 2.1%-2.3%), and 15.4% (95% CI, 15.2%-15.7%), respectively. With optimized statin treatment, projected absolute reductions in these incidences were 1.3% (95% CI, 0.9%-1.7%), 0.8% (95% CI, 0.7%-1.0%), 0.2% (95% CI, 0.1%-0.3%), and 2.3% (95% CI, 2.0%-2.7%), respectively. With optimized statin and ezetimibe treatment, projected absolute reductions were 1.8% (95% CI, 1.2%-2.4%), 1.1% (95% CI, 0.9%-1.3%), 0.3% (95% CI, 0.2%-0.4%), and 3.1% (95% CI, 2.6%-3.6%), respectively. Conclusions and Relevance: In this cohort study of veterans with CAD, suboptimal LLT was prevalent in the clinical setting. Optimization of statin therapy was projected to produce clinically relevant reductions in the risks of death and cardiovascular events. Despite a lesser lipid-lowering efficacy of ezetimibe, its widespread use on a population level in conjunction with optimized statin therapy may be associated with further meaningful reductions in cardiovascular risk.

Description of patient questions received by clinical pharmacists in the Nudge Study.

PURPOSE: The Nudge Study is a patient level-randomized trial testing different text message medication refill reminders sent to patients assigned to 4 arms: (1) usual care, (2) generic text, (3) optimized text, and (4) optimized text plus chatbot. This report describes the frequency and types of patient questions sent to clinical pharmacists (CPs) following text reminders. METHODS: Patients were enrolled from Denver Health and Hospital Authority (DHHA) and Veterans Affairs Eastern Colorado Health Care System (VA ECHCS) from October 1, 2019, through May 30, 2021. Included patients responded to at least 1 text or interactive voice response (IVR) message. Patients were dichotomized as those who posed at least 1 question to a CP and those who posed no questions. RESULTS: Of the 6,325 patients enrolled in an intervention arm, 3,323 (52.5%) responded to at least 1 text or IVR message, and among those responding, 305 (9.2%) responded with a pharmacist question. Patient factors associated with submitting a CP question included age (45-74 years), enrollment from DHHA, and receipt of the optimized text or optimized text plus chatbot message versus the generic text. Questions to CP were in the following categories: medication related (48.2%), refill logistics (38.4%), cost (9.2%), and other (17.7%). CONCLUSION: In a text messaging intervention focused on medication refills, there were few questions directed to the CP. Patients assigned to receive optimized texts were more likely to have questions. We hypothesize that this may suggest greater patient engagement regarding their condition, resulting in more questions.

Interhospital Variability in Utilization of Cardioversion for Atrial Fibrillation in the Emergency Department.

The role for direct current cardioversion (DCCV) in the management of atrial fibrillation (AF) in the emergency department (ED) is unclear. Factors associated with DCCV in current practice are not well described, nor is the variation across patients and institutions. All ED encounters with a primary diagnosis of AF were identified from the Nationwide Emergency Department Sample from 2006 to 2017. The independent association of patient and hospital factors with use of DCCV was assessed using multivariable hierarchical logistic regression. The relative contributions of patient, hospital, and unmeasured hospital factors were assessed using reference effect measures methods. Among 1,280,914 visits to 3,264 EDs with primary diagnosis of AF, 31,422 patients (2.4%) underwent DCCV in the ED. History of stroke (odds ratio [OR] 0.14, 95% confidence interval [CI] 0.09 to 0.22, p <0.001) and dementia (OR 0.14, 95% CI 0.10 to 0.19, p <0.001) was associated with lowest odds of DCCV. Comparing patients more likely to receive DCCV (ninety-fifth percentile) with patients with median risk, the influence of unmeasured hospital factors (OR 14.13, 95% CI 12.55 to 16.09) exceeded the contributions of patient (OR 5.66, 95% CI 5.28 to 6.15) and measured hospital factors (OR 3.89, 95% CI 2.87 to 5.60). In conclusion, DCCV use in the ED varied widely across institutions. Disproportionately large unmeasured hospital variation suggests that presenting hospital is the most determinative factor in the use of DCCV for ED management of AF. Clarification is needed on best practices for management of AF in the ED, including the use of DCCV.

Transitions of Care Among Patients Undergoing Percutaneous Coronary Intervention for Stable Angina: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Program.

Background Effective transitions from the procedural to outpatient setting are essential to ensure high-quality cardiovascular care across health care systems, particularly among patients undergoing invasive cardiac procedures. We evaluated the association of postprocedural follow-up visits and antiplatelet prescriptions with clinical outcomes among patients undergoing percutaneous coronary intervention for stable angina at community or Veterans Affairs (VA) hospitals. Methods and Results Patients who actively received care within the VA Healthcare System and underwent percutaneous coronary intervention for stable angina at a community or VA hospital between October 1, 2015, and September 30, 2019, were identified. We compared mortality for patients receiving community or VA care, and among subgroups of community-treated patients by the presence of a postprocedural follow-up visit within 30 days or prescription for antiplatelet (P2Y12) medication within 120 days of the procedure. Among 12 837 patients who survived the first 30 days, 5133 were treated at community hospitals, and 7704 were treated in the VA. Prescriptions for antiplatelet therapy were less common for those treated in the community (85%) compared with the VA at 1 year (95%; hazard ratio [HR], 0.46; 95% CI, 0.44-47). Compared with VA-treated patients, the hazards for death were similar for patients treated in the community with a follow-up visit (HR, 1.17; 95% CI, 0.97-1.40) or with a fill for an antiplatelet therapy (HR, 1.08; 95% CI, 0.90-1.30). However, patients treated in the community without a follow-up visit had an 86% (HR, 1.86; 95% CI, 1.40-2.48) increased hazard of death, and those without antiplatelet prescription fill had a 144% increased hazard of death (HR, 2.44; 95% CI, 1.85-3.21) compared with all VA-treated patients. Conclusions Patients treated at community facilities have a decreased chance of receiving antiplatelet prescriptions after percutaneous coronary intervention with a concordant increased hazard of mortality, emphasizing the importance of transitions of care across health care systems when assessing cardiovascular quality.

Association of Residual Ischemic Disease With Clinical Outcomes After Percutaneous Coronary Intervention.

BACKGROUND: Anatomical scoring systems have been used to assess completeness of revascularization but are challenging to apply to large real-world datasets. OBJECTIVES: The aim of this study was to assess the prevalence of complete revascularization and its association with longitudinal clinical outcomes in the U.S. Department of Veterans Affairs (VA) health care system using an automatically computed anatomic complexity score. METHODS: Patients undergoing percutaneous coronary intervention (PCI) between October 1, 2007, and September 30, 2020, were identified, and the burden of prerevascularization and postrevascularization ischemic disease was quantified using the VA SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score. The association between residual VA SYNTAX score and long-term major adverse cardiovascular events (MACE; death, myocardial infarction, repeat revascularization, and stroke) was assessed. RESULTS: A total of 57,476 veterans underwent PCI during the study period. After adjustment, the highest tertile of residual VA SYNTAX score was associated with increased hazard of MACE (HR: 2.06; 95% CI: 1.98-2.15) and death (HR: 1.50; 95% CI: 1.41-1.59) at 3 years compared to complete revascularization (residual VA SYNTAX score = 0). Hazard of 1- and 3-year MACE increased as a function of residual disease, regardless of baseline disease severity or initial presentation with acute or chronic coronary syndrome. CONCLUSIONS: Residual ischemic disease was strongly associated with long-term clinical outcomes in a contemporary national cohort of PCI patients. Automatically computed anatomic complexity scores can be used to assess the longitudinal risk for residual ischemic disease after PCI and may be implemented to improve interventional quality.

Timely Colonoscopy After Positive Fecal Immunochemical Tests in the Veterans Health Administration: A Qualitative Assessment of Current Practice and Perceived Barriers.

INTRODUCTION: The Veterans Health Administration introduced a clinical reminder system in 2018 to help address process gaps in colorectal cancer screening, including the diagnostic evaluation of positive fecal immunochemical test (FIT) results. We conducted a qualitative study to explore the differences between facilities who performed in the top vs bottom decile for follow-up colonoscopy. METHODS: Seventeen semistructured interviews with gastroenterology (GI) providers and staff were conducted at 9 high-performing and 8 low-performing sites. RESULTS: We identified 2 domains, current practices and perceived barriers, and most findings were described by both high- and low-performing sites. Findings exclusive to 1 group mainly pertained to current practices, especially arranging colonoscopy for FIT-positive patients. We observed only 1 difference in the perceived barriers domain, which pertained to primary care providers. DISCUSSION: These results suggest that what primarily distinguishes high- and low-performing sites is not a difference in barriers but rather in the GI clinical care process. Developing and disseminating patient education materials about the importance of diagnostic colonoscopy, eliminating in-person precolonoscopy visits when clinically appropriate, and involving GI in missed colonoscopy appointments and outside referrals should all be considered to increase follow-up colonoscopy rates. Our study illustrates the challenges of performing a timely colonoscopy after a positive FIT result and provides insights on improving the clinical care process for patients who are at substantially increased risk for colorectal cancer.

Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.

ABSTRACT: Opt-out procedures are sometimes used instead of standard consent practices to enable patients to exercise their autonomous preferences regarding research participation while reducing patient and researcher burden. However, little is known about the characteristics of patients who opt-out of research and their reasons for doing so. We gathered such information in a large pragmatic clinical trial (PCT) evaluating the effect of theory informed text messages on medication adherence.Eligible patients, identified through electronic health records, were sent information about the study and provided with an opportunity to opt-out. Those opting out were asked to complete a voluntary survey regarding their reasons for doing so. Demographic data were compared among patients opting-out vs those included in the study using chi-squared tests and a log binomial regression model.Of 9046 patients receiving study packets, 906 (10.0%) patients returned opt-out forms. Of those, 451 (49.8%) returned the opt-out survey. Patients who opted out were more likely to be older, white, and nonHispanic than those who were included in the PCT. Survey respondents expressed high levels of trust in their health care providers, research, and system. Nearly half (46.6%) reported concerns about time as a reason to opt-out.In this PCT, 10% of patients receiving packets opted out, with significant differences in age, race, gender, and ethnicity compared to those included. Future trials should further investigate representativeness and reasons patients choose to opt-out of participating in research.