National Trends in Hospital Performance in Guideline-Recommended Pharmacologic Treatment for Heart Failure at Discharge.

BACKGROUND: The use of recommended heart failure (HF) medications has improved over time, but opportunities for improvement persist among women and at rural hospitals. OBJECTIVES: This study aims to characterize national trends in performance in the use of guideline-recommended pharmacologic treatment for HF at U.S. Department of Veterans Affairs (VA) hospitals, at which medication copayments are modest. METHODS: Among patients discharged from VA hospitals with HF between January 1, 2013, and December 31, 2019, receipt of all guideline-recommended HF pharmacotherapy among eligible patients was assessed, consisting of evidence-based beta-blockers; angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor neprilysin inhibitors; mineralocorticoid receptor antagonists; and oral anticoagulation. RESULTS: Of 55,560 patients at 122 hospitals, 32,304 (58.1%) received all guideline-recommended HF medications for which they were eligible. The proportion of patients receiving all recommended medications was higher in 2019 relative to 2013 (OR: 1.54; 95% CI: 1.44-1.65). The median of hospital performance was 59.1% (Q1-Q3: 53.2%-66.2%), improving with substantial variation across sites from 2013 (median 56.4%; Q1-Q3: 50.0%-62.0%) to 2019 (median 65.7%; Q1-Q3: 56.3%-73.5%). Women were less likely to receive recommended therapies than men (adjusted OR [aOR]: 0.84; 95% CI: 0.74-0.96). Compared with non-Hispanic White patients, non-Hispanic Black patients were less likely to receive recommended therapies (aOR: 0.83; 95% CI: 0.79-0.87). Urban hospital location was associated with lower likelihood of medication receipt (aOR: 0.73; 95% CI: 0.59-0.92). CONCLUSIONS: Forty-two percent of patients did not receive all recommended HF medications at discharge, particularly women, minority patients, and those receiving care at urban hospitals. Rates of use increased over time, with variation in performance across hospitals.

Protocol for a pragmatic trial testing a self-directed lifestyle program targeting weight loss among patients with obstructive sleep apnea (POWER Trial).

BACKGROUND: Obesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA. METHODS: POWER randomizes 696 patients with obesity (BMI 30-45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation. CONCLUSIONS: The results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost.

Clinical Characteristics and Outcomes Among People Living With HIV Undergoing Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Clinical characteristics and outcomes in people living with HIV (PLWH) undergoing percutaneous coronary intervention (PCI) remain poorly described. We sought to compare real-world treatment of coronary artery disease, as well as patient and procedural factors and outcomes after PCI between PLWH and uninfected controls. Methods and Results We utilized procedural registry data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program between January 1, 2009 and December 31, 2019 to analyze patients with obstructive coronary artery disease on angiography. In the PCI subgroup, we used inverse probability of treatment weighting and applied Cox proportional hazards to evaluate the association of HIV serostatus with outcomes, including all-cause mortality at 5 years. Among 184 310 patients with obstructive coronary artery disease, treatment strategy was similar between PLWH and controls-35.7% versus 34.2% PCI, 13.6% versus 15% coronary artery bypass grafting, and 50.7% versus 50.8% medical therapy. The PCI cohort consisted of 546 (0.9%) PLWH and 56 811 (99.1%) controls. PLWH undergoing PCI had well-controlled HIV disease, and compared with controls, were younger, more likely to be Black, had fewer traditional risk factors, more acute coronary syndrome, less extensive coronary artery disease, and similar types of stents and P2Y12 therapy. However, PLWH experienced worse survival as early as 6 months post-PCI, which persisted over time and amounted to a 21% increased mortality risk by 5 years (hazard ratio, 1.21 [95% CI, 1.03-1.42; P=0.02]). Conclusions Despite well-controlled HIV disease, a more favorable overall cardiovascular risk profile, and similar PCI procedural metrics, PLWH still have significantly worse long-term survival following PCI than controls.

The Influence of the Rural Transitions Nurse Program for Veterans on Healthcare Utilization Costs.

BACKGROUND: The Veterans Affairs (VA) Healthcare System Rural Transitions Nurse Program (TNP) addresses barriers veterans face when transitioning from urban tertiary VA hospitals to home. Previous clinical evaluations of TNP have shown that enrolled veterans were more likely to follow up with their primary care provider within 14 days of discharge and experience a significant reduction in mortality within 30 days compared to propensity-score matched controls. OBJECTIVE: Examine changes from pre- to post-hospitalization in total, inpatient, and outpatient 30-day healthcare utilization costs for TNP enrollees compared to controls. DESIGN: Quantitative analyses modeling the changes in cost via multivariable linear mixed-effects models to determine the association between TNP enrollment and changes in these costs. PARTICIPANTS: Veterans meeting TNP eligibility criteria who were discharged home following an inpatient hospitalization at one of the 11 implementation sites from April 2017 to September 2019. INTERVENTION: The four-step TNP transitional care intervention. MAIN MEASURES: Changes in 30-day total, inpatient, and outpatient healthcare utilization costs were calculated for TNP enrollees and controls. KEY RESULTS: Among 3001 TNP enrollees and 6002 controls, no statistically significant difference in the change in total costs (p = 0.65, 95% CI: (- $675, $350)) was identified. However, on average, the increase in inpatient costs from pre- to post-hospitalization was approximately $549 less for TNP enrollees (p = 0.02, 95% CI: (- $856, - $246)). The average increase in outpatient costs from pre- to post-hospitalization was approximately $421 more for TNP enrollees compared to controls (p = 0.003, 95% CI: ($109, $671)). CONCLUSIONS: Although we found no difference in change in total costs between veterans enrolled in TNP and controls, TNP was associated with a smaller increase in direct inpatient medical costs and a larger increase in direct outpatient medical costs. This suggests a shifting of costs from the inpatient to outpatient setting.

Multifaceted Intervention to Improve P2Y12 Inhibitor Adherence After Percutaneous Coronary Intervention: A Stepped Wedge Trial.

Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients' bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (-3.4%; 98.3% CI, -1.2% to -5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%-7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%-4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (-1.7%; 98.3% CI, -2.3% to -1.1%). Conclusions A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

Iso-osmolar versus low-osmolar contrast media and outcomes after percutaneous coronary intervention: Insights from the VA CART Program.

OBJECTIVES: To assess whether contrast media type is associated with outcomes in veterans undergoing percutaneous coronary intervention (PCI). BACKGROUND: There is uncertainty about the impact of iso-osmolar contrast medium (IOCM) versus low-osmolar contrast medium (LOCM) on acute kidney injury (AKI) and other major adverse renal or cardiovascular events (MARCE) after PCI. We assessed the association between contrast media type and MARCE in patients who underwent PCI within the Veterans Administration Healthcare System. METHODS: We reviewed PCIs performed between 2009 and 2019 using data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. The primary endpoint was MARCE, a composite of myocardial infarction, stroke, all-cause death, AKI, and dialysis onset at 30 days. RESULTS: The analysis cohort consisted of 50,389 patients of whom 25,555 received LOCM and 24,834 received IOCM. There was significant variation in contrast type across sites. After adjustment for comorbidities, no significant association between contrast media type and MARCE was observed in both site-unadjusted (odds ratio [OR] for IOCM: 0.99; 95% confidence interval [CI]: 0.92-1.08; p = 0.97) and site-adjusted (OR: 1.06; 95% CI: 0.95-1.18; p = 0.30) analyses. Similar results were obtained when contrast volume was imputed or the data was subset to individuals with available contrast volume. CONCLUSION: In a large cohort of veterans undergoing PCI, we found considerable site variation in the type of contrast media used but no significant association between contrast media type and the incidence of MARCE, both before and after adjustment for the site.

Radial versus femoral access for left main percutaneous coronary intervention: An analysis from the Veterans Affairs Clinical, Reporting, and Tracking Program.

OBJECTIVES: We aimed to compare clinical characteristics and procedural outcomes of left main percutaneous interventions (LM-PCI) by transradial (TRA) versus transfemoral (TFA) approach in the VA healthcare system. BACKGROUND: TRA for percutaneous coronary intervention (PCI) is steadily increasing. However, the frequency and efficacy of TRA for LM-PCI remain less studied. METHODS: All LM-PCIs performed in the VA healthcare system were identified for fiscal year 2008 through 2018. Patients' baseline characteristics and procedure-related variables were compared by access site. Both short- and long-term clinical outcomes were analyzed using propensity score matching. RESULTS: A total of 4004 LM-PCI were performed in the VA via either radial or femoral access from 2008 to 2018. Among these, 596 (14.9%) LM PCIs were performed via TRA. Use of TRA for LM-PCI increased from 2.2% to 31.5% over the study period. Propensity matched outcome analysis, comparing TRA versus TFA, showed a similar procedural success (98.4% for TRA vs. 97.8% for TFA; RR: 1.01 [0.98, 1.03]) and 1-year major adverse cardiovascular events (MACE) (25.9% for TRA vs. 26.8% TFA; RR: 0.96 [0.74, 1.25]). There were no statistically significant differences among secondary outcomes analyses including major bleeding. CONCLUSION: Use of TRA for LM-PCI has been steadily increasing in the VA healthcare system. These findings demonstrate similar procedural success and 1-year MACE across access strategies, suggesting an opportunity to continue increasing TRA use for LM-PCI.

The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial.

BACKGROUND: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral "nudges" using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. METHODS: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. DISCUSSION: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment. TRIAL REGISTRATION: ClinicalTrials.gov NCT03973931 . Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study.

BACKGROUND: Medication refill behavior in patients with cardiovascular diseases is suboptimal. Brief behavioral interventions called Nudges may impact medication refill behavior and can be delivered at scale to patients using text messaging. METHODS: Patients who were prescribed and filled at least one medication for hypertension, hyperlipidemia, diabetes, atrial fibrillation, and coronary artery disease were identified for the pilot study. Patients eligible for the pilot (N=400) were enrolled with an opportunity to opt out. In phase I of the pilot, we tested text message delivery to 60 patients. In phase II, we tested intervention feasibility by identifying those with refill gap of ≥7 days and randomized them to intervention or control arms. Patients were texted Nudges and assessed whether they refilled their medications. RESULTS: Of 400 patients sent study invitations, 56 (14%) opted out. In phase I, we successfully delivered text messages to 58 of 60 patients and captured patient responses via text. In phase II, 207 of 286 (72.4%) patients had a medication gap ≥7 days for one or more cardiovascular medications and were randomized to intervention or control. Enrolled patients averaged 61.7 years old, were primarily male (69.1%) and White (72.5%) with hypertension being the most prevalent qualifying condition (78.7%). There was a trend towards intervention patients being more likely to refill at least 1 gapping medication (30.6% versus 18.0%; P=0.12) and all gapping medications (17.8% versus 10.0%; P=0.27). CONCLUSIONS: It is possible to set up automated processes within health care delivery systems to identify patients with gaps in medication adherence and send Nudges to facilitate medication refills. Text message Nudges could potentially be a feasible and effective method to facilitate medication refills. A large multi-site randomized trial to determine the impact of text-based Nudges on overall CVD morbidity and mortality is now underway to explore this further. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03973931.

Association Between Increased Hospital Reimbursement for Cardiac Rehabilitation and Utilization of Cardiac Rehabilitation by Medicare Beneficiaries: An Interrupted Time Series.

BACKGROUND: Although cardiac rehabilitation (CR) is a Class I Guideline recommendation, and has been shown to be a cost-effective intervention after a cardiac event, it has been reimbursed at levels insufficient to cover hospital operating costs. In January 2011, Medicare increased payment for CR in hospital outpatient settings by ≈180%. We evaluated the association between this payment increase and participation in CR of eligible Medicare beneficiaries to better understand the relationship between reimbursement policy and CR utilization. METHODS: From a 5% Medicare claims sample, we identified patients with acute myocardial infarction, coronary artery bypass surgery, percutaneous coronary intervention, or cardiac valve surgery between January 1, 2009 and September 30, 2012, alive 30 days after their event, with continuous enrollment in Medicare fee-for-service, Part A/B for 4 months. Trends and changes in CR participation were estimated using an interrupted time series approach with a hierarchical logistic model, hospital random intercepts, adjusted for patient, hospital, market, and seasonality factors. Estimates were expressed using average marginal effects on a percent scale. RESULTS: Among 76 695 eligible patients, average annual CR participation was 19.5% overall. In the period before payment increase, adjusted annual participation grew by 1.1 percentage points (95% CI, 0.48-2.4). No immediate change occurred in CR participation when the new payment was implemented. In the period after payment increase, on average, 20% of patients participated in CR annually. The annual growth rate in CR participation slowed in the post-period by 1.3 percentage points (95% CI, -2.4 to -0.12) compared with the prior period. Results were somewhat sensitive to time window variations. CONCLUSIONS: The 2011 increase in Medicare reimbursement for CR was not associated with an increase in participation. Future studies should evaluate whether payment did not reach a threshold to incentivize hospitals or if hospitals were not sensitive to reimbursement changes.

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

BACKGROUND: Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site. METHODS: We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort. RESULTS: We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, P<0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; P=0.107) and after (3% versus 3%; P=0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; P<0.001) and increased at comparable rates (2% versus 1%, P=0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, P=0.025) such that it was similar at the end of the study (P=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching. CONCLUSIONS: There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.

Factors associated with long-term survival in patients with stroke after coronary artery bypass grafting.

OBJECTIVE: Occurrence of a stroke within 30 days following coronary artery bypass grafting (CABG) is an uncommon, but often devastating, complication. This study aimed to identify factors associated with long-term survival (beyond 30 days) in patients with stroke after CABG. METHODS: De-identified patients' records from the Veterans Affairs Surgical Quality Improvement Program database were used to identify risk factors and perioperative complications associated with survival for up to 20 years in patients with post-CABG stroke. The multivariable Cox proportional hazards model was used for analyzing survival. RESULTS: The median survival time for patients with stroke (n = 1422) was 6.7 years. The mortality rate for these patients was highest in the first year post-CABG and was significantly elevated compared with non-stroke patients. Survival rates at 1, 5, and 10 years for stroke versus non-stroke patients were 79% vs. 96%, 58% vs. 83%, and 36% vs. 63%, respectively. High preoperative serum creatinine levels, postoperative occurrence of renal failure, prolonged ventilation, coma, and reoperation for bleeding were important predictors of 1-year mortality of patients with post-CABG stroke. CONCLUSIONS: Veterans with post-CABG stroke have a considerably higher risk for mortality during the first year compared with patients without stroke.

Noninvasive Ventilation Use in Critically Ill Patients with Acute Asthma Exacerbations.

Rationale: Noninvasive ventilation decreases the need for invasive mechanical ventilation and mortality among patients with chronic obstructive pulmonary disease but has not been well studied in asthma.Objectives: To assess the association between noninvasive ventilation and subsequent need for invasive mechanical ventilation and in-hospital mortality among patients admitted with asthma exacerbation to the ICU.Methods: We performed a retrospective cohort study using administrative data collected during 2010-2017 from 682 hospitals in the United States. Outcomes included receipt of invasive mechanical ventilation and in-hospital mortality. Generalized estimating equations, propensity-matched models, and marginal structural models were used to assess the association between noninvasive ventilation and outcomes.Measurements and Main Results: The study population included 53,654 participants with asthma exacerbation. During the study period, 13,540 patients received noninvasive ventilation (25.2%; 95% confidence interval [CI], 24.9-25.6%), 14,498 underwent invasive mechanical ventilation (27.0%; 95% CI, 26.7-27.4%), and 1,291 died (2.4%; 95% CI, 2.3-2.5%). Among those receiving noninvasive ventilation, 3,013 patients (22.3%; 95% CI, 21.6-23.0%) required invasive mechanical ventilation after first receiving noninvasive ventilation, 136 of whom died (4.5%; 95% CI, 3.8-5.3%). Across all models, the use of noninvasive ventilation was associated with a lower odds of receiving invasive mechanical ventilation (adjusted generalized estimating equation odds ratio, 0.36; 95% CI, 0.32-0.40) and in-hospital mortality (odds ratio, 0.48; 95% CI 0.40-0.58). Those who received noninvasive ventilation before invasive mechanical ventilation were more likely to have comorbid pneumonia and severe sepsis.Conclusions: Noninvasive ventilation use during asthma exacerbation was associated with improved outcomes but should be used cautiously with acute comorbid conditions.

Bayesian profiling for cost with zeros to decompose total cost into probability of cost and mean nonzero cost.

Cost of health care can vary substantially across hospitals, centers, or providers. Data from electronic health records provide information for studying patterns of cost variation and identifying high or low cost centers. Cost data often include zero values when patients receive no care, and joint two-part models have been developed for clustered cost data with zeros. Standard methods for center comparisons, sometimes called profiling, can use these methods to incorporate zero values into total cost. However, zero costs also provide opportunities to further examine sources of cost variation and outliers. For example, a hospital may have high (or low) cost due to frequency of nonzero cost, amount of nonzero cost, or a combination of those. We give methods for decomposing hospital differences in total cost with zeros into components for probability of use (i.e., of nonzero cost) and for cost of use (mean of nonzero cost). The components multiply to total cost and quantify components on the same easily interpreted multiplicative scales. The methods are based on Bayesian hierarchical models and counterfactual arguments, with Markov chain Monte Carlo estimation. We used simulated data to illustrate use, interpretation, and visualization of the methods in diverse situations, and applied the methods to 30,024 patients at 57 US Veterans Administration hospitals to characterize outlier hospitals in one year cost of inpatient care following a cardiac procedure. Twenty eight percent of patients had zero cost. These methods are useful in providing insight into cost variation and outliers for planning future studies or interventions.

Appropriateness of Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease in US Department of Veterans Affairs Hospitals From 2013 to 2015.

Importance: In hospitals outside of the US Department of Veterans Affairs (VA) system, 1 in 10 percutaneous coronary interventions (PCIs) for stable coronary artery disease is considered rarely appropriate by the appropriate use criteria, with variation across hospitals. The appropriateness of PCIs in VA hospitals has not been documented. Objective: To characterize the appropriateness of PCIs in VA hospitals. Design, Setting, and Participants: This retrospective cohort study included patients with stable coronary artery disease undergoing elective PCI from November 1, 2013, to October 31, 2015, within the VA Clinical Assessment, Reporting, and Tracking Program, an operational program that includes 59 VA hospitals. Data were analyzed from March 1, 2019, to August 8, 2019. Exposures: Elective PCI at a VA hospital. Main Outcomes and Measures: Proportion of PCIs classified as appropriate, may be appropriate, or rarely appropriate; extent of hospital-level variation in rarely appropriate PCIs using criteria issued by cardiovascular professional societies in 2012. The extent of hospital-level variation in rates of rarely appropriate PCI was characterized using hospital proportions and random-effect logistic regression. Results: Among 2611 patients undergoing elective PCI (mean [SD] age, 66.3 [7.6] years; 2577 [98.7%] men) at 59 hospitals, a total of 778 PCIs (29.8%) were classified as appropriate, 1561 PCIs (59.8%) were classified as may be appropriate, and 272 PCIs (10.4%) were classified as rarely appropriate. Rarely appropriate PCIs were more commonly performed in patients who had low-risk stress test findings (220 patients [89.1%]), who were taking no (100 patients [36.8%]) or 1 (167 patients [61.4%]) antianginal medication, or who had 1 coronary artery stenosis (185 patients [68.0%]). The unadjusted hospital-level rates of rarely appropriate PCIs ranged from 0% to 28.6%, with a median (interquartile range) of 9.7% (6.3%-13.9%). Random-effect models yielded an estimated median (interquartile range) rate of rarely appropriate PCI of 10.4% (8.7%-12.3%). Conclusions and Relevance: These findings suggest that in VA practice, most PCIs for stable coronary artery disease were classified as appropriate or may be appropriate. However, 1 in 10 PCIs was classified as rarely appropriate, with variation across VA hospitals. Efforts to improve patient selection are needed.

A comparison of recreational skiing- and snowboarding-related injuries at a Colorado ski resort, 2012/13-2016/17.

The purpose of this study was to compare injury patterns between recreational skiers and snowboarders. Injured skiers (n = 3,961) and snowboarders (n = 2,428) presented to a mountainside medical clinic, 2012/13-2016/17. Variables investigated for analysis included demographics/characteristics, injury event information, and injury information. Skiers were older than snowboarders (34.3 ± 19.3 vs. 23.2 ± 10.5 years, p < 0.001); a greater proportion of skiers were female (46.3% vs. 27.8%, p < 0.001). Most skiers (84.4%) and snowboarders (84.5%) were helmeted at the time of injury (p = 0.93). Snowboarders were most frequently beginners (38.9%), skiers were intermediates (37.8%). Falls to snow (skiers = 72.3%, snowboarders = 84.8%) and collisions with natural objects (skiers = 9.7%, snowboarders = 7.4%) were common injury mechanisms. Common skiing injuries were knee sprains (20.5%) and head trauma (8.9%); common snowboarding injuries were wrist fractures (25.7%), shoulder separations (9.1%), and head trauma (9.0%). Given that injury patterns significantly differ between sports, it is important for clinicians, ski patrollers, and resorts to develop and deliver sport-specific injury prevention interventions to most effectively decrease injury burden.

Comparison of a time-varying covariate model and a joint model of time-to-event outcomes in the presence of measurement error and interval censoring: application to kidney transplantation.

BACKGROUND: Tacrolimus (TAC) is an immunosuppressant drug given to kidney transplant recipients post-transplant to prevent antibody formation and kidney rejection. The optimal therapeutic dose for TAC is poorly defined and therapy requires frequent monitoring of drug trough levels. Analyzing the association between TAC levels over time and the development of potentially harmful de novo donor specific antibodies (dnDSA) is complex because TAC levels are subject to measurement error and dnDSA is assessed at discrete times, so it is an interval censored time-to-event outcome. METHODS: Using data from the University of Colorado Transplant Center, we investigated the association between TAC and dnDSA using a shared random effects (intercept and slope) model with longitudinal and interval censored survival sub-models (JM) and compared it with the more traditional interval censored survival model with a time-varying covariate (TVC). We carried out simulations to compare bias, level and power for the association parameter in the TVC and JM under varying conditions of measurement error and interval censoring. In addition, using Markov Chain Monte Carlo (MCMC) methods allowed us to calculate clinically relevant quantities along with credible intervals (CrI). RESULTS: The shared random effects model was a better fit and showed both the average TAC and the slope of TAC were associated with risk of dnDSA. The simulation studies demonstrated that, in the presence of heavy interval censoring and high measurement error, the TVC survival model underestimates the association between the survival and longitudinal measurement and has inflated type I error and considerably less power to detect associations. CONCLUSIONS: To avoid underestimating associations, shared random effects models should be used in analyses of data with interval censoring and measurement error.

Contemporary Use of Embolic Protection Devices During Saphenous Vein Graft Intervention.

BACKGROUND: Guidelines recommend use of embolic protection devices during percutaneous coronary intervention of saphenous vein grafts, but the use of these devices in contemporary practice is unclear. We thus sought to evaluate the patient characteristics and clinical outcomes associated with embolic protection device use during contemporary saphenous vein graft percutaneous coronary intervention. METHODS AND RESULTS: We identified patients undergoing isolated saphenous vein graft percutaneous coronary intervention in the Veterans Affairs Healthcare System from January 2008 to June 2017. Patient and procedural characteristics associated with embolic protection device use were assessed, as well as unmeasured site variation. A propensity-matched cohort was constructed to compare outcomes at 30 days, including unsuccessful intervention, periprocedural myocardial infarction, and death. We identified 7266 vein graft interventions, and embolic protection was used in 37.9% of cases, with a significant decline over time ( P=0.001) that was most pronounced from 2014 to 2017 ( P<0.001). There was significant institutional variation in the use of embolic protection, with a 15.50 (95% credible interval, 9.21-29.71)-fold difference in odds of device use by changing facilities independent of patient or procedural factors. Use of embolic protection was associated with reduced risk of unsuccessful intervention (odds ratio, 0.27; 95% credible interval, 0.17-0.42) and 30-day mortality (odds ratio, 0.56; 95% credible interval, 0.36-0.87). CONCLUSIONS: Use of embolic protection is decreasing with time and occurs in less than half of vein graft interventions. There is significant site variation in the use of embolic protection independent of patient characteristics, suggesting opportunities for the development of uniform practices to improve outcomes among those undergoing saphenous vein graft percutaneous coronary intervention.

Two-part models for cost with zeros to decompose effects of covariates on probability of cost, mean nonzero cost, and mean total cost.

Health care cost data often contain many zero values, for patients who did not use any care. Two-part models with logistic models for part I, probability of use (ie, nonzero cost) and log-link models for part II, mean cost of use (ie, nonzero cost) are often used. Effects of exposures or covariates on total (marginal) cost are often of interest, and recent work has proposed useful methods. Factors that affect total cost do so through a combination of effects on probability of use and cost of use. Such a decomposition is needed to understand and act on factors that affect total cost, but little work has been done on this question. This paper presents two new methods for decomposing effects on total cost, namely, an adjusted approach based on log-binomial models for part I and a population average approach based on counterfactual arguments. Extensive simulations illustrate performance, interpretation, and robustness over a wide range of data features. The method is applied to risk-adjusted 30-day outpatient cardiac cost for patients following percutaneous coronary intervention from the Department of Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. Results illustrate the simple decomposition of effects on total cost into components for probability of use and cost of use.

Using empirical Bayes predictors from generalized linear mixed models to test and visualize associations among longitudinal outcomes.

Medical research is often designed to investigate changes in a collection of response variables that are measured repeatedly on the same subjects. The multivariate generalized linear mixed model (MGLMM) can be used to evaluate random coefficient associations (e.g. simple correlations, partial regression coefficients) among outcomes that may be non-normal and differently distributed by specifying a multivariate normal distribution for their random effects and then evaluating the latent relationship between them. Empirical Bayes predictors are readily available for each subject from any mixed model and are observable and hence, plotable. Here, we evaluate whether second-stage association analyses of empirical Bayes predictors from a MGLMM, provide a good approximation and visual representation of these latent association analyses using medical examples and simulations. Additionally, we compare these results with association analyses of empirical Bayes predictors generated from separate mixed models for each outcome, a procedure that could circumvent computational problems that arise when the dimension of the joint covariance matrix of random effects is large and prohibits estimation of latent associations. As has been shown in other analytic contexts, the p-values for all second-stage coefficients that were determined by naively assuming normality of empirical Bayes predictors provide a good approximation to p-values determined via permutation analysis. Analyzing outcomes that are interrelated with separate models in the first stage and then associating the resulting empirical Bayes predictors in a second stage results in different mean and covariance parameter estimates from the maximum likelihood estimates generated by a MGLMM. The potential for erroneous inference from using results from these separate models increases as the magnitude of the association among the outcomes increases. Thus if computable, scatterplots of the conditionally independent empirical Bayes predictors from a MGLMM are always preferable to scatterplots of empirical Bayes predictors generated by separate models, unless the true association between outcomes is zero.