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Clopidogrel use post coronary artery bypass grafting (CABG) has become more popular under the assumption that it improves graft patency. The purpose of this sub-analysis from the Randomized On and Off-Pump Bypass (ROOBY) trial is to evaluate the role of clopidogrel use post CABG to improve graft patency when added to standard aspirin therapy.The ROOBY trial was a multi-center, randomized, controlled clinical trial that compared on-pump versus off-pump coronary artery bypass grafting (CABG). Clopidogrel use post CABG was left at the discretion of the operator. Detailed data regarding the use and timing of clopidogrel post CABG were collected prospectively, along with 1-year angiograms to evaluate graft status.Of the 2,203 subjects undergoing CABG, 953 patient records had complete clopidogrel use and 1-year angiographic data. Of these, 345 (36.2%) received clopidogrel post CABG prior to discharge. Compared with patients with no post-CABG clopidogrel use, baseline characteristics were similar for the clopidogrel group except for the following: lower preoperative aspirin use (80.2% vs 86.7%, p = 0.009); higher preoperative clopidogrel use (23.5% vs 14.0%, p0.001), less on-pump (35.9% vs 55.9%, p0.0001); and lower endoscopic vein harvesting (30.8% vs 42.5%, p0.001) rates. Overall 1-year graft patency rates were not different between the clopidogrel and no-clopidogrel groups (86.5% vs 85.3%, p = 0.43). Multivariable analyses did not alter these findings.This study suggests that routine post-CABG clopidogrel use may not translate to improved 1-year graft patency. Future studies appear warranted to better define the role of more aggressive antiplatelet therapy post CABG on graft patency and clinical outcomes.

We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention.A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data.A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits.The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women.

Background Hospital readmission rates after surgery can represent an overall hospital effect or a combination of specialty and patient effects. We hypothesized that hospital readmission rates for procedures within specialties were more strongly correlated than rates across specialties within the same hospital. Study Design For general, orthopaedic, and vascular specialties at Veterans Affairs hospitals during 2008 to 2014, 30-day risk-adjusted readmission rates were estimated for 6 high-volume procedures and each specialty. Relationships were assessed using the Pearson correlation coefficient. Results At 84 hospitals, 64,724 orthopaedic, 24,963 general, and 10,399 vascular inpatient procedures were performed; mean readmission rates were 6.3%, 13.6%, and 16.4%, respectively. There was no correlation between specialty-specific adjusted hospital readmission rates: general and orthopaedic ( r = 0.21; p = 0.06), general and vascular ( r = 0.15; p = 0.19), and vascular and orthopaedic surgery ( r = 0.07; p = 0.55). Within specialties, we found modest correlations between knee and hip arthroplasty readmission rates ( r = 0.39; p r = 0.24; p = 0.03), but not between lower-extremity bypass and endovascular aortic repair ( r = 0.13; p = 0.26). Overall, controlling for patient-level factors, 1.9% of the variation in readmissions was attributable to specialty-level factors; only 0.6% was attributable to hospital-level factors. Conclusions Hospital readmission rates for orthopaedic, vascular, and general surgery were not correlated between specialties; within each of the 3 specialties, modest correlations were found between 2 procedures within 2 of these specialties. These findings suggest that hospital surgical readmission rates are primarily explained by patient- and procedure-specific factors and less by broader specialty and/or hospital effects.

Key Points Question What is the cost associated with National Quality Forum–identified intensive medical services in the last month of life to beneficiaries and to the health care system? Findings In this cohort study of 48 937 patients with cancer enrolled in Medicare and the Veterans Health Administration, those receiving no intensive service had a health system cost of $7660, whereas for the 59% of patients receiving 1 or more intensive services in the last month of life, the cost was $23 612. Expected beneficiary costs in the last month of life were $133 for patients with no intensive service and $1257 for patients with at least 1 intensive service. Meaning Despite recommendations, more than half of patients with cancer receive intensive services at the end of life at a substantial cost to beneficiaries and the heath system., Importance Despite recommendations to reduce intensive medical treatment at the end of life, many patients with cancer continue to receive such services. Objective To quantify expected beneficiary and health system costs incurred in association with receipt of intensive medical services in the last month of life. Design, Setting, and Participants This retrospective cohort study used data collected nationally from Medicare and the Veterans Health Administration for care provided in fiscal years 2010 to 2014. Participants were 48 937 adults aged 66 years or older who died of solid tumor and were continuously enrolled in fee-for-service Medicare and the Veterans Health Administration in the 12 months prior to death. The data were analyzed from February to August 2019. Exposures American Society of Clinical Oncology metrics regarding medically intensive services provided in the last month of life, including hospital stay, intensive care unit stay, chemotherapy, 2 or more emergency department visits, or hospice for 3 or fewer days. Main Outcomes and Measures Costs in the last month of life associated with receipt of intensive medical services were evaluated for both beneficiaries and the health system. Costs were estimated from generalized linear models, adjusting for patient demographics and comorbidities and conditioning on geographic region. Results Of 48 937 veterans who received care through the Veterans Health Administration and Medicare, most were white (90.8%) and male (98.9%). More than half (58.9%) received at least 1 medically intensive service in the last month of life. Patients who received no medically intensive service generated a mean (SD) health system cost of $7660 ($1793), whereas patients who received 1 or more medically intensive services generated a mean (SD) health system cost of $23 612 ($5528); thus, the additional financial consequence to the health care system for medically intensive services was $15 952 (95% CI, $15 676-$16 206; P, To provide physicians with reference cost estimates, this cohort study quantifies beneficiary and health system costs incurred in association with receipt of intensive medical services in the last month of life among patients with advanced cancer.

INTRODUCTION: Healthcare value is a national priority, and there are substantial efforts to reduce overuse of low-value testing. Residency training programs and teaching hospitals have been implicated in excessive testing. We evaluated the impact of surgery residents on the frequency of inpatient testing and investigated potential inter-resident variation. METHODS: Inpatient laboratory and imaging orders placed on general surgery services were extracted from an academic institution from 2014–2016 and linked to National Surgical Quality Improvement Program data. Using negative binomial mixed effects regression with unstructured covariance, we evaluated the frequency of testing orders compared to median utilization, accounting for case, patient, and attending-level variables. RESULTS: 111,055 laboratory and 7,360 imaging orders were linked with 2,357 patients. Multivariable analysis demonstrated multiple significant predictors of increased testing including: postoperative complications, medical comorbidities, length of stay, relative value units, attending surgeon, and resident surgeon (95% confidence intervals >1, p1, p

Importance The existing readmission quality metric does not meaningfully distinguish readmissions associated with surgical quality from those that are not associated with surgical quality and thus may not reflect the quality of surgical care. Objective To compare a quality metric that classifies readmissions associated with surgical quality with the existing metric of any unplanned readmission in a surgical population. Design, Setting, and Participants Cohort study using US nationwide administrative data collected on 4 high-volume surgical procedures performed at 103 Veterans Affairs hospitals from October 1, 2007, through September 30, 2014. Data analysis was conducted from October 1, 2017, to January 24, 2019. Main Outcomes and Measures Hospital-level rates of unplanned readmission (existing metric) and surgical readmissions associated with surgical quality (new metric) in the 30 days following hospital discharge for an inpatient surgical procedure. Results The study population included 109 258 patients who underwent surgery at 103 hospitals. Patients were majority male (94.1%) and white (78.2%) with a mean (SD) age of 64.0 (10.0) years at the time of surgery. After case-mix adjustment, 30-day surgical readmissions ranged from 4.6% (95% CI, 4.5%-4.8%) among knee arthroplasties to 11.1% (95% CI, 10.9%-11.3%) among colorectal resections. The new surgical readmission metric was significantly correlated with facility-level postdischarge complications for all procedures, with ρ coefficients ranging from 0.33 (95% CI, 0.13-0.51) for cholecystectomy to 0.52 (95% CI, 0.38-0.68) for colorectal resection. Correlations between postdischarge complications and the new surgical readmission metric were higher than correlations between complications and the existing readmission metric for all procedures examined (knee arthroplasty: 0.50 vs 0.48; hip replacement: 0.44 vs 0.18; colorectal resection: 0.52 vs 0.42; and cholecystectomy: 0.33 vs 0.10). When compared with using the existing readmission metric, using the new surgical readmission metric could change hip replacement–associated payment penalty determinations in 28.4% of hospitals and knee arthroplasty–associated penalties in 26.0% of hospitals. Conclusions and Relevance In this study, surgical quality–associated readmissions were more correlated with postdischarge complications at a higher rate than were unplanned readmissions. Thus, a metric based on such readmissions may be a better measure of surgical care quality. This work provides an important step in the development of future value-based payments and promotes evidence-based quality metrics targeting the quality of surgical care.

We sought to analyze utilization and survival outcomes of cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma (RCC) before and after introduction of targeted therapy. We identified patients with metastatic RCC between 1993 and 2010 in the SEER registry and examined temporal trends in utilization. We performed a joinpoint regression to determine when changes in utilization of CN occurred. We fitted multivariable proportional hazard models in full and propensity score-matched cohorts. We performed a difference-in-difference analysis to compare survival outcomes before and after introduction of targeted therapy. The proportion of patients undergoing CN increased from 1993 to 2004, from 29% to 39%. We identified a primary joinpoint of 2004, just prior to the introduction of targeted therapy. Beginning in 2005, there was a modest decrease in utilization of CN. CN was associated with a lower adjusted relative hazard (0.41, 95% confidence interval 0.34–0.43). Median survival among patients receiving CN increased in the targeted therapy era (19 vs. 13 months), while median survival among patients not receiving CN increased only slightly (4 vs. 3 months). Difference-in-difference analysis showed a significant decrease in hazard of death among patients who received CN in the targeted therapy era. Despite decreased utilization in the targeted therapy era, CN remains associated with improved survival. Prospective randomized trials are needed to confirm the benefit of CN among patients with metastatic RCC treated with novel targeted therapies.

Questions have been raised about the costs and outcomes for patients receiving on-pump and off-pump coronary artery bypass graft surgery. As part of the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) multisite trial, a cost-effectiveness analysis was performed to compare on-pump versus off-pump patients' quality-adjusted life-years and costs at 1 year.One-year outcomes and costs (standardized to 2010 dollars) were estimated in multivariate regression models, controlling for site and baseline patient factors. The 1-year incremental cost-effectiveness analysis ratio with 95% confidence intervals was calculated using bootstrapping.Eighteen centers randomly assigned 2,203 participants to on-pump (n=1,099) versus off-pump (n=1,104) coronary artery bypass graft surgery. Both groups' quality of life improved significantly after surgery (p0.01) compared with baseline, but no differences were found between treatment groups. Adjusted cost of the index coronary artery bypass graft surgery hospitalization was $36,046 on-pump and $36,536 off-pump (p=0.16). At 1 year, on-pump adjusted cost was $56,023 versus $59,623 off-pump (p=0.046). Off-pump-to-on-pump conversions after first distal anastomosis (4.8%) had significantly higher 1-year costs. Excluding conversions, there were no significant differences between treatments for index hospitalization or 1-year total costs.At 1 year, off-pump coronary artery bypass graft surgery was more expensive than on-pump when late off-pump-to-on-pump conversions were included. Excluding late conversions, there was no difference in quality-adjusted life-years or costs.ClinicalTrials.gov identifier NCT00032630; http://clinicaltrials.gov/ct2/show/NCT00032630.

SUMMARY Objectives To compare the 1-year survival for different age strata of intensive care unit (ICU) patients after receipt of packed red blood cell (PRBC) transfusions. Background Despite guidelines documenting risks of PRBC transfusion and data showing that increasing age is associated with ICU mortality, little data exist on whether age alters the transfusion-related risk of decreased survival. Methods We retrospectively examined data on 2393 consecutive male ICU patients admitted to a tertiary-care hospital from 2003 to 2009 in age strata: 21–50, 51–60, 61–70, 71–80 and >80 years. We calculated Cox regression models to determine the modifying effect of age on the impact of PRBC transfusion on 1-year survival by using interaction terms between receipt of transfusion and age strata, controlling for type of admission and Charlson co-morbidity indices. We also examined the distribution of admission haematocrit and whether transfusion rates differed by age strata. Results All age strata experienced statistically similar risks of decreased 1-year survival after receipt of PRBC transfusions. However, patients age >80 were more likely than younger cohorts to have haematocrits of 25–30% at admission and were transfused at approximately twice the rate of each of the younger age strata. Discussion We found no significant interaction between receipt of red cell transfusion and age, as variables, and survival at 1 year as an outcome.

We examine the extent to which ClinicalTrials.gov is meeting its goal of providing oversight and transparency of clinical trials with human subjects. We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type. We also conducted a detailed analysis of incomplete data.Among trials with only government sponsorship (N=9252), 36% were observational and 64% interventional; in contrast, almost all (90%) industry-only sponsored trials were interventional. Industry-only sponsored interventional trials (N=30,036) were most likely to report a drug intervention (81%), followed by biologics (9%) and devices (8%). Government-only interventional trials (N=5886) were significantly more likely to test behavioral interventions (28%) and procedures (13%) than industry-only trials (p0.001). Medical conditions most frequently studied in industry-only trials were cancer (19%), cardiovascular conditions (12%) and endocrine/metabolic disorders (11%). Government-only funded trials were more likely to study mental health (19% vs. 7% for industry, p.001), and viral infections, including HIV (15% vs 7% for industry, p.001). Government-funded studies are significantly more likely to be missing data about study design and intervention arms in the registry. For all studies, we report ambiguous and contradictory data entries.Industry-sponsored studies differ systematically from government-sponsored studies in study type, choice of interventions, conditions studied, and completeness of submitted information. Imprecise study design information, incomplete coding of conditions, out-of-date or unspecified enrollment numbers, and other missing data continue to hinder robust analyses of trials registered in ClinicalTrials.gov.

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) convened a working group in June 2011 to examine alternative institutional review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical trials where multiple individual reviews may be inefficient. Group members included experts in heart, lung, and blood research, research oversight, bioethics, health economics, regulations, and information technology (IT). The group discussed alternative IRB models, ethical concerns, metrics for evaluating IRBs, IT needs, and economic considerations. Participants noted research gaps in IRB best practices and in metrics. The group arrived at recommendations for process changes, such as defining specific IRB performance requirements in funding announcements, requiring funded researchers to use more efficient alternative IRB models, and developing IT systems to facilitate information sharing and collaboration among IRBs. Despite the success of the National Cancer Institute's central IRB (CIRB), the working group, concerned about the creation costs and unknown cost efficiency of a new CIRB, and about the risk of shifting the burden of dealing with multiple IRBs from sponsors to research institutions, did not recommend the creation of an NHLBI-funded CIRB.

Objective To assess whether patient factors, such as age and preoperative kidney function, were associated with receipt of partial nephrectomy in a national integrated healthcare system. Materials and Methods We identified patients treated with a radical or partial nephrectomy from 2002 to 2014 in the Veterans Health Administration. We examined associations among patient age, sex, race or ethnicity, multimorbidity, baseline kidney function, tumor characteristics, and receipt of partial nephrectomy. We estimated the odds of receiving a partial nephrectomy and assessed interactions between covariates and the year of surgery to explore whether patient factors associated with partial nephrectomy changed over time. Results In our cohort of 14,186 patients, 4508 (31.2%) received a partial nephrectomy. Use of partial nephrectomy increased from 17% in 2002 to 32% in 2008 and to 38% in 2014. Patient race or ethnicity, age, tumor stage, and year of surgery were independently associated with receipt of partial nephrectomy. Black veterans had significantly increased odds of receipt of partial nephrectomy, whereas older patients had significantly reduced odds. Partial nephrectomy utilization increased for all groups over time, but older patients and patients with worse baseline kidney function showed the least increase in odds of partial nephrectomy. Conclusion Although the utilization of partial nephrectomy increased for all groups, the greatest increase occurred in the youngest patients and those with the highest baseline kidney function. These trends warrant further investigation to ensure that patients at the highest risk of impaired kidney function are considered for partial nephrectomy whenever possible.

Health coaches can help patients gain knowledge, skills, and confidence to manage their chronic conditions. Coaches may be particularly valuable in resource-poor settings, but they are not typically reimbursed by insurance, raising questions about their budgetary impact.The Health Coaching in Primary Care (HCPC) study was a randomized controlled trial that showed health coaches were effective at helping low-income patients improve control of their type 2 diabetes, hypertension, and/or hyperlipidemia at 12 months compared with usual care.We estimated the cost of employing 3 health coaches and mapped these costs to participants. We tested whether the added costs of the coaches were offset by any savings in healthcare utilization within 1 year. Healthcare utilization data were obtained from 5 sources. Multivariate models assessed differences in costs at 1 year controlling for baseline characteristics.Coaches worked an average of 9 hours with each participant over the length of the study. On average, the health coach intervention cost $483 per participant per year. The average healthcare costs for the coaching group was $3207 compared with $3276 for the control group (P = .90). There was no evidence that the coaching intervention saved money at 1 year.Health coaches have been shown to improve clinical outcomes related to chronic disease management. We found that employing health coaches adds an additional cost of $483 per patient per year. The data do not suggest that health coaches pay for themselves by reducing healthcare utilization in the first year.

Objective. This study aims to determine 1) the epidemiology of perioperative opioid use; and 2) the association between patterns of preoperative opioid use and time-to-cessation of postoperative opioids. Design. Retrospective, cohort study. Setting. National, population-level study of Veterans Healthcare Administration (VHA) electronic clinical data. Subjects. All VHA patients (n = 64,391) who underwent surgery in 2011, discharged after stays of ≥1 day, and receiving ≥1 opioid prescription within 90 days of discharge. Methods. Patients’ preoperative opioid use were categorized as 1) no opioids, 2) tramadol only, 3) short-acting (SA) acute/intermittent (≤ 90 days fill), 4) SA chronic (> 90 days fill), or 5) any long-acting (LA). After defining cessation as 90 consecutive, opioid-free days, the authors calculated time-to-opioid-cessation (in days), from day 1 to day 365, after hospital discharge. The authors developed extended Cox regression models with a priori identified predictors. Sensitivity analyses used alternative cessation definitions (30 or 180 consecutive days). Results. Almost 60% of the patients received preoperative opioids: tramadol (7.5%), SA acute/intermittent (24.1%), SA chronic (17.5%), and LA (5.2%). For patients opioid-free preoperatively, median time-to-cessation of opioids postoperatively was 15 days. The SA acute/intermittent cohort (HR =1.96; 95% CI =1.92-2.00) had greater risk for prolonged time-to-cessation than those opioid-free (reference), but lower risk than those taking tramadol only, SA chronic (HR = 9.09; 95% CI = 8.33-9.09), or LA opioids (HR = 9.09; 95% CI = 8.33-10.00). Diagnoses of chronic pain, substance-use, or affective disorders were weaker positive predictors. Sensitivity analyses maintained findings. Conclusion . Greater preoperative levels of opioid use were associated with progressively longer time-to-cessation postoperatively.

To investigate the association of preoperative β-blocker usage and maximal heart rates observed during the induction of general anesthesia.Retrospective descriptive, univariate, and multivariate analyses of electronic hospital and anesthesia medical records.A tertiary-care medical center within the Veterans Health Administration.Consecutive adult elective and emergent patients presenting for vascular surgery during calendar years 2005 to 2011.None.Of the 430 eligible cases, 218 were prescribed β-blockers, and 212 were not taking β-blockers. The two groups were comparable across baseline patient factors (ie, demographic, morphometric, surgical duration, and surgical procedures) and induction medication doses. The β-blocker group experienced a lower maximal heart rate during the induction of general anesthesia compared with the non-β-blocker group (105 ± 41 beats/min v 115 ± 45 beats/min, respectively; p0.01). Adjusted linear regression found a statistically significant association between lower maximal heart rate and the use of β-blockers (β = -11.1 beats/min, p0.01). There was no difference between groups in total intraoperative β-blocker administration.Preoperative β-blockade of vascular surgery patients undergoing general anesthesia is associated with a lower maximal heart rate during anesthetic induction. There may be potential benefits in administering β-blockers to reduce physiologic stress in this surgical population at risk for perioperative cardiac morbidity. Future research should further explore intraoperative hemodynamic effects in light of existing practice guidelines for optimal medication selection, dosage, and heart rate control.

Study Design. We reviewed existing methods for identifying patients with neck and back pain in administrative data. We compared these methods using data from the Department of Veterans Affairs. Objective. To answer the following questions: (1) what diagnosis codes should be used to identify patients with neck pain and back pain in administrative data; (2) because the majority of complaints are characterized as nonspecific or mechanical, what diagnosis codes should be used to identify patients with nonspecific or mechanical problems in administrative data; and (3) what procedure and surgical codes should be used to identify patients who have undergone a surgical procedure on the neck or back. Summary of Background Data. Musculoskeletal neck and back pain are pervasive problems, associated with chronic pain, disability, and high rates of health care utilization. Administrative data have been widely used in formative research, which has largely relied on the original work of Volinn, Cherkin, Deyo, and Einstadter and the Back Pain Patient Outcomes Assessment Team first published in 1992. Significant variation in reports of incidence, prevalence, and morbidity associated with these problems may be due to nonstandard or conflicting methods to define study cohorts. Methods. A literature review produced 7 methods for identifying neck and back pain in administrative data. These code lists were used to search Veterans Health Administration data for patients with back and neck problems, and to further categorize each case by spinal segment involved, as nonspecific/mechanical and as surgical or not. Results. There is considerable overlap in most algorithms. However, gaps persist. Conclusion. Gaps are evident in existing methods and a new framework to identify patients with neck pain and back pain in administrative data is proposed.

Background Only 7.8 % of individuals meeting diagnostic criteria for alcohol use disorder (AUD) receive treatment in a given year. Most individuals with AUDs are identified in primary care (PC) settings and referred to substance use disorders (SUD) clinics; however, only a minority of those referred attend treatment services. Safe and effective pharmacological treatments for AUD exist, but they are rarely prescribed by PC providers. The objective of this study is to refine, implement, and evaluate an intervention to integrate pharmacological AUD treatment options into PC settings. This paper provides a detailed description of the intervention design and the evaluation components. Methods/design Three large Veterans Health Administration (VHA) facilities are participating in the intervention. The intervention targets stakeholder groups with tailored strategies based on implementation theory and prior research identifying barriers to implementation of AUD pharmacotherapy. Local SUD providers and primary care mental health integration (PCMHI) providers are trained to serve as local implementation/clinical champions and receive external facilitation. PC providers receive access to consultation from local and national clinical champions, educational materials, and a dashboard of patients with AUD on their caseloads for case identification. Veterans with AUD diagnoses receive educational information in the mail just prior to a scheduled PC visit. Effectiveness of the intervention will be evaluated through an interrupted time series with matched controls to monitor change in facility level AUD pharmacotherapy prescribing rates. Following Stetler’s four-phase formative evaluation (FE) strategy, FE methods include (1) developmental FE (pre-implementation interviews with champions, PC providers, and Veterans), (2) implementation-focused FE (tracking attendance at facilitation meetings, academic detailing efforts by local champions, and patient dashboard utilization), (3) progress-focused FE (tracking rates of AUD pharmacotherapy prescribing and rates of referral to PCMHI and SUD specialty care), and (4) interpretive FE (post-implementation interviews with champions and PC providers). Analysis of FE data will be guided by the Consolidated Framework for Implementation Research (CFIR). Discussion If demonstrated to be successful, this implementation strategy will provide a replicable, feasible, and relative low-cost method for integrating AUD treatment services into PC settings, thereby increasing access to AUD treatment.

Given that many studies have reported that the costs of substance use disorder (SUD) treatment are more than offset by other savings (e.g., in health care, in criminal justice, in foster care), why haven't health care system managers rushed to expand treatment? This article attempts to explain this puzzling discrepancy by analyzing 1998-2006 data from the national Veterans Affairs (VA) health care system. The main outcome measures were annual cost and utilization for VA SUD-diagnosed patients. The key independent variable was the medical centers' annual spending for SUD treatment. There was no evidence that SUD spending was associated with lower medical center costs over time within the medical center that paid for the treatment. Health care system managers may not be influenced by research suggesting that the costs of SUD treatment are more than fully offset because they bear the cost of providing treatment while the savings largely accrue to other systems.

BACKGROUND: This study examined the association of hematocrit (Hct) levels measured upon intensive care unit (ICU) admission and red blood cell transfusions to long-term (1-year or 180-day) mortality for both surgical and medical patients. STUDY DESIGN AND METHODS: Administrative and laboratory data were collected retrospectively on 2393 consecutive medical and surgical male patients admitted to the ICU between 2003 and 2009. We stratified patients based on their median Hct level during the first 24 hours of their ICU stay (Hct

The Spinal Cord Injury Vocational Integration Program (SCI-VIP) is a 5-year multisite randomized clinical trial to test for differences in employment and rehabilitation outcomes in veterans with spinal cord injury, including a cost-effectiveness analysis. This article provides a review of the background on economic analyses in health care and a description of the methods we will follow for the cost-effectiveness analysis of the SCI-VIP intervention.

Objective The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) initiated a multi-site randomized trial (CSP 474) to determine graph patency between radial artery or saphenous vein grafts in coronary artery bypass surgery (CABG). In this paper, we describe the study and compare participants' baseline characteristics to non-participants who received CABG surgery in the VA. Method We identified our participants in the VA administrative databases along with all other CABG patients who did not have a concomitant valve procedure between FY2003 and FY2008. We extracted demographic, clinical information and organizational information at the time of the surgery from the databases. We conducted multiple logistic regression to determine characteristics associated with participation at three levels: between participants and non-participants within participating sites, between participating sites and non-participating sites, between participants and all non-participants. Results Enrollment ended in early 2008. Participants were similar to non-participants across many parameters. Likewise, participating sites were also quite similar to non-participating sites, although participating sites had a higher volume of CABG surgery, a lower percentage of CABG patients with a prior inpatient mental health admission than non-participating sites. After controlling for site differences, CSP 474 participants were younger and had fewer co-morbid conditions than non-participants. Conclusions Participants were significantly younger than non-participants. Participants also had lower rates of some cardiac-related illness including, congestive heart failure, peripheral vascular disease, and cerebrovascular disease than non-participants.

We sought to determine the impact of a rapid response system on cardiac arrest rates and mortality in a United States veteran population.We describe a prospective analysis of cardiac arrests in 9 months before and 27 months after institution of a rapid response system, and retrospective analysis of mortality 3.5 years before the intervention and 27 months after the intervention. The study included all inpatients from a university-affiliated United States Veterans Affairs Medical Center, before and after implementation of a rapid response system, including an educational program, patient calling criteria, and a physician-led medical emergency team. Primary end points were hospital-wide cardiac arrests and mortality rates normalized to hospital discharges. Comparisons of event rates between various time points during the implementation process were made by analysis of variance.Three hundred seventy-eight calls were made to the medical emergency team in the time period studied. Compared with preintervention time points, cardiac arrests were reduced by 57%, amounting to a reduction of 5.6 cardiac arrests per 1000 hospital discharges (P0.01). Mortality was reduced during the intervention, but this was attributable to a natural decrease occurring over all phases of the study.A significant reduction in the rate of cardiac arrests was realized with this intervention, as well as a trend toward lower mortality. We estimate that 51 arrests were prevented in the timeframe studied. Our results suggest that further reductions in morbidity can be realized by expansion of rapid response systems throughout the Veterans Affairs network.

Background The internet can contribute to improved access to information and services among underserved populations. Little is known about veterans' use of the internet for health, and how it is affected by socio-demographic characteristics. This knowledge gap is acute given the US Department of Veterans Affairs' (VA's) deployment of a major patient portal/personal health record system. Objectives To assess the frequency and correlates of veterans' use of the internet and identify personal characteristics impeding veterans' health-related internet use. Methods Survey of 12 878 randomly selected adults from a panel of 60 000 US households. Veterans were oversampled. Results Of the 3408 veterans responding, 54% had used the internet and 29% had used the internet specifically for health. In multi-variable analyses, general internet use was positively associated with younger age (OR = 0.03, CI = 0.01_0.06, oldest versus youngest group), higher income (OR = 3.12, CI = 2.10_4.63, _$75 000 versus Conclusions In the first large, systematic survey of veterans' internet usewe found that more education and urban location were strongly, and positively, associated with veterans' health-related internet use, even after controlling for multiple socio-demographic characteristics. Interventions may be needed for less educated and rural veterans, e.g. by providers discussing internet use with their patients, or by the VA training veterans in health-related internet use.

Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality. Conclusion The CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.

Personal health records (PHRs) are designed to help people manage information about their health. Over the past decade, there has been a proliferation of PHRs, but research regarding their effects on clinical, behavioral, and financial outcomes remains limited. The potential for PHRs to facilitate patient-centered care and health system transformation underscores the importance of embracing a broader perspective on PHR research.Drawing from the experiences of VA staff to evaluate the My HealtheVet (MHV) PHR, this article advocates for a health services research perspective on the study of PHR systems.We describe an organizing framework and research agenda, and offer insights that have emerged from our ongoing efforts regarding the design of PHR-related studies, the need to address PHR data ownership and consent, and the promotion of effective PHR research collaborations.These lessons are applicable to other PHR systems and the conduct of PHR research across different organizational contexts.

Equivalence principle tests are probes for new fundamental physics. We have conducted several laboratory experiments to test the equivalence principle with unprecedented precision and generality using a torsion balance placed on a continuously rotating turntable. We present preliminary results comparing the differential accelerations of Ti, Be, and Al towards local masses, the earth and the center of our galaxy.

Background. Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period. Objective. To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke. Methods. The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment ≥6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale. Results. A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9. Conclusions. VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010.

Unlike Medicare, the Veterans Health Administration (VA) health care system does not require veterans with cancer to make the "terrible choice" between receipt of hospice services or disease-modifying chemotherapy/radiation therapy. For this report, the authors characterized the VA's provision of concurrent care, defined as days in the last 6 months of life during which veterans simultaneously received hospice services and chemotherapy or radiation therapy.This retrospective cohort study included veteran decedents with cancer during 2006 through 2012 who were identified from claims with cancer diagnoses. Hospice and cancer treatment were identified using VA and Medicare administrative data. Descriptive statistics were used to characterize the changes in concurrent care, hospice, palliative care, and chemotherapy or radiation treatment.The proportion of veterans receiving chemotherapy or radiation therapy remained stable at approximately 45%, whereas the proportion of veterans who received hospice increased from 55% to 68%. The receipt of concurrent care also increased during this time from 16.2% to 24.5%. The median time between hospice initiation and death remained stable at around 21 days. Among veterans who received chemotherapy or radiation therapy in their last 6 months of life, the median time between treatment termination and death ranged from 35 to 40 days. There was considerable variation between VA medical centers in the use of concurrent care (interquartile range, 16%-34% in 2012).Concurrent receipt of hospice and chemotherapy or radiation therapy increased among veterans dying from cancer without reductions in the receipt of cancer therapy. This approach reflects the expansion of hospice services in the VA with VA policy allowing the concurrent receipt of hospice and antineoplastic therapies. Cancer 2016;122:782-790. © 2015 American Cancer Society.

Self-report is often used to estimate health care utilization. However, the accuracy of such data is of paramount concern. The authors conducted a systematic review of 42 studies that evaluated the accuracy of self-report utilization data, where utilization was defined as a visit to a clinical provider or entity. They also present a broad conceptual model that identifies major issues to consider when collecting, analyzing, and reporting such data. The results show that self-report data are of variable accuracy. Factors that affect accuracy include (1) sample population and cognitive abilities, (2) recall time frame, (3) type of utilization, (4) utilization frequency, (5) questionnaire design, (6) mode of data collection, and (7) memory aids and probes.

Behavioral health interventions are often gauged with a dichotomous outcome, "success" or "failure." Hidden by this dichotomy is a series of behavior changes that can be followed with the Transtheoretical Model (stages of change). There has been little consideration, however, about whether this information can and should be used in cost-effectiveness analysis. We review the stages of change model and its applications to behavioral health interventions. We then discuss analytical methods for including stages of change, or similar behavior change models, in cost-effectiveness analysis (CEA). This is typically not done but it may be critical for study design and for interpreting CEA results.

Objectives. We sought information about the cost-related underuse of medications—which medications are underused, by whom, and how often. Methods. Chronically ill adults were asked to identify how often they underused prescription medication for 16 health conditions because of the cost. Results. Eighteen percent of respondents cut back on medication use owing to cost in the previous year, and 14% used less medication at least monthly. Although rates of underuse varied substantially across treatments, prescription coverage and out-of-pocket costs were determinants of underuse across medication types. Conclusions. Many chronically ill adults frequently cut back on medications owing to cost. Patients are selective about the treatments they forgo. Out-of-pocket costs and inadequate prescription coverage may lead to adherence problems for many important medication types.

Background: Research with human subjects is essential for most clinical and social science research. As such, the ethical treatment of subjects, including the role of Institutional Review Boards (IRBs), is of paramount concern. The prevailing system of IRBs in the United States reflects an integrated approach in which research organizations have their own local IRB. Recent regulatory changes and a few high-profile problems have prompted proposals for greater investments in IRBs. Objectives: We conducted regression analyses, looking at how IRB size was associated with IRB costs (economies of scale). Research Design: We studied data from a cross-sectional survey. Subjects: We studied IRBs at Veterans Affairs (VA) and VA-affiliated medical centers (n = 109); 81 (73%) IRB administrators completed the survey. Fourteen of the administrators had missing data and were excluded from final analysis, leaving a sample of 67. Measures: The primary dependent variable was IRB costs in 2001, which we estimated from the survey. Independent variables included IRB size measured as the number of actions (ie, number of initial reviews, amendments, continuing/annual reviews, and harms/adverse event reports) reviewed by the IRB in the last year. Results: The results indicate that very large economies of scale exist, especially for IRBs that handle fewer than 150 actions per year. Conclusions: A discussion of the costs of benefits of having 3000 to 5000 local IRBs in the United States is warranted because other organizational arrangements could be economically and socially advantageous.

Objectives To update the cost of urinary incontinence (UI) for year 2000 and compare it with the cost of overactive bladder (OAB). Methods Using the cost-of-illness framework, disease epidemiologic data were combined with treatment rates, consequence probabilities, and average cost estimates. All costs reflect the costs during 2000. Results The total cost of UI and OAB was $19.5 billion and $12.6 billion, respectively (year 2000 dollars). With UI, $14.2 billion was borne by community residents and $5.3 billion by institutional residents. With OAB, $9.1 and $3.5 billion, respectively, was incurred by community and institutional residents. Conclusions OAB affected 34 million individuals compared with 17 million with UI. Despite the differences in epidemiology, the total and per-person costs of UI were higher than the OAB costs because OAB individuals without incontinent episodes incurred fewer costs, on average.

Chronic conditions are among the most common causes of death and disability in the United States. Patients with such conditions receive disproportionate amounts of health care services and therefore cost more per capita than the average patient. This study assesses the prevalence among the Department of Veterans Affairs (VA) health care users and VA expenditures (costs) of 29 common chronic conditions. The authors used regression to identify the marginal impact of these conditions on total, inpatient, outpatient, and pharmacy costs. Excluding costs of contracted medical services at non-VA facilities, total VA health care expenditures in fiscal year 1999 (FY1999) were $14.3 billion. Among the 3.4 million VA patients in FY1999, 72 percent had 1 or more of the 29 chronic conditions, and these patients accounted for 96 percent of the total costs ($13.7 billion). In addition, 35 percent (1.2 million) of VA health care users had 3 or more of the 29 chronic conditions. These individuals accounted for 73 percent of the total cost. Overall, VA health care users have more chronic diseases than the general population.

Recent reports have claimed that institutional review boards (IRBs) are underfunded, yet little is known about the costs of operating IRBs. This study estimated the costs for operating high-volume and low-volume IRBs.IRB costs were calculated from published summary data. Costs were standardized to reflect 2001 dollars.Total estimated costs for operating high-volume and low-volume IRBs were $770,674 and $76,626, respectively. The average cost per action, a measure of economic efficiency, was lower for high-volume IRBs ($277 per action) than it was for low-volume IRBs ($799 per action).Although high-volume IRBs are more expensive than are low-volume IRBs in absolute terms, they are more economically efficient. Policy debates should consider the potential savings from large IRBs, perhaps by encouraging small IRBs to merge, although this may result in less local review, control, and oversight.

Objectives To estimate the economic costs of overactive bladder (OAB), including community and nursing home residents, and to compare the costs in male versus female and older versus younger populations. Methods The National Overactive Bladder Evaluation Program included a representative telephone survey of 5204 community-dwelling adults 18 years and older in the United States and a follow-up postal survey of all individuals with OAB identified and age and sex-matched controls. The postal survey asked respondents about bladder symptoms, self-care use, treatment use, work loss, and OAB-related health consequences. Survey data estimates were combined with year 2000 average cost data to calculate the cost of OAB in the community. Institutional costs were estimated from the costs of urinary incontinence in nursing homes, limited to only those with urge incontinence or mixed incontinence (urge and stress). Results The estimated total economic cost of OAB was $12.02 billion in 2000, with $9.17 and $2.85 billion incurred in the community and institutions, respectively. Community female and male OAB costs totaled $7.37 and $1.79 billion, respectively. The estimated total cost was sensitive to the estimated prevalence of OAB; therefore, we calculated the average cost per community-dwelling person with OAB, which was $267 per year. Conclusions By quantifying the total economic costs of OAB, this study—the first obtained from national survey data—provides an important perspective of this condition in society. The conservative estimates of the total cost of OAB were comparable to those of osteoporosis and gynecologic and breast cancer. Although this provides information on the direct and indirect costs of OAB, quality-of-life issues must be taken into account to gain a better understanding of this condition.

Neck and back pain are pervasive problems. Some have suggested that rising incidence may be associated with the evidence of rising prevalence. To describe the trends in diagnosis of painful neck and back conditions in a large national healthcare system. A retrospective observational cohort study to describe the incidence and prevalence of diagnosis of neck and back pain in a national cohort. Patients were identified by International Classification of Diseases, 9th Revision (ICD-9) codes in Department of Veterans Affairs (VA) national utilization datasets in calendar years 2002 to 2011. Descriptive statistics were used to analyze the data. Prevalent cases were compared with all veterans who sought health care in each year. Incident cases were identified following a 2 years clean period in which the patient was enrolled and received care, but not services for any back or neck pain conditions. From 2004 to 2011, 3% to 4% of the population was diagnosed with incident back pain problems, the rate increasing on average, 1.75% per year. During the same period, 12.3% to 16.2% of the population was diagnosed with a prevalent back pain problem, the rate increasing on average 4.09% per year. In a national population, the prevalence rate for diagnosis of neck and back pain grew 1.8 to 2.3 times faster than the incidence rate. This suggests that the average duration of episodes of care is increasing. Additional research is needed to understand the influences on the differential rate of change and to develop efficient and effective care systems.

Background and Purpose— Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. Methods— We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. Results— A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively ( P Conclusions— The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00372411.

The Department of Veterans Affairs (VA) mandates disclosure of large-scale adverse events to patients, even if risk of harm is not clearly present. Concerns about past disclosures warranted further examination of the impact of this policy.Through a collaborative partnership between VA leaders, policymakers, researchers and stakeholders, the objective was to empirically identify critical aspects of disclosure processes as a first step towards improving future disclosures.Semi-structured interviews were conducted with participants at nine VA facilities where recent disclosures took place.Ninety-seven stakeholders participated in the interviews: 38 employees, 28 leaders (from facilities, regions and national offices), 27 Veteran patients and family members, and four congressional staff members.Facility and regional leaders were interviewed by telephone, followed by a two-day site visit where employees, patients and family members were interviewed face-to-face. National leaders and congressional staff also completed telephone interviews. Interviews were analyzed using rapid qualitative assessment processes. Themes were mapped to the stages of the Crisis and Emergency Risk Communication model: pre-crisis, initial event, maintenance, resolution and evaluation.Many areas for improvement during disclosure were identified, such as preparing facilities better (pre-crisis), creating rapid communications, modifying disclosure language, addressing perceptions of harm, reducing complexity, and seeking assistance from others (initial event), managing communication with other stakeholders (maintenance), minimizing effects on staff and improving trust (resolution), and addressing facilities' needs (evaluation).Through the partnership, five recommendations to improve disclosures during each stage of communication have been widely disseminated throughout the VA using non-academic strategies. Some improvements have been made; other recommendations will be addressed through implementation of a large-scale adverse event disclosure toolkit. These toolkit strategies will enable leaders to provide timely and transparent information to patients and families, while reducing the burden on employees and the healthcare system during these events.

A better understanding of overall survival among patients with clinically localized prostate cancer (PCa) in the US Veterans Health Administration (VHA) is critical to inform PCa treatment decisions, especially in light of data from the Prostate Intervention Versus Observation Trial (PIVOT). We sought to describe patterns of survival for all patients with clinically localized PCa treated by the VHA. We created an analytic cohort of 35 954 patients with clinically localized PCa diagnosed from 1995 to 2001, approximating the PIVOT inclusion criteria (age of diagnosis ≤75 yr and clinical stage T2 or lower). Mean patient age was 65.9 yr, and median follow-up was 161 mo. Overall, 22.5% of patients were treated with surgery, 16.6% were treated with radiotherapy, and 23.1% were treated with androgen deprivation. Median survival of the entire cohort was 14 yr (25th, 75th percentiles, range: 7.9–20 yr). Among patients who received treatment with curative intent, median survival was 17.9 yr following surgery and 12.9 yr following radiotherapy. One-third of patients died within 10 yr of diagnosis compared with nearly half of the participants in PIVOT. This finding sounds a note of caution when generalizing the mortality data from PIVOT to VHA patients and those in the community. Patient summary More than one-third of patients diagnosed with clinically localized prostate cancer treated through the US Veterans Health Administration from 1995 to 2001 died within 10 yr of their diagnosis. Caution should be used when generalizing the estimates of competing mortality data from PIVOT.