Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.

Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Methods and Results Participants in ADAPTABLE were stratified according to baseline use of clopidogrel or prasugrel (P2Y12 group). The primary effectiveness end point was a composite of death, myocardial infarction, or stroke; and the primary safety end point was major bleeding requiring blood transfusions. We used multivariable Cox regression to compare the relative effectiveness and safety of aspirin dose within P2Y12 and non-P2Y12 groups. Of 13 815 (91.6%) participants with available data, 3051 (22.1%) were receiving clopidogrel (2849 [93.4%]) or prasugrel (203 [6.7%]) at baseline. P2Y12 inhibitor use was associated with higher risk of the primary effectiveness end point (10.86% versus 6.31%; adjusted hazard ratio [HR], 1.40 [95% CI, 1.22-1.62]) but was not associated with bleeding (0.95% versus 0.53%; adjusted HR, 1.42 [95% CI, 0.91-2.22]). We found no interaction in the relative effectiveness and safety of high- versus low-dose aspirin by P2Y12 inhibitor use. Overall, dose switching or discontinuation was more common in the high-dose compared with low-dose aspirin group, but the pattern was not modified by P2Y12 inhibitor use. Conclusions In this prespecified analysis of ADAPTABLE, we found that the relative effectiveness and safety of high- versus low-dose aspirin was not modified by baseline P2Y12 inhibitor use. Registration https://www.clinical.trials.gov. Unique identifier: NCT02697916.

Psychosocial Determinants of Readmission After Surgery.

BACKGROUND: Quality of life and psychosocial determinants of health, such as health literacy and social support, are associated with increased health care utilization and adverse outcomes in medical populations. However, the effect on surgical health care utilization is less understood. OBJECTIVE: We sought to examine the effect of patient-reported quality of life and psychosocial determinants of health on unplanned hospital readmissions in a surgical population. RESEARCH DESIGN: This is a prospective cohort study using patient interviews at the time of hospital discharge from a Veterans Affairs hospital. SUBJECTS: We include Veterans undergoing elective inpatient general, vascular, or thoracic surgery (August 1, 2015-June 30, 2017). MEASURES: We assessed unplanned readmission to any medical facility within 30 days of hospital discharge. RESULTS: A total of 736 patients completed the 30-day postoperative follow-up, and 16.3% experienced readmission. Lower patient-reported physical and mental health, inadequate health literacy, and discharge home with help after surgery or to a skilled nursing or rehabilitation facility were associated with an increased incidence of readmission. Classification regression identified the patient-reported Veterans Short Form 12 (SF12) Mental Component Score <31 as the most important psychosocial determinant of readmission after surgery. CONCLUSIONS: Mental health concerns, inadequate health literacy, and lower social support after hospital discharge are significant predictors of increased unplanned readmissions after major general, vascular, or thoracic surgery. These elements should be incorporated into routinely collected electronic health record data. Also, discharge plans should accommodate varying levels of health literacy and consider how the patient's mental health and social support needs will affect recovery.

Patient-reported health literacy scores are associated with readmissions following surgery.

BACKGROUND: Health literacy (HL) impacts medical care. We hypothesized that patients with low HL would have higher readmission rates following surgery. METHODS: We conducted a prospective, multi-institutional study from 8/2015-6/2017 within the Veterans Affairs (VA) System including veterans who underwent general, vascular, or thoracic surgery. HL was assessed by Brief Health Literacy Screener and stratified into adequate vs. low. Patients were followed for 30 days post-discharge. Multivariable analyses examined correlations and logistic regression models adjusted for covariates. RESULTS: 736 patients were enrolled in the study; 98% (n = 722) completed the HL survey. At discharge, 33.2% of patients had low HL. The overall 30-day readmission rate was 16.3%, with a significant difference by HL (Adequate HL: 13.3% vs. Low HL: 22.5%, p < 0.01). After adjusting for clinical and demographic covariates, patients with low HL were 59% more likely to be readmitted (OR = 1.59, 95% CI = 1.02-2.50). CONCLUSION: Low HL is common among VA surgery patients and is associated with readmission. Future studies should be focused on interventions to target this vulnerable patient population.

Preoperative opioid use and postoperative pain associated with surgical readmissions.

BACKGROUND: The extent of preoperative opioid utilization and the relationship with pain-related readmissions are not well understood. METHODS: VA Surgical Quality Improvement Program data on general, vascular, and orthopedic surgeries (2007-2014) were merged with pharmacy data to evaluate preoperative opioid use and pain-related readmissions. Opioid use in the 6-month preoperative period was categorized as none, infrequent, frequent, and daily. RESULTS: In the six-month preoperative period, 65.7% had no opioid use, 16.7% had infrequent use, 6.3% frequent use, and 11.4% were daily opioid users. Adjusted odds of pain-related readmission were higher for opioid-exposed groups vs the opioid-naïve group: infrequent (OR 1.17; 95% CI:1.04-1.31), frequent (OR 1.28; 95% CI:1.08-1.52), and daily (OR 1.49; 95% CI:1.27-1.74). Among preoperative opioid users, those with a pain-related readmission had higher daily preoperative oral morphine equivalents (mean 44.5 vs. 36.1, p < 0.001). CONCLUSIONS: Patients using opioids preoperatively experienced higher rates of pain-related readmissions, which increased with frequency and dosage of opioid exposure.

Association Between Preoperative Proteinuria and Postoperative Acute Kidney Injury and Readmission.

Importance: Proteinuria indicates renal dysfunction and is a risk factor for morbidity among medical patients, but less is understood among surgical populations. There is a paucity of studies investigating how preoperative proteinuria is associated with surgical outcomes, including postoperative acute kidney injury (AKI) and readmission. Objective: To assess preoperative urine protein levels as a biomarker for adverse surgical outcomes. Design, Setting, and Participants: A retrospective, population-based study was conducted in a cohort of patients with and without known preoperative renal dysfunction undergoing elective inpatient surgery performed at 119 Veterans Affairs facilities from October 1, 2007, to September 30, 2014. Data analysis was conducted from April 4 to December 1, 2016. Preoperative dialysis, septic, cardiac, ophthalmology, transplantation, and urologic cases were excluded. Exposures: Preoperative proteinuria as assessed by urinalysis using the closest value within 6 months of surgery: negative (0 mg/dL), trace (15-29 mg/dL), 1+ (30-100 mg/dL), 2+ (101-300 mg/dL), 3+ (301-1000 mg/dL), and 4+ (>1000 mg/dL). Main Outcomes and Measures: Primary outcome was postoperative predischarge AKI and 30-day postdischarge unplanned readmission. Secondary outcomes included any 30-day postoperative outcome. Results: Of 346 676 surgeries, 153 767 met inclusion criteria, with the majority including orthopedic (37%), general (29%), and vascular procedures (14%). Evidence of proteinuria was shown in 43.8% of the population (trace: 20.6%, 1+: 16.0%, 2+: 5.5%, 3+: 1.6%) with 20.4%, 14.9%, 4.3%, and 0.9%, respectively, of the patients having a normal preoperative estimated glomerular filtration rate (eGFR). In unadjusted analysis, preoperative proteinuria was significantly associated with postoperative AKI (negative: 8.6%, trace: 12%, 1+: 14.5%, 2+: 21.2%, 3+: 27.6%; P < .001) and readmission (9.3%, 11.3%, 13.3%, 15.8%, 17.5%, respectively, P < .001). After adjustment, preoperative proteinuria was associated with postoperative AKI in a dose-dependent relationship (trace: odds ratio [OR], 1.2; 95% CI, 1.1-1.3, to 3+: OR, 2.0; 95% CI, 1.8-2.2) and 30-day unplanned readmission (trace: OR, 1.0; 95% CI, 1.0-1.1, to 3+: OR, 1.3; 95% CI, 1.1-1.4). Preoperative proteinuria was associated with AKI independent of eGFR. Conclusions and Relevance: Proteinuria was associated with postoperative AKI and 30-day unplanned readmission independent of preoperative eGFR. Simple urine assessment for proteinuria may identify patients at higher risk of AKI and readmission to guide perioperative management.

Visit-to-Visit Office Blood Pressure Variability and Cardiovascular Outcomes in SPRINT (Systolic Blood Pressure Intervention Trial).

Studies of visit-to-visit office blood pressure (BP) variability (OBPV) as a predictor of cardiovascular events and death in high-risk patients treated to lower BP targets are lacking. We conducted a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial), a well-characterized cohort of participants randomized to intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP targets. We defined OBPV as the coefficient of variation of the systolic BP using measurements taken during the 3-,6-, 9-, and 12-month study visits. In our cohort of 7879 participants, older age, female sex, black race, current smoking, chronic kidney disease, and coronary disease were independent determinants of higher OBPV. Use of thiazide-type diuretics or dihydropyridine calcium channel blockers was associated with lower OBPV whereas angiotensin-converting enzyme inhibitors or angiotensin receptor blocker use was associated with higher OBPV. There was no difference in OBPV in participants randomized to standard or intensive treatment groups. We found that OBPV had no significant associations with the composite end point of fatal and nonfatal cardiovascular events (n=324 primary end points; adjusted hazard ratio, 1.20; 95% confidence interval, 0.85-1.69, highest versus lowest quintile) nor with heart failure or stroke. The highest quintile of OBPV (versus lowest) was associated with all-cause mortality (adjusted hazard ratio, 1.92; confidence interval, 1.22-3.03) although the association of OBPV overall with all-cause mortality was marginal (P=0.07). Our results suggest that clinicians should continue to focus on office BP control rather than on OBPV unless definitive benefits of reducing OBPV are shown in prospective trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.

Hospital Readmissions after Surgery: How Important Are Hospital and Specialty Factors?

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 < 0.01) and colectomy and ventral hernia repair (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.

Primary care physician decision making regarding severe obesity treatment and bariatric surgery: a qualitative study.

BACKGROUND: Less than 1% of severely obese US adults undergo bariatric surgery annually. It is critical to understand the factors that contribute to its utilization. OBJECTIVES: To understand how primary care physicians (PCPs) make decisions regarding severe obesity treatment and bariatric surgery referral. SETTING: Focus groups with PCPs practicing in small, medium, and large cities in Wisconsin. METHODS: PCPs were asked to discuss prioritization of treatment for a severely obese patient with multiple co-morbidities and considerations regarding bariatric surgery referral. Focus group sessions were analyzed by using a directed approach to content analysis. A taxonomy of consensus codes was developed. Code summaries were created and representative quotes identified. RESULTS: Sixteen PCPs participated in 3 focus groups. Four treatment prioritization approaches were identified: (1) treat the disease that is easiest to address; (2) treat the disease that is perceived as the most dangerous; (3) let the patient set the agenda; and (4) address obesity first because it is the common denominator underlying other co-morbid conditions. Only the latter approach placed emphasis on obesity treatment. Five factors made PCPs hesitate to refer patients for bariatric surgery: (1) wanting to "do no harm"; (2) questioning the long-term effectiveness of bariatric surgery; (3) limited knowledge about bariatric surgery; (4) not wanting to recommend bariatric surgery too early; and (5) not knowing if insurance would cover bariatric surgery. CONCLUSION: Decision making by PCPs for severely obese patients seems to underprioritize obesity treatment and overestimate bariatric surgery risks. This could be addressed with PCP education and improvements in communication between PCPs and bariatric surgeons.

Cisplatin and etoposide versus carboplatin and paclitaxel with concurrent radiotherapy for stage III non-small-cell lung cancer: an analysis of Veterans Health Administration data.

PURPOSE: The optimal chemotherapy regimen to use with radiotherapy in stage III non-small-cell lung cancer is unknown. Here, we compare the outcome of patents treated within the Veterans Health Administration with either etoposide-cisplatin (EP) or carboplatin-paclitaxel (CP). METHODS: We identified patients treated with EP and CP with concurrent radiotherapy from 2001 to 2010. Survival rates were compared using Cox proportional hazards regression models with adjustments for confounding provided by propensity score methods and an instrumental variables analysis. Comorbidities and treatment complications were identified through administrative data. RESULTS: A total of 1,842 patients were included; EP was used in 27% (n = 499). Treatment with EP was not associated with a survival advantage in a Cox proportional hazards model (hazard ratio [HR], 0.97; 95% CI, 0.85 to 1.10), a propensity score matched cohort (HR, 1.07; 95% CI, 0.91 to 1.24), or a propensity score adjusted model (HR, 0.97; 95% CI, 0.85 to 1.10). In an instrumental variables analysis, there was no survival advantage for patients treated in centers where EP was used more than 50% of the time as compared with centers where EP was used in less than 10% of the patients (HR, 1.07; 95% CI, 0.90 to 1.26). Patients treated with EP, compared with patients treated with CP, had more hospitalizations (2.4 v 1.7 hospitalizations, respectively; P < .001), outpatient visits (17.6 v 12.6 visits, respectively; P < .001), infectious complications (47.3% v 39.4%, respectively; P = .0022), acute kidney disease/dehydration (30.5% v 21.2%, respectively; P < .001), and mucositis/esophagitis (18.6% v 14.4%, respectively; P = .0246). CONCLUSION: After accounting for prognostic variables, patients treated with EP versus CP had similar overall survival, but EP was associated with increased morbidity.

Informed decision-making and colorectal cancer screening: is it occurring in primary care?

BACKGROUND: Current recommendations advise patients to participate in the decision-making for selecting a colorectal cancer (CRC) screening option. The degree to which providers communicate the information necessary to prepare patients for participation in this process is not known. OBJECTIVE: To assess the level of informed decision-making occurring during actual patient-provider communications on CRC screening and test for the association between informed decision-making and screening behavior. RESEARCH DESIGN: Observational study of audiotaped clinic visits between patients and their providers in the primary care clinic at a Veterans Administration Medical Center. SUBJECTS: Male patients, age 50-74 years, presenting to a primary care visit at the study site. MEASURES: The Informed Decision-Making (IDM) Model was used to code the audiotapes for 9 elements of communication that should occur to prepare patients for participation in decision-making. The primary outcome is completion of CRC screening during the study period. RESULTS: The analytic cohort consisted of 91 patients due for CRC screening who had a test ordered at the visit. Six of the 9 IDM elements occurred in < or =20% of the visits with none addressed in > or =50%. CRC screening occurred less frequently for those discussing "pros and cons" (12% vs. 46%, P = 0.01) and "patient preferences" (6% vs. 47%, P = 0.001) compared with those who did not. CONCLUSIONS: We found that a lack of informed decision-making occurred during CRC screening discussions and that particular elements of the process were negatively associated with screening. Further research is needed to better understand the effects of informed decision-making on screening behavior.

Relevance of carotid stenosis progression as a predictor of ischemic neurological outcomes.

BACKGROUND: The progression of carotid stenosis may be a better predictor of adverse neurological outcomes than a single measurement of stenosis in asymptomatic patients. METHODS: Retrospective review of prospectively collected data from a noninvasive vascular surgery laboratory between 1988 and 1997 at a Veterans Affairs Medical Center. A total of 1701 carotid arteries from 1004 asymptomatic patients were prospectively followed by duplex ultrasonographic scanning. Carotid arteries treated with endarterectomy were excluded. The main outcome measures were ipsilateral transient ischemic attack (TIA) and cerebrovascular accident (CVA). RESULTS: The baseline degree of carotid stenosis was less than 50% of artery diameter in 75% of patients. The annual rates of ipsilateral TIA and CVA were each 3.3%. When categorized with respect to carotid artery, the annual rates of ipsilateral TIAs and CVAs were 2.0% and 2.1%, respectively. Univariable Cox proportional hazards modeling showed that both baseline carotid stenosis and progression of stenosis were significant predictors of the composite outcome TIA and CVA, as well as the outcome CVA alone. In multivariable modeling, the progression of carotid stenosis was a highly significant predictor of the composite outcome TIA and CVA (risk ratio [RR], 1.68; P<.001) and of CVA alone (RR, 1.78; P<.001). However, baseline stenosis was found to be a significant predictor of time to the combined outcome (RR, 1.29; P =.01) but not of CVA alone. Clinical risk factors did not add any additional predictive information. CONCLUSION: The progression of carotid stenosis assessed by serial duplex scanning is a better predictor of ischemic neurological events than a single measurement of stenosis.