Impact of veteran-led peer mentorship on posttraumatic stress disorder.

Peer mentorship shows promise as a strategy to support veteran mental health. A community-academic partnership involving a veteran-led nonprofit organization and institutions of higher education evaluated a collaboratively developed peer mentor intervention. We assessed posttraumatic stress disorder (PTSD), postdeployment experiences, social functioning, and psychological strengths at baseline, midpoint, and 12-week discharge using the PTSD Checklist for DSM-5 (PCL-5), Deployment Risk and Resilience Inventory-2, Social Adaptation Self-evaluation Scale, and Values in Action Survey. Brief weekly check-in surveys reinforced mentor contact and assessed retention. The sample included 307 veterans who were served by 17 veteran peer mentors. Mixed-effects linear models found a modest effect for PTSD symptom change, with a mean PCL-5 score reduction of 4.04 points, 95% CI [-6.44, -1.64], d = 0.44. More symptomatic veterans showed a larger effect, with average reductions of 9.03 points, 95% CI [-12.11, -5.95], d = 0.77. There were no significant findings for other outcome variables. Compared to younger veterans, those aged 32-57 years were less likely to drop out by 6 weeks, aORs = 0.32-0.26. Week-by-week hazard of drop-out was lower with mentors ≥ 35 years old, aHR = 0.62, 95% CI [0.37, 1.05]. Unadjusted survival differed by mentor military branch, p = .028, but the small mentor sample reduced interpretability. Like many community research efforts, this study lacked a control group, limiting the inferences that can be drawn. Continued study of veteran peer mentorship is important as this modality is often viewed as more tolerable than therapy.

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.

Influence of Baseline Diastolic Blood Pressure on Effects of Intensive Compared With Standard Blood Pressure Control.

BACKGROUND: In individuals with a low diastolic blood pressure (DBP), the potential benefits or risks of intensive systolic blood pressure (SBP) lowering are unclear. METHODS: SPRINT (Systolic Blood Pressure Intervention Trial) was a randomized controlled trial that compared the effects of intensive (target <120 mm Hg) and standard (target <140 mm Hg) SBP control in 9361 older adults with high blood pressure at increased risk of cardiovascular disease. The primary outcome was a composite of cardiovascular disease events. All-cause death and incident chronic kidney disease were secondary outcomes. This post hoc analysis examined whether the effects of the SBP intervention differed by baseline DBP. RESULTS: Mean baseline SBP and DBP were 139.7±15.6 and 78.1±11.9 mm Hg, respectively. Regardless of the randomized treatment, baseline DBP had a U-shaped association with the hazard of the primary cardiovascular disease outcome. However, the effects of the intensive SBP intervention on the primary outcome were not influenced by baseline DBP level (P for interaction=0.83). The primary outcome hazard ratio for intensive versus standard treatment was 0.78 (95% confidence interval, 0.57-1.07) in the lowest DBP quintile (mean baseline DBP, 61±5 mm Hg) and 0.74 (95% confidence interval, 0.61-0.90) in the upper 4 DBP quintiles (mean baseline DBP, 82±9 mm Hg), with an interaction P value of 0.78. Results were similar for all-cause death and kidney events. CONCLUSIONS: Low baseline DBP was associated with increased risk of cardiovascular disease events, but there was no evidence that the benefit of the intensive SBP lowering differed by baseline DBP. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01206062.

Randomized trial of technology-assisted self-monitoring of blood glucose by low-income seniors: improved glycemic control in type 2 diabetes mellitus.

Self-monitoring of blood glucose (SMBG) has been recommended for people with type 2 diabetes mellitus. This trial tested an automated self-management monitor (ASMM) that reminds patients to perform SMBG, provides feedback on results of SMBG, and action tips for improved self-management. This delayed-start trial randomized participants to using the ASMM immediately (IG), or following a delay of 6 months (DG). Glycated hemoglobin (HgbA1c) level and survey data was collected at home visits every 3 months. 44 diabetic men and women, mean age 70, completed the 12-month trial. Baseline HgbA1c was 8.1 % ± 1.0, dropping to 7.3 ± 1.0 by 9 months, with a 3-month lag in the DG (F = 3.56, p = 0.004). Decrease in HgbA1c was significantly correlated to increased frequency of SMBG, R = 0.588, p < 0.01. Providing older diabetics with objective immediate contingent feedback resulted in more frequent SMBG that correlated with better glycemic control. This type of technology may provide real-time feedback not only to patient users, but to the health care system, allowing better integration of provider recommendations with patient-centered action.

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial.

IMPORTANCE: The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. OBJECTIVE: To evaluate the effects of intensive (<120 mm Hg) compared with standard (<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015. INTERVENTIONS: Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319). MAIN OUTCOMES AND MEASURES: The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome. RESULTS: Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]). CONCLUSIONS AND RELEVANCE: Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01206062.

Understanding VA Maternity Care Coordinators Interactions and Collaboration With Primary Care Providers.

INTRODUCTION: Maternal morbidity is higher among the Veteran population in part because of high rates of chronic medical and mental health conditions. To improve care for pregnant Veterans, the Department of Veteran Affairs created the position of the Maternity Care Coordinator (MCC) to provide care coordination during a Veteran's pregnancy. Maternity Care Coordinators must work with primary care providers (PCPs); yet, little is known about their collaboration and interaction. The objective of this work is to better understand how MCCs interact with PCPs. METHOD: Between March and May of 2021, we conducted qualitative interviews with 30 MCCs using a semi-structured interview guide to learn about their role and interactions with PCPs. RESULTS: We identified 3 main themes in interactions between MCCs and PCPs, which correlated to times during the Veteran's pregnancy: initial interactions, care coordination during the pregnancy, and end of pregnancy transitions of care. Most MCCs indicated a positive and collaborative relationship with PCPs. There was significant variability in how closely MCCs worked with PCPs. MCCs reported that PCPs were not always comfortable caring for pregnant Veterans. DISCUSSION: Although MCCs generally indicated a positive and collaborative interaction with PCPs, our data suggest that there are opportunities to improve communication between PCPs and MCCs and to educate PCPs on knowledge of maternity benefits, the role of the MCC, and how to care for pregnant and postpartum Veterans. The Veteran Affairs MCC can also serve as a model for other health systems aiming to improve care coordinator among pregnant patients.

Yoga for Veterans with PTSD: Intervention Feasibility, Changes in PTSD Symptom Severity, and Psychological and Physiological Health-Related Fitness Outcomes.

Posttraumatic stress disorder (PTSD) is a burdensome disorder associated with lower quality of life and increased morbidity and mortality. Veterans are particularly at risk for PTSD resulting from experiencing traumatic events during military service. Current treatments for PTSD often fail to remediate symptoms and are associated with high dropout rates; therefore, complementary and integrative health approaches, such as yoga, are being considered to treat PTSD-related symptoms. The present study investigated the feasibility of a 12-week, 1-hour/week, in-person, trauma-informed mindful resilience yoga intervention for improving PTSD symptom severity and secondary psychological outcomes (e.g., physical and mental health, sleep, mindfulness, and self-efficacy), physiological health-related fitness outcomes (e.g., body composition and muscular strength), and physical activity outcomes (e.g., accelerometry) in a sample of veterans with PTSD. Results demonstrated the intervention to be feasible, with 12 participants (9 male, 3 female; mean age 50.3) completing the program (10 participants completed ≥ 75% of the 12 sessions). Statistically significant improvement was demonstrated in the "nonjudging of inner experience" aspect of mindfulness (p = 0.005, d = 1.280). Although not considered statistically significant (p > 0.008), the majority of outcomes demonstrated trending improvement from pre- to postintervention, with small to large Cohen's d effect sizes. The novelty of this study is represented by the trending improvements in physiological health-related fitness outcomes, with lean mass and handgrip strength demonstrating small effect sizes (d = 0.243 and d = 0.267, respectively). Our results extend the existing literature on the feasibility and potential effectiveness of yoga as a complementary or integrative therapy for PTSD in the veteran population.

Equitable community-based participatory research engagement with communities of color drives All of Us Wisconsin genomic research priorities.

OBJECTIVE: The NIH All of Us Research Program aims to advance personalized medicine by not only linking patient records, surveys, and genomic data but also engaging with participants, particularly from groups traditionally underrepresented in biomedical research (UBR). This study details how the dialogue between scientists and community members, including many from communities of color, shaped local research priorities. MATERIALS AND METHODS: We recruited area quantitative, basic, and clinical scientists as well as community members from our Community and Participant Advisory Boards with a predetermined interest in All of Us research as members of a Special Interest Group (SIG). An expert community engagement scientist facilitated 6 SIG meetings over the year, explicitly fostering openness and flexibility during conversations. We qualitatively analyzed discussions using a social movement framework tailored for community-based participatory research (CBPR) mobilization. RESULTS: The SIG evolved through CBPR stages of emergence, coalescence, momentum, and maintenance/integration. Researchers prioritized community needs above personal academic interests while community members kept discussions focused on tangible return of value to communities. One key outcome includes SIG-driven shifts in programmatic and research priorities of the All of Us Research Program in Southeastern Wisconsin. One major challenge was building equitable conversations that balanced scientific rigor and community understanding. DISCUSSION: Our approach allowed for a rich dialogue to emerge. Points of connection and disconnection between community members and scientists offered important guidance for emerging areas of genomic inquiry. CONCLUSION: Our study presents a robust foundation for future efforts to engage diverse communities in CBPR, particularly on healthcare concerns affecting UBR communities.

Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Male and Female Patients: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.

Importance: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses. Objective: To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial. Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024. Interventions: Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD. Main Outcomes and Measures: The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion. Results: A total of 15 076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10 352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence. Conclusions and Relevance: In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events. Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.

Importance: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. Objective: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. Exposures: Randomized exposure to 81 mg or 325 mg of aspirin daily. Main Outcomes and Measures: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. Results: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. Conclusions and Relevance: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

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.

Effectiveness and Safety of Enteric-Coated vs Uncoated Aspirin in Patients With Cardiovascular Disease: A Secondary Analysis of the ADAPTABLE Randomized Clinical Trial.

Importance: Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulations. Objective: To assess whether receipt of enteric-coated vs uncoated aspirin is associated with effectiveness or safety outcomes. Design, Setting, and Participants: This is a post hoc secondary analysis of ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic study of 15 076 patients with atherosclerotic cardiovascular disease having data in the National Patient-Centered Clinical Research Network. Patients were enrolled from April 19, 2016, through June 30, 2020, and randomly assigned to receive high (325 mg) vs low (81 mg) doses of daily aspirin. The present analysis assessed the effectiveness and safety of enteric-coated vs uncoated aspirin among those participants who reported aspirin formulation at baseline. Data were analyzed from November 11, 2019, to July 3, 2023. Intervention: ADAPTABLE participants were regrouped according to aspirin formulation self-reported at baseline, with a median (IQR) follow-up of 26.2 (19.8-35.4) months. Main Outcomes and Measures: The primary effectiveness end point was the cumulative incidence of the composite of myocardial infarction, stroke, or death from any cause, and the primary safety end point was major bleeding events (hospitalization for a bleeding event with use of a blood product or intracranial hemorrhage). Cumulative incidence at median follow-up for primary effectiveness and primary safety end points was compared between participants taking enteric-coated or uncoated aspirin using unadjusted and multivariable Cox proportional hazards models. All analyses were conducted for the intention-to-treat population. Results: Baseline aspirin formulation used in ADAPTABLE was self-reported for 10 678 participants (median [IQR] age, 68.0 [61.3-73.7] years; 7285 men [68.2%]), of whom 7366 (69.0%) took enteric-coated aspirin and 3312 (31.0%) took uncoated aspirin. No significant difference in effectiveness (adjusted hazard ratio [AHR], 0.94; 95% CI, 0.80-1.09; P = .40) or safety (AHR, 0.82; 95% CI, 0.49-1.37; P = .46) outcomes between the enteric-coated aspirin and uncoated aspirin cohorts was found. Within enteric-coated aspirin and uncoated aspirin, aspirin dose had no association with effectiveness (enteric-coated aspirin AHR, 1.13; 95% CI, 0.88-1.45 and uncoated aspirin AHR, 0.99; 95% CI, 0.83-1.18; interaction P = .41) or safety (enteric-coated aspirin AHR, 2.37; 95% CI, 1.02-5.50 and uncoated aspirin AHR, 0.89; 95% CI, 0.49-1.64; interaction P = .07). Conclusions and Relevance: In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteric-coated aspirin cannot be excluded. More research is needed to confirm whether enteric-coated aspirin formulations or newer formulations will improve outcomes in this population. Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale.

Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.

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.

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.

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.

Effect of Intensive Blood Pressure Control on Gait Speed and Mobility Limitation in Adults 75 Years or Older: A Randomized Clinical Trial.

Importance: Intensive blood pressure (BP) control confers a benefit on cardiovascular morbidity and mortality; whether it affects physical function outcomes is unknown. Objective: To examine the effect of intensive BP control on changes in gait speed and mobility status. Design, Setting, and Participants: This randomized, clinical trial included 2636 individuals 75 years or older with hypertension and no history of type 2 diabetes or stroke who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Data were collected from November 8, 2010, to December 1, 2015. Analysis was based on intention to treat. Interventions: Participants were randomized to intensive treatment with a systolic BP target of less than 120 mm Hg (n = 1317) vs standard treatment with a BP target of less than 140 mm Hg (n = 1319). Main Outcomes and Measures: Gait speed was measured using a 4-m walk test. Self-reported information concerning mobility was obtained from items on the Veterans RAND 12-Item Health Survey and the EQ-5D. Mobility limitation was defined as a gait speed less than 0.6 meters per second (m/s) or self-reported limitations in walking and climbing stairs. Results: Among the 2629 participants in whom mobility status could be defined (996 women [37.9%]; 1633 men [62.1%]; mean [SD] age, 79.9 [4.0] years), median (interquartile range) follow-up was 3 (2-3) years. No difference in mean gait speed decline was noted between the intensive- and standard-treatment groups (mean difference, 0.0004 m/s per year; 95% CI, -0.005 to 0.005; P = .88). No evidence of any treatment group differences in subgroups defined by age, sex, race or ethnicity, baseline systolic BP, chronic kidney disease, or a history of cardiovascular disease were found. A modest interaction was found for the Veterans RAND 12-Item Health Survey Physical Component Summary score, although the effect did not reach statistical significance in either subgroup, with mean differences of 0.004 (95% CI, -0.002 to 0.010) m/s per year among those with scores of at least 40 and -0.008 (95% CI, -0.016 to 0.001) m/s per year among those with scores less than 40 (P = .03 for interaction). Multistate models allowing for the competing risk of death demonstrated no effect of intensive treatment on transitions to mobility limitation (hazard ratio, 1.06; 95% CI, 0.92-1.22). Conclusions and Relevance: Among adults 75 years or older in SPRINT, treating to a systolic BP target of less than 120 mm Hg compared with a target of less than 140 mm Hg had no effect on changes in gait speed and was not associated with changes in mobility limitation. Trial Registration: clinicaltrials.gov Identifier: NCT01206062.