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Aim: To evaluate whether recent low adherence to metformin monotherapy is associated with hypoglycaemia after addition of a sulfonylurea. Methods: We assembled a retrospective cohort of veterans who filled a new prescription for metformin between 2001 and 2011 and intensified treatment with a sulfonylurea after ≥1 year of metformin use. We calculated metformin adherence from pharmacy data using the proportion of days covered in the 180‐day period before intensification. The primary outcome was hypoglycaemia, defined as a hospitalization or emergency department visit for hypoglycaemia or an outpatient blood glucose measurement <3.3 mmol/l in the year following intensification. Cox proportional hazards models were used to compare the risk of hypoglycaemia between participants with low (<80%) and high (≥80%) adherence. Adherence was also modelled as a continuous variable using restricted cubic splines. Results: Of 187 267 participants who initiated metformin monotherapy, 49 424 added a sulfonylurea after ≥1 year. The median (interquartile range) rate of treatment adherence was 87 (50–100)% and 43% had adherence <80%. Hypoglycaemia rates per 1000 person‐years were 23.1 (95% CI 21.1–25.4) and 24.5 (95% CI 22.7–26.4) in participants with low and high adherence, respectively (adjusted hazard ratio 0.95, 95% CI 0.84–1.08). The risk of hypoglycaemia was similar across all levels of adherence when adherence was modelled as a continuous variable. Conclusions: We found no evidence that past low adherence to metformin monotherapy was associated with hypoglycaemia after intensification with a sulfonylurea. What's new?: Providers often intensify anti‐hyperglycaemic treatment for people with Type 2 diabetes mellitus based on laboratory measurements without accurate assessment of adherence, potentially exposing those with low adherence to a more intensive regimen than necessary.This retrospective cohort study, which included incident users of metformin intensifying treatment, found that recent low adherence to metformin monotherapy was not associated with hypoglycaemia in the year following intensification with a sulfonylurea.While it is important for providers to evaluate medication adherence, this study does not suggest that intensifying treatment in the presence of recent non‐adherence is associated with a higher risk of hypoglycaemia. [ABSTRACT FROM AUTHOR]

Background: Inadequate blood pressure control is a persistent gap in quality care.Objective: To evaluate provider and patient interventions to improve blood pressure control.Design: Cluster randomized, controlled trial.Setting: 2 hospital-based and 8 community-based clinics in the Veterans Affairs Tennessee Valley Healthcare System.Patients: 1341 veterans with essential hypertension cared for by 182 providers. Eligible patients had 2 or more blood pressure measurements greater than 140/90 mm Hg in a 6-month period and were taking a single antihypertensive agent.Intervention: Providers who cared for eligible patients were randomly assigned to receive an e-mail with a Web-based link to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) guidelines (provider education); provider education and a patient-specific hypertension computerized alert (provider education and alert); or provider education, hypertension alert, and patient education, in which patients were sent a letter advocating drug adherence, lifestyle modification, and conversations with providers (patient education).Measurements: Proportion of patients with a systolic blood pressure less than 140 mm Hg at 6 months; intensification of antihypertensive medication.Results: Mean baseline blood pressure was 157/83 mm Hg with no differences between groups (P = 0.105). Six-month follow-up data were available for 975 patients (73%). Patients of providers who were randomly assigned to the patient education group had better blood pressure control (138/75 mm Hg) than those in the provider education and alert or provider education alone groups (146/76 mm Hg and 145/78 mm Hg, respectively). More patients in the patient education group had a systolic blood pressure of 140 mm Hg or less compared with those in the provider education or provider education and alert groups (adjusted relative risk for the patient education group compared with the provider education alone group, 1.31 [95% CI, 1.06 to 1.62]; P = 0.012).Limitations: Follow-up blood pressure measurements were missing for 27% of study patients. The study could not detect a mechanism by which patient education improved blood pressure control.Conclusions: A multifactorial intervention including patient education improved blood pressure control compared with provider education alone. [ABSTRACT FROM AUTHOR]

Abstract Background CRP gene polymorphisms are associated with serum C-reactive protein concentrations and may play a role in chronic kidney disease (CKD) progression. We recently reported an association between the gene variant rs2808630 and CKD progression in African Americans with hypertensive kidney disease. This association has not been studied in other ethnic groups. Methods We used data from 5955 participants from Phase 2 of The Third National Health and Nutrition Examination Survey (1991-1994) to study the association between CRP polymorphisms and CKD prevalence in a population-based sample. The primary outcome was CKD defined as estimated glomerular filtration rate (eGFR) CRP gene, rs2808630, rs1205, rs3093066, rs1417938, rs3093058, and rs1800947, were evaluated. Results CRP rs2808630 AG compared to the referent AA genotype was associated with CKD in non-Hispanic blacks (n = 1649, 293 of whom had CKD) with an adjusted odds ratio (OR) of 3.09 (95% CI 1.65-5.8; p = 0.001). For the secondary outcomes, rs2808630 AG compared to the referent AA genotype was associated with albuminuria with an adjusted OR of 3.07 (95% CI 1.59-5.94; p = 0.002), however not with eGFR. There was no association between the SNPs and CKD, albuminuria or eGFR in non-Hispanic whites or Mexicans Americans. Conclusions In this cross-sectional study, the 3' flanking CRP gene variant rs2808630 was associated with CKD, mainly through its association with albuminuria in the non-Hispanic blacks. Despite not finding an association with eGFR, our results support our previous study demonstrating an association between CRP gene variant rs2808630 and CKD progression in a longitudinal cohort of African American with hypertensive kidney disease.

OBJECTIVE: To evaluate an electronic quality (eQuality) assessment tool for dictated disability examination records. METHODS: We applied automated concept-based indexing techniques to automated quality screening of Department of Veterans Affairs spine disability examinations that had previously undergone gold standard quality review by human experts using established quality indicators. We developed automated quality screening rules and refined them iteratively on a training set of disability examination reports. We applied the resulting rules to a novel test set of spine disability examination reports. The initial data set was composed of all electronically available examination reports (N=125,576) finalized by the Veterans Health Administration between July and September 2001. RESULTS: Sensitivity was 91% for the training set and 87% for the test set (P-.02). Specificity was 74% for the training set and 71% for the test set (P=.44). Human performance ranged from 4% to 6% higher (P<.001) than the eQuality tool in sensitivity and 13% to 16% higher in specificity (P<.001). In addition, the eQuality tool was equivalent or higher in sensitivity for 5 of 9 individual quality indicators. CONCLUSION: The results demonstrate that a properly authored computer-based expert systems approach can perform quality measurement as well as human reviewers for many quality indicators. Although automation will likely always rely on expert guidance to be accurate and meaningful, eQuality is an important new method to assist clinicians in their efforts to practice safe and effective medicine. [ABSTRACT FROM AUTHOR]

Objective: To compare the risk of composite peripheral artery disease (PAD) surgical outcome, including peripheral revascularization and amputation procedures, between new users of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP-4is)., Research Design and Methods: This retrospective cohort study of U.S. veterans age ≥18 years with diabetes who received care from the Veterans Health Administration was performed from 1 October 2000 to 31 December 2021. Data were linked to Medicare, Medicaid, and the National Death Index. New use of SGLT2i or DPP-4i medications as an add-on to metformin, sulfonylurea, or insulin treatment alone or in combination was evaluated for an association with PAD surgical procedure for peripheral revascularization and amputation. A Cox proportional hazards model for time-to-PAD event analysis compared the risk of a PAD event between SGLT2is and DPP-4is in a propensity score-weighted cohort with a competing risk of death and allowance for events to occur up to 90 days or 360 days after stopping SGLT2is., Results: The weighted cohort included 76,072 SGLT2i vs. 75,833 DPP-4i use episodes. The median age was 69 years, HbA1c was 8.4% (interquartile range [IQR] 7.5-9.4%), and the median diabetes duration was 10.1 (IQR 6.6-14.6) years. There were 874 and 780 PAD events among SGLT2i and DPP-4i users, respectively, for an event rate of 11.2 (95% CI 10.5-11.9) and 10.0 (9.4-10.6) per 1,000 person-years (adjusted hazard ratio [aHR] 1.18 [95% CI 1.08-1.29]). When PAD events were allowed for 360 days after SGLT2i use ended, the aHR was 1.16 (95% CI 1.06-1.26)., Conclusions: SGLT2i as an add-on diabetes therapy was associated with an increased cause-specific hazard of PAD surgeries compared with DPP-4i., (© 2024 by the American Diabetes Association.)

Background and Aims: Sarcopenia, defined as a loss in muscle mass and strength, is common in patients with advanced chronic kidney disease (CKD), leading to poor outcomes. Intermuscular adipose tissue (IMAT) accumulation is associated with metabolic and functional abnormalities in chronic disease conditions. This study assesses IMAT in maintenance hemodialysis (MHD) patients and its association with metabolic markers and physical performance., Methods and Results: We performed a cross-sectional study comparing MHD patients with controls. IMAT accumulation was measured by analyzing the fat-to-muscle ratio of the calf muscles through Magnetic Resonance Imaging (MRI) scans. Body composition and metabolic markers were assessed (hs-CRP, TNF-α, IL-6, and insulin resistance). Circulating cell-free mitochondrial DNA (ccf-mtDNA) was quantified using qRT-PCR. Muscle function was evaluated with handgrip strength. Inverse propensity weighted (IPW) method was used to test the difference between IMAT levels of the groups. Twenty-five MHD patients and 23 controls were analyzed. The MHD group had higher IMAT accumulation than controls (p < 0.01). IMAT was positively correlated with Body Mass Index (BMI) and fat mass index (FMI) in controls. MHD patients exhibited elevated TNF-α, IL-6, and hs-CRP levels (p < 0.01). Positive correlations were found between IMAT and IL-6 in MHD patients and between IMAT and TNF-α in controls. Handgrip strength was negatively correlated with IMAT in the entire cohort (p <0.01)., Conclusion: Our findings highlight the potential role of IMAT in muscle catabolism and functional decline in advanced CKD. Targeting IMAT could be a valuable strategy for improving health outcomes in this population.

Objectives: Anorexia is common in patients with chronic kidney disease (CKD) and could lead to protein-energy wasting (PEW). An altered sense of smell, a reflection of olfactory dysfunction, is a potential mechanism that exacerbates the impact of anorexia on PEW. In this study, we examined the extent of the altered sense of smell and its association with PEW in patients with moderate-to-advanced CKD., Methods: We studied 139 individuals (34 healthy subjects- controls, 50 patients with stage 3-4 CKD, and 55 patients on maintenance hemodialysis (MHD)) using the odor identification test (Sniffin' Sticks odor screening test containing 12 different smells). The odor identification test was scored as either correct or incorrect, and each participant's total odor score was calculated. Malnutrition inflammation score (MIS) was used to assess PEW., Results: Patients with CKD had higher C-reactive protein and lower serum albumin concentrations compared to healthy individuals. Total odor scores were different between groups, with controls having the highest scores and MHD patients having the lowest scores. A similar difference was observed in MIS, and MHD patients displayed the worst nutritional score (P ≤ .001). The number of participants with severe olfactory dysfunction (≤6 correct answers) was significantly higher in the CKD and MHD groups compared to the controls (P ≤ .01). There was an inverse trend between the total odor score and the MIS score for the study population. However, this relationship was not statistically significant (r = -0.124, P = .21)., Conclusion: This cross-sectional study suggests that olfactory dysfunction, as assessed by the odor identification test, is altered in patients with advanced CKD, most notably in ones on MHD. Although the diminished sense of smell was observed alongside development of PEW, we explicitly noted that there is no statistically significant correlation., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Rationale: Incidence rates for pulmonary hypertension using diagnostic data in patients with cardiopulmonary disease are not known., Objectives: To determine incidence rates of, risk factors for, and mortality hazard associated with pulmonary hypertension among patients referred for transthoracic echocardiography., Methods: Retrospective cohort study using data from the Veterans Health Administration (1999-2020) and Vanderbilt University Medical Center (1994-2020). Pulmonary hypertension was defined as pulmonary artery systolic pressure >35mmHg with prevalent cases excluded. Heart failure and chronic obstructive pulmonary disease were the primary exposures of interest. The primary outcome was incident pulmonary hypertension. Secondarily, we examined mortality rate following incident diagnosis., Measurements and Main Results: We identified 245,067 VA patients (94% male, 20% Black) and 117,526 Vanderbilt patients (46% male, 11% Black) without pulmonary hypertension, of whom 38,882 VA patients and 8,061 Vanderbilt patients developed pulmonary hypertension. Only 18-19% of patients with echo-based pulmonary hypertension also had a diagnostic code. Hazard of pulmonary hypertension was 4-fold higher in patients with heart failure and chronic obstructive pulmonary disease compared to patients without either. Mortality rates increased from pulmonary artery systolic pressure of 35mmHg to 45mmHg then plateaued. Independent risk factors for incident pulmonary hypertension included older age, male sex, black race, and cardiometabolic comorbidities., Conclusions: Pulmonary hypertension incidence rates estimated by diagnostic data are higher than code-based rates. Heart failure and chronic obstructive pulmonary disease strongly associate with incident pulmonary hypertension. Pulmonary artery systolic pressure >45mmHg at diagnosis is associated with high mortality. New pulmonary hypertension on echocardiography is an important prognostic sign.

Purpose: Helicobacter pylori is the most common cause of infection-associated cancer worldwide. We aimed to evaluate the impact of H. pylori infection and treatment on colorectal cancer (CRC) incidence and mortality., Patients: US Veterans who completed H. pylori testing between 1999 and 2018., Methods: We conducted a retrospective cohort analysis among adults within the Veterans Health Administration who completed testing for H. pylori. The primary exposures were (1) H. pylori test result (positive/negative) and (2) H. pylori treatment (untreated/treated) among H. pylori-positive individuals. The primary outcomes were CRC incidence and mortality. Follow-up started at the first H. pylori testing and continued until the earliest of incident or fatal CRC, non-CRC death, or December 31, 2019., Results: Among 812,736 individuals tested for H. pylori, 205,178 (25.2%) tested positive. Being H. pylori-positive versus H. pylori-negative was associated with higher CRC incidence and mortality. H. pylori treatment versus no treatment was associated with lower CRC incidence and mortality (absolute risk reduction 0.23%-0.35%) through 15-year follow-up. Being H. pylori-positive versus H. pylori-negative was associated with an 18% (adjusted hazard ratio [adjusted HR], 1.18 [95% CI, 1.12 to 1.24]) and 12% (adjusted HR, 1.12 [95% CI, 1.03 to 1.21]) higher incident and fatal CRC risk, respectively. Individuals with untreated versus treated H. pylori infection had 23% (adjusted HR, 1.23 [95% CI, 1.13 to 1.34]) and 40% (adjusted HR, 1.40 [95% CI, 1.24 to 1.58]) higher incident and fatal CRC risk, respectively. The results were more pronounced in the analysis restricted to individuals with nonserologic testing., Conclusion: H. pylori positivity may be associated with small but statistically significant higher CRC incidence and mortality; untreated individuals, especially those with confirmed active infection, appear to be most at risk.

Background: Many patients who start peritoneal dialysis (PD) transition to hemodialysis (HD) after a PD-related complication. Patient psychological factors may influence clinical outcomes. One possible factor is health mindset, or patient belief that their health knowledge and ability can change. The goal of this study is to evaluate the longitudinal associations of baseline health mindset with patient outcomes after one year., Methods: The Health Mindset Scale (HMS, score 3-18) was administered on paper during clinic to a convenience sample of 100 adult PD patients, to quantify patient mindset along a continuum from fixed mindset (lower scores) to growth mindset (higher scores). Participants were 31% African American, 4% Hispanic, and 64% White American. Demographic and comorbid information were abstracted from medical records. Outcomes assessed at 1 year were death, transition to HD, renal transplant, and maintaining PD., Results: HMS scores were highest in patients who subsequently received a renal transplant (mean 15, SD 2.1), indicating a growth mindset. HMS scores in patients who died were lower (mean 10, SD 5.2) suggesting a more fixed mindset. Among those who maintained PD, HMS scores were between fixed and growth mindset (mean 12.8, SD 4.2) and similar to those who transitioned to HD (mean 13, SD 4.2). One-way ANOVA for difference in HMS scores by clinical outcome was p = 0.042., Conclusions: This initial longitudinal study suggests associations between mindset and clinical outcomes. The HMS is a novel and easily administered instrument that quantifies one patient psychological component that could contribute to patient outcomes, and that could also be modified. The HMS may identify individuals who could benefit from specific interventions to favor a growth mindset, with the goal of supporting optimal clinical outcomes., Competing Interests: DISCLOSURES The corresponding author completed a consultant agreement with Medcomp Fall 2022. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background & Aims: There are no contemporary large-scale studies evaluating the burden of Helicobacter pylori in the United States according to detailed demographics. The primary objective was to evaluate H pylori positivity in a large national healthcare system according to individual demographics and geography., Methods: We conducted a nationwide retrospective analysis of adults in the Veterans Health Administration who completed H pylori testing between 1999 and 2018. The primary outcome was H pylori positivity overall, as well as according to zip code-level geography, race, ethnicity, age, sex, and time period., Results: Among 913,328 individuals (mean, 58.1 years; 90.2% male) included between 1999 and 2018, H pylori was diagnosed in 25.8%. Positivity was highest in non-Hispanic black (median, 40.2%; 95% confidence interval [CI], 40.0%-40.5%) and Hispanic (36.7%; 95% CI, 36.4%-37.1%) individuals and lowest in non-Hispanic white individuals (20.1%; 95% CI, 20.0%-20.2%). Although H pylori positivity declined in all racial and ethnic groups over the timeframe, the disproportionate burden of H pylori in non-Hispanic black and Hispanic compared with non-Hispanic white individuals persisted. Approximately 4.7% of the variation in H pylori positivity was explained by demographics, with race and ethnicity accounting for the vast majority., Conclusions: The burden of H pylori is substantial in the United States among veterans. These data should (1) motivate research aimed at better understanding why marked demographic differences in H pylori burden persist so that mitigating interventions may be implemented and (2) guide resource allocation to optimize H pylori testing and eradication in high-risk groups., (Published by Elsevier Inc.)

Introduction: Bile acids have been implicated in gastric carcinogenesis. We hypothesized that bile acid sequestrant medication (BAM) use is associated with a lower gastric cancer (GC) incidence., Methods: We assembled a cohort of veterans receiving longitudinal care within the Veterans Health Administration between 2000 and 2020 who completed testing for Helicobacterpylori . The index date was the date of completed H. pylori testing. The primary exposure was the number of filled BAM prescription(s) in the 5 years before the index date. The primary outcome was incident GC, stratified by anatomic subsite. Follow-up began at the index date and ended at the earliest of GC, death, after 2 years of follow-up, or the study end (May 31, 2020). We used Kaplan-Meier curves to visualize differences in GC incidence by exposure group and multivariable Cox proportional hazards models to estimate the association between BAM exposure and anatomic site-specific GC., Results: Among 417,239 individuals (89% male, mean age 54 years, 63% non-Hispanic White), 4,916 (1.2%) filled at least one BAM prescription, 2,623 of whom filled ≥4. Compared with unexposed individuals, those with ≥4 BAM fills before entry had a lower incidence (adjusted hazard ratio 0.71; 95% confidence interval, 0.37-1.36) of GC, but confidence intervals were wide. Results were consistent irrespective of GC anatomic site., Discussion: BAMs may have a protective effect against both cardia and noncardia GC. Further research and external validation are needed to confirm these findings., (Copyright © 2023 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)

Objective: To validate an algorithm that identifies fractures using billing codes from the International Classification of Diseases Ninth Revision (ICD-9) and Tenth Revision (ICD-10) for inpatient, outpatient, and emergency department visits in a population of patients., Methods: We identified and reviewed a random sample of 543 encounters for adults receiving care within a single Veterans Health Administration healthcare system and had a first fracture episode between 2010 and 2019. To determine if an encounter represented a true incident fracture, we performed chart abstraction and assessed the type of fracture and mechanism. We calculated the positive predictive value (PPV) for the overall algorithm and each component diagnosis code along with 95% confidence intervals. Inverse probabilities of selection sampling weights were used to reflect the underlying study population., Results: The algorithm had an initial PPV of 73.5% (confidence interval [CI] 69.5, 77.1), with low performance when weighted to reflect the full population (PPV 66.3% [CI 58.8, 73.1]). The modified algorithm was restricted to diagnosis codes with PPVs > 50% and outpatient codes were restricted to the first outpatient position, with the exception of one high performing code. The resulting unweighted PPV improved to 90.1% (CI 86.2, 93.0) and weighted PPV of 91.3% (CI 86.8, 94.4). A confirmation sample demonstrated verified performance with PPV of 87.3% (76.0, 93.7). PPVs by location of care (inpatient, emergency department and outpatient) remained greater than 85% in the modified algorithm., Conclusions: The modified algorithm, which included primary billing codes for inpatient, outpatient, and emergency department visits, demonstrated excellent PPV for identification of fractures among a cohort of patients within the Veterans Health Administration system., (Published 2023. This article is a U.S. Government work and is in the public domain in the USA.)

Background and Aims: There are limited contemporary population-based data on Helicobacter pylori epidemiology and outcomes in the United States. Our primary aim was to create a validated cohort of veterans with H pylori testing or treatment using Veterans Health Administration data., Methods: Using Veterans Health Administration structured and unstructured data, we developed and validated 4 algorithms for H pylori infection (3 algorithms) and treatment status (1 algorithm). During the development phase, we iteratively modified each algorithm based on a manual review of random sets of electronic health records (reference standard). The a priori validation goal was to achieve a one-sided 95% confidence lower bound (LB) for positive predictive value (PPV) and/or negative predictive value (NPV) >90%. We applied the Bonferroni correction when both PPV and NPV were relevant., Results: For H pylori infection, we achieved 99.0% PPV (LB = 94.6%) and 100% NPV (LB = 96.4%) for discriminating H pylori positive vs negative status using structured (ie, laboratory tests) and 95% PPV (LB = 90.3%) and 97.9% NPV (LB = 93.9%) using unstructured (ie, histopathology reports) data. Diagnostic codes achieved 98% PPV (LB = 93.0%) for H pylori diagnosis. The treatment algorithm was composed of multiple antimicrobial combinations and overall achieved ≥98% PPV (LB = 93.0%) for H pylori treatment, except for amoxicillin/levofloxacin (PPV<60%). Application of these algorithms yielded nearly 1.2 million veterans with H pylori testing and/or treatment between 1999 and 2018., Conclusion: We assembled a validated national cohort of veterans who were tested or treated for H pylori infection. This cohort can be used for evaluating H pylori epidemiology and treatment patterns, as well as complications of chronic infection.

Background: The effectiveness of glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in preventing major adverse cardiac events (MACE) is uncertain for those without preexisting cardiovascular disease., Objective: To test the hypothesis that MACE incidence was lower with the addition of GLP1RA or SGLT2i compared with dipeptidyl peptidase-4 inhibitors (DPP4i) for primary cardiovascular prevention., Design: Retrospective cohort study of U.S. veterans from 2001 to 2019., Setting: Veterans aged 18 years or older receiving care from the Veterans Health Administration, with data linkage to Medicare, Medicaid, and the National Death Index., Patients: Veterans adding GLP1RA, SGLT2i, or DPP4i onto metformin, sulfonylurea, or insulin treatment alone or in combination. Episodes were stratified by history of cardiovascular disease., Measurements: Study outcomes were MACE (acute myocardial infarction, stroke, or cardiovascular death) and heart failure (HF) hospitalization. Cox models compared the outcome between medication groups using pairwise comparisons in a weighted cohort adjusted for covariates., Results: The cohort included 28 759 GLP1RA versus 28 628 DPP4i weighted pairs and 21 200 SGLT2i versus 21 170 DPP4i weighted pairs. Median age was 67 years, and diabetes duration was 8.5 years. Glucagon-like peptide-1 receptor agonists were associated with lower MACE and HF versus DPP4i (adjusted hazard ratio [aHR], 0.82 [95% CI, 0.72 to 0.94]), yielding an adjusted risk difference (aRD) of 3.2 events (CI, 1.1 to 5.0) per 1000 person-years. Sodium-glucose cotransporter-2 inhibitors were not associated with MACE and HF (aHR, 0.91 [CI, 0.78 to 1.08]; aRD, 1.28 [-1.12 to 3.32]) compared with DPP4i., Limitation: Residual confounding; use of DPP4i, GLP1RA, and SGLT2i as first-line therapies were not examined., Conclusion: The addition of GLP1RA was associated with primary reductions of MACE and HF hospitalization compared with DPP4i use; SGLT2i addition was not associated with primary MACE prevention., Primary Funding Source: VA Clinical Science Research and Development and supported in part by the Centers for Diabetes Translation Research., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-2751.

Background: Text message-delivered interventions are a feasible and scalable approach for improving chronic disease self-care and reducing health disparities; however, information on long-term user engagement with these interventions is limited., Objective: The aim of this study is to examine user engagement in a 12-month text message-delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health), among racially and socioeconomically diverse patients with type 2 diabetes (T2D). We explored time trends in engagement, associations between patient characteristics and engagement, and whether the addition of a human component or allowing patients to change their text frequency affected engagement. Qualitative data informed patients' subjective experience of their engagement., Methods: We recruited patients with T2D for a randomized trial evaluating mobile phone support relative to enhanced treatment as usual. This analysis was limited to participants assigned to the intervention. Participants completed a survey and hemoglobin A1c (HbA1c) test and received REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts. For the first 6 months, texts were sent daily, and half of the participants also received monthly phone coaching. After 6 months, coaching stopped, and participants had the option to receive fewer texts for the subsequent 6 months. We defined engagement via responses to the interactive texts and responses to a follow-up interview. We used regression models to analyze associations with response rate and thematic and structural analysis to understand participants' reasons for responding to the texts and their preferred text frequency., Results: The participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income

Posttraumatic stress disorder (PTSD) is one of the fastest growing compensated medical conditions. The present study compared usual disability examiner practices for PTSD with a standardized assessment that incorporates evidence-based assessments. The design was a multicenter, cluster randomized, parallel-group study involving 33 clinical examiners and 384 veterans at 6 Veterans Affairs medical centers. The standardized group incorporated the Clinician Administered PTSD Scale and the World Health Organization Disability Assessment Schedule-II into their assessment interview. The main outcome measures were completeness and accuracy of PTSD diagnosis and completeness of functional assessment. The standardized assessments were 85% complete for diagnosis compared to 30% for nonstandardized assessments (p < .001), and, for functional impairment, 76% versus 3% (p < .001). The findings demonstrate that the quality of PTSD disability examination would be improved by using evidence-based assessment., (Published 2012. This article is a US Government work and is in the public domain in the USA.)

There is increasing evidence that patient centered care, including communication skills, is an essential component to chronic illness care. Our aim was to evaluate patient centered primary care as a determinant of medication adherence. We mailed 1,341 veterans with hypertension the Short Form Primary Care Assessment Survey (PCAS) which measures elements of patient centered primary care. We prospectively collected each patient's antihypertensive medication adherence for 6 months. Patients were characterized as adherent if they had medication for >80%. 654 surveys were returned (50.7%); and 499 patients with complete data were analyzed. Antihypertensive adherence increased as scores in patient centered care increased [RR 3.18 (95% CI 1.44, 16.23) bootstrap 5000 resamples] for PCAS score of 4.5 (highest quartile) versus 1.5 (lowest quartile). Future research is needed to determine if improving patient centered care, particularly communication skills, could lead to improvements in health related behaviors such as medication adherence and health outcomes.

Background: Collaborative and toolkit approaches have gained traction for improving quality in health care., Objective: To determine if a quality improvement virtual collaborative intervention would perform better than a toolkit-only approach at preventing central line-associated bloodstream infections (CLABSIs) and ventilator-associated pneumonias (VAPs)., Design and Setting: Cluster randomized trial with the Intensive Care Units (ICUs) of 60 hospitals assigned to the Toolkit (n=29) or Virtual Collaborative (n=31) group from January 2006 through September 2007., Measurement: CLABSI and VAP rates. Follow-up survey on improvement interventions, toolkit utilization, and strategies for implementing improvement., Results: A total of 83% of the Collaborative ICUs implemented all CLABSI interventions compared to 64% of those in the Toolkit group (P = 0.13), implemented daily catheter reviews more often (P = 0.04), and began this intervention sooner (P < 0.01). Eighty-six percent of the Collaborative group implemented the VAP bundle compared to 64% of the Toolkit group (P = 0.06). The CLABSI rate was 2.42 infections per 1000 catheter days at baseline and 2.73 at 18 months (P = 0.59). The VAP rate was 3.97 per 1000 ventilator days at baseline and 4.61 at 18 months (P = 0.50). Neither group improved outcomes over time; there was no differential performance between the 2 groups for either CLABSI rates (P = 0.71) or VAP rates (P = 0.80)., Conclusion: The intensive collaborative approach outpaced the simpler toolkit approach in changing processes of care, but neither approach improved outcomes. Incorporating quality improvement methods, such as ICU checklists, into routine care processes is complex, highly context-dependent, and may take longer than 18 months to achieve., (Copyright © 2011 Society of Hospital Medicine.)

Matching is a powerful statistical tool in design and analysis. Conventional two-group, or bipartite, matching has been widely used in practice. However, its utility is limited to simpler designs. In contrast, nonbipartite matching is not limited to the two-group case, handling multiparty matching situations. It can be used to find the set of matches that minimize the sum of distances based on a given distance matrix. It brings greater flexibility to the matching design, such as multigroup comparisons. Thanks to improvements in computing power and freely available algorithms to solve nonbipartite problems, the cost in terms of computation time and complexity is low. This article reviews the optimal nonbipartite matching algorithm and its statistical applications, including observational studies with complex designs and an exact distribution-free test comparing two multivariate distributions. We also introduce an R package that performs optimal nonbipartite matching. We present an easily accessible web application to make nonbipartite matching freely available to general researchers.

Thiazolidinediones (TZD) have been shown to down-regulate prostate-specific antigen (PSA) levels in prostate cancer cell lines and decrease PSA velocity among prostate cancer patients; however, the effect of TZDs on serum PSA levels among men with diabetes at risk for prostate cancer is unknown. We conducted a retrospective cohort study of veterans receiving care for diabetes between 1999 and 2005 to determine if TZD use affects PSA levels in veterans at risk for prostate cancer. Eligible patients were male, >or=45 years old, taking at least one oral antidiabetic medication, and with two or more recorded PSA values. Patients with a prior history of prostate cancer or prostatectomy were excluded. Of the 13,791 patients included in the adjusted analysis, 2,016 (14.6%) were prescribed a TZD. No effect of cumulative TZD dose on change in PSA was detected (P = 0.26). Increased TZD exposure was not associated with a change in PSA, suggesting that TZD treatment for diabetes is unlikely to affect prostate cancer detection.

Background: Trauma patients without intracranial hemorrhage or focal neurologic deficits are typically considered low risk for lasting neuropsychological and emotional deficits, and such sequela may be overlooked, especially in those with skull fractures and concussions. We undertook this study to determine the prevalence of and risk factors for persistent cognitive impairment and emotional and functional difficulties in a sample of adult trauma intensive care unit survivors without intracranial hemorrhage., Methods: We queried the Vanderbilt University Trauma Registry for all patients admitted during 2003 with an Injury Severity Score >25 and a head computed tomography scan showing no intracranial hemorrhage. Of the 97 patients identified, 58 were evaluated, in person between 12 to 24 months after hospital discharge, with a comprehensive battery of cognitive, emotional, and functional instruments. The Informant Questionnaire of Cognitive Decline in the Elderly-Short Form (IQCODE-SF) was used to evaluate for pre-existing cognitive deficits in patients suspected of having cognitive impairment before their trauma., Results: A total of 33 (57%) patients were determined to have cognitive impairment, which was most pronounced in the domains of attention and executive functioning/verbal fluency. Of these patients, one (3%) was determined by the IQCODE-SF to be cognitively impaired before trauma intensive care unit hospitalization. Of the 58 patients studied, 21 (36.2%) had a concussion or skull fracture and 37 (63.8%) had neither. Cognitive impairment was significantly more likely to occur in patients who sustained a concussion or skull fracture than in trauma patients who did not (81% versus 43%; p = 0.006). Patients reported significant depressive symptoms (56%), significant symptoms of posttraumatic stress disorder (38%), and significant symptoms of anxiety (29%). Quality of life scores were lower than in the general United States population and employment difficulties were widespread. A total of 34% of patients reported being unemployed at follow-up, and cognitive impairment was more common among these patients compared with patients in the workforce (p = 0.03). Neither cognitive impairment nor emotional dysfunction was associated with age, sex, race, Injury Severity Score, blood loss, ventilatory days, or intramedullary nailing of long-bone fractures., Conclusions: The majority of trauma survivors without intracranial hemorrhage display persistent cognitive impairment, which is nearly twice as likely in those with skull fractures or concussions. This cognitive impairment was associated with functional defects, poor quality of life, and an inability to return to work. Future research must delineate modifiable risk factors for these poor outcomes, especially in patients with skull fractures and concussions, to help improve long-term cognitive and functional status.

Purpose: Younger individuals with relatives diagnosed with cancer are at greater risk for developing certain cancer when compared with older individuals with affected relatives. The purpose of this study was to calculate the age-specific proportion of individuals reporting positive family histories for colon, breast, and prostate cancer., Methods: Family cancer history information was reviewed on 32,374 adults interviewed for the 2000 National Health Interview Survey. Family histories were categorized as high risk, with a relative diagnosed before 50 years of age or with multiple affected relatives, or moderate risk, with a single relative diagnosed at age 50 years or older., Results: For individuals with a family history of colorectal cancer, the odds of having a high-risk pedigree decreased by 1% (95% confidence interval 0%-2%) for every year of age increase. For women reporting a family breast cancer history, the odds of reporting a pedigree with high-risk features decreased by 3% (95% confidence interval 2%-4%) for each year of age increase. Age was not associated with reporting a high-risk pedigree for prostate cancer., Conclusion: For colorectal and breast cancers, younger individuals reporting a family history of these cancers were more likely to report a pedigree with high-risk features than older individuals.