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OBJECTIVE We examined users' preferences for and engagement with text messages delivered as part of an emergency department (ED)-based intervention to improve antihypertensive medication adherence. METHODS We recruited ED patients with elevated blood pressure for a pilot randomized trial evaluating a medication adherence intervention with text messages. Intervention participants chose text content and frequency, received texts for 45 days, and completed a feedback survey. We defined engagement via responses to texts. We examined participant characteristics associated with text preferences, engagement, and feedback. RESULTS Participants (N = 101) were 57% female and 46% non-White. Most participants (71%) chose to receive both reminder and informational texts; 94% chose reminder texts once per day and 97% chose informational texts three times per week. Median text message response rate was 56% (IQR 26-80%). Participants who were Black (p

The adverse effects of proton pump inhibitors (PPIs) have been documented for pneumonia; however, there is no consensus regarding whether the use of PPIs might be harmful regarding the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In this regard, we aimed to measure the potential associations of the current use of PPIs with the infection rates of COVID-19 among patients who underwent SARS-CoV-2 testing.Data were derived from a Korean nationwide cohort study with propensity score matching. We included 132 316 patients older than 18 years who tested for SARS-CoV-2 between 1 January and 15 May 2020. Endpoints were SARS-CoV-2 positivity (primary) and severe clinical outcomes of COVID-19 (secondary: admission to intensive care unit, administration of invasive ventilation or death).In the entire cohort, there were 111 911 non-users, 14 163 current PPI users and 6242 past PPI users. After propensity score matching, the SARS-CoV-2 test positivity rate was not associated with the current or past use of PPIs. Among patients with confirmed COVID-19, the current use of PPIs conferred a 79% greater risk of severe clinical outcomes of COVID-19, while the relationship with the past use of PPIs remained insignificant. Current PPI use starting within the previous 30 days was associated with a 90% increased risk of severe clinical outcomes of COVID-19.Patients taking PPIs are at increased risk for severe clinical outcomes of COVID-19 but not susceptible to SARS-CoV-2 infection. This suggests that physicians need to assess benefit-risk assessments in the management of acid-related diseases amid the COVID-19 pandemic.

ST-segment elevation myocardial infarction (STEMI) predominantly affects older adults. Lower incidence among younger patients may challenge diagnosis.We hypothesize that among patients ≤ 50 years old, emergent percutaneous coronary intervention (PCI) for STEMI is delayed when compared with patients aged 50 years.This 3-year, 10-center retrospective cohort study included emergency department (ED) STEMI patients ≥ 18 years of age treated with emergent PCI. We excluded patients with an electrocardiogram (ECG) completed prior to ED arrival or a nondiagnostic initial ECG. Our primary outcome was door-to-balloon (D2B) time. We compared characteristics and outcomes among younger vs. older STEMI patients, and among age subgroups.There were 576 ED STEMI PCI patients, of whom 100 were ≤ 50 years old and 476 were50 years old. Median age was 44 years in the younger cohort (interquartile range [IQR] 41-47) vs. 62 years (IQR 57-70) among older patients. Median D2B time for the younger cohort was 76.5 min (IQR 67.5-102.5) vs. 81.0 min (IQR 65.0-105.5) in the older cohort (p = 0.91). This outcome did not change when ages 40 or 45 years were used to demarcate younger vs. older. The younger cohort had a higher prevalence of nonwhite races (38% vs. 21%; p 0.001) and those currently smoking (36% vs. 23%; p = 0.005). The very young (≤30 years; 6/576) and very old (80 years; 45/576) had 5.51 and 2.2 greater odds of delays.We found no statistically significant difference in D2B times between patients ≤ 50 years old and those 50 years old. Nonwhite patients and those who smoke were disproportionately represented within the younger population. The very young and very old had higher odds of D2B times90 min.

ObjectiveThere is a need to support healthcare providers, including physician-mothers at all training levels, related to breastfeeding and expressing breast milk. This study was designed to understand the attitudes and preferences of lactating employees regarding current lactation resources at an academic medical center.MethodsCross-sectional survey. Respondents reported their satisfaction with current lactation resources on scale of 0 [complete dissatisfaction] to 100 [complete satisfaction]. Respondents were asked to identify greatest priorities for improvements to existing lactation spaces.Results304 (34.2%) respondents, of whom 69.3% anticipated using a lactation room in the next 5 years. Satisfaction with the current status of lactation rooms was low (mean score 37.8; SD 25.3). Accessible and proximal lactation spaces were highest priorities. More than 50% of respondents indicated daily use of a “nontraditional” lactation space.ConclusionThis study demonstrates the current state of healthcare providers' lactation-related experiences and highlights priorities for improvement, particularly provision of adequate lactation spaces.

Objectives: To compare patient-reported social determinants of health (SDOH) to the Brokamp Area Deprivation Index (ADI), and evaluate the association of patient-reported SDOH and ADI with mortality in patients with cardiovascular disease (CVD). Design: Prospective cohort. Setting: Academic medical center. Participants: Adults with acute coronary syndrome (ACS) and/or acute exacerbation of heart failure (HF) hospitalized between 2011 and 2015. Methods: Patient-reported SDOH included: income range, education, health insurance, and household size. ADI was calculated using census tract level variables of poverty, median income, high school completion, lack of health insurance, assisted income, and vacant housing. Primary outcome: All-cause mortality, up to 5 years follow-up. Results: The sample was 60% male, 84% White, and 93% insured; mean patient-reported household income was $48,000 (SD $34,000). ADI components were significantly associated with corresponding patient-report­ed variables. In age, sex, and race adjusted Cox regression models, ADI was associated with mortality for ACS (HR 1.23, 95% CI 1.06, 1.42), but not HF (HR 1.09, 95% CI .99, 1.21). Mortality models for ACS improved with consideration of social determinants data (C-statistics: base demographic model=.612; ADI added=.644; patient-reported SDOH added=.675; both ADI and patient-reported SDOH added=.689). HF mortality models improved only slightly (C-statistics: .600, .602, .617, .620, respectively). Conclusions: The Brokamp ADI is associated with mortality in hospitalized patients with CVD. In the absence of available patient-reported data, hospitals could implement the Brokamp ADI as an approximation for patient-reported data to enhance risk stratification of patients with CVD. Ethn Dis. 2021;31(1):9-22; doi:10.18865/ed.31.1.9

BackgroundA systems-level approach to smoking cessation treatment may optimize healthcare provider adherence to guidelines. Institutions such as the Veterans Health Administration (VHA) are unique in their systematic approach, but comparisons of provider behavior in different healthcare systems are limited.MethodsWe surveyed general medicine providers and specialists in a large academic health center (AHC) and its affiliated VHA in the Mid-South in 2017 to determine the cross-sectional association of healthcare system in which the provider practiced (exposure: AHC versus VHA) with self-reported provision of evidence-based smoking cessation treatment (delivery of counseling plus smoking cessation medication or referral) at least once in the past 12 months (composite outcome). Multivariable logistic regression with adjustment for specialty was performed in 2017–2019.ResultsOf 625 healthcare providers surveyed, 407 (65%) responded, and 366 (59%) were analyzed. Most respondents practiced at the AHC (273[75%] vs VHA 93[25%]) and were general internists (215[59%]); pulmonologists (39[11%]); hematologists/oncologists (69[19%]); and gynecologists (43[12%]). Most respondents (328[90%]) reported the primary outcome. The adjusted odds of evidence-based smoking cessation treatment were higher among VHA vs. AHC healthcare providers (aOR = 4.3; 95% CI 1.3–14.4;p = .02). Health systems differed by provision of individual treatment components, including smoking cessation medication use (98% VHA vs. 90% AHC,p = 0.02) and referral to smoking cessation services (91% VHA vs. 65% AHCp = 0.001).ConclusionsVHA healthcare providers were significantly more likely to provide evidence-based smoking cessation treatment compared to AHC healthcare providers. Healthcare systems’ prioritization of and investment in smoking cessation treatment is critical to improving providers’ adherence to guidelines.

The National Comprehensive Cancer Network has defined metrics for colorectal cancer; however, the association of metric adherence with patient clinical outcomes remains underexplored. The study aim was to evaluate the association of National Comprehensive Cancer Network metric adherence with recurrence and mortality in Veterans with nonmetastatic colorectal cancer. Veterans with stage I–III colorectal cancer who underwent non-emergent resection from 2001 to 2015 at a single Veterans Affairs Medical Center were included. The primary predictor was completion of eligible National Comprehensive Cancer Network metrics. The primary outcome was a composite of recurrence or all-cause death in three phases of care: surgical (up to 6 months after resection), treatment (6–18 months after resection), and surveillance (18 months–3 years after resection). Hazard ratios were estimated via Cox proportional hazards regression in a propensity score–weighted cohort. A total of 1107 electronic medical records of patients undergoing colorectal surgery were reviewed, and 379 patients were included (301 colon and 78 rectal cancer). In the surgical phase, the weighted analysis yielded a hazard ratio of 0.37 (95% confidence interval 0.12–1.13) for metric-adherent patients compared with non-adherent patients. In the treatment and surveillance phases, the hazard ratios for metric-adherent care were 0.68 (95% confidence interval 0.25–1.85) and 0.91 (95% confidence interval 0.31–2.68), respectively. The National Comprehensive Cancer Network guideline metric adherence was associated with a lower rate of recurrence and death in the surgical phase of care among stage I–III patients with resected colorectal cancer.

Background Although endoscopy is recommended at 1 year after colorectal cancer (CRC) resection to detect locally recurrent CRC, earlier work at our Veterans Affairs (VA) facility demonstrated that 35% of patients achieve this metric. Study Design The interdisciplinary team used quality improvement methods to standardize processes and implement a gastroenterology-managed virtual surveillance clinic. The intervention clinic was implemented in August 2014. Veterans who underwent resection for stage I to III CRC at a single VA facility from January 2010 to December 2017 were included, with those undergoing resection between January 2010 and July 2014 considered pre-intervention and those undergoing resection between August 2014 and December 2017 considered post-intervention. The primary endpoint was the proportion of eligible patients for whom endoscopy was completed within 1 year of resection. Secondary outcomes were the proportion of patients who completed endoscopy within 18 months of resection or at any time post-resection and time to surveillance endoscopy. Results A total of 186 patients underwent resection for stage I to III CRC from 2010 to 2017; of these, 160 (86%) were eligible for endoscopy at 1-year post-resection (98 pre-intervention and 62 post-intervention). In the pre-intervention period, 30 of 98 patients (30.6%) underwent surveillance endoscopy within 1 year vs 31 of 62 (50.0%) post-intervention (p = 0.031). When evaluated at 18 months after resection, 56 of 98 patients (57.1%) in the pre-intervention group vs 52 of 62 (83.9%) in the post-intervention group underwent surveillance endoscopy (p = 0.001). Median time from resection to endoscopy decreased during the study period, from 1.19 years pre-intervention (interquartile range 0.93 to 1.74 years) to 1.0 years post-intervention (interquartile range 0.93 to 1.09 years) (p = 0.006). Conclusions Implementation of a virtual surveillance clinic with standardized processes was associated with increased guideline-concordant endoscopic surveillance after CRC resection.

Background Risk reduction through dietary modifications is an adjunct strategy for prevention of oesophageal cancer, a leading cause of cancer-related mortality and morbidity worldwide. We aimed to estimate the association between calcium and magnesium intakes and incident oesophageal cancer (OC). Methods We conducted a retrospective analysis of the NIH-AARP Diet and Health Study prospective cohort. We used multivariable Cox proportional hazard modeling to estimate the association between total intakes and incident OC overall and by histology (oesophageal squamous cell carcinoma (OSCC) and adenocarcinoma (OAC)). Sensitivity and stratified analyses were performed. Results Among 536,359 included respondents, 1414 incident OCs occurred over 6.5 million person-years follow-up time. Increasing dietary calcium intake was associated with an adjusted 32–41% lower risk of OSCC compared to the lowest quartile (p-trend 0.01). There was a positive association between increasing magnesium intake and OAC risk, but only among participants with low calcium:magnesium intake ratios (p-trend 0.04). There was a significant interaction with smoking status. Conclusions Based on a retrospective analysis of the NIH-AARP Diet and Health Study prospective cohort, dietary intakes of calcium and magnesium were significantly associated with risk of OSCC and, among certain participants, OAC, respectively. If validated, these findings could inform dietary modifications among at-risk individuals. Mechanistic investigations would provide additional insight.

Patients with rheumatoid arthritis (RA) often receive opioid analgesics for pain management. We examined the association between mental health conditions and the risk of chronic opioid therapy.A retrospective cohort of veterans with RA initiating opioid use was assembled using Veterans Health Administration databases (2001-2012). Mental health conditions included anxiety (N = 1108, 12.9%), depression (N = 1912, 22.2%), bipolar disease (N = 131, 1.5%), and post-traumatic stress disorder (N = 768, 8.9%) and were identified by ICD coded diagnoses and use of specific medications. Cohort members were followed from opioid initiation through chronic opioid therapy, defined as the continuous availability of opioids for at least 90 days. Multivariable Cox proportional hazard regression models assessed the association between mental health conditions and chronic opioid therapy accounting for relevant covariates. Subgroup analyses examined whether the strength of the observed association varied by the duration of the initial opioid prescription.We identified 14,767 patients with RA with 22,452 episodes of opioid use initiation. Mental health conditions were identified in 8607 (38.3%) patients. Compared with patients without mental health conditions, patients with mental health conditions have a higher risk of developing chronic opioid therapy (469.3 vs 378.1 per 1000 person-years, adjusted hazard ratio [aHR] 1.18, 95% CI 1.09, 1.29). The increased risk was highest for those with a history of opioid use disorder (aHR 1.94, 95% CI 1.09, 3.46) and also elevated for those with other substance use disorders (aHR 1.35, 95% CI 1.05, 1.73). Duration of the initial opioid prescription was independently associated with chronic opioid therapy, regardless of the estimated opioid daily dose.History of mental health conditions and duration of the initial opioid prescription were associated with an increased risk of chronic opioid therapy among patients with RA.Key Points• Approximately a third of patients with RA are exposed to opioid analgesics.• Patients with RA and history of mental health disease, especially substance use disorders, who initiate opioid use have an increased risk of chronic opioid therapy.• This study provides insight in an underrepresented population of mainly male patients with RA.

The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure 1 g/d, heart failure, dementia, or stroke. Postrandomization exclusions included participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics. The outcome was incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics. The secondary outcome was impaired fasting glucose (100–125 mg/dL [5.55–6.94 mmol/L]) among those with normoglycemia ( Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01206062.

In a prospective cohort study of Veterans and community health nurses, we enrolled hospitalized older Veterans referred to home care for skilled nursing and/or physical or occupational therapy for posthospitalization care. We assessed preadmission activities of daily living and instrumental activities of daily living, health literacy, numeracy, and cognition. Postdischarge phone calls identified medication errors and medication reconciliation efforts by home healthcare clinicians. Veterans Administration-based community health nurses completed surveys about content and timing of postdischarge interactions with home healthcare clinicians. We determined the types and frequency of medication errors among older Veterans receiving home healthcare, patient-provider communication patterns in this setting, and patient characteristics affecting medication error rates. Most Veterans (24/30, 80%) had at least one discordant medication, and only one noted that errors were identified and resolved. Veterans were asked about medications in the home healthcare setting, but far fewer were questioned about medication-taking details, adherence, and as-needed or nonoral medications. Higher numeracy was associated with fewer errors. Veterans Administration community health nurses reported contact by home healthcare clinicians in 41% of cases (7/17). Given the high rate of medication errors discovered, future work should focus on implementing best practices for medication review in this setting, as well as documenting barriers/facilitators of patient-provider communication.

Social determinants of health (SDH) contribute to nearly 50% of health outcomes; however, SDH data collection is inconsistent in clinical practice. This study used mixed methods to evaluate health care professionals' perceptions of universal SDH screening at an academic medical center by surveying physicians, advanced practice providers, nurses, social workers, case managers, pharmacists, and administrators. An electronic survey assessed SDH screening practices, prioritization of SDH domains, disciplines to perform screening, and attitudes and barriers to universal screening. Likert-scale responses were dichotomized and compared disciplines with proportions tests. Qualitative interviews identified themes and elaborated survey findings. Participant discipline was the primary predictor variable. Of 193 survey participants (62.5% response rate), most were physicians (31%) or social workers (22%). Participants overwhelmingly reported using SDH information in patient care (93%), and social workers as the most appropriate role for screening (95%). Most respondents (75%) believed health literacy is important, but 40% reported routine assessment. Housing status (73% vs. 53%) and financial strain (62% vs. 48%) followed similar patterns. SDH screening barriers included lacking resources to address identified needs (51%), time to ask (45%), support staff to ask (33%), and training in responding to identified needs (28%). Social workers cited barriers less often than non-social workers (

RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.

BACKGROUND For patients with high-risk stage II or stage III colorectal cancer (CRC), adjuvant chemotherapy (AC) improves survival, yet use varies substantially across medical oncology settings. AIM Utilization of guideline concordant CRC AC was assessed at a Veterans Health Administration (VHA) facility to determine quality improvement initiatives. METHODS AND RESULTS The study was a retrospective review of CRC surgeries from January 1, 2000 to December 31, 2015 at a South Regional VHA. Inclusion criteria consisted of pathologic high-risk stage II or stage III CRC, with exclusion for age ≥80, age ≥75 hospitalized with major co-morbidity in the prior year, and death or discharge to hospice within 30 days of the index surgery. The primary predictor was year-group; partitioned 2000-2005, 2006-2010, 2011-2015 to account for changes in NCCN high risk stage II definitions. Primary outcome was AC receipt. Secondary outcome was reason for chemotherapy omission. Among 180 eligible surgeries (121 colon and 59 rectal cancers), patients were mostly male (96%), white (79%) and with median age 64 years. Overall, 117 (65%) received AC. Compared to 2000-2005, patients undergoing surgery between 2011 and 2015 were less likely to receive AC (odds ratio 0.35; 95% confidence interval [CI] 0.14-0.82), due to more patients declining AC (27% vs. 6%, p

BackgroundAntibiotics are not recommended for treatment of acute uncomplicated bronchitis (AUB), but are often prescribed (85% of AUB visits within the Veterans Affairs nationally). This quality improvement project aimed to decrease antibiotic prescribing for AUB in community-based outpatient centres from 65% to MethodsFrom January to December 2018, community-based outpatient clinics’ 6 months’ average of prescribed antibiotics for AUB and upper respiratory infections was 63% (667 of 1054) and 64.6% (314 of 486) when reviewing the last 6 months. Seven plan–do–study–act (PDSA) cycles were implemented by an interprofessional antimicrobial stewardship team between January 2019 and March 2020. Balancing measures were a return patient phone call or visit within 4 weeks for the same complaint. Χ2 tests and statistical process control charts using Western Electric rules were used to analyse intervention data.ResultsThe AUB antibiotic prescribing rate decreased from 64.6% (314 of 486) in the 6 months prior to the intervention to 36.8% (154 of 418) in the final 6 months of the intervention. No change was seen in balancing measures. The largest reduction in antibiotic prescribing was seen after implementation of PDSA 6 in which 14 high prescribers were identified and targeted for individualised reviews of encounters of patients with AUB with an antimicrobial steward.ConclusionsOperational implementation of successful stewardship interventions is challenging and differs from the traditional implementation study environment. As a nascent outpatient stewardship programme with limited resources and no additional intervention funding, we successfully reduced antibiotic prescribing from 64.6% to 36.8%, a reduction of 43% from baseline. The most success was seen with targeted education of high prescribers.

Background and AimsLow pH deactivates most pathogens, including coronaviruses. Proton pump inhibitors (PPIs) are potent gastric acid suppressing medications. Whether PPI use vs non-use is associated with severe Coronavirus disease-2019 (COVID-19) outcomes remains uncertain. We aimed to compare severe COVID-19 outcomes between current outpatient PPI users and non-users.MethodsWe conducted a retrospective propensity score-weighted analysis of a national cohort of US veterans with established care who tested positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) through January 9, 2021, and who had 60 days of follow-up. The positive test date was the index date. Current outpatient PPI use up to and including the index date (primary exposure) was compared to non-use, defined as no PPI prescription fill in the 365 days prior to the index date. The primary outcome was a composite of use of mechanical ventilation or death within 60 days. Weighted logistic regression models evaluated severe COVID-19 outcomes between current PPI users vs non-users.ResultsOf 97,674 Veterans with SARS-CoV-2 testing, 14,958 tested positive (6262 [41.9%] current PPI users, 8696 [58.1%] non-users) and comprised the analytic cohort. After weighting, all covariates were well-balanced. In the weighted cohort, there was no difference in the primary composite outcome (8.2% vs 8.0%; OR 1.03, 95% CI 0.91-1.16), secondary composite outcome, nor individual component outcomes between current PPI users and non-users. There was no significant interaction between age and PPI use on outcomes.ConclusionAmong patients with SARS-CoV-2 infection, current PPI use vs non-use is not associated with severe COVID-19 outcomes.

Apparent treatment-resistant hypertension (ATRH) has been linked to end-stage kidney disease (ESKD) and cardiovascular disease. We tested the hypothesis that the effect of ATRH on ESKD is greater in Black patients than in White patients and investigated the effect of ATRH on ESKD independent of APOL1 genotype. In a retrospective cohort of 139 685 hypertensive veterans (22% Black, 5% women) in the Million Veteran Program, ATRH was defined as failure to achieve outpatient blood pressure P -interactionAPOL1 genotype. Patients with ATRH experienced excess ESKD and cardiovascular disease risk. This excess ATRH-related ESKD risk was magnified among Black patients independently of APOL1 genotype. Targeted treatment of ATRH could curtail ESKD and cardiovascular disease incidence.

OBJECTIVE. We studied Hispanic/Latina women's satisfaction with care after receiving group or individual educational sessions (vs standard of care) with a promotora before screening mammography. A promotora is a culturally appropriate community health worker for the Hispanic/Latino community. Promotoras have been shown to increase screening mammography rates and follow-up of abnormal mammograms in this population. However, a promotora's impact on elements of patient care and patient satisfaction remains poorly described. MATERIALS AND METHODS. Hispanic/Latina women 40-64 years old were randomized to one of three groups: the control group (standard-of-care well woman screening), an individual educational session with a promotora followed by well woman screening with access to the promotora, or a group educational session followed by well woman screening with access to the promotora. Access to the promotora included the opportunity to ask questions during well woman screening and a follow-up telephone call to discuss results and follow-up if necessary. Participants completed a premammography survey that assessed demographics and health literacy and a postmammography survey that assessed satisfaction with care, interpersonal processes of care, and satisfaction with the promotora. We used multivariable linear regression models and two-sample t tests for continuous outcome measures and a multivariable logistic regression model for dichotomized outcomes. RESULTS. Of the 100 women enrolled in the study, 94 completed well woman screening and the postmammography survey. Hispanic/Latina women with access to the promotora providing educational sessions in either the group (mean satisfaction with care score, 78.1) or individual (mean satisfaction with care score, 78.8) setting reported higher satisfaction with care than those receiving the standard of care (mean satisfaction with care score, 74.9) (p < 0.05). The odds of highly compassionate care in women receiving educational sessions was increased and was particularly strong for those receiving individual educational sessions compared with standard of care (odds ratio, 4.78 [95% CI, 1.51-15.13]). We found that increased satisfaction with the promotora was significantly associated with increased satisfaction with care but that group versus individual educational sessions did not significantly impact satisfaction with the promotora. CONCLUSION. Our study findings have important implications as patient navigators and shared decision making become integral to cancer screening. Group educational sessions may offer a method to decrease the time and expense of providing educational services in the cancer screening setting. However, the overall more positive interpersonal experiences suggested in the individual setting suggest that a larger study is warranted to better understand differences between group and individual educational settings.

ObjectiveMany patients with advanced serious illness or at the end of life experience delirium, a potentially reversible form of acute brain dysfunction, which may impair ability to participate in medical decision-making and to engage with their loved ones. Screening for delirium provides an opportunity to address modifiable causes. Unfortunately, delirium remains underrecognized. The main objective of this pilot was to validate the brief Confusion Assessment Method (bCAM), a two-minute delirium-screening tool, in a veteran palliative care sample.MethodThis was a pilot prospective, observational study that included hospitalized patients evaluated by the palliative care service at a single Veterans’ Administration Medical Center. The bCAM was compared against the reference standard, the Diagnostic and Statistical Manual of Mental Disorders, fifth edition. Both assessments were blinded and conducted within 30 minutes of each other.ResultWe enrolled 36 patients who were a median of 67 years (interquartile range 63–73). The primary reasons for admission to the hospital were sepsis or severe infection (33%), severe cardiac disease (including heart failure, cardiogenic shock, and myocardial infarction) (17%), or gastrointestinal/liver disease (17%). The bCAM performed well against the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, for detecting delirium, with a sensitivity (95% confidence interval) of 0.80 (0.4, 0.96) and specificity of 0.87 (0.67, 0.96).Significance of ResultsDelirium was present in 27% of patients enrolled and never recognized by the palliative care service in routine clinical care. The bCAM provided good sensitivity and specificity in a pilot of palliative care patients, providing a method for nonpsychiatrically trained personnel to detect delirium.

Purpose PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. Methods We adapted existing computable phenotypes (CP) for the identification of patients with T2DM and evaluated their performance across four PCORnet sites (2012-2016). Patients entered the cohort on the earliest date they met one of three CP categories: (CP1) coded T2DM diagnosis (ICD-9/ICD-10) and an antidiabetic prescription, (CP2) diagnosis and glycosylated hemoglobin (HbA1c) ≥6.5%, or (CP3) an antidiabetic prescription and HbA1c ≥6.5%. We required evidence of health care utilization in each of the 2 prior years for each patient, as we also developed an incident T2DM CP to identify the subset of patients without documentation of T2DM in the 365 days before t0 . Among a systematic sample of patients, we calculated the positive predictive value (PPV) for the T2DM CP and incident-T2DM CP using electronic health record (EHR) review as reference. Results The CP identified 50 657 patients with T2DM. The PPV of patients randomly selected for validation was 96.2% (n = 1572; CI:95.1-97.0) and was consistently high across sites. The PPV for the incident-T2DM CP was 5.8% (CI:4.5-7.5). Conclusions The T2DM CP accurately and efficiently identified patients with T2DM across multiple sites that participate in PCORnet, although the incident T2DM CP requires further study. PCORnet is a valuable data source for future epidemiological and comparative effectiveness research among patients with T2DM.

Background Metformin and sulfonylurea are commonly prescribed oral medications for type 2 diabetes mellitus. The association of metformin and sulfonylureas on heart failure outcomes in patients with reduced estimated glomerular filtration rate remains poorly understood. Methods and Results This retrospective cohort combined data from National Veterans Health Administration, Medicare, Medicaid, and the National Death Index. New users of metformin or sulfonylurea who reached an estimated glomerular filtration rate of 60 mL/min per 1.73 m 2 or serum creatinine of 1.5 mg/dL and continued metformin or sulfonylurea were included. The primary outcome was hospitalization for heart failure. Echocardiogram reports were obtained to determine each patient's ejection fraction (EF) (reduced EF 2 ). The prevalence of underlying heart failure (12.1%) and cardiovascular disease (31.7%) was similar between groups. There were 16.9 (95% CI, 15.8–18.1) versus 20.7 (95% CI, 19.5–22.0) heart failure hospitalizations per 1000 person‐years for metformin and sulfonylurea users, respectively, yielding a cause‐specific hazard of 0.85 (95% CI, 0.78–0.93). Among heart failure hospitalizations, 44.5% did not have echocardiogram information available; 29.3% were categorized as reduced EF, 8.9% as midrange EF, and 17.2% as preserved EF. Heart failure hospitalization with reduced EF (hazard ratio, 0.79; 95% CI, 0.67–0.93) and unknown EF (hazard ratio, 0.84; 95% CI 0.74–96) were significantly lower in metformin versus sulfonylurea users. Conclusions Among patients with type 2 diabetes mellitus who developed worsening kidney function, persistent metformin compared with sulfonylurea use was associated with reduced heart failure hospitalization.

BACKGROUND: Kidney reabsorption of magnesium (Mg) is essential for homeostasis. OBJECTIVES: We developed and validated models with the kidney reabsorption-related magnesium depletion score (MDS) to predict states of magnesium deficiency and disease outcomes. METHODS: MDS was validated in predicting body magnesium status among 77 adults (aged 62 ± 8 y, 51% men) at high risk of magnesium deficiency in the Personalized Prevention of Colorectal Cancer Trial (PPCCT) (registered at clinicaltrials.gov as NCT01105169) using the magnesium tolerance test (MTT). We then validated MDS for risk stratification and for associations with inflammation and mortality among >10,000 US adults (weighted: aged 48 ± 0.3 y, 47% men) in the NHANES, a nationally representative study. A proportional hazards regression model was used for associations between magnesium intake and the MDS with risks of total and cardiovascular disease (CVD) mortality. RESULTS: In the PPCCT, the area under the receiver operating characteristic (ROC) curve (AUC) for magnesium deficiency was 0.63 (95% CI: 0.50, 0.76) for the model incorporating the MDS with sex and age compared with 0.53 (95% CI: 0.40, 0.67) for the model with serum magnesium alone. In the NHANES, mean serum C-reactive protein significantly increased with increasing MDS (P-trend

Introduction The Veterans Affairs Partnership to increase Access to Lung Screening (VA-PALS) is an enterprise-wide initiative to implement lung cancer screening programs at VA medical centers (VAMCs). VA-PALS will be using implementation strategies that include program navigators to coordinate screening activities, trainings for navigators and radiologists, an open-source software management system, tools to standardize low-dose computed tomography image quality, and access to a support network. VAMCs can utilize strategies according to their local needs. In this protocol, we describe the planned program evaluation for the initial 10 VAMCs participating in VA-PALS. Materials and methods The implementation of programs will be evaluated using the Consolidated Framework for Implementation Research to ensure broad contextual guidance. Program evaluation measures have been developed using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Adaptations of screening processes will be assessed using the Framework for Reporting Adaptations and Modifications to Evidence Based Interventions. Measures collected will reflect the inner settings, estimate and describe the population reached, adoption by providers, implementation of the programs, report clinical outcomes and maintenance of programs. Analyses will include descriptive statistics and regression to evaluate predictors and assess implementation over time. Discussion This theory-based protocol will evaluate the implementation of lung cancer screening programs across the Veterans Health Administration using scientific frameworks. The findings will inform plans to expand the VA-PALS initiative beyond the original sites and can guide implementation of lung cancer screening programs more broadly.

Background The Veterans Affairs Partnership to increase Access to Lung Screening (VA-PALS) is an enterprise-wide initiative to implement high quality lung cancer screening programs at VA medical centers (VAMCs). VA-PALS will be using implementation strategies that include program navigators to coordinate screening activities, trainings for navigators and radiologists, an open-source software management system, tools to standardize low-dose computed tomography (LDCT) image quality, and access to a support network. Individual VAMCs can utilize strategies according to their local contextual factors. In this protocol, we describe the planned program evaluation for the initial 10 VAMCs participating in VA-PALS. Methods The implementation of programs will be evaluated using the Consolidated Framework for Implementation Research to ensure broad contextual guidance. Program evaluation measures have been developed using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Adaptations of screening processes will be assessed every six months using the Framework for Reporting Adaptations and Modifications to Evidence Based Interventions. Measures collected will reflect the inner setting at each VAMC, estimate and describe the population reached, adoption by providers, implementation of the programs, report patient clinical outcomes and maintenance of screening programs. Analyses will primarily use descriptive statistics with means, medians, and frequencies. Outcomes will be compared over time and among VA-PALS VAMCs and non-VA-PALS VAMCs in interrupted time series analyses. Assessment of contextual factors and the relationship between predictors, such as organizational readiness and improved implementation, will be evaluated. Adaptations of processes to overcome barriers will be identified and evaluated for association with implementation. Conclusion This theory-based protocol will evaluate the implementation of lung cancer screening programs across the Veterans Health Administration (VHA) using scientific frameworks. The findings will inform plans to expand the VA-PALS initiative beyond the original sites and can guide implementation of lung cancer screening programs more broadly within and outside VHA.

We used electronic medical record (EMR) data in the National Patient‐Centered Clinical Research Network (PCORnet) to characterize “real‐world” prescription patterns of Type 2 diabetes (T2D) medications. We identified a retrospective cohort of 613,203 adult patients with T2D from 33 datamarts (median patient number: 12,711) from 2012 through 2017 using a validated computable phenotype. We characterized outpatient T2D prescriptions for each patient in the 90 days before and after cohort entry, as well as demographics, comorbidities, non‐T2D prescriptions, and clinical and laboratory variables in the 730 days prior to cohort entry. Approximately half of the individuals in the cohort were females and 20% Black. Hypertension (60.3%) and hyperlipidemia (50.5%) were highly prevalent. Most patients were prescribed either a single T2D drug class (42.2%) or had no evidence of a T2D prescription in the EMR (42.4%). A smaller percentage was prescribed multiple T2D drug types (15.4%). Among patients prescribed a single T2D drug type, metformin was the most common (42.6%), followed by insulin (18.2%) and sulfonylureas (13.9%). Newer classes represented approximately 13% of single T2D drug type prescriptions (dipeptidyl peptidase‐4 inhibitors [6.6%], glucagon‐like peptide‐1 receptor agonists [2.5%], thiazolidinediones [2.0%], and sodium‐glucose cotransporter‐2 inhibitors [1.6%]). Among patients prescribed multiple T2D drug types, the most common combination was metformin and sulfonylureas (63.5%). Metformin‐based regimens were highly prevalent in PCORnet's T2D population, whereas newer agents were prescribed less frequently. PCORnet is a novel source for the potential conduct of observational studies among patients with T2D.

Despite the need for leaders in health care improvement across health professions, there are no standards for the knowledge and skills that should be achieved through advanced interprofessional health care improvement training. Existing health care improvement training competencies focus on foundational knowledge expected of all trainees or for specific career pathways. Health care improvement leaders fill multiple roles within organizations and promote interprofessional improvement practice. The diverse skill set required of modern health care improvement leaders necessitates the development of training competencies specifically for fellowships in applied health care improvement.The authors describe the development of the revised national Veterans Affairs Quality Scholars (VAQS) Program competencies. The VAQS Program is an interprofessional, postdoctoral training program whose mission is to develop leaders and scholars to improve health care. An interprofessional committee of VAQS faculty reviewed and revised the competencies over 4 months beginning in fall 2018. The first draft was developed using 111 competencies submitted by eleven VAQS training sites and a review of published competencies. The final version included 22 competencies spanning 5 domains: interprofessional collaboration and teamwork; improvement and implementation science; organization and system leadership; methodological skills and analytic techniques for improvement and research; and teaching and coaching.Once attained, the VAQS competencies will guide the skill development that interprofessional health care improvement leaders need to participate in and lead health care improvement scholarship and implementation. These broad competencies are relevant to advanced training programs that develop health care improvement leaders and scholars and may be used by employers to understand the knowledge and skills expected of individuals who complete advanced fellowships in applied health care improvement.

Objectives Lung cancer has the highest cancer-related mortality in the United States and among Veterans. Screening of high-risk individuals with low-dose CT (LDCT) can improve survival through detection of early-stage lung cancer. Organizational factors that aid or impede implementation of this evidence-based practice in diverse populations are not well described. We evaluated organizational readiness for change and change valence (belief that change is beneficial and valuable) for implementation of LDCT screening. Methods We performed a cross-sectional survey of providers, staff, and administrators in radiology and primary care at a single Veterans Affairs Medical Center. Survey measures included Shea’s validated Organizational Readiness for Implementing Change (ORIC) scale and Shea’s 10 items to assess change valence. ORIC and change valence were scored on a scale from 1 to 7 (higher scores representing higher readiness for change or valence). Multivariable linear regressions were conducted to determine predictors of ORIC and change valence. Results Of 523 employees contacted, 282 completed survey items (53.9% overall response rate). Higher ORIC scores were associated with radiology versus primary care (mean 5.48, SD 1.42 versus 5.07, SD 1.22, β = 0.37, P = .039). Self-identified leaders in lung cancer screening had both higher ORIC (5.56, SD 1.39 versus 5.11, SD 1.26, β = 0.43, P = .050) and change valence scores (5.89, SD 1.21 versus 5.36, SD 1.19, β = 0.51, P = .012). Discussion Radiology health professionals have higher levels of readiness for change for implementation of LDCT screening than those in primary care. Understanding health professionals’ behavioral determinants for change can inform future lung cancer screening implementation strategies.

Background Emergency department ( ED ) visits for hypertension are rising, but the importance of elevated blood pressure ( BP ) measured during the ED visit is controversial. We evaluated the relationship between ED BP and mean BP over the subsequent year. Methods and Results We performed a retrospective cohort study from January 1, 2010 to December 31, 2013 of 8105 adult patients who made 1 visit to an academic medical center ED with ≥2 ED BP s and ≥2 BP s measured in the subsequent year. The primary exposure was lowest ED systolic BP . The primary outcome was mean systolic BP ≥140 mm Hg over the year following the index ED visit. Diastolic BP was examined as a secondary exposure and outcome. Multiple logistic regression was performed adjusting for several covariates, with interaction terms for hypertension diagnosis, ED disposition, pain‐related ED chief complaint, and sex. Patients whose lowest ED systolic BP was 140 to 159 mm Hg had an adjusted odds ratio of having a mean SBP ≥140 mm Hg in the subsequent year of 10.9 (95% CI , 7.6–15.6). Patients without diagnosed hypertension and ED BP 140/90 to 159/99 mm Hg were more likely to have elevated BP in the following year. Hospitalization increased the likelihood of persistently elevated systolic BP but not diastolic BP . There was no effect modification by pain‐related ED complaint. Conclusions When ED BP is consistently elevated, BP is highly likely to remain elevated in the subsequent year, regardless of pain, and particularly among patients without diagnosed hypertension. Further research is needed to determine the optimal management of elevated ED BP .

Background Many Veterans are high risk for lung cancer. Low-dose computed tomography (LDCT) is an effective strategy for lung cancer early detection in a high-risk population. Our objective was to describe and compare annual and geographic utilization trends for LDCT screening in the Veteran’s Health Administration (VHA). Methods A national retrospective cohort of screened Veterans from January 1, 2011 to May 31, 2018 was used to calculate annual and regional rates of initial LDCT utilization per 1000 eligible Veterans. We identified Veterans with a first LDCT exam using common procedure terminology codes G0297 or 71250 and described as “lung cancer screening,” “screening,” or “LCS.” The number of screen-eligible Veterans per year was calculated as unique Veterans aged 55 to 80 years seen at a Veterans Affairs medical center (VAMC) in that year, multiplied by 32% (estimated proportion with eligible smoking history). We present 95% confidence intervals (CI) for rates. Results Screened Veterans had a mean age of 66.1 years (standard deviation [SD] = 5.6); 95.5% male; 77.4% Caucasian. There were 119 300 LDCT exams, of which 80 819 (67.7%) were initial. Nationally, initial screens increased from 0 (95% CI = 0.00 to 0.00) in 2011 to 29.6 (95% CI = 29.26 to 29.88) scans per 1000 eligible Veterans in 2018 (Ptrend < .001). Initial screens increased over time within all geographic regions, most prominently in northeastern and Florida VAMCs. Conclusion VHA LDCT utilization increased from 2011 to 2018. However, overall utilization remained low. Future interventions are needed to increase lung cancer screening utilization among eligible Veterans.

Background: Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)—a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events. Methods and Results: A multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network—a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation. Conclusions: The ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02697916.

BACKGROUND/OBJECTIVES Chronic kidney disease (CKD) is associated with frailty. Fibroblast growth factor 23 (FGF23) is elevated in CKD and associated with frailty among non-CKD older adults and individuals with human immunodeficiency virus. Whether FGF23 is associated with frailty and falls in CKD is unknown. DESIGN Cross-sectional and longitudinal observational study. SETTING Systolic Blood Pressure Intervention Trial (SPRINT), a randomized trial evaluating standard (systolic blood pressure [SBP]

Background: Patients with type 2 diabetes are at risk for the development of secondary complications, including impaired renal function and heart failure (HF). Before 2016, safety concerns limited metformin use in patients with kidney disease. Metformin’s association with HF outcomes and type of HF exacerbation in those with reduced kidney function remains incompletely described. Objective: To compare HF hospitalization between patients treated with metformin versus sulfonylurea following development of reduced kidney function. Research Design/Methods: This national retrospective cohort combined data from Veterans Health Administration, Medicare, Medicaid and National Death Index from 2001 through 2016. We identified patients with new-onset type 2 diabetes by selecting those who were new users of metformin or a sulfonylurea. We followed these patients longitudinally and enrolled those who experienced a kidney function decline and persisted on metformin or sulfonylurea. Patients entered the study on the date of development of reduced kidney function (estimated Glomerular Filtration Rate &lt60 ml/min or serum creatinine &gt1.4 [female] or 1.5 [male] mg/dL) and were followed through the primary outcome: hospitalization for HF, or a competing risk: all cause death; drug non-persistence; or study end (December 31 st 2016). The primary analysis used a propensity score weighted model. Echocardiogram reports were obtained from 1 year prior to admission through 7 days after admission through natural language processing to determine the ejection fraction (EF) and HF type [reduced EF&lt40%; indeterminate EF 40-50% or preserved EF&gt50%] for that hospitalization. Results: The weighted cohort included 24,683 metformin and 24,802 sulfonylurea users who developed reduced kidney function. At cohort entry, median age was 70 years (63, 78), eGFR 55.8 ml/min/1.73m^2 (51.6, 58.2), and A1c 6.6% (6.1,7.2). Cardiac comorbidities were prevalent at cohort entry, as groups had 12.1% prevalence of CHF (2,987 of 24,683 metformin; 3,009 of 24,802 sulfonylurea), and 31.9% metformin (7,797 of 24,683) and 31.6% sulfonylurea (7,869 of 24,802) users had underlying cardiovascular disease. There were 775 and 991 HF hospitalizations among metformin and sulfonylurea users. HF hospitalizations were 16.9 (15.7, 18.1) vs. 20.7 (19.5, 22.0) per 1,000 person-years respectively (adjusted hazard ratio 0.85, 95% CI: 0.78, 0.93). Of the 775 metformin and 991 sulfonylurea users hospitalized for HF, 44% (339 of 775) vs 45% (447 of 991) did not have an echocardiogram; 28% (214 of 775) vs 31% (302 of 991) had reduced EF; 9% (74 of 775) vs 9% (85 of 991) had indeterminate EF; 19% (148 of 775) vs 16% (157 of 991) had preserved EF. Conclusions: Among patients with type 2 diabetes who develop worsening renal function, persistent metformin use is associated with reduced HF hospitalization compared to sulfonylurea.

Orthostatic hypotension (OH) is frequently observed with hypertension treatment, but its contribution to adverse outcomes is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) was a randomized trial of adults, age ≥50 years at high risk for cardiovascular disease with a seated systolic blood pressure (BP) of 130 to 180 mm Hg and a standing systolic BP ≥110 mm Hg. Participants were randomized to a systolic BP treatment goal of either Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01206062.

Purpose High-quality medication reconciliation reduces medication discrepancies, but smaller hospitals serving rural patients may have difficulty implementing this because of limited resources. We sought to adapt and implement an evidence-based toolkit of best practices for medication reconciliation in smaller hospitals, evaluate the effect on unintentional medication discrepancies, and assess facilitators and barriers to implementation. Methods We conducted a 2-year mentored-implementation quality improvement feasibility study in 3 Veterans Affairs (VA) hospitals serving rural patients. The primary outcome was unintentional medication discrepancies per medication per patient, determined by comparing the “gold standard” preadmission medication history to the documented preadmission medication list and admission and discharge orders. Results In total, 797 patients were included; their average age was 68.7 years, 94.4% were male, and they were prescribed an average of 9.6 medications. Sites 2 and 3 implemented toolkit interventions, including clarifying roles among clinical personnel, educating providers on taking a best possible medication history, and hiring pharmacy professionals to obtain a best possible medication history and perform discharge medication reconciliation. Site 1 did not implement an intervention. Discrepancies improved in intervention patients compared with controls at Site 3 (adjusted incidence rate ratio [IRR], 0.55; 95% confidence interval [CI], 0.45–0.67) but increased in intervention patients compared with controls at Site 2 (adjusted IRR, 1.22; 95% CI, 1.08–1.36). Conclusions An evidence-based toolkit for medication reconciliation adapted to the VA setting was adopted in 2 of 3 small, rural, resource-limited hospitals, resulting in both reduced and increased unintentional medication discrepancies. We highlight facilitators and barriers to implementing evidence-based medication reconciliation in smaller hospitals.

PURPOSE: Several observational studies suggest that metformin reduces incidence cancer risk; however, many of these studies suffer from time-related biases and several cancer outcomes have not been investigated due to small sample sizes. METHODS: We constructed a propensity score-matched retrospective cohort of 84,434 veterans newly prescribed metformin or a sulfonylurea as monotherapy. We used Cox proportional hazard regression to assess the association between metformin use compared to sulfonylurea use and incidence cancer risk for 10 solid tumors. We adjusted for clinical covariates including hemoglobin A1C, anti-hypertensive and lipid lowering medications, and body mass index. Incidence cancers were defined by ICD-9-CM codes. RESULTS: Among 42,217 new metformin users and 42,217 matched-new sulfonylurea users, we identified 2,575 incidence cancers. Metformin was inversely associated with liver cancer (adjusted hazard ratio [aHR] = 0.44, 95% CI 0.31, 0.64) compared to sulfonylurea. We found no association between metformin use and risk of incidence bladder, breast, colorectal, esophageal, gastric, lung, pancreatic, prostate, or renal cancer when compared to sulfonylurea use. CONCLUSIONS: In this large cohort study that accounted for time related-biases, we observed no association between the use of metformin and most cancers; however, we found a strong inverse association between metformin and liver cancer. Randomized trials of metformin for prevention of liver cancer would be useful to verify these observations.

Methods to obtain informed consent digitally or electronically may increase the participation of racially and geographically diverse pregnant women in prospective research, which is essential to improve the evidence base for maternity care. We evaluated the feasibility and utility of e-consent in the first year of a multiyear clinical trial involving pregnant women. Of the 86 women screened, 71 were eligible, 65 (93% of eligible) agreed to review the e-consent form, and 61 (86% of eligible) completed the e-consent process. Of the interested women who were sent the e-consent link, all were able to complete the e-consent process, even those who reported low health literacy. Women of all racial and ethnic groups were equally likely to consent, and the sample of women who consented was consistent with practice demographics. E-consent is feasible and easy to use with pregnant women and may expedite enrollment of a representative sample.

Background The Patient Centered Outcomes Research Institute (PCORI) established Clinical Data Research Networks (CDRNs) to support pragmatic research. The objective was to electronically identify, recruit, and survey coronary heart disease (CHD) patients and describe their characteristics, health status, and willingness to participate in future research. Methods We developed a computable phenotype and assembled CHD patients 30 years or older and had visits or hospitalizations between 2009 and 2015. A sample of patients was surveyed between August 2014 and September 2015. Survey administration included the following methods: face-to-face, telephone, paper or web portal. Survey items covered broad domains including: health literacy and numeracy, and socio-demographics, physical and mental health, health behaviors, access to medical care, and willingness to participate in future research. Results Of 5517 approached patients, 2605 completed the survey. Participants were mostly white (∼88%), male (68%) and had a median age of 69 years (interquartile range [IQR] 61–76 years). Most respondents' health literacy and numeracy were adequate (83.2% and 84.3%, respectively). Only 4% of respondents reported that their overall health or physical health was excellent. The majority (∼58%) reported that their health was good or very good, while 40% reported that their general and physical health were fair or poor. The majority reported that their quality of life was good to excellent (81%). Limitations in physical health and function were common, including often/always having fatigue (25%), pain (38.7%), or sleep difficulty (19.7%). A patient sample (n = 1936) was provided with a trial summary which would randomize their aspirin dose; and 63% reported that they would consider participating. Conclusion Many patients with CHD had limitations in physical health. However, the majority reported a good or excellent quality of life.

Background: Antibiotics are not recommended but are often prescribed for upper respiratory-tract infections (URIs). Prescribers cite patient expectation as a driver of inappropriate antibiotic prescribing; prior literature has demonstrated higher satisfaction scores in patients who receive antibiotics compared to those who do not. We assessed whether veteran satisfaction at URI visits was associated with antibiotic receipt or with reported expectation for antibiotics. Methods: We surveyed veterans with documented URI encounters in the Veterans’ Affairs Tennessee Valley Healthcare System between January 1, 2018, and December 31, 2019. Patients not evaluated in person, with documented dementia, or who died prior to the study start date were excluded. Veterans were asked to recall their URI visit and to complete the Patient Safety Questionnaire (PSQ)-18 (Rand Corporation) and questions assessing antibiotic expectations. The PSQ-18, an 18-item survey that assesses patient satisfaction, uses a 5-point Likert scale (ie, strongly disagree, disagree, uncertain, agree, strongly agree), yielding a composite score of 18–90. Higher scores represent more satisfaction with care. Demographic and visit-specific information were extracted via chart review. We used multivariable linear regression to assess differences in composite PSQ-18 satisfaction scores between those who did and did not receive an antibiotic, adjusted for patient and visit characteristics, and to assess differences in satisfaction scores for those who did and did not report expecting antibiotics, adjusted for antibiotic receipt. Results: We identified 1,435 patients seen for URI at 17 sites. After exclusions, 1,343 veterans were eligible for chart abstraction. After excluding 42 responders who responded after study close or returned blank surveys, the final analytic cohort included 432 (32.2%) of 1,343 responders; 225 (52.1%) received an antibiotic and 207 (47.9%) did not. Mean total satisfaction for veterans who received an antibiotic was 67.8 (SD, ±9.4) compared to 66.7 (SD, ±9.7) for those who did not (Figure 1). Increased total satisfaction was not significantly associated with antibiotic receipt (0.65; 95% CI, −2.0 to 3.3). Most veterans (72.0%) disagreed that visit satisfaction depended on antibiotic receipt. However, only 30.8% reported that they would not expect an antibiotic for URI visits. A significant reduction in total satisfaction (−4.1; 95% CI, −6.3 to −1.9) was associated with expecting compared to not expecting an antibiotic. Conclusions: Our findings suggest that prescribing an antibiotic is not associated with increased veteran satisfaction for URI visits but is associated with expecting an antibiotic. Future work will evaluate methods to change veteran antibiotic expectations.Funding: NoDisclosures: None

OBJECTIVE To determine whether the effects of intensive ( RESEARCH DESIGN AND METHODS This was a post hoc analysis of SPRINT. SPRINT participants were categorized by prediabetes status, defined as baseline fasting serum glucose ≥100 mg/dL versus those with normoglycemia (fasting serum glucose RESULTS Among 9,361 participants randomized (age 67.9 ± 9.4 years; 35.5% female), 3,898 and 5,425 had baseline prediabetes and normoglycemia, respectively. After a median follow-up of 3.26 years, the hazard ratio for the primary outcome was 0.69 (95% CI 0.53, 0.89) and 0.83 (95% CI 0.66, 1.03) among those with prediabetes and normoglycemia, respectively (P value for interaction 0.30). For all-cause mortality, the hazard ratio with intensive SBP treatment was 0.77 (95% CI 0.55, 1.06) for prediabetes and 0.71 (95% CI 0.54, 0.94) for normoglycemia (P value for interaction 0.74). Effects of intensive versus standard SBP treatment on prespecified renal outcomes and serious adverse events were similar for prediabetes and normoglycemia (all interaction P > 0.05). CONCLUSIONS In SPRINT, the beneficial effects of intensive SBP treatment were similar among those with prediabetes and fasting normoglycemia.

OBJECTIVE To compare the risk of lactic acidosis hospitalization between patients treated with metformin versus sulfonylureas following development of reduced kidney function. RESEARCH DESIGN AND METHODS This retrospective cohort combined data from the National Veterans Health Administration, Medicare, Medicaid, and the National Death Index. New users of metformin or sulfonylureas were followed from development of reduced kidney function (estimated glomerular filtration rate [eGFR] RESULTS The weighted cohort included 24,542 metformin users and 24,662 sulfonylurea users who developed reduced kidney function (median age 70 years, median eGFR 55.8 mL/min/1.73 m2). There were 4.18 (95% CI 3.63, 4.81) vs. 3.69 (3.19, 4.27) lactic acidosis hospitalizations per 1,000 person-years among metformin and sulfonylurea users, respectively (adjusted hazard ratio [aHR] 1.21 [95% CI 0.99, 1.50]). Results were consistent for both primary discharge diagnosis (aHR 1.11 [0.87, 1.44]) and laboratory-confirmed lactic acidosis (1.25 [0.92, 1.70]). CONCLUSIONS Among veterans with diabetes who developed reduced kidney function, occurrence of lactic acidosis hospitalization was uncommon and not statistically different between patients who continued metformin and those patients who continued sulfonylureas.

Gastric cancer remains a leading cause of cancer-related mortality. Identifying dietary and other modifiable disease determinants has important implications for risk attenuation in susceptible individuals. Our primary aim was to estimate the association between dietary and supplemental intakes of calcium and magnesium and the risk of incident gastric cancer. We conducted a prospective cohort analysis of the National Institutes of Health-American Association of Retired Persons Diet and Health Study. We used Cox proportional hazard modeling to estimate the association between calcium and magnesium intakes with risk of incident gastric adenocarcinoma (GA) overall and by anatomic location, noncardia GA (NCGA) and cardia GA (CGA). A total of 536,403 respondents (59% males, 41% females) were included for analysis, among whom 1,518 incident GAs (797 NCGA and 721 CGA) occurred. Increasing calcium intake was associated with lower risk of GA overall (p-trend = 0.05), driven primarily by the association with NCGA, where the above median calcium intakes were associated with a 23% reduction in risk compared to the lowest quartile (p-trend = 0.05). This magnitude of NCGA risk reduction was greater among nonwhite ethnic group and Hispanics (hazard ratio [HR] 0.51, 95% confidence interval [CI]: 0.24-1.07, p-trend = 0.04), current/former smokers (HR 0.58, 95% CI: 0.41-0.81), obese individuals (HR 0.54, 95% CI: 0.31-0.96) and those with high NCGA risk scores (HR 0.50, 95% CI: 0.31-0.80). Among men only, increasing magnesium intake was associated with 22-27% reduced risk of NCGA (p-trend = 0.05), while for the cohort, dietary magnesium intake in the highest vs. lowest quartile was associated with a 34% reduced risk of NCGA (HR 0.66, 95% CI: 0.48-0.90). These findings have important implications for risk factor modification. Future investigations are needed not only to confirm our results, but to define mechanisms underlying these associations.

IMPORTANCE: Before 2016, safety concerns limited metformin use in patients with kidney disease; however, the effectiveness of metformin on clinical outcomes in patients with reduced kidney function remains unknown. OBJECTIVE: To compare major adverse cardiovascular events (MACE) among patients with diabetes and reduced kidney function who continued treatment with metformin or a sulfonylurea. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of US veterans receiving care within the national Veterans Health Administration, with data supplemented by linkage to Medicare, Medicaid, and National Death Index data from 2001 through 2016. There were 174 882 persistent new users of metformin and sulfonylureas who reached a reduced kidney function threshold (estimated glomerular filtration rate

Chronic kidney disease (CKD), defined by low estimated glomerular filtration rate (eGFR), contributes to global morbidity and mortality. Here we conduct a transethnic Genome-Wide Association Study of eGFR in 280,722 participants of the Million Veteran Program (MVP), with replication in 765,289 participants from the Chronic Kidney Disease Genetics (CKDGen) Consortium. We identify 82 previously unreported variants, confirm 54 loci, and report interesting findings including association of the sickle cell allele of betaglobin among non-Hispanic blacks. Our transcriptome-wide association study of kidney function in healthy kidney tissue identifies 36 previously unreported and nine known genes, and maps gene expression to renal cell types. In a Phenome-Wide Association Study in 192,868 MVP participants using a weighted genetic score we detect associations with CKD stages and complications and kidney stones. This investigation reinterprets the genetic architecture of kidney function to identify the gene, tissue, and anatomical context of renal homeostasis and the clinical consequences of dysregulation., Persistently low levels of estimated glomerular filtration rate (eGFR) are a biomarker of chronic kidney disease. Here, the authors reinterpret the genetic architecture of kidney function across ancestries, to identify not only genes, but the tissue and anatomical contexts of renal homeostasis.

Background: Understanding the long-term cardiovascular safety of type 2 diabetes (T2D) medications is a high-priority research area. We used electronic medical record (EMR) data in the National Patient Centered Clinical Research Network (PCORnet) to characterize “real-world” use of T2D medications. Methods and Results: We identified a retrospective cohort of patients with T2D using a validated computable phenotype. We queried 4 unique PCORnet sites for data regarding T2D medication use in the 90 days before and after cohort entry. We described patient demographics, comorbidities, non-T2D medication use, and clinical variables in the 730 days prior to cohort entry. We identified 49,654 patients with T2D across the 4 sites (range: 2,276-20,322). Use of T2D medications, characterized by pharmacologic class, and selected characteristics are presented in Table. Among patients prescribed a single class of T2D medication, metformin was the most common (52.5%). Among patients prescribed multiple classes of T2D agents, the most common combination was metformin and sulfonylureas (49%). Conclusions: Across 4 PCORnet sites, metformin-based regimens were very prevalent, and approximately 10% of regimens included newer agents. PCORnet will be a valuable resource for future observational studies of T2D medications and long-term cardiovascular outcomes in “real-world” populations. Disclosure K.N. Bachmann: Stock/Shareholder; Self; Medtronic. C. Roumie: None. A.D. Wiese: None. C.G. Grijalva: None. J.B. Buse: Consultant; Self; Neurimmune AG. Research Support; Self; AstraZeneca, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg, Novo Nordisk A/S, Senseonics, vTv Therapeutics, Zafgen, Inc. R. Bradford: None. E.O. Zalimeni: None. P. Knoepp: None. H.L. Morris: None. W.T. Donahoo: None. N. Fanous: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health. B. Katalenich: None. M.M. Cook: None. R.L. Rothman: Consultant; Self; Abbott, edlogics. R.J. Chakkalakal: None. Funding National Institutes of Health (UL1TR002489, UL1TR002489); U.S. Department of Veterans Affairs (IK2CX001678); Patient-Centered Outcomes Research Institute (CDRN-1306-04869)

Background: In 2008, the American Diabetes Association (ADA) suggested metformin be used in patients with diabetes and reduced renal function. We evaluated time trends in metformin discontinuation for patients who reached reduced renal threshold. Methods: Using National Veterans Administration and Medicare databases, we assembled a cohort of metformin and glipizide users who reached serum creatinine >1.5/1.4 mg/dL for males/females. Odds ratio (OR) of medication discontinuation within 180 days of renal threshold over time was modeled using multivariable logistic regression, with metformin discontinuation in 2008 as reference. Results: There were 18,025 metformin patients and 22,595 glipizide who met renal threshold. In 2008, 55.3% metformin patients discontinued within 180 days of renal threshold. Figure 1 depicts probability of metformin and glipizide discontinuation annually. The odds of metformin discontinuation was 1.25 (1.23, 1.35) vs. glipizide. In a fitted regression of discontinuation probability, there was no statistical difference in slopes between the two treatments (p=0.125). Conclusions: Probability of discontinuing metformin with reduced renal function decreased over time but was more likely than glipizide discontinuation. The decrease in discontinuation over time was similar in both treatments. Disclosure P. Chu: None. M.R. Griffin: None. J. Min: None. A.J. Hackstadt: None. J.J. Chipman: None. R.A. Greevy: None. A.M. Hung: None. C.G. Grijalva: None. C. Roumie: None. Funding U.S. Department of Veterans Affairs (CX000570-07 to C.R.)

Background: Safety concerns limit metformin use in kidney disease. We compared major adverse cardiovascular events (MACE) for metformin or sulfonylureas users with reduced glomerular filtration rate (GFR). Methods: A retrospective cohort combined Veterans Administration, Medicare, and National Death Index databases. Metformin or sulfonylurea users were followed from renal threshold (GFR Results: There were 67752 and 28976 persistent metformin and sulfonylurea users who reached renal threshold. The weighted cohort included 24683 metformin vs. 24801 sulfonylurea patients; 98% male; 82% white, median age 70 years (62.8, 77.8). Median GFR was 56 ml/min [51.6, 58.2] and HbA1c 6.6% [6.1, 7.1]. Metformin users had lower cause specific hazard of MACE vs. sulfonylurea (adjusted HR 0.81 [0.75, 0.87]). Subgroup results were similar by age, race and GFR. Conclusion: Compared to sulfonylureas, metformin use in patients with reduced GFR is associated with lower MACE risk. Disclosure C. Roumie: None. J.J. Chipman: None. J. Min: None. A.M. Hung: None. A.J. Hackstadt: None. R.A. Greevy: None. C.G. Grijalva: None. T. Elasy: None. M.R. Griffin: None. Funding U.S. Department of Veterans Affairs (CX000570-06)

Background Detection of early-stage lung cancer improves during subsequent rounds of screening with low-dose CT and potentially leads to saving lives with curative treatment. Therefore, adherence to annual lung screening is important. We hypothesized that adherence to annual screening would increase after hiring of a dedicated program coordinator. Methods We performed a mixed-methods study in a retrospective cohort of patients who underwent lung screening at our academic institution between January 1, 2014, and March 31, 2018. Patients with baseline lung screening examinations performed between January 1, 2014, and September 30, 2016, with Lung CT Screening Reporting & Data System 1 or 2 scores and a 12-month follow-up recommendation were included. We tracked patient adherence to annual follow-up lung screening over time (before and after hiring of a program coordinator) and conducted a cross-sectional survey of patients nonadherent to annual follow-up to elicit quantitative and qualitative feedback. Results Of the 319 patients who completed baseline lung screening with normal results, 189 (59%) were adherent to annual follow-up recommendations and 130 (41%) were nonadherent. Patient adherence varied over time: 21.7% adherence (10 of 46) before hiring a program coordinator and 65.6% adherence (179 of 273) after the program coordinator’s hire date. Patients reported the following reasons for nonadherence to annual lung screening: lack of transportation, financial cost, lack of communication by physicians, and lack of current symptoms. Conclusions Adherence to annual lung screening after normal baseline studies increased significantly over time. Hiring a full-time program coordinator was likely associated with this increased in adherence.

AIMS: To evaluate whether weight change or hypoglycemia mediated the association between insulin use and death. MATERIALS AND METHODS: In a retrospective cohort of Veterans who filled a new prescription for metformin and added insulin or sulfonylurea (2001–2012), we assessed change in body mass index (BMI) and hypoglycemia during the first 12 months of treatment intensification. Cox proportional hazards models compared the risk of death between treatment groups. Using the difference method, we estimated the indirect effect and proportion mediated through each mediator. A sensitivity analysis assessed mediators in the first 6 months of intensified therapy. RESULTS: Among 28,892 patients surviving 12 months, deaths per 1000 person-years were 15.4 for insulin users and 12.9 for sulfonylurea users (hazard ratio [HR] 1.20, 95% confidence interval [CI] 0.87,1.64). Change in BMI and hypoglycemia mediated 13% (−98, 98) and −1% (−37, 71) of this association, respectively. Among 30,214 patients surviving 6 months, deaths per 1000 person-years were 34.8 for insulin users and 21.3 for sulfonylurea users (HR 1.66, 95% CI 1.28, 2.15). Change in BMI and hypoglycemia mediated 9% (1, 23) and 0% (−9, 4) of this association, respectively. CONCLUSIONS: We observed an increased risk of death among metformin users intensifying treatment with insulin versus sulfonylurea and surviving 6 months of intensified therapy, but not among those surviving 12 months. This association was mediated in part by weight change.

PURPOSE To evaluate the accuracy of a composite definition for the identification of hypoglycemia events that used both administrative claims and laboratory data in a cohort of patients. METHODS We reviewed medical records in a sample of presumed hypoglycemia events among patients who received care at the Veterans Health Administration Tennessee Valley Healthcare System in 2001 to 2012. A hypoglycemia event was defined as a hospitalization or emergency department visit judged by the treating clinician to be due to hypoglycemia, or an outpatient laboratory or point-of-care blood glucose measurement