Brief Report: Real-World Efficacy and Safety of Sotorasib in U.S. Veterans with KRAS G12C-Mutated NSCLC.

Introduction: The KRAS G12C inhibitor sotorasib was approved for treating advanced NSCLC in the second line or later on the basis of the CodeBreaK100 trial. Nevertheless, data on the real-world efficacy and safety of sotorasib, and to its optimal dose, remain limited. Methods: Patients treated with sotorasib for NSCLC through the Veterans Health Administration were retrospectively identified from the Corporate Data Warehouse. Survival, response, and toxicity data were obtained from chart review. Results: Among the 128 patients treated with sotorasib through the Veterans Health Administration, objective response rate was 34%, progression-free survival (PFS) six months, and overall survival 12 months. Similar PFS was observed among the 16 patients who received frontline sotorasib without any prior systemic therapy for NSCLC. Toxicity leading to sotorasib interruption or dose reduction occurred in 37% of patients, whereas sotorasib discontinuation for toxicity occurred in 25%. Notably, sotorasib dose reduction was associated with substantially improved PFS and OS. Conclusions: In this real-world study, the observed efficacy of sotorasib was similar to the results of CodeBreaK100. Patients who received frontline sotorasib had similar PFS to our overall cohort, suggesting that first-line sotorasib monotherapy may benefit patients who are not eligible for chemotherapy. Toxicities leading to sotorasib interruption, dose reduction, or discontinuation were common. Sotorasib dose reduction was associated with improved survival, suggesting that sotorasib dose reduction may not compromise efficacy.

Risk of clinically relevant hyperglycemia with metoprolol compared to carvedilol in older adults with heart failure and diabetes.

BACKGROUND: Although prior literature suggests that metoprolol may worsen glucose control compared to carvedilol, whether this has clinical relevance among older adults with diabetes and heart failure (HF) remains an open question. METHODS: This was a US retrospective cohort study utilizing data sourced from a 50% national sample of Medicare fee-for-service claims of patients with part D prescription drug coverage (2007-2017). Among patients with diabetes and HF, we identified initiators of metoprolol or carvedilol, which were 1:1 propensity score matched on >90 variables. The primary outcome was initiation of a new oral or injectable antidiabetic medication (proxy for uncontrolled diabetes); secondary outcomes included initiation of insulin and severe hyperglycemic event (composite of emergency room visits or hospitalizations related to hyperglycemia). RESULTS: Among 24 239 propensity score-matched pairs (mean [SD] age 77.7 [8.0] years; male [39.1%]), there were 8150 (incidence rate per 100 person-years [IR] = 33.5) episodes of antidiabetic medication initiation among metoprolol users (exposure arm) compared to 8576 (IR = 33.4) among carvedilol users (comparator arm) compared to corresponding to an adjusted hazard ratio (aHR) of 0.97 (95% confidence interval [CI]: 0.94, 1.01). Similarly, metoprolol was not associated with a significant increase in the risk of secondary outcomes including insulin initiation: aHR of 0.98 (95% CI: 0.93, 1.04) and severe hyperglycemic events: aHR of 0.98 (95% CI: 0.93, 1.02). CONCLUSIONS: In this large study of older adults with HF and diabetes, initiation of metoprolol compared to carvedilol was not associated with an increase in the risk of clinically relevant hyperglycemia.

Association of Serious Hypoglycemic Events in Older Adults With Changes in Glycemic Performance Measures.

BACKGROUND: Reducing serious hypoglycemic events is a Federal-wide objective. Despite studies of trends for rates of serious hypoglycemia in existing literature, rigorous evaluation of links between the observed trends and changes in professional guidelines or performance measures for glycemic control is lacking. OBJECTIVE: To evaluate whether changes in professional society guidelines and performance measures for glycemic control correspond to changes in rates of serous hypoglycemia. RESEARCH DESIGN: This was a retrospective observational study. We merged Veterans Health Administration (VHA) and Medicare patient-level databases of VHA patients and identified those aged 65 years and above and receiving hypoglycemic agents. We derived age-adjusted and sex-adjusted annual rates and constructed piecewise Poisson regression models adjusting for age and sex to assess time trends of the rates. SUBJECTS: VHA patients, 2002-2015. MEASURES: The main outcome was the annual rates (2004-2015) of serious hypoglycemia, defined as hypoglycemia-related emergency department visits or hospitalizations. Secondary outcomes were annual rates of hemoglobin (Hb) A1c level <7% and >9%. Age and sex were additional variables. RESULTS: The annual rate for hypoglycemia decreased by 4.8% (rate ratio: 0.952; 95% confidence interval, 0.949-0.956) for 2008-2015 but did not change (1.001; 0.994-1.001) in 2004-2008. In 2008-2015, the annual rate for HbA1c <7% decreased by 5.0% (0.950; 0.949-0.951) but for HbA1c >9%, increased by 7.9% (1.079; 1.076-1.082). CONCLUSION: The cooccurrence of decreasing rates for HbA1c<7% and serious hypoglycemia since 2008 supports the possibility that withdrawal of a <7% HbA1c measure in 2008 impacted clinical practice and patient outcomes.

How patients interpret early signs of foot problems and reasons for delays in care: Findings from interviews with patients who have undergone toe amputations.

AIMS: To describe how patients respond to early signs of foot problems and the factors that result in delays in care. METHODS: Semi-structured interviews were conducted with a large sample of Veterans from across the United States with diabetes mellitus who had undergone a toe amputation. Data were analyzed using inductive content analysis. RESULTS: We interviewed 61 male patients. Mean age was 66 years, 41% were married, and 37% had a high school education or less. The patient-level factors related to delayed care included: 1) not knowing something was wrong, 2) misinterpreting symptoms, 3) "sudden" and "unexpected" illness progression, and 4) competing priorities getting in the way of care-seeking. The system-level factors included: 5) asking patients to watch it, 6) difficulty getting the right type of care when needed, and 7) distance to care and other transportation barriers. CONCLUSION: A confluence of patient factors (e.g., not examining their feet regularly or thoroughly and/or not acting quickly when they noticed something was wrong) and system factors (e.g., absence of a mechanism to support patient's appraisal of symptoms, lack of access to timely and convenient-located appointments) delayed care. Identifying patient- and system-level interventions that can shorten or eliminate care delays could help reduce rates of limb loss.

Mental Health Conditions and Hospitalizations for Ambulatory Care Sensitive Conditions Among Veterans with Diabetes.

BACKGROUND: Veterans with diabetes and mental health conditions have a higher risk for suboptimal care and complications related to their diseases than veterans with diabetes who do not have mental health conditions. We hypothesized that among veterans with diabetes, patients with mental health conditions are more likely to be hospitalized for ambulatory care sensitive conditions (ACSC) than those without mental health conditions. OBJECTIVES: To examine the association between depression, anxiety, and serious mental illness and hospitalizations for ACSC among veterans with diabetes after controlling for demographics and comorbidities. METHODS: We used a retrospective cohort design with merged Veterans Health Administration (VHA) and Medicare electronic health records from 2008 to 2010. Andersen's Behavioral Model of Health Services Use was used to select the variables associated with hospitalizations for ACSC (ie, predisposing, enabling and need characteristics, personal health practices, and external environment). We used chi-square tests and logistic regressions for our analyses. RESULTS: Among the dual VHA/Medicare-enrolled veterans with any hospitalization in 2010, 30% had hospitalizations for ACSC. Veterans with diabetes and co-occurring depression were at increased likelihood to be hospitalized for ACSC, after adjusting for all other covariates (adjusted odds ratio, 1.08; 95% confidence interval, 1.04-1.11). Similar findings were observed for anxiety. Veterans with serious mental illness were as likely as veterans without serious mental illness to be hospitalized for ACSC. CONCLUSION: Veterans with depression and anxiety were more likely to be hospitalized for any or acute ACSC than veterans without mental health conditions. Patients hospitalized for acute ACSC were more susceptible than patients hospitalized for chronic ACSC to have mental health conditions. As the VHA continues to evolve from care provider to community care payer (per the Veterans Affairs MISSION Act), our results highlight the ongoing importance of care coordination and communication between payers and providers.

Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial.

Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments. We investigated whether the consumption of Concord grape juice (CGJ), rich in anti-inflammatory flavonoids, would be tolerated and safe in individuals with GWI and explored improvement in cognitive function and fatigue. Thirty-six veterans with GWI enrolled in a 24-week randomized, double-blind, Phase I/IIA clinical trial to explore safety, tolerability, and feasibility of 16 ounces daily of commercially available CGJ compared to placebo. Participants completed neurocognitive tests and self-reported surveys at baseline, 12 and 24 weeks. Thirty-one participants (86%) completed the study; no dropouts were related to side effects. Thirty participants (83%) documented ≥80% adherence. There were no statistically significant unadjusted differences between CGJ and placebo groups in change in efficacy measures from baseline to endpoint. We employed general linear regression models controlling for baseline differences between groups which indicated statistically significant improvement in the Halstead Category Test-Russell Revised Version (RCAT) at endpoint in the CGJ group compared to placebo (8.4 points, p = 0.04). Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses (p-values: 0.09-0.32), nor did the fatigue variable (p = 0.67). CGJ was safe and well-tolerated by veterans with GWI. Our data suggest high tolerability and potential benefit from CGJ in veterans with GWI and can be used to inform future studies of efficacy.

Risk of Ipsilateral Reamputation Following an Incident Toe Amputation Among U.S. Military Veterans With Diabetes, 2005-2016.

OBJECTIVE: To assess whether the risk of subsequent lower-limb amputations and death following an initial toe amputation among individuals with diabetes has changed over time and varies by demographic characteristics and geographic region. RESEARCH DESIGN AND METHODS: Using Veterans Health Administration (VHA) electronic medical records from 1 October 2004 to 30 September 2016, we determined risk of subsequent ipsilateral minor and major amputation within 1 year after an initial toe/ray amputation among veterans with diabetes. To assess changes in the annual rate of subsequent amputation over time, we estimated age-adjusted incidence of minor and major subsequent ipsilateral amputation for each year, separately for African Americans (AAs) and whites. Geographic variation was assessed across VHA markets (n = 89) using log-linear Poisson regression models adjusting for age and ethnoracial category. RESULTS: Among 17,786 individuals who had an initial toe amputation, 34% had another amputation on the same limb within 1 year, including 10% who had a major ipsilateral amputation. Median time to subsequent ipsilateral amputation (minor or major) was 36 days. One-year risk of subsequent major amputation decreased over time, but risk of subsequent minor amputation did not. Risk of subsequent major ipsilateral amputation was higher in AAs than whites. After adjusting for age and ethnoracial category, 1-year risk of major subsequent amputation varied fivefold across VHA markets. CONCLUSIONS: Nearly one-third of individuals require reamputation following an initial toe amputation, although risks of subsequent major ipsilateral amputation have decreased over time. Nevertheless, risks remain particularly high for AAs and vary substantially geographically.

Racial differences in trends of serious hypoglycemia among higher risk older adults in US Veterans Health Administration, 2004-2015: Relationship to comorbid conditions, insulin use, and hemoglobin A1c level.

AIMS: To evaluate temporal trends in racial/ethnic groups in rates of serious hypoglycemia among higher risk patients dually enrolled in Veterans Health Administration and Medicare fee-for-service and assess the relationship(s) between hypoglycemia rates, insulin/secretagogues and comorbid conditions. METHODS: Retrospective observational serial cross-sectional design. Patients were ≥65 years receiving insulin and/or secretagogues. The primary outcome was the annual (period prevalence) rates (2004-2015), per 1000 patient years, of serious hypoglycemic events, defined as hypoglycemic-related emergency department visits or hospitalizations. RESULTS: Subjects were 77-83% White, 7-10% Black, 4-5% Hispanic, <2% women; 38-58% were ≥75 years old; 72-75% had ≥1 comorbidity. In 2004-2015, rates declined from 63.2 to 33.6(-46.9%) in Blacks; 29.7 to 20.3 (-31.6%) in Whites; and 41.8 to 29.6 (-29.3%) in Hispanics. The Black-White rate differences narrowed regardless of insulin use, hemoglobin A1c level, and frequency and various combinations of comorbid conditions. Among insulin users, the Black-White contrast decreased from 34.7 (98.5 vs. 63.8) in 2004 to 13.2 (43.6 vs. 30.4) in 2015; in non-insulin users, the contrast was 25.7 (44.1 vs. 18.4) in 2004 and 10.1 (18.9 vs. 8.8) in 2015. CONCLUSION: Marked declines in serious hypoglycemia events occurred across race, medications, and comorbidities, suggesting significant changes in clinical practice.

Variations in VA and Medicare Use Among Veterans With Diabetes: Impacts on Ambulatory Care Sensitive Conditions Hospitalizations for 2008, 2009, and 2010.

INTRODUCTION: VA and Medicare use among older Veterans has been considered fragmented care, however, it may represent access to needed care. METHODS: The population studied were Veterans with diabetes, age 66 years and older, dually enrolled in VA and Medicare. DATA SOURCE/STUDY SETTING: We conducted a dynamic retrospective cohort study with 2008, 2009, and 2010 as the outcome years (Ambulatory Care Sensitive Conditions Hospitalization (ACSC-H) or not). We analyzed administrative data to identify comorbidities; ambulatory care utilization to identify variations in use before hospitalization. We linked 2007 primary care (PC) survey data to assess if organizational factors were associated with ACSC-H. MEASURES AND ANALYSIS: We identified ACSC-Hs using a validated definition. We categorized VA/Medicare use as: single system; dual system: supplemental specialty care use; or primary care use. Using hierarchical logistic regression models, we tested for associations between VA/Medicare use, organizational characteristics, and ACSC-H controlling for patient-level, organizational-level, and area-level characteristics. RESULTS: Our analytic population was comprised of 210,726 Medicare-eligible Veterans; more than one quarter had an ACSC-H. We found that single system users had higher odds of ACSC-H compared with dual system specialty supplemental care use (odds ratio, 1.14; 95% confidence interval, 1.09-1.20), and no significant difference between dual-system users. Veterans obtaining care at sites where PC leaders reported greater autonomy (eg, authority over personnel issues) had lower odds of ACSC-H (odds ratio, 0.74; 95% confidence interval, 0.59-0.92). DISCUSSION: Our findings suggest that earlier assumptions about VA/Medicare use should be weighed against the possibility that neither VA nor Medicare may address complex Veterans' health needs. Greater PC leader autonomy may allow for tailoring of care to match local clinical contexts.

Balancing measures: identifying unintended consequences of diabetes quality performance measures in patients at high risk for hypoglycemia.

OBJECTIVE: To determine if changes in overtreatment rates were associated with changes in undertreatment rates. DESIGN: Pre-test/post-test study used cross-sectional administrative data from calendar years (CYs) 2013 and 2016. SETTING: The Veterans Health Administration. PARTICIPANTS: Patients with diabetes at risk for hypoglycemia (n = 171 875 and 166 703 in 2013 and 2016, respectively). INTERVENTION: Observational study of extant initiatives to reduce overtreatment. MAIN OUTCOME MEASURES: Overtreatment rate of diabetes defined at the proportion of patients in the group at high risk for hypoglycemia with A1c < 7.0%. Undertreatment defined as A1C > 9%. RESULTS: There was marked variation in overtreatment rates; for A1c < 7%, overtreatment rates ranged from 26.4% to 58.2% and 26.2% to 49.2% at the facility level in 2013 and 2016, respectively. The mean (±standard deviation (SD)) facility-level overtreatment rates fell from 40.3 (±5.3)% in 2013 to 37.75 (±4.70)% in 2016 (P < 0.001, paired t-test). Facility undertreatment rates ranged from 5.8% to 16.9% and 6.8% to 18.7% at the facility level in 2013 and 2016, respectively. The mean (±SD) undertreatment rate rose from 10.3 (±2.2)% in 2013 to 11.0 (±2.4)% in 2016 (P ≤ 0.001, paired t-test). However, change at individual facilities ranged from a decrease of 4.6% to an increase of 7.2%. Within year correlations were stronger than between year correlations. Overtreatment defined as A1c < 7 in this population inversely correlated strongly with undertreatment (r = -0.653, P < 0.001). CONCLUSIONS: Promotion of overtreatment reduction may be associated with an increase in undertreatment in patients with diabetes. Unintended consequence should be considered when implementing and evaluating quality measures and systems should include balancing measures to identify potential unintended harms.

Dizziness, Vertigo, and Mental Health Comorbidity in Gulf War Veterans.

BACKGROUND: Gulf War Illness (GWI) is a chronic condition involving symptoms across multiple body systems. Previous research has implicated the vestibular system as a potential underlying factor in the symptoms experienced by veterans with GWI, due in part to exposure to potentially ototoxic chemicals and events. PURPOSE: To characterize the presence of vertigo and dizziness symptoms in a sample of veterans with GWI using validated self-report instruments, accounting for mental health comorbidities. RESEARCH DESIGN: This is a case series, follow-up, prospective interview of clinical veterans; results presented are purely descriptive. STUDY SAMPLE: Our sample of 50 veterans was a follow-up to a case series of clinical Gulf War veterans evaluated at the War Related Illness and Injury Study Center. DATA COLLECTION AND ANALYSIS: Veterans participated in a 70-min phone interview where the following questionnaires were administered: Vertigo Symptom Scale (VSS), Patient Health Questionnaire (depression scale), Patient Health Questionnaire (somatization scale), Beck Anxiety Inventory, Posttraumatic Stress Disorder (PTSD) Checklist, Defense and Veterans Brain Injury Center Traumatic Brain Injury Questionnaire, and GWI (Kansas) Questionnaire. We used descriptive (mean/median, standard deviation, interquartile range, and percentage) statistics to describe our sample and illuminate possible relationships between measures. RESULTS: Our primary finding is a substantial report of vertigo symptoms in our sample, according to the VSS. Ninety percent of participants scored above the VSS threshold (>12), suggesting "severe dizziness." The most commonly endorsed symptom on the VSS was "headache or pressure in the head." CONCLUSIONS: We conclude that there is significant burden of vertigo symptoms in veterans with GWI, suggesting a need for objective tests of vestibular function in this population. Furthermore, the relationship between symptoms of vertigo and dizziness, vestibular function, and PTSD warrants further exploration using objective measures.

Autonomic Symptoms in Gulf War Veterans Evaluated at the War Related Illness and Injury Study Center.

INTRODUCTION: We characterized the presence of autonomic symptoms in a sample of Veterans with Gulf War Illness (GWI) using the Composite Autonomic Symptom Scale (COMPASS-31). In addition, we examined the report of autonomic symptoms across comorbid mental health conditions in this sample. MATERIALS AND METHODS: Case-series follow-up of Gulf War veterans evaluated by the War Related Illness and Injury Study Center (WRIISC) between 2011 and 2016 (n = 153). Phone-based interview consisted of questionnaires designed to investigate autonomic symptoms, physical symptoms, mental health conditions, and GWI. Sixty-One Veterans agreed to participate in this follow-up arm of the study. We restricted our analysis to only those Veterans meeting CDC and/or Kansas criteria for GWI, leaving us with a sample of 56 Veterans. RESULTS: Veterans in our sample were, male (n = 55, 98%), 49 (±6.8) years old and used 8 (±6.6) medications. The mean COMPASS-31 score for our sample was 45.6 (±18.3). There were no differences in reports of autonomic symptoms between participants who screened positive or negative for depression or post-traumatic stress disorder, but COMPASS-31 scores were higher among those who screened positive for anxiety (49.6 (±16.0)) compared with those who screened negative (29.3 (±18.9)) (p < 0.001). CONCLUSIONS: The elevated COMPASS-31 scores suggest that there may be autonomic dysfunction present in our sample of Veterans with GWI, consistent with other published reports. Additionally, we believe that the high scores on the anxiety measure may reflect assessment of physiological symptoms that are not specific to anxiety, and may reflect GWI symptoms. Objective physiological tests of the autonomic nervous system are warranted to better characterize autonomic function and the clinical relevance of COMPASS-31 in this population.

Impact of presumed service-connected diagnosis on the Department of Veterans Affairs healthcare utilization patterns of Vietnam-Theater Veterans: A cross-sectional study.

During the Vietnam War, the US military sprayed almost 20 million gallons of Agent Orange (AO), an herbicide contaminated with dioxin, over Vietnam. Approximately, 2.7 million US military personnel may have been exposed to AO during their deployment. Ordinarily, veterans who can demonstrate a nexus between a diagnosed condition and military service are eligible for Department of Veterans Affairs (VA) service-connected disability compensation. Vietnam Veterans have had difficulty, however, establishing a nexus between AO exposure and certain medical conditions that developed many years after the war. In response, VA has designated certain conditions as "presumed service connected" for Vietnam Veterans who were present and possibly exposed. Veterans with any of these designated conditions do not have to document AO exposure, making it easier for them to access the VA disability system. The extent to which VA healthcare utilization patterns reflect easier access afforded those with diagnosed presumptive conditions remains unknown. In this cross-sectional study, we hypothesized that Vietnam Veterans with diagnosed presumptive conditions would be heavier users of the VA healthcare system than those without these conditions. In our analysis of 85,699 Vietnam Veterans, we used binary and cumulative logit multivariable regression to assess associations between diagnosed presumptive conditions and VA healthcare utilization in 2013. We found that diagnosed presumptive conditions were associated with higher odds of 5+ VHA primary care visits (OR = 2.01, 95% CI: 1.93-2.07), 5+ specialty care visits (OR = 2.11, 95% CI: 2.04-2.18), emergency department use (OR = 1.22, 95% CI: 1.11-1.34), and hospitalization (OR = 1.23, 95% CI: 1.17-1.29). Consistent with legislative intent, presumptive policies appear to facilitate greater VA system utilization for Vietnam Veterans who may have been exposed to AO.

Report of Autonomic Symptoms in a Clinical Sample of Veterans with Gulf War Illness.

Introduction: Previous studies suggest that autonomic dysfunction may be an underlying factor in Gulf War Illness. This study examined self-reported symptoms of autonomic dysfunction and their relationship with physical functioning among veterans with Gulf War Illness. Materials and Methods: We abstracted medical records of Gulf War Veterans clinically evaluated at the New Jersey War Related Illness and Injury Study Center between 2010 and 2016. The outcome measure was the Veteran version of the Short Form Health Survey (VR-36) physical functioning scale. Autonomic function was assessed using a composite variable constructed from the chart abstraction to mimic the Composite Autonomic Symptom Scale (COMPASS-31). Results: Seventy-six veterans were included in the final analysis. The autonomic symptom burden score was 45 (±14). Increased autonomic symptom burden, greater mental health burden (PTSD/depression), and greater body mass index were individually associated with poorer physical functioning. A general linear regression containing these variables revealed that patients with both PTSD and depression (b = -15.2, p = 0.03) or either PTSD or depression (b = -22.7, p < 0.01) had lower physical functioning than those without; the other variables became not significant (body mass index: p = 0.07; autonomic function: p = 0.89). Conclusion: The average autonomic function score indicated significant burden in Gulf War Veterans, consistent with published research. We did not detect an independent association between autonomic symptom burden and physical functioning, likely due to the non-specific nature of the measure used to capture autonomic symptoms or the stronger association between mental health conditions and physical functioning. Future work utilizing valid and standardized instruments to clinically evaluate autonomic function is warranted.

An expanded prevention quality diabetes composite: Quantifying the burden of preventable hospitalizations for older adults with diabetes.

AIM: To expand the existing United States Agency for Health Research and Quality (AHRQ) Diabetes composite (AHRQ-DC) to include additional preventable hospitalizations specific or relevant to diabetes. METHODS: A cross-sectional analysis of 834,696 veteran patients with diabetes aged ≥65 years in 2012. An Expanded Diabetes Composite (Expanded-DC) was developed utilizing: (1) the diabetes-specific category: the AHRQ-DC (short-term and long-term complications, uncontrolled diabetes, lower extremity amputations) and two proposed conditions: hypoglycemia and lower extremity ulcers/inflammation/infections (LEU) and (2) the diabetes-relevant category: the AHRQ-Acute Composite (dehydration, pneumonia, urinary tract infections) and one proposed condition, acute kidney injury (AKI). RESULTS: The study population was 98% male, 80% White, 10% Black, and 5% Hispanic; 71% had complex comorbidities. There were 64,243 (77.0 admissions/1000 patients) hospitalizations in the Expanded-DC, compared to 13,523 (16.2) in the AHRQ-DC, a 4.7 fold increase. Hospitalizations from AHRQ-Acute Composite and the three proposed conditions added 79% to the Expanded-DC. LEU and hypoglycemia added 39% to the diabetes-specific category. AKI added 18% to the diabetes-relevant category. Blacks incurred more preventable hospitalizations (85.9) than Whites (74.7); as did patients with complex comorbidities (93.6) versus those without (34.6). CONCLUSION: The AHRQ-DC substantially underestimates rates of clinically important preventable hospitalizations in older diabetes patients.

State-Level Variability in Veteran Reliance on Veterans Health Administration and Potentially Preventable Hospitalizations: A Geospatial Analysis.

Most Veterans who use the Veterans Health Administration (VHA) also utilize private-sector health care providers. To better inform local and regional health care planning, we assessed the association between reliance on VHA ambulatory care and total and system-specific preventable hospitalization rates (PHRs) at the state level. We conducted a retrospective dynamic cohort study using Veterans with diabetes mellitus, aged 66 years or older, and dually enrolled in VHA and Medicare parts A and B from 2004 to 2010. While controlling for median age and proportion of males, we measured the association between reliance on VHA ambulatory care and PHRs at the state level using multivariable ordinary least square regression, geographically weighted regression, and generalized additive models. We measured geospatial patterns in PHRs using global Moran's I and univariate local indicator spatial analysis. Approximately 30% of hospitalized Veterans experienced a preventable hospitalization. Reliance on VHA ambulatory care at the state level ranged from 13.92% to 67.78% and was generally not associated with PHRs. Geospatial analysis consistently identified a cluster of western states with low PHRs from 2006 to 2010. Given the generally low reliance on VHA ambulatory care and lack of association between this reliance and PHRs, policy changes to improve Veterans' health care outcomes should address private-sector care in addition to VHA care.

Identification of outliers and positive deviants for healthcare improvement: looking for high performers in hypoglycemia safety in patients with diabetes.

BACKGROUND: The study objectives were to determine: (1) how statistical outliers exhibiting low rates of diabetes overtreatment performed on a reciprocal measure - rates of diabetes undertreatment; and (2) the impact of different criteria on high performing outlier status. METHODS: The design was serial cross-sectional, using yearly Veterans Health Administration (VHA) administrative data (2009-2013). Our primary outcome measure was facility rate of HbA1c overtreatment of diabetes in patients at risk for hypoglycemia. Outlier status was assessed by using two approaches: calculating a facility outlier value within year, comparator group, and A1c threshold while incorporating at risk population sizes; and examining standardized model residuals across year and A1c threshold. Facilities with outlier values in the lowest decile for all years of data using more than one threshold and comparator or with time-averaged model residuals in the lowest decile for all A1c thresholds were considered high performing outliers. RESULTS: Using outlier values, three of the 27 high performers from 2009 were also identified in 2010-2013 and considered outliers. There was only modest overlap between facilities identified as top performers based on three thresholds: A1c < 6%, A1c < 6.5%, and A1c < 7%. There was little effect of facility complexity or regional Veterans Integrated Service Networks (VISNs) on outlier identification. Consistent high performing facilities for overtreatment had higher rates of undertreatment (A1c > 9%) than VA average in the population of patients at high risk for hypoglycemia. CONCLUSIONS: Statistical identification of positive deviants for diabetes overtreatment was dependent upon the specific measures and approaches used. Moreover, because two facilities may arrive at the same results via very different pathways, it is important to consider that a "best" practice may actually reflect a separate "worst" practice.

A Proposal for an Out-of-Range Glycemic Population Health Safety Measure for Older Adults With Diabetes.

OBJECTIVE: To evaluate patient-level glycemic control and facility variation of a proposed out-of-range (OOR) measure (overtreatment [OT] [HbA1c <7% (53 mmol/mol)] or undertreatment [UT] [>9% (75 mmol/mol)]) compared with the standard measure (SM) (HbA1c <8% [64 mmol/mol]) in high-risk older adults. RESEARCH DESIGN AND METHODS: Veterans Health Administration patients ≥65 years of age in 2012 who were taking antihyperglycemic agents in 2013 were identified. Patient-level rates and facility-level rates/rankings were calculated by age and comorbid illness burden. RESULTS: We identified 303,097 patients who were taking antiglycemic agents other than metformin only. The study population comprised 193,689 patients with at least one significant medical, neurological, or mental health condition; 98.2% were taking a sulfonylurea and/or insulin; 55.2% were aged 65-75 years; and 44.8% were aged >75 years. The 47.4% of patients 65-75 years met the OOR measure (33.4% OT, 14% UT), and 65.7% met the SM. For patients aged >75 years, rates were 48.1% for OOR (39.2% OT; 8.9% UT) and 73.2% for SM. Facility-level rates for OOR for patients aged 65-75 years ranged from 33.7 to 60.4% (median 47.4%), with a strong inverse correlation (ρ = -0.41) between SM and OOR performance rankings. Among the best-performing 20% facilities on the SM, 14 of 28 ranked in the worst-performing 20% on the OOR measure; 12 of 27 of the worst-performing 20% facilities on the SM ranked in the best-performing 20% on the OOR measure. CONCLUSIONS: Facility rankings that are based on an SM (potential benefits) and OOR measure (potential risks) differ substantially. An OOR for high-risk populations can focus quality improvement on individual patient evaluation to reduce the risk for short-term harms.