Correlates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder.

Persons diagnosed with schizophrenia (SCZ) or bipolar I disorder (BPI) are at high risk for self-injurious behavior, suicidal ideation, and suicidal behaviors (SB). Characterizing associations between diagnosed health problems, prior pharmacological treatments, and polygenic scores (PGS) has potential to inform risk stratification. We examined self-reported SB and ideation using the Columbia Suicide Severity Rating Scale (C-SSRS) among 3,942 SCZ and 5,414 BPI patients receiving care within the Veterans Health Administration (VHA). These cross-sectional data were integrated with electronic health records (EHRs), and compared across lifetime diagnoses, treatment histories, follow-up screenings, and mortality data. PGS were constructed using available genomic data for related traits. Genome-wide association studies were performed to identify and prioritize specific loci. Only 20% of the veterans who reported SB had a corroborating ICD-9/10 EHR code. Among those without prior SB, more than 20% reported new-onset SB at follow-up. SB were associated with a range of additional clinical diagnoses, and with treatment with specific classes of psychotropic medications (e.g., antidepressants, antipsychotics, etc.). PGS for externalizing behaviors, smoking initiation, suicide attempt, and major depressive disorder were associated with SB. The GWAS for SB yielded no significant loci. Among individuals with a diagnosed mental illness, self-reported SB were strongly associated with clinical variables across several EHR domains. Analyses point to sequelae of substance-related and psychiatric comorbidities as strong correlates of prior and subsequent SB. Nonetheless, past SB was frequently not documented in health records, underscoring the value of regular screening with direct, in-person assessments, especially among high-risk individuals.

Correlates of suicidal behaviors and genetic risk among United States veterans with schizophrenia or bipolar I disorder.

Objective: Persons diagnosed with schizophrenia (SCZ) or bipolar I disorder (BPI) are at high risk for self-injurious behavior, suicidal ideation, and suicidal behaviors (SB). Characterizing associations between diagnosed mental and physical health problems, prior pharmacological treatments, and aggregate genetic factors has potential to inform risk stratification and mitigation strategies. Methods: In this study of 3,942 SCZ and 5,414 BPI patients receiving VA care, self-reported SB and ideation were assessed using the Columbia Suicide Severity Rating Scale (C-SSRS). These cross-sectional data were integrated with electronic health records (EHR), and compared by lifetime diagnoses, treatment histories, follow-up screenings, and mortality data. Polygenic scores (PGS) for traits related to psychiatric disorders, substance use, and cognition were constructed using available genomic data, and exploratory genome-wide association studies were performed to identify and prioritize specific loci. Results: Only 20% of veterans who self-reported SB had a corroborating ICD-9/10 code in their EHR; and among those who denied prior behaviors, more than 20% reported new-onset SB at follow-up. SB were associated with a range of psychiatric and non-psychiatric diagnoses, and with treatment with specific classes of psychotropic medications (e.g., antidepressants, antipsychotics, etc.). PGS for externalizing behaviors, smoking, suicide attempt, and major depressive disorder were also associated with attempt and ideation. Conclusions: Among individuals with a diagnosed mental illness, a GWAS for SB did not yield any significant loci. Self-reported SB were strongly associated with clinical variables across several EHR domains. Overall, clinical and polygenic analyses point to sequelae of substance-use related behaviors and other psychiatric comorbidities as strong correlates of prior and subsequent SB. Nonetheless, past SB was frequently not documented in clinical settings, underscoring the value of regular screening based on direct, in-person assessments, especially among high-risk individuals.

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials.

BACKGROUND/AIMS: High follow-up is critical in randomized clinical trials. We developed novel approaches to modify in-person visits and complete follow-up during COVID-19. Since these strategies are broadly applicable to circumstances wherein follow-up is difficult, they may help in contingency planning. The objective of this article is to develop and evaluate new approaches to replace detailed, in-person study visits for two trials focused on preventing diabetic foot complications. METHODS: A quasi-experimental pre-post design compared approaches for follow-up during COVID-19 to approaches pre-COVID-19. Study subjects were outpatients at two Veterans Affairs Medical Centers. Following a research "hold," research resumed in February 2021 for Self-monitoring, Thermometry and Educating Patients for Ulcer Prevention (STEP UP) (n = 241), which focused on preventing recurrent foot ulcers, and in April 2021 for Preventing Amputation by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT) (n = 406), which focused on preventing pre-ulcerative and ulcerative lesions. To complete data collection, we shortened visits, focused on primary and secondary outcomes, and conducted virtual visits when appropriate. For STEP UP, we created a 20-min assessment process that could be administered by phone. Since PATRIOT required plantar photographs to assess foot lesions, we conducted short face-to-face visits. We explored differences and assessed proportion completing visit, visit completion/100 person-months and compared COVID-19 to pre- COVID-19 using unadjusted risk ratios, incidence rate ratios, all with associated 95% confidence intervals (CIs). Finally, we report time-to-visit curves. RESULTS: In both studies, participants whose follow-up concluded pre- COVID-19 seemed older than those whose follow-up concluded during COVID-19 (PATRIOT: 68.0 (67.2, 68.9) versus 65.2 years (61.9, 68.5); STEP UP: 67.5 (66.2, 68.9) versus 65.3 (63.3, 67.3)). For STEP UP, we completed 91 visits pre- COVID-19 (37.8% (31.6%, 44.2%)) and 63 visits during COVID-19 (78.8% (68.2%, 87.1%)). This was over 1309 person-months pre-COVID-19, and over 208.8 person-months during COVID-19; the visit completion rate/100 person-months were: pre-COVID-19 7.0 (5.6, 8.5), COVID-19 30.2 (23.2, 38.6); risk ratio: 2.1 (1.7, 2.5); and incidence rate ratio 4.3 (3.1, 5.9). Similarly, for PATRIOT, we completed 316 visits pre-COVID-19 (77.8% (73.5%, 81.8%)) and 27 assessments during COVID-19 (84.4% (67.2%, 94.7%)). This was over 1192.7 person-months pre-COVID-19 and 39.3 person-months during COVID-19. The visit completion rate/100 person-months in PATRIOT were: pre-COVID-19 2.7 (2.4, 3.0), COVID-19 6.9 (4.5, 10); risk ratio 1.1 (0.9, 1.3); incidence rate ratio 2.6 (1.8, 3.8). For both studies, the follow-up curves began separating at < 2 months. CONCLUSIONS: We achieved higher completion rates during COVID-19 compared to pre-COVID-19 by modifying visits and focusing on primary and secondary outcomes. These strategies prevent excessive missing data, support more valid conclusions, and improve efficiency. They may provide important alternative strategies to achieving higher follow-up in randomized clinical trials.

Does exercise training improve exercise tolerance, quality of life, and echocardiographic parameters in patients with heart failure with preserved ejection fraction? A systematic review and meta-analysis of randomized controlled trials.

Patients with heart failure with preserved ejection fraction (HFpEF) often experience dyspnea, decreased exercise tolerance, and decreased quality of life (QOL). Exercise training is a promising non-pharmacological treatment, with some improvement in exercise tolerance and QOL in HFpEF patients in randomized controlled trials (RCTs). We conducted a systematic review and meta-analysis of RCTs examining the effect of exercise therapy on exercise tolerance, QOL, and echocardiographic parameters in patients with HFpEF. Article database search of PubMed, Embase, and Cochrane Central Register of Controlled Trials identified 15 publications representing 579 unique patients. Results are presented as weighted mean difference (WMD) with 95% confidence intervals (CI). Exercise training (compared to control) demonstrated a significant improvement in exercise tolerance as measured by peak absolute VO2 (WMD [95% CI] = 164.67 [65.54, 263.79] mL/min), peak relative VO2 (WMD [95% CI] = 1.85 [0.98, 2.73] mL/min/kg), workload (WMD [95% CI] = 12.92 [4.67, 21.17] W), exercise time (WMD [95% CI] = 2.05 [1.57, 2.53] min), anaerobic threshold (WMD [95% CI] = 170.31 [35.40, 305.22] mL/min/kg), and 6-min walk test distance (WMD [95% CI] = 32.77 [20.72, 44.83] m); in QOL as measured by Short Form (SF-36) physical functioning domain (WMD [95% CI] = 9.95 [2.85, 17.05]) and SF-36 vitality domain (WMD [95% CI] = 6.24 [0.15, 12.34]); and in the echocardiographic measure of LVESD (WMD [95% CI] = - 0.16 [- 0.28, - 0.04] cm). In conclusion, we found after systematic review and meta-analysis of RCTs that exercise therapy improves exercise tolerance and physical-related quality of life measures.

Penetrance and Pleiotropy of Polygenic Risk Scores for Schizophrenia, Bipolar Disorder, and Depression Among Adults in the US Veterans Affairs Health Care System.

Importance: Serious mental illnesses, including schizophrenia, bipolar disorder, and depression, are heritable, highly multifactorial disorders and major causes of disability worldwide. Objective: To benchmark the penetrance of current neuropsychiatric polygenic risk scores (PRSs) in the Veterans Health Administration health care system and to explore associations between PRS and broad categories of human disease via phenome-wide association studies. Design, Setting, and Participants: Extensive Veterans Health Administration's electronic health records were assessed from October 1999 to January 2021, and an embedded cohort of 9378 individuals with confirmed diagnoses of schizophrenia or bipolar 1 disorder were found. The performance of schizophrenia, bipolar disorder, and major depression PRSs were compared in participants of African or European ancestry in the Million Veteran Program (approximately 400 000 individuals), and associations between PRSs and 1650 disease categories based on ICD-9/10 billing codes were explored. Last, genomic structural equation modeling was applied to derive novel PRSs indexing common and disorder-specific genetic factors. Analysis took place from January 2021 to January 2022. Main Outcomes and Measures: Diagnoses based on in-person structured clinical interviews were compared with ICD-9/10 billing codes. PRSs were constructed using summary statistics from genome-wide association studies of schizophrenia, bipolar disorder, and major depression. Results: Of 707 299 enrolled study participants, 459 667 were genotyped at the time of writing; 84 806 were of broadly African ancestry (mean [SD] age, 58 [12.1] years) and 314 909 were of broadly European ancestry (mean [SD] age, 66.4 [13.5] years). Among 9378 individuals with confirmed diagnoses of schizophrenia or bipolar 1 disorder, 8962 (95.6%) were correctly identified using ICD-9/10 codes (2 or more). Among those of European ancestry, PRSs were robustly associated with having received a diagnosis of schizophrenia (odds ratio [OR], 1.81 [95% CI, 1.76-1.87]; P < 10-257) or bipolar disorder (OR, 1.42 [95% CI, 1.39-1.44]; P < 10-295). Corresponding effect sizes in participants of African ancestry were considerably smaller for schizophrenia (OR, 1.35 [95% CI, 1.29-1.42]; P < 10-38) and bipolar disorder (OR, 1.16 [95% CI, 1.11-1.12]; P < 10-10). Neuropsychiatric PRSs were associated with increased risk for a range of psychiatric and physical health problems. Conclusions and Relevance: Using diagnoses confirmed by in-person structured clinical interviews and current neuropsychiatric PRSs, the validity of an electronic health records-based phenotyping approach in US veterans was demonstrated, highlighting the potential of PRSs for disentangling biological and mediated pleiotropy.

Association of the built environment and neighborhood resources with obesity-related health behaviors in older veterans with hypertension.

OBJECTIVE: To evaluate the association of the built environment and neighborhood resources with exercise, diet, and body mass index (BMI). METHOD: Person-level data were collected from 533 veterans with uncontrolled hypertension. Neighborhood measures were: (a) census-tract level walkability; and (b) healthy food proximity (HFP). Robust or logistic regression (adjusting for age, race, education, comorbidity, and clustered by provider) was used to evaluate associations between neighborhood and exercise duration (hours/week), exercise adherence (% adherent), saturated fat index (0-10), Healthy Eating Index (HEI; 0-100), HEI adherence (≥ 74 score), stage of change (SOC) for exercise and diet (% in action/maintenance), BMI (kg/m²), and obesity (BMI ≥ 30 kg/m²). RESULTS: The adjusted difference in HEI score (standard error [SE]) between the highest and lowest walkability tertiles was 3.67 (1.35), p = .006; the corresponding comparison for the saturated fat index was 1.03 (.50), p = .041 and BMI was -1.12 (.45), p = .013. The adjusted odds ratio (OR; 95% confidence intervals [CI]) between the highest and lowest walkability tertiles for HEI adherence was 2.16 [1.22, 3.82], p = .009 and for action/maintenance for exercise SOC was 1.78 [1.15, 2.76], p = .011. The adjusted difference (SE) between the highest and lowest HFP tertiles for exercise duration was .65 (.31), p = .03. The adjusted OR [95% CI] between the highest and lowest HFP tertiles for exercise adherence was 1.74 [1.08, 2.79], p = .023 and for action/maintenance for exercise SOC was 1.75 [1.10, 2.79], p = .034. CONCLUSIONS: Geographical location is associated with exercise and diet. Environment-tailored health recommendations could promote healthier lifestyles and decrease obesity-related cardiovascular disease. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial.

[Figure: see text].

Validity and reliability of a short self-efficacy instrument for hypertension treatment adherence among adults with uncontrolled hypertension.

OBJECTIVE: To establish the reliability and validity of a self-report measure designed to assess self-efficacy for hypertension treatment adherence. METHODS: This investigation was embedded within a six-month randomized clinical trial (RCT), which demonstrated that a tailored, stage-matched intervention was more effective at improving hypertension control than usual care among individuals (n = 533) with repeated uncontrolled hypertension. The instrument used to assess self-efficacy for hypertension treatment adherence (SE-HTA) comprised three subscales that assessed diet self-efficacy (DSE), exercise self-efficacy (ESE), and medication self-efficacy (MSE). To determine SE-HTA validity and reliability, we assessed internal consistency using Cronbach's α coefficients, conducted exploratory factor analysis, and evaluated convergent and discriminant validity, as well as test-retest reliability using Spearman's ρ correlation coefficients. RESULTS: Cronbach's α (internal consistency) values for DSE, ESE, and MSE were 0.81, 0.82 and 0.74. Factor analysis and the scree plot demonstrated three distinct factors, which correspond to the three subscales contained in the SE-HTA instrument. SE-HTA possessed good convergent and discriminant validity, and moderate test-retest reliability. CONCLUSION: The SE-HTA instrument containing diet, exercise, and medication adherence subscales is valid and reliable in adults with uncontrolled hypertension. PRACTICE IMPLICATIONS: This SE-HTA instrument measures self-efficacy and could help facilitate behavior change in hypertension.

Management of Dyslipidemia for Cardiovascular Disease Risk Reduction: Synopsis of the 2020 Updated U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline.

DESCRIPTION: In June 2020, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) released a joint update of their clinical practice guideline for managing dyslipidemia to reduce cardiovascular disease risk in adults. This synopsis describes the major recommendations. METHODS: On 6 August to 9 August 2019, the VA/DoD Evidence-Based Practice Work Group (EBPWG) convened a joint VA/DoD guideline development effort that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions, systematically searched and evaluated the literature (English-language publications from 1 December 2013 to 16 May 2019), and developed 27 recommendations and a simple 1-page algorithm. The recommendations were graded by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. RECOMMENDATIONS: This synopsis summarizes key features of the guideline in 7 crucial areas: targeting of statin dose (not low-density lipoprotein cholesterol goals), additional tests for risk prediction, primary and secondary prevention, laboratory testing, physical activity, and nutrition.

Management of Dyslipidemia for cardiovascular disease risk Reduction: synopsis of the 2020 updated U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

In June 2020, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) released a joint update of their clinical practice guideline for managing dyslipidemia to reduce cardiovascular disease risk in adults. This synopsis describes the major recommendations. The guideline panel developed key questions, systematically searched and evaluated the literature (English-language publications from 1 December 2013 to 16 May 2019), and developed 27 recommendations and a simple 1-page algorithm. The recommendations were graded by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. This synopsis summarizes key features of the guideline in 7 crucial areas: targeting of statin dose (not low-density lipoprotein cholesterol goals), additional tests for risk prediction, primary and secondary prevention, laboratory testing, physical activity, and nutrition.

The Influence of Metabolic Syndrome in Predicting Mortality Risk Among US Adults: Importance of Metabolic Syndrome Even in Adults With Normal Weight.

INTRODUCTION: Although metabolic syndrome (MetS) is less prevalent among normal-weight adults than among overweight and obese adults, it does occur. The objective of our study was to examine how mortality risks differed in weight categories stratified by presence/absence of MetS. METHODS: We linked data for US adults responding to the National Health and Nutrition Examination Survey from 1999 through 2010 to data released from the National Death Index up to 2011. We grouped data according to categories of body mass index (normal [18.5 to <25.0 kg/m2], overweight [25.0 to <30.0 kg/m2], and obese [≥30.0 kg/m2]) and presence/absence of MetS. After conducting unadjusted analyses, we used Cox proportional hazards models to evaluate mortality risk as multivariable hazard ratios among obesity-MetS categories while controlling for selected covariates. RESULTS: The analysis included 12,047 adults. The prevalence of MetS was 61.6% in the obese group, 33.2% in the overweight group, and 8.6% in the normal-weight group. The multivariate adjusted hazard ratio (95% confidence interval) for mortality among the obesity-MetS groups, compared with the normal-weight-no-MetS group, were as follows: normal-weight-MetS (1.70 [1.16-2.51]), overweight-no-MetS (0.99 [0.77-1.28]), overweight-MetS (1.10 [0.85-1.42]), obese-no-MetS (1.08 [0.76-1.54]), and obese-MetS (1.30 [1.07-1.60]); differences were significant only for the normal-weight-MetS group and obese-MetS group. CONCLUSION: MetS is a risk factor for mortality among normal-weight and obese adults. In our study, normal-weight adults with MetS had the highest mortality among the 6 groups studied, suggesting that interventions should also focus on MetS patients with normal weight.

Predicting adults likely to develop heart failure using readily available clinical information: An analysis of heart failure incidence using the NHEFS.

BACKGROUND: Heart failure is a heavy burden on the health care system in the United States. Once heart failure develops, the quality of life and longevity are dramatically affected. As such, its prevention is critical for the well-being of at risk patients. We evaluated the predictive ability of readily available clinical information to identify those likely to develop heart failure. METHODS: We used a classification and regression tree (CART) model to determine the top predictors for heart failure incidence using the NHANES Epidemiologic Follow-up Study (NHEFS). The identified predictors were hypertension, diabetes, obesity, and myocardial infarction (MI). We evaluated the relationship between these variables and incident heart failure by the product-limit method and Cox models. All analyses incorporated the complex sample design to provide population estimates. RESULTS: We analyzed data from 14,407 adults in the NHEFS. Participants with diabetes, MI, hypertension, or obesity had a higher incidence of heart failure than those without risk factors, with diabetes and MI being the most potent predictors. Individuals with multiple risk factors had a higher incidence of heart failure as well as a higher hazard ratio than those with just one risk factor. Combinations that included diabetes and MI had the highest incidence rates of heart failure per 1000 person years and the highest hazard ratios for incident heart failure. CONCLUSIONS: Having diabetes, MI, hypertension or obesity significantly increased the risk for incident heart failure, especially combinations including diabetes and MI. This suggests that individuals with these conditions, singly or in combination, should be prioritized in efforts to predict and prevent heart failure incidence.

A Tailored Behavioral Intervention to Promote Adherence to the DASH Diet.

Objectives: In this study, we evaluated the effects of a Transtheoretical model (TTM)-based tailored behavioral intervention (TBI), a non-tailored intervention (NTI) or usual care (UC) on: (1) the Dietary Approaches to Stop Hypertension (DASH) dietary pattern in 533 individuals with uncontrolled hypertension; and (2) the change from baseline to 6 months in proportion of participants in action or maintenance stages of change (SOC). Methods: This was a randomized clinical trial. Diet was evaluated using the validated Harvard DASH score calculated from Willett Food Frequency Questionnaires (range 8-40). The randomized groups were compared using the Wilcoxon rank-sum test, with adjustment for clustering by physician and baseline DASH scores. Results: At 6 months, compared to UC, TBI had a 1.28 point increase in DASH score (p ≤ .01) while NTI was not significant. At 6-month follow-up, TBI was more effective in advancing dietary SOC when compared to UC (56% vs 43%, p < .01) and NTI was not effective (46% vs 43%, p = .64). Conclusions: A phone-delivered tailored TTM-based intervention achieved greater improvement in DASH score and dietary SOC, suggesting that TTM-based tailored interventions can increase patients' dietary adherence.

Accuracy of Administrative Coding to Identify Reduced and Preserved Left Ventricular Ejection Fraction.

BACKGROUND: Coding of systolic function in heart failure is important, but the accuracy is uncertain. METHODS AND RESULTS: We used data from a chart review of VA heart failure hospitalizations from 2006 to 2013. Trained abstractors determined the documented diagnosis of heart failure and the left ventricular ejection fraction (LVEF). We compared this LVEF with the primary and secondary International Classification of Disease, 9th edition, codes for heart failure for the same hospitalization. Among 43,044 hospitalizations for heart failure, the primary discharge diagnosis was coded as systolic heart failure in 18%, diastolic heart failure in 17%, and other heart failure codes in 65%. For an LVEF <40%, a systolic heart failure code had a sensitivity of 29% and a positive predictive value of 76%. The code for systolic heart failure was used more frequently over time, with sensitivity increasing from 16% to 37% but at the expense of the positive predictive value, which decreased from 80% to 74%. The overall area under the receiver operating characteristic curve for the relationship between LVEF and the systolic heart failure code was 0.71. Using LVEF >50% to define diastolic heart failure led to a sensitivity of 29% for a diastolic heart failure code, with a positive predictive value of 78%. In multivariate analysis, a systolic heart failure code had an odds ratio for 1-year mortality of 1.1 (95% confidence interval 1.03-1.17) compared to not having a systolic heart failure code. CONCLUSIONS: Coding for systolic and diastolic heart failure is associated with LVEF, but the accuracy is too poor to substitute for the documented LVEF in performance measurement.

HbA1c, lipid profiles and risk of incident type 2 Diabetes in United States Veterans.

United States Veterans are at excess risk for type 2 diabetes, but population differentials in risk have not been characterized. We determined risk of type 2 diabetes in relation to prediabetes and dyslipidemic profiles in Veterans at the VA New York Harbor (VA NYHHS) during 2004-2014. Prediabetes was based on American Diabetes Association hemoglobin A1c (HbA1c) testing cut-points, one of several possible criteria used to define prediabetes. We evaluated transition to type 2 diabetes in 4,297 normoglycemic Veterans and 7,060 Veterans with prediabetes. Cox proportional hazards regression was used to relate HbA1c levels, lipid profiles, demographic, anthropometric and comorbid cardiovascular factors to incident diabetes (Hazard Ratio [HR] and 95% confidence intervals). Compared to normoglycemic Veterans (HbA1c: 5.0-5.6%; 31-38 mmol/mol), risks for diabetes were >2-fold in the moderate prediabetes risk group (HbA1c: 5.7-5.9%; 39-41 mmol/mol) (HR 2.37 [1.98-2.85]) and >5-fold in the high risk prediabetes group (HbA1c: 6.0-6.4%; 42-46 mmol/mol) (HR 5.59 [4.75-6.58]). Risks for diabetes were increased with elevated VLDL (≥40mg/dl; HR 1.31 [1.09-1.58]) and TG/HDL (≥1.5mg/dl; HR 1.34 [1.12-1.59]), and decreased with elevated HDL (≥35mg/dl; HR 0.80 [0.67-0.96]). Transition to diabetes in Veterans was related in age-stratified risk score analyses to HbA1c, VLDL, HDL and TG/HDL, BMI, hypertension and race, with 5-year risk differentials of 62% for the lowest (5-year risk, 13.5%) vs. the highest quartile (5-year risk, 21.9%) of the risk score. This investigation identified substantial differentials in risk of diabetes in Veterans, based on a readily-derived risk score suitable for risk stratification for type 2 diabetes prevention.

Impact of diabetes on heart failure incidence in adults with ischemic heart disease.

BACKGROUND: Ischemic heart disease (IHD) is the most potent risk factor for heart failure (HF). Our study aims to evaluate the incremental impact of diabetes on the incidence of HF in individuals with IHD. METHODS: Data from the NHANES Epidemiologic Follow-Up Study (Baseline: 1971 to 1974) were linked to the facility and mortality files up to 1992. Our analyses were restricted to patients with IHD without prevalent HF at baseline. The cumulative incidence of HF in patients with diabetes and IHD versus those with IHD alone was assessed using failure curves. Cox proportional hazards models were used to control for important covariates. All analyses incorporated the complex sample design by including the weights and clustering variables. RESULTS: Out of the 14,407 participants, 497 had IHD without prevalent HF and had information about diabetes status. Among these participants, the cumulative incidence of HF was 38.1% for those with diabetes (n=63) and 26.5% in those without diabetes (n=434) (log-rank p-value<0.005). The multivariate hazard ratio (adjusted for age, BMI, alcohol consumption, hypertension, high cholesterol, and smoking) for incident HF for people who had myocardial infarction (MI) and diabetes compared to people who had MI alone was 2.98 (95% CI 1.51, 5.88). CONCLUSION: Among participants with MI, those with diabetes had a substantially higher incidence of HF than those without diabetes. Based on these findings, practitioners should focus greater attention on patients with diabetes and previous MI in order to potentially prevent incident HF.

Prognostic Utility of the Braden Scale and the Morse Fall Scale in Hospitalized Patients With Heart Failure.

Geriatric syndromes are common in hospitalized elders with heart failure (HF), but association with clinical outcomes is not well characterized. The purpose of this study ( N = 289) was to assess presence of geriatric syndromes using Joint Commission-mandated measures, the Braden Scale (BS) and Morse Fall Scale (MFS), and to explore prognostic utility in hospitalized HF patients. Data extracted from the electronic medical record included sociodemographics, medications, clinical data, comorbid conditions, and the BS and MFS. The primary outcome of mortality was assessed using Social Security Death Master File. Statistical analysis included Cox proportional hazards models to assess association between BS and MFS scores and all-cause mortality with adjustment for known clinical prognostic factors. Higher risk BS and MFS scores were common in hospitalized HF patients, but were not independent predictors of survival. Further study of the clinical utility of these scores and other measures of geriatric syndromes in HF is warranted.

The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial.

BACKGROUND: Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. OBJECTIVE: The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. METHODS: This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. RESULTS: A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. CONCLUSIONS: MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. TRIAL REGISTRATION: Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

BACKGROUND: Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. OBJECTIVE: The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. METHODS: This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. RESULTS: Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. CONCLUSIONS: This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. TRIAL REGISTRATION: Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO).