Faculty Bibliography

BACKGROUND/AIMS/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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.

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.

OBJECTIVE:To evaluate the association of the built environment and neighborhood resources with exercise, diet, and body mass index (BMI). METHOD/METHODS: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:= .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).

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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.

DESCRIPTION/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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.

INTRODUCTION/BACKGROUND: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:]) 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/CONCLUSIONS: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.

BACKGROUND:Heart failure is a heavy burden to the health care system in the United States. Once heart failure develops, the quality of life and longevity are dramatically affected. It is critical to prevent it. We evaluated the predictive ability of readily available clinical information to identify those likely to develop heart failure. METHODS:We used a 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.

Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite antihypertensive drug treatment for >/=6 months. The interventions were a tailored stage-matched intervention (SMI) or a nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was 64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]). At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.

OBJECTIVE:The authors sought to identify predictors of and trends in the incidence of above (AKA) and below (BKA) knee amputations in a nationwide sample. BACKGROUND:Recently available major lower extremity amputation incidence estimates are drawn from earlier data and may benefit from an update. There is a potential for significant reductions given an increasing emphasis on structured amputation prevention programs and widespread adoption of sophisticated revascularization techniques. METHODS:Inpatient admissions with a diagnosis of atherosclerosis and/or related amputation were identified from the National Inpatient Sample. The primary outcome was the trend in BKA and AKA incidence. Multilevel logistic regression, stratified by landmark periods, was used to identify amputation predictors over time by comparing amputees to patients admitted with a diagnosis of atherosclerosis who did not undergo amputation. Population attributable fractions were used to estimate the proportion of each outcome due to a specific risk factor. RESULTS:Between January 1993 and December 2021, we identified 197,018 patients who underwent BKA and 151,018 who underwent AKA. BKA incidence decreased from 12/100,000 people in 1993 to 8/100,000 in 2010 (2.2% reduction per year). This trend reversed after 2010, ending in 13/100,000 in 2021 (9% increase per year; P <0.001). AKA incidence decreased from 11/100,000 people in 1993 to 6/100,000 in 2012 (2.1% reduction per year). This trend reversed in 2012, ending in 8/100,000 in 2021 (4% increase per year; P <0.001). The mean age for BKA decreased from 68 years in 1993 to 61.6 years in 2021, and for AKA, from 75 years to 66.7 years ( P <0.001 for both). We compared admissions for major amputation to 2,421,352 admissions for atherosclerosis without amputation. After 2010, BKA patients were more likely to be younger [odds ratio (OR)=1.0 vs. 0.97], White (OR=0.73 vs. 1.02), obese (OR=0.91 vs. 1.24), and hypertensive (OR=0.97 vs. 1.07; ORs presented for pre-2010 and post-2010 periods, respectively). After 2012, AKA patients were younger (OR=1.04 vs. 0.99), less likely to be female (OR=1.04 vs. 0.75), and showed shifts in effect size but not direction of important risk factors such as White race (OR=0.61 vs. 0.9), hypertension (OR=0.79 vs. 0.92), and obesity (OR=0.73 vs. 0.91). The population attributable fractions confirmed a progressive shift in the effect of risk factors on the changing incidence of both BKA and AKA. The effect of other risk factors such as diabetes (OR=4.3 and 1.6 for BKA and AKA, respectively) and dialysis (OR=2.4 and 2.1 for BKA and AKA, respectively) remained unchanged over time. CONCLUSION/CONCLUSIONS:Major amputation incidence has steadily increased since 2010, accompanied by a substantial shift in the associated comorbidity and demographic profile. This shift is particularly striking among patients with BKA who, after 2010, are more likely to be younger, White, obese, and hypertensive. Treatment paradigms to address this serious public health issue will need to be reconsidered to reflect increasing attribution to metabolic syndrome.