Browsing by Author "Saha, Chandan K."
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Item Burden of Fatty Liver and Hepatic Fibrosis in Persons with HIV: A Diverse Cross-sectional US Multicenter Study(Wolters Kluwer, 2023) Gawrieh, Samer; Lake, Jordan E.; Debroy, Paula; Sjoquist, Julia A.; Robison, Montreca; Tann, Mark; Akisik, Fatih; Bhamidipalli, Surya S.; Saha, Chandan K.; Zachary, Kimon; Robbins, Gregory K.; Gupta, Samir K.; Chung, Raymond T.; Chalasani, Naga; Corey, Kathleen E.; Radiology and Imaging Sciences, School of MedicineBackground aims: The current prevalence of fatty liver disease (FLD) due to alcohol-associated (AFLD) and nonalcoholic (NAFLD) origins in US persons with HIV (PWH) is not well defined. We prospectively evaluated the burden of FLD and hepatic fibrosis in a diverse cohort of PWH. Approach results: Consenting participants in outpatient HIV clinics in 3 centers in the US underwent detailed phenotyping, including liver ultrasound and vibration-controlled transient elastography for controlled attenuation parameter and liver stiffness measurement. The prevalence of AFLD, NAFLD, and clinically significant and advanced fibrosis was determined. Univariate and multivariate logistic regression models were used to evaluate factors associated with the risk of NAFLD. Of 342 participants, 95.6% were on antiretroviral therapy, 93.9% had adequate viral suppression, 48.7% (95% CI 43%-54%) had steatosis by ultrasound, and 50.6% (95% CI 45%-56%) had steatosis by controlled attenuation parameter ≥263 dB/m. NAFLD accounted for 90% of FLD. In multivariable analysis, old age, higher body mass index, diabetes, and higher alanine aminotransferase, but not antiretroviral therapy or CD4 + cell count, were independently associated with increased NAFLD risk. In all PWH with fatty liver, the frequency of liver stiffness measurement 8-12 kPa was 13.9% (95% CI 9%-20%) and ≥12 kPa 6.4% (95% CI 3%-11%), with a similar frequency of these liver stiffness measurement cutoffs in NAFLD. Conclusions: Nearly half of the virally-suppressed PWH have FLD, 90% of which is due to NAFLD. A fifth of the PWH with FLD has clinically significant fibrosis, and 6% have advanced fibrosis. These data lend support to systematic screening for high-risk NAFLD in PWH.Item Comparison of Commercial and Self-Initiated Weight Loss Programs in People With Prediabetes: A Randomized Control Trial(American Public Health Association, 2016-05) Marrero, David G.; Palmer, Kelly N. B.; Phillips, Erin O.; Miller-Kovach, Karen; Foster, Gary D.; Saha, Chandan K.; Medicine, School of MedicineTo determine if a widely available weight-management program (Weight Watchers) could achieve sufficient weight loss in persons with prediabetes compared with a Diabetes Prevention Program-based individual counseling program supported by National Diabetes Education Program materials. METHODS: We conducted an individual, randomized intervention trial in Indianapolis, Indiana, in 2013 to 2014, in 225 persons with prediabetes. We compared the Weight Watchers weight-management program (n = 112) with Your Game Plan to Prevent Type 2 Diabetes, a program developed by the National Diabetes Education Program. Outcomes were weight and metabolic markers measured at baseline, 6 months, and 12 months. RESULTS: Intervention participants lost significantly more weight than controls at 6 months (5.5% vs 0.8%) and 12 months (5.5% vs 0.2%; both P < .001). The intervention group also had significantly greater improvements in hemoglobin A1c and high-density lipoprotein cholesterol level than did controls. CONCLUSIONS: A large weight-management program is effective for achieving lifestyle changes associated with diabetes prevention. Such programs could significantly increase the availability of diabetes prevention programs worldwide making an immediate and significant public health impact.Item Computer decision support changes physician practice but not knowledge regarding autism spectrum disorders(Schattauer, 2015) Bauer, Nerissa S.; Carroll, Aaron E.; Saha, Chandan K.; Downs, Stephen M.; Department of Pediatrics, Indiana University School of MedicineObjective: To examine whether adding an autism module promoting adherence to clinical guidelines to an existing computer decision support system (CDSS) changed physician knowledge and self-reported clinical practice. Methods: The CHICA (Child Health Improvement through Computer Automation) system, a CDSS, was enhanced with a module to improve management of autism in 2 of the 4 community pediatric clinics using the system. We examined the knowledge and beliefs of pediatric users using cross-sectional surveys administered at 3 time points (baseline, 12 months and 24 months post-implementation) between November 2010 and January 2013. Surveys measured knowledge, beliefs and self-reported practice patterns related to autism. Results: A total of 45, 39, and 42 pediatricians responded at each time point, respectively, a 95-100% response rate. Respondents’ knowledge of autism and perception of role for diagnosis did not vary between control and intervention groups either at baseline or any of the two post-intervention time points. At baseline, there was no difference between these groups in rates in the routine use of parent-rated screening instruments for autism. However, by 12 and 24 months post-implementation there was a significant difference between intervention and control clinics in terms of the intervention clinics consistently screening eligible patients with a validated autism tool. Physicians at all clinics reported ongoing challenges to community resources for further work-up and treatment related to autism. Conclusions: A CDSS module to improve primary care management of ASD in pediatric practice led to significant improvements in physician-reported use of validated screening tools to screen for ASDs. However it did not lead to corresponding changes in physician knowledge or attitudes.Item Effectiveness of Computer Automation for the Diagnosis and Management of Childhood Type 2 Diabetes A Randomized Clinical Trial(AMA, 2017-04) Hannon, Tamara S.; Dugan, Tamar M.; Saha, Chandan K.; McKee, Steven J.; Downs, Stephen M.; Carroll, Aaron E.; Pediatrics, School of MedicineImportance Type 2 diabetes (T2D) is increasingly common in young individuals. Primary prevention and screening among children and adolescents who are at substantial risk for T2D are recommended, but implementation of T2D screening practices in the pediatric primary care setting is uncommon. Objective To determine the feasibility and effectiveness of a computerized clinical decision support system to identify pediatric patients at high risk for T2D and to coordinate screening for and diagnosis of prediabetes and T2D. Design, Setting, and Participants This cluster-randomized clinical trial included patients from 4 primary care pediatric clinics. Two clinics were randomized to the computerized clinical decision support intervention, aimed at physicians, and 2 were randomized to the control condition. Patients of interest included children, adolescents, and young adults 10 years or older. Data were collected from January 1, 2013, through December 1, 2016. Interventions Comparison of physician screening and follow-up practices after adding a T2D module to an existing computer decision support system. Main Outcomes and Measures Electronic medical record (EMR) data from patients 10 years or older were reviewed to determine the rates at which pediatric patients were identified as having a body mass index (BMI) at or above the 85th percentile and 2 or more risk factors for T2D and underwent screening for T2D. Results Medical records were reviewed for 1369 eligible children (712 boys [52.0%] and 657 girls [48.0%]; median [interquartile range] age, 12.9 [11.2-15.3]), of whom 684 were randomized to the control group and 685 to the intervention group. Of these, 663 (48.4%) had a BMI at or above the 85th percentile. Five hundred sixty-five patients (41.3%) met T2D screening criteria, with no difference between control and intervention sites. The T2D module led to a significant increase in the percentage of patients undergoing screening for T2D (89 of 283 [31.4%] vs 26 of 282 [9.2%]; adjusted odds ratio, 4.6; 95% CI, 1.5-14.7) and a greater proportion attending a scheduled follow-up appointment (45 of 153 [29.4%] vs 38 of 201 [18.9%]; adjusted odds ratio, 1.8; 95% CI, 1.5-2.2). Conclusions and Relevance Use of a computerized clinical decision support system to automate the identification and screening of pediatric patients at high risk for T2D can help overcome barriers to the screening process. The support system significantly increased screening among patients who met the American Diabetes Association criteria and adherence to follow-up appointments with primary care clinicians.Item Getting Under the Skin of Clinical Inertia in Insulin Initiation: The Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project(2012-01) Ratanawongsa, Neda; Crosson, Jesse C.; Schillinger, Dean; Karter, Andrew J.; Saha, Chandan K.; Marrero, David G.Purpose The purpose of this cross-sectional study is to explore primary care providers’ (PCPs) perceptions about barriers to initiating insulin among patients. Studies suggest that many patients with poorly controlled type 2 diabetes do not receive insulin initiation by PCPs. Methods As part of the Translating Research Into Action for Diabetes study, the authors conducted structured interviews in health systems in Indiana, New Jersey, and California, asking PCPs about the importance of insulin initiation and factors affecting this decision. The authors calculated proportions choosing each multiple-choice response option and listed the most frequently offered open-ended response categories. Results Among 83 PCPs, 45% were women; 60% were white; and they averaged 13.4 years in practice. Four-fifths of PCPs endorsed guideline-concordant glycemic targets, but 54% individualized targets based on patient age, life expectancy, medical comorbidities, self-management capacity, and willingness. Most (64%) reported that many patients were resistant to new oral or insulin therapies due to fears about the therapy and what it meant about their disease progression. Two-thirds (64%) cited patient resistance as a barrier to insulin initiation, and 43% cited problems with patient self-management, including cognitive or mental health issues, dexterity, or ability to adhere. Eighty percent felt that patient nonadherence would dissuade them from initiating insulin at least some of the time. Conclusions PCPs perceived that patient resistance and poor self- management skills were significant barriers to initiating insulin. Future studies should investigate whether systems-level interventions to improve patient-provider communication about insulin and enhance providers’ perceptions of patient self-management capacity can increase guideline-concordant, patient-centered insulin initiation.Item Moderate-vigorous physical activity improves long-term clinical outcomes without worsening pain in fibromyalgia(Wiley, 2013) Kaleth, Anthony S.; Saha, Chandan K.; Jensen, Mark P.; Slaven, James E.; Ang, Dennis C.; Exercise & Kinesiology, School of Health and Human SciencesObjective: To evaluate the relationship between long-term maintenance of moderate to vigorous physical activity (MVPA) and clinical outcomes in fibromyalgia (FM). Methods: Patients with FM (n = 170) received individualized exercise prescriptions and completed baseline and followup physical activity assessments using the Community Health Activities Model Program for Seniors questionnaire at weeks 12, 24, and 36. The primary outcome was the change in the Fibromyalgia Impact Questionnaire-Physical Impairment (FIQ-PI) score. The secondary outcomes included improvements in overall well-being (FIQ total score), pain severity ratings, and depression. Results: Using a threshold increase in MVPA of ≥10 metabolic equivalent hours/week above usual activities, 27 subjects (15.9%) increased and sustained (SUS-PA), 68 (40%) increased but then declined (UNSUS-PA), and 75 (44.1%) did not achieve (LO-PA) this benchmark. Compared to LO-PA subjects, both SUS-PA and UNSUS-PA subjects reported greater improvement in FIQ-PI (P < 0.01) and FIQ total score (P < 0.05). Additionally, the SUS-PA group reported greater improvement in pain severity compared to the LO-PA group (P < 0.05). However, there were no significant group differences between SUS-PA and UNSUS-PA for any primary or secondary outcome measure. Conclusion: Increased participation in MVPA for at least 12 weeks improved physical function and overall well-being in patients with FM. Although sustained physical activity was not associated with greater clinical benefit compared with unsustained physical activity, these findings also suggest that performing greater volumes of physical activity is not associated with worsening pain in FM. Future research is needed to determine the relationship between sustained MVPA participation and subsequent improvement in patient outcomes.Item Non-alcoholic fatty liver disease is not associated with impairment in health-related quality of life in virally suppressed persons with human immune deficiency virus(Public Library of Science, 2023-02-10) Gawrieh, Samer; Corey, Kathleen E.; Lake, Jordan E.; Samala, Niharika; Desai, Archita P.; Debroy, Paula; Sjoquist, Julia A.; Robison, Montreca; Tann, Mark; Akisik, Fatih; Bhamidipalli, Surya S.; Saha, Chandan K.; Zachary, Kimon; Robbins, Gregory K.; Gupta, Samir K.; Chung, Raymond T.; Chalasani, Naga; Medicine, School of MedicineNon-alcoholic fatty liver disease (NAFLD) is the most common liver disease in persons with HIV (PWH) (HIV-NAFLD). It is unknown if HIV-NAFLD is associated with impairment in health-related quality of life (HRQOL). We examined HRQOL in PWH with and without NAFLD, compared HRQOL in HIV- versus primary NAFLD, and determined factors associated with HRQOL in these groups. Prospectively enrolled 200 PWH and 474 participants with primary NAFLD completed the Rand SF-36 assessment which measures 8 domains of HRQOL. Individual domain scores were used to create composite physical and mental component summary scores. Univariate and multivariate analyses determined variables associated with HRQOL in PWH and in HIV- and primary NAFLD. In PWH, 48% had HIV-NAFLD, 10.2% had clinically significant fibrosis, 99.5% were on antiretroviral therapy, and 96.5% had HIV RNA <200 copies/ml. There was no difference in HRQOL in PWH with or without NAFLD. Diabetes, non-Hispanic ethnicity, and nadir CD4 counts were independently associated with impaired HRQOL in PWH. In HIV-NAFLD, HRQOL did not differ between participants with or without clinically significant fibrosis. Participants with HIV-NAFLD compared to those with primary NAFLD were less frequently cisgender females, White, more frequently Hispanic, had lower BMI and lower frequency of obesity and diabetes. HRQOL of individuals with HIV-NAFLD was not significantly different from those with primary NAFLD. In conclusion, in virally suppressed PWH, HRQOL is not different between participants with or without HIV-NAFLD. HRQOL is not different between HIV-NAFLD and primary NAFLD.Item Pentoxifylline, Inflammation, and Endothelial Function in HIV-Infected Persons: A Randomized, Placebo-Controlled Trial(Public Library of Science, 2013-04-09) Gupta, Samir K.; Mi, Deming; Dubé, Michael P.; Saha, Chandan K.; Johnson, Raymond M.; Stein, James H.; Clauss, Matthias A.; Mather, Kieren J.; Desta, Zeruesenay; Liu, Ziyue; Medicine, School of MedicineBackground: Untreated HIV may increase the risk of cardiovascular events. Our preliminary in vitro and in vivo research suggests that pentoxifylline (PTX) reduces vascular inflammation and improves endothelial function in HIV-infected persons not requiring antiretroviral therapy. Methods: We performed a randomized, placebo-controlled trial of PTX 400 mg orally thrice daily for 8 weeks in 26 participants. The primary endpoint was change in flow-mediated dilation (FMD) of the brachial artery after 8 weeks. Nitroglycerin-mediated dilation (NTGMD) and circulating markers of inflammation, cellular immune activation, coagulation, and metabolism were also assessed. Results: The difference in mean absolute change (SD) in FMD after 8 weeks between the placebo [-1.06 (1.45)%] and PTX [-1.93 (3.03)%] groups was not significant (P = 0.44). No differences in NTGMD were observed. The only significant between-group difference in the changes in biomarkers from baseline to week 8 was in soluble tumor necrosis factor receptor-1 (sTNFRI) [-83.2 pg/mL in the placebo group vs. +65.9 pg/mL in the PTX group; P = 0.03]. PTX was generally well-tolerated. Conclusions: PTX did not improve endothelial function and unexpectedly increased the inflammatory biomarker sTNFRI in HIV-infected participants not requiring antiretroviral therapy. Additional interventional research is needed to reduce inflammation and cardiovascular risk in this population.Item Program ACTIVE II: 6- and 12-Month Outcomes of a Treatment Approach for Major Depressive Disorder in Adults with Type 2 Diabetes(Elsevier, 2024) Saha, Chandan K.; Shubrook, Jay H.; Hornsby, Guy; Yang, Ziyi; Pillay, Yegan; Mather, Kieren J.; de Groot, Mary; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthAims: To evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D). Methods: Program ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT + EXER) and usual care (UC) for adults with MDD and T2D. Results: Primary outcomes: change in A1c and depressive symptoms at 6- (N = 87) and 12-months (N = 75) from baseline. In those with a baseline A1c ≥7.0 %, CBT + EXER showed lasting A1c benefit at 6- (-1.2 %; SE: 0.6; p = 0.032) and 12-months (-1.4 %; SE: 0.6; p = 0.025) compared to UC. All groups had clinically significant improvements in depressive symptoms. At 6 months, CBT + EXER had significant improvements in diabetes-related distress regimen burden (p = 0.005); and social support (CIRS, p = 0.043) compared to UC. Conclusions: The Program ACTIVE II CBT + EXER intervention demonstrated a sustained improvement in A1c for a subgroup of study participants with a baseline A1c ≥7.0 %. However, this finding should be considered preliminary because of small sample size. All 3 behavioral intervention groups demonstrated improvements in psychosocial outcomes one-year post-intervention. These findings point to the enduring benefits of community-based interventions to extend the availability of depression treatment for T2D patients.Item The Association between Sleep and Depression during Late Pregnancy and the Early Postpartum Period(Thieme, 2024-01-23) Jones, Angela G.; Hadaie, Bachar S.; Bennett, Rachel; Kumar, Nimisha; Saha, Chandan K.; Haas, David M.; Obstetrics and Gynecology, School of MedicineObjective: To assess and correlate sleep quality and depressed mood symptoms in the late pregnancy and early postpartum periods. Study Design: In a prospective pilot observational study, participants completed the Pittsburgh Sleep Quality Index (PSQI) and the Edinburgh Postnatal Depression Scale (EPDS) questionnaires at delivery, 1, and 2 months postpartum. Pearson's correlation coefficients and PROC MIXED function estimated overall correlation for repeated measures. Results: Twenty-six women were enrolled with a mean gestational age at delivery of 38.4 (± 2.4) weeks. Sleep quality and mood data were available at the three time points for 24, 16, and 11 participants, respectively. Poor sleep scores were noted by 75.0, 87.5, and 72.7% of women at the three time points. An elevated EPDS score of 10 or higher was claimed by 20.8, 12.5, and 18.2% of women, respectively. Higher PSQI scores were positively associated with higher EPDS scores overall ( r = 0.71, p < 0.001) and at each of the individual time points ( r = 0.79, p < 0.0001; r = 0.52, p = 0.04; and r = 0.70, p = 0.016, respectively). None of the women reporting good sleep quality had elevated EPDS scores. Conclusion: Poor sleep is commonly reported around delivery, and at 1 and 2 months postpartum, and there is an association between poor sleep and depression symptoms.