ABDA Score: A Non-invasive Model to Identify Subjects with Fibrotic Non-alcoholic Steatohepatitis in the Community.

Background: Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NASH) are prevalent in the community, especially among those with metabolic syndrome. Patients with fibrotic NASH are at increased risk of liver-related-events. Currently available non-invasive tests have not been utilized for screening for fibrotic NASH among the community. We aimed to develop a screening tool for fibrotic NASH among community members. Methods: We included two large cohorts aimed at assessing cardiovascular disease among community members. Fibrotic NASH was defined using the FibroScan-aspartate aminotransferase score of ≥0.67 that identifies ≥F2 fibrosis and a non-alcoholic fatty liver disease activity score ≥4 with a specificity of 90%. Metabolic parameters, biochemical tests and anthropometry were used to develop a multivariate model. Results: The derivation cohort (n = 1660) included a population with a median age 45 years, 42.5% males, metabolic syndrome in 66% and 2.7% (n = 45) with fibrotic NASH. Multivariate analysis identified the four significant variables (Age, body mass index , Diabetes and alanine aminotransferas levels) used to derive an ABDA score. The score had high diagnostic accuracy (the area under receiver-operating characteristic curve, 0.952) with adequate internal validity. An ABDA score ≥-3.52 identified fibrotic NASH in the derivation cohort with a sensitivity and specificity of 88.9% and 88.3%. The score was validated in a second cohort (n = 357) that included 21 patients (5.9%) with fibrotic NASH, where it demonstrated a high area under receiver-operating characteristic curve (0.948), sensitivity (81%) and specificity (89.3%). Conclusions: ABDA score utilizes four easily available parameters to identify fibrotic NASH with high accuracy in the community.

A multi-center pediatric to adult care transition intervention program to improve clinic visit adherence and clinical outcomes among adolescents and emerging adults with type 1 diabetes mellitus [PATHWAY]: Protocol for a randomized controlled trial.

OBJECTIVE: This multi-center randomized controlled trial aims to evaluate the effectiveness of a context-specific transition intervention program to improve clinic visit adherence and clinical outcomes among emerging adults with type 1 diabetes mellitus (T1DM) in Delhi, India. METHODS: We will recruit patients with T1DM of duration ≥1 year and age 15-19.5 years from the participating pediatric sites. After a baseline assessment and a "basic introductory session", which apprises participants about the concept of transition, study participants (proposed sample size =156) will be randomly allocated into an intervention and control arm. Participants in the intervention arm will receive a structured transition program delivered over 15 months. On the other hand, control arm participants will continue to receive usual care from the pediatric site till the time of transfer to the adult site. The study assessments will be done at baseline, at the time of transfer, and at 1 and 2 years following the transfer. The primary outcome is the difference in clinic attendance rate between intervention and control arms at the end of 1 year post-transfer. The secondary outcomes include the difference in clinic attendance rate at the end of 2 years, the difference in proportion of participants with a minimum of 4 visits in the first follow-up year, and process indicators such as diabetes knowledge and self-management skills, diabetes treatment satisfaction, overall quality of life, diabetes-related distress, hospitalization for acute complications and screening for chronic diabetes complications, and HbA1c. CONCLUSION: This study will provide important new evidence about a potential strategy to improve clinical care among adolescents and emerging adults with T1DM in lower resource contexts during the vulnerable phase of transition from pediatric to adult healthcare. The trial is registered on the Clinical Trials Registry of India (http://ctri.nic.in) under the CTRI registration number CTRI/2020/10/028379.

Rural-Urban differentials in prevalence, spectrum and determinants of Non-alcoholic Fatty Liver Disease in North Indian population.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disease ranging from simple steatosis, non-alcoholic steatohepatitis (NASH), through to advanced fibrosis and cirrhosis. We assessed the prevalence, spectrum, and determinants of NAFLD among adults in urban and rural North India. METHODS: A representative sample of adults aged 30-60 years were recruited from urban Delhi and rural Ballabhgarh during 2017-2019. Participants underwent abdominal ultrasonography (USG) and vibration controlled transient elastography (VCTE) with FibroScan to assess fatty liver and fibrosis, respectively. We estimated the age- and sex-standardised prevalence of NAFLD and its spectrum. The factors associated with 'ultrasound-diagnosed NAFLD' were identified using multivariate logistic regression. RESULTS: A total of 828 urban (mean ± SD age: 45.5 ± 8.0 years; women: 52.7%) and 832 rural (mean ± SD age: 45.1 ± 7.9 years; women: 62.4%) participants were recruited. The age- and sex-standardized prevalence of ultrasound-diagnosed NAFLD was 65.7% (95%CI: 60.3-71.2) in the urban and 61.1% (55.8-66.5) in the rural areas, respectively. The prevalence of NAFLD with elevated alanine transaminase (≥40IU/L) was 23.2% (19.8-26.6), and 22.5% (19.0-26.0) and any fibrosis by liver stiffness measurement on transient elastography (≥6.9 kPa) was 16.5% (13.8-19.8) and 5.2% (3.8-6.7) in urban and rural participants, respectively. In both urban and rural areas, diabetes, central obesity and insulin resistance were significantly associated with NAFLD. CONCLUSION: NAFLD prevalence was high among rural and urban North Indian adults, including fibrosis or raised hepatic enzymes. The strong association of metabolic determinants confirms its linkage with metabolic syndrome.

Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care.

INTRODUCTION: Type 1 diabetes (T1D) is increasing in young people worldwide and more children in resource limited settings are living into adulthood. There is a need for rigorous testing and reporting of evidence-based and stakeholder-informed strategies that transition individuals with T1D from pediatric to adult care. We present the development of and design of the first structured transition program in Delhi, India, to inform similar efforts in India and resource limited settings. METHODS: The intervention development team included clinicians and researchers with expertise in T1D and the implementation context. To select intervention outcomes, establish intervention targets, and design session modules, we drew upon formative research conducted at prospective intervention implementation sites, consensus guidelines, and previous care transition and behavior change research conducted in developed settings. We used the Template for Intervention Description and Replication and GUIDance for the rEporting of intervention Development checklists to report the intervention and development process. RESULTS: The 15-month program ("PATHWAY") includes five quarterly ~30 minute sessions delivered predominantly by diabetes educators at pediatric and adult clinics, which coincide with routine care visits. Primary program components include educational and behavioral sessions that address psychosocial drivers of clinic attendance and self-management, diabetes educators as transition coordinators and counselors, and a one-year "overlap period" of alternating visits between pediatric and adult providers. CONCLUSIONS: We followed a systematic and transparent process to develop PATHWAY, which facilitated rich description of intervention context, guiding principles, targets, and components. Dependence on previously published program examples to design PATHWAY may have introduced challenges for program feasibility and effectiveness, underscoring the importance of input gathering from prospective intervention actors at multiple points in the development process. This detailed report in combination with future evaluations of PATHWAY support efforts to increase rigorous development and testing of strategies to improve outcomes among emerging adults with T1D.