Effect of a multicomponent quality improvement strategy on sustained achievement of diabetes care goals and macrovascular and microvascular complications in South Asia at 6.5 years follow-up: Post hoc analyses of the CARRS randomized clinical trial.

BACKGROUND: Diabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial. METHODS AND FINDINGS: This parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dL) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus BP <130/80 mm Hg and/or LDL-cholesterol <100 mg/dL) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were co-primary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.77; 95% confidence interval [CI], 1.45, 2.16), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: -13.2, -1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention. CONCLUSIONS: In urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01212328.

Poor Medication Access as a Driver of Excess Heart-Failure Readmissions Among Patients Living in Economically Deprived Neighborhoods.

BACKGROUND: Patients residing in socioeconomically deprived neighborhoods experience higher hospital readmission rates after hospitalization for heart failure (HF). The role of medication access in the excessive readmissions in this group is poorly understood. This study explored patients' perspectives on medication access by individuals living in socioeconomically deprived neighborhoods who had experienced HF readmission. METHODS: We conducted semistructured in-depth interviews with 25 patients (mean age 61 ± 9 years, 96% Black, 40% women) who were readmitted with acute HF at Emory Healthcare hospitals and were living in highly deprived neighborhoods (top decile of the Social Deprivation Index). Qualitative descriptive analyses of the interviews were performed by using a multilevel coding strategy. RESULTS: Most patients (84%) highlighted medications as a driver of HF readmission. Patients' reported reasons for lack of medication access included medication costs (60%), having access to refills only through an emergency department or hospitalization (36%), limited access to transportation (12%), and limited understanding of medications' role in disease management (12%). CONCLUSION: Lack of access to medications for patients with HF who live in socioeconomically distressed neighborhoods exacerbate excess hospitalizations in this vulnerable population. This study focuses on patients' perspectives and experiences and identifies some potentially high-value areas to focus on in trying to enhance access and adherence to evidence-based therapies.

Association of Psychosocial Risk Factors With Quality of Life and Readmissions 1 Year After LVAD Implantation.

BACKGROUND: Among patients with advanced heart failure (HF), treatment with a left ventricular assist device (LVAD) improves health-related quality of life (HRQOL). We investigated the association between psychosocial risk factors, HRQOL and outcomes after LVAD implantation. METHODS: A retrospective cohort (n = 9832) of adults aged ≥ 19 years who received durable LVADs between 2008 and 2017 was identified by using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Patients were considered to have psychosocial risk factors if ≥ 1 of the following were present: (1) substance abuse; (2) limited social support; (3) limited cognitive understanding; (4) repeated nonadherence; and (5) major psychiatric disease. Multivariable logistic and linear regression models were used to evaluate the association between psychosocial risk factors and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores from baseline to 1 year, persistently poor HRQOL (KCCQ-12 score < 45 at baseline and 1 year), and 1-year rehospitalization. RESULTS: Among the final analytic cohort, 2024 (20.6%) patients had ≥ 1 psychosocial risk factors. Psychosocial risk factors were associated with a smaller improvement in KCCQ-12 scores from baseline to 1 year (mean ± SD, 29.1 ± 25.9 vs 32.6 ± 26.1; P = 0.015) for a difference of -3.51 (95% confidence interval [CI]: -5.88 to -1.13). Psychosocial risk factors were associated with persistently poor HRQOL (adjusted odds ratio [aOR] 1.35, 95% confidence interval [CI] 1.04-1.74), and 1-year all-cause readmission (adjusted hazard ratio [aHR] 1.11, 95% CI 1.05-1.18). Limited social support, major psychiatric disorder and repeated nonadherence were associated with persistently poor HRQOL, while major psychiatric disorder was associated with 1-year rehospitalization. CONCLUSION: The presence of psychosocial risk factors is associated with lower KCCQ-12 scores and higher risk for readmission at 1 year after LVAD implantation. These associations are statistically significant, but further research is needed to determine whether these differences are clinically meaningful.

COVID-19 pandemic-related healthcare interruptions and diabetes distress: a national study of US adults with diabetes.

BACKGROUND: Early COVID-19 pandemic research found changes in health care and diabetes management, as well as increased diabetes distress. This study aims to determine the association between COVID-19 pandemic-related healthcare interruptions and diabetes distress among adults with Type 1 and Type 2 diabetes in the US in 2021. METHODS: Multinomial logistic regression was used to analyze moderate and high levels of diabetes distress (reference = no diabetes distress) in 228 individuals with Type 1 diabetes and 2534 individuals with Type 2 diabetes interviewed in the National Health Interview Survey in 2021. RESULTS: Among adults with Type 1 diabetes, 41.2% experienced moderate diabetes distress and 19.1% experienced high diabetes distress, and among adults with Type 2 diabetes, 40.8% experienced moderate diabetes distress and 10.0% experienced high diabetes distress. In adults with Type 1 diabetes, experiencing delayed medical care was associated with an adjusted odds ratio (aOR) of 4.31 (95% CI: 1.91-9.72) for moderate diabetes distress and 3.69 (95% CI: 1.20-11.30) for high diabetes distress. In adults with Type 2 diabetes, experiencing delayed medical care was associated with an aOR of 1.61 (95% CI: 1.25-2.07) for moderate diabetes distress and 2.27 (95% CI: 1.48-3.49) for high diabetes distress. Similar associations were observed between not receiving medical care due to the pandemic and diabetes distress. CONCLUSION: Among people with diabetes, experiencing delayed medical care and not receiving care due to the pandemic were associated with higher reports of diabetes distress.

The US Coronavirus Disease 2019 (COVID-19) Surveillance Environment: An Ecological Analysis of the Relationship of Testing Adequacy in the Context of Vaccination.

BACKGROUND: Coronavirus disease 2019 (COVID-19) testing is a critical component of public health surveillance and pandemic control, especially among the unvaccinated, as the nation resumes in-person activities. This study examined the relationships between COVID-19 testing rates, testing positivity rates, and vaccination coverage across US counties. METHODS: Data from the Health and Human Services' Community Profile Report and 2016-2020 American Community Survey 5-Year Estimates were used. A total of 3114 US counties were analyzed from January through September 2021. Associations among the testing metrics and vaccination coverage were estimated using multiple linear regression models with fixed effects for states and adjusted for county demographics. COVID-19 testing rates (polymerase chain reaction [PCR] testing per 1000), testing positivity (percentage of all PCR tests that were positive), and vaccination coverage (percentage of county population that was fully vaccinated) were determined. RESULTS: Nationally, median daily COVID-19 testing rates were highest in January and September (35.5 and 34.6 tests per capita, respectively) and lowest in July (13.2 tests per capita). Monthly testing positivity was between 0.03 and 0.12 percentage points lower for each percentage points of vaccination coverage, and monthly testing rates were between 0.08 and 0.22 tests per capita higher for each percentage point of vaccination coverage. CONCLUSIONS: The quantity of COVID-19 testing was associated with vaccination coverage, implying counties having populations with relatively lower protection against the virus are conducting less testing than counties with relatively more protection. Monitoring testing practices in relation to vaccination coverage may be used to monitor the sufficiency of COVID-19 testing based on population susceptibility to the virus.

Racial differences in low natriuretic peptide levels: Implications for heart failure clinical trials.

BACKGROUND: Some patients with heart failure (HF) have low natriuretic peptide (NP) levels. It is unclear whether specific populations are disproportionately excluded from participation in randomized clinical trials (RCT) with inclusion requirements for elevated NPs. We investigated factors associated with unexpectedly low NP levels in a cohort of patients hospitalized with HF, and the implications on racial diversity in a prototype HF RCT. METHODS: We created a retrospective cohort of 31,704 patients (age 72 ± 16 years, 49% female, 52% Black) hospitalized with HF from 2010 to 2020 with B-type natriuretic peptide (BNP) measurements. Factors associated with unexpectedly low BNP levels (<50 pg/mL) were identified using multivariable logistic regression models. We simulated patient eligibility for a prototype HF trial using specific inclusion and exclusion criteria, and varying BNP cut-offs. RESULTS: Unexpectedly low BNP levels were observed in 8.9% of the cohort. Factors associated with unexpectedly low BNP levels included HFpEF (aOR 3.76, 95% CI: 3.36, 4.20), obesity (aOR 1.96, 95% CI: 1.73, 2.21), self-identification as Black (aOR 1.53, 95% CI: 1.36, 1.71), and male gender (aOR 1.45, 95% CI: 1.31, 1.60). Applying limited clinical inclusion and exclusion criteria from PARAGLIDE-HF disproportionately excluded Black patients, with impairment in renal function having the greatest impact. Adding thresholds for BNP of ≥35, ≥50, ≥67, ≥100, and ≥150 pg/mL demonstrated the risk of exclusion was higher for Black compared to non-Black patients (RR = 2.03 [95% CI: 1.73, 2.39], 1.90 [95% CI: 1.68, 2.15], 1.63 [95% CI: 1.48, 1.81], 1.38 [95% CI: 1.28, 1.50], and 1.23 [95% CI: 1.15, 1.31], respectively). CONCLUSIONS: Nearly 10% of patients hospitalized with HF have unexpectedly low BNP levels. Simulating inclusion into a prototype HFpEF RCT demonstrated that requiring increasingly elevated NP levels disproportionately excludes Black patients.

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention.

BACKGROUND: Collaborative care (CC) is a multicomponent team-based approach to providing mental health care with systematic integration into outpatient medical settings. The 12-month INDEPENDENT CC intervention improved joint disease control measures in patients with both depression and diabetes at 12 and 24 months following randomization. OBJECTIVE: This study investigated the durability of intervention effects on patient outcomes at 36 months following randomization. PARTICIPANTS: Adult patients with poorly controlled T2D and depression in India randomized to CC or usual care. DESIGN: Post hoc analyses of between-group differences in patient outcomes at 36 months post-randomization (N = 331) and maintenance of outcomes from 12 to 36 months (N = 314). MAIN MEASURES: We evaluated combined risk factor improvement since baseline, defined as ≥ 50.0% reduction in Symptom Checklist Depression Scale (SCL-20) scores along with reduction of at least 0.5 percentage point hemoglobin A1C, 5 mmHg systolic blood pressure, or 10 mg/dL low-density lipoprotein cholesterol. Improvements in single risk factors were also examined. KEY RESULTS: There were no between-group differences in improvements since baseline in multiple or single risk factors at 36 months. Patients in the CC group with improved outcomes at 12 months were more likely to maintain a ≥ 50.0% reduction since baseline in SCL-20 scores (CC [54.9%] vs. UC [40.9%]; RR: 1.27 [95% CI: 1.04, 1.56]) and 0.5 percentage point reduction since baseline in hemoglobin A1C (CC [31.9%] vs. UC [19.5%]; RR: 1.64 [95% CI: 1.11, 2.41]) at 36 months. CONCLUSIONS: While improvements since baseline in patient outcomes did not differ between the collaborative care and usual care groups at 36 months, patients who received CC were more likely to maintain improvements in depressive symptoms and glucose levels at 36 months if they had achieved these improvements at the end of active intervention. TRIAL REGISTRATION NUMBER: NCT02022111.

A retrospective review on the histopathological pattern of childhood malignant solid tumors in Ethiopia.

In low- and middle-income countries (LMICs), malignancies remain underreported due to lack of quality data. This study outlines the histopathological pattern of pediatric solid malignancies in children aged 0-15 years at the largest referral hospital in Ethiopia. A total of 432 solid malignancies were evaluated. The most common malignancies were lymphoma (21.8%), retinoblastoma (19.4%), and Wilms tumor (13.9%). Burkitt lymphoma accounted for 2.1%, despite being the most reported pediatric malignancy in sub-Saharan Africa in published literature. Definitive diagnosis could not be made in 7% of cases, related to the lack of confirmatory testing. The study highlights the need for improvement in diagnostic capabilities in LMICs.

Early life predictors of body composition trajectories from adolescence to mid-adulthood.

OBJECTIVES: Guatemala has experienced rapid increases in adult obesity. We characterized body composition trajectories from adolescence to mid-adulthood and determined the predictive role of parental characteristics, early life factors, and a nutrition intervention. METHODS: One thousand three hundred and sixty-four individuals who participated as children in a nutrition trial (1969-1977) were followed prospectively. Body composition characterized as body mass index (BMI), fat mass index (FMI), and fat-free mass indices (FFMI), was available at four ages between 10 and 55 years. We applied latent class growth analysis to derive sex-specific body composition trajectories. We estimated associations between parental (age, height, schooling) and self-characteristics (birth order, socioeconomic status, schooling, and exposure to a nutrition supplement) with body composition trajectories. RESULTS: In women, we identified two latent classes of FMI (low: 79.6%; high: 20.4%) and BMI (low: 73.0%; high: 27.0%), and three of FFMI (low: 20.2%; middle: 55.9%; high: 23.9%). In men, we identified two latent classes of FMI (low: 79.6%; high: 20.4%) and FFMI (low: 62.4%; high: 37.6%), and three of BMI (low: 43.1%; middle: 46.9%; high: 10.0%). Among women, self's schooling attainment inversely predicted FMI (OR [being in a high latent class]: 0.91, 95% CI: 0.85, 0.97), and maternal schooling positively predicted FFMI (OR: 1.16, 95% CI: 0.97, 1.39). Among men, maternal schooling, paternal age, and self's schooling attainment positively predicted FMI. Maternal schooling positively predicted FFMI, whereas maternal age and paternal schooling were inverse predictors. The nutrition intervention did not predict body composition class membership. CONCLUSIONS: Parents' age and schooling, and self's schooling attainment are small but significant predictors of adult body composition trajectories.

A population-based study of the trend in SARS-CoV-2 diagnostic modalities from the beginning of the pandemic to the Omicron surge in Kyoto City, Kyoto, Japan.

BACKGROUND: The coronavirus disease 2019 (COVID-19) presents critical diagnostic challenges for managing the pandemic. We investigated the 30-month changes in COVID-19 testing modalities and functional testing sites from the early period of the pandemic to the most recent Omicron surge in 2022 in Kyoto City, Japan. METHODS: This is a retrospective-observational study using a local anonymized population database that included patients' demographic and clinical information, testing methods and facilities from January 2020 to June 2022, a total of 30 months. We computed the distribution of symptomatic presentation, testing methods, and testing facilities among cases. Differences over time were tested using chi-square tests of independence. RESULTS: During the study period, 133,115 confirmed COVID-19 cases were reported, of which 90.9% were symptomatic. Although nucleic acid amplification testing occupied 68.9% of all testing, the ratio of lateral flow devices (LFDs) rapidly increased in 2022. As the pandemic continued, the testing capability was shifted from COVID-19 designated facilities to general practitioners, who became the leading testing providers (57.3% of 99,945 tests in 2022). CONCLUSIONS: There was a dynamic shift in testing modality during the first 30 months of the pandemic in Kyoto City. General practitioners increased their role substantially as the use of LFDs spread dramatically in 2022. By comprehending and documenting the evolution of testing methods and testing locations, it is anticipated that this will contribute to the establishment of an even more efficient testing infrastructure for the next pandemic.

Burden, patterns, and impact of multimorbidity in North India: findings from a rural population-based study.

AIM: To estimate the prevalence, socio-demographic determinants, common disease combinations, and health impact of multimorbidity among a young rural population. METHODS: We conducted a cross-sectional survey among participants aged ≥30 years in rural Punjab, North India, from Jan 2019 to April 2019. Multimorbidity was defined as the coexistence of ≥two conditions using a 14-condition tool validated in India. We also calculated a multimorbidity-weighted index (MWI), which provides a weight to each disease based on its impact on physical functioning. Logistic regression was conducted to evaluate the association with sociodemographic variables, mental health (PHQ-9), physical functioning (ADL scale), and self-rated health (SRH). RESULTS: We analyzed data from 3213 adults [Mean age 51.5 (±13), 54% women]. Prevalence of single chronic condition, multimorbidity, and MWI was 28.6, 18% and - 1.9 respectively. Age, higher wealth index and ever use alcohol were significantly associated with multimorbidity. Overall, 2.8% of respondents had limited physical functioning, 2.1% had depression, and 61.5% reported low SRH. Poorer health outcomes were more prevalent among the elderly, women, less educated, and those having lower wealth index and multimorbidity, were found to be significantly associated with poor health outcomes. CONCLUSIONS: The burden of multimorbidity was high in this young rural population, which portends significant adverse effects on their health and quality of life. The Indian health system should be reconfigured to address this emerging health priority holistically, by adopting a more integrated and sustainable model of care.

Improving care for hypertension and diabetes in india by addition of clinical decision support system and task shifting in the national NCD program: I-TREC model of care.

BACKGROUND: The growing burden of hypertension and diabetes is one of the major public health challenges being faced by the health system in India. Clinical Decision Support Systems (CDSS) that assist with tailoring evidence-based management approaches combined with task-shifting from more specialized to less specialized providers may together enhance the impact of a program. We sought to integrate a technology "CDSS" and a strategy "Task-shifting" within the Government of India's (GoI) Non-Communicable Diseases (NCD) System under the Comprehensive Primary Health Care (CPHC) initiative to enhance the program's impact to address the growing burden of hypertension and diabetes in India. METHODS: We developed a model of care "I-TREC" entirely calibrated for implementation within the current health system across all facility types (Primary Health Centre, Community Health Centre, and District Hospital) in a block in Shaheed Bhagat Singh (SBS) Nagar district of Punjab, India. We undertook an academic-community partnership to incorporate the combination of a CDSS with task-shifting into the GoI CPHC-NCD system, a platform that assists healthcare providers to record patient information for routine NCD care. Academic partners developed clinical algorithms, a revised clinic workflow, and provider training modules with iterative collaboration and consultation with government and technology partners to incorporate CDSS within the existing system. DISCUSSION: The CDSS-enabled GoI CPHC-NCD system provides evidence-based recommendations for hypertension and diabetes; threshold-based prompts to assure referral mechanism across health facilities; integrated patient database, and care coordination through workflow management and dashboard alerts. To enable efficient implementation, modifications were made in the patient workflow and the fulcrum of the use of technology shifted from physician to nurse. CONCLUSION: Designed to be applicable nationwide, the I-TREC model of care is being piloted in a block in the state of Punjab, India. Learnings from I-TREC will provide a roadmap to other public health experts to integrate and adapt their interventions at the national level. TRIAL REGISTRATION: CTRI/2020/01/022723.

Lifetime risk of diabetes in metropolitan cities in India.

AIMS/HYPOTHESIS: We aimed to estimate the lifetime risk of diabetes and diabetes-free life expectancy in metropolitan cities in India among the population aged 20 years or more, and their variation by sex, age and BMI. METHODS: A Markov simulation model was adopted to estimate age-, sex- and BMI-specific lifetime risk of developing diabetes and diabetes-free life expectancy. The main data inputs used were as follows: age-, sex- and BMI-specific incidence rates of diabetes in urban India taken from the Centre for Cardiometabolic Risk Reduction in South Asia (2010-2018); age-, sex- and urban-specific rates of mortality from period lifetables reported by the Government of India (2014); and prevalence of diabetes from the Indian Council for Medical Research INdia DIABetes study (2008-2015). RESULTS: Lifetime risk (95% CI) of diabetes in 20-year-old men and women was 55.5 (51.6, 59.7)% and 64.6 (60.0, 69.5)%, respectively. Women generally had a higher lifetime risk across the lifespan. Remaining lifetime risk (95% CI) declined with age to 37.7 (30.1, 46.7)% at age 60 years among women and 27.5 (23.1, 32.4)% in men. Lifetime risk (95% CI) was highest among obese Indians: 86.0 (76.6, 91.5)% among 20-year-old women and 86.9 (75.4, 93.8)% among men. We identified considerably higher diabetes-free life expectancy at lower levels of BMI. CONCLUSIONS/INTERPRETATION: Lifetime risk of diabetes in metropolitan cities in India is alarming across the spectrum of weight and rises dramatically with higher BMI. Prevention of diabetes among metropolitan Indians of all ages is an urgent national priority, particularly given the rapid increase in urban obesogenic environments across the country. Graphical abstract.

Effectiveness of Ustekinumab Dose Escalation in Patients With Crohn's Disease.

BACKGROUND & AIMS: A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses. METHODS: We performed a retrospective study to determine the effectiveness of ustekinumab dose interval shortening, collecting data from 506 patients with CD who received subcutaneous ustekinumab 90 mg every 8 weeks at a single center. We obtained data from 110 patients who initially received subcutaneous ustekinumab 90 mg every 8 weeks and then had their interval shortened to every 4 weeks. Harvey Bradshaw Index (HBI) scores before and after the dose interval shortening was available for 78 patients in the cohort (71%), levels of C-reactive protein (CRP) for 60 patients (55%), and levels of fecal calprotectin for 8 patients (7%). RESULTS: Following dose interval shortening, the patients' median HBI decreased from 4.5 to 3 (P = .002), the median level of CRP decreased from 8 mg/L to 3 mg/L (P = .031), and median level of fecal calprotectin decreased from 378 µg/g to 157 µg/g (P = .57). Among patients who had an HBI >4, a level of CRP ≥5mg/dL, a level of fecal calprotectin >250ug/g, or endoscopic evidence for disease activity before dose interval shortening, after the dose interval was shortened, 28% achieved clinical remission (an HBI score ≤4), 22% had a normal level of CRP (<5 mg/dL), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission. CONCLUSIONS: Shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe.

Linear Growth Trajectories in Early Childhood and Adult Cognitive and Socioemotional Functioning in a Guatemalan Cohort.

BACKGROUND: Growth faltering in early childhood is associated with poor human capital attainment, but associations of linear growth in childhood with executive and socioemotional functioning in adulthood are understudied. OBJECTIVES: In a Guatemalan cohort, we identified distinct trajectories of linear growth in early childhood, assessed their predictors, and examined associations between growth trajectories and neurodevelopmental outcomes in adulthood. We also assessed the mediating role of schooling on the association of growth trajectories with adult cognitive outcomes. METHODS: In 2017-2019, we prospectively followed 1499 Guatemalan adults who participated in a food supplementation trial in early childhood (1969-1977). We derived height-for-age sex-specific growth trajectories from birth to 84 mo using latent class growth analysis. RESULTS: We identified 3 growth trajectories (low, intermediate, high) with parallel slopes and intercepts already differentiated at birth in both sexes. Children of taller mothers were more likely to belong to the high and intermediate trajectories [relative risk ratio (RRR): 1.21; 95% CI: 1.15, 1.26, and RRR: 1.11; 95% CI: 1.07, 1.15, per 1-cm increase in height, respectively] compared with the low trajectory. Children in the wealthiest compared with the poorest socioeconomic tertile were more likely to belong to the high trajectory compared with the low trajectory (RRR: 2.24; 95% CI: 1.29, 3.88). In males, membership in the high compared with low trajectory was positively associated with nonverbal fluid intelligence, working memory, inhibitory control, and cognitive flexibility at ages 40-57 y. Sex-adjusted results showed that membership in the high compared with low trajectory was positively associated with meaning and purpose scores at ages 40-57 y. Associations of intermediate compared with low growth trajectories with study outcomes were also positive but of lesser magnitude. Schooling partially mediated the associations between high and intermediate growth trajectories and measures of cognitive ability in adulthood. CONCLUSIONS: Modifiable and nonmodifiable risk factors predicted growth throughout childhood. Membership in the high and intermediate growth trajectories was positively associated with adult cognitive and socioemotional functioning.

Temporal changes in diabetes prevalence and achievement of care goals in urban South Asia from 2010 to 2016 - The Center for Cardio-metabolic Risk Reduction in South Asia Study.

AIM: Achievement of treatment targets among individuals with diabetes remains suboptimal in many parts of the globe. We aimed to assess changes in diabetes prevalence and achievement of diabetes care goals in South Asia using two consecutive cross-sectional population-based surveys. METHODS: Two representative samples of South Asian adults were recruited using identical methods from Chennai, Delhi, and Karachi in 2010-11 (n = 16,288; response rate-94.7%) and 2015-16 (n = 14,587; response rate-94.0%) through the Center for Cardio-metabolic Risk Reduction in South Asia (CARRS) Study. Quality of care goals were defined as HbA1c <53 mmol/mol (7.0%), blood pressure (BP) control: <140/90 mmHg, lipid control: LDL cholesterol <2.56 mmol/l (100 mg/dl), and self-reported non-smoking. RESULTS: Weighted prevalence of self-reported diabetes increased by 9.0% [13% (95%CI: 13-14) to 15% (14-15)] while that of newly diagnosed diabetes decreased by 16% [6.1% (5.7-6.6) to 5.1% (4.6-5.6)]. There were improvements in achieving glycaemic (25% to 30%, p = 0.002) and lipid (34% to 45%, p < 0.001) goals, but no notable improvements in BP control or smoking status. The proportion of individuals with self-reported diabetes meeting more than one target also increased. CONCLUSIONS: Diabetes prevalence continues to grow among urban South Asians and large gaps still exist in the attainment of treatment targets. Concerted policy, systemic, clinical and individual efforts are needed to close these care gaps.

A model for national assessment of barriers for implementing digital technology interventions to improve hypertension management in the public health care system in India.

BACKGROUND: There is substantial interest in leveraging digital health technology to support hypertension management in low- and middle-income countries such as India. The potential for healthcare infrastructure and broader context to support such initiatives in India has not been examined. We evaluated existing healthcare infrastructure to support digital health interventions and examined epidemiologic, socioeconomic, and geographical contextual correlates of healthcare infrastructure in 544 districts covering 29 states and union territories across India. METHODS: The study was a cross-sectional analysis of India's Fourth District Level Household and Facility Survey (DLHS-4; 2012-2014), the most up-to-date nationally representative district-level healthcare infrastructure data. Facilities were the unit of analysis, and analyses accounted for clustering within states. The main outcome was healthcare system infrastructural context to implement hypertension management programs. Domains included diagnostics (functional BP instrument), medications (anti-hypertensive medication in stock), essential clinical staff (e.g., staff nurse, medical officer, pharmacist), and IT specific infrastructure (regular power supply, internet connection, computer availability). Descriptive analysis was conducted for infrastructure indicators based on the Indian Public Health Standards, and logistic regression was conducted to estimate the association between epidemiologic and geographical context (exposures) and the composite measure of healthcare system. RESULTS: Data from 32,215 government facilities were analyzed. Among lowest-tier subcenters, 30% had some IT infrastructure, while at the highest-tier district hospitals, 92% possessed IT infrastructure. At mid-tier primary health centres and community health centres, IT infrastructure availability was 28 and 51%, respectively. For all but sub-centres, the availability of essential staff was lower than the availability of IT infrastructure. For all but district hospitals, higher levels of blood pressure, body mass index, and urban residents were correlated with more favorable infrastructure. By region, districts in Western India tended towards having the best prepared health facilities. CONCLUSIONS: IT infrastructure to support digital health interventions is more frequently lacking at lower and mid-tier healthcare facilities compared with apex facilities in India. Gaps were generally larger for staffing than physical infrastructure, suggesting that beyond IT infrastructure, shortages in essential staff impose significant constraints to the adoption of digital health interventions. These data provide early benchmarks for state- and district-level planning.

Is India's public health care system prepared for cervical cancer screening?: Evaluating facility readiness from the fourth round of the District Level Household and Facility Survey (DLHS-4).

India's cervical cancer screening program was launched in 2016. We evaluated baseline facility readiness using nationally representative data from the 2012-13 District Level Household and Facility Survey on 4 tiers of the public health care system - 18,367 sub-health centres (SHCs), 8540 primary health centres (PHCs), 4810 community health centres and 1540 district/sub-divisional hospitals. To evaluate facility readiness we used the Improving Data for Decision Making in Global Cervical Cancer Programmes toolkit on six domains - potential staffing, infrastructure, equipment and supplies, infection prevention, medicines and laboratory testing, and data management. Composite scores were created by summing responses within domains, standardizing scores across domains at each facility level, and averaging across districts/states. Overall, readiness scores were low for cervical cancer screening. At SHCs, the lowest scores were observed in 'infrastructure' (0.55) and 'infection prevention' (0.44), while PHCs had low 'potential staffing' scores (0.50) due to limited manpower to diagnose and treat (cryotherapy) potential cases. Scores were higher for tiers conducting diagnostic work-up and treatment/referral. The highest scores were in 'potential staffing' except for PHCs, while the lowest scores were in 'infection & prevention' and 'medicines and laboratory'. Goa and Maharashtra were consistently among the top 5 ranking states for readiness. Substantial heterogeneity in facility readiness for cervical cancer screening spans states and tiers of India's public healthcare system. Infrastructure and staffing are large barriers to screening at PHCs, which are crucial for referral of high-risk patients. Our results suggest focus areas in cervical cancer screening at the district level for policy makers.

The Integrated Tracking, Referral, and Electronic Decision Support, and Care Coordination (I-TREC) program: scalable strategies for the management of hypertension and diabetes within the government healthcare system of India.

BACKGROUND: Hypertension and diabetes are among the most common and deadly chronic conditions globally. In India, most adults with these conditions remain undiagnosed, untreated, or poorly treated and uncontrolled. Innovative and scalable approaches to deliver proven-effective strategies for medical and lifestyle management of these conditions are needed. METHODS: The overall goal of this implementation science study is to evaluate the Integrated Tracking, Referral, Electronic decision support, and Care coordination (I-TREC) program. I-TREC leverages information technology (IT) to manage hypertension and diabetes in adults aged ≥30 years across the hierarchy of Indian public healthcare facilities. The I-TREC program combines multiple evidence-based interventions: an electronic case record form (eCRF) to consolidate and track patient information and referrals across the publicly-funded healthcare system; an electronic clinical decision support system (CDSS) to assist clinicians to provide tailored guideline-based care to patients; a revised workflow to ensure coordinated care within and across facilities; and enhanced training for physicians and nurses regarding non-communicable disease (NCD) medical content and lifestyle management. The program will be implemented and evaluated in a predominantly rural district of Punjab, India. The evaluation will employ a quasi-experimental design with mixed methods data collection. Evaluation indicators assess changes in the continuum of care for hypertension and diabetes and are grounded in the Reach, Effectiveness, Adoption Implementation, and Maintenance (RE-AIM) framework. Data will be triangulated from multiple sources, including community surveys, health facility assessments, stakeholder interviews, and patient-level data from the I-TREC program's electronic database. DISCUSSION: I-TREC consolidates previously proven strategies for improved management of hypertension and diabetes at single-levels of the healthcare system into a scalable model for coordinated care delivery across all levels of the healthcare system hierarchy. Findings have the potential to inform best practices to ultimately deliver quality public-sector hypertension and diabetes care across India. TRIAL REGISTRATION: The study is registered with Clinical Trials Registry of India (registration number CTRI/2020/01/022723 ). The study was registered prior to the launch of the intervention on 13 January 2020. The current version of protocol is version 2 dated 6 June 2018.

Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial.

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented. Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression. Design, Setting, and Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018. Interventions: Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months. Main Outcomes and Measures: The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol. Results: Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0). Conclusions and Relevance: Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02022111.