Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study.

AIMS: The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) trial tested a collaborative care model including electronic clinical decision support (CDS) for treating diabetes and depression in India. We aimed to assess which features of this clinically and cost-effective intervention were associated with improvements in diabetes and depression measures. METHODS: Post-hoc analysis of the INDEPENDENT trial data (189 intervention participants) was conducted to determine each intervention feature's effect: 1. Collaborative case reviews between expert psychiatrists and the care team; 2. Patient care-coordinator contacts; and 3. Clinicians' CDS prompt modifications. Primary outcome was baseline-to-12-months improvements in diabetes control, blood pressure, cholesterol, and depression. Implementer interviews revealed barriers and facilitators of intervention success. Joint displays integrated mixed methods' results. RESULTS: High baseline HbA1c≥ 74.9 mmol/mol (9%) was associated with 5.72 fewer care-coordinator contacts than those with better baseline HbA1c (76.8 mmol/mol, 9.18%, p < 0.001). Prompt modification proportions varied from 38.3% (diabetes) to 1.3% (LDL). Interviews found that providers' and participants' visit frequencies were preference dependent. Qualitative data elucidated patient-level factors that influenced number of clinical contacts and prompt modifications explaining their lack of association with clinical outcomes. CONCLUSION: Our mixed methods approach underlines the importance of the complementarity of different intervention features. Qualitative findings further illuminate reasons for variations in fidelity from the core model.

Reliability and Validity of the Adolescence Stress Scale (ADOSS) for Indian Adolescents.

Background: Stress levels increase tremendously in adolescence. Indian adolescents derive much of their stress from school and family pressures. Developing a standardized tool to assess adolescent stress can help early diagnosis. This article aimed to assess the reliability and validity of the ADOlescence Stress Scale (ADOSS). Methods: ADOSS was administrated by trained interviewers to 100 adolescents (10-17 years) of both sexes in Chennai, South India. Salivary cortisol was used as an objective measure of stress in 40 adolescents. Reliability was assessed within a two weeks interval. Exploratory factor analysis was done for the baseline ADOSS scores. The internal consistency (Cronbach's alpha and spilt-half correlation), test-retest agreement (Kappa value), and inter-rater reliability (ICC) were assessed. Pearson correlation between salivary cortisol and ADOSS score was done. Results: The inter-factor correlation between the inherent four ADOSS factors (personal, academic, family, and social) was between 0.73 and 0.87, and split-half correlation was between 0.70 and 0.83, showing that the factors are reliable and coherent. Test-retest agreement was Kappa: 0.63, P = 0.001, and ICC was 0.84. Pearson correlation showed a statistically significant positive correlation between cortisol levels and ADOSS scores (r = 0.87, P = 0.001). Conclusion: ADOSS is a reliable and valid tool to assess the overall stress of Indian adolescents in the age group of 10-17 years.

Strategies for participant retention in long term clinical trials: A participant -centric approaches.

A clinical trial is the most foolproof method to evaluate the efficacy of a new intervention. Successful completion of clinical trials depends on the retention of the participants enrolled. Poor participant retention can lead to significant time and cost burden and have potentially adverse biases on the results. A high retention rate of participants is an important criterion for the validity and credibility of randomized controlled clinical trials. Many long-term trials fail due to low retention of study participants. Efforts at participant retention should start even before the first participant is recruited into the study. Retention is not only the responsibility of the investigators but also all other stakeholders in a clinical trial. In recent years, retention materials, participant camps, and introduction of national study coordinators have helped in improving retention. Quality of the relationship developed between the research staff and the study participant is a key factor for success of any trial. In our experience, in the context of resource-challenged low- and middle-income countries, we have found that it is possible to achieve high retention rates, 95%-100%. The rapport built between the investigating team and the participant plays a vital role in retention. In addition, personalized care, including listening to the participant's problems and enabling to contact investigators or study team at any time of the day, has shown benefits in retention.

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.

Cost-Effectiveness of a Collaborative Care Model Among Patients With Type 2 Diabetes and Depression in India.

OBJECTIVE: To assess the cost-effectiveness of collaborative versus usual care in adults with poorly controlled type 2 diabetes and depression in India. RESEARCH DESIGN AND METHODS: We performed a within-trial cost-effectiveness analysis of a 24-month parallel, open-label, pragmatic randomized clinical trial at four urban clinics in India from multipayer and societal perspectives. The trial randomly assigned 404 patients with poorly controlled type 2 diabetes (HbA1c ≥8.0%, systolic blood pressure ≥140 mmHg, or LDL cholesterol ≥130 mg/dL) and depressive symptoms (9-item Patient Health Questionnaire score ≥10) to collaborative care (support from nonphysician care coordinators, electronic registers, and specialist-supported case review) for 12 months, followed by 12 months of usual care or 24 months of usual care. We calculated incremental cost-effectiveness ratios (ICERs) in Indian rupees (INR) and international dollars (Int'l-$) and the probability of cost-effectiveness using quality-adjusted life-years (QALYs) and depression-free days (DFDs). RESULTS: From a multipayer perspective, collaborative care costed an additional INR309,558 (Int'l-$15,344) per QALY and an additional INR290.2 (Int'l-$14.4) per DFD gained compared with usual care. The probability of cost-effectiveness was 56.4% using a willingness to pay of INR336,000 (Int'l-$16,654) per QALY (approximately three times per-capita gross domestic product). The willingness to pay per DFD to achieve a probability of cost-effectiveness >95% was INR401.6 (Int'l-$19.9). From a societal perspective, cost-effectiveness was marginally lower. In sensitivity analyses, integrating collaborative care in clinical workflows reduced incremental costs by ∼47% (ICER 162,689 per QALY, cost-effectiveness probability 89.4%), but cost-effectiveness decreased when adjusting for baseline values. CONCLUSIONS: Collaborative care for patients with type 2 diabetes and depression in urban India can be cost-effective, especially when integrated in clinical workflows. Long-term cost-effectiveness might be more favorable. Scalability across lower- and middle-income country settings depends on heterogeneous contextual factors.

A realist process evaluation of the INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) randomized controlled trial in India.

Aims: We aimed to determine what key resources, mechanisms, and contextual factors are necessary to integrate depression and diabetes treatment into low-resource settings. Methods: A realist evaluation framework was employed to conduct a comparative case study. Data were collected through document review, key informant interviews (n = 4), activity logs, and interviews with implementing health care providers (n = 11) to test and refine program theories for collaborative care. Results: Efforts to enhance patient care coordination (i.e., adapting clinics' patient flow and resources, on-going trainings, and on-site support for care coordinators) improved implementation of depression treatment by usual care diabetes physicians. Clinician's avoidance of the term depression was identified as a barrier to mental health counseling and treatment. Conclusions: The variations in organizational features and processes linked to implementation activities across two clinics provided an opportunity to examine how and why different contextual factors help or hinder the implementation process. Findings from this study demonstrate that successful implementation of an integrated depression and diabetes care model is feasible in a low-resource setting, while the revised program theories provide an explanatory framework of coordinated care implementation processes that can inform future efforts to disseminate and scale this care model.

Effect of a collaborative care model on anxiety symptoms among patients with depression and diabetes in India: The INDEPENDENT randomized clinical trial.

OBJECTIVE: We assessed the impact of a collaborative care intervention on anxiety symptoms among participants in India with comorbid depression, poorly controlled diabetes, and moderate to severe anxiety symptoms. METHOD: We analyzed data from a randomized controlled trial conducted at four diabetes clinics in India. Participants received either collaborative care or usual care. We included only participants who scored ⩾10 on the Generalized Anxiety Disorder-7 (GAD-7) at baseline. We estimated the effect of the intervention on clinically significant reduction in anxiety symptoms; we considered several potential baseline moderators and mediation by anti-depressant use. RESULTS: One hundred and seventy-two participants scored 10 or above on the GAD-7 at baseline. Collaborative care participants were more likely than control participants to achieve a clinically significant reduction in anxiety symptoms at 6 and 12 months (65.7% vs. 41.4% at 12 months, p = 0.002); these differences were not sustained at 18 or 24 months. There was little evidence of moderation by participant characteristics at baseline, and effects were not mediated by anti-depressant use. CONCLUSIONS: Collaborative care for the treatment of depression and type 2 diabetes can lead to clinically significant reductions in anxiety symptoms among patients with anxiety. Effects were notable during the active intervention period but not over the year post-intervention.

Comparison of Glycemic Excursion Using Flash Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose.

Purpose: To determine the effect of Voglibose add-on therapy on daily glycemic excursions (using FreeStyle® Libre Pro™, a Flash glucose monitoring system) in Indian patients with type 2 diabetes mellitus (T2DM) receiving a stable dose of metformin (Met) or metformin+sulfonylurea (Met+SU). Patients and Methods: T2DM patients with glycosylated hemoglobin (HbA1c) ≥7.0% and at least two postprandial excursions ≥140 mg/dL (within 2 h of meal) during the screening phase (visit 1/day -14 ± 2) were enrolled in this prospective, multicenter interventional study. The patients were randomized at visit 2 (day 0 ± 2) to receive Voglibose 0.2 or 0.3 mg tablets (BID/TID) as add-on therapy to Met and Met+SU. All the patients were followed at day 14 ± 2 (visit 3), month 3 ± 14 days (visit 4), 14 weeks (i.e., visit 4 + 14 days) ±2 days (visit 5), and month 6 ± 14 days (visit 6). Continuous glucose monitoring was performed to study glycemic excursions at visits 2, 3, and 5. The study outcomes were: change in average number of glycemic excursions per day, percent time spent in glucose fluctuations, mean Postprandial glucose (PPG), Fasting plasma glucose (FPG), day and night time mean glucose levels from baseline to day 14 and week 14; change in mean amplitude of glycemic excursion (MAGE) from baseline to 14 weeks; and mean HbA1c level at 3 and 6 months. Results: Out of 110 patients enrolled, 101 patients (91.8%) (Met+SU+Voglibose: 73 and Met+Voglibose: 28) completed the study. There was a significant decrease in average number of glycemic excursions per day from baseline to day 14 in the Met+Sul+Voglibose group and to week 14 in the Met+Voglibose group. There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups and to week 14 in the Met+SU+Voglibose group. A significant reduction in mean PPG area under the curve, day and night time mean glucose levels, and mean FPG levels from baseline to day 14 was reported in both treatment groups. A significant reduction in night time glucose, and average MAGE and HbA1c levels was reported from baseline to week 14 in the Met+Voglibose group and the Met+SU+Voglibose group, respectively. At 6 months, body weight, glucose levels, cholesterol, low-density lipoprotein-cholesterol, and HbA1c were significantly lower, especially in the Met+SU+Voglibose arm. Conclusion: Voglibose was useful in reducing glycemic variability and improving glycemic control in Asian Indian adults with T2DM. (CTRI/2018/04/013074).

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.

Acceptability and Utilization of Newer Technologies and Effects on Glycemic Control in Type 2 Diabetes: Lessons Learned from Lockdown.

Aim: To evaluate the effects of a prolonged lockdown due to Coronavirus (COVID-19) on the adoption of newer technologies and changes in glycemic control on patients with type 2 diabetes (T2D) in India. Methods: The study population included a random list of 3000 individuals with T2D derived from 30,748 individuals who had visited a large tertiary diabetes center during the past year. The survey was carried out through a telephonic interview. A structured questionnaire was used to collect information on changes in lifestyle, access and challenges to diabetes care and use of technologies such as telemedicine facilities and use of self-monitoring of blood glucose (SMBG), etc. Results: Of the 2510 individuals successfully interviewed (83.7% response rate), 382 (15.2%) reported having attempted to consult their health care providers during the lockdown, of whom only 30.6% utilized the telemedicine facility. However, 96 (82%) of those who utilized the telemedicine facility (n = 117) were happy with their experience and 68 (58.1%) were willing to continue to use the facility in the future. Only 11.4% of participants utilized online support for management of diabetes. Use of SMBG increased significantly from 15.5% to 51.3% during the lockdown. There was an improvement in glycemic control during the lockdown (HbA1c:before vs. during lockdown: 8.2% ± 1.9% vs. 7.7% ± 1.7%, P < 0.001) in a nonrandomly selected subset of subjects (n = 205). Conclusions: Acceptance of telemedicine facilities remains suboptimal in this Asian Indian population, in spite of high levels of satisfaction among those who utilized it. The COVID-19 pandemic and the subsequent lockdown have not adversely affected metabolic control in our patients, and indeed there appears to be an improvement in HbA1c levels. Greater accessibility and acceptance of technology could help individuals with diabetes to maintain better contact with their physicians and ensure better metabolic control in the future.

Estimation of the prevalence of depression using diagnostic instruments in the elderly population in India, 2000-2019: a systematic review protocol.

INTRODUCTION: Depression is a common mental disorder in the elderly population, which significantly impacts their quality of life. However, correct estimates of its magnitude are not available in the elderly in India. The present systematic review and meta-analysis would attempt to estimate the prevalence of depression using diagnostic instruments among elderly persons aged 60 years and above. METHODS AND ANALYSIS: Searches will be performed in PubMed, Scopus, Embase, Web of Science, CINAHL and PsycINFO. Community-based cross-sectional and cohort studies (2001 to September 2019) reporting the prevalence of depression in the elderly, using diagnostic instruments will be included. Studies conducted among chronic disease patients, in-hospital patients and special groups such as with disaster-stricken populations, and studies reporting the only one or two subcategories of depression, will be excluded. Disagreements in study selection and data abstraction will be resolved by consensus and arbitration by a third reviewer. AXIS critical appraisal tool will be used for quality assessment of individual studies. Findings of eligible studies will be pooled using fixed-effects or random-effects meta-analysis whichever is appropriate. Heterogeneity between studies will be examined by Cochran's Q test and quantified by I² statistic. A cumulative meta-analysis will be used to detect temporal trends in the prevalence of depression and the effect of poor-quality studies on the pooled estimate. Publication bias will be assessed by visual inspection of funnel plots and the Egger test. ETHICS AND DISSEMINATION: No ethical approval will be needed because it will be a systematic review. Data from previously published studies will be retrieved and analysed. Findings will be disseminated through a peer-reviewed publication in a scientific journal and conferences. PROSPERO REGISTRATION NUMBER: CRD42019138453.

Adaptations and patient responses to behavioral intervention components in a depression-focused chronic disease care model implemented in India.

Integrated care models offer one approach to treat patients with chronic multimorbidity. However, because these models consist of multiple components designed to provide individualized care, they should be adapted to best meet the needs of patients in diverse settings. This paper presents qualitative and quantitative data from a realist process evaluation embedded in the INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study to uncover what worked, for whom, how, and in what circumstances. We aimed to examine adaptations made to a care coordinator-led behavioral intervention, and how patients responded to adaptations, through a secondary analysis of these data. A purposive sample of 62 patients and 3 care coordinators were recruited based on their involvement with the INDEPENDENT care model across two clinics. Patients were interviewed and surveyed about their experiences in the care model and care coordinators were interviewed about their experiences implementing intervention components. Interview data were coded for reported modifications in intervention content, tools, and delivery; then, these adaptations were categorized by how they served to enhance implementation in the Indian context. Adaptations made in the delivery of this care model served two functions: (a) to improve health promotion communication between care coordinators and patients and (b) to improve patient engagement. Patients' expressed needs were consistent with what care coordinators perceived. Patients were satisfied with adaptations designed to improve intervention fit for local contexts. Study findings demonstrate that adapting components of an integrated care model can enhance patient satisfaction and engagement with behavioral interventions.

Altered circulatory levels of miR-128, BDNF, cortisol and shortened telomeres in patients with type 2 diabetes and depression.

AIMS: Several studies have reported the role of biomarkers either in diabetes or depression. The present study is aimed at profiling the circulating levels of miR-128, brain-derived neurotrophic factor (BDNF), cortisol and telomere length in patients with type 2 diabetes with and without depression compared to individuals with normal glucose tolerance. METHODS: Study subjects (n = 160) were recruited from an ongoing epidemiological study in southern India. Non-diabetic and diabetic individuals were diagnosed as per the World Health Organization criteria. Depression score was derived using PHQ-12 questionnaire. Real-time quantitative PCR and ELISA methodologies were used to quantify the biomarkers. RESULTS: Circulatory levels of miR-128 and cortisol were significantly (p < 0.05) increased with decreased BDNF levels and shortened telomeres in T2DM patients with or without depression compared to NGT individuals. T2DM patients with depression had the highest levels of miR-128 and cortisol and lowest levels of BDNF and telomere length compared to other groups. Pearson correlation analysis showed miR-128 levels were negatively associated with BDNF, telomere length and HDL cholesterol and positively correlated with cortisol, depression score, poor glycemic control and insulin resistance. Regression analysis confirmed that miR-128 was significantly associated with depression score even after adjusted for several confounding factors. However, this association was lost when adjusted for cortisol or telomere length. CONCLUSIONS: Patients with type 2 diabetes and depression exhibited increased circulatory levels of miR-128 and serum cortisol and decreased levels of BDNF and shortened telomeres. These neuroendocrine signatures were more markedly altered in those with combined diabetes and depression.

Epidemiology of Depression and its Relationship to Diabetes in India.

Depression is one of the most common chronic mental illnesses globally and in India. It has been reported that depression is twice as common in individuals with type 2 diabetes. The prevalence of both depression and type 2 diabetes are rapidly increasing. This article reviews the prevalence of depression in the general population as well as in patients with type 2 diabetes and its complications with special reference to recent data from India. It also makes a case for screening for depression in diabetes clinics and integrating depression treatment with diabetes care in order to make the treatment more wholistic.

Input of stakeholders on reducing depressive symptoms and improving diabetes outcomes in India: Formative work for the INDEPENDENT Study.

AIMS: Depression and diabetes are highly comorbid, adversely affecting treatment adherence and resulting in poor outcomes. To improve treatment and outcomes for people dually-affected by diabetes and depression in India, we aimed to develop and test an integrated care model. In the formative phase of this INtegrated DEPrEssioN and Diabetes TreatmENT (INDEPENDENT) study, we sought stakeholder perspectives to inform culturally-sensitive adaptations of the intervention. METHODS: At our Delhi, Chennai, and Vishakhapatnam sites, we conducted focus groups for patients with diabetes and depression and interviewed healthcare workers, family members, and patients. These key informants were asked about experiences with diabetes and depression and for feedback on intervention materials. Data were analyzed using a grounded theory approach. RESULTS: Three major themes emerged that have bearing on adaptation of the proposed intervention: importance of family assistance, concerns regarding patient/family understanding of diabetes, and feedback regarding the proposed intervention (e.g. adequate time needed for implementation; training program and intervention should address stigma). CONCLUSIONS: Based on our findings, the following components would add value when incorporated into the intervention: 1) engaging families in the treatment process, 2) clear/simple written information, 3) clear non-jargon verbal explanations, and 4) coaching to help patients cope with stigma.

Association of depression with common carotid artery intima media thickness and augmentation index in a large Urban South Indian population- The Chennai Urban Rural Epidemiology Study (CURES - 138).

AIM: The aim of the study was to assess the relationship of depression with carotid intima media thickness and augmentation index in Asian Indians. RESEARCH DESIGN AND METHODS: For this study, 1505 subjects were randomly selected from a population based study conducted in Chennai, South India. Right common carotid artery intima medial thickness [IMT] was determined using high-resolution B-mode ultrasonography. Augmentation index [AI] was measured using the Sphygmocor apparatus. Depressive symptoms were assessed using a previously validated instrument, the Patient Health Questionnaire -12 (PHQ -12). RESULTS: Of the 1505 subjects included in this study, depressive symptoms were present in 16.6% (n = 250) of the subjects. The mean IMT and AI values among subjects with depression were significantly higher than those without depression [0.83 ± 0.43 mm vs 0.73 ± 0.12 mm, P < 0.001] and IMT was higher in females with depression while AI was higher in males with depression. However, both IMT and AI were higher among those with depression in both genders. In multiple logistic regression model, depressive symptoms were associated with IMT even after adjusting for age, gender, body mass index, fasting plasma glucose, serum cholesterol and hypertension (Odds ratio [OR] =2.17, 95% Confidence intervals [CI]:1.01- 4.63, P = 0.047) but in the case of AI, the significance was lost in the adjusted model (OR = 1.01, 95% CI: 0.991-1.02, P = 0.445). CONCLUSION: Among Asian Indians, presence of depressive symptoms was associated with carotid intima media thickness and Augmentation index, even after adjusting for potential confounders.

Why are clinical trials necessary in India?

Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP). This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

Noninvasive type 2 diabetes screening: clinical evaluation of SCOUT DS in an Asian Indian cohort.

OBJECTIVE: This study evaluated the noninvasive, point-of-care diabetes screening device, Scout DS (VeraLight Inc., Albuquerque, NM) (SCOUT), in a native Asian Indian cohort. RESEARCH DESIGN AND METHODS: SCOUT is a tabletop, skin fluorescence spectrometer that reports a risk score following a 3-4-min noninvasive measurement of a subject's left volar forearm. SCOUT, fasting plasma glucose (FPG), and hemoglobin A(1c) (A1C) were compared for detection of abnormal glucose tolerance (AGT) in a cohort of 256 subjects without previous diagnosis of diabetes or impaired glucose tolerance in Chennai, India. After an overnight fast, a 75-g, 2-h oral glucose tolerance test was administered, and AGT was defined as a plasma glucose value ≥ 140 mg/dL (7.8 mmol/dL). Sensitivity, false-positive rate (FPR), and receiver-operating characteristics area under the curve for AGT detection were computed for SCOUT, FPG, and A1C. Intra-day reproducibility of SCOUT was assessed. RESULTS: SCOUT, FPG, and A1C (at respective thresholds of 50, 110 mg/dL, and 5.7%) exhibited sensitivities of 87%, 32%, and 86%, respectively, and FPR of 52%, 3%, and 58%, respectively. For the 177 subjects receiving a valid SCOUT Diabetes Score on both measurement attempts, the coefficient of variation was 5.8%, and the Pearson correlation was 0.91. A SCOUT score could be obtained on 91% of subjects after two attempts. CONCLUSIONS: The performance of SCOUT is similar to that of A1C, whereas FPG had a much lower sensitivity. SCOUT is an effective tool for AGT screening in Asian Indians.

Association of depression with complications of type 2 diabetes--the Chennai Urban Rural Epidemiology Study (CURES- 102).

OBJECTIVE: The aim of the study was to assess the relationship between depression and diabetic complications among urban south Indian type 2 diabetic subjects [T2DM]. METHODS: T2DM subjects [n = 847] were recruited from the Chennai Urban Rural Epidemiology Study [CURES], a population based study in Chennai (formerly Madras) in South India. A previously validated depression questionnaire [PHQ-12 item] was administered. Four field stereo retinal colour photography was done and diabetic retinopathy [DR] was classified according to the Early Treatment Diabetic Retinopathy Study grading system. Neuropathy was diagnosed if the vibratory perception threshold of the right great toe, measured by biothesiometry, was > or = 20. Nephropathy was diagnosed if urinary albumin excretion was > or = 300 microg/mg creatinine. Peripheral vascular disease [PVD] was diagnosed if an ankle-brachial index was < 0.9. Coronary artery disease [CAD] was diagnosed based on a past history of documented myocardial infarction and/or electrocardiographic evidence of Q wave and/or ST segment changes. RESULTS: Of the 847 T2DM studied, 198 (23.4%) were found have depression. The prevalence of depression was significantly higher among diabetic subjects with DR (35.0% vs 21.1%, p < 0.001), neuropathy (28.4% vs 15.9%, p = 0.023), nephropathy (35.6% vs 24.5%, p = 0.04) and PVD (48.0% vs 27.4%, p < 0.001) as compared to subjects without these complications. DR, neuropathy, nephropathy, and PVD were associated with depression even after adjusting for age, gender, duration of diabetes and glycated haemoglobin. DR (Odds ratio [OR] = 2.19, Confidence interval [CI]:1.45-3.51, p < 0.001) was associated with depression even after adjusting for neuropathy and nephropathy. There was also a significant association between depression and neuropathy, after adjusting for retinopathy and nephropathy (OR = 2.07, CI: 1.41-3.04, p < 0.001). There was a significant association of depression with nephropathy but this was lost (OR = 1.71, CI: 0.87-3.35, p = 0.119) after adjustment for retinopathy. PVD (OR = 3.52, CI: 1.94-6.40, p < 0.001) remained significantly associated with depression even after adjusting for CAD. However, there was no significant association of depression with CAD (OR = 0.73, CI: 0.42 -1.27, p = 0.264). CONCLUSION: Among Asian Indians, the prevalence of depression is higher in T2DM subjects with retinopathy, neuropathy, nephropathy and PVD compared to those without the respective complications.