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.

Endoscopic treatment of spinal arachnoid cysts.

BACKGROUND/OBJECTIVE: Spinal arachnoid cysts (SAC) are intradural lesions, which may provoke a compression of the spinal cord and roots. Endoscopic techniques are increasingly used to minimize the surgical access and the postoperative scar tissue. Shunts may also represent an option. The aim of this paper is to illustrate the technique of endoscopic-assisted fenestration and positioning of a cysto-peritoneal diversion in a thoracic SAC using a flexible endoscope and to perform a systematic literature review on this subject. MATERIAL AND METHODS: We reported our case and we performed a review of the literature, searching for all the adult cases of Type III SACs in English language treated through endoscopic procedures. RESULTS: We found 5 articles matching our search criteria and we included 9 adult patients in our analysis. Six patients were females and the most common localization was the thoracic spine. Six patients underwent selective laminectomies followed by endoscopic fenestration without cyst wall resection. Three patients had a percutaneous endoscopic inspection of the cyst and in two cases a cysto-subarachnoid shunt space was performed. Improvement of pre-operative neurological deficit was reported in six patients, no patients experienced clinical deterioration. The mean follow-up was 22 months and no progression or recurrence was reported. CONCLUSION: The implementation of endoscopy allows a minimally invasive treatments with good visualization of cyst anatomy and precise shunt positioning under real-time guidance. Endoscopy is technically demanding but it can offer similar clinical outcomes when compared to microscopic procedures with a limited rate of post-operative complications.The long-term risk of recurrence should be established by prospective studies.

Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial.

BACKGROUND: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly). OBJECTIVES: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial. METHODS: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks. RESULTS: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes). CONCLUSIONS: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408).

Prevalence of dyslipidaemia and factors associated with dyslipidaemia among South Asian adults: The Center for Cardiometabolic Risk Reduction in South Asia Cohort Study.

Background: . The pattern of dyslipidaemia in South Asia is believed to be different from that in other parts of the world. Nonetheless, limited population-based data are available from the region. We assessed the prevalence, types of, and factors associated with dyslipidaemia among South Asians. Methods: . We used baseline data (2010-11) of the Center for Cardiometabolic Risk Reduction in South Asia (CARRS) cohort of 16 287 representative urban adults aged ≥20 years from Chennai and Delhi in India and Karachi in Pakistan. Total cholesterol (TC) was measured by the enzymatic-cholesterol oxidase peroxidase method, high-density lipoprotein-cholesterol (HDL-C) by the direct homogeneous method and triglycerides (TG) by enzymatic methods. Low-density lipoprotein-cholesterol (LDL-C) was calculated using Friedewald's formula. We defined high TC ≥200 mg/dl or on medication; hypertriglyceridaemia ≥150 mg/dl, high LDL-C ≥130 mg/dl or on medication and low HDL-C <40 mg/dl for males, <50 mg/dl for females. Multivariate logistic regression was carried out to assess the factors associated with dyslipidaemia. Results: . The prevalence of any dyslipidaemia was 76.4%, 64.3% and 68.5% among males and 89.3%, 74.4% and 79.4% among females in Chennai, Delhi and Karachi, respectively. The prevalence of elevated TC was higher in Chennai compared to Delhi and Karachi (31.3%, 28.8% and 22.9%, respectively); males had a significantly greater prevalence of high TG, whereas females had a greater prevalence of low HDL-C in all the three cities. The most common lipid abnormality in all three cities was low HDL-C, which was seen in 67.1%, 49.7% and 61.3% in Chennai, Delhi and Karachi, respectively. Only 2% of the participants were on lipid-lowering drugs. Adjusted for other factors, dyslipidaemia was positively associated with age, female sex, obesity, hypertension, diabetes and tobacco use. Discussion: . Overall, almost seven in ten adults in urban South Asia have some form of dyslipidaemia, and the predominant subtypes were low HDL-C and high TG.

Association between poor oral health and diabetes among Indian adult population: potential for integration with NCDs.

BACKGROUND: Studies in high-income countries have reported associations between oral health and diabetes. There is however a lack of evidence on this association from low and middle-income countries, especially India. The current study aimed to assess the prevalence of common oral diseases and their association with diabetes. METHODS: This cross-sectional study was nested within the second Cardiometabolic Risk Reduction in South Asia Surveillance Study. A subset of study participants residing in Delhi were administered the World Health Organization's Oral Health Assessment Questionnaire and underwent oral examination for caries experience and periodontal health assessment using standard indices. Diabetes status was ascertained by fasting blood glucose, glycosylated hemoglobin values or self-reported medication use. Information was captured on co-variates of interest. The association between oral health and diabetes was investigated using Multivariable Zero-Inflated Poisson (ZIP) regression analysis. RESULTS: Out of 2045 participants, 47% were women and the mean age of study participants was 42.17 (12.8) years. The age-standardised prevalence (95% confidence interval) estimates were 78.9% (75.6-81.7) for dental caries, 35.9% (32.3-39.6) for periodontitis. Nearly 85% participants suffered from at least one oral disease. Compared to diabetes-free counterparts, participants with diabetes had more severe caries experience [Mean Count Ratio (MCR) = 1.07 (1.03-1.12)] and attachment loss [MCR = 1.10 (1.04-1.17)]. Also, the adjusted prevalence of periodontitis was significantly higher among participants with diabetes [42.3%(40.0-45.0)] compared to those without diabetes [31.3%(30.3-32.2)]. CONCLUSION: We found that eight out of ten participants in urban Delhi suffered from some form of oral disease and participants with diabetes had worse oral health. This highlights the need for public health strategies to integrate oral health within the existing Non-Communicable Disease control programs.

Strategies for Stakeholder Engagement and Uptake of New Intervention: Experience From State-Wide Implementation of mHealth Technology for NCD Care in Tripura, India.

BACKGROUND: Appropriate strategies and key stakeholder engagement are the keys to successful implementation of new health care interventions. OBJECTIVES: The study sought to articulate the key strategies used for scaling up a research-based intervention, mPower Heart electronic Clinical Decision Support System (e-CDSS), for state-wide implementation at health facilities in Tripura. METHODS: Multiple strategies were used for statewide implementation of mPower Heart e-CDSS at noncommunicable diseases clinics across the government health facilities in Tripura: formation of a technical coordination-cum-support unit, change management, enabling environment, adapting the intervention with user focus, and strengthening the Health Information System. RESULTS: The effective delivery of a new health system intervention requires engagement at multiple levels including political leadership, health administrators, and health professionals, which can be achieved by forming a technical coordination-cum-support unit. It is important to specify the role and responsibilities of existing manpower and provide a structured training program. Enabling environment at health facilities (providing essential equipment, space and time, etc.) is also crucial. Successful implementation also requires that patients, health care providers, the health system, and leadership recognize the immediate and long-term benefits of the new intervention and have a buy-in in the intervention. With constant encouragement and nudge from administrative authorities and by using multiple strategies, 40 government health facilities adopted the mPower Heart e-CDSS. From its launch in May 2017 until November 20, 2018, a total of 100,810 eligible individuals were screened and enrolled, with 35,884 treated for hypertension, 9,698 for diabetes, and 5,527 for both hypertension and diabetes. CONCLUSIONS: Multiple strategies, based on implementation principles, are required for successful scaling up of research-based interventions.

Association between socioeconomic position and cardiovascular disease risk factors in rural north India: The Solan Surveillance Study.

BACKGROUND: Although most Indians live in rural settings, data on cardiovascular disease risk factors in these groups are limited. We describe the association between socioeconomic position and cardiovascular disease risk factors in a large rural population in north India. METHODS: We performed representative, community-based sampling from 2013 to 2014 of Solan district in Himachal Pradesh. We used education, occupation, household income, and household assets as indicators of socioeconomic position. We used tobacco use, alcohol use, low physical activity, obesity, hypertension, and diabetes as risk factors for cardiovascular disease. We performed hierarchical multivariable logistic regression, adjusting for age, sex and clustering of the health sub-centers, to evaluate the cross-sectional association of socioeconomic position indicators and cardiovascular disease risk factors. RESULTS: Among 38,457 participants, mean (SD) age was 42.7 (15.9) years, and 57% were women. The odds of tobacco use was lowest in participants with graduate school and above education (adjusted OR 0.11, 95% CI 0.09, 0.13), household income >15,000 INR (adjusted OR 0.35, 95% CI 0.29, 0.43), and highest quartile of assets (adjusted OR 0.28, 95% CI 0.24, 0.34) compared with other groups but not occupation (skilled worker adjusted OR 0.93, 95% CI 0.74, 1.16). Alcohol use was lower among individuals in the higher quartile of income (adjusted OR 0.75, 95% CI 0.64, 0.88) and assets (adjusted OR 0.70, 95% CI 0.59, 0.82). The odds of obesity was highest in participants with graduate school and above education (adjusted OR 2.33, 95% CI 1.85, 2.94), household income > 15,000 Indian rupees (adjusted OR 1.89, 95% CI 1.63, 2.19), and highest quartile of household assets (adjusted OR 2.87, 95% CI 2.39, 3.45). The odds of prevalent hypertension and diabetes were also generally higher among individuals with higher socioeconomic position. CONCLUSIONS: Individuals with lower socioeconomic position in Himachal Pradesh were more likely to have abnormal behavioral risk factors, and individuals with higher socioeconomic position were more likely to have abnormal clinical risk factors.

Development of a Yoga-Based Cardiac Rehabilitation (Yoga-CaRe) Programme for Secondary Prevention of Myocardial Infarction.

Cardiac rehabilitation (CR) after myocardial infarction is highly effective. It is unavailable in public hospitals in India due to limited resources. Our objective was to develop a scalable model of CR for India based on yoga, which could also appeal to some groups with low uptake of CR (e.g., ethnic minorities, women, and older people) globally. The intervention was developed using a structured process. A literature review and consultations with yoga experts, CR experts, and postmyocardial infarction patients were conducted to systematically identify and shortlist appropriate yoga exercises and postures, breathing exercises, meditation and relaxation practices, and lifestyle changes, which were incorporated into a conventional CR framework. The draft intervention was further refined based on the feedback from an internal stakeholder group and an external panel of international experts, before being piloted with yoga instructors and patients with myocardial infarction. A four-phase yoga-based CR (Yoga-CaRe) programme was developed for delivery by a single yoga instructor with basic training. The programme consists of a total of 13 instructor-led sessions (2 individual and 11 group) over a 3-month period. Group sessions include guided practice of yoga exercises and postures, breathing exercises, and meditation and relaxation practices, and support for the lifestyle change and coping through a moderated discussion. Patients are encouraged to self-practice daily at home and continue long-term with the help of a booklet and digital video disc (DVD). Family members/carers are encouraged to join throughout. In conclusion, a novel yoga-based CR programme has been developed, which promises to provide a scalable CR solution for India and an alternative choice for CR globally. It is currently being evaluated in a large multicentre randomised controlled trial across India.

Rationale and protocol for estimating the economic value of a multicomponent quality improvement strategy for diabetes care in South Asia.

BACKGROUND: Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia. METHODS/DESIGN: This economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018. DISCUSSION: We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01212328.

Strategic Opportunities for Leveraging Low-cost, High-impact Technological Innovations to Promote Cardiovascular Health in India.

Accelerated epidemiological transition in India over the last 40 years has resulted in a dramatic increase in the burden of cardiovascular diseases and the related risk factors of diabetes and hypertension. This increase in disease burden has been accompanied by pervasive health disparities associated with low disease detection rates, inadequate awareness, poor use of evidence-based interventions, and low adherence rates among patients in rural regions in India and those with low socioeconomic status. Several research groups in India have developed innovative technologies and care-delivery models for screening, diagnosis, clinical management, remote-monitoring, self-management, and rehabilitation for a range of chronic conditions. These innovations can leverage advances in sensor technology, genomic tools, artificial intelligence, big-data analytics, and so on, for improving access to and delivering quality and affordable personalized medicine in primary care. In addition, several health technology start-ups are entering this booming market that is set to grow rapidly. Innovations outside biomedical space (eg, protection of traditional wisdom in diet, lifestyle, yoga) are equally important and are part of a comprehensive solution. Such low-cost, culturally tailored, robust innovations to promote health and reduce disparities require partnership among multi-sectors including academia, industry, civil society, and health systems operating in a conducive policy environment that fosters adequate public and private investments. In this article, we present the unique opportunity for India to use culturally tailored, low-cost, high-impact technological innovations and strategies to ameliorate the perennial challenges of social, policy, and environmental challenges including poverty, low educational attainment, culture, and other socioeconomic factors to promote cardiovascular health and advance health equity.

Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. METHODS: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. CONCLUSION: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings.

Multimorbidity in South Asian adults: prevalence, risk factors and mortality.

BACKGROUND: We report the prevalence, risk factors and mortality associated with multimorbidity in urban South Asian adults. METHODS: Hypertension, diabetes, heart disease, stroke and chronic kidney disease were measured at baseline in a sample of 16 287 adults ages ≥20 years in Delhi, Chennai and Karachi in 2010-11 followed for an average of 38 months. Multimorbidity was defined as having ≥2 chronic conditions at baseline. We identified correlates of multimorbidity at baseline using multinomial logistic models, and we assessed the prospective association between multimorbidity and mortality using Cox proportional hazards models. RESULTS: The adjusted prevalence of multimorbidity was 9.4%; multimorbidity was highest in adults who were aged ≥60 years (37%), consumed alcohol (12.3%), body mass index ≥25 m/kg2 (14.1%), high waist circumference (17.1%) and had family history of a chronic condition (12.4%). Compared with adults with no chronic conditions, the fully adjusted relative hazard of death was twice as high in adults with two morbidities (hazard ratio [HR] = 2.3; 95% confidence interval [CI]: 1.6, 3.3) and thrice as high in adults with ≥3 morbidities (HR = 3.1; 95% CI: 1.9, 5.1). CONCLUSION: Multimorbidity affects nearly 1 in 10 urban South Asians, and each additional morbidity carries a progressively higher risk of death. Identifying locally appropriate strategies for prevention and coordinated management of multimorbidity will benefit population health in the region.

Cardiovascular risk prediction in India: Comparison of the original and recalibrated Framingham prognostic models in urban populations.

Introduction: Cardiovascular diseases (CVDs) are the leading cause of death in India. The CVD risk approach is a cost-effective way to identify those at high risk, especially in a low resource setting. As there is no validated prognostic model for an Indian urban population, we have re-calibrated the original Framingham model using data from two urban Indian studies. Methods: We have estimated three risk score equations using three different models. The first model was based on Framingham original model; the second and third are the recalibrated models using risk factor prevalence from CARRS (Centre for cArdiometabolic Risk Reduction in South-Asia) and ICMR (Indian Council of Medical Research) studies, and estimated survival from WHO 2012 data for India. We applied these three risk scores to the CARRS and ICMR participants and estimated the proportion of those at high-risk (>30% 10 years CVD risk) who would be eligible to receive preventive treatment such as statins. Results: In the CARRS study, the proportion of men with 10 years CVD risk > 30% (and therefore eligible for statin treatment) was 13.3%, 21%, and 13.6% using Framingham, CARRS and ICMR risk models, respectively. The corresponding proportions of women were 3.5%, 16.4%, and 11.6%. In the ICMR study the corresponding proportions of men were 16.3%, 24.2%, and 16.5% and for women, these were 5.6%, 20.5%, and 15.3%. Conclusion: Although the recalibrated model based on local population can improve the validity of CVD risk scores our study exemplifies the variation between recalibrated models using different data from the same country. Considering the growing burden of cardiovascular diseases in India, and the impact that the risk approach has on influencing cardiovascular prevention treatment, such as statins, it is essential to develop high quality and well powered local cohorts (with outcome data) to develop local prognostic models.

Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial.

BACKGROUND: The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide, including in India. Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension, diabetes mellitus, and depression individually, but an integrated package for multiple chronic condition management in primary care has not been evaluated. METHODS: In a prospective, multicenter, open-label, cluster-randomized controlled trial involving 40 community health centers, using hypertension and diabetes mellitus as entry points, we evaluated the effectiveness of mWellcare, an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions (hypertension, diabetes mellitus, current tobacco and alcohol use, and depression) versus enhanced usual care among patients with hypertension and diabetes mellitus in India. At trial end (12-month follow-up), using intention-to-treat analysis, we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose, total cholesterol, predicted 10-year risk of cardiovascular disease, depression score, and proportions reporting tobacco and alcohol use as secondary outcomes. Mixed-effects regression models were used to account for clustering and other confounding variables. RESULTS: Among 3698 enrolled participants across 40 clusters (mean age, 55.1 years; SD, 11 years; 55.2% men), 3324 completed the trial. There was no evidence of difference between the 2 arms for systolic blood pressure (Δ=-0.98; 95% CI, -4.64 to 2.67) and glycated hemoglobin (Δ=0.11; 95% CI, -0.24 to 0.45) even after adjustment of several key variables (adjusted differences for systolic blood pressure: - 0.31 [95% CI, -3.91 to 3.29]; for glycated hemoglobin: 0.08 [95% CI, -0.27 to 0.44]). The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were -13.65 mm Hg versus -12.66 mm Hg, respectively, and for glycated hemoglobin were -0.48% and -0.58%, respectively. Similarly, there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes. CONCLUSIONS: We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT02480062.

Enzyme-Driven Switchable Fluorescence-SERS Diagnostic Nanococktail for the Multiplex Detection of Lung Cancer Biomarkers.

Comprehensive profiling of multiple protein targets plays a critical role in deeper understanding of specific disease conditions associated with high heterogeneity and complexity. Herein, we present the design and fabrication of smart programmable nanoarchitectures, which could integrate clinically relevant diagnostic modalities for the multiplexed detection of most prevalent panel of disease biomarkers present in lung cancer. The multiplex nanoprobes were prepared by attaching dual-functional Raman-active fluorogens onto spherical gold nanoparticles through a peptide linker, Phe-Lys-Cys (FKC), which is engineered with a cathepsin B (cathB) enzyme cleavage site. The presence of cathB induces the scission of FKC upon homing into the cancer cells, resulting in the release of the initially latent fluorophores with a concomitant quenching of the surface-enhanced Raman signal intensity, thereby realizing an on-off switching between the fluorescence and Raman modalities. The enzyme-triggered switchable nanoprobes were utilized for the simultaneous detection of pathologically relevant lung cancer targets by tethering with specific antibody units. The multiplex-targeted multicolor coded detection capability of the antitags was successfully developed as a valid protein screening methodology, which can address the unmet challenges in the conventional clinical scenario for the precise and early diagnosis of lung cancer.

Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings.

BACKGROUND: Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India. Innovative approaches such as clinical decision support (CDS) software could play a major role in improving the quality of hypertension/diabetes care in primary care settings. OBJECTIVE: To describe the steps and processes in the development of mWellcare, a complex intervention based on mobile health (mHealth) technology. METHODS: The Medical Research Council framework was used to develop mWellcare in four steps: (1) identify gaps in usual care through literature review and health facility assessments; (2) identify the components of the intervention through discussions and consultations with experts; (3) develop intervention (clinical algorithms and mHealth system); and (4) evaluate acceptability and feasibility through pilot testing in five community health centers. RESULTS: Lack of evidence-based, integrated, and systematic management of chronic conditions were major gaps identified. Experts in information technology, clinical fields, and public health professionals identified intervention components to address these gaps. Thereafter, clinical algorithm contextualized to primary care settings were prepared and the mWellcare intervention was developed. During the 2-month pilot, 631 patients diagnosed with hypertension and/or diabetes were registered, with a follow-up rate of 36.2%. The major barrier was resistance to follow mWellcare recommended patient workflow, and to overcome it, we emphasized onsite training and orientation program to cover all health care team member in each CHC. CONCLUSION: A pilot-tested mWellcare intervention is an mHealth system with important components, i.e. integrated management of chronic conditions, evidence-based CDS, longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit, which will be used by nurses at primary health care settings in India. The effectiveness and cost-effectiveness of the intervention will be tested through a cluster randomized trial (trial registration number NCT02480062).

m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial.

BACKGROUND: The proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through innovative strategies directed at health system strengthening. METHODS: We designed an intervention consisting of two important components - an electronic decision support system (EDSS) used by a trained nurse care coordinator (NCC). Based on preliminary data, we hypothesized that this intervention will be able to reduce mean systolic blood pressure by 6.5 mmHg among those with uncontrolled blood pressure in the intervention arm compared to the standard treatment arm (paper-based hypertension treatment guidelines). The study will adopt a cluster randomized trial design with the community health center (CHC) as the unit of randomization. The trial will be conducted in Visakhapatnam district (southern India). A total of 1876 participants aged ≥30 years with high blood pressure - systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg will be enrolled from 12 CHCs. The intervention consists of trained NCCs equipped with an evidence-based hypertension treatment algorithm in the form of the EDSS with regular SMSs to patients with hypertension to promote hypertension treatment and blood pressure control for 12 months. The primary outcome will be difference in the mean change of SBP, from baseline to 12 months, between the intervention and the standard treatment arm. The secondary outcomes are the difference in mean change of DBP; difference in the proportion of patients with controlled blood pressure (< 140/90 mmHg); difference in mean change of fasting blood sugar, HbA1C, eGFR, and albumin to creatinine ratio; difference in the proportion of patients visiting the CHC regularly (number of actual visits to the CHC/number of visits suggested by the EDSS > 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months. DISCUSSION: The study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03164317 ). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry - India (CTRI).

Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review.

OBJECTIVE: This review sought to summarize the extant literature on the efficacy of 4 modalities of psychoeducation (individual, group, family, internet- based) in the management of patients with bipolar disorder. DATA SOURCES: We searched the digital databases (Science Direct, Scopus, PubMed/MEDLINE) for relevant randomized controlled trials (RCTs) pertaining to psychoeducation in bipolar disorder from inception to February 2017. Keywords and combinations used included psychoeducation, bipolar disorder, individual, family, group, and internet. Reference lists of review articles were also used for retrieval of relevant articles. STUDY SELECTION: We retrieved 48 studies and ultimately reviewed 40 RCTs meeting inclusion criteria. Studies were included if they were in English, were RCTs of different psychoeducation modalities managing patients with bipolar disorder, and used standardized assessment of outcomes of psychoeducation. DATA EXTRACTION: We examined each of the selected publications for relevant data. RESULTS: The majority of psychoeducation RCTs (28 of 40 studies, 70.0%) focused on group and family psychoeducation, with positive benefits reported in clinical outcomes, treatment, and functioning measures. Group psychoeducation was associated with reduced illness recurrences, decreased number and duration of hospitalizations, increased time to illness relapse, better treatment adherence, higher therapeutic lithium levels, and reduced stigma. Family psychoeducation was associated with reductions in illness recurrence, hospitalization rates, and better illness trajectory as well as increased caregiver knowledge, skills, support, and sense of well-being and reduced caregiver burden. There are fewer RCTs on individual and internet-based psychoeducation, with findings being inconsistent or negative. CONCLUSIONS: Future studies may include direct comparisons of different psychoeducation modalities to elucidate specific benefits of unique psychoeducation interventions at different phases of bipolar disorder.

Improving access to medicines via the Health Impact Fund in India: a stakeholder analysis.

BACKGROUND: In India, 50-65% of the population face difficulties in accessing medicines. The Health Impact Fund (HIF) is a novel proposal whereby pharmaceutical companies would be paid based on the measured global health impact of their drugs. We conducted a key stakeholder analysis to explore access to medicines in India, acceptability of the HIF and potential barriers and facilitators at policy level. OBJECTIVES: To conduct a stakeholder analysis of the HIF in India: to determine key stakeholder views regarding access to medicines in India; to evaluate acceptability of the HIF; and to assess potential barriers and facilitators to the HIF as a policy. METHODS: In New Delhi, we conducted semi-structured interviews. There was purposive recruitment of participants with snowball sampling. Transcribed data were analysed using stakeholder analysis frameworks and directed content analysis. RESULTS: Participation rate was 29% (14/49). 14 semi-structured interviews were conducted among stakeholders in New Delhi. All participants highlighted access to medicines as a problem in India. There were mixed views about the HIF in terms of relevance and scaleability. Stakeholders felt it should focus on diseases with limited or no market and potentially incorporate direct investment in research. CONCLUSIONS: First, access to medicines is perceived to be a major problem in India by all stakeholders, but affordability is just one factor. Second, stakeholders despite considerable support for the idea of the HIF, there are major concerns about scaleability, generalisability and impact on access to medicines. Third, the HIF and other novel drug-related health policies can afford to be more radical, e.g. working outside the existing intellectual property rights regime, targeting generic as well as branded drugs, or extending to research and development. Further innovations in access to medicines must involve country-specific key stakeholders in order to increase the likelihood of their success.