Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial.

BACKGROUND: New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS: We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS: While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION: The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

QTRAP LC/MS/MS of Garlic Nanoparticles and Improving Sunflower Oil Stabilization during Accelerated Shelf Life Storage.

The purpose of this research was to assess and utilize the bioactive compounds of garlic nanoparticles (Ga-NPs) as a natural antioxidant in sunflower oil (SFO) stored at 65 ± 1 °C for 24 days. The garlic nanoparticles (Ga-NPs) from the Balady cultivar were prepared, characterized, and added to SFO at three concentrations: 200, 600, and 1000 ppm (w/v), and they were compared with 600 ppm garlic lyophilized powder extract (Ga-LPE), 200 ppm BHT, 200 ppm α-tocopherol, and SFO without Ga-NPs (control). The QTRAP LC/MS/MS profile of Ga-NPs revealed the presence of four organosulfur compounds. Ga-NPs exhibited the highest capacity for phenolic, flavonoid, and antioxidant compounds. In Ga-NP SFO samples, the values of peroxide, p-anisidine, totox, conjugated dienes, and conjugated trienes were significantly lower than the control. The antioxidant indices of SFO samples containing Ga-NPs were higher than the control. The Ga-NPs enhanced the sensory acceptability of SFO treatments up to day 24 of storage. The shelf life of SFO treated with Ga-NPs was substantially increased (presuming a Q10 amount). The results show that Ga-NPs are a powerful antioxidant that improves SFO stability and extends the shelf life (~384 days at 25 °C).

Expert consensus for in-hospital neurorehabilitation during the COVID-19 pandemic in low- and middle-income countries.

Background: People with neurological dysfunction have been significantly affected by the ongoing coronavirus disease 2019 (COVID-19) crisis in receiving adequate and quality rehabilitation services. There are no clear guidelines or recommendations for rehabilitation providers in dealing with patients with neurological dysfunction during a pandemic situation especially in low- and middle-income countries. The objective of this paper was to develop consensus-based expert recommendations for in-hospital based neurorehabilitation during the COVID-19 pandemic for low- and middle-income countries based on available evidence.  Methods: A group of experts in neurorehabilitation consisting of neurologists, physiotherapists and occupational therapists were identified for the consensus groups. A scoping review was conducted to identify existing evidence and recommendations for neurorehabilitation during COVID-19. Specific statements with level 2b evidence from studies identified were developed. These statements were circulated to 13 experts for consensus. The statements that received ≥80% agreement were grouped in different themes and the recommendations were developed.  Results: 75 statements for expert consensus were generated. 72 statements received consensus from 13 experts. These statements were thematically grouped as recommendations for neurorehabilitation service providers, patients, formal and informal caregivers of affected individuals, rehabilitation service organizations, and administrators.  Conclusions: The development of this consensus statement is of fundamental significance to neurological rehabilitation service providers and people living with neurological disabilities. It is crucial that governments, health systems, clinicians and stakeholders involved in upholding the standard of neurorehabilitation practice in low- and middle-income countries consider conversion of the consensus statement to minimum standard requirements within the context of the pandemic as well as for the future.

Additive association of knowledge and awareness on control of hypertension: a cross-sectional survey in rural India.

OBJECTIVE: To determine whether there is an interaction between knowledge about hypertension and awareness of hypertension on the treatment and control of hypertension in three regions of South India at different stages of epidemiological transition (see Video, Supplemental Digital Content 1, http://links.lww.com/HJH/B426). METHODS: Using a cross-sectional design, we randomly selected villages within each of rural Trivandrum, West Godavari, and Chittoor. Sampling was stratified by age group and sex. We measured blood pressure and administered a questionnaire to determine knowledge and awareness of hypertension. Logistic regression was used to assess associations of awareness and knowledge about hypertension with its treatment and control in participants with hypertension, while examining for statistical interaction. RESULTS: Among a total of 11 657 participants (50% male; median age 45 years), 3455 had hypertension. In analyses adjusted for age and sex, both knowledge score [adjusted odds ratio (aOR) 1.14 [95% confidence interval (CI) 1.12--1.17)] and awareness [aOR 104 (95% CI 82--134)] were associated with treatment for hypertension. Similarly, both knowledge score [aOR 1.10; 95% CI (1.08--1.12)] and awareness [aOR 13.4; 95% CI (10.7--16.7)], were positively associated with control of blood pressure in those with hypertension, independent of age and sex. There was an interaction between knowledge and awareness on both treatment and control of hypertension (P of attributable proportion <0.001 for each). CONCLUSION: Health education to improve knowledge about hypertension and screening programs to improve awareness of hypertension may act in an additive fashion to improve management of hypertension in rural Indian populations.

Family-led rehabilitation in India (ATTEND)-Findings from the process evaluation of a randomized controlled trial.

BACKGROUND: Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. AIMS: This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients', carers', and providers' perspectives. METHODS: Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. RESULTS: Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients' motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. CONCLUSION: Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development.

A contemporary picture of the burden of death and disability in Indian adolescents: data from the Global Burden of Disease Study.

Background: Adolescents (10-19 years old) comprise a fifth of the Indian population (253.2 million), yet there is very little published information about the burden of disease and injury for this age group. This paper aims to provide a contemporary picture of the leading causes of death and disability for Indian adolescent girls and boys for 2013, and changes in deaths and disability between 1990 and 2013. Methods: Data from the Global Burden of Disease (GBD) study for India, for the years 1990 and 2013, were accessed. Data were categorized into two age groups: 10 to 14 years (younger adolescents) and 15 to 19 years (older adolescents) and analysed separately for girls and boys. Results: The study shows that for both younger and older adolescent boys and for older adolescent girls, non-communicable diseases (NCDs) and injuries are responsible for a greater number of deaths and disability-adjusted life-years (DALYs) than communicable diseases. Communicable diseases are still important causes of death and disability for young adolescents. Among older adolescents there is an increasing burden of death and disability due to self-harm, road traffic injuries, fire- and heat-related injuries and mental disorders such as depressive disorders. Conclusions: Although strategies to reduce the burden of communicable diseases among adolescents must continue to be an important focus, innovative, evidence-based strategies aimed at reducing the growing burden of NCDs and injuries must be elevated as a priority.

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.

Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol.

INTRODUCTION: Hypertension is emerging in rural populations of India. Barriers to diagnosis and treatment of hypertension may differ regionally according to economic development. Our main objectives are to estimate the prevalence, awareness, treatment and control of hypertension in 3 diverse regions of rural India; identify barriers to diagnosis and treatment in each setting and evaluate the feasibility of a community-based intervention to improve control of hypertension. METHODS AND ANALYSIS: This study includes 4 main activities: (1) assessment of risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours in ∼14 500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an intervention provided by Accredited Social Health Activists (ASHAs), comprising group-based education and support for individuals with hypertension to self-manage blood pressure. Wards/villages/hamlets of a larger Mandal are identified as the primary sampling unit (PSU). PSUs are then randomly selected for inclusion in the cross-sectional survey, with further randomisation to intervention or control. Changes in knowledge of hypertension and risk factors, and clinical and anthropometric measures, are assessed. Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs. ETHICS AND DISSEMINATION: Approval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health and Family Welfare (India), institutional review boards at each site and Monash University. In addition to publication in peer-reviewed articles, results will be shared with federal, state and local government health officers, local healthcare providers and communities. TRIAL REGISTRATION NUMBER: CTRI/2016/02/006678; Pre-results.

Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial.

BACKGROUND: Globally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are often unaffordable in many populations but evidence from systematic reviews of stroke unit care and early supported discharge rehabilitation trials suggest that some components might form the basis of affordable interventions in low-resource settings. We describe the background, history and design of the ATTEND trial, a complex intervention centred on family-led stroke rehabilitation in India. METHODS/DESIGN: The ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India. DISCUSSION: The ATTEND trial is testing the effectiveness of a low-cost rehabilitation intervention that could be widely generalizable to other low- and middle-income countries. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2013/04/003557 . Australian New Zealand Clinical Trials Registry ACTRN12613000078752 . Universal Trial Number U1111-1138-6707.

Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India.

INTRODUCTION: We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. METHODS AND ANALYSIS: The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. ETHICS AND DISSEMINATION: The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. TRIAL REGISTRATION NUMBER: CTRI/2013/04/003557.

FAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study.

BACKGROUND: The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care. METHODS: A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133. RESULTS: A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study. CONCLUSION: The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.

Task shifting for non-communicable disease management in low and middle income countries--a systematic review.

BACKGROUND: One potential solution to limited healthcare access in low and middle income countries (LMIC) is task-shifting- the training of non-physician healthcare workers (NPHWs) to perform tasks traditionally undertaken by physicians. The aim of this paper is to conduct a systematic review of studies involving task-shifting for the management of non-communicable disease (NCD) in LMIC. METHODS: A search strategy with the following terms "task-shifting", "non-physician healthcare workers", "community healthcare worker", "hypertension", "diabetes", "cardiovascular disease", "mental health", "depression", "chronic obstructive pulmonary disease", "respiratory disease", "cancer" was conducted using Medline via Pubmed and the Cochrane library. Two reviewers independently reviewed the databases and extracted the data. FINDINGS: Our search generated 7176 articles of which 22 were included in the review. Seven studies were randomised controlled trials and 15 were observational studies. Tasks performed by NPHWs included screening for NCDs and providing primary health care. The majority of studies showed improved health outcomes when compared with usual healthcare, including reductions in blood pressure, increased uptake of medications and lower depression scores. Factors such as training of NPHWs, provision of algorithms and protocols for screening, treatment and drug titration were the main enablers of the task-shifting intervention. The main barriers identified were restrictions on prescribing medications and availability of medicines. Only two studies described cost-effective analyses, both of which demonstrated that task-shifting was cost-effective. CONCLUSIONS: Task-shifting from physicians to NPHWs, if accompanied by health system re-structuring is a potentially effective and affordable strategy for improving access to healthcare for NCDs. Since the majority of study designs reviewed were of inadequate quality, future research methods should include robust evaluations of such strategies.