Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design.

BACKGROUND: India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases. METHODS: This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be conducted. Qualitative and process documentation data will be used to explain how the intervention could have worked. DISCUSSION: By taking into consideration several health system building blocks and trying to understand how they interact, our study aims to generate evidence for health planners on how to optimise health services to improve access to medicines. TRIAL REGISTRATION: Protocol registered on Clinical Trials Registry of India with registration identifier number CTRI/2015/03/005640 on 17(th) March 2015.

"How can our children learn from us about our way of life or understand who they are?": Residential schools and their impact on the wellbeing of Indigenous youth in Attapadi, South India.

Residential schools are commonly used in India to provide education for Indigenous youth, which requires young people to stay for long periods at distance from their families and communities. Internationally, there is clear evidence for the deleterious effects of residential schools on the mental health and social and community outcomes of Indigenous children, however little is known about the Indian Indigenous experience. This study examined the impact of residential schooling on Indigenous children's wellbeing and that of their communities, using data from an ethnographic research project in Attapadi, Kerala, including interviews, focus group discussions and participant observation with Indigenous communities. Key outcomes from residential schooling reported by the participants include the fear of losing Indigenous identity, shame of being Indigenous, change in the attitude of young people when they returned from schools, and feelings of confusion and stress that young Indigenous participants felt trying to fit into their communities on their return. Findings suggest that these Indigenous youth felt disconnected from several factors that are known to promote resilience for Indigenous communities including a strong cultural identity, connection to the land and ancestors, thereby making them more vulnerable to poor mental health and negative impacts on their overall wellbeing. Addressing these concerns requires a detailed understanding of the specific factors influencing outcomes for Indigenous youth within the Indian residential schooling system, and designing and implementing data-informed conceptual, structural and policy change including the provision of culturally safe mental health services.

Alarming level of severe acute malnutrition in Indian districts.

Over the last two decades, severe acute malnutrition (SAM) has been increasing in India despite favourable national-level economic growth. The latest round of the National Family Health Survey 5 (NFHS-5) results was released, allowing us to assess changes in the malnutrition trends. Analysis of the previous rounds of the NFHS (NFHS-4) has already shown disturbing levels of wasting, often co-occurring with other forms of anthropometric failures. These have been shown to occur in clusters of districts across India that already needed urgent policy and programmatic action. A rapid assessment of data from NFHS-5 for some of these districts for which data are now available shows an alarming increase in SAM in several malnutrition hotspot districts. Surprisingly, some districts outside hotspots and in states and regions that have previously not been known for high malnutrition too have shown increasing SAM prevalence in the latest round. The data from NFHS-5 was collected just before the COVID-19 pandemic and hence does not yet reflect the likely impact of the pandemic on food security, livelihoods and other social stressors among the most marginalised Indian households. Based on this emerging pattern of increasing SAM, we call for an urgent policy and programmatic action to strengthen the Anganwadi system, which caters to preschool children in India and community-based management of acute malnutrition based on recent evidence on their effectiveness.

Factors influencing receipt of iron supplementation by young children and their mothers in rural India: local and national cross-sectional studies.

BACKGROUND: In India, 55% of women and 69.5% of preschool children are anaemic despite national policies recommending routine iron supplementation. Understanding factors associated with receipt of iron in the field could help optimise implementation of anaemia control policies. Thus, we undertook 1) a cross-sectional study to evaluate iron supplementation to children (and mothers) in rural Karnataka, India, and 2) an analysis of all-India rural data from the National Family Health Study 2005-6 (NFHS-3). METHODS: All children aged 12-23 months and their mothers served by 6 of 8 randomly selected sub-centres managed by 2 rural Primary Health Centres of rural Karnataka were eligible for the Karnataka Study, conducted between August and October 2008. Socioeconomic and demographic data, access to health services and iron receipt were recorded. Secondly, NFHS-3 rural data were analysed. For both studies, logistic regression was used to evaluate factors associated with receipt of iron. RESULTS: The Karnataka Study recruited 405 children and 377 of their mothers. 41.5% of children had received iron, and 11.5% received iron through the public system. By multiple logistic regression, factors associated with children's receipt of iron included: wealth (Odds Ratio (OR) 2.63 [95% CI 1.11, 6.24] for top vs bottom wealth quintile), male sex (OR 2.45 [1.47, 4.10]), mother receiving postnatal iron (OR 2.31 [1.25, 4.28]), mother having undergone antenatal blood test (OR 2.10 [1.09, 4.03]); Muslim religion (OR 0.02 [0.00, 0.27]), attendance at Anganwadi centre (OR 0.23 [0.11, 0.49]), fully vaccinated (OR 0.33 [0.15, 0.75]), or children of mothers with more antenatal health visits (8-9 visits OR 0.25 [0.11, 0.55]) were less likely to receive iron. Nationally, 3.7% of rural children were receiving iron; this was associated with wealth (OR 1.12 [1.02, 1.23] per quintile), maternal education (compared with no education: completed secondary education OR 2.15 [1.17, 3.97], maternal antenatal iron (2.24 [1.56, 3.22]), and child attending an Anganwadi (OR 1.47 [1.20, 1.80]). CONCLUSION: In rural India, public distribution of iron to children is inadequate and disparities exist. Measures to optimize receipt of government supplied iron to all children regardless of wealth and ethnic background could help alleviate anaemia in this population.

Towards a multilevel governance framework on the implementation of patient rights in health facilities: a protocol for a systematic scoping review.

INTRODUCTION: Patient rights are "those rights that are attributed to a person seeking healthcare". Patient rights have implications for quality of healthcare and acts as a key accountability tool. It can galvanise structural improvements in the health system and reinforces ethical healthcare. States are duty bound to respect, protect and promote patient rights. The rhetoric on patient rights is burgeoning across the globe. With changing modes of governance arrangements, a number of state and non-state actors and institutions at various levels play a role in the design and implementation of (patient rights) policies. However, there is limited understanding on the multilevel institutional mechanisms for patient rights implementation in health facilities. We attempt to fill this gap by analysing the available scholarship on patient rights through a critical interpretive synthesis approach in a systematic scoping review. METHODS: The review question is 'how do the multilevel actors, institutional structures, processes interact and influence the patient rights implementation in healthcare facilities? How do they work at what level and in which contexts?" Three databases PubMed, LexisNexis and Web of Science will be systematically searched until 30 th April 2020, for empirical and non-empirical literature in English from both lower middle-income countries and high-income countries. Targeted search will be performed in grey literature and through citation and reference tracking of key records. Using the critical interpretive synthesis approach, a multilevel governance framework on the implementation of patient rights in health facilities which is grounded in the data will be developed. ETHICS AND DISSEMINATION: The review uses published literature hence ethics approval is not required. The findings of the review will be published in a peer-reviewed journal. REGISTRATION NUMBER: PROSPERO 2020 CRD42020176939.

The COVID-19 pandemic: diverse contexts; different epidemics-how and why?

It is very exceptional that a new disease becomes a true pandemic. Since its emergence in Wuhan, China, in late 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, has spread to nearly all countries of the world in only a few months. However, in different countries, the COVID-19 epidemic takes variable shapes and forms in how it affects communities. Until now, the insights gained on COVID-19 have been largely dominated by the COVID-19 epidemics and the lockdowns in China, Europe and the USA. But this variety of global trajectories is little described, analysed or understood. In only a few months, an enormous amount of scientific evidence on SARS-CoV-2 and COVID-19 has been uncovered (knowns). But important knowledge gaps remain (unknowns). Learning from the variety of ways the COVID-19 epidemic is unfolding across the globe can potentially contribute to solving the COVID-19 puzzle. This paper tries to make sense of this variability-by exploring the important role that context plays in these different COVID-19 epidemics; by comparing COVID-19 epidemics with other respiratory diseases, including other coronaviruses that circulate continuously; and by highlighting the critical unknowns and uncertainties that remain. These unknowns and uncertainties require a deeper understanding of the variable trajectories of COVID-19. Unravelling them will be important for discerning potential future scenarios, such as the first wave in virgin territories still untouched by COVID-19 and for future waves elsewhere.

A community based field research project investigating anaemia amongst young children living in rural Karnataka, India: a cross sectional study.

BACKGROUND: Anaemia is an important problem amongst young children living in rural India. However, there has not previously been a detailed study of the biological aetiology of this anaemia, exploring the relative contributions of iron, vitamin B12, folate and Vitamin A deficiency, inflammation, genetic haemoglobinopathy, hookworm and malaria. Nor have studies related these aetiologic biological factors to household food security, standard of living and child feeding practices. Barriers to conducting such work have included perceived reluctance of village communities to permit their children to undergo venipuncture, and logistical issues. We have successfully completed a community based, cross sectional field study exploring in detail the causes of anaemia amongst young children in a rural setting. METHODS AND DESIGN: A cross sectional, community based study. We engaged in extensive community consultation and tailored our study design to the outcomes of these discussions. We utilised local women as field workers, harnessing the capacity of local health workers to assist with the study. We adopted a programmatic approach with a census rather than random sampling strategy in the village, incorporating appropriate case management for children identified to have anaemia. We developed a questionnaire based on existing standard measurement tools for standard of living, food security and nutrition. Specimen processing was conducted at the Primary Health Centre laboratory prior to transport to an urban research laboratory. DISCUSSION: Adopting this study design, we have recruited 415 of 470 potentially eligible children who were living in the selected villages. We achieved support from the community and cooperation of local health workers. Our results will improve the understanding into anaemia amongst young children in rural India. However, many further studies are required to understand the health problems of the population of rural India, and our study design and technique provide a useful demonstration of a successful strategy.

Affirmative action, minorities, and public services in India: Charting a future research and practice agenda.

The National Health Policy in India mentions equity as a key policy principle and emphasises the role of affirmative action in achieving health equity for a range of excluded groups. We conducted a scoping review of literature and three multi-stakeholder workshops to better understand the available evidence on the impact of affirmative action policies in enhancing the inclusion of ethnic and religious minorities in health, education and governance in India. We consider these public services an important mechanism to enhance the social inclusion of many excluded groups. On the whole, the available empirical evidence regarding the uptake and impact of affirmative action policies is limited. Reservation policies in higher education and electoral constituencies have had a limited positive impact in enhancing the access and representation of minorities. However, reservations in government jobs remain poorly implemented. In general, class, gender and location intersect, creating inter- and intra-group differentials in the impact of these policies. Several government initiatives aimed at enhancing the access of religious minorities to public services/institutions remain poorly evaluated. Future research and practice need to focus on neglected but relevant research themes such as the role of private sector providers in supporting the inclusion of minorities, the political aspects of policy development and implementation, and the role of social mobilisation and movements. Evidence gaps also need to be filled in relation to information systems for monitoring and assessment of social disadvantage, implementation and evaluative research on inclusive policies and understanding how the pathways to inequities can be effectively addressed.

Enhancing the autonomy of Indian nurses.

With additional training and qualification, nurses in several countries are recognised as independent professionals. Evidence from several countries shows that capacitating nurses to practise independently could contribute to better health outcomes. Recently, the idea of nurses practising independently has been gaining momentum in Indian health policy circles as well, and the Ministry of Health and Family Welfare is contemplating the introduction of nurse practitioners (NPs) in primary healthcare. We briefly assess the policy environment for the role of NPs in India. We argue for the need to conceptualise health stewardship anew, keeping the nursing profession in mind, within the currently doctor-centred health system in India. We argue that, in the current policy environment, conditions for independent nursing practice or for the introduction of a robust NP in primary healthcare do not yet exist.

Whose problem is it anyway? Crimes against women in India.

The recent public outcry following a brutal gang rape of a young woman in India's national capital was a watershed moment in the world's largest democracy. It generated widespread public and political support for strengthening legal provisions to punish sex offenders. Although the legal response is a useful deterrent against such heinous crimes, women continue to suffer due to deeply rooted social prejudices that make them vulnerable to violence and discrimination in society. In this commentary, we aim to analyse the current developments with respect to gender violence in India within a background of the social position of women in Indian society. Using secondary data related to sex-selective abortions and crimes against women, and a critical review of the portrayal of women in Indian cinema, we reflect on the role of health workers, researchers and public health professionals in shaping a social response towards improving gender parity in our country.

Evaluation of capacity-building program of district health managers in India: a contextualized theoretical framework.

Performance of local health services managers at district level is crucial to ensure that health services are of good quality and cater to the health needs of the population in the area. In many low- and middle-income countries, health services managers are poorly equipped with public health management capacities needed for planning and managing their local health system. In the south Indian Tumkur district, a consortium of five non-governmental organizations partnered with the state government to organize a capacity-building program for health managers. The program consisted of a mix of periodic contact classes, mentoring and assignments and was spread over 30 months. In this paper, we develop a theoretical framework in the form of a refined program theory to understand how such a capacity-building program could bring about organizational change. A well-formulated program theory enables an understanding of how interventions could bring about improvements and an evaluation of the intervention. In the refined program theory of the intervention, we identified various factors at individual, institutional, and environmental levels that could interact with the hypothesized mechanisms of organizational change, such as staff's perceived self-efficacy and commitment to their organizations. Based on this program theory, we formulated context-mechanism-outcome configurations that can be used to evaluate the intervention and, more specifically, to understand what worked, for whom and under what conditions. We discuss the application of program theory development in conducting a realist evaluation. Realist evaluation embraces principles of systems thinking by providing a method for understanding how elements of the system interact with one another in producing a given outcome.

How does capacity building of health managers work? A realist evaluation study protocol.

INTRODUCTION: There has been a lot of attention on the role of human resource management interventions to improve delivery of health services in low- and middle-income countries. However, studies on this subject are few due to limited research on implementation of programmes and methodological difficulties in conducting experimental studies on human resource interventions. The authors present the protocol of an evaluation of a district-level capacity-building intervention to identify the determinants of performance of health workers in managerial positions and to understand how changes (if any) are brought about. METHODS AND ANALYSIS: The aim of this study is to understand how capacity building works. The authors will use realist evaluation to evaluate an intervention in Karnataka, India. The intervention is a capacity-building programme that seeks to improve management capacities of health managers at district and subdistrict levels through periodic classroom-based teaching and mentoring support at the workplace. The authors conducted interviews and reviewed literature on capacity building in health to draw out the programme theory of the intervention. Based on this, the authors formulated hypothetical pathways connecting the expected outcomes of the intervention (planning and supervision) to the inputs (contact classes and mentoring). The authors prepared a questionnaire to assess elements of the programme theory-organisational culture, self-efficacy and supervision. The authors shall conduct a survey among health managers as well as collect qualitative data through interviews with participants and non-participants selected purposively based on their planning and supervision performance. The authors will construct explanations in the form of context-mechanism-outcome configurations from the results. This will be iterative and the authors will use a realist evaluation framework to refine the explanatory theories that are based on the findings to explain and validate an improved theory on 'what works for whom and under what conditions'. DISCUSSION: The scope for applying realist evaluation to study human resource management interventions in health are discussed.

Vitamin B-12, folate, iron, and vitamin A concentrations in rural Indian children are associated with continued breastfeeding, complementary diet, and maternal nutrition.

BACKGROUND: Determinants of vitamin B-12, folate, iron, and vitamin A concentrations in young children in rural south Asia are poorly understood. These micronutrients are crucial for the production of hemoglobin and have other important physiologic functions. OBJECTIVE: We sought to develop explanatory models for concentrations of vitamin B-12, folate, ferritin, and retinol binding protein (RBP) in children aged between 1 and 2 y in rural Karnataka, India. DESIGN: We performed a cross-sectional study in 12-23-mo-old toddlers who lived in 2 rural districts of Karnataka, India. For each child, data concerning dietary, food-security, and sociodemographic and maternal factors were obtained, and serum vitamin B-12, folate, ferritin, and RBP were measured. Multiple regression and structural equation modeling were applied to determine associations with micronutrient concentrations. RESULTS: Of 396 sampled children, 254 children (65.6%) had at least one micronutrient deficiency. With the use of multiple regression, continued breastfeeding was independently associated with the concentration of each micronutrient [(log) vitamin B-12: standardized coefficient of -0.30 (P < 0.001); folate: standardized coefficient of +0.20 (P < 0.001); (log) ferritin: standardized coefficient of -0.18 (P = 0.004); (log) RBP: standardized coefficient of-0.21 (P < 0.001)]. Children who continued to breastfeed received less nutrition from complementary foods and belonged to poorer families with higher food insecurity. A structural equation model for children's vitamin B-12 concentrations was developed that highlighted the interrelation between wealth, continued breastfeeding, complementary diet, and vitamin B-12 concentrations in children. CONCLUSIONS: Micronutrient deficiencies are common in this population. Rural Indian children between 1 and 2 y of age who continue to breastfeed should be especially targeted during micronutrient-supplementation programs. This trial was registered in the Australian and New Zealand Clinical Trials Registry as ACTRN12611000596909.

Determinants of anemia among young children in rural India.

OBJECTIVE: More than 75% of Indian toddlers are anemic. Data on factors associated with anemia in India are limited. The objective of this study was to determine biological, nutritional, and socioeconomic risk factors for anemia in this vulnerable age group. METHODS: We conducted a cross-sectional study of children aged 12 to 23 months in 2 rural districts of Karnataka, India. Children were excluded if they were unwell or had received a blood transfusion. Hemoglobin, ferritin, folate, vitamin B(12), retinol-binding protein, and C-reactive protein (CRP) levels were determined. Children were also tested for hemoglobinopathy, malaria infection, and hookworm infestation. Anthropometric measurements, nutritional intake, family wealth, and food security were recorded. In addition, maternal hemoglobin level was measured. RESULTS: Anemia (hemoglobin level < 11.0 g/dL) was detected in 75.3% of the 401 children sampled. Anemia was associated with iron deficiency (low ferritin level), maternal anemia, and food insecurity. Children's ferritin levels were directly associated with their iron intake and CRP levels and with maternal hemoglobin level and inversely associated with continued breastfeeding and the child's energy intake. A multivariate model for the child's hemoglobin level revealed associations with log(ferritin level) (coefficient: 1.20; P < .001), folate level (0.05; P < .01), maternal hemoglobin level (0.16; P < .001), family wealth index (0.02; P < .05), child's age (0.05 per month; P < .005), hemoglobinopathy (-1.51; P < .001), CRP level (-0.18; P < .001), and male gender (-0.38; P < .05). Wealth index and food insecurity could be interchanged in this model. CONCLUSIONS: Hemoglobin level was primarily associated with iron status in these Indian toddlers; however, maternal hemoglobin level, family wealth, and food insecurity were also important factors. Strategies for minimizing childhood anemia must include optimized iron intake but should simultaneously address maternal anemia, poverty, and food insecurity.