Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.

Despite progress in reducing the infant mortality in India, the neonatal mortality decline has been slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming to prevent neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention includes probiotic supplementation. This article communicates the decision by the ProSPoNS trial investigators to establish a Central Endpoint Adjudication Committee (CEAC) as an addendum to the protocol published in Trials in 2021 for the purpose of clarifying the primary outcome. In the published protocol, the study hypothesis and primary objective are based on "sepsis," the primary outcome has been specified as sepsis/PSBI, whereas the sample size estimation was performed based on the "physician diagnosed sepsis." To align all the three above, the investigators meeting, held on 17th-18th August 2023, at MGIMS Sevagram, Wardha, deliberated and unanimously agreed that "physician diagnosed sepsis" is the primary study outcome which includes sepsis/PSBI. The CEAC, chaired by an external subject expert and members including trial statistician, a microbiologist, and all site principal investigators will employ four criteria to determine "physician diagnosed sepsis": (1) blood culture status, (2) sepsis screen status, (3) PSBI/non-PSBI signs and symptoms, and (4) the clinical course for each sickness event. Importantly, this clarification maintains consistency with the approved study protocol (Protocol No. 5/7/915/2012 version 3.1 dated 14 Feb 2020), emphasizing the commitment to methodological transparency and adherence to predefined standards. The decision to utilize the guidance of a CEAC is recommended as the gold standard in multicentric complex clinical trials to achieve consistency and accuracy in assessment of outcomes.Trial registrationClinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.

The role of dairy in healthy and sustainable food systems: community voices from India.

BACKGROUND: Managing the role of dairy foods in healthy and sustainable food systems is challenging. Milk production is associated with greenhouse gas emissions and milk-based processed foods can be high in fat, sugar and salt; yet, milk production provides income generating opportunities for farmers and dairy foods provide essential nutrients to young children, with a cultural significance in many communities. This is particularly relevant to India, the world's largest producer of milk. The aim of this study was to use Photovoice, a participatory research method, to explore the experiences and perceptions of communities in India on the role of dairy products in local sustainable and healthy food systems. METHODS: Purposive sampling recruited two women's self-help groups in Visakhapatnam, Andhra Pradesh: one in a rural area and one in an urban area. A total of 31 participants (10-17 urban group and 12-14 rural group), produced photographs with captions to represent their views on how dairy was produced, sold, and consumed in their community. A discussion workshop was held in each area, with prompts to consider health and the environment. Workshop transcripts, photographs and captions were analysed qualitatively using thematic analysis. RESULTS: A range of experiences and perceptions were discussed by the two women's self help groups. Participants had an awareness of their local food system and how stages of dairy food supply chains were non-linear and inherently interconnected. Three main themes were identified: 1) Quality and value matters to producers and consumers; 2) The need to adapt to sustain dairy farmer livelihoods in water scarce areas; 3) It's not only about health. CONCLUSIONS: Moderate milk-producing states such as Andhra Pradesh will continue to develop their dairy industry through policy actions. Including communities in policy discussions through innovative methods like Photovoice can help to maximise the positive and minimise the negative role of dairy in evolving local food systems.

A Photovoice Study to Reveal Community Perceptions of Highly Processed Packaged Foods in India.

India is experiencing a nutrition transition, with sales of packaged and processed foods rapidly increasing in recent years. This study sought to understand the views and experiences of self-help groups about highly processed, packaged food in Visakhapatnam, India, using the Photovoice method. Participants were able to record, reflect on and critique their environments through participatory analysis, identifying key themes, and offering a critical lens on their food environment and experiences. On an average eight and 14 members participated in the Photovoice workshops held in urban and rural Visakhapatnam respectively. The key themes emerging from the photos and text data are that participants experienced highly processed packaged foods as being: 1) democratic (easily available and consumed by all, affordable and accessible; 2) convenient (easy to prepare) and 3) unhealthy (for human consumption and for environmental sustainability). These data demonstrate the challenges facing public health nutritionists in wishing to shift dietary behaviors to healthy habits: on the surface participants acknowledged their unhealthy characteristics, however these products may now be embedded in dietary culture. Traditional methods for changing dietary habits may not be able to capture the complexity and systems approach is required to explore the most effective entry points for affecting change.

Models of care for patients with hypertension and diabetes in humanitarian crises: a systematic review.

Care for non-communicable diseases, including hypertension and diabetes (HTN/DM), is recognized as a growing challenge in humanitarian crises, particularly in low- and middle-income countries (LMICs) where most crises occur. There is little evidence to support humanitarian actors and governments in designing efficient, effective, and context-adapted models of care for HTN/DM in such settings. This article aimed to systematically review the evidence on models of care targeting people with HTN/DM affected by humanitarian crises in LMICs. A search of the MEDLINE, Embase, Global Health, Global Indexus Medicus, Web of Science, and EconLit bibliographic databases and grey literature sources was performed. Studies were selected that described models of care for HTN/DM in humanitarian crises in LMICs. We descriptively analysed and compared models of care using a conceptual framework and evaluated study quality using the Mixed Methods Appraisal Tool. We report our findings according to PRISMA guidelines. The search yielded 10 645 citations, of which 45 were eligible for this review. Quantitative methods were most commonly used (n = 34), with four qualitative, three mixed methods, and four descriptive reviews of specific care models were also included. Most studies detailed primary care facility-based services for HTN/DM, focusing on health system inputs. More limited references were made to community-based services. Health care workforce and treatment protocols were commonly described framework components, whereas few studies described patient centredness, quality of care, financing and governance, broader health policy, and sociocultural contexts. There were few programme evaluations or effectiveness studies, and only one study reported costs. Most studies were of low quality. We concluded that an increasing body of literature describing models of care for patients with HTN/DM in humanitarian crises demonstrated the development of context-adapted services but showed little evidence of impact. Our conceptual framework could be used for further research and development of NCD models of care.