Evaluation of acceptability and feasibility of using manual pill organizers and pill reminder apps for improving medication adherence among elderly population from rural Maharashtra.

Background: Approximately 40%-75% of elderly individuals suffering from chronic diseases are nonadherent to medications. Manual pill organizers (MPO) and pill reminder apps (PRAs) are simple interventions that can improve medication adherence. This was a mixed-methods study to understand the feasibility and acceptability of MPO and a locally developed PRA amongst elderly individuals from rural Maharashtra.

Changes in Cardiometabolic Risk Factors Over Two Decades in a Rural Population in Western India.

Background: Surveillance and control of cardiometabolic risk factors can be a cost-effective strategy for controlling noncommunicable diseases in resource-limited settings. However, long-term studies on them in rural India are limited.

Objectives: The objective of this study was to assess the changes in the burden of cardiometabolic risk factors between the years 2005 and 2022-2023.

Medication adherence scales in non-communicable diseases: A scoping review of design gaps, constructs and validation processes.

Introduction: NCDs arise from complex interactions of modifiable factors such as unhealthy lifestyles, poor diet, and psychosocial challenges, along with non-modifiable factors like age and genetics. Notably, medication non-adherence is a widespread and growing concern, significantly contributing to disease progression and poor outcomes globally.

Objective: This scoping review aims to synthesize evidence on medication adherence scales used for selected non communicable diseases.

Effect of probiotic and prebiotics supplementation on hemoglobin levels and iron absorption among women of reproductive age and children: a systematic review and meta-analysis.

Background: This review aims to assess the effect of oral administration of probiotics and/or prebiotics in children and women of reproductive age (WRA) to improve intestinal iron absorption, hemoglobin, and ferritin levels.

Methods: Randomized controlled trials from published literature on probiotics and or prebiotics for prevention or treatment of anemia as a supplement or fortification in children or WRA till Jan 31, 2023, were included. Studies on probiotics and prebiotics in patients with anemia due to other causes were excluded.

Development and Validation of a Novel Tool to Measure Medication Adherence for Noncommunicable Diseases in India: Protocol for an Exploratory Sequential Mixed Methods Multicentric Study.

Background: In high-income countries, only 50% of patients treated for chronic diseases adhere to the prescribed treatment. This issue is even more pronounced in resource-limited countries. Medication adherence scales are simple, low-cost approaches to identify nonadherence in clinical practice.

Acceptability of Microbiota-Directed Complementary Foods in Treating Indian Children with Moderate Acute Malnutrition: eACT-MAM Pre-Proof-of-Concept Study.

Background: In India, currently, there are no standard guidelines for the management of moderate acute malnutrition (MAM). Previous research in Bangladesh has shown that children with MAM have impaired gut microbiota development, and microbiota-directed complementary foods (MDCF) can potentially repair their gut microbiota.

Objectives: The objectives of this study were to evaluate the acceptability and safety of supplementing shelf-stable formulation of MDCF in Indian children with MAM as compared with a locally prepared ready-to-use supplementary food (RUSF) in 3 geographically distinct Indian populations and to establish and pilot systems of intervention delivery, collection, transport, and storage of stool samples using stringent protocols.

A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults.

Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152).

Effect of reduced two-dose (1+1) schedule of 10 and 13-valent pneumococcal conjugate vaccines (Synflorix and Prevenar13) on nasopharyngeal carriage and serotype-specific immune response in the first two years of life: Results from an open-labelled randomized controlled trial in Indian children.

Introduction: This study aimed to assess the effect of a reduced dose regime (1 + 1) of PCV10 and PCV13 along with 3-dose regimes on pneumococcal vaccine-type (VT) carriage and immunogenicity in the first two years of life in PCV-naïve Indian children.

Methods: A total of 805 healthy infants aged 6-8 weeks were randomised to 7 groups (n = 115). Six groups received Synflorix(PCV10) or Prevenar13(PCV13) in the following schedules: 3 + 0 (three primary at 6, 10, and 14 weeks); 2 + 1 (two primary 6 and 14 weeks with booster at 9 months; 1 + 1 (one primary at 14 weeks with booster at 9 months).

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies.

Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial.

Routinely children are exposed to various procedures as a part of clinical care and/or research participation. Public health strategies to contain current COVID-19 pandemic demanded massive nasopharyngeal swab testing but limited data exist to confirm the extent of the pain and distress that result from this procedure. These data could help clinicians to formulate mitigation strategies, influence public health directives, and inform review boards/ethics committees to decide on risk-benefit ratio of the procedure.

Determinants of maternal influenza vaccination in the context of low- and middle-income countries: A systematic review.

Background: Pregnancy and early infancy are considered to be the vulnerable phases for severe influenza infection causing morbidity and mortality. Despite WHO recommendations, influenza is not included in the immunization programs of many low- and middle-income countries. This systematic review is aimed at identifying barriers and facilitators for maternal influenza vaccination amongst the perinatal women and their health care providers in low- and middle-income countries.

Nasopharyngeal pneumococcal carriage in South Asian infants: Results of observational cohort studies in vaccinated and unvaccinated populations.

Background: Nasopharyngeal pneumococcal carriage (NPC) is a prerequisite for invasive pneumococcal disease and reduced carriage of vaccine serotypes is a marker for the protection offered by the pneumococcal conjugate vaccine (PCV). The present study reports NPC during the first year of life in a vaccinated (with PCV10) cohort in Bangladesh and an unvaccinated cohort in India.

Methods: A total of 450 and 459 infants were recruited from India and Bangladesh respectively within 0-7 days after birth.

Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial.

Background: Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency.

Conducting community-based pediatric research in rural India: Experience from vadu rural health program.

This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies.

Development and Implementation of Liposomal Encapsulated Micronutrient Fortified Body Oil Intervention for Infant Massage: An Innovative Concept to Prevent Micronutrient Deficiencies in Children.

Indian communities have the ancient cultural practice of gentle oil massage for infants which has been shown to play a beneficial role in neuro-motor development. The concept of incorporating nanosized liposomes of micronutrients (i.e.

Feasibility of implementation of simplified management of young infants with possible serious bacterial infection when referral is not feasible in tribal areas of Pune district, Maharashtra, India.

Introduction: Neonatal infections are a common cause of death in India, but many families cannot access appropriate hospitals for its treatment due to various reasons. We implemented the World Health Organization PSBI management guideline when referral is not feasible within the public health system in Pune, India to evaluate feasibility, barriers and facilitators for its implementation.

Methods: A national-level consultative meeting between government officials and study partners resulted in a consensus on adaptation and implementation in four demonstration sites in selected states in India.

Demographic surveillance over 12 years helps elicit determinants of low birth weights in India.

Background: Low birth weight is an important predictor of maternal and child health. Birth weight is likely to be affected by maternal health, socioeconomic status and quality of health care facilities.

Objective: To assess trends in the birth weight, the proportion of low birth weight, maternal factors and health care facilities for delivery in villages of Western Maharashtra from the year 2004 to 2016 and to analyze factors associated with low birth weight for total birth data of 2004-2016.

Delayed vaccination and its predictors among children under 2 years in India: Insights from the national family health survey-4.

Objective: Delayed vaccination increases the susceptibility window for vaccine preventable diseases. Our analysis estimates the proportion of children between 10 and 23 months of age with delayed vaccination in India and the associated socio-demographic, maternal and child related factors.

Methods: We used individual level data from the National Family and Health Survey 4, conducted in 2015-2016.

Facilitators and barriers for use of rotavirus vaccine amongst various stakeholders and its implications for Indian context - A systematic review.

We performed a systematic review to evaluate factors affecting uptake of rotavirus vaccine amongst physicians, parents and health system. We identified 15 studies that met the inclusion criteria from 790 screened studies published between Jan 2005 to Jan 2016. Perceived severity of rotavirus disease, efficacy of vaccine and recommendation by health authorities positively influenced uptake of vaccine amongst health care providers.

Reporting of adverse events for marketed drugs: Need for strengthening safety database.

Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported.