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It is widely assumed that telehealth tools like mHealth (mobile health), telemedicine, and tele-education can supplement the efficiency of Healthcare Providers (HCPs). We conducted a systematic review of evidence on the barriers and facilitators associated with the use of telehealth by HCPs in India. A systematic literature search following a pre-registered protocol (https://doi.org/10.17605/OSF.IO/KQ3U9 [PROTOCOL DOI]) was conducted on PubMed. The search strategy, inclusion, and exclusion criteria were based on the World Health Organization's action framework on Human Resources for Health (HRH) and Universal Health Coverage (UHC) in India with a specific focus on telehealth tools. Eligible articles published in English from 1st January 2001 to 17th February 2022 were included. One hundred and six studies were included in the review. Of these, 53 studies (50%) involved mHealth interventions, 25 (23.6%) involved telemedicine interventions whereas the remaining 28 (26.4%) involved the use of tele-education interventions by HCPs in India. In each category, most of the studies followed a quantitative study design and were mostly published in the last 5 years. The study sites were more commonly present in states in south India. The facilitators and barriers related to each type of intervention were analyzed under the following sub-headings- 1) Human resource related, 2) Application related 3) Technical, and 4) Others. The interventions were most commonly used for improving the management of mental health, non-communicable diseases, and maternal and child health. The use of telehealth has not been uniformly studied in India. The facilitators and barriers to telehealth use need to be kept in mind while designing the intervention. Future studies should focus on looking at region-specific, intervention-specific, and health cadre-specific barriers and facilitators for the use of telehealth.

Abstract 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 registration Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.

Summary: Background: There are limited global data on head-to-head comparisons of vaccine platforms assessing both humoral and cellular immune responses, stratified by pre-vaccination serostatus. The COVID-19 vaccination drive for the Indian population in the age group 18–45 years began in April 2021 when seropositivity rates in the general population were rising due to the delta wave of COVID-19 pandemic during April–May 2021. Methods: Between June 30, 2021, and Jan 28, 2022, we enrolled 691 participants in the age group 18–45 years across four clinical sites in India. In this non-randomised and laboratory blinded study, participants received either two doses of Covaxin® (4 weeks apart) or two doses of Covishield™ (12 weeks apart) as per the national vaccination policy. The primary outcome was the seroconversion rate and the geometric mean titre (GMT) of antibodies against the SARS-CoV-2 spike and nucleocapsid proteins post two doses. The secondary outcome was the frequency of cellular immune responses pre- and post-vaccination. Findings: When compared to pre-vaccination baseline, both vaccines elicited statistically significant seroconversion and binding antibody levels in both seronegative and seropositive individuals. In the per-protocol cohort, Covishield™ elicited higher antibody responses than Covaxin® as measured by seroconversion rate (98.3% vs 74.4%, p

Abstract 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. Hence, an observational study to assess perceived distress was nested in a phase IV alternate and reduced dose schedule trial of the pneumococcal conjugate vaccine (PCV) in which nasopharyngeal swab (NPS) was used to collect nasopharyngeal secretions as part of the study procedure. Out of 805 infant participants enrolled in the main study, a total of 425 infants were enrolled and observed for procedural distress at 18 weeks and 10 months of age using the Face Leg Activity Cry and Consolability (FLACC) Scale. The FLACC score and duration of cry were recorded. The mean FLACC score changed substantially from preprocedural to procedure in both age groups (from 0.08 to 5.8 at 18 weeks and from 0.5 to 7.007 at 10 months. P =

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. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.

BackgroundPregnancy 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.MethodsWe selected 11 studies from the 1669 records identified from PubMed, CABI, EMBASE and Global Health databases. Studies related to both pandemic and routine influenza vaccination and studies conducted amongst women in the antenatal as well as postnatal period were included. Both qualitative, quantitative, cross-sectional and interventional studies were included.ResultsKnowledge about influenza disease, perception of the disease severity during pregnancy and risk to the foetus/newborn and perceived benefits of influenza vaccination during pregnancy were associated with increased uptake of influenza vaccination during pregnancy. Recommendation by health care provider, vaccination in previous pregnancy and availability of vaccine in public health system facilitated vaccine uptake. High parity, higher education, vaccination in the later months of pregnancy, less than 4 antenatal visits, concerns about vaccine safety and negative publicity in media were identified as barriers for influenza vaccination. Lack of government recommendation, concerns about safety and effectiveness and distrust in manufacturer were the barriers for the healthcare providers to recommend vaccination.ConclusionWhile availability of influenza vaccine in public health system can be a key to the success of vaccine implementation program, increasing the awareness about need and benefits of maternal influenza vaccination amongst pregnant women as well as their health care providers is crucial to improve the acceptance of maternal influenza vaccination in low and middle-income countries.