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1.
Indian J Public Health ; 68(2): 243-250, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38953813

RESUMEN

BACKGROUND: There are several leadership training programs for health researchers in India. However, there is a need to develop context-tailored leadership and mentoring approaches. OBJECTIVE: The objective of the study is to critically analyze the available leadership training programs in India for health researchers and service providers, for the leadership domains incorporated and overall training approaches. MATERIALS AND METHODS: We used an exploratory-descriptive design to identify and review leadership training programs for health researchers and service providers/managers that had been offered by Indian institutions between 2013 and 2018. Our analytic approach was based on "transformational leadership" and "leader-member exchange" theories of leadership, curricula of popular leadership training programs worldwide, and the International Clinical Epidemiology Network model for leadership in health research in India based on a nationwide primary study. RESULTS: We identified and reviewed 20 leadership training programs. These were heterogeneous in aim, scope (broad-based/thematic), course content, design, target participants and class profile, mode of delivery and training method, duration, frequency, and fund arrangements. The programs infrequently included topics on soft skills, mentoring, risk mitigation, collaboration for research, funding dynamics, institutional transformation, self-view and peer perception, and personal well-being. The programs insufficiently addressed contextual challenges of career exploration and risk mitigation, project management, strategic planning, and decision-making, ethics and integrity, negotiations, networking and collaboration, understanding funding dynamics, and mentoring. Only three programs linked to the training to the participants' ecosystem. CONCLUSIONS: There is a need to develop customized course contents and training strategies that address the requirements of the local context vis-à-vis globally connected research ecosystems.


Asunto(s)
Liderazgo , India , Humanos , Curriculum , Investigadores/educación , Investigación sobre Servicios de Salud , Tutoría/organización & administración
2.
Trials ; 25(1): 458, 2024 Jul 05.
Artículo en Inglés | MEDLINE | ID: mdl-38970042

RESUMEN

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.


Asunto(s)
Sepsis Neonatal , Humanos , Recién Nacido , Sepsis Neonatal/diagnóstico , Sepsis Neonatal/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Determinación de Punto Final/normas , India , Probióticos/uso terapéutico , Probióticos/efectos adversos , Resultado del Tratamiento , Mortalidad Infantil , Proyectos de Investigación , Tamaño de la Muestra
3.
PLoS One ; 19(6): e0305159, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38941353

RESUMEN

Biomedical research collaborations are to be contextualized in the larger global health agenda which also opens up new information pathways, expands research networks, and brings additional resources. A qualitative inquiry was employed to understand the perceived benefits and challenges of research collaborations by biomedical scientists from India (Global South [GS] country) and the Global North (GN). In-depth interviews were conducted with 47 biomedical scientists from India and 06 from the GN. The data was analyzed using the grounded theory approach. Complementarity of skills and resources, access to funds, improved quality of work, an opportunity to conduct multi-centric studies, development of collaborative networks, better and larger number of publications, mutual learning, opportunity to work with credible researchers, address common interests, leverage interpersonal and trusted relationships and larger societal good were some of the critical factors for eagerness of participants in joint scientific endeavors. However, the challenging aspects of dissent and disagreements were the power imbalance between the collaborators, the development of a trust deficit, and local administrative issues. The challenges reported in the current publication, also echoed in several previous publications can be surmounted and negotiated amicably when the rules of the game, law of the land, sharing of the credits, and interest of the collaborating parties are addressed and agreed up in a fair and just manner before the start of the collaboration. Overall biomedical partnerships are complex collaborations with its challenges, the processes are dynamic and outcomes are emergent. This requires constant and proactive evolution of the preparation, implementation and sustainability of the collaborative efforts be it national or international.


Asunto(s)
Investigación Biomédica , Conducta Cooperativa , Investigadores , India , Humanos , Investigadores/psicología , Femenino , Masculino , Cooperación Internacional
5.
Sci Rep ; 14(1): 6664, 2024 03 20.
Artículo en Inglés | MEDLINE | ID: mdl-38509132

RESUMEN

Both developed and developing countries carry a large burden of pediatric intussusception. Sentinel site surveillance-based studies have highlighted the difference in the regional incidence of intussusception. The objectives of this manuscript were to geospatially map the locations of hospital-confirmed childhood intussusception cases reported from sentinel hospitals, identify clustering and dispersion, and reveal the potential causes of the underlying pattern. Geospatial analysis revealed positive clustering patterns, i.e., a Moran's I of 0.071 at a statistically significant (p value < 0.0010) Z score of 16.14 for the intussusception cases across India (cases mapped n = 2221), with 14 hotspots in two states (Kerala = 6 and Tamil Nadu = 8) at the 95% CI. Granular analysis indicated that 67% of the reported cases resided < 50 km from the sentinel hospitals, and the average travel distance to the sentinel hospital from the patient residence was calculated as 47 km (CI 95% min 1 km-max 378 km). Easy access and facility referral preferences were identified as the main causes of the existing clustering pattern of the disease. We recommend designing community-based surveillance studies to improve the understanding of the prevalence and regional epidemiological burden of the disease.


Asunto(s)
Intususcepción , Humanos , Niño , India/epidemiología , Intususcepción/epidemiología , Intususcepción/etiología , Prevalencia , Hospitales , Vigilancia de Guardia
6.
ACS Chem Neurosci ; 14(22): 3975-3978, 2023 11 15.
Artículo en Inglés | MEDLINE | ID: mdl-37878665

RESUMEN

Alzheimer's disease (AD) is a devastating neurodegenerative disorder that affects millions of people worldwide. The characteristic pathological manifestation of AD includes the deposition of extracellular insoluble ß amyloid plaques and intracellular neurofibrillary tangles formed from hyperphosphorylated tau protein. Cost effective and minimally invasive peripheral blood-based biomarkers are critical for early AD diagnosis. Currently, the plasma based two fraction of ß amyloid peptide ratio (Aß42/40) and phosphorylated tau (p-tau) are considered as blood-based biomarkers for AD diagnosis. Recent research indicates that oxidative stress (OS) occurs prior to amyloid plaque (Aß) formation and abnormal tau phosphorylation in AD. The imbalance of the master antioxidant, glutathione (GSH), and prooxidants (iron, zinc, and copper)─plays a crucial role in AD neurodegeneration. We present peripheral blood-based OS related biomarkers that are mechanistically involved in the disease process and may serve as a novel screening tool for early detection of AD onset. This OS based approach may also provide a quick and cost efficient method to monitor the effects of disease-modifying therapies in AD clinical trials.


Asunto(s)
Enfermedad de Alzheimer , Humanos , Enfermedad de Alzheimer/metabolismo , Proteínas tau/metabolismo , Péptidos beta-Amiloides/metabolismo , Ovillos Neurofibrilares/metabolismo , Biomarcadores
7.
J Glob Health ; 13: 04062, 2023 Aug 18.
Artículo en Inglés | MEDLINE | ID: mdl-37594179

RESUMEN

Background: Information on the average and incremental costs of implementing alternative strategies for treating young infants 0-59 days old in primary health facilities with signs of possible serious bacterial infection (PSBI) when a referral is not feasible is limited but valuable for policymakers. Methods: Direct activity costs were calculated for outpatient treatment of PSBI and pneumonia in two districts of India: Palwal, Haryana and Lucknow, Uttar Pradesh. These included costs of staff time and consumables for initial assessment, classification, and referrals; recommended treatment of fast breathing (oral amoxicillin for seven days) and PSBI (injection gentamicin and oral amoxicillin for seven days); and daily assessments. Indirect operational costs included staff training; staff time cost for general management, supervision, and coordination; referral transport; and communication. Results: The average cost per young infant treated for recommended and acceptable treatment for PSBI was 16 US dollars (US$) (95% CI = US$15.4-16.3) in 2018-19 and US$18.5 in 2022 (adjusted for inflation) when all direct and indirect operational costs were considered. The average cost of recommended treatment for pneumonia was US$10.1 (95% CI = US$9.7-10.6) or US$11.7 in 2022, per treated young infant. The incremental cost 2018-2019 for supplies, medicines, and operations (excluding staff time costs) per infant treated for PSBI was US$6.1 and US$4.3 and for pneumonia was US$3.5 and US$2.2 in Palwal and Lucknow, respectively. Operation and administrative costs were 25% in Palwal and 12% in Lucknow of the total PSBI treatment costs. The average cost per live birth for treating PSBI in each population was US$5 in Palwal and US$3 in Lucknow. Higher operation costs for social mobilisation activities in Palwal led to the empowerment of families and timely care-seeking. Conclusions: Costs of treatment of PSBI with the recommended regimen in an outpatient setting, when a referral is not feasible, are under US$20 per treated child and must be budgeted to reduce deaths from neonatal sepsis. The investment must be made in activities that lead to successful identification, prompt care seeking, timely initiation of treatment and follow-up.


Asunto(s)
Infecciones Bacterianas , Pacientes Ambulatorios , Niño , Recién Nacido , Lactante , Humanos , Instituciones de Atención Ambulatoria , Amoxicilina , India , Atención Primaria de Salud
8.
BMJ Open ; 13(8): e066644, 2023 08 09.
Artículo en Inglés | MEDLINE | ID: mdl-37558443

RESUMEN

INTRODUCTION: Indian Council of Medical Research (ICMR), New Delhi has established a nationwide registry 'Indian Registry for Venous Thromoembolism Disorder (i-RegVeD)' for real-time analytics of sociodemographic profile of patients, disease patterns, management strategies, treatment choices and outcomes of patients with venous thromboemobolism (VTE). The purpose is to generate evidence on VTE in order to fill the gaps in the knowledge of the disease across various demographic regions. METHODS AND ANALYSIS: This prospective hospital-based registry will be a continuous data collection process on the occurrence and characteristics of VTE from the 16 hospital sites pan India. This process would include obtaining clinical profiles, risk factors, diagnostic tests, treatment and outcome information of patients collected from medical records through an active method of data abstraction and data capture mechanism guided by an online web-based tool. ETHICS AND DISSEMINATION: At centralised programme management unit, the study protocol was approved by the Institutional Ethics Committees (IEC) named ICMR-Central Ethics Committee on Human Research and similarly each of the participating site has obtained the ethical approval by their respective IECs. The results from this study will be disseminated publicly on the study website (https://iregved.icmr.org.in) as well as through scientific meetings and publications.


Asunto(s)
Tromboembolia Venosa , Humanos , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/terapia , Tromboembolia Venosa/etiología , Estudios Prospectivos , Comités de Ética en Investigación , Hospitales , Sistema de Registros , India/epidemiología
9.
Vaccine ; 41(22): 3399-3402, 2023 05 22.
Artículo en Inglés | MEDLINE | ID: mdl-37121805

RESUMEN

Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or "pseudo unblinding," in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.


Asunto(s)
Vacunación , Vacunas , Humanos , Vacunación/efectos adversos , Vacunas/efectos adversos
10.
BMJ Open ; 13(3): e068215, 2023 03 29.
Artículo en Inglés | MEDLINE | ID: mdl-36990484

RESUMEN

INTRODUCTION: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. METHODS AND ANALYSIS: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost-utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. ETHICS AND DISSEMINATION: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. REGISTRATION: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. TRIAL REGISTRATION NUMBER: CTRI/2019/05/019197; Clinical Trial Registry.


Asunto(s)
Sepsis Neonatal , Probióticos , Recién Nacido , Humanos , Lactante , Sepsis Neonatal/prevención & control , Análisis Costo-Beneficio , Peso al Nacer , India , Probióticos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto
11.
Healthcare (Basel) ; 11(3)2023 Jan 31.
Artículo en Inglés | MEDLINE | ID: mdl-36766985

RESUMEN

BACKGROUND: Six diverse Demographic Development and Environmental Surveillance System (DDESS) sites were established in urban slum, urban resettlement, peri-urban, rural, and tribal areas located in Northern, North-East, Eastern, and Southern regions of India from June 2020 to March 2022. Understanding the community dynamics and engaging people in the community is critically important in the process of establishing DDESS. We ascertained the barriers, challenges, and facilitators during the establishment of multiple DDESS sites across India. METHODS: This was a cross-sectional descriptive mixed-methods study. RESULTS: Multiple barriers and challenges encountered were reported in the process of community engagement (CE), such as geographical inaccessibility, language barriers, adverse weather, non-responsiveness due to perceived lack of individual benefit or financial gain, fear of contracting COVID-19, COVID-19 vaccine hesitancy, etc. Facilitators in the CE process were pre-existing links with the community, constitution of community advisory boards, community need assessment, concomitant delivery of outreach health services, and skill-building facilities. CONCLUSION: Most community barriers in the development of DDESS sites in resource-limited settings can be overcome through a multipronged approach, including effective community engagement by focusing on demonstrating trust at the local level, enlisting community mobilization and support, utilizing pre-existing community linkages, initiating community diagnosis, and meeting perceived community health needs.

13.
Front Public Health ; 10: 956422, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36249255

RESUMEN

Background: Home visitation has emerged as an effective model to provide high-quality care during pregnancy, childbirth, and post-natal period and improve the health outcomes of mother- new born dyad. This 3600 assessment documented the constraints faced by the community health workers (known as the Accredited Social Health Activists, ASHAs) to accomplish home visitation and deliver quality services in a poor-performing district and co-created the strategies to overcome these using a nexus planning approach. Methods: The study was conducted in the Raisen district of Madhya Pradesh, India. The grounded theory approach was applied for data collection and analysis using in-depth interviews, and focus group discussions with stakeholders representing from health system (including the ASHAs) and the community (rural population). A key group of diverse stakeholders were convened to utilize the nexus planning five domain framework (social-cultural, educational, organizational, economic, and physical) to prioritize the challenges and co-create solutions for improving the home visitation program performance and quality. The nexus framework provides a systemic lens for evaluating the success of the ASHAs home visitation program. Results: The societal (caste and economic discrimination), and personal (domestic responsibilities and cultural constraints of working in the village milieu) issues emerged as the key constraints for completing home visits. The programmatic gaps in imparting technical knowledge and skills, mentoring system, communication abilities, and unsatisfactory remuneration system were the other barriers to the credibility of the services. The nexus planning framework emphasized that each of the above factors/domains is intertwined and affects or depends on each other for home-based maternal and newborn care services delivered with quality through the ASHAs. Conclusion: The home visitation program services, quality and impact can be enhanced by addressing the social-cultural, organizational, educational, economic, and physical nexus domains with concurrent efforts for skill and confidence enhancement of the ASHAs and their credibility.


Asunto(s)
Agentes Comunitarios de Salud , Visita Domiciliaria , Femenino , Humanos , Lactante , Recién Nacido , Madres , Embarazo , Investigación Cualitativa , Población Rural
15.
Indian J Med Res ; 155(5&6): 513-517, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35859397

RESUMEN

COVID-19 was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Since then, efforts were initiated to develop safe and effective vaccines. Till date, 11 vaccines have been included in the WHO's emergency use list. The emergence and spread of variant strains of SARS-CoV-2 has altered the disease transmission dynamics, thus creating a need for continuously monitoring the real-world effectiveness of various vaccines and assessing their overall impact on disease control. To achieve this goal, the Indian Council of Medical Research (ICMR) along with the Ministry of Health and Family Welfare, Government of India, took the lead to develop the India COVID-19 Vaccination Tracker by synergizing three different public health databases: National COVID-19 testing database, CoWIN vaccination database and the COVID-19 India portal. A Vaccine Data Analytics Committee (VDAC) was constituted to advise on various modalities of the proposed tracker. The VDAC reviewed the data related to COVID-19 testing, vaccination and patient outcomes available in the three databases and selected relevant data points for inclusion in the tracker, following which databases were integrated, using common identifiers, wherever feasible. Multiple data filters were applied to retrieve information of all individuals ≥18 yr who died after the acquisition of COVID-19 infection with or without vaccination, irrespective of the time between vaccination and test positivity. Vaccine effectiveness (VE) against the reduction of mortality and hospitalizations was initially assessed. As compared to the hospitalization data, mortality reporting was found to be much better in terms of correctness and completeness. Therefore, hospitalization data were not considered for analysis and presentation in the vaccine tracker. The vaccine tracker thus depicts VE against mortality, calculated by a cohort approach using person-time analysis. Incidence of COVID-19 deaths among one- and two-dose vaccine recipients was compared with that among unvaccinated groups, to estimate the rate ratios (RRs). VE was estimated as 96.6 and 97.5 per cent, with one and two doses of the vaccines, respectively, during the period of reporting. The India COVID-19 Vaccination Tracker was officially launched on September 9, 2021. The high VE against mortality, as demonstrated by the tracker, has helped aid in allaying vaccine hesitancy, augmenting and maintaining the momentum of India's COVID-19 vaccination drive.


Asunto(s)
COVID-19 , Vacunas , Humanos , Vacunas contra la COVID-19 , COVID-19/epidemiología , COVID-19/prevención & control , SARS-CoV-2 , Prueba de COVID-19
16.
PLoS One ; 17(6): e0269524, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35696401

RESUMEN

INTRODUCTION: Research on simplified antibiotic regimens for outpatient treatment of 'Possible Serious Bacterial Infection' (PSBI) and the subsequent World Health Organization (WHO) guidelines provide an opportunity to increase treatment coverage. This multi-country implementation research initiative aimed to learn how to implement the WHO guideline in diverse contexts. These experiences have been individually published; this overview paper provides a summary of results and lessons learned across sites. METHODS SUMMARY: A common mixed qualitative and quantitative methods protocol for implementation research was used in eleven sites in the Democratic Republic of Congo (Equateur province), Ethiopia (Tigray and Oromia regions), India (Haryana, Himachal Pradesh, Maharashtra, and Uttar Pradesh states), Malawi (Central Region), Nigeria (Kaduna and Oyo states), and Pakistan (Sindh province). Key steps in implementation research were: i) policy dialogue with the national government and key stakeholders, ii) the establishment of a 'Technical Support Unit' with the research team and district level managers, and iii) development of an implementation strategy and its refinement using an iterative process of implementation, programme learning and evaluation. RESULTS SUMMARY: All sites successfully developed and evaluated an implementation strategy to increase coverage of PSBI treatment. During the study period, a total of 6677 young infants from the study catchment area were identified and treated at health facilities in the study area as inpatients or outpatients among 88179 live births identified. The estimated coverage of PSBI treatment was 75.7% (95% CI 74.8% to 78.6%), assuming a 10% incidence of PSBI among all live births. The treatment coverage was variable, ranging from 53.3% in Lucknow, India to 97.3% in Ibadan, Nigeria. The coverage of inpatient treatment ranged from 1.9% in Zaria, Nigeria, to 33.9% in Tigray, Ethiopia. The outpatient treatment coverage ranged from 30.6% in Pune, India, to 93.6% in Zaria, Nigeria. Overall, the case fatality rate (CFR) was 14.6% (95% CI 11.5% to 18.2%) for 0-59-day old infants with critical illness, 1.9% (95% CI 1.5% to 2.4%) for 0-59-day old infants with clinical severe infection and 0.1% for fast breathing in 7-59 days old. Among infants treated as outpatients, CFR was 13.7% (95% CI 8.7% to 20.2%) for 0-59-day old infants with critical illness, 0.9% (95% CI 0.6% to 1.2%) for 0-59-day old infants with clinical severe infection, and 0.1% for infants 7-59 days old with fast breathing. CONCLUSION: Important lessons on how to conduct each step of implementation research, and the challenges and facilitators for implementation of PSBI management guideline in routine health systems are summarised and discussed. These lessons will be used to introduce and scale-up implementation in relevant Low- and middle-income countries.


Asunto(s)
Infecciones Bacterianas , Pacientes Ambulatorios , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/terapia , Enfermedad Crítica , Humanos , India , Lactante , Nigeria/epidemiología , Derivación y Consulta
17.
EClinicalMedicine ; 50: 101506, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35770255

RESUMEN

Background: Most perinatal and neonatal deaths occur in low- and middle-income countries (LMICs), yet, quality data on burden of adverse outcomes of pregnancy is limited in such countries. Methods: A network of 21 maternity units, across seven countries, undertook surveillance for low birthweight, preterm birth, small for gestational age (SGA), stillbirths, congenital microcephaly, in-hospital neonatal deaths, and neonatal infections in a cohort of over 85,000 births from May 2019 - August 2020. For each outcome, site-specific rates per 1,000 livebirths (or per 1,000 total births for stillbirth) and 95% confidence intervals (CI) were calculated. Descriptive sensitivity analysis was conducted to gain insight regarding underreporting of four outcomes at 16 sites. Findings: Estimated rates varied across countries and sites, ranging between 43·3-329·5 and 21·4-276·6/1000 livebirths for low birthweight and preterm birth respectively and 11·8-81/1,000 livebirths for SGA. No cases of congenital microcephaly were reported by three sites while the highest estimated rate was 13/1,000 livebirths. Neonatal infection and neonatal death rates varied between 1·8-73 and 0-59·9/1000 livebirths respectively while stillbirth rates ranged between 0-57·1/1000 total births across study sites. Results from the sensitivity analysis confirmed the underreporting of congenital microcephaly and SGA in our study. Interpretation: Our study establishes site-specific baseline rates for important adverse perinatal and neonatal outcomes and addresses a critical evidence gap towards improved monitoring of benefits and risks of emerging pregnancy and neonatal interventions. Funding: The study was sponsored by the World Health Organization with funding from the Bill and Melinda Gates Foundation.

18.
Vaccine X ; 11: 100160, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35434599

RESUMEN

The WHO Global Vaccine Safety Multi-Country Collaboration study on safety in pregnancy aims to estimate the minimum detectable risk for selected perinatal and neonatal outcomes and assess the applicability of standardized case definitions for study outcomes and maternal immunization in low- and middle-income countries (LMICs). This paper documents the operational lessons learned from the study. A prospective observational study was conducted across 21 hospitals in seven countries. All births occurring at sites were screened to identify select perinatal and neonatal outcomes from May 2019 to August 2020. Up to 100 cases per outcome were recruited to assess the applicability of standardized case definitions. A multi-pronged study quality assurance plan was implemented. The impact of the COVID-19 pandemic on site functioning and project implementation was also assessed. Multi-layered ethics and administrative approvals, limited clinical documentation, difficulty in identifying outcomes requiring in-hospital follow-up, and poor quality internet connectivity emerged as important barriers to study implementation. Use of electronic platforms, application of a rigorous quality assurance plan with frequent interaction between the central and site teams helped improve data quality. The COVID-19 pandemic disrupted data collection for up to 6 weeks in some sites. Our study succeeded in establishing an international hospital-based surveillance network for evaluating perinatal and neonatal outcomes using common study protocol and procedures in geographically diverse sites with differing levels of infrastructure, clinical and health-utilization practices. The enhanced surveillance capacity of participating sites shall help support future pharmacovigilance efforts for pregnancy interventions.

19.
Front Public Health ; 10: 810353, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35400044

RESUMEN

Introduction: Large-scale sero-prevalence studies with representation from all age groups are required to estimate the true burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in the community. Serial serological surveys in fixed cohorts enable study of dynamics of viral transmission and correlates of immune response over time in the context of gradual introduction of COVID-19 vaccines and repeated upsurge of cases during the pandemic. Methods: This longitudinal study will involve follow-up of a cohort of 25,000 individuals (5,000 per site) aged 2 years and above recruited from five existing demographic surveillance sites in India. The cohort will be tested for the presence of IgG antibodies against S1/S2 spike protein subunits of SARS-CoV-2 in four rounds; once at baseline and subsequently, at intervals of 4 months for a year between January 2021 and January 2022. Neutralization assays will be carried out in a subset of seropositive samples in each round to quantify the antibody response and to estimate the durability of antibody response. Serial serological surveys will be complemented by fortnightly phone based syndromic surveillance to assess the burden of symptomatic acute febrile illness/ influenza like illness in the same cohort. A bio-repository will also be established to store the serum samples collected in all rounds of serological surveys. Discussion: The population based sero-epidemiological studies will help to determine the burden of COVID-19 at the community level in urban and rural Indian populations and guide in monitoring the trends in the transmission of SARS-CoV-2 infection. Risk factors for infection will be identified to inform future control strategies. The serial serological surveys in the same set of participants will help determine the viral transmission dynamics and durability of neutralizing immune response in participants with or without symptomatic COVID infection.


Asunto(s)
COVID-19 , COVID-19/epidemiología , Vacunas contra la COVID-19 , Estudios de Cohortes , Humanos , Estudios Longitudinales , SARS-CoV-2
20.
Arch Dis Child ; 107(7): 644-649, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34969670

RESUMEN

The World Health Organization (WHO) has a mandate to promote maternal and child health and welfare through support to governments in the form of technical assistance, standards, epidemiological and statistical services, promoting teaching and training of healthcare professionals and providing direct aid in emergencies. The Strategic and Technical Advisory Group of Experts (STAGE) for maternal, newborn, child and adolescent health and nutrition (MNCAHN) was established in 2020 to advise the Director-General of WHO on issues relating to MNCAHN. STAGE comprises individuals from multiple low-income and middle-income and high-income countries, has representatives from many professional disciplines and with diverse experience and interests.Progress in MNCAHN requires improvements in quality of services, equity of access and the evolution of services as technical guidance, community needs and epidemiology changes. Knowledge translation of WHO guidance and other guidelines is an important part of this. Countries need effective and responsive structures for adaptation and implementation of evidence-based interventions, strategies to improve guideline uptake, education and training and mechanisms to monitor quality and safety. This paper summarises STAGE's recommendations on how to improve knowledge translation in MNCAHN. They include support for national and regional technical advisory groups and subnational committees that coordinate maternal and child health; support for national plans for MNCAHN and their implementation and monitoring; the production of a small number of consolidated MNCAHN guidelines to promote integrated and holistic care; education and quality improvement strategies to support guidelines uptake; monitoring of gaps in knowledge translation and operational research in MNCAHN.


Asunto(s)
Salud del Adolescente , Servicios de Salud Materna , Adolescente , Niño , Familia , Femenino , Humanos , Recién Nacido , Estado Nutricional , Embarazo , Ciencia Traslacional Biomédica , Organización Mundial de la Salud
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