Data Management in Multicountry Consortium Studies: The Enterics For Global Health (EFGH) Shigella Surveillance Study Example

Open Forum Infectious Diseases, Journal Year: 2024, Volume and Issue: 11(Supplement_1), P. S48 - S57

Published: March 1, 2024

Rigorous data management systems and planning are essential to successful research projects, especially for large, multicountry consortium studies involving partnerships across multiple institutions. Here we describe the development implementation of procedures Enterics For Global Health (EFGH) Shigella surveillance study-a 7-country diarrhea study that will conduct facility-based concurrent with population-based enumeration a health care utilization survey estimate incidence Shigella--associated in children 6 35 months old. The goals EFGH utilize knowledge experience members collect high-quality ensure equity access decision-making. During phase before initiation, working group representatives from each country site, coordination team, other partners met regularly develop study. This resulted Data Management Plan, which included selecting REDCap SurveyCTO as primary database systems. Consequently, laid out processing storage, monitoring reporting, quality control assurance activities, access. system associated real-time visualizations allow rapid cleaning activities progress enable quicker time analysis. Experiences this contribute toward enriching sparse landscape methods publications serve case future seeking manage consistently rigorously while maintaining equitable data.

Language: Английский

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Optimizing Vaccine Trials for Enteric Diseases: The Enterics for Global Health (EFGH) Shigella Surveillance Study

Open Forum Infectious Diseases, Journal Year: 2024, Volume and Issue: 11(Supplement_1), P. S1 - S5

Published: March 1, 2024

In this introductory article, we describe the rationale for Enterics Global Health (EFGH) Shigella surveillance study, which is largely to optimize design and implementation of pivotal vaccine trials in target population infants young children living low- middle-income countries. Such optimization will ideally lead a shorter time availability population. We also provide brief description articles included supplement.

Language: Английский

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WHO Workshop Report: Regulatory Science to Inform Clinical Pathways for Shigella Vaccines Intended for Use in Children in Low- and Middle-Income Countries

Vaccines, Journal Year: 2025, Volume and Issue: 13(5), P. 439 - 439

Published: April 23, 2025

Infectious diarrhea caused by Shigella remains a significant global health concern, and several vaccine candidates are approaching phase III clinical studies in the target population of young children low- middle-income countries. The World Health Organization (WHO) has published preferred product characteristics (PPCs) for vaccines to provide strategic guidance that aids advancing development highlights policy considerations use LMIC settings where is most needed. However, selection appropriate endpoints was not clearly defined within PPCs an important issue study design. Previously, expert panel identified areas alignment consensus on many design components while also recognizing further discussions data were required solidify recommendations key aspects. Therefore, WHO convened diverse range stakeholders, including manufacturers, regulators, policymakers across national, regional, levels, with aim achieving soliciting inputs from regulatory community surrounding considerations. intent this report outline points those inform strategies investment decisions developers donors share next steps.

Language: Английский

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Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study

Open Forum Infectious Diseases, Journal Year: 2024, Volume and Issue: 11(Supplement_1), P. S41 - S47

Published: March 1, 2024

Comparative costs of public health interventions provide valuable data for decision making. However, the availability comprehensive and context-specific is often limited. The Enterics Global Health (EFGH) Shigella surveillance study-a facility-based diarrhea study across 7 countries-aims to generate evidence on system household associated with medically attended in children. EFGH working groups comprising representatives from each country (Bangladesh, Kenya, Malawi, Mali, Pakistan, Peru, Gambia) developed methods. Over a 24-month period, surveys will collect resource use medical treatment an estimated 9800 children aged 6-35 months diarrhea. Through these surveys, we describe quantify resources used (eg, medication, supplies, provider salaries), nonmedical travel facility), amount caregiver time lost work care their sick child. To assign identified resource, combination interviews, national price lists, databases World Organization International Labor Organization. Our primary outcome be cost per inpatient outpatient episode countries, levels care, illness severity. We conduct sensitivity scenario analysis determine how unit vary scenarios. Results this contribute existing body literature costing inform future policy decisions related investments preventive strategies Shigella.

Language: Английский

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Landscape of Bacterial Enteric Disease and Traveler´s Diarrhea in South America

The Journal of Infectious Diseases, Journal Year: 2024, Volume and Issue: 231(Supplement_1), P. S10 - S18

Published: Dec. 10, 2024

Diarrheal disease is a global public health threat. Cases of enteric caused by bacterial enteropathogens result in significant burden and can lead to antimicrobial resistance patterns that increase evolve over time geography, posing serious challenges for local populations as well civilian travelers military personnel deployed endemic regions. This review describes the prevalence most common agents diarrheal South America, distribution antibiotic predominant strains are present region. Furthermore, development relevant prevention treatment strategies described, United States Naval Medical Research Unit SOUTH surveillance research efforts this regional context highlighted.

Language: Английский

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