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

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

Cost-effectiveness and public health impact of RTS,S/AS01 E malaria vaccine in Malawi, using a Markov static model.

Background: The RTS,S/AS01 E malaria vaccine is being assessed in Malawi, Ghana and Kenya as part of a large-scale pilot implementation programme. Even if impactful, its incorporation into immunisation programmes will depend on demonstrating cost-effectiveness. We analysed the cost-effectiveness and public health impact of the RTS,S/AS01 E malaria vaccine use in Malawi. Methods: We calculated the Incremental Cost Effectiveness Ratio (ICER) per disability-adjusted life year (DALY) averted by vaccination and compared it to Malawi's mean per capita Gross Domestic Product. We used a previously validated Markov model, which simulated malaria progression in a 2017 Malawian birth cohort for 15 years. We used a 46% vaccine efficacy, 75% vaccine coverage, USD5 estimated cost per vaccine dose, published local treatment costs for clinical malaria and Malawi specific malaria indicators for interventions such as bed net and antimalarial use. We took a healthcare provider, household and societal perspective. Costs were discounted at 3% per year, no discounting was applied to DALYs. For public health impact, we calculated the DALYs, and malaria events averted. Results: The ICER/DALY averted was USD115 and USD109 for the health system perspective and societal perspective respectively, lower than GDP per capita of USD398.6 for Malawi. Sensitivity analyses exploring the impact of variation in vaccine costs, vaccine coverage rate and coverage of four doses showed vaccine implementation would be cost-effective across a wide range of different outcomes. RTS,S/AS01 was predicted to avert a median of 93,940 (range 20,490-126,540) clinical cases and 394 (127-708) deaths for the three-dose schedule, or 116,480 (31,450-160,410) clinical cases and 484 (189-859) deaths for the four-dose schedule, per 100 000 fully vaccinated children. Conclusions: We predict the introduction of the RTS,S/AS01 vaccine in the Malawian expanded programme of immunisation (EPI) likely to be highly cost effective.