James H Stark1,2, Eve Wool2,3, Lena Tran2,4, Elizabeth Robinson2,5, Meaghan Chemelski2,6, Daniel Weibel7, Wan-Ting Huang8, Sonali Kochhar9, Janet R Hardy10, Steven Bailey1, Edward Galiwango11, Dan Kajungu11. 1. Worldwide Safety and Regulatory, Pfizer, New York, NY, USA. 2. College of Global Public Health, New York University, New York, NY, USA. 3. Northwell Health Solutions, Population Health Management, Manhasset, NY, USA. 4. Lucile Packard Children's Hospital Stanford, Stanford Children's Health, Palo Alto, CA, USA. 5. New York University, School of Medicine, New York, NY, USA. 6. Maine Medical Center Research Institute, Clinical Trials Office, Scarborough, ME, USA. 7. Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands. 8. Office of Preventive Medicine, Taiwan Centers for Disease Control, Taipei, Taiwan. 9. Global Healthcare Consulting; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands. 10. ECC Population Health Group and University of South Florida, Tampa, FL, USA. 11. Makerere University Centre for Health and Population Research, Iganga Mayuge Health and Demographic Surveillance Site, Iganga, Uganda.
Abstract
BACKGROUND: Standardized case definitions for obstetric and neonatal outcomes were developed by the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project. These definitions can facilitate comparable assessment of maternal immunization safety surveillance and research. This study assessed the capabilities of health centers (HC) in Uganda to implement these definitions in a low income country, which has not been explored. METHODS: Healthcare practitioners at 15 government-accredited health centers and one government-funded district hospital in the Iganga-Mayuge Health and Demographic Surveillance Site (IMHDSS) in Uganda were interviewed about the facility's clinical diagnostic and laboratory capabilities. Five obstetric and five neonatal case definitions were evaluated. Definitions with the highest diagnostic certainty were designated as level 1, while definitions that decreased in certainty were designated as level 2 or 4. HCs were evaluated on diagnostic and laboratory capabilities to apply the GAIA definitions. RESULTS: Higher-level facilities in the IMHDSS demonstrated the ability to diagnose more specific levels of the GAIA obstetric and neonatal outcomes than lower-level facilities. Furthermore, for the neonatal outcome assessment, there was an increased ability to diagnose outcomes moving from GAIA level 1 to level 3. CONCLUSIONS: The ability of health centers to implement globally standardized definitions is promising for implementation of standardized data collection methods for global vaccine safety surveillance and research.
BACKGROUND: Standardized case definitions for obstetric and neonatal outcomes were developed by the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project. These definitions can facilitate comparable assessment of maternal immunization safety surveillance and research. This study assessed the capabilities of health centers (HC) in Uganda to implement these definitions in a low income country, which has not been explored. METHODS: Healthcare practitioners at 15 government-accredited health centers and one government-funded district hospital in the Iganga-Mayuge Health and Demographic Surveillance Site (IMHDSS) in Uganda were interviewed about the facility's clinical diagnostic and laboratory capabilities. Five obstetric and five neonatal case definitions were evaluated. Definitions with the highest diagnostic certainty were designated as level 1, while definitions that decreased in certainty were designated as level 2 or 4. HCs were evaluated on diagnostic and laboratory capabilities to apply the GAIA definitions. RESULTS: Higher-level facilities in the IMHDSS demonstrated the ability to diagnose more specific levels of the GAIA obstetric and neonatal outcomes than lower-level facilities. Furthermore, for the neonatal outcome assessment, there was an increased ability to diagnose outcomes moving from GAIA level 1 to level 3. CONCLUSIONS: The ability of health centers to implement globally standardized definitions is promising for implementation of standardized data collection methods for global vaccine safety surveillance and research.