The safety of maternal immunisation (MI) is critical. A globally standardised approach to harmonise safety data collection would improve data quality, comparability, pooling and standardisation across MI clinical research, epidemiological studies and AEFI surveillance in High Income Countries (HIC) as well as Low and Middle Income Countries (LMIC). The Brighton Collaboration (BC) Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project had developed globally standardised case definitions (CDs) of key obstetric and neonatal terms for the safety assessment of MI. The CDs had undergone limited field testing, particularly in LMIC.
Sonali Kochhar from Global Healthcare Consulting in New Delhi and her team assessed in her pump-priming project titled "Evaluating the field performance and validating novel case definitions designed to harmonise safety monitoring for immunisation in pregnancy in LMIC" the field performance of three GAIA CDs (preterm birth, stillbirth and hypertension) and one enabling term (the Gestationalage (GA) assessment algorithm) in South Africa and The Gambia. They analysed the applicability (levels of diagnostic certainty 1–5), applicability utilising the data routinely collected in clinical trials (CT), feasibility (practicality) of implementation, reliability (specific aspects of the CDs and GA algorithm repeatedly interpreted in the same way by different study staff in LMIC), and ability to systematically analyse discordant cases and to describe issues identified by the clinical staff in applying the CDs.
Participants for this study included pregnant women participating in CTs of MI (for trivalent inactivated influenza vaccine conducted at the Respiratory and Meningeal Pathogens Research Unit at the Chris Hani Baragwanath Academic Hospital (CHBAH), Soweto, between 2011 and 2013, and an ongoing maternal and neonatal pneumococcal vaccination trial at MRC Unit, The Gambia.
The diagnosis of preterm birth, hypertension and the enabling term (GA assessment algorithm) could be made using the GAIA CDs in LMICs with high reliability, minimum selection bias and utilising the data routinely collected in the CTs in LMIC. The stillbirth CD required modification to address the issues encountered. Suggestions for modification of the case definition were made in the publication and shared with the BC. The CDs are currently being utilised in vaccine CTs being conducted in both HIC and LMIC.
The results of the project have been published in Kochhar S, Clarke E, Izu A, Kekane-Mochwari KE, Cutland CL. Immunization in pregnancy safety surveillance in low and middle-income countries- field performance and validation of novel case definitions. Vaccine 2019; 37(22):2967-2974. doi: 10.1016/j.vaccine.2019.03.074.
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