Adroitz Consultants, Nairobi, Kenya.
Adroitz Consultants, Nairobi, Kenya.
Vaccine. 2023 Sep 7;41(39):5722-5729. doi: 10.1016/j.vaccine.2023.07.063. Epub 2023 Aug 5.
Active surveillance systems for monitoring vaccine safety among pregnant women address some of the limitations of a current passive surveillance approach utilized in low- and middle-income countries (LMIC). However, few active surveillance systems in LMIC exist. Our study assessed the feasibility of utilizing three existing data collection systems in Kenya for active surveillance of maternal immunization and to assess the applicability of Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions that were initially developed for clinical trials within these systems.
We assessed applicability of GAIA case definition for maternal Tetanus Toxoid exposure, stillbirth, low birth weight, small for gestational age, Neonatal Invasive Blood Stream Infection (NIBSI), prematurity and neonatal death in two routine web-based health information systems (Kenya EMR and DHIS-2), and a web-based population-based pregnancy research platform (ANCOV) in Kenya.
All three HIS were capable of reporting selected outcomes to varying degrees of GAIA certainty. The ANCOV platform was the most robust in collecting and collating clinical data for effective maternal pharmacovigilance. The utilization of facility- and district-aggregated data limits the usefulness of DHIS-2 in pharmacovigilance as currently operationalized. While the Kenya EMR contained individual level data and meets the key considerations for effective pharmacovigilance, it was used primarily for HIV care and treatment records in a small proportion of health facilities and would require additional resources to expand to all antenatal care facilities and to link maternal and infant records.
Population-based research studies may offer a responsive short-term option for implementing maternal vaccine pharmacovigilance in LMICs. However, the foundation exists for long-term capacity building within the national health electronic data systems to provide this critical service as well as ensure participation of the country in international studies on maternal vaccine safety.
主动监测系统用于监测孕妇的疫苗安全性，可解决中低收入国家（LMIC）当前被动监测方法的一些局限性。然而，LMIC 中很少有主动监测系统。我们的研究评估了在肯尼亚利用三个现有的数据收集系统进行孕产妇免疫主动监测的可行性，并评估了最初为这些系统内的临床试验开发的妊娠免疫安全评估全球对齐（GAIA）病例定义的适用性。
我们评估了 GAIA 病例定义在两个常规基于网络的健康信息系统（肯尼亚电子病历和 DHIS-2）和肯尼亚基于网络的人群妊娠研究平台（ANCOV）中用于母体破伤风类毒素暴露、死胎、低出生体重、小于胎龄、新生儿侵袭性血流感染（NIBSI）、早产和新生儿死亡的适用性。
所有三个 HIS 都能够在不同程度上报告选定的 GAIA 结果。ANCOV 平台在收集和整理临床数据方面最为强大，可有效进行药物警戒。DHIS-2 目前的运作方式限制了其在药物警戒中使用，因为它只能汇总和汇总来自机构和地区的数据。虽然肯尼亚电子病历包含个人层面的数据，并满足有效药物警戒的关键考虑因素，但它主要用于少数卫生机构的艾滋病毒护理和治疗记录，需要额外资源才能扩展到所有产前保健设施，并将母婴记录联系起来。
基于人群的研究可能为在 LMIC 中实施孕产妇疫苗药物警戒提供一种有响应性的短期选择。然而，国家卫生电子数据系统已经具备了进行长期能力建设的基础，可以提供这项关键服务，并确保国家参与国际孕产妇疫苗安全性研究。
