Standardizing case definitions for monitoring the safety of maternal vaccines globally: <scp>GAIA</scp> definitions, a review of progress to date

Davies, Hannah G; Bowman, Conor; Watson, Gabriella; Dodd, Caitlin; Jones, Christine E; Muñoz, Flor M.; Heath, Paul T; Cutland, Clare; Doaré, Kirsty Le

doi:10.1002/ijgo.14843

Cited by 4 publications

(3 citation statements)

References 38 publications

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“…Although our study used a validated claims-based algorithm to identify women with live births and to estimate pregnancy start date, errors or biases in the algorithm may affect the results. However, the algorithm has been commonly used in previous studies and has acceptable sensitivity and specificity . Furthermore, given the claim-based analysis, our study could not comprehensively account for all other potential confounders owing to unavailability and underrepresentation, such as body mass index, parity, and prenatal vitamin and aspirin use, and so forth.…”

Section: Discussionmentioning

confidence: 99%

“…However, the algorithm has been commonly used in previous studies and has acceptable sensitivity and specificity. 47 , 48 Furthermore, given the claim-based analysis, our study could not comprehensively account for all other potential confounders owing to unavailability and underrepresentation, such as body mass index, parity, and prenatal vitamin and aspirin use, and so forth. Future research, especially those using linked databases, should aim to investigate a broader set of confounding variables.…”

Section: Discussionmentioning

confidence: 99%

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Risk Factors for Severe Maternal Morbidity Among Women Enrolled in Mississippi Medicaid

Maharjan,

Goswami,

Rong

et al. 2024

JAMA Netw Open

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ImportanceMississippi has one of the highest rates of severe maternal morbidity (SMM) in the US, and SMMs have been reported to be more frequent among Medicaid-insured women. A substantial proportion of pregnant women in Mississippi are covered by Medicaid; hence, there is a need to identify potential risk factors for SMM in this population.ObjectiveTo examine the associations of health care access and clinical and sociodemographic characteristics with SMM events among Mississippi Medicaid–enrolled women who had a live birth.Design, Setting, and ParticipantsA nested case-control study was conducted using 2018 to 2021 Mississippi Medicaid administrative claims database. The study included Medicaid beneficiaries aged 12 to 55 years who had a live birth and were continuously enrolled throughout their pregnancy period and 12 months after delivery. Individuals in the case group had SMM events and were matched to controls on their delivery date using incidence density sampling. Data analysis was performed from June to September 2022.ExposureRisk factors examined in the study included sociodemographic factors (age and race), health care access (distance from delivery center, social vulnerability index, and level of maternity care), and clinical factors (maternal comorbidity index, first-trimester pregnancy-related visits, and postpartum care).Main Outcomes and MeasuresThe main outcome of the study was an SMM event. Adjusted odds ratio (aORs) and 95% CIs were calculated using conditional logistic regression.ResultsAmong 13 485 Mississippi Medicaid–enrolled women (mean [SD] age, 25.0 [5.6] years; 8601 [63.8%] Black; 4419 [32.8%] White; 465 [3.4%] other race [American Indian, Asian, Hispanic, multiracial, and unknown]) who had a live birth, 410 (3.0%) were in the case group (mean [SD] age, 26.8 [6.4] years; 289 [70.5%] Black; 112 [27.3%] White; 9 [2.2%] other race) and 820 were in the matched control group (mean [SD] age, 24.9 [5.7] years; 518 [63.2%] Black; 282 [34.4%] White; 20 [2.4%] other race). Black individuals (aOR, 1.44; 95% CI, 1.08-1.93) and those with higher maternal comorbidity index (aOR, 1.27; 95% CI, 1.16-1.40) had higher odds of experiencing SMM compared with White individuals and those with lower maternal comorbidity index, respectively. Likewise, an increase of 100 miles (160 km) in distance between beneficiaries’ residence to the delivery center was associated with higher odds of experiencing SMM (aOR, 1.14; 95% CI, 1.07-1.20).Conclusions and RelevanceThe study findings hold substantial implications for identifying high-risk individuals within Medicaid programs and call for the development of targeted multicomponent, multilevel interventions for improving maternal health outcomes in this highly vulnerable population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Risk Factors for Severe Maternal Morbidity Among Women Enrolled in Mississippi Medicaid

Maharjan,

Goswami,

Rong

et al. 2024

JAMA Netw Open

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“…A pharmaco‐vigilance network which identifies and addresses possible adverse events in pregnant women and their newborns is essential to build confidence in vaccines. Standardized case definitions developed by the Brighton Collaboration assist with harmonization of maternal immunization data across diverse settings, and have been field tested in high‐income countries, but there is a paucity of testing in low‐ and middle‐income country (LMIC) settings 16 . In a prospective cohort of Taiwanese pregnant women, mild, self‐limiting adverse events including headache and muscle aches were reported more frequently in (mRNA COVID‐19) vaccinated compared to unvaccinated women, but no serious adverse events in women or their infants were detected 17 .…”

Section: Maternal Immunizationmentioning

confidence: 99%

Editorial: Vaccinations and women's reproductive health

Cutland

Fortner

Heine

et al. 2023

Intl J Gynecology & Obste

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The 3rd Sustainable Development Goal targets include (i) the reduction of global maternal mortality, (ii) ending preventable newborn and child deaths and (iii) universal access to sexual and reproductive healthcare and safe and effective vaccines. 1 The importance of access to safe and effective vaccines to reduce morbidity and mortality has been highlighted by the COVID-19 pandemic. Most vaccination programs specifically target infants and young children; however, there has been a recent increase in use of vaccines in adolescents and adults, especially in women.Thank you to Iftikhar Latif for extensive support afforded to the guest editorial team.

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Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review

Davies,

Thorley,

Al-Bahadili

et al. 2024

Vaccine: X

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Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 4 publications

References 38 publications

Risk Factors for Severe Maternal Morbidity Among Women Enrolled in Mississippi Medicaid

Risk Factors for Severe Maternal Morbidity Among Women Enrolled in Mississippi Medicaid

Editorial: Vaccinations and women's reproductive health

Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review

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