Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multisite, rare-event, distributed setting: Part 2 in-depth example of a reanalysis of the measles-mumps-rubella-varicella combination vaccine and seizure risk.
J Clin Epidemiol
; 113: 114-122, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31055178
ABSTRACT
OBJECTIVE:
In-depth example of two new group sequential methods for postmarket safety monitoring of new medical products. STUDY DESIGN ANDSETTING:
Existing trial-based group sequential approaches have been extended to adjust for confounders, accommodate rare events, and address privacy-related constraints on data sharing. Most adaptations have involved design-based confounder strategies, for example, self-controlled or exposure matching, while analysis-based approaches like regression and weighting have received less attention. We describe the methodology of two new group sequential approaches that use analysis-based confounder adjustment (GS GEE) and weighting (GS IPTW). Using data from the Food and Drug Administration's Sentinel network, we apply both methods in the context of a known positive association the measles-mumps-rubella-varicella vaccine and seizure risk in infants.RESULTS:
Estimates from both new approaches were similar and comparable to prior studies using design-based methods to address confounding. The time to detection of a safety signal was considerably shorter for GS IPTW, which estimates a risk difference, compared to GS GEE, which provides relative estimates of excess risk.CONCLUSION:
Future group sequential safety surveillance efforts should consider analysis-based confounder adjustment techniques that evaluate safety signals on the risk difference scale to achieve greater statistical power and more timely results.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Rubéola (Sarampo Alemão)
/
Varicela
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Vacinas Combinadas
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Vacina contra Varicela
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Convulsões Febris
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Vacina contra Sarampo-Caxumba-Rubéola
/
Sarampo
/
Caxumba
Tipo de estudo:
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Risk_factors_studies
/
Screening_studies
Limite:
Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article