Analysis of Randomised Trials Including Multiple Births When Birth Size Is Informative

Paediatric and Perinatal Epidemiology
Lisa Nicole YellandShaun R Seaman

Abstract

Informative birth size occurs when the average outcome depends on the number of infants per birth. Although analysis methods have been proposed for handling informative birth size, their performance is not well understood. Our aim was to evaluate the performance of these methods and to provide recommendations for their application in randomised trials including infants from single and multiple births. Three generalised estimating equation (GEE) approaches were considered for estimating the effect of treatment on a continuous or binary outcome: cluster weighted GEEs, which produce treatment effects with a mother-level interpretation when birth size is informative; standard GEEs with an independence working correlation structure, which produce treatment effects with an infant-level interpretation when birth size is informative; and standard GEEs with an exchangeable working correlation structure, which do not account for informative birth size. The methods were compared through simulation and analysis of an example dataset. Treatment effect estimates were affected by informative birth size in the simulation study when the effect of treatment in singletons differed from that in multiples (i.e. in the presence of a treatment group ...Continue Reading

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Citations

Apr 11, 2019·Obstetrics and Gynecology·Elizabeth JaniakAlisa B Goldberg
May 1, 2020·Acta Clinica Belgica·Isabelle DehaeneKoenraad Smets
Apr 7, 2020·Epidemiology·Ran S RotemMarc G Weisskopf
May 5, 2018·Paediatric and Perinatal Epidemiology·Lisa N YellandKatherine J Lee
Jul 6, 2020·Archives of Gynecology and Obstetrics·Isabelle DehaeneKristien Roelens
Jan 12, 2017·Statistics in Medicine·Lisa N YellandKatherine J Lee

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