Evidence map›Paper›PMID 26332368›Full record

ArticlePaediatric and perinatal epidemiology2015

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

Lisa N Yelland, Thomas R Sullivan, Menelaos Pavlou, Shaun R Seaman

Open access · greenAbstract read
In one paragraph

Article in Paediatric and perinatal epidemiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Lisa N YellandWomen's and Children's Health Research Institute, North Adelaide, South Australia, Australia.
Thomas R SullivanSchool of Population Health, The University of Adelaide, Adelaide, South Australia, Australia.
Menelaos PavlouDepartment of Statistical Science, University College London, London, UK.
Shaun R SeamanMRC Biostatistics Unit, Cambridge, UK.
University of Adelaide · AUMRC Biostatistics Unit · GBUniversity College London · GB

Funding

Medical Research Council ID U1052 60558Medical Research Council MC_U105260558
6 · The paper itself

Abstract

backgroundInformative 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.

methodsThree 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.

resultsTreatment 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 by multiple birth interaction). The strength of evidence supporting the effectiveness of treatment varied between methods in the example dataset.

conclusionsInformative birth size is always a possibility in randomised trials including infants from both single and multiple births, and analysis methods should be pre-specified with this in mind. We recommend estimating treatment effects using standard GEEs with an independence working correlation structure to give an infant-level interpretation.

Indexed as

Infant, Low Birth WeightInfant, PrematureAdultFemaleFetal Growth RetardationHumansInfant, NewbornMalePopulation SurveillancePregnancyPregnancy, MultiplePremature BirthRandomized Controlled Trials as TopicReference Standardsclusteringgeneralised estimating equationsinformative cluster sizemultiple birthsstatistical methodology

Identifiers

PMID26332368
PMCPMC4847643
OpenAlexW1939969949

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.