Assessing the external validity of a randomized controlled trial of anthelminthic in mothers and their children in Entebbe, Uganda
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Date
2014
Journal Title
Journal ISSN
Volume Title
Publisher
Trials
Abstract
The ‘external validity’ of randomized controlled trials is an important measure of quality, but is often
not formally assessed. Trials concerning mass drug administration for helminth control are likely to guide public
health policy and careful interpretation of their context is needed. We aimed to determine how representative
participants in one such trial were of their community. We explore implications for trial interpretation and resulting
public health recommendations.
The trial assessed was the Entebbe Mother and Baby Study (EMaBS), a trial of anthelminthic treatment
during pregnancy and early childhood. In a novel approach for assessing external validity, we conducted a two-stage
cluster sample community survey within the trial catchment area and compared characteristics of potentially-eligible
community children with characteristics of children participating in the trial.
Description
Keywords
Helminths, Anthelminthics, External validity, Generalizability, Cluster sample community survey, Uganda
Citation
Millard et al.: Assessing the external validity of a randomized controlled trial of anthelminthics in mothers and their children in Entebbe, Uganda. Trials 2014 15:310. doi:10.1186/1745-6215-15-310