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We consider the application of instrumental variable techniques in a longitudinal clinical trial in paediatric HIV/AIDS, with a substantial degree of non-compliance to randomized treatment (Nelfinavir versus placebo) and with left censoring of the outcome variable (HIV RNA concentration). We consider in detail the assumptions and implications behind the inclusion and exclusion of interactions between randomized arm and baseline covariates in modelling actual treatment received, and between treatment and baseline covariates in modelling outcome. Estimated treatment effects were sensitive to inclusion of interactions, and we show how such sensitivity can be explored and explained.

Original publication

DOI

10.1002/sim.2644

Type

Journal article

Journal

Stat Med

Publication Date

30/03/2007

Volume

26

Pages

1473 - 1496

Keywords

Anti-HIV Agents, Child, Data Interpretation, Statistical, Female, HIV, HIV Infections, Humans, Longitudinal Studies, Male, Models, Statistical, Nelfinavir, Patient Compliance, RNA, Viral, Randomized Controlled Trials as Topic