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  • Correction to the FIELD study report

    Author(s)
    Keech, Anthony
    Simes, John
    Barter, Philip
    Best, James
    Scott, Russell
    Taskinen, Marja-Riitta
    Hamilton-Craig, Ian
    et al.
    Griffith University Author(s)
    Hamilton-Craig, Ian
    Year published
    2006
    Metadata
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    Abstract
    In undertaking further analyses of the FIELD study,1 we recently detected that the reported effects of fenofibrate adjusted for on-study use of other lipid-lowering therapy are not time-dependent as was stated. The aim of the analysis was to account for the higher rate of use of other lipid-lowering therapy (mostly statins) during the study in the placebo group (average 17%) than in the fenofibrate group (average 8%). A programming mis-specification meant that this secondary analysis used drop-in to other lipid-lowering therapy as a fixed, rather than as a time-dependent, covariate in the Cox regression model. The net effect ...
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    In undertaking further analyses of the FIELD study,1 we recently detected that the reported effects of fenofibrate adjusted for on-study use of other lipid-lowering therapy are not time-dependent as was stated. The aim of the analysis was to account for the higher rate of use of other lipid-lowering therapy (mostly statins) during the study in the placebo group (average 17%) than in the fenofibrate group (average 8%). A programming mis-specification meant that this secondary analysis used drop-in to other lipid-lowering therapy as a fixed, rather than as a time-dependent, covariate in the Cox regression model. The net effect is that, for patients who started lipid-lowering treatment during the trial without a prior on-study event, all their trial experience from the date of randomisation was grouped separately in the analysis for the comparisons of fenofibrate versus placebo (fixed covariate model). In this sense, subsequent lipid-lowering therapy was modelled like a baseline covariate. By contrast, the time-dependent model groups only the patients' experience after drop-in separately in the analysis.
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    Journal Title
    The Lancet
    Volume
    368
    Issue
    9545
    DOI
    https://doi.org/10.1016/S0140-6736(06)69594-9
    Subject
    Medical and Health Sciences
    Publication URI
    http://hdl.handle.net/10072/32294
    Collection
    • Journal articles

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