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Debate: Subgroup analyses in clinical trials: fun to look at - but don't believe them!

Analysis of subgroup results in a clinical trial is surprisingly unreliable, even in a large trial. This is the result of a combination of reduced statistical power, increased variance and the play of chance. Reliance on such analyses is likely to be more erroneous, and hence harmful, than applicati...

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Detalles Bibliográficos
Autor principal: Sleight, Peter
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2000
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59592/
https://www.ncbi.nlm.nih.gov/pubmed/11714402
http://dx.doi.org/10.1186/cvm-1-1-025
Descripción
Sumario:Analysis of subgroup results in a clinical trial is surprisingly unreliable, even in a large trial. This is the result of a combination of reduced statistical power, increased variance and the play of chance. Reliance on such analyses is likely to be more erroneous, and hence harmful, than application of the overall proportional (or relative) result in the whole trial to the estimate of absolute risk in that subgroup. Plausible explanations can usually be found for effects that are, in reality, simply due to the play of chance. When clinicians believe such subgroup analyses, there is a real danger of harm to the individual patient.