Subgroup analyses are common and often associated with claims of difference of treatment effects between subgroups—termed “subgroup effect”, “effect modification”, or “interaction between a subgroup variable and treatment”.1 2 3 A difference in effect between subgroups, if true, is likely to have important implications for clinical practice and policy making.
Many subgroup claims are, however, subsequently shown to be false.4 Thus, investigators, clinicians, and policy makers face the challenge of whether or not to believe apparent differences in effect.
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The question is then a decision of where on this continuum a putative subgroup effect lies.
In 1991, Yusuf et al12 discussed principles of analysing and interpreting subgroup effects, and stated that qualitative interactions (that is, when treatment is beneficial in one subgroup but harmful in another) are rare.
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