How to use a subgroup analysis users' guides to the medical literature

摘要

Clinicians, when trying to apply trial results to patient care, need to individualize patient care and, potentially, managepatientsbasedonresultsofsubgroupanalyses.Apparentlycompellingsubgroup effects oftenprovespurious,andguidanceisneededto differentiate crediblefromless crediblesubgroup claims.We therefore provide 5 criteria to usewhenassessing the validity of subgroup analyses: (1)Canchanceexplain the apparent subgroup effect; (2) Is the effect consistent across studies; (3)Was the subgroup hypothesis one of a small number of hypotheses developed a priori with directionspecified;(4) Istherestrongpreexistingbiologicalsupport;and(5)Istheevidencesupporting the effect based on within- or between-study comparisons. The first 4 criteria are applicable to individualstudiesorsystematicreviews, thelastonlytosystematicreviewsofmultiplestudies.These criteria will help clinicians deciding whether to use subgroup analyses to guide their patient care.