title: [Generalization of the results of clinical studies through the analysis of subgroups].
abstract: Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.
authors.affiliation: Centro de Estudos de Medicina Baseada na Evidência, Faculdade de Medicina da Universidade de Lisboa, Portugal.
authors.forename: João
authors.initials: J
authors.lastname: Costa
authors.forename: Filipa
authors.initials: F
authors.lastname: Fareleira
authors.forename: Raquel
authors.initials: R
authors.lastname: Ascensão
authors.forename: António
authors.initials: A
authors.lastname: Vaz Carneiro
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D012107:Research Design