Generalization of the results of clinical studies through the analysis of subgroups

Authors

  • João Costa Centro de Estudos de Medicina Baseada na Evidência. Faculdade de Medicina da Universidade de Lisboa. Lisboa. Portugal.
  • Filipa Fareleira Centro de Estudos de Medicina Baseada na Evidência. Faculdade de Medicina da Universidade de Lisboa. Lisboa. Portugal.
  • Raquel Ascensão Centro de Estudos de Medicina Baseada na Evidência. Faculdade de Medicina da Universidade de Lisboa. Lisboa. Portugal.
  • António Vaz Carneiro Centro de Estudos de Medicina Baseada na Evidência. Faculdade de Medicina da Universidade de Lisboa. Lisboa. Portugal.

DOI:

https://doi.org/10.20344/amp.16

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.

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Published

2012-05-25

How to Cite

1.
Costa J, Fareleira F, Ascensão R, Vaz Carneiro A. Generalization of the results of clinical studies through the analysis of subgroups. Acta Med Port [Internet]. 2012 May 25 [cited 2024 Nov. 8];25(1):44-50. Available from: https://actamedicaportuguesa.com/revista/index.php/amp/article/view/16

Issue

Section

Review Articles