Tailoring treatments using treatment effect modification.
Pharmacoepidemiol Drug Saf
; 25(4): 355-62, 2016 Apr.
Article
em En
| MEDLINE
| ID: mdl-26877168
ABSTRACT
BACKGROUND AND OBJECTIVE:
Applying results from clinical studies to individual patients can be a difficult process. Using the concept of treatment effect modification (also referred to as interaction), defined as a difference in treatment response between patient groups, we discuss whether and how treatment effects can be tailored to better meet patients' needs.RESULTS:
First we argue that contrary to how most studies are designed, treatment effect modification should be expected. Second, given this expected heterogeneity, a small number of clinically relevant subgroups should be a priori selected, depending on the expected magnitude of effect modification, and prevalence of the patient type. Third, by defining generalizability as the absence of treatment effect modification we show that generalizability can be evaluated within the usual statistical framework of equivalence testing. Fourth, when equivalence cannot be confirmed, we address the need for further analyses and studies tailoring treatment towards groups of patients with similar response to treatment. Fifth, we argue that to properly frame, the entire body of evidence on effect modification should be quantified in a prior probability.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Ensaios Clínicos como Assunto
/
Medicina de Precisão
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Pharmacoepidemiol Drug Saf
Assunto da revista:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Holanda