Are we leaving money on the table in infertility RCTs? Trialists should statistically adjust for prespecified, prognostic covariates to increase power.
Hum Reprod
; 37(5): 895-901, 2022 05 03.
Article
en En
| MEDLINE
| ID: mdl-35199145
ABSTRACT
Infertility randomized controlled trials (RCTs) are often too small to detect realistic treatment effects. Large observational studies have been proposed as a solution. However, this strategy threatens to weaken the evidence base further, because non-random assignment to treatments makes it impossible to distinguish effects of treatment from confounding factors. Alternative solutions are required. Power in an RCT can be increased by adjusting for prespecified, prognostic covariates when performing statistical analysis, and if stratified randomization or minimization has been used, it is essential to adjust in order to get the correct answer. We present data showing that this simple, free and frequently necessary strategy for increasing power is seldom employed, even in trials appearing in leading journals. We use this article to motivate a pedagogical discussion and provide a worked example. While covariate adjustment cannot solve the problem of underpowered trials outright, there is an imperative to use sound methodology to maximize the information each trial yields.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Infertilidad
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Hum Reprod
Asunto de la revista:
MEDICINA REPRODUTIVA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Reino Unido