Diferencias entre las características basales de los pacientes en los ensayos clínicos, según el tamaño de la muestra. Un estudio meta-epidemiológico
Year: 2013
Type: article
Abstract: Objective: To determine the differences in qualitative and quantitative variables in the baseline characteristics of the controlled clinical trials randomized by sample size. Methods: Observational, cross-sectional study including randomized clinical trials published in four high impact factor general medical journals. They were divided into five strata according to sample size; the differences between qualitative and quantitative variables of baseline characteristics were evaluated. Results: One thousand variables of patients participating in clinical trials were analyzed. By comparing each of the groups according to sample size with respect to the group of ≥ 5000 patients, it was determined that the mean differences decreased as the sample sizes included a greater number of patients. Conclusions: The differences in results of the baseline characteristics of clinical trials are inversely proportional to the sample size, and the average differences in groups above 500 patients would be less than 1.2%.
Authors: Daniel Isaza, Mateo Zuluaga‐Gómez, Jorge Hernando Donado Gómez
Institution: Universidad Pontificia Bolivariana
Language: Spanish
Subfield: Statistics, Probability and Uncertainty
Field: Decision Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W2158382668