Methodological analysis of an article

Methodological analysis, in particular of an article on a clinical trial, first comprises a check of the quality of the study design: description of the primary objective and assumptions leading to the conduct of the study; description of patients; description and justification of the treatments compared and primary end-point; justification for the number of included patients; description of randomization; suitable statistical tests selected a priori; respect of legal and ethical framework. Then, in the results, the comparability of the randomly assigned groups must be checked. The primary end-point must be assessed by intention to treat analysis, then per protocol where necessary Lastly, it is necessary to seek bias liable to reduce the quality of the demonstration. (c) 2005 Elsevier SAS. Tous droits reserves.