[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.
Glémain
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Clinique urologique, Hôtel-Dieu, place Alexis-Ricordeau, 44093 Nantes, France. pglemain@chu-nantes.fr
D002986:Clinical Trials as Topic / Q000592:standards*; D011643:Publishing