SCORING SYSTEMS FOR THE METHODOLOGICAL EV ALUATION OF THERAPEUTIC TRIALS - AN OVERVIEW

Scoring systems give a check-list and methodological informations whic h have to be found in controlled therapeutic trials reports and papers . These systems try to quantify each item to give a global score. The Chalmer's list is the most wellknown. It allows a balance in scoring t aking in account the qualify of the endpoints. Other lists are more si mple. Many check-lists allow the scoring of the methodological design or the statistical analysis. In all systems the major methodological p oints are : the randomization, the description of the population, the double blind, the estimation of the sample size, the handling of withd rawal and drop out, the major endpoint, the patients follow-up, the st atistical analysis and the data presentation. All these scoring system s have several limits: the quantitative evaluation of each item is sub jective and the point scoring has never been validated, some scoring s ystems are old and don't integrate new methodological methods, the sco res never included the clinical interest of the trial, some items are questionable, others are forgotten (intention to treat analysis, steer ing comity...). Scoring systems allow a control of the methodological qualify of clinical trials but don't include the clinical or scientifi c interest of the study. These systems are a useful methodological too l for publication process in medical journals and for new drugs author ization. The evaluation by authors themselves of the quality of their papers using a standardized scoring system could clarify the reviewers decisions.