Classification of clinical trials on high impact journals scale effectiveness-efficacy

• Grant number: 12/10821-9
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2012
• End date: August 31, 2014
• Field of knowledge: Health Sciences - Collective Health - Epidemiology
• Principal Investigator: Regina Paolucci El Dib
• Grantee: Regina Paolucci El Dib
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

When discussing treatment and talk about evidence, we refer to the effectiveness and efficiency. When we refer to mention effective treatment that works in real-world conditions. Effectiveness, when operating under conditions of treatment ideal world. However, the use of these terms seems to be random trials, not reflecting the real purpose of the study. In addition, renowned educational institutions involved in Evidence Based Medicine and the Cochrane Collaboration and the Centre for Evidence-Based Medicine disseminate a very vague definition of these terms (as described in the first two sentences of this summary) is not based on specific variables and determinants as, for example, all participants who have the condition of interest are selected for the study irrespective of predicted risk, responsiveness or comorbidities? Instructions on how to apply the intervention are flexible, offering professionals a considerable leeway in deciding how to formulate and apply it? The outcomes assessed in a clinical trial are relevant or just markers (surrogates) for the condition under study? The instrument PRECIS was developed in 2009 with the purpose of identifying and quantifying the characteristics of clinical trials that distinguishes between pragmatic (effectiveness) and explanatory (efficacy) to assist researchers in preparing and planning this study design. However, it is unclear whether investigators when designing a clinical trial using the PRECIS to differentiate between effectiveness and efficiency, and then facilitate the applicability of the results in clinical practice. Thus, the objective of this study will be assess whether the clinical trials published in high impact journals in the last three years, using the criteria proposed by PRECIS to differentiate between effectiveness and efficiency, and consider whether they have made use appropriate to these terms. It is noteworthy that, according to PRECIS, the classification of a clinical trial is not a dichotomy, ie, there is a gradient in between effectiveness and efficacy, it is very difficult to conduct a clinical trial "purely" pragmatic or "purely" explanatory. The purpose of this study involves the classification of clinical trials within that gradient (AU)