Iniciativa STROBE: subsídios para a comunicação de estudos observacionais

Abstract

Reporting of observational studies is often inadequate, hampering the assessment of their strengths and weaknesses and, consequently, the generalization of study results. The initiative named Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) developed a checklist of 22 items, the STROBE Statement, with recommendations about what should be included in a more accurate and complete description of observational studies. Between June and December 2008, a group of Brazilian researchers was dedicated to the translation and adaptation of the STROBE Statement into Portuguese. The present study aimed to show the translation into Portuguese, introduce the discussion on the context of use, the potential and limitations of the STROBE initiative. Clinical trials and observational studies in the context of modern biomedical researchRandomized clinical trials have been described as the gold standard for biomedical research as they show high internal validity and, consequently, greater accuracy in the effi cacy and effectiveness evaluation of several therapeutic and preventive health practices. 4 However, public health studies have frequently dealt with problems where this study design is not adequate and/or ethical, or, yet, for which the translation of randomized controlled trial fi ndings into concrete intervention and/or treatment conditions faces great diffi culties due to the lack of external validity of fi ndings obtained in a clinical trial context. According to Victora et al,26 randomized clinical trials frequently represent an inadequate choice to assess the performance and impact of large scale interventions, especially in contexts of heterogeneity, whether they are social, economic and/or geographic in nature. In addition, there are operational aspects that can hinder or even preclude the implementation of clinical trials: individuals may not want to be randomized for a given intervention group, randomized selection may not be possible or ethically acceptable in the research context, or, yet, only participants with certain characteristics might accept to be selected. 31 In view of the impossibility or inadequacy of implementation of randomized clinical trials, whether due to ethical or operational questions, observational studies appear as a more feasible solution and, in cohort studies, are relevant alternatives to evaluate the impact of interventions throughout time. 22Observational studies are more adequate to evaluate rare or late side effects associated with certain treatments and they often provide a more accurate indication of what can be achieved in routine clinical practice, once they take The adverse effects of non-steroidal anti-infl ammatory drugs on cardiovascular morbi-mortality has been documented in studies with large sample sizes and longterm follow-up. Until then, these side effects had been imperceptible in the context of clinical trials and even of pharmacovigilance, involving a small number of cases and/or having a relatively short follow-up period. 10Previous...

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