Med Clin Barcelona
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Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.
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With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. ⋯ The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.
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It has been repeatedly shown that the information supplied in publications of clinical trials is frequently insufficient or inaccurate and that some methodologic problems are associated with exaggerated estimates of the effect of healthcare interventions. To improve the quality of reports of clinical trials, a group of scientists and editors developed the CONSORT statement (Consolidated Standards of Reporting Trials), a 22-item checklist (plus flow diagram), that can be used by authors, editors, reviewers, and readers. ⋯ This article presents the Spanish translation of the two elements integrating the revised CONSORT, the flow diagram and the 22-item checklist, and provides a short comment on each of them. Previous publications of the CONSORT statement and other useful resources such as examples of what are considered good communications may be obtained from the CONSORT web site (http://www.consort-statement.org).
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Healthcare research is extremely important, with the clear potential to influence treatment and prevention of disease, possibly on a global scale. Yet deficiencies in how research studies are reported are both well-documented and widespread across all medical specialties, types of interventions and study designs. Although randomised trials have received the most attention in this regard, similar concerns have been expressed about reporting of other types of research including diagnostic and epidemiological studies. ⋯ From this simple idea comes the scientific rationale of developing guidelines on how to report research. We consider desirable attributes of such guidelines, emphasising the importance of being evidence-based where possible. We describe recommended processes to produce guidelines that have evolved over several years during the preparation of a sequence of reporting guidelines including CONSORT, QUOROM, STARD and STROBE.