CONSORT 2010 statement: updated Guidelines for Reporting Parallel Group Randomised Trials

Family Health International, Research Triangle Park, NC 27709, USA.
BMC Medicine (Impact Factor: 7.25). 03/2010; 8(1):18. DOI: 10.1186/1741-7015-8-18
Source: PubMed


The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

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    • "Wampold, Lichtenberg, and Waehler (2002) expanded this framework by including deliberations related to the degree of specificity, utility of multiple type of comparison groups, treatment component analysis, broad assessment, methods for consolidating results across studies, and viability of interventions from one community to the next. Although these endorsements promoted two separate and unique methodologies for establishing evidentiary support for interventions, several authors have argued that between-groups designs, especially randomized controlled trials with an emphasis on null hypothesis testing, should be regarded as the gold standard of research methodologies (Balshem et al., 2011; Schulz, Altman, & Moher, 2010). The generalizability, transparency of methodology, and inferences related to causality inherent among well-designed between-groups research programs has provided a great wealth of knowledge related to best practices that have historically moved the counseling profession forward. "
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    • "There is increasing interest into the internal and external validity of randomized controlled trials, based on the assessment of, for example, risk of bias [1], quality of reporting [2], appropriateness of statistical evaluation, or effects of sponsorship on trial outcomes [3]. One factor which potentially impacts on the totality of available evidence and its robustness is the choice of trial comparators: Certain classes of procedures or products might serve as comparator more often than others, and some comparators might be avoided at all. "
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