CONSORT comes to TRANSFUSION

In January 2007 we introduced the readers of TRANSFUSION to the CONSORT Statement.1 CONSORT (Consolidated Standards of Reporting Trials) is an initiative that resulted from a merging of two independent groups who in the early 1990s were both working to improve the reporting of randomized controlled trials (RCTs). These groups were composed of clinical trial specialists, epidemiologists, statisticians, and journal editors. Their efforts resulted in the CONSORT Statement that was first published in 19962 and was later revised in 2001.3 The CONSORT statement provides a minimum set of evidence-based recommendations for reporting parallel group RCTs. For authors, these recommendations provide a road map for complete and transparent reporting of clinical trials. For reviewers, CONSORT provides a template to assess the quality of the report and provide useful feedback regarding changes that would improve the submission. The ultimate goal is to publish a high-quality manuscript that gives readers the information they need to appraise the article critically and make an interpretation as to the generalizability of the findings to practice. The CONSORT Statement has two important components: a 22-item checklist and a flow diagram.3 Both the checklist and the flow diagram can be accessed at the website http://www.consort-statement.org. The checklist has 22 items that are all evidence-based. Failing to report the information on the items can be associated with a biased estimate of a treatment effect or omitting information that is critical for the reader to determine the relevance and reliability of the results. The checklist items are categorized under the headings of title, abstract, introduction, methods, results, and discussion. The checklist is user-friendly with specific examples and explanations provided. The flow diagram is a method to summarize how study participants pass through the various stages of an RCT: enrollment, treatment allocation, follow-up, and analysis. All manuscripts reporting the results of an RCT should include such a flow diagram because it provides transparency and allows readers to identify potential biases or limitations of the study. After a quick inspection of the requirements in the checklist and the flow diagram, it will immediately become apparent that researchers need to be familiar with CONSORT not only when the study is reported but also when the study is designed. Most of the checklist items require careful consideration when designing a research protocol. Failure to consider these important issues can jeopardize the validity of the study results and make it impossible to comply with CONSORT when reporting. The CONSORT website also provides several other resources for TRANSFUSION readers and contributors: The CONSORT “Explanation and Elaboration” document is designed to enhance the use, understanding, and dissemination of the CONSORT Statement, and the “Extensions of the CONSORT Statement” have been developed for other types of study designs, interventions, and data. Both can be accessed through the CONSORT website. Our international readers will be pleased to know that CONSORT now is available in 10 different languages other than English. There is scientific evidence to suggest that the use of CONSORT results in improved quality of RCT reporting.4,5 Continuous monitoring of the biomedical literature also facilitates modifications to the checklist and flow diagram, whereby items can be changed, deleted, or added as necessary.6 CONSORT is endorsed by the International Committee of Medical Journal Editors (ICMJE),7 the Council of Science Editors (CSE), and the World Association of Medical Editors (WAME) and is being supported by a growing number of health care and medical journals.8-11 The Editor and Associate Editors of TRANSFUSION have all endorsed the concept that the CONSORT Statement should be followed when submitting an RCT manuscript to TRANSFUSION. The Journal's Editorial Board has been apprised of this requirement and reviewers will be asked to review RCT submissions based on the CONSORT requirements. The instructions for authors published in the January 2008 volume of the journal have also been changed to reflect the new requirement.12 These requirements will not only serve our readers by providing comprehensive and transparent research findings, but will also serve the many patients who consent to participate in clinical research by ensuring that studies are well designed and well reported.

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