Kenneth f schulz, douglas g altman, david moher, david moher subject. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. The most recent version of the checklist was published in 2010. Recently, a version of the consort 2010 statement has been translated into mandarin and is available on the consort website. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions.
However if undertaken incorrectly they can lead to further confusion. Table 1 stricta 2010 checklist of information to include when reporting interventions in a clinical trial of acupuncture item detail 1. If relevant, we also recommend reading consort extensions for cluster randomised trials, noninferiority and equivalence trials, nonpharmacological. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates the. Consort 2010 contains a statement, supplemented with a set of questions on the conducted rct, requiring a clearly formalized answer, and a flowchart for visual presentation of the results. Development of consort 2010 thirty one members of the consort 2010 group met in montebello, canada, in january 2007 to update the 2001 consort statement. Item reported no checklist item on page no consort statement. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and. Title and abstract 1a identification as a randomized trial in the title 1b structured summary of trial design, methods, results, and conclusions for specific guidance see. Intent of consort 2010 the consort 2010 statement is this paper including the 25 item checklist in the table table 1 and the flow diagram figure 1.
It provides guidance for reporting all randomized controlled trials, but focuses on the most common design typeindividually. After an expert meeting in january 2007, the consort statement has been further revised and is published as the consort 2010 statement. We present an extension to the consort statement for randomised pilot an d feasibility trials conducted in advance of a future definitive randomised controlled trial, and present the 26item checklist, a separate checklist for the abstract, a template for a consort flow chart, and. Download the consort 2010 publications consort statement. Reporting of noninferiority and equivalence randomized trials. Mar 24, 2010 a consort explanation and elaboration article was published in 2001 alongside the 2001 version of the consort statement. Consort guidelines for randomised pilot or feasibility studies. Standards of reporting trials consort statement, the sentinel reporting guideline for twogroup parallel randomized trials to appear in the. The statement also recommends including a flow diagram to show the flow of. Adherence in leading medical journals to the consort 2010. Fulltext pdf documents of the consort 2010 statement, consort 2010 checklist, consort 2010 flow diagram and the consort 2010 explanation and elaboration document are available from. Pdf abstract the consort statement is used worldwide to improve the reporting of randomised controlled trials. Mar 24, 2010 the consort statement is used worldwide to improve the reporting of randomised controlled trials.
Apr 01, 2019 consort 2010 contains a statement, supplemented with a set of questions on the conducted rct, requiring a clearly formalized answer, and a flowchart for visual presentation of the results. The current definitive version of the consort statement and uptodate information on. Consort 2010 statement on randomised controlled trials randomised controlled trials rcts can be an invaluable tool in determining the best treatment for patients. The statement consists of a checklist and flow diagram that authors can use for reporting an rct. The statement, recently updated as consort 2010, comprises evidencebased. Reporting of multiarm parallelgroup randomized trials.
Updated guidelines for reporting parallel group randomised trials. Consort 2010 checklist of information to include when. Consort 2010 checklist of information to include when reporting a. Doing it with sas anusha mallavarapu, cytel, pune, india dean shults, cytel, uk abstract. The statement was revised in 2001, with a further update in 2010. It was first published in 1996, revised in 2001, last updated in 2010,1 2 and published simultaneously in 10 leading medical journals, including the lancet, jama, bmj. Translations of reporting guidelines the equator network. Consort 2010 changes and testing blindness in rcts. The consort 2010 statement is this paper including the 25 item checklist in the table and the flow diagram. Consort 2010 checklist of information to include when reporting a randomized triala section and topic item no. You can download the consort 2010 statement documents here. Reporting guidelines for clinical trial reports for.
Reporting of noninferiority and equivalence randomized. It was first published in 1996, revised in 2001, last updated in 2010 1, 2 and published simultaneously in 10 leading medical journals. The consort statement is used worldwide to improve the reporting of randomised controlled trials. Consort 2010 statement on randomised controlled trials. Methodology revised standards for reporting interventions in. Jan 31, 2021 clinicians and lay people tend to overestimate the effectiveness of a treatment when only the relative effect is presented, particularly if the relative effect is large, but the absolute effect is small. Jan 31, 2021 consort statement for abstract checklist, the consort flow chart, and where applicable, the appropriate consort extension statements for example, for cluster rcts, pragmatic trials, etc. More recently, there has been a growing recognition that interventions involving artificial intelligence ai need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. Item reported no checklist item on page no consort. The most recent version of the statement the consort 2010 statement consists of a 25item checklist and a participant flow diagram, along with some brief descriptive text. The main product of the consort group is the consort statement, which is an evidencebased, minimum set of recommendations for reporting randomized trials. Consort encompasses various initiatives developed by the consort group to alleviate the. While those statements improved the reporting quality for.
The consolidated standards of reporting trials consort statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials rcts. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted. We strongly recommend reading this statement in conjunction with the consort 2010 explanation and elaboration for important clarifications on all the items. In recognition of this problem, item 17b of the consolidated standards of reporting trials consort 2010 statement stipulates authors present both absolute and relative effects for binary. Some participants were given primary responsibility for aggre. Randomised controlled trials rcts are one methodological approach for this. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates. Sep 04, 2012 the consolidated standards of reporting trials consort statement was developed to improve the reporting of randomised controlled trials. If relevant, we also recommend reading consort extensions for cluster randomised trials, noninferiority and equivalence trials, nonpharmacological treatments, herbal interventions, and. It suggests creating a consort diagram that represents the participant flow in the trial. The statement also recommends including a flow diagram to show the. Jun 30, 2017 initial work on this extension to the consort checklist preceded the 2010 update of the consort statement but was mainly conducted between 20 and 2016. Pdf the consort statement is used worldwide to improve the reporting of randomised controlled trials.
Schulz and colleagues describe the latest version, consort 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. The consort 2010 statement provides minimum guidelines for reporting randomised trials. It was initially published in 1996 and focused on the reporting of parallel group randomised controlled trials. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design typeindividually randomised, two group, parallel trials. The consort statement, which provides guidance on how to conduct a rigorous rct, was updated earlier this year. Spi 2018 is an official extension of the consort 2010. Consort for multiarm parallelgroup randomised trials. The consort consolidated standards of reporting trials statement is used worldwide to improve the reporting of randomized, controlled trials. This ayq markaz increases the reliability of the findings.
To encourage dissemination of the consort 2010 statement, this article is freely accessible on and will also be. The consort statement has been extended to other trial designs such as cluster randomization, and. A separate consort statement for the reporting of abstracts was published in. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in.
Consort statement was developed to improve the reporting. Their flagship guidelinethe consort 2010 statementincludes a 25. Consolidated standards of reporting trials consort statement. Schulz and colleagues describe the latest version, consort 2010, which updates the reporting guideline based on new. Intent of consort 2010 the consort 2010 statement is this paper including the 25 item checklist in the table and the flow diagram. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type individually randomised, two group, parallel trials. They are the cornerstone of evidence based medicine. Oct 21, 2016 the consolidated standards of reporting trials consort statement. The consolidated standards of reporting trials consort statement is a guideline designed to improve the transparency and quality of the. Consolidated standards of reporting trials wikipedia. This is a declaration of the standard, and how it was developed.
Consort 2010 statement journal of clinical epidemiology. Acupuncture rationale a style of acupuncture eg, tcm, japanese, korean, western medical, five element, ear acupuncture, etc. Abstract the consort statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth schulz and colleagues describe the latest version. The consort 2010 statement is this paper including the 25 item checklist in the table and flow diagram figure. The consort consolidated standards of reporting trials statement 2010 is used worldwide to improve the reporting of parallel group, randomized trials. The original consort consolidated standards of reporting trials statement was developed to help alleviate the problem of inadequate reporting of randomized controlled trials rcts. Extensions of consort 2010 to different trial designs have also been published, including cluster randomised trials,6 noninferiority and equivalence trials,7 nof1 trials,8 pragmatic trials,9 and within person trials. Chen and yang suggest that the consort group could collaborate with medical associations in developing countries and nonenglishspeaking countries to help them regularly train their medical editors.
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