Templates of the consort flow diagram are available in pdf and in ms word 52. 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. The consort consolidated standards of reporting trials 2010 guideline is intended to improve the reporting of parallelgroup randomized controlled trial rct, enabling readers to understand a trials design, conduct, analysis and interpretation, and to assess the validity of its results. The consort consolidated standards of reporting trials statement was developed to help biomedical researchers report randomised controlled trials rcts transparently. Extension to randomised pilot and feasibility trials article pdf available december 2016 with 1,219 reads how we measure reads. 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, annals of internal. We have developed an extension to the consort 2010 statement for social and psychological interventions consort spi 2018 to help behavioural and social scientists report these studies transparently. We have made several substantive and some cosmetic changes to this version of the consort explanatory document full details are highlighted in the 2010 version of the consort statement. Example of template disclosure statement for professional medical writing support.
Sager guidelines reporting of sex and gender information pdf. Consort is a protocol developed by a group of researchers not only to identify problems arising from conducting rcts, but also to report, in a full and clear manner, the results yielded by research, thereby facilitating rcts reading and quality assessment. Application within and adaptations for orthodontic trials. The consort consolidated standards of reporting trials statement, most recently updated in 2010, is an evidencebased, minimum set of recommendations for reporting the findings of randomized trials 1,2 it offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and. In this paper we introduce and explain corresponding updates in an extension of the consort checklist specific. Consort 2010 checklist of information to include when reporting a. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design typeindividually randomised, two group, parallel trials. Evaluation template next step, interrater reliability. Eldridge sm, chan cl, campbell mj, bond cm, hopewell s, thabane l, lancaster ga. Tidier checklist should be used in conjunction with the consort statement see. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates the. Intent of consort 2010 the consort 2010 statement is this paper including the 25 item checklist in the table and the flow diagram. Evidencebased exercise prescription is facilitated by the.
Consort 2010 flow diagram randomised trials pdf ms word. Schulz kf, altman dg, moher d, for the consort group. When applicable, explanation of any interim analyses and stopping guidelines. 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 randomized, 2group, parallel trials. Flowchart is a stata modulepackage that generates publicationquality subject disposition flowchart diagrams in latex format. Consort 2010 flow diagram assessed for eligibility n excluded n not meeting inclusion criteria n declined to participate n other reasons n analysed n excluded from analysis give reasons n lost to followup give reasons n discontinued intervention give reasons n. Exercise prescription is sensible when supported by highquality evidence of effectiveness, and it is likely that the design of an exercise programme eg, how long a person exercises each day, the duration of a programme, the level of intensity of the exercise influences programme effectiveness. One new checklist subitem, keywords, was added to facilitate indexing and data. Question what additional information should be provided when reporting a multiarm randomized trial that uses a parallelgroup design but has 3 or more groups findings this reporting guideline is an extension of the consolidated standards of reporting trials consort 2010 statement. Reporting of participant flow diagrams in published.
The consort 2010 statement provides the latest recommendations from the consort group on essential items to be included in the report of an rct. Suggestions for additional reporting requirements especially for trials with children in form of a consort c children checklist were already published in 2010 by saintraymond et al. The quality of description of interventions in publications, however, is remarkably poor. The author takes no responsibility whether this goal has been achieved successfully, should anyone care to use the example as a template when submitting a manuscript of their own to a.
When a clinical trial protocol is being reported, the tidier checklist should be used in conjunction with the spirit statement as an extension of item 11 of the spirit 20. The flowchart is meant to conform to the specifications of the consort 2010 statement guidelines adhered to by the majority of scientific biomedical journals. The consort 2010 statement, this revised explanatory and elaboration document, and the. Merck guidelines for publication of clinical trials. The final diagram is the same in style as ones used in the prisma statement, consort 2010 statement, or strobe statement reporting guidelines. Consort extension for reporting nof1 trials cent 2015 statement. It provides guidance for reporting all randomized controlled trials, but focuses on the most common design typeindividually. A checklist for evaluating the validity and suitability of. A consort explanation and elaboration article was published in 2001 alongside the 2001 version of the consort statement. Consort is part of a broader effort, to improve the reporting of different types of health research, and indeed, to improve the quality of research used in decisionmaking in healthcare. Tidier checklist intervention description and replication pdf. The consort statement is endorsed by prominent general medical journals, many specialty medical journals, and leading editorial organizations. Ten consort items have been modified, and examples of good reporting and an.
Consort 2010 checklist of information to include when reporting a randomised trial. Sample template for the consort diagram in word and pdf. Application within and adaptations for orthodontic trials nikolaos pandis,a padhraig s. 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. The consort statement is used worldwide to improve the reporting of randomised controlled trials. The consolidated standards of reporting trials consort statement. A consortstyle flowchart of a randomized controlled trial. Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. To improve the completeness of reporting, and ultimately the replicability, of. Intent of consort 2010 the consort 2010 statement is this paper including the 25 item checklist in the table and flow diagram figure. Consortstatement explanation and examples for consort 2010 title. After an expert meeting in january 2007, the consort statement has been further revised and is published as the consort 2010 statement. Diagram template have been used since time immemorial to provide visual support to.
Consort 2010 checklist randomised trials pdf ms word. Flow diagram of the progress through the phases of a parallel randomised trial of two groups that is, enrolment, intervention allocation, followup, and data analysis. In the mid1990s, in response to concerns about the quality of reporting of randomised controlled trials rcts, an international group of trialists, statisticians, epidemiologists and biomedical editors developed the consolidated standards of reporting trials consort statement, which has been revised and updated twice 2, 3, each with a companion explanatory document 4, 5. Experimental studies study designs the equator network. Relevant more generic specialised reporting guidelines i. To encourage dissemination of the consort 2010 statement, this article is freely accessible on. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, prevents researchers. You will find several collections of documents available for download on this website, including. Kenneth schulz and colleagues describe the latest version, consort 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. The tidier template for intervention des cription and.
Translations of reporting guidelines the equator network. We have described an extension of the consort checklist specific to reporting within person randomised trials. Consort 2010 checklist of information to include when reporting a randomized triala section and topic item no. We have made several substantive and some cosmetic changes to this version of the consort explanatory document full details are highlighted in the 2010 version of the consort statement 59. Reporting of multiarm parallelgroup randomized trials. The consort 2010 statement is this paper including the 25 item checklist in the table and the flow diagram. The consort 2010 statement provides the latest recommendations from the consort group on essential items to be included in the report of a rct. The authors thank name and qualifications of company, city, country for providing medical writing support editorial support specify andor expand as appropriate, which was funded by sponsor, city, country in. The consort 2010 statement was extended by introducing the idea of tcm pattern and the features of chm formulas. Altmand bern, switzerland, corfu, greece, london and oxford, united kingdom, and paris, france. Exercise is effective for the prevention and management of acute and chronic health conditions. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted. Download the consort 2010 publications consort statement.
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