CONSORT (Consolidated Standards Of Reporting Trials) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of

randomized controlled trial A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical te ...

s. It is part of the larger

EQUATOR Network The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative aimed at promoting transparent and accurate reporting of health research studies to enhance the value and reliability of medical researc ...

initiative to enhance the transparency and accuracy of reporting in research.

The CONSORT Statement

The main product of the CONSORT Group is the CONSORT Statement,Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar23;340:c332 which is an

evidence-based Evidence-based practice (EBP) is the idea that occupational practices ought to be based on scientific evidence. While seemingly obviously desirable, the proposal has been controversial, with some arguing that results may not specialize to indiv ...

, minimum set of recommendations for reporting randomized trials. 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 interpretation. The most recent version of the Statement—the CONSORT 2010 Statement—consists of a 25-item checklist and a participant flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial. The Statement has been translated into several languages. The CONSORT "Explanation and Elaboration" documentMoher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869 explains and illustrates the principles underlying the CONSORT Statement. It is strongly recommended that it be used in conjunction with the CONSORT Statement. Considered an evolving document, the CONSORT Statement is subject to periodic changes as new evidence emerges; the most recent update was published in March 2010. The current definitive version of the CONSORT Statement and up-to-date information on extensions are placed on the CONSORT website.

Extensions

The main CONSORT Statement is based on the "standard" two-group parallel design. Extensions of the CONSORT Statement have been developed to give additional guidance for randomized trials with specific designs (e.g., cluster randomized trials, noninferiority and equivalence trials, pragmatic trials,), data (e.g., harms,

abstracts An abstract is a brief summary of a research article, thesis, review, conference proceeding, or any in-depth analysis of a particular subject and is often used to help the reader quickly ascertain the paper's purpose. When used, an abstract always ...

), and various types of intervention (e.g.,

herbals A herbal is a book containing the names and descriptions of plants, usually with information on their medicinal, tonic, culinary, toxic, hallucinatory, aromatic, or magical powers, and the legends associated with them.Arber, p. 14. A herbal m ...

, non-pharmacologic treatments,

acupuncture Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the body. Acupuncture is a pseudoscience; the theories and practices of TCM are not based on scientif ...

). A number of guidelines have been designed to complement CONSORT, including TIDieR (encouraging adequate descriptions of interventions) and TIDieR-Placebo (encouraging adequate descriptions of

placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. In general, placebos can af ...

or sham controls). This list is by no means exhaustive, and work is ongoing.

History

In 1993, 30 experts - medical journal editors, clinical trialists,

epidemiologists Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and determinants of health and disease conditions in a defined population. It is a cornerstone of public health, and shapes policy decisions and eviden ...

, and methodologists - met in

Ottawa, Canada Ottawa (, ; Canadian French: ) is the capital city of Canada. It is located at the confluence of the Ottawa River and the Rideau River in the southern portion of the province of Ontario. Ottawa borders Gatineau, Quebec, and forms the core ...

to discuss ways of improving the reporting of randomized trials. This meeting resulted in the Standardized Reporting of Trials (SORT) statement, a 32-item checklist and flow diagram in which investigators were encouraged to report on how randomized trials were conducted. Concurrently, and independently, another group of experts, the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, convened in

California, USA California is a U.S. state, state in the Western United States, located along the West Coast of the United States, Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the List of states and territori ...

, and were working on a similar mandate. This group also published recommendations for authors reporting randomized trials. At the suggestion of Dr. Drummond Rennie, from

JAMA ''The Journal of the American Medical Association'' (''JAMA'') is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of biom ...

, in 1995 representatives from both these groups met in

Chicago, USA (''City in a Garden''); I Will , image_map = , map_caption = Interactive Map of Chicago , coordinates = , coordinates_footnotes = , subdivision_type = Country , subdivision_name ...

, with the aim of merging the best of the SORT and Asilomar proposals into a single, coherent evidence-based recommendation. This resulted in the Consolidated Standards of Reporting Trials (CONSORT) Statement, which was first published in 1996. Further meetings of the CONSORT Group in 1999 and 2000 led to the publication of the revised CONSORT Statement in 2001. Since the revision in 2001, the evidence base to inform CONSORT has grown considerably; empirical data highlighting new concerns regarding the reporting of randomized trials. Therefore, a third CONSORT Group meeting was held in 2007, resulting in publication of a newly revised CONSORT Statement and explanatory document in 2010. Users of the guideline are strongly recommended to refer to the most up-to-date version while writing or interpreting reports of clinical trials.

Impact

The CONSORT Statement has gained considerable support since its inception in 1996. Over 600 journals and editorial groups worldwide now endorse it, including

The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, ...

, BMJ,

New England Journal of Medicine ''The New England Journal of Medicine'' (''NEJM'') is a weekly medical journal published by the Massachusetts Medical Society. It is among the most prestigious peer-reviewed medical journals as well as the oldest continuously published one. His ...

, World Association of Medical Editors, and

International Committee of Medical Journal Editors The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for stan ...

. The 2001 revised Statement has been cited over 1,200 times and the accompanying explanatory document over 500 times. Another indication of CONSORT's impact is reflected in the approximately 17,500 hits per month that the CONSORT website has received. It has also recently been published as a book for those involved in the planning, conducting and interpretation of clinical trials. A 2006 systematic review suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials. Similar initiatives to improve the reporting of other types of research have arisen after the introduction of CONSORT. They include: Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Standards for the Reporting of Diagnostic Accuracy Studies (STARD), Strengthening the Reporting of Genetic Association studies (STREGA),

Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the b ...

(PRISMA), Standards for Quality Improvement Reporting Excellence (SQUIRE), among others. These reporting guidelines have been incorporated into the

initiative to enhance the transparent and accurate reporting of research studies.Simera I, Altman DG, Moher D, Schulz K, Hoey J. The EQUATOR Network: facilitating transparent and accurate reporting of health research. Serials 2008 Nov 21 (3): 183-87

References

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External links