Consolidated Standards of Reporting Trials
Encyclopedia
CONSORT encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trial
s.
, 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’ document explains and illustrates the principles underlying the CONSORT Statement. It is strongly recommended that it is 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.
), and interventions (e.g., herbals
, non-pharmacologic treatments, acupuncture
). This list is, by no means, exhaustive, and work is ongoing.
editors, clinical trialists, epidemiologists
, and methodologists
- met in Ottawa, Canada
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
, 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
, in 1995 representatives from both these groups met in Chicago, USA
, 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.
, BMJ
, JAMA
, New England Journal of Medicine
, World Association of Medical Editors, and International Committee of Medical Journal Editors. 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.
Results from a recent systematic review
suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials.
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
s.
The CONSORT Statement
The main product of the CONSORT Group is the CONSORT Statement, which is an evidence-basedEvidence-based medicine
Evidence-based medicine or evidence-based practice aims to apply the best available evidence gained from the scientific method to clinical decision making. It seeks to assess the strength of evidence of the risks and benefits of treatments and diagnostic tests...
, 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
Checklist
A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task...
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’ document explains and illustrates the principles underlying the CONSORT Statement. It is strongly recommended that it is 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 of the CONSORT Statement
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, abstractsAbstract (summary)
An abstract is a brief summary of a research article, thesis, review, conference proceeding or any in-depth analysis of a particular subject or discipline, and is often used to help the reader quickly ascertain the paper's purpose. When used, an abstract always appears at the beginning of a...
), and interventions (e.g., herbals
Herbalism
Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, herblore, and phytotherapy...
, non-pharmacologic treatments, acupuncture
Acupuncture
Acupuncture is a type of alternative medicine that treats patients by insertion and manipulation of solid, generally thin needles in the body....
). This list is, by no means, exhaustive, and work is ongoing.
History
In 1993, 30 experts - medical journalMedical journal
A public health journal is a scientific journal devoted to the field of public health, including epidemiology, biostatistics, and health care . Public health journals, like most scientific journals, are peer-reviewed...
editors, clinical trialists, epidemiologists
Epidemiology
Epidemiology is the study of health-event, health-characteristic, or health-determinant patterns in a population. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive...
, and methodologists
Methodology
Methodology is generally a guideline for solving a problem, with specificcomponents such as phases, tasks, methods, techniques and tools . It can be defined also as follows:...
- met in Ottawa, Canada
Ottawa
Ottawa is the capital of Canada, the second largest city in the Province of Ontario, and the fourth largest city in the country. The city is located on the south bank of the Ottawa River in the eastern portion of Southern Ontario...
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
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
, 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
Journal of the American Medical Association
The Journal of the American Medical Association is a weekly, peer-reviewed, medical journal, published by the American Medical Association. Beginning in July 2011, the editor in chief will be Howard C. Bauchner, vice chairman of pediatrics at Boston University’s School of Medicine, replacing ...
, in 1995 representatives from both these groups met in Chicago, USA
Chicago
Chicago is the largest city in the US state of Illinois. With nearly 2.7 million residents, it is the most populous city in the Midwestern United States and the third most populous in the US, after New York City and Los Angeles...
, 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 LancetThe Lancet
The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's best known, oldest, and most respected general medical journals...
, BMJ
British Medical Journal
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
, JAMA
Journal of the American Medical Association
The Journal of the American Medical Association is a weekly, peer-reviewed, medical journal, published by the American Medical Association. Beginning in July 2011, the editor in chief will be Howard C. Bauchner, vice chairman of pediatrics at Boston University’s School of Medicine, replacing ...
, New England Journal of Medicine
New England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
, World Association of Medical Editors, and International Committee of Medical Journal Editors. 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.
Results from a recent systematic review
Systematic review
A systematic review is a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question. Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine...
suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials.