Enhancing the CONSORT initiative: renewal of intellectual support for the CONSORT Group

Lead Research Organisation: Oxford University Hospitals NHS Trust
Department Name: Centre for Statisics in Medicine

Abstract

Randomized trials provide the best evidence of the effectiveness (and harms) of health care interventions; they are a crucially important part of the practice of evidence-based medicine. Proper reporting of trials is thus essential to ensure maximum benefit accrues from the trials conducted at great effort and expense. Yet a wealth of evidence shows that reporting of randomized trials is well short of ideal. The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed in 1996 to try to improve the reporting of randomized trials. If randomized trials are not well reported it is difficult for clinicians to use best evidence to inform best practice; patients may not get the best care.

The main product of CONSORT Group is the CONSORT Statement, an evidence-based, minimum set of recommendations for reporting randomized trials. In the form of a checklist and flow diagram, CONSORT offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. Originally published in 1996, the CONSORT Statement was updated in 2001 and mostly recently in 2010. In addition, several extensions have been developed for specific types of randomized trials. There is now a large and increasing body of evidence that CONSORT has had a beneficial impact on the quality of published articles. CONSORT is used and endorsed of by hundreds of medical journals worldwide. The CONSORT website is viewed nearly a quarter of a million times, annually.

It is important that CONSORT is kept up to date to reflect new evidence and changing opinion. In 2005, the CONSORT Group successfully received five year funding from the Health Technology Assessment Research Methodology Programme to support its activities and develop a major update of the recommendations. That funding is coming to the end and we now seek a renewal to enable us to continue to support and enhance the work of the CONSORT Group. We outline four broad, interlinked areas of planned activity relating to the CONSORT Statement and its extensions: to continue to refine and update the guidelines; to continue efforts to improve the implementation of and adherence to CONSORT; to conduct relevant research relating to how randomized trials are reported; and to provide vital infrastructure to support the activities of the CONSORT Group.

Technical Summary

The explicit primary goal of the CONSORT Group is to foster and facilitate proper reporting of randomized trials, primarily through developing guidelines for reporting the findings of completed trials. The work of CONSORT is of extreme relevance to the quality and value of clinical research across all medical areas. Research projects require considerable care in planning and execution if they are to contribute usefully to scientific knowledge and the care of people. However, serious deficiencies in the reporting of trials in the form of journal articles are well-documented. Randomized trials are the focus of particular scrutiny because of their important direct link to health care. The CONSORT Statement (1996, 2001 and 2010) presented recommendations for the proper reporting of randomized trials. Despite clear evidence that CONSORT has helped to improve reports of randomized trials the quality of reporting is still unacceptably low.

In 2005, the CONSORT Group successfully received five year funding to support its activities from the Health Technology Assessment Research Methodology Programme in the UK. The support provided by the current grant has greatly benefitted the CONSORT Group and helped us to be very productive in recent years. The CONSORT Statement is an evidence-based reporting guideline, however, to maintain its credibility it must remain up to date. That funding is coming to the end and we now seek a renewal to enable us to support and enhance the work of the CONSORT Group. We outline four broad, interlinked areas of planned activity relating to the CONSORT Statement and its extensions: to continue to refine and update the CONSORT guideline and its extensions; to continue efforts to improve the implementation of and adherence to the CONSORT Statement and its extensions; to conduct relevant research relating to how randomized trials are reported; and to provide vital infrastructure to support the activities of the CONSORT Group.

Planned Impact

The CONSORT Statement has been endorsed by the World Association of Medical Editors (WAME), the International Committee of Medical Journal Editors (ICMJE), the Council of Science Editors (CSE), and well over 600 journals worldwide. CONSORT is also supported by some research funders. Support from all these groups should raise adherence to CONSORT and thus improve the quality of published information about randomized trials.

Adherence to the CONSORT guidelines for reporting randomized trials ensures that readers have the information necessary to judge the reliability (in particular, by understanding exactly how the research was done), providing a sound basis for judging the value of that research to the reader. This in turn should lead to improvements in the way research is reported and interpreted leading to widespread incremental improvements in the quality of the information available to clinicians, patients and policy makers.

Publications

10 25 50
 
Description Citation and international endorsement of the CONSORT Statement
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www.consort-statement.org/about-consort/impact-of-consort
 
Title CONSORT website 
Description The CONSORT website provides access to information on the CONSORT Statement, its extensions and related activities. 
Type Of Material Improvements to research infrastructure 
Year Produced 2010 
Provided To Others? Yes  
Impact The CONSORT website receives approximately 20,000 hits per month. It was redesigned as part of this grant to make it more user friendly and interactive. 
URL http://www.consort-statement.org
 
Description CONSORT extension for reporting pilot randomized trials 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact A CONSORT extension for reporting pilot randomized trials (carried out in preparation for the main trial) will be published in the next 12-18 months.
Year(s) Of Engagement Activity 2014
 
Description CONSORT extension for reporting social and psychological intervention trials 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Development of a CONSORT extension for reporting social and psychological intervention trials

A number of publications have resulted from this meeting [see publications]
Year(s) Of Engagement Activity 2014
URL http://www.spi.ox.ac.uk/research/site/consort-spi/home.html
 
Description Presentation at ACT Now: Accuracy, Completeness and Transparency in health research reporting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Oral presentation on the impact of CONSORT for Abstracts guidance of journal editorial policies. Presentation at international conference on transparency of reporting attended by journal editors, funders, scientists, publishers.

Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ. 2012 Jun 22;344:e4178.
Year(s) Of Engagement Activity 2012
URL http://www.equator-network.org/2012/10/10/act-now-accuracy-completeness-and-transparency-in-health-r...
 
Description Presentations at International Peer Review Congress, Chicago 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Members of the CONSORT Executive gave several oral and poster presentations at the International Peer Review Congress

Collaboration with a number of journal editors
Year(s) Of Engagement Activity 2013
URL http://www.peerreviewcongress.org
 
Description Updating and implementation of CONSORT extension for reporting non-pharmacological treatment interventions 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Meeting of the CONSORT Group for reporting randomized trials of non-pharmacological treatment interventions (NPT). The aim of the meeting was to update the guidance and to develop strategies to improve implementation of the guideline.

A revised CONSORT NPT checklist is in preparation and will be published in 2015. An implementation strategy is being developed with the Annals of Surgery.
Year(s) Of Engagement Activity 2014
URL http://www.consort-statement.org/extensions?ContentWidgetId=558
 
Description Updating and implementation of the CONSORT statement for reporting randomized trials 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Strategies to improve the dissemination and implementation of the CONSORT Statement, and its extensions, were discussed and developed.

Different implementation strategies (designed at the author, journal, editor, peer reviewer and publisher level) will be evaluated - notable impact will be measured after these strategies have been fully evaluated.
Year(s) Of Engagement Activity 2014
URL http://www.consort-statement.org/