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

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.

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.

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.