Thread: Knowledge updates

Reporting guidelines in medical research

Veerle Persy, Antwerp, Belgium

Rationale Clinical trials-”and randomized controlled trials in particular-”are the backbone of evidence-based medicine. The quality of the resulting publications must be optimal in order to provide adequate support for medical decision making.

The quality and relevance of research is mostly judged through the published report. Unclear, incomplete or poor-quality reporting of study methodology and findings hampers critical appraisal of the study and limits the appropriate use of its results. Risks of inadequate reporting include direct harm to patients as well as inadequate use of limited health-care resources.

Reporting guidelines provide standards and checklists that aim to increase the quality of clinical trial reporting. They establish a standard mode of reporting trial findings that increases the completeness and transparency of reporting, reduces the influence of bias, and facilitates critical appraisal and interpretation. Guidelines are designed for use at every stage in the life of the trial, from its inception and implementation, through analysis and interpretation, writing and editing, to publication. Reporting guidelines evolve and expand with the increasing importance placed on evidence-based medicine and on the quality and regulatory aspects of clinical research.

Purpose This talk will present an overview of reporting guidelines for reporting health research, with a focus on recent and forthcoming developments.

Presentation content A brief overview of the background and history of reporting guidelines will be given, followed by discussion of current guidelines and suggestions on where to find these. The EQUATOR network-”an initiative dedicated to improving the quality of scientific literature-”will be highlighted as a valuable source of information on reporting guidelines.

The CONSORT 2010 statement, and updates currently in the pipeline, will be used to demonstrate how these guidelines can co-evolve with scientific and regulatory quality demands on the publications that carry the results of medical research. Additional examples will be given to illustrate how they are adopted and endorsed by scientific journals and the impact of these actions.

The final section of the talk will be devoted to best practice in reporting guidelines, discussing the roles of study sponsors, authors (and medical writers), author's editors and journal editors in the implementation of reporting guidelines for medical research. This section will focus on the practical use of guidelines, providing details of necessary processes and -œhow-to- information for those who contribute to the medical results publication process, and for authors' editors in particular.


Veerle Persy graduated as MD in 1998 and obtained a PhD in Medical Sciences in 2003 from University of Antwerp. Her research as a Postdoctoral Fellow of the Fund for Scientific Research Flanders (Belgium) focused on the mechanisms of vascular calcification in chronic renal failure. In 2007 she founded Hugin Mugin Research, a company providing medical writing, data management and consulting services for the pharmaceutical and life sciences sectors.