Randomized controlled trials (RCTs) are the foundation for advancing clinical practice. However, not all RCTs are created equal. To communicate how an RCT was designed and what it found, authors must report clear and accurate information about its methodology and results. Unfortunately, many reviews have shown that authors often don’t provide complete and transparent information about the clinical trial, which can lead to misinterpretation of the validity and reliability of the results.
In 1996, a group of editors and scientists decided to remedy this situation by creating a statement called the CONSORT (Consolidated Standards of Reporting Trials). In 2010, the document was revised and released simultaneously in prominent journals.
What is the CONSORT statement, and how can it help medical communicators in their work to help authors who are writing reports of randomized, controlled trials?
What Is the CONSORT Statement?
The CONSORT statement establishes a standard for how authors should report the results of randomized controlled trials. It includes a 25-item checklist of essential items authors need to include to ensure complete and transparent reporting of a randomized trial. It also includes a flow diagram showing how subjects progress through the phases of a parallel randomized trial.
Health care professionals rely on the results of randomized controlled trials to provide effective treatments. As Moher and his colleagues write in a BMJ article titled CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, “Biased results from poorly designed and reported trials can mislead decision making in health care at all levels, from treatment decisions for a patient to formulation of national health policies.”
A Need for Standardization
In 2010, a group of journals published an update to the CONSORT statement in an attempt to more widely disseminate the standards for the reporting of randomized controlled trials. One of those journals, Annals of Internal Medicine, included an article by Kenneth F. Schulz, PhD, MBA; Douglas G. Altman, DSc; and David Moher, PhD, for the CONSORT Group. “Randomized, controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions,” the authors write. “However, randomized trials can yield biased results if they lack methodological rigor. To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings.”
In short, following the release of the CONSORT statement in 1996, the reporting quality was improving, but not enough. Hence the need to update and further disseminate the CONSORT statement.
The CONSORT 2010 Statement includes two main parts: a 25-item checklist and a flow diagram. It is especially useful for reporting randomized, controlled, 2-group, parallel trials. Other extensions and resources are available for other trial designs.
The CONSORT statement is not currently available through the CONSORT website, but it is reproduced in articles that discuss the statement.
The CONSORT checklist follows the general IMRAD structure for the sections of a scientific research paper: Introduction, Methods, Results, and Discussion.
For example, the CONSORT checklist asks the author whether the title of the trial identifies it as a randomized trial and whether the Abstract reflects the trial’s design, methods, results, and conclusions.
The checklist runs through Introduction items that include the background and objectives, and it provides a detailed focus on the Methods and Results.
Questions concerning the Methods section address the following:
- Trial design
- Sample size
- Sequence generation
- Allocation concealment mechanism
- Statistical methods
The questions are designed to elicit clear reporting on all the elements that make for an accurate and effective trial.
When authors pay attention to the checklist items, the result is clearer and more transparent reporting of trials. “Note that the CONSORT 2010 Statement does not include recommendations for designing, conducting, and analyzing trials,” write Schulz and his colleagues. “It solely addresses the reporting of what was done and what was found.”
The Results items in the checklist include participants flow, recruitment, baseline data, numbers analyzed, outcomes and estimation, ancillary analyses, and harms.
Finally, the checklist includes items on the limitations of the trial and its funding and accessibility.
The Flow Diagram
The flow diagram illustrates the process of a parallel randomized trial as a way to clearly report the critical process of randomization. The checklist and flowchart work together to create a clear and cohesive picture of the randomization process and the trial.
The CONSORT statement with its checklist and flow diagram is a useful tool for medical editors and writers seeking to create polished and effective manuscripts. The authors of the CONSORT 2010 Statement are clear that the guideline is part of an evolving scientific landscape. It will likely continue to be revised and reappraised as science and medicine continue to evolve.