To comprehend the results of a randomised controlled trial (RCT), readers must understand
its design, conduct, analysis, and interpretation. That goal can be achieved only
through total transparency from authors. Despite several decades of educational efforts,
the reporting of RCTs needs improvement. Investigators and editors developed the original
CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve
reporting by use of a checklist and flow diagram. The revised CONSORT statement presented
here incorporates new evidence and addresses some criticisms of the original statement.
The checklist items pertain to the content of the Title, Abstract, Introduction, Methods,
Results, and Discussion. The revised checklist includes 22 items selected because
empirical evidence indicates that not reporting this information is associated with
biased estimates of treatment effect, or because the information is essential to judge
the reliability or relevance of the findings. We intended the flow diagram to depict
the passage of participants through an RCT. The revised flow diagram depicts information
from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis).
The diagram explicitly shows the number of participants, for each intervention group,
included in the primary data analysis. Inclusion of these numbers allows the reader
to judge whether the authors have done an intention-to-treat analysis. In sum, the
CONSORT statement is intended to improve the reporting of an RCT, enabling readers
to understand a trial's conduct and to assess the validity of its results.