Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond

Abstract

Improvements in the quality of reporting of RCTs must be based on strong evidence. A series of studies beginning in 1995 found empirical evidence that results may be biased when trials use inferior methods or are reported without adequate description of the methods; notably, failure to conceal the allocation process is associated with an exaggeration of the effectiveness of an intervention of 30% or more.1^,2 The cause for concern is obvious: if the conduct or reporting of RCTs is poor, treatments may be introduced that are less effective than was thought or that might even be ineffective. This concern led the Consolidated Standards of Reporting Trials (CONSORT) group to formulate a series of recommendations in 19963 and 2001.4^,5 This commentary summarizes developments within CONSORT since 2001.