Do overly complex reporting guidelines remove the focus from good clinical trials?

Yes—Jeremy Howick, Rebecca Webster, and J André Knottnerus

In 1996 a group of medical journal editors, clinical trialists, epidemiologists, and methodologists met in Chicago to develop a checklist to help researchers report the results of their clinical trials completely and transparently.1 The result was the Consolidated Standards of Reporting Trials (CONSORT), which has aimed to improve reporting of randomised controlled trials (RCTs) ever since.

The original 1996 statement included a half page guide embedded in a three page explanatory document.2 The updated 2010 CONSORT statement includes 25 items embedded in a 28 page paper, as well as a separate explanatory document. That’s just the basic version. There are versions of CONSORT for trials of herbal treatments, orthodontic treatments, feasibility, and at least 25 other subtypes.3 And that’s just CONSORT; many other reporting guidelines have been developed since 1996.

Multiple guidelines are often required for a single study, each with a host of supplementary documents. Identifying, understanding, and implementing these guidelines takes time and effort. This would be justified if these efforts all improved study quality—or better still, patient outcomes. Such evidence is absent.

The fact is that guideline developers measure their success by checking to see how well researchers adhere to the guidance.4 Such efforts often reveal that the guidelines are barely used.5 Worse, checking whether guidelines are used doesn’t tell us whether the guidelines (in their current form) are useful for improving research in the first place.