The legacy of CONSORT and Douglas G Altman

The update of the Consolidated Standards of Reporting Trials (CONSORT) statement has now been published.12 It reflects a systematic examination of new evidence about the reporting of randomised controlled trials, methodological advancements in the conduct of randomised controlled trials and statistical approaches, and feedback from a broad spectrum of users since the last update in 2010. Douglas Altman was a massive contributor to CONSORT before his death in 2018. Many of those contributions are obvious as he was a member of the CONSORT executive and coauthor of all the CONSORT papers from 1997 to 2018. Many contributions, however, are not well recognised, because he was not an author of the first CONSORT paper in 1996, or its precursor, Standards of Reporting Trials (SORT).34 While not on the bylines, his influence permeated that work. We think his contributions should be noted in the story of how CONSORT came to be.

The inadequate reporting of randomised controlled trials became increasingly apparent with the growth of systematic reviews in the 1980s. Every proper systematic review had to assess the methodological quality of its component trials, and they frequently found that the reporting in the randomised controlled trials they identified was negligible or inadequate. As a result, in 1993, one of us (DM) organised a meeting of assessment tool developers so that we could develop a new assessment instrument for randomised controlled trials. However, early in the meeting, we realised that the actual reporting of randomised controlled trials in journals was too poor to even proceed with our original idea. The group switched its goal to improving the reporting of randomised controlled trials, leading to the SORT guideline.4 This redirection fell right into one of Doug’s interests.

Much of the critical background and impetus to SORT was provided by an earlier paper by Doug and the statistician Caroline Doré, which described the poor reporting of randomised trials published in major medical journals.5 Moreover, that same paper suggested that a checklist format for prospective authors and editors to follow could improve the reporting of RCTs. Indeed, that is the format eventually adopted by CONSORT.

The SORT group thought that it was important to ensure that the guidance we developed was evidence based. For each potential checklist item, the participants examined whether evidence supported its inclusion. A key resource for us was the then unpublished results of a study on the empirical evidence of bias in randomised controlled trials. Doug was a coauthor of that study, which was eventually published in 1995.6 It became a seminal example in SORT—and subsequent CONSORT statements—of the evidence needed to convince authors to properly report randomisation.

SORT published its report in 1994.4 Contemporaneously, the Asilomar group, with a remit similar to SORT, produced other recommendations.7 The two groups met and agreed to create one reporting guideline, worrying that the presence of two separate guidelines would result in neither being used. That produced the CONSORT manuscript. When it was submitted to JAMA for review, the most prominent reviewer was none other than Doug, who up until that point had not been directly involved in either the SORT or Asilomar efforts. Doug’s thorough and thoughtful review led to a better structure for the CONSORT paper and checklist. He also recommended that, in the future, CONSORT should produce a separate paper to provide evidence and explanations for each included checklist item. Additionally, Doug wrote an editorial documenting his thoughts on the CONSORT effort.8 Doug’s name was not on the CONSORT 1996 byline, but his imprint surely was.

Shortly after the publication of CONSORT 1996, we invited Doug to join the CONSORT executive group. He immediately led the effort to produce what he had recommended in his manuscript review—a separate paper that we called CONSORT explanation and elaboration, which helped to answer users’ questions.9 For the next 20 years, Doug fully contributed his brilliant, visionary, and practical mind to CONSORT, coauthoring CONSORT statements and explanation and elaboration articles in 2001 and 2010.9101112

Since the introduction of CONSORT in 1996, it has received acclaim as a landmark achievement in randomised trial reporting. Results from a randomised trial indicate that use of CONSORT within the peer review process improved the quality of subsequent publications.13 Journal endorsement of CONSORT is associated with more complete and transparent reporting of critical components of randomised trials.141516 CONSORT is endorsed by hundreds of journals around the world and by prominent editorial groups, including the World Association of Medical Editors and the International Committee of Medical Journal Editors. Google Scholar indicates that the original CONSORT papers have been cited more than 56 000 times.

The future of CONSORT is bright. We have successfully transitioned the leadership of CONSORT to the next generation. The CONSORT executive has been invigorated with younger researchers and has merged with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) executive. That brings us to another enduring contribution by Doug. He mentored Sally Hopewell, the principal grantee who superbly enabled and led the update of CONSORT 2025 in conjunction with Isabelle Boutron.

Doug became instrumental in developing many CONSORT extensions and other reporting guidelines, such as PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses),17 STROBE (Strengthening the Reporting of Observational studies in Epidemiology),18 and STARD (Standards for Reporting of Diagnostic Accuracy Studies).19 And, in a related major achievement, he initiated the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, whose mission is “to achieve accurate, complete, and transparent reporting of all health research studies to support research reproducibility and usefulness.”20 Doug’s achievements are vast, and many more exist outside the scope of CONSORT and reporting guidelines.

Indeed, to say that Doug was uniquely productive markedly understates his impact. His ranking by ScholarGPS—which evaluates scientists based on number of publications, citations of publications, and quality of publications—shows that out of almost 30 million scientists rated in the world, Doug is at the top.21 Quibble if you will with ScholarGPS methods, but that is an incredible achievement.

While epitomising a scientific icon, Doug was also a wonderful and amiable human being. We worked with him for over 25 years, enjoyed every minute, and learnt plenty. Without Doug in our lives, one of us (KFS) would know far less about cricket, the other (DM) far less about the various foods of the world, and all those reading would know much less about rigour in reporting scientific research. We honour Doug as friends and colleagues.