From CONSORT to AI: The Evolution and Future of Research Reporting Guidelines

Introduction

The 1980s saw the rise of evidence-based medicine (EBM), a transformative approach largely pioneered by Canadian physician David Sackett, often hailed as the father of EBM. Initially aimed at helping clinicians—across medicine, nursing, and midwifery—make informed treatment decisions, EBM emphasized the “conscientious, explicit, and judicious use of current best evidence” in patient care.

Over time, EBM evolved from a clinician-focused tool into a resource for organizations and government health departments, guiding policy decisions and directing resources toward treatments deemed most effective within economic constraints.

The Emergence of Research Reporting Guidelines

Research reporting guidelines were born out of the need to address inconsistencies in how studies were documented. As analytical methods and data presentation, particularly in randomized controlled trials (RCTs), became more sophisticated, systematic reviews emerged as the highest standard of evidence. A critical element of these reviews involved assessing the quality of studies, but inconsistencies—such as incomplete reporting of randomization methods or controls—highlighted the need for standardized reporting.

Irish epidemiologist David Moher, based in Canada, spearheaded this effort. Concerned with improving RCT reporting, Moher and colleagues introduced the CONSORT guidelines in 1996, offering a checklist for authors to ensure thorough and transparent reporting. This initiative not only enhanced reporting standards but also indirectly influenced how RCTs were conducted, as researchers increasingly designed studies with these guidelines in mind.

Since their inception, CONSORT guidelines have been updated multiple times and extended to cover specialized areas such as herbal medicine, acupuncture, and adverse event reporting. These updates are available through the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research), founded in 2006 to centralize and promote reporting guidelines. Currently, the network lists over 660 reporting guidelines, although only a subset, such as CONSORT, STROBE (Strengthening the Reporting of Observational Studies in Epidemiology, 2007), and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses, 2007), are widely used.

By enforcing more complete reporting, these guidelines have enhanced transparency and standardized research documentation. Leading healthcare journals often require adherence to appropriate EQUATOR guidelines, with flow charts like those in CONSORT and PRISMA becoming standard features in articles reporting clinical trials and systematic reviews.

Reporting Guidelines in Practice

CONSORT has particularly improved the conduct and reporting of RCTs, including prompting the registration of trials in public databases. All major publishers and journals are signatories of the AllTrials agreement, which mandates prospective registration of RCTs. Submissions failing to meet this criterion risk outright rejection.

For journal editors and peer reviewers, reporting guidelines streamline manuscript assessment. Editors can quickly screen submissions for compliance, while reviewers can use checklists to verify adherence, improving the efficiency and rigor of the review process.

Technological Advances and New Challenges

The Internet, and later the World Wide Web (WWW) from 1991 onward, transformed academic research by facilitating faster access, sharing, and systematic reviews. This accessibility fueled the Open Access movement but also gave rise to predatory publishers, who exploit the system by superficially citing reporting guidelines like CONSORT and PRISMA while ignoring rigorous standards. Even mainstream journals occasionally fall short in adherence, with studies of COVID-19 RCTs showing median compliance to CONSORT at just 54.3%.

The emergence of artificial intelligence (AI) and large language models (LLMs), including ChatGPT and Microsoft Co-Pilot, introduces both opportunities and challenges. AI can automate checklist completion, generate guideline-compliant flow charts and abstracts, and assist editors and reviewers in verifying adherence. However, practical and ethical concerns persist: AI accuracy must be validated, potential biases in outputs assessed, and data ownership and sharing carefully managed.

Future Directions

The proliferation of reporting guidelines has clearly improved research quality, evidenced by the continuous updates and extensions of widely used frameworks like CONSORT and PRISMA. Yet, quantifying their exact impact remains challenging, and the relationship between guidelines and increasing article retractions is still unclear.

Looking forward, consolidation of similar guidelines may reduce confusion, and broader adoption of AI in both reporting and peer review seems inevitable. Reporting guidelines will remain central to research integrity, requiring ongoing awareness and engagement from both researchers and editors.

Conclusion

Reporting guidelines have transformed scientific publishing, promoting transparency, standardization, and higher research quality. As they continue to evolve alongside technological innovations like AI, their influence will grow, underscoring the responsibility of the academic community to implement them effectively and ethically.