Editorial: Harmonization and Publication of the 2025 Updates of the CONSORT and SPIRIT Statements for Clinical Trials

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996 and emphasized the importance of accurate and complete reporting of clinical trials. In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guidelines for trial protocols were first published. There have been several extensions of CONSORT as new developments have been incorporated into clinical trials, and conditions have changed. For the first time, in 2025, the CONSORT and SPIRIT statements for clinical trials have been published simultaneously, aiming to harmonize these essential guidelines. However, it is important to recognize the practical challenges and complexities that have inevitably developed during the past three decades since the first CONSORT statement was published. This editorial aims to describe the opportunities and challenges of harmonizing the publication of the 2025 updates of the CONSORT and SPIRIT statements.

The movement for evidence-based medicine began more than 40 years ago, in 1981, when a group of clinical epidemiologists, led by Dr David Sackett, first published a series of articles in the Canadian Medical Association Journal (CMAJ) advising physicians on how to appraise the medical literature, including publications from clinical trials [1]. Evidence-based medicine is now regarded as one of the most critical milestones in shaping modern medicine and is defined as integrating the best research evidence with clinical expertise and patient values [1]. The logical extension of evidence-based medicine is evidence-based clinical practice [1]. Fundamental to evidence-based medicine and evidence-based clinical practice is the integrity and reliability of the data from controlled clinical trials, which require guidelines for trial planning, conduct, and reporting [2].

The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996 and emphasized the importance of accurate and complete reporting of clinical trials [3]. In 1996, the CONSORT checklist was only half a page [3]. Because published articles in medical journals were the only records of clinical trial outcomes, the CONSORT reporting guidelines aimed to describe the minimum information required, with most of the early CONSORT recommendations focused on methods and results [3]. The first CONSORT update was published in 2001 and included trial registration as desirable but not as an essential requirement for the conduct of clinical trials [4]. The 2010 update of the CONSORT statement added trial registration as a required checklist item [5]. In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guidelines for trial protocols introduced data and code-sharing recommendations [6,7]. In 2017, guidance for statistical analysis plans was published [8]. The 2010 CONSORT statement and the 2013 SPIRIT guidelines were not published simultaneously but aimed to standardize the reporting of clinical trials and clinical trial protocols [5,7,9].

There have been several extensions of CONSORT as new developments have been incorporated into clinical trials and as conditions changed for clinical trials due to the COVID-19 pandemic. Artificial intelligence (AI) is a significant recent development, including physical robotics and devices, virtual AI, and machine learning. Therefore, in September 2020, the CONSORT-A1 extension was developed and included 14 additional items that should be reported for AI interventions [10]. The CONSORT-AI guidelines aimed to improve clinical trial reporting that included AI interventions, assist authors, journal editors, and reviewers, and develop the required evidence for future use of AI in clinical medicine [11,12]. Also, the CONSORT and SPIRIT Extension for Clinical Trials Revised in Extenuating Circumstance (CONSERVE) was published in June 2021 [13,14]. The scope of CONSERVE 2021 included modifications to address the ethical conduct, feasibility, scientific content, and data analysis as a joint extension for the CONSORT and SPIRIT reporting guidelines at that time [13]. CONSERVE 2021 aimed to facilitate the identification of the information required for the trial protocol and the completed trial report for investigators, following the trial modifications needed in response to extenuating circumstances that included the ongoing COVID-19 pandemic [13,14].

In April 2025, updates for both CONSORT and SPIRIT were published in tandem, which may result in clarification and harmonization while including some new items [15]. On April 14, 2025, Hopewell and colleagues published the 2025 updated CONSORT statement and guidelines for reporting randomized trials [15]. An extensive international survey was conducted online and involved 317 participants, followed by a two-day expert consensus meeting with 30 international experts [15]. The 2025 CONSORT guideline changes included seven new checklist items, a revision of three items, the integration of several items from key CONSORT extensions, and a restructured CONSORT checklist [15,16]. The 2025 CONSORT statement now consists of a 30-item checklist of essential items required when reporting the results of a randomized trial, with a study flowchart [15,16]. Importantly, CONSORT 2025 includes a section on Open Science recommending reporting research artifacts and making them publicly available [15].

On April 28, 2025, Chan and colleagues published the 2025 SPIRIT statement and checklist to update SPIRIT 2013 [17]. The international survey involved the CONSORT statement participants (317), as did the consensus meeting of 30 participants [17]. The revisions included two new protocol items, five revised items, removing five items, and integrating key items from relevant reporting guidelines [17]. Changes include a new Open Science section, the assessment of harms, the description of interventions and comparators, and an additional item on patient-public engagement in trial design [17]. The 2025 SPIRIT statement consists of an evidence-based checklist of 34 items to address in a trial protocol and a flow diagram to illustrate the trial schedules [17,18]. The updated SPIRIT 2025 statement aims to enhance the transparency and completeness of trial protocols [17].

However, there are several potential challenges in implementing the 2025 CONSORT and SPIRIT updates. In 1996, the CONSORT checklist was predicted to grow as more critical information for all clinical trials and specific types of clinical trials developed [3]. However, the full CONSORT 2025 and SPIRIT 2025 checklists are now 12 pages [16,18]. Since 2015, journal editors have highlighted the challenges of increasing numbers of extensions and checklist requirements for CONSORT [19]. This amount of detail required and the challenges to investigators of clinical trials have been highlighted by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network library, an online repository for reporting guidelines [20]. The EQUATOR network library has identified 32 CONSORT extensions and 10 SPIRIT extensions to address different research questions, which means that multiple extensions may now apply to most clinical trials [20]. Therefore, investigators must now consult several guideline documents [20].

A further criticism of the continued expansion of CONSORT is the lack of guidance on the structure of the reporting publication content, which is a challenge for authors, journal editors, and peer reviewers to implement the CONSORT recommendations [20]. Therefore, a possible criticism of the expanding CONSORT statement is the need for clear guidance on the essential content (headings and subheadings) for the main text of reporting publications [20,21]. Also, although developing and publishing guidelines for reporting clinical trials are essential, reporting guideline endorsement is not always associated with improved or adequate trial reporting [21,22]. This persistent problem highlights the need for standards for assessing adherence to SPIRIT 2025 and CONSORT 2025, which would be of value to authors, journal editors, and peer reviewers [21,22]. The developers of the SPIRIT and CONSORT statements have suggested that authors, journal editors, and peer reviewers should use reporting guidelines to improve reporting quality, with objective criteria for assessing adherence to each item and rules to support emerging technologies, such as AI for manuscript preparation and peer review [23,24].

Even with these recognized limitations, the 2025 updates for CONSORT and SPIRIT highlight how much the infrastructure and technology that support research transparency have improved since 1996. Of interest is that the Transparency and Openness Promotion (TOP) guidelines are currently being updated to provide a framework that journals and clinicians can use to promote research transparency [25]. The TOP guidelines will include seven practices supporting the verification of presented results and the evaluation of sharing study protocols, statistical analysis plans, research materials, analytical code, and study data [25]. Therefore, future updates of the SPIRIT and CONSORT statements could describe how these practices could be implemented to allow published content from clinical trials to be more easily verified.

Conclusions

For the first time, in 2025, the CONSORT and SPIRIT statements for clinical trials have been published simultaneously, aiming to harmonize these essential guidelines. However, it is important to recognize the practical challenges and complexities that have inevitably developed during the past three decades since the first CONSORT statement was published.