A new reporting checklist published in the BMJ seeks to address a recognised gap in guidance for randomised controlled trials (RCTs) that incorporate cohort data and routinely collected health data. The document, known as SPIRIT-ROUTINE, extends the original SPIRIT framework and is intended to improve transparency and completeness in trial protocol development.
Background: The SPIRIT Framework
The SPIRIT initiative was established in 2013 by an international group of researchers with the goal of producing evidence-based recommendations on what information should appear in RCT protocols. The resulting statement introduced a 33-item checklist of minimum recommended protocol elements, accompanied by a detailed explanation and elaboration document to assist researchers in applying each item.
Since its publication, SPIRIT guidance has attracted broad institutional support. Journals, regulatory bodies, industry sponsors, trial networks, academic institutions, contract research organisations, and patient groups have all endorsed the framework, according to the BMJ article. That level of uptake has made SPIRIT one of the more influential methodological standards in clinical trial research.
Why an Extension Was Needed
The original 2013 checklist was not designed with every trial methodology in mind. As research practice has evolved — particularly the growing use of electronic health records, disease registries, and other administrative data sources — the need for supplementary guidance became apparent. The SPIRIT and CONSORT executive groups formally recognised this gap, which prompted the development of the SPIRIT-ROUTINE extension.
Routinely collected data, gathered as part of standard clinical care rather than for research purposes, present distinct methodological and reporting challenges. Questions around data provenance, completeness, linkage, and governance do not map neatly onto the items in the original checklist. Similarly, trials that embed participants within existing cohort studies require protocol elements that the 2013 framework did not anticipate.
What SPIRIT-ROUTINE Covers
The new extension checklist is designed to sit alongside the core SPIRIT items rather than replace them. It provides additional recommended elements specific to trials that use cohort infrastructure or rely on routinely collected data as primary or secondary outcome sources. The BMJ publication includes an explanation and elaboration section for each new item, offering researchers practical context for how and why each element should be addressed in a protocol.
The checklist is intended to support researchers at the protocol-writing stage, helping to ensure that key decisions about data sources, access arrangements, and quality considerations are documented prospectively rather than retrospectively.
Broader Context of SPIRIT Extensions
SPIRIT-ROUTINE is one of several extensions developed since 2013 to address specific trial types and contexts. The extension model allows the core framework to remain stable while accommodating the methodological diversity of contemporary clinical research. Each extension undergoes a development process informed by existing literature and expert input, with the aim of producing guidance that is both evidence-based and practically applicable.
The publication of SPIRIT-ROUTINE in the BMJ follows the same format as earlier extensions, pairing the checklist itself with explanatory material. This structure is consistent with how the original SPIRIT statement was presented and reflects the initiative's emphasis on usability alongside methodological rigour.
Implications for Trial Reporting
Incomplete or inconsistent protocol reporting has long been identified as a barrier to research transparency and reproducibility. When trial protocols omit key information about data sources or collection methods, it becomes difficult for reviewers, regulators, and other researchers to assess the validity of a study's design or to replicate its methods. Checklists like SPIRIT-ROUTINE are intended to reduce this variability by establishing a shared standard for what a complete protocol should contain.
Whether journals and funders will formally adopt the SPIRIT-ROUTINE extension as a submission or grant requirement remains to be seen, though the pattern with earlier SPIRIT guidance suggests that institutional endorsement tends to follow publication over time.