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SPIRIT-Outcomes 2022 Extension: guidelines for transparent inclusion of clinical trial outcomes in trial protocols


  • The SPIRIT-Outcomes 2022 Extension addresses the need for better guidance in describing outcomes in clinical trial protocols.
  • The new extension should be used in conjunction with the original SPIRIT 2013 Statement to improve transparency and integrity of clinical trial reporting.

The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-Outcomes 2022 Extension aims to provide harmonised, evidence- and consensus-based outcome reporting standards for clinical trial protocols. An addition to the existing suite of extensions supporting the original SPIRIT 2013 Statement, the latest extension was recently published in JAMA by Dr Nancy Butcher and colleagues.

The SPIRIT-Outcomes 2022 Extension recommends nine items that should be included in trial protocols, regardless of trial design and population, to define and justify the chosen primary, secondary and other outcomes of the trial. The nine items cover:

  • defining and justifying the chosen study outcomes, including the timing of their measurement and what constitutes a minimal important difference for use in sample size calculations
  • describing who will assess the outcome, and the responsiveness of the chosen outcome assessment tools in the target population
  • describing any statistical methods to account for multiplicity in the analysis or interpretation of the primary and secondary outcomes.

Developed using the EQUATOR methodology for developing reporting guidelines, the authors highlight that these nine checklist items define the minimally required outcome-specific information that should be included in a trial protocol in addition to the items included in the SPIRIT 2013 Statement. The SPIRIT-Outcomes 2022 Extension was developed in parallel with the associated CONSORT-Outcomes 2022 Extension and the authors noted how the two should be used together to maximise their utility in improving the transparency of clinical trial reporting and addressing selective nonreporting of trial results.

The SPIRIT-Outcomes 2022 Extension should be used in conjunction with the CONSORT-Outcomes 2022 Extension to improve the transparency of clinical trial reporting and address selective nonreporting of trial results.

An important aspect in the development of both extensions was representation from patient and public partners on the expert panels. The authors call for such patient and public partnerships when developing future guidelines to bring in a broader range of perspectives, which will ultimately benefit patient-centricity.

The SPIRIT-Outcomes 2022 Extension guidelines are hoped to be particularly useful to trial protocol authors, ethics review boards and journal editors. The authors urge the use of these guidelines for transparency and integrity in trial reporting, and welcome feedback from users of the extension to inform future updates.


Do you think the new SPIRIT-Outcomes 2022 Extension will improve the quality of clinical trial protocol reporting?

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