Guidelines for Reporting Outcomes in Trial Protocols The SPIRIT-Outcomes 2022 Extension

Butcher NJ, Monsour A, Mew EJ, et al. - Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. JAMA. 2022;328(23):2345–2356. - 2022
  • Research question
  • Develop a protocol
  • Outcome selection and measurement
Access tool
doi: 10.1001/jama.2022.21243

Developed as part of the Instrument for Reporting Planned Endpoints in Clinical Trials (InsPECT) project and aligned with the CONSORT‑Outcomes 2022 extension, this guideline creates a coherent pathway from protocol to trial report. It provides harmonized, evidence‑based standards for describing outcomes in randomized clinical trial protocols and is intended to be used alongside the SPIRIT 2013 statement. It defines 9 additional outcome‑specific reporting items that elaborate SPIRIT checklist items on the choice of primary and secondary outcomes, sample size justification, outcome assessment methods, and statistical analysis of outcomes.

Covers key aspects of outcome reporting, including:

  • Rationale for selecting the primary outcome domain and its clinical relevance.
  • Definition and justification of minimal important change and minimal important difference where relevant.
  • Prespecification of cutoff values, outcome time points, and handling of composite outcomes.
  • Target difference for sample size calculations and responsiveness of study instruments.
  • Choice of outcome assessors and planned methods to account for multiplicity in outcome analyses.

Content and scope:

  • Offers a fillable SPIRIT‑Outcomes checklist (for combined or separate completion with SPIRIT 2013) to support protocol authors in systematically addressing outcome‑specific content.
  • Provides supplementary eTables and eAppendices describing development methods (scoping review, Delphi survey, consensus meeting), definitions of key outcome terms, examples of core outcome elements, and optional additional items for some protocols or associated documents such as statistical analysis plans.
  • Describes intended key users and implementation strategies, including use by trial protocol authors, ethics review boards, regulators, funders, systematic reviewers, journals, and trial registries (for example ClinicalTrials.gov), promoting consistent outcome reporting across the trial lifecycle.

It is particularly relevant for clinical studies seeking robust ethical and regulatory approvals, standardized trial conduct, and transparent outcome reporting that supports replication, meta‑analysis, and reduction of research waste. Additional materials and data related to SPIRIT‑Outcomes are available via the SPIRIT website and an Open Science Framework project linked from the article.

Back to toolbox