CONSORT and SPIRIT 2025: trial reports and protocols

Two documents at different times

SPIRIT 2025 provides 34 minimum protocol items and CONSORT 2025 provides 30 randomized-trial reporting items. Item counts are not quality scores or ethics approval. Design-specific extensions and journal requirements may also apply.

A protocol states plans; a report states what actually happened. Do not turn future-tense plans into a final report without checking actual participant flow and procedures.

Before starting: an executable protocol

Operationalize the question, eligibility, interventions, outcomes and timing, randomization, allocation concealment, feasible blinding, sample size, analysis and safety management. A schedule of assessments helps execution.

Identify registration, protocol version, analysis plan and document access. Registration does not replace ethics review or informed consent. This guide does not authorize an unspecified human study.

After execution: consistent accounting

Hypothetical accounting: 80 randomized participants, 40 per group, with primary-outcome observations for 36 and 38. Record reasons for the missing four and two observations and address them in the missing-data approach. This is not an actual trial result.

Reconcile enrollment, allocation, follow-up and analysis. Tables, flow diagrams and text must match the defined analysis population. Distinguish missing outcomes, withdrawals and post hoc exclusions.

An evidence matrix rather than ticks

For each applicable item identify the document location, evidence and status: present, incomplete or not applicable with reason. Consult the complete original guidance; this page is not a reproduced official checklist.

Date and justify outcome, analysis or schedule changes. Harms, conflicts, funding and data/code access statements must match actual records.

Version choice and specialist review

Where a journal requests an older form, explain the required version and retain important updated information. Save the instructions and retrieval date.

Trials require appropriate expertise and oversight. Clinical, ethical and statistical accuracy needs relevant review; a reporting matrix cannot repair deficient design or conduct.

Completed teaching worksheet

This is a hypothetical teaching case, not observed data, an actual review or a publication acceptance. Numbers illustrate decisions.

Deliverables and completion checks

• Versioned protocol and report matrices.
• Consistent participant flow and change records.
• Specialist-review, registration and access documentation.

Version and scope references: Hopewell et al. (2025) — CONSORT 2025 statement · Chan et al. (2025) — SPIRIT 2025 statement