# CONSORT and SPIRIT 2025: trial reports and protocols

Decision workbook and teaching example · 2026-10-06

The completed case is fictional. Its values and decisions are not actual findings; complete your project using relevant permissions, methods and requirements.

- Project: ____________________
- Researcher and role: ____________________
- Date and version: ____________________
- Data seen before the decision: ____________________
- Aim and scope: ____________________

## Completed example

| Stage/decision | Example | Check or action |
| --- | --- | --- |
| Protocol | Versioned SPIRIT 2025 | Map items to evidence. |
| Report | CONSORT 2025 | Separate plans and actual conduct. |
| Allocation | 80; hypothetical 40 + 40 | Reconcile actual records. |
| Outcome | 36 and 38 observed in example | Explain missingness and handling. |
| Change | Dated decision and reason | Do not conceal or backdate it. |

## Complete your own record

| Topic | Actual decision and reason | Evidence link and status |
| --- | --- | --- |
| Protocol | __________ | __________ |
| Report | __________ | __________ |
| Allocation | __________ | __________ |
| Outcome | __________ | __________ |
| Change | __________ | __________ |

## Completion checks

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

## Changes and limitations

| Date | Change | Data known at decision time | Reason | Consequence for claim | Reviewer |
| --- | --- | --- | --- | --- | --- |
| __________ | __________ | __________ | __________ | __________ | __________ |

## Sources and further reading

- [Hopewell et al. (2025) — CONSORT 2025 statement](https://www.bmj.com/content/389/bmj-2024-081123)
- [Chan et al. (2025) — SPIRIT 2025 statement](https://www.bmj.com/content/389/bmj-2024-081477)
- [SPIRIT–CONSORT — Published statements, including the 2025 updates](https://www.consort-spirit.org/published-statements)
- [EQUATOR Network — Reporting guidelines](https://www.equator-network.org/)

Related guide: https://didgar-research-site1.vercel.app/en/guides/consort-spirit-2025/