The quitting-study protocol changed: trace which version applied

Choose the delivery detail you need to understand

Start with a concrete claim, such as how support contacts were delivered or which materials participants received. Find the protocol identifier linked to the study and confirm the documents concern the same project. A current summary may describe the latest arrangement without showing the initial one. Keep the document date separate from the period when it governed delivery.

The original SPIRIT 2025 expanded checklist recommends a protocol version date, identifier, and a list of changes from the previous version with reasons. This is reporting guidance, not evidence that every trial followed it. It supports asking for a traceable change account. We do not infer regulatory status or ethics approval from a completed checklist.

SPIRIT–CONSORT Group: SPIRIT2025 expanded checklist

Make a version-to-period table

Use four columns in an original note: version and date, delivery provision changed, stated reason, and implementation period. If the last field is unknown, leave it unknown. A protocol posted late can describe an earlier change, so posting date and operational date need separate evidence. Do not invent a transition date by splitting recruitment in half.

In a hypothetical trial, an amended protocol changes the channel for reminder delivery after a practical access problem. The reader notes both versions and asks which enrolled participants were covered by the new channel. This invented example asserts no outcome or actual trial. Its useful output is a version-to-period map showing which description supports the delivery claim you plan to repeat.

Distinguish amendment from departure

A documented amendment changes the plan. A departure concerns what happened relative to the plan applicable at the time. The same observed delivery change could be described differently depending on timing and the documented procedure. Read the authors' account rather than declaring every difference a violation or assuming an amendment retroactively explains all earlier conduct.

The process can also leave uncertainty about whether participants received the revised arrangement. A dated plan is not a delivery receipt. Locate any implementation information in the final report, retaining scope and missing detail. If the distinction is technically or ethically consequential, direct a question to the responsible methods or research source; do not decide whether an approval requirement was met from a version number alone.

Carry the changing program into your summary

A faithful description can say the study’s delivery plan changed in this documented way during this stated period, with implementation details known or unresolved. Keep outcome-definition changes and adaptive statistical rules separate; those involve additional questions. Here the decision is how to describe the program actually being discussed, not whether one favorable endpoint was selected.

Do not assume that a commercial service available now matches every historical protocol version. Verify its actual arrangement and ask qualified professionals about clinical relevance if needed. A program change can be explained without promising effectiveness or alleging misconduct. This guide ends with a traceable delivery description and one unanswered timing question, keeping the first posted plan from silently representing the entire completed study.