A quit-smoking trial is registered: which plan was recorded, and when?

01

A fictional timeline with two different questions

This exercise invents every document, date and arrangement; there is no real identifier or result. An adult randomized trial compares a goal worksheet plus a short consultation with the same consultation alone. Protocol version 1, dated 8 January 2025, names defined six-month continuous abstinence as primary. Registration is submitted on 10 January; first enrollment consent is on 12 January; the record appears publicly on 17 January.

Version 2, dated 20 May 2025, explains a switch from in-person to telephone interviews for an operational reason. It says this was decided before reviewing unblinded group results. The June 2026 report instead calls a three-month, seven-day abstinence measure primary. No explanation for that separate outcome change is visible in the material read.

The posting date alone does not prove late submission. The documented interview revision also does not explain a different abstinence definition and time point. Preserve both distinctions: ‘Submission preceded first consent in the listed dates; the primary-outcome difference remains unexplained in these documents.’ A dated author's statement is not your independent verification of what the team knew. Nothing here proves fraud, suppressed negative results or the worksheet's effectiveness.

02

Keep the identity and the dates attached to the record

Follow the report's registry identifier to the original registry record, checking that participants, intervention and investigators belong to the same trial. WHO's ICTRP provides a route to registry information; it is not itself a registry in which a trial is registered. A translated mirror or a copied screenshot may omit history or updates.

Record first submission, first public posting, first enrollment consent and version dates with their exact labels where available. If a date is planned rather than actual, retain that distinction. Missing submission information means the timing is unresolved; neither the current ‘last updated’ date nor the paper's publication date restores the original history.

These are research-transparency and journal recommendations, not a claim about every country's legal rules. ICMJE includes relevant behavioral and educational interventions in its clinical-trial definition; observational registration is a separate case. A registry may check record fields, but that does not establish that the study was conducted as planned or that its conclusion is correct.

[1][2][3]

03

Match an outcome, not just the word ‘abstinence’

CONSORT 2025 asks for access to the protocol and full statistical analysis plan, defined primary and secondary outcomes, and the timing and reasons for important amendments. Compare the definition, measurement, analysis population and time point across the versions. Continuous abstinence and a seven-day measure at another visit answer different questions.

Check the analysis plan for how missing data and additional analyses were to be handled; a registry's brief outcome name may not tell you that. Distinguish pre-specified analyses from those suggested by the data. A later analysis can be informative when identified as such, without becoming the original confirmatory question.

An amendment can be justified. Locate its version, reason and timing, and ask specifically whether it covers the difference you found. Search full reports and linked supplements before saying a planned result was never reported. If an explanation cannot be located, write ‘not found in the documents read’ rather than inventing a result, motive or misconduct finding.

[3]

04

A registered trial is not a personal care plan

This exercise uses public documents, not your smoking history, medicines or symptoms. Personal support and treatment questions belong with a qualified local professional. NHS information describes UK service routes through local services and health professionals; it is not a universal directory for English-speaking readers elsewhere.

[4]

05

What to keep in mind

• Do not use the latest registry page as the original plan.
• Submission and public posting are different dates.
• An explained amendment does not explain every discrepancy.

06

Common questions