Open the trial record, compare its registered primary outcome fields with the outcomes reported in the paper, and log any switching or added outcomes before marking the study eligible.
ClinicalTrials.gov defines structured registration and results fields covering study identification, status, design, eligibility, locations, outcomes, and reported results. Those outcome fields give you the registration side of the comparison; the paper supplies the reported side.
- Locate the registered record using the study title, registry identifier, or a search filtered by condition, intervention, and status. Confirm the record matches the paper's study population and design before using it as the comparison source.
- Copy the registered primary outcome fields into your evidence table, keeping the registered wording and any stated time frame. Then copy the outcomes the paper reports as primary, using the paper's wording.
- Compare the two sets field by field. Flag a switched outcome when a registered primary outcome is reported as secondary or omitted, and flag an added outcome when the paper reports a primary outcome absent from the registration. Record each flag with the registered wording, the reported wording, and the source location in both documents.
- Resolve the flag before eligibility is decided. If the record and paper disagree, note the discrepancy as unresolved and check whether another registry entry or a published protocol explains it; record what each source states.
PRISMA 2020 provides a checklist and flow diagrams for transparent reporting of why a review was done, what methods were used, and what studies were found and included. Use that structure to document the outcome comparison and its resolution in the review record.
