Design-Study Skill

Core Review Questions

Always inspect:

1. The exact research question.
2. The analysis unit: patient, lesion, exam, study, phase, report.
3. The index date or decision point.
4. How inclusion and exclusion criteria are applied.
5. Any information leakage.
6. The reference standard or endpoint definition.
7. A clinically meaningful comparator.
8. The validation strategy.
9. The uncertainty reporting required.
10. The best-fitting reporting guideline.
11. Whether exposure/outcome/covariate definitions are literature-grounded or invented ad hoc from the data dictionary. If ad hoc, defer to /define-variables before drafting Methods.