Observational and real-world-evidence manuscript

The job

Report evidence from routine care, registries, databases, cohorts, case-control designs, or other nonrandomized sources with explicit provenance, cohort construction, analytic methods, and design limitations.

Extra controls

• Define data source, coverage, quality, and linkage.
• Describe operational definitions and coding.
• Explain selection, confounding, adjustment, missingness, and sensitivity analyses.
• Report estimates and uncertainty.
• Keep association and causation distinct.
• Discuss directness and generalizability to the intended population.

The observational study can answer questions a trial may not, but its usefulness depends on transparent methods rather than causal-sounding prose.