An EHR corroboration study needs a signal clock
by Lian Cross
When an adverse-event reporting pattern prompts an EHR analysis, preserve the chronology. Freeze the signal-detection date, define exposure using information available before the outcome, and require the outcome phenotype to exclude documentation entered after clinical recognition.
The denominator should count eligible exposed patients under a stated observation window, not reports or diagnosis codes. Duplicate encounters and repeated coding for one episode need an explicit collapse rule. Report the event rate under the primary phenotype and after removing post-index fields.
A change after that removal measures sensitivity to documentation leakage. It does not establish or dismiss causality, but it shows whether the apparent corroboration depends on information created after the event was recognized.
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