Post marketing safety surveillance depends in part on the ability to detect concerning clinical events at scale. Spontaneous reporting might be an effective component of safety surveillance, but it requires awareness and understanding among healthcare professionals to achieve its potential. Reliance on readily available structured data such as diagnostic codes risk under- coding and imprecision. Clinical textual data might bridge these gaps, and natural language processing (NLP) has been shown to aid in scalable phenotyping across healthcare records in multiple clinical domains. In this study, we developed and validated a novel incident phenotyping approach using unstructured clinical textual data agnostic to Electronic Health Record (EHR) and note type. It is based on a published, validated approach (PheRe) used to ascertain social determinants of health and suicidality across entire healthcare records. To demonstrate generalizability, we validated this approach on two separate phenotypes that share common challenges with respect to accurate ascertainment: 1) suicide attempt; 2) sleep- related behaviors. With samples of 89,428 records and 35,863 records for suicide attempt and sleep-related behaviors, respectively, we conducted silver standard (diagnostic coding) and gold standard (manual chart review) validation. We showed Area Under the Precision-Recall Curve of ~ 0.77 (95% CI 0.75-0.78) for suicide attempt and AUPR ~ 0.31 (95% CI 0.28-0.34) for sleep- related behaviors. We also evaluated performance by coded race and demonstrated differences in performance by race were dissimilar across phenotypes and require algorithmovigilance and debiasing prior to implementation.

The authors have declared no competing interest.

This study was funded by the U.S. Food and Drug Administration's Sentinel Initiative. All investigators were supported on FDA WO2006. Dr. Walsh is also supported in part by NIMH R01MH121455 and R01MH116269.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB of Vanderbilt University Medical Center gave ethical approval for this work.

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