Stream: EBMonFHIR
Topic: Represent unstructured inclusion/exclusion criteria
Eric Moyer (Mar 14 2022 at 19:00):
Both ClinicalTrials.gov and dbGaP have unstructured text for their eligibility criteria right now. What is the right way to represent that in FHIR? (The dbGaP FHIR API currently shoves it into a text status=additional field. But that is a bad solution.) Maybe a better solution is:
"characteristic": [
{
"code": {
text: "HTML Text"
},
"valueCodeableConcept": {
text: "<div><p><i>Exclusion criteria:</i></p><ol><li>The repository has added Mini mental status (MMSE) score to the controls CDE.</li>...</div>"
},
"exclude": false
}
]
Brian Alper (Mar 14 2022 at 21:34):
@Eric Moyer That looks like a reasonable way to do it for now, though I would state "eligibility criteria" or "eligibility criteria in text form" as the code.text value. Later you could convert this from valueCodeableConcept.text value for the text summary to valueReference.reference to an EvidenceVariable Resource to support structured eligibility criteria expression. We are developing this with BRR and have an Eligibility Criteria Track for the May connectathon. We also have 3 examples of structured eligibility criteria at https://fevir.net/resources/Project/32444
Last updated: Apr 12 2022 at 19:14 UTC
