Stream: implementers
Topic: FHIR ResearchStudy
Zach Lister (May 29 2020 at 17:09):
Hello, I am working on using a FHIR ResearchStudy to be a uniform way to return clinical trial results. The "enrollment" field is where the inclusion and exclusion criteria are placed as a Reference to a Group. Unfortunately, the inclusion and exclusion criteria are an unformatted text blob that would be too much work to format properly to place into the Group. Where is the correct location to place the unformatted text in the Reference to the Group object?
Rob Dingwell (Jun 02 2020 at 18:33):
To clarify the question a bit further @Zach Lister is looking to map the output from a clinical trial matching service into a ResearchStudy resource. The enrollment criteria for a ResearchStudy is defined within a referenced Group. The matching service returns the inclusion and exclusion criteria for the clinical trial as a single lump of text (this looks to be taken directly from clinicaltrials.gov).
In this case there is not a reference-able Group object from the ct matching service so a self contained Group resource seems out of the question. That leaves a contained resource. The first thought was to simply create the contained Group resource and add the enrollment criteria to the 'text' attribute of that resource. The issue with that is that the FHIR spec states that contained resources should not have a narrative section. The characteristic attribute of the group appears unsuitable for a blob of text. Then there is the notion of simply using the display attribute of the Group reference but that feels a bit ugly as well.
If anyone has some thoughts or guidance on where the best place to place this information it would be approciated.
Zach Lister (Jun 30 2020 at 15:17):
Circling back to this post to see if there are any thoughts on how to handle the criteria
Salima Houta (Jul 06 2020 at 14:27):
Hello, we also work with the research study and structure the data in the resource "Group" (attribute "characteristics"). However, we have the problem that we also want to define which data should be collected for the clinical study (e.g. all diagnoses, all medications, twice blood pressure per day).
We have not found a suitable attribute for this. The attribute "focus" of the resource "Research Study" seems to have a different focus.
Has anyone had any experience in projects or has already worked on a similar requirement.
I am happy about help!
Lloyd McKenzie (Jul 06 2020 at 14:29):
The 'protocol' that defines what activity should happen during a study would be captured using the PlanDefinition resource.
Last updated: Apr 12 2022 at 19:14 UTC
