Please provide the following information about what you wanting to accomplish with your model change request:
Purpose: Align research enrollment with Patient registration in FHIR
Who it benefits: Researchers trying to understand a fuller picture of participants that are enrolled in multiple studies
Use case: Across KF we are aware of the same person being enrolled in multiple research studies. Sometimes we are aware of this upfront (many of the cancer ones because biospecimens are coming from COG), e.g. the KF Neuroblastoma study has high overlap with the TARGET Neuroblastoma study in NCI CRDC or the BASIC3 study across KF and CSER. Other times, this is found out retrospectively via various linkage mechanisms. We want some mechanism to be able to represent this to allow researchers to be aware of this and allow access to all of the data that a researcher has access to.
One of the initial thoughts is that in the research context "Patient" we should really represent as a "Person" that belongs to multiple research studies. However, after re-examining some of the use cases and discussions with @RobertJCarroll it may make more sense to make a similar analogy to how Patients visit different clinical systems and have different MRNs/registration/etc. FHIR has provided a mechanism to link these Patients. In this context, there would be a "Patient" created for each instance of a participant with in a research study. Of note is the "distributed system" aspects:
In a distributed architecture, multiple systems keep separate patient records concerning the same patient. These records are not considered duplicates, but contain a distributed, potentially overlapping view of the patient's data. Each such record may have its own focus or maintaining organization and there need not be a sense of one record being more complete or more authoritative than another. In such cases, links of type 'see also' can be used to point to other patient records. It is not a requirement that such links are bilateral.
This may also make downstream authentication and authorization easier as we can partition out the Patient data based on the study/consent governance under which it was acquired. If we go this route we should probably have guidelines on the right times to create links, if they should be bi-directional and probably a few other things I'm missing!
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Please provide the following information about what you wanting to accomplish with your model change request:
One of the initial thoughts is that in the research context "Patient" we should really represent as a "Person" that belongs to multiple research studies. However, after re-examining some of the use cases and discussions with @RobertJCarroll it may make more sense to make a similar analogy to how Patients visit different clinical systems and have different MRNs/registration/etc. FHIR has provided a mechanism to link these Patients. In this context, there would be a "Patient" created for each instance of a participant with in a research study. Of note is the "distributed system" aspects:
This may also make downstream authentication and authorization easier as we can partition out the Patient data based on the study/consent governance under which it was acquired. If we go this route we should probably have guidelines on the right times to create links, if they should be bi-directional and probably a few other things I'm missing!