FHIR
Page tree
Skip to end of metadata
Go to start of metadata

Short Description

Designing an interoperable definition for Clinical Research activities is going to be a key driver for accelerating the reuse of healthcare data in accelerated delivery of treatments to Patients.  This project has focused on using FHIR for communicating study designs, so that they could be incorporated

Long Description

With the productisation of the draft IG for Schedule of Activities we will need to work on formal advancement of the stability of the content therein in order to have the IG ready for ballot in the New Year.  Previous sessions have been primarily educational opportunities, this requirement will be removed by the pre-session education day, the focus will be on implementation testing

Type

Test a FHIR-associated specification

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group  

Vulcan SOA 

BR&R

PHUSE

Track Lead(s)

Mike Ward, Geoff Low

Track Lead Email(s)

ward_michael_j@lilly.com; geoff.low@3ds.com

Related Tracks

Vulcan RWE, Vulcan AE

FHIR Version

FHIR R4

Specification(s) this track uses

  • Terminology Servers this track users? - not known at this point
  • Specific Terminology Code Systems and Value Sets needed for this track? - not known at this point

Artifacts of focus

Triggering and Visit Windows

  • Planned lapse of time between scheduled clinical activities. e.g., 28 days after preceding linked activity
  • Allowed highs and lows of time for scheduling that clinical activity. e.g., +/- 5 days 

Expected participants

BioPharma

Hopefully EHR Vendor

Zulip stream

https://chat.fhir.org/#narrow/stream/267892-Vulcan.2FRWD

Track Kick Off Call

Schedule of Activities Background Preview Sessions

May Connectathon Goals and Objectives

Track Details

Test Case 1

Within a patient’s EHR record, identify the lab records that are defined as part of the SOA and ignore those that are not

  • Load existing SOA in ODM.xml format that includes
    • Subject definition
    • Planned Visits and interval times between visits
    • Planned Lab tests to occur in each visit
  • Load datasets that include
    • Subject information (DM domain)
    • Visit information (SV domain)
    • Lab tests results (LB domain)
      • Some lab tests are defined in the SOA
      • Other lab tests are from standard of care not in SOA
  • Create the Care Plan from the Planned Definition
    • Bundle with patient, research activities, observations
    • Reconcile that patient to that care plan and the desired observations
    • Associate completed hematology panel to patient
  • Create a service request to schedule hematology lab panel, once completed, results are available, and tag that data as being associated with the patient

Resources Available

Resources Needed

EHR preloaded with records from

  • Patient information
  • Lab dataset results
  • Clinical encounter dates

Scenarios

Action: Identifies Lab Results as belonging to a Visit as defined per protocol

Precondition: Study Definition defined 

Data Files

Bundles for 10 patients worth of data can be found here:  https://github.com/glow-mdsol/soa-bridge-match/tree/develop/upstream

These have support for:

  • DM
  • AE
  • CM
  • EX
  • SV


Test Case 2

Test Visit Windows

  • Use existing resources from Test Case 1
  • In EHR, create >=5 patients and associated clinical encounters
    • A patient with clinical encounters that are within expected visit windows (e.g., 14 days between visits 4 and 5)
    • A patient with clinical encounters that are outside of expected visit window
      • -e.g., 22 days between visits 4 and 5 (expected = 14 days)
      • -e.g., 19 days between visits 8 and 9 (expected = 28 days)
    • A patient who has unscheduled visits (e.g., visit 8.1) with accompanying lab results
    • A patient with a varying mix of the above scenarios
    • A patient who has a one visit with no other visits
  • Develop queries to identify
    • when visit activities are executed outside of the planned visit window
    • when planned visits are missing
    • when extra visits and associated activities’ data are available

Resources Available

Resources Needed

EHR preloaded with records from

  • Patient information
  • Lab dataset results (additional records with patient scenarios defined above)
  • Clinical encounter dates (additional records with patient scenarios defined above)

Data Files:

Bundles for 10 patients worth of data can be found here:  https://github.com/glow-mdsol/soa-bridge-match/tree/develop/upstream

These have support for:

  • DM
  • AE
  • CM
  • EX
  • SV


Test Case 3

Scheduled versus Unscheduled:

Identify data collected as part of clinical care associated with that patient, not in the SOA, but become of value for the subject record.

  • Use resources from Test Cases 1 and 2
  • Take all LB observations for a subject, and determine which ones were "scheduled" (e.g., at visit 8) vs “unscheduled“ (e.g., v8.1)
    • There would be lab results no aligned with the protocol defined assignment to collect those test
    • They are part of the patient's CarePlan within Clinical Care
  • Determine
    • if/how/can does the Research CarePlan see those results or at least be aware that those records exist?
    • if the above findings necessitate a separate Research CarePlan from the Clinical CarePlan


Resources Available

Resources Needed

EHR preloaded with records from

  • Patient information
  • Lab dataset results (additional records with patient scenarios defined in Test Case 2)
  • Clinical encounter dates (additional records with patient scenarios defined in Test Case 2)

Data Files

Bundles for 10 patients worth of data can be found here:  https://github.com/glow-mdsol/soa-bridge-match/tree/develop/upstream

These have support for:

  • DM
  • AE
  • CM
  • EX
  • SV