Retrieval of Real World Data for Clinical Research, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/vulcan-rwd/ and changes regularly. See the Directory of published versions
The following use case was used to determine the requirements for determining a patient cohort along with what data elements were necessary when retrieving clinical data:
The details of this study can be found on ClinicalTrials.gov: NCT05088265.
This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months.
The patients for this study would have the following criteria:
These criteria would be represented by the following queries:
/Patient?birthdate=le<birthdate of 12 years before today>&gender=male,female
/Condition?code:in=http://hl7.org/fhir/uv/vulcan-rwd/ValueSet/ExampleDiabetesConditionCodes
/Observation?status=final&code:in=http://hl7.org/fhir/uv/vulcan-rwd/ValueSet/ExampleHbA1cTestCodes
The patients would also not have the following criteria:
This exclusion criteria would be represented by the following query:
/Condition?code=http://hl7.org/fhir/sid/icd-10-cm|Z33.1
/Procedure?code:in=http://hl7/org/fhir/uv/vulcan-rwd/ValueSet/ExampleDialysisProcedureCodes
The patients that were common to the first three queries and were not found in the exclusion queries would form the set of patients representing this cohort.
For patients that meet the criteria above, the following data, as a minimum, would be retrieved: