Recruitment and Eligibility Criteria in a Study or Substudy
Recruitment
We created a Backport Extension NFDI4Health_EX_MDS_Recruitment_Backport_R5 aligning with ResearchStudy.recruitment from R5. This extension holds information on the Eligibility Criteria and Population of a Study.
| FHIR elements | NFDI4Health elements |
|---|---|
| ResearchStudy.extensionrecruitment.extension[targetNumber] | Design.population.targetSampleSize |
| ResearchStudy.extensionrecruitment.extension[actualNumber] | Design.population.obtainedSampleSize |
| ResearchStudy.extensionrecruitment.extension[eligibility] | Design.eligibilityCriteria |
| ResearchStudy.extensionrecruitment.extension[actualGroup] | Design.population.description, Design.population.coverage, Design.population.countries, Design.population.region |
Comparison Group
We created a Backport Extension NFDI4Health_EX_MDS_Study_Comparison_Group_Backport_R5 aligning with ResearchStudy.comparisonGroup from R5. This extension holds information on the Groups/Arms and Exposures/Interventions of a Study.
- in case of an interventional study, comparison group contains information on arms and interventions
- in case of a non interventional study comparison group contains information on groups and exposures
| FHIR elements | NFDI4Health elements |
|---|---|
| ResearchStudy.extension[comparisonGroup].extension[name] | "Design.groups.name" |
| ResearchStudy.extension[comparisonGroup].extension[name] | "Design.arms" |
| ResearchStudy.extension[comparisonGroup].extension[description] | "Design.groups.description" |
| ResearchStudy.extension[comparisonGroup].extension[description] | "Design.arms.description" |
| ResearchStudy.extension[comparisonGroup].extension[type] | "Design.arms.type" |
| ResearchStudy.extension[comparisonGroup].extension[intendedExposure] | "Design.interventions" |
| ResearchStudy.extension[comparisonGroup].extension[intendedExposure] | "Design.exposures" |
| ResearchStudy.extension[comparisonGroup].extension[observedGroup] | "Design.groups.label" |