There is a community desire and May Connectathon Track (https://confluence.hl7.org/pages/viewpage.action?pageId=90360749) focused on adapting EvidenceVariable to support eligibility criteria for research studies.

We have provided two options for the proposed changes:

Option 1:

• 15 element changes to support complex characteristics:

1. Addition of copyright 0..1 markdown
2. Addition of approvalDate 0..1 dateTime
3. Addition of lastReviewDate 0..1 dateTime
4. Addition of effectivePeriod 0..1 Period
5. Addition of characteristic.lilnkId 0..1 id
6. Change datatype of characteristic.note 0..* from Annotation to string
7. Change datatype of characteristic.type 0..1 from CodeableConcept to type[x] CodeableConcept | Reference(EvidenceVariable) | id
8. Change datatype of characteristic.definition[x] 1..1 to add more datatypes resulting in CodeableConcept | boolean | Quantity | Range | Reference() | canonical() | Expression
9. Addition of characteristic.offset 0..1 CodeableConcept
10. Change datatype of characteristic.timeFromEvent.event 0..1 from CodeableConcept to event[x] CodeableConcept | Reference() | dateTime | id
11. Change datatype of characteristic.timeFromEvent.note 0..* from Annotation to string
12. Addition of characteristic.combination 0..1 BackboneElement
13. Addition of characteristic.combination.code 1..1 code (all-of | any-of | at-least | at-most | net-effect)
14. Addition of characteristic.combination.threshold 0..1 positiveInt
15. Addition of characteristic.combination.characteristic 1..* see characteristic

Option 2:

16 element changes to support complex characteristics:

1. Addition of copyright 0..1 markdown
2. Addition of approvalDate 0..1 dateTime
3. Addition of lastReviewDate 0..1 dateTime
4. Addition of effectivePeriod 0..1 Period
5. Addition of characteristic.lilnkId 0..1 id
6. Change datatype of characteristic.note 0..* from Annotation to string
7. Change cardinality of characteristic.definition[x] from 1..1 to 0..1 (and add a rule that either definition[x] is used OR both type[x] and value[x] is used but not BOTH definition and type/value)
8. Change datatype of characteristic.type 0..1 from CodeableConcept to type[x] CodeableConcept | Reference(EvidenceVariable) | id
9. Addition of characteristic.value[x] 0..1 CodeableConcept | boolean | Quantity | Range | Reference()
10. Addition of characteristic.offset 0..1 CodeableConcept
11. Change datatype of characteristic.timeFromEvent.event 0..1 from CodeableConcept to event[x] CodeableConcept | Reference() | dateTime | id
12. Change datatype of characteristic.timeFromEvent.note 0..* from Annotation to string
13. Addition of characteristic.combination 0..1 BackboneElement
14. Addition of characteristic.combination.code 1..1 code (all-of | any-of | at-least | at-most | net-effect)
15. Addition of characteristic.combination.threshold 0..1 positiveInt
16. Addition of characteristic.combination.characteristic 1..* see characteristic

An example using Option 1 (Eligibility Criteria for Bariatric Surgery Randomized Trial) can be viewed at https://fevir.net/resources/EvidenceVariablePlusCharacteristic/32064

Proposed for discussion at BRR meeting Tuesday, March 1 at 4 pm Eastern to develop a Proposed Disposition, to then bring to CDS meeting Wednesday, March 2.