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Type:
Change Request
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Resolution: Persuasive
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Priority:
Medium
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FHIR Core (FHIR)
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R5
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Clinical Decision Support
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Evidence
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Resource Content
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Brian Alper/Peter Muir: 22-0-0
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Enhancement
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Non-compatible
Problem to Solve: The certainty element in Evidence Resources needs to handle recursive use and multiple types at each level.
Use cases:
1) Report a simple overall certainty of evidence for a body of evidence using the GRADE rating system.
2) Report a detailed certainty of evidence for a body of evidence with many subcomponents using the GRADE rating system.
3) Report an overall risk of bias judgment for a single study using ROB-2 assessment tool.
4) Report a detailed risk of bias assessment with many subcomponents for a single study using ROB-2 assessment tool.
5) Report certainty ratings from different groups or individuals.
6) Report certainty ratings using different code systems.
Best practices: Provide explicit expressions of what is being rated, what system is being used to rate it, what the rating is, who is responsible for the rating, and the rationale for the rating.
Recommended changes to FHIR:
The certainty structure will change to.
Evidence.certainty 0..* BackboneElement
Evidence.certainty.description 0..1 string
Evidence.certainty.note 0..* Annotation
Evidence.certainty.type 0..1 CodeableConcept (extensible binding with EvidenceCertaintyType)
Evidence.certainty.rating 0..1 CodeableConcept (extensible binding with EvidenceCertaintyRating)
Evidence.certainty.rater 0..1 string
Evidence.certainty.subcomponent 0..* ('@Evidence.certainty)
Evidence.certainty.subcomponent using a recursive element model, which simplifies the structure. EvidenceCertaintyType and EvidenceCertaintyRating will link to value sets that combine related value sets from the prior non-recursive pattern since they now share the same system.
The new state of the two systems:
EvidenceCertaintyType
| Overall | 1 | Overall certainty | Overall certainty of evidence (quality of evidence) |
| RiskOfBias | 2 | Risk of bias | methodologic concerns reducing internal validity |
| Inconsistency | 3 | Inconsistency | concerns that findings are not similar enough to support certainty |
| Indirectness | 4 | Indirectness | concerns reducing external validity |
| Imprecision | 5 | Imprecision | fuzzy or wide variability |
| PublicationBias | 6 | Publication bias | likelihood that what is published misrepresents what is available to publish |
| DoseResponseGradient | 7 | Dose response gradient | higher certainty due to dose response relationship |
| PlausibleConfounding | 8 | Plausible confounding | higher certainty due to risk of bias in opposite direction |
| LargeEffect | 9 | Large effect | higher certainty due to large effect size |
EvidenceCertaintyRating
| high | 1 | High quality | High quality evidence. |
| moderate | 2 | Moderate quality | Moderate quality evidence. |
| low | 3 | Low quality | Low quality evidence. |
| very-low | 4 | Very low quality | Very low quality evidence. |
| no-concern | 5 | no serious concern | no serious concern |
| serious-concern | 6 | serious concern | serious concern |
| very-serious-concern | 7 | very serious concern | very serious concern |
| extremely-serious-concern | 8 | extremely serious concern | extremely serious concern |
| present | 9 | present | possible reason for increasing quality rating was checked and found to be present |
| absent | 10 | absent | possible reason for increasing quality rating was checked and found to be absent |
| no-change | 11 | no change to rating | no change to quality rating |
| downcode1 | 12 | reduce rating: -1 | reduce quality rating by 1 |
| downcode2 | 13 | reduce rating: -2 | reduce quality rating by 2 |
| downcode3 | 14 | reduce rating: -3 | reduce quality rating by 3 |
| upcode1 | 15 | increase rating: +1 | increase quality rating by 1 |
| upcode2 | 16 | increase rating: +2 | increase quality rating by 2 |
We also updated the descriptors for some of the elements. Example: "synthesisType" short name was changed from "The particular type of synthesis if this is a synthesis summary" to "The method to combine studies"
Importance/Tradeoffs: important to simplify the certainty element in general and to coordinate with use across Evidence and PlanDefinition resources; tradeoff is a breaking change for prior use of certaintySubcomponent elements but we are introducing this change before there are hundreds of such items. These changes are needed for FHIR build R4B for January ballot.
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