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Evidence of health treatments efficacy

Resource Profile

Evidence of Health Treatment Efficacy Implementation Guide published by Linca Telecomunicações Ltda. This guide is not an authorized publication; it is the continuous build for version 1.0.0. This version is based on the current content of <link> and changes regularly. See the implementation guide for version fhir r5

Resource Profile

Page standards status: Informative

This Resource Profile meets the requirements of the EBM on FHIR Implementation Guide. It sets minimum expectations for the Evidence resource to record, search, and fetch data related to efficacy of health treatments regarding a specific disease, based on scientific articles. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

  • Query for treatments efficacy for specific disease.

  • Record or update a scientific article about efficacy of a health treatment.

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile-specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Evidence Resource Must Have:

  1. Treatment

  2. Disease

  3. Scientific article stating the efficacy of the treatment for the disease

  4. Categorized Efficacy Outcomes in accordance to the definitions shown here.

  5. The entity or person who created this FHIR resource

See guidance below:

Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the Evidence of health treatments efficacy resource to support implementation and certification.

  • Only scientific articles that contain the data about efficacy can be inserted in the plataform. If the scientific article has not such data it cannot be posted.

  • If the scientific articles covers different types of treatments one evidence resource should be created for each treatment.

Usages

  • Examples for this Profile: Examples

  • CapabilityStatements using this Profile: >link<

Resource Content
profile
SWzTJ.jpg

sampleSize

1..1

Count of participants in the study sample

ClsJ0.jpg

target[x]

1..1

The artifact that is related to this Evidence

SWzTJ.jpg

0..*

Values and parameters for a single statistic

ClsJ0.jpg

1..1

Text corresponding to the code of the study design

ClsJ0.jpg

1..1

Representation defined by the system
Fixed Value: Efficacy Study

ClsJ0.jpg

1..1

Identity of the terminology system
Fixed Value: 
https://terminology.hl7.org/CodeSystem/research-study-purpose-type

SWzTJ.jpg

1..1

Concept - reference to a terminology

SWzTJ.jpg

code

1..1

Type of use context being specified: population

Design sem nome (11).png

valueCodeableConcept

1..1

Concept - reference to a terminology

Design sem nome (11).png

coding

1..1

Country being specified in the article

Design sem nome (11).png

system

1..1

Design sem nome (11).png

code

1..1

Code used to identify the country by the ISO code

Design sem nome (11).png

display

1..1

Name of the country where the study described in the article was conducted

network.png

extension:studyCountry

1..1

Country where the study described in the article was conducted. 

https://treatments.telix.health/implementationguide/extensions/study-country

ClsJ0.jpg

1..1

Identity of the terminology system
Fixed Value in case of Active Ingredient:
http://www.whocc.no/atc

Fixed Value in case of medication of a specific brand: https://icd.who.int/dev11/l-ichi/en

Fixed value in case of non-drug treatment: https://www.gs1.org/industries/healthcare

ClsJ0.jpg

1..1

Symbol in syntax defined by the system

Fixed Value: intervention

ClsJ0.jpg

1..1

Identity of the terminology system
Fixed Value: https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html

SWzTJ.jpg

classification:population

1..1

A population (e.g. disease or condition) this Evidence is about

ClsJ0.jpg

system

1..1

Identity of the terminology system
Fixed Value: https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html

ClsJ0.jpg

code

1..1

Value that defines the context

Fixed Value: population

ClsJ0.jpg

display

1..1

Text that describes the value that defines the context
Fixed Value: Population

SWzTJ.jpg

valueCodableConcept

1..1

Concept - reference to a terminology

ClsJ0.jpg

system

1..1

Identity of the terminology system
Fixed Value:
https://icd.who.int/en/

ClsJ0.jpg

version

1..1

Version of the system - if relevant

ClsJ0.jpg

code

1..1

Code Symbol in syntax defined by the system of the disease of which the fhir resource is about

ClsJ0.jpg

display

1..1

Name in the syntax defined by the system of the disease related to the FHIR resource code

SWzTJ.jpg

classification:intervention

1..1

An intervention (e.g. medication or procedure) or exposure this Evidence is about

SWzTJ.jpg

1..1

Type of use context being specified: intervention

ClsJ0.jpg

1..1

Representation defined by the system

Fixed Value: Intervention

SWzTJ.jpg

1..1

ATC is used for drug treatments that specify only the active ingredient of the medication. GTIN is used for drug treatments that specify the brand name and dosage. ICHI is used for non-drug treatments. Use only one concept.

ClsJ0.jpg

1..1

Version of the system - if relevant

ClsJ0.jpg

1..1

Code Symbol in syntax defined by the system of the health treatment (intervention) of which the fhir resource is about

ClsJ0.jpg

1..1

Name in the syntax defined by the system of the intervention 

ClsJ0.jpg

url

1..1

Canonical identifier for this evidence, represented as a globally unique URI
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic

ClsJ0.jpg

title

0..1

Name for this summary (human friendly)

ClsJ0.jpg

status

1..1

draft | active | retired | unknown
Binding:
PublicationStatus (Required)

ClsJ0.jpg

date

0..1

Date last changed - should be altered to be the date of the publication

ClsJ0.jpg

publisher

0..1

Name of the publisher/steward (organization or individual)

ClsJ0.jpg

contact

1..*

Contact details for the publisher

ClsJ0.jpg

author

1..1

Who created the resource

SWzTJ.jpg

Evidence

0

Single evidence bit
+ Warning: Name should be usable as an identifier for the module by machine processing applications such as code generation
Elements defined in Ancestors:
id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: MetadataResource

SWzTJ.jpg

1..1

The outcome measure this Evidence is about

SWzTJ.jpg

1..1

Type of context being specified

ClsJ0.jpg

1..1

Identity of the terminology system
Fixed Value: https://build.fhir.org/ig/HL7/ebm/en/ValueSet-179431.html

ClsJ0.jpg

1..1

Symbol in syntax defined by the system

Fixed Value: outcome-measure

ClsJ0.jpg

1..1

Representation defined by the system

Fixed Value: Outcome Measure

ClsJ0.jpg

1..1

Version of the system - if relevant

ClsJ0.jpg

1..1

Symbol in syntax defined by the system
Fixed Value: efficacy

ClsJ0.jpg

1..1

Description of the particular summary

SWzTJ.jpg

1..1

Relationships to other Resources

ClsJ0.jpg

1..1

Declarative description of the Evidence

ClsJ0.jpg

1..1

Fixed value: outcome

SWzTJ.jpg

1..*

Evidence variable: Outcome

ClsJ0.jpg

1..1

A text description or summary of the variable

ClsJ0.jpg

1..1

Code corresponding to the Study Design of the study in the scientific article

SWzTJ.jpg

1..1

The design of the study that produced this evidence

ClsJ0.jpg

⠀⠀numberOfEvents

1..1

Quantity of people of the study that initiated the treatment

ClsJ0.jpg

1..1

Quantity of people of the study that had the selected benefit (Cure, remission, response, ..)

ClsJ0.jpg

⠀⠀⠀ numberOfParticipants

1..1

Cumulative number of participants in the study, including control or placebo groups, or people who received other treatments.

SWzTJ.jpg

1..1

Associated category for categorical variable - see table

ClsJ0.jpg

1..1

Version of the system - if relevant

ClsJ0.jpg

1..1

Representation defined by the system

ClsJ0.jpg

1..1

Symbol in syntax defined by the system

Telix Implementation Guide - 2026 - Linca Telecomunicações

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