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Difference between revisions of "Study FHIR Resource Proposal"

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Current version: https://confluence.hl7.org/display/FHIR/Study+FHIR+Resource+Proposal<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
 
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This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
 
This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
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=PutProposedResourceNameHere=
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=Study=
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(Could also do ResearchStudy if there's a concern about confusion with ImagingStudy)
  
 
<!-- Resource names should meet the following characteristics:
 
<!-- Resource names should meet the following characteristics:
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==Owning committee name==
 
==Owning committee name==
 +
[[Regulated_Clinical_Research_Information_Management]]
  
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<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
 
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[[YourCommitteeName]]
 
 
==Committee Approval Date:==
 
==Committee Approval Date:==
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<i>Please enter the date that the committee approved this Resource proposal</i>
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<i>Pending</i>
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
  
−
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
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*[[BRIDG]]
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* Work Group Name
 
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* or link
 
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* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
−
 
+
Pending?
−
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
  
 
==Scope of coverage==
 
==Scope of coverage==
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This covers the management of clinical (human) and pre-clinical (animal) research studies, including both the study design phase and the study execution phase.  (Note that for veterinary studies, the clinical/pre-clinical distinction may not be relevant.) It covers all types of studies (drug, device, therapy, etc.) and both prospective and retrospective analyses and is international in scope.  It excludes bench research and experiments.
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<!-- Define the full scope of coverage for the resource.  The scope must be clearly delineated such that it does not overlap with any other existing or expected resource.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
 
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Scope should consider numerous aspects of breadth of scope, including:
 
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* Subject: Human vs. non-human vs. non-patient (e.g. lab bench medicine)
 
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* Disciplines: Environmental Health, Palliative, Respiratory, Psychology, Maternity, Clinical Research
 
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* Delivery environment (Community, Geriatric, Home care, Emergency, Inpatient, Intensive, Neonatal, Pediatric, Primary)
 
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* Locale: Country, region
 
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As a rule, resources should encompass all of these aspects.
 
−
  -->
 
  
 
==RIM scope==
 
==RIM scope==
−
 
+
Observation[classCode=CLNTRL, moodCode=EVN] (even when planned, the study is specific to a particular planned execution so is essentially an event in "new" state)
−
<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
 
  
 
==Resource appropriateness==
 
==Resource appropriateness==
 +
Clinical studies are a widely used structure in healthcare.  Patients are linked as participants in studies.  Clinical study designs are shared.  Observations and Questionnaires are linked to studies.  Results of clinical studies are submitted.  Registries of clinical studies are searched.  Queries are made to find patients who are potentially relevant to studies.
  
−
<!-- Does the resource meet the following characteristics?
+
Studies always have some sort of identifier.  Clinical studies will reference other resources (e.g. protocols, patients, practitioners, but have their own status and can be maintained independently.  While the potential number of elements on Study is large, the number of "core" elements common across most types of studies in most jurisdictions will hopefully fall into the <50 data element range.
−
 
 
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Must
 
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* Represents a well understood, "important" concept in the business of healthcare
 
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* Represents a concept expected to be tracked with distinct, reliable, unique ids
 
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* Reasonable for the resource to be independently created, queried and maintained
 
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Should
 
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* Declared interest in need for standardization of data exchange</span>
 
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* Resource is expected to contain an appropriate number of "core" (non-extension) data elements (in most cases, somewhere in the range of 20-50)
 
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* Have the characteristics of high cohesion & low coupling – need to explore whether coupling is good some places, not elsewhere – layers from Bo’s document
 
−
-->
 
  
 
==Expected implementations==
 
==Expected implementations==
−
 
+
Needed for DAF research IG to support pCOREnet queries. Also needed to support BRIDG to FHIR mapping and CDISC to FHIR mapping
−
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
 
  
 
==Content sources==
 
==Content sources==
−
 
+
BRIDG, SDTM/SEND, pCOREnet, clinicaltrials.gov, who.int/ictrp, clinicaltrialsregister.eu
−
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
 
−
 
 
−
Are there any source specifications that you wish to consult but are concerned about access to or expertise to consider? -->
 
  
 
==Example Scenarios==
 
==Example Scenarios==
  
−
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
+
*Clinical trial with multiple arms comparing a drug to a placebo
 +
*Animal trial evaluating different doses of a medication
 +
*Trial comparing the long-term outcomes of a medical device
 +
*Retrospective trial examining impact of use of surgery vs. physiotherapy on patient outcomes for patients with a particular condition
  
 
==Resource Relationships==
 
==Resource Relationships==
  
−
<!-- What are the resources do you expect will reference this resource and in what context?
+
*Will reference PlanDefinition for the protocol that guides the study
−
 
+
*Will reference StudyParticipation to capture information about enrolled participants (Patient)
−
What resources do you expect this resource reference and in what context?
+
*Will be referenced (by extension) by various resources to link clinical data relevant to the study to the study
−
 
 
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Note: These may be existing resources or "expected" resource
 
−
 
 
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Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 
−
-->
 
  
 
==Timelines==
 
==Timelines==
−
 
+
Intention is to have a draft included in the STU 3 publication (for DAF Research) as a placeholder.  STU in release 4
−
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
 
  
 
==gForge Users==
 
==gForge Users==
−
 
+
Rik Smithies, Lloyd McKenzie (already have committer access)
−
<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->
 
  
 
==When Resource Proposal Is Complete==
 
==When Resource Proposal Is Complete==
 
'''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''
 
'''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''

Latest revision as of 15:28, 31 October 2019

Current version: https://confluence.hl7.org/display/FHIR/Study+FHIR+Resource+Proposal
OpenHotTopic.GIF

This page documents a Pending FHIR Resource Proposal



Study

(Could also do ResearchStudy if there's a concern about confusion with ImagingStudy)


Owning committee name

Regulated_Clinical_Research_Information_Management

Committee Approval Date:

Pending

Contributing or Reviewing Work Groups

FHIR Resource Development Project Insight ID

Pending?

Scope of coverage

This covers the management of clinical (human) and pre-clinical (animal) research studies, including both the study design phase and the study execution phase. (Note that for veterinary studies, the clinical/pre-clinical distinction may not be relevant.) It covers all types of studies (drug, device, therapy, etc.) and both prospective and retrospective analyses and is international in scope. It excludes bench research and experiments.

RIM scope

Observation[classCode=CLNTRL, moodCode=EVN] (even when planned, the study is specific to a particular planned execution so is essentially an event in "new" state)

Resource appropriateness

Clinical studies are a widely used structure in healthcare. Patients are linked as participants in studies. Clinical study designs are shared. Observations and Questionnaires are linked to studies. Results of clinical studies are submitted. Registries of clinical studies are searched. Queries are made to find patients who are potentially relevant to studies.

Studies always have some sort of identifier. Clinical studies will reference other resources (e.g. protocols, patients, practitioners, but have their own status and can be maintained independently. While the potential number of elements on Study is large, the number of "core" elements common across most types of studies in most jurisdictions will hopefully fall into the <50 data element range.

Expected implementations

Needed for DAF research IG to support pCOREnet queries. Also needed to support BRIDG to FHIR mapping and CDISC to FHIR mapping

Content sources

BRIDG, SDTM/SEND, pCOREnet, clinicaltrials.gov, who.int/ictrp, clinicaltrialsregister.eu

Example Scenarios

  • Clinical trial with multiple arms comparing a drug to a placebo
  • Animal trial evaluating different doses of a medication
  • Trial comparing the long-term outcomes of a medical device
  • Retrospective trial examining impact of use of surgery vs. physiotherapy on patient outcomes for patients with a particular condition

Resource Relationships

  • Will reference PlanDefinition for the protocol that guides the study
  • Will reference StudyParticipation to capture information about enrolled participants (Patient)
  • Will be referenced (by extension) by various resources to link clinical data relevant to the study to the study

Timelines

Intention is to have a draft included in the STU 3 publication (for DAF Research) as a placeholder. STU in release 4

gForge Users

Rik Smithies, Lloyd McKenzie (already have committer access)

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

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