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Difference between revisions of "ComparativeEvidence FHIR Resource Proposal"

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(Created page with "{{subst::Template:FHIR Resource Proposal}}")
 
(ComparativeEvidence Resource Proposal created)
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=PutProposedResourceNameHere=
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=ComparativeEvidence=
  
<!-- Resource names should meet the following characteristics:
 
* Lower camel case
 
* U.S. English
 
* Domain-friendly
 
* Short
 
* Clear
 
* Unique
 
* Avoid non-universal abbreviations (e.g. URL would be ok)
 
* Be expressed as a noun
 
* Be consistent with other similar resources
 
-->
 
  
 
==Owning work group name==
 
==Owning work group name==
  
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
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Clinical Decision Support
[[YourWorkGroupName]]
 
  
 
==Committee Approval Date:==
 
==Committee Approval Date:==
<i>Please enter the date that the committee approved this Resource proposal</i>
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Initial PSS for EBMonFHIR project: June 22, 2018
 +
Resource Approval by CDS WG: May 8, 2019 (TBD)
  
 
==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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Clincial Quality Information
* Work Group Name
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Biomedical Research and Regulation
* or link
 
* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
  
<!-- 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 -->
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1422
  
 
==Scope of coverage==
 
==Scope of coverage==
  
<!-- 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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The scope of the ComparativeEvidence resource is to describe the statistics comparing two or exposure states.  
  
Scope should consider numerous aspects of breadth of scope, including:
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A common type of statistic that will be reported is an effect estimate characterizing the estimate of an effect of an exposure (often a therapeutic intervention) compared to an alternative exposure (often not receiving the therapeutic intervention) on a measured variable (often a health outcome) in a group (often a population of people with specific characteristics).
* Subject: Human vs. non-human vs. non-patient (e.g. lab bench medicine)
+
 
* Disciplines: Environmental Health, Palliative, Respiratory, Psychology, Maternity, Clinical Research
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Expressing effect estimates and other comparative evidence reports is done throughout reporting of biomedical research, systematic reviews, and clinical reference across all disciplines.
* Delivery environment (Community, Geriatric, Home care, Emergency, Inpatient, Intensive, Neonatal, Pediatric, Primary)
 
* Locale: Country, region
 
  
As a rule, resources should encompass all of these aspects.
 
-->
 
  
 
==RIM scope==
 
==RIM scope==
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==Resource appropriateness==
 
==Resource appropriateness==
  
<!-- Does the resource meet the following characteristics?
+
Across the evidence-based medicine community (hundreds of thousands of people communicating the results of healthcare research through original research and systematic reviews and expressing the findings from a body of evidence), the summary of findings (summary of effect estimates synthesized from a body of evidence) is the primary method of expressing quantitative results. Standardization is necessary to support interoperability across the evidence-based medicine domain.
  
Must
 
* Represents a well understood, "important" concept in the business of healthcare
 
* Represents a concept expected to be tracked with distinct, reliable, unique ids
 
* Reasonable for the resource to be independently created, queried and maintained
 
  
Should
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==Expected implementations==
* Declared interest in need for standardization of data exchange</span>
 
* Resource is expected to contain an appropriate number of "core" (non-extension) data elements (in most cases, somewhere in the range of 20-50)
 
* 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==
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Many knowledge producers who express the biomedical research community knowledge will be the implementers using this resource. Examples of these knowledge producers include Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Cochrane, Duodecim Medical Publications Ltd (from the Finnish Medical Society), EBSCO Health, MAGIC (stands for Making GRADE the Irresistible Choice), and numerous guideline development organizations.
  
<!--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==
  
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
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None expected beyond the standard source specifications. However, the method for expressing citations (eg referring to a publication) is not yet defined and may require additional source specifications.
  
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.) -->
+
A systematic review and meta-analysis combines 17 trials comparing Superdrug against Placebo in 12,356 study participants with Stressitis and finds that Superdrug reduces the Stressiness Score by a mean of 4.6 points but increases headache by 50% (ie 4% of people taking Placebo and 6% of people taking Superdrug had a headache).
 +
 
 +
 
 +
The effect estimates that may be reported from this example include:
  
==Resource Relationships==
+
Mean reduction of 4.6 points in a score
 +
Relative risk increase of 50% (or risk ratio 1.5) for the risk of headache
 +
Absolute risk increase of 2% (or risk difference 0.02) for the risk of headache
  
<!-- What are the resources do you expect will reference this resource and in what context?
+
The ComparativeEvidence resource describes:
  
What resources do you expect this resource reference and in what context?
+
descriptions of the population (eg Stressitis), exposure (eg Superdrug), alternative exposure (eg Placebo), and outcome (eg. Stressiness Score, or risk of headache) that the effect estimates are about
 +
the statistics for these effect estimates where statistic datatype can include classification of the statistic type, sample size for the statistic, quantity of the statistic, a precision estimate (such as a 95% confidence interval), and ratings of the certainty of the statistic
 +
descriptions of the source of the effect estimates (eg author, citation, type of research)
  
Note: These may be existing resources or "expected" resource
 
  
Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
+
==Resource Relationships==
-->
+
 
 +
The ComparativeEvidence Resource will reference Group Resource (to describe intended and actual population cohorts) and EvidenceVariable Resource (to describe exposures and measured variables)
 +
 
  
 
==Resource Boundaries==
 
==Resource Boundaries==
  
<!-- What are the boundaries between this resource and other resources where implementers might have questions about which should be used when?
+
To be determined if implementers have questions that need explanations to support distinction and clarification.
 
+
ComparativeEvidence will describe comparative statistics where one measured variable is analyzed with multiple exposures.  A similarly structured resource (CohortSummary) will describe association statistics where multiple measured variables are analyzed with one exposure.  The ComparativeEvidence and CohortSummary resources are purposefully created as separate resources to simplify the compound nesting relationships of exposures and measured variables for classifying statistics.
Are we confident existing implementations will be able to make the distinction? -->
 
  
 
==Timelines==
 
==Timelines==
  
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
+
First STU Ballot 2019 September
  
 
==gForge Users==
 
==gForge Users==
  
<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->
+
brynrhodes (github user) KhalidShahin-EBSCO (github user)
  
 
==When Resource Proposal Is Complete==
 
==When Resource Proposal Is Complete==

Revision as of 18:46, 7 May 2019



ComparativeEvidence

Owning work group name

Clinical Decision Support

Committee Approval Date:

Initial PSS for EBMonFHIR project: June 22, 2018 Resource Approval by CDS WG: May 8, 2019 (TBD)

Contributing or Reviewing Work Groups

Clincial Quality Information Biomedical Research and Regulation

FHIR Resource Development Project Insight ID

1422

Scope of coverage

The scope of the ComparativeEvidence resource is to describe the statistics comparing two or exposure states.

A common type of statistic that will be reported is an effect estimate characterizing the estimate of an effect of an exposure (often a therapeutic intervention) compared to an alternative exposure (often not receiving the therapeutic intervention) on a measured variable (often a health outcome) in a group (often a population of people with specific characteristics).

Expressing effect estimates and other comparative evidence reports is done throughout reporting of biomedical research, systematic reviews, and clinical reference across all disciplines.


RIM scope

Resource appropriateness

Across the evidence-based medicine community (hundreds of thousands of people communicating the results of healthcare research through original research and systematic reviews and expressing the findings from a body of evidence), the summary of findings (summary of effect estimates synthesized from a body of evidence) is the primary method of expressing quantitative results. Standardization is necessary to support interoperability across the evidence-based medicine domain.


Expected implementations

Many knowledge producers who express the biomedical research community knowledge will be the implementers using this resource. Examples of these knowledge producers include Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Cochrane, Duodecim Medical Publications Ltd (from the Finnish Medical Society), EBSCO Health, MAGIC (stands for Making GRADE the Irresistible Choice), and numerous guideline development organizations.


Content sources

None expected beyond the standard source specifications. However, the method for expressing citations (eg referring to a publication) is not yet defined and may require additional source specifications.


Example Scenarios

A systematic review and meta-analysis combines 17 trials comparing Superdrug against Placebo in 12,356 study participants with Stressitis and finds that Superdrug reduces the Stressiness Score by a mean of 4.6 points but increases headache by 50% (ie 4% of people taking Placebo and 6% of people taking Superdrug had a headache).


The effect estimates that may be reported from this example include:

Mean reduction of 4.6 points in a score Relative risk increase of 50% (or risk ratio 1.5) for the risk of headache Absolute risk increase of 2% (or risk difference 0.02) for the risk of headache

The ComparativeEvidence resource describes:

descriptions of the population (eg Stressitis), exposure (eg Superdrug), alternative exposure (eg Placebo), and outcome (eg. Stressiness Score, or risk of headache) that the effect estimates are about the statistics for these effect estimates where statistic datatype can include classification of the statistic type, sample size for the statistic, quantity of the statistic, a precision estimate (such as a 95% confidence interval), and ratings of the certainty of the statistic descriptions of the source of the effect estimates (eg author, citation, type of research)


Resource Relationships

The ComparativeEvidence Resource will reference Group Resource (to describe intended and actual population cohorts) and EvidenceVariable Resource (to describe exposures and measured variables)


Resource Boundaries

To be determined if implementers have questions that need explanations to support distinction and clarification. ComparativeEvidence will describe comparative statistics where one measured variable is analyzed with multiple exposures. A similarly structured resource (CohortSummary) will describe association statistics where multiple measured variables are analyzed with one exposure. The ComparativeEvidence and CohortSummary resources are purposefully created as separate resources to simplify the compound nesting relationships of exposures and measured variables for classifying statistics.

Timelines

First STU Ballot 2019 September

gForge Users

brynrhodes (github user) KhalidShahin-EBSCO (github user)

When Resource Proposal Is Complete

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

FMG Notes