Difference between revisions of "Profile Editions"

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(Page under revision by Process Cmte during 2022.03)
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(Page under revision by Process Cmte during 2022.10)
  
===QIBA ZZZZZ Profile (YYYY)===
 
  
A Technically Confirmed or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance.
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Profile editions are named/referenced following this template:
  
The published Profile captures trade-off choices between what requirements were considered reasonably achievable and what performance is useful/acceptable.
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* <'''Modality'''> <'''Biomarker Name'''> - <'''Publication Date'''> ('''Stage''')
  
Those choices, however, represent a snapshot at a particular point in time.   
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The Biomarker Name is determined by the authoring Biomarker Committee and Modality Coordination Committee based on what is both clear and convenient to their communityOften it will make sense to include the relevant anatomy if that is key to the biomarker scope. The use of abbreviations and acronyms is up to the committee based on what would be clear to their intended clinical audience. Try to keep the Biomarker Name short enough that people can conveniently refer to it verbally.
  
As the underlying biomarker is adopted, performance expectations may increase, for example to meet the needs of a new clinical application, and new technologies may become more widely available in the installed base, making it practical to add them to the conformance requirements.
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For examples, refer to the '''[[Profiles]]''' page.
  
Making such changes to the Claim or Requirements of an existing edition of a Profile would invalidate published Conformance Statements.  
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When referring to a profile outside the context of QIBA, prefix with "QIBA" and suffix with "Profile".  
  
We can, however, publish a new edition of the Profile, which documents the same biomarker but with revisions to the claim and requirements. 
 
  
Possible Patterns/Templates:
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''Rationale'':
* QIBA CT Volumetry - (2019) Consensus Profile
 
* QIBA CT Volumetry - (2022) Tech Confirmed Profile
 
* QIBA Shear Wave Speed - V3.2 2020.03.21 Public Comment Profile
 
* QIBA Shear Wave Speed - V3.3 2022.02.18 Consensus Profile
 
* QIBA MR Elastography - (2021) Consensus Profile
 
* QIBA MR Elastography - (2021a) Consensus Profile
 
* QIBA MR DWI - V1.2 2018.10.21 Consensus Profile
 
* QIBA MR DWI - V2.0 2020.04.04 Consensus Profile
 
  
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The modality is a useful way to group biomarkers and is often a key piece of scope.
Discussion:
 
  
TODO Consider working the Stage in.  e.g. 2020 Stage:2.  Also should we also incorporate versioning 3.1. Work up the use cases - publication, conformance, document change tracking, etc.
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It is important to understand that a Profile embodies trade-off choices between what requirements were considered reasonably achievable and what performance was considered useful/acceptable. Those choices, however, represent a snapshot at a particular point in timeOver time, performance expectations may increase, for example to meet the needs of a new clinical application, and new technologies may become more widely available in the installed base, making it practical to raise conformance requirements.
  
What if groups update within one year? 2020 -> 2020A? Agree we need to have a mechanism.
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The publication date indicates both which of two editions of a profile is newer, and also provides a temporal context for the tradeoffs. A 2018 profile reflects the expectations and technologies of 2018.  
  
Is it a good thing if our "stable specification" are changing multiple times a year?
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It is expected that new editions of a profile may be published when there are significant advancements in technology and/or expectations. Older sites and systems can still claim conformance to the older editions of a profile, while others will pursue more cutting edge performance. 
  
Using MRE as an example, what about changes that are not normative changes?
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The [[QIBA Profile Stages|'''Profile Stage''']] is important to understand the level of maturity and stability of the Profile. A Clinically Feasible or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance. 
  
Claim Format:  
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''Usage'':  
* This product conforms to the Tech Confirmed QIBA XXX Profile (2020) vs Claim Confirmed QIBA XXXX Profile (2020)
 
* This product conforms to the Tech Confirmed QIBA XXX Profile V3.1 2020.09.22 vs Claim Confirmed QIBA XXX Profile V3.2 2020.12.22
 
  
"Significant differences" = changes in the conformance requirements pass thresholds or the assessment procedures; biomarker is the same,
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A product conformance claim might say
 
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* This product conforms to the PET Amyloid 2022-06-03 (Clinically Feasible) Profile as the Acquisition Device actor.
Questions
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A site conformance claim might say
* Different biomarker (2D->3D)
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* This site conforms to the CT Lung Density 2020-09-04 (Consensus) Profile.
* Different anatomy
 
* Different values (refined) in performance claim
 
* Q. When is a separate profile warranted?
 
* Q. Can someone claim conformance for the Profile in one piece of anatomy but not others?
 
 
 
Example:
 
 
 
The '''QIBA ZZZZZ Profile (2013)''', which represents what was considered reasonable performance in 2013, can be published alongside '''QIBA ZZZZZ Profile (2015)''', which reflects the emergence and adoption of newer technologies that provide a significant and useful improvement in performance. Although some sites and products might still only be able to claim conformance to QIBA ZZZZZ Profile (2013), we still know what level they are operating on.
 
 
 
Note that additional field testing might be needed before the revised edition could be considered Technically or Clinically Confirmed.
 

Revision as of 01:25, 5 October 2022

(Page under revision by Process Cmte during 2022.10)


Profile editions are named/referenced following this template:

  • <Modality> <Biomarker Name> - <Publication Date> (Stage)

The Biomarker Name is determined by the authoring Biomarker Committee and Modality Coordination Committee based on what is both clear and convenient to their community. Often it will make sense to include the relevant anatomy if that is key to the biomarker scope. The use of abbreviations and acronyms is up to the committee based on what would be clear to their intended clinical audience. Try to keep the Biomarker Name short enough that people can conveniently refer to it verbally.

For examples, refer to the Profiles page.

When referring to a profile outside the context of QIBA, prefix with "QIBA" and suffix with "Profile".


Rationale:

The modality is a useful way to group biomarkers and is often a key piece of scope.

It is important to understand that a Profile embodies trade-off choices between what requirements were considered reasonably achievable and what performance was considered useful/acceptable. Those choices, however, represent a snapshot at a particular point in time. Over time, performance expectations may increase, for example to meet the needs of a new clinical application, and new technologies may become more widely available in the installed base, making it practical to raise conformance requirements.

The publication date indicates both which of two editions of a profile is newer, and also provides a temporal context for the tradeoffs. A 2018 profile reflects the expectations and technologies of 2018.

It is expected that new editions of a profile may be published when there are significant advancements in technology and/or expectations. Older sites and systems can still claim conformance to the older editions of a profile, while others will pursue more cutting edge performance.

The Profile Stage is important to understand the level of maturity and stability of the Profile. A Clinically Feasible or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance.

Usage:

A product conformance claim might say

  • This product conforms to the PET Amyloid 2022-06-03 (Clinically Feasible) Profile as the Acquisition Device actor.

A site conformance claim might say

  • This site conforms to the CT Lung Density 2020-09-04 (Consensus) Profile.