Profile Editions

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(Page under revision by Process Cmte during 2022.10)


Because multiple editions of a given Profile are formally published as it advances through the QIBA Process, ensure certain details are visible when referencing the Profile by using the following template:

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

Modality and Stage should be obvious. Publication Date is the date of the draft at the end of the publication approval process.

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.