Guidance Document Process

DRAFT

Periodically, it may be useful for the QIBA Community to publish a document that is not a Profile but does provide expert guidance from QIBA on performing imaging in situations where quantitative image quality is needed.

<Q. Should QIBA get into general imaging guidance or should that be left to others?> Technical Performance, imaging related to an existing biomarker, "good" data, don't step on existing standards, appropriateness criteria, people publishing papers alleging to report quantitative information from imaging but may not have been managing their acquisitions/image "quality" adequately, comparability of results needs comparable imaging, building databases of imaging to then build AI algorithms, (but no QIB for COVID), image quality issues you should pay attention to, this kind of thing might not happen a lot - new disease calls for guidance but existing disease might be more stable/covered, other entities cover "how to do imaging" but we can help with quantitative(compatible) data, even just formatting/data handling, people often don't publish around our profiles and Guidance can serve as a flag and pointer to our Profiles.

("Profile Light")("Target of Opportunity")

A QIBA Guidance document does not include a performance claim or formal conformance requirements and is not constrained to the common structure of a QIBA Profile. In fact, it is probably best if Guidance uses different formatting to avoid confusion with QIBA Profiles.

A QIBA Guidance does provide recommendations/best practices related to imaging procedures and associated patient handling, device qualification, etc.

The typical audience of a QIBA Guidance document includes:

• Clinical radiologists - looking to good quality for a new disease
• (Also covers staff supporting radiologists - physicists, techs, )
• Treating clinicians - ordering appropriateness, patient handling, quality expectations, improve, achieve diagnostic need
• Vendors - want to provide reference protocol but harmonize with others, general consistency
• Imaging Centers - educational materials, eg to support clinical trial population (
• Clinical Trials/CROs who want "good imaging" even if there is no quantitative claim
• (Guidance may have broader target, both broader audience and broader target like any F-18 PET) -
• Hosp Admin/Dept Heads - how to make good use of resources - adopt imaging for COVID - novel disease -

A QIBA Guidance document is developed by Task Force formed by the Steering/Executive Committee.

• The original idea/proposal may come from a Modality Coordinating Committee or within the Steering/Executive Committee.
• Task Force membership is recommended to include a similar breadth of expertise to a Biomarker Committee, i.e. it would ideally include input from radiologists, clinical specialists, physicists, equipment/SW vendors, technologists,

<Q. Can we add a brief text explaining when/why QIBA would benefit from doing one? We don’t exactly want to encourage anyone who has a paper and wants to up its profile by getting a QIBA Guidance sticker...>

<more people for better consensus><do we need disclaimers about less depth of consensus than a Profile?><note Guidance not exactly equal to Consensus?>

While QIBA Guidance development may benefit from a Public Comment period, it is not required to do so. Similarly, as it is not expected to track and publish comment resolutions. Depending on affiliated organizations with an interest and/or gaps in the Task Force, targeted review may be helpful. <better words>

Before publication, the QIBA Guidance document is approved by the Steering/Executive Committee.

• For modality-specific Guidance, the Steering/Executive Committee may request the corresponding Modality Coordinating Committee to do an initial review and make a recommendation to the Steering/Executive Committee.
• For non-modality-specific Guidance (e.g., trans-modality papers, metrology papers, etc.) the Steering/Executive Committee may convene an ad hoc review group made up of members from relevant QIBA Committees.
• In some circumstances, QIBA Guidance may need to be issued quickly, in which case the Steering/Executive Committee may choose to shorten typical ballot/review periods.

Typically the Task Force is dissolved when the document has been approved and published and no near term maintenance/updates are expected.

Note: This process is not intended to apply to papers written by any group of expert authors that refer to QIBA or its activities in the text, but are not presented as guidance from QIBA.

<Add note that if "rejected" by Steering, you can strip off "QIBA Guidance" and publish as a simple paper> <QIBA should consider whether the result then goes through peer review into a journal vs just gets posted>