Difference between revisions of "Process Coordinating Committee"

From QIBA Wiki
Jump to navigation Jump to search
 
(374 intermediate revisions by 4 users not shown)
Line 1: Line 1:
 
{{TOCright}}
 
{{TOCright}}
:Chairs: Kevin O'Donnell (Chair); Dan Sullivan, MD (Vice-chair)
+
:Chairs: Kevin O'Donnell, MASc (Chair); Michael Boss, PhD (Vice Chair)
:Secretary: Susan Weinmann (RSNA Staff)
+
 
:Roster: ''<link to roster of active attendees and who has voting privileges>''
+
* [https://docs.google.com/spreadsheets/d/e/2PACX-1vTrNnQ5nDG4cx3PR85G9xylDRqBWu9NGPRUyYk2p-f3ryIwE6W1bMmwmxkoFQFTF7w2-c5e3TSgzSkp/pubhtml Roster]
 +
* [https://docs.google.com/spreadsheets/d/13AN9KO9QsLEKJDCsfUDbC3LLCGUKqDfK1_fYna0iwYk/edit?usp=sharing Attendance, Quorum and Voting Eligibility]
  
 
==Scope==  
 
==Scope==  
Line 11: Line 12:
 
:* Support infrastructure for Committees
 
:* Support infrastructure for Committees
  
==Meetings==
+
==Meeting Agendas/Summaries==
 +
 
 +
* Quarterly agenda topic: What to highlight during next CC call slots. See [[Process Education]] for potential topics.
 +
 
 +
'''Agendas:'''
 +
*[[2022-09-06 Process Committee Agenda]]
 +
*[[2022-08-16 Process Committee Agenda]]
 +
*[[2022-08-02 Process Committee Agenda]]
 +
*[[2022-07-05 Process Committee Agenda]]
 +
*[[2022-05-17 Process Committee Agenda]]
 +
 
 +
'''''[[Process Committee Agenda Archive]]'''''
 +
 
 +
'''Approved call summaries:'''
 +
*[[Media:2023 12-19 QIBA Process Cmte Meeting Summary-FINAL.pdf|December 19, 2023]]
 +
*[[Media:2023 12-05 QIBA Process Cmte Meeting Summary-FINAL.pdf|December 5, 2023]]
 +
*[[Media:2023 11-21 QIBA Process Cmte Meeting Summary-FINAL.pdf|November 21, 2023]]
 +
 
 +
'''''[[Process Committee Call Summaries Archive]]'''''
  
* Upcoming: '''Biweekly Tcons, Wednesdays @ 3-4pm Central Time''' (Contact Susan for details)
+
==Working Documents==
* [[Process Committee Call Summaries|Summaries of Past Calls/Meetings]]
 
  
==Current Work==
+
* [[Claim Guidance]]
:* Claim Guidance
+
* [[Assessment Procedure Guidance]]
::* '''Committee will review the current doc (see below) and post to the wiki'''
+
* [[QIBA Profile Stages]]
::* Next revision cycle (2017Q3?)
+
* [[Process Education]]
:::* Try to include a greater variety of modalities/targets.
+
* [https://docs.google.com/document/d/100wJv_r0KZVAfIIMP0V8dLDdsjVQb6Uznxymf7yO8LI/edit?usp=sharing Profile Writing Guidance Ideas]
:::* See if we have come across a good example for TDI based CI (e.g. Scenarios BDFMNO)
+
* [https://docs.google.com/spreadsheets/d/1bVP9pSjxtCVinlASCAeGDf5vjc2lCfj16qEg7hkft0Q/edit?usp=sharing Wiki Use Cases]
:::* PDFF will bring in a new style with a bias and slope that isn't 1.
 
:::* MRE also different. Getting absolute measure not relative? Longitudinal claim. Assuming linearity based on some data, but not assessing yet.
 
  
:* Profile Template
+
 
::* '''Adjust Profile Template (change tracked) to regroup time-muddled Activities'''
+
'''New Topics'''
::* Support adoption of the updated Profile Template.
+
 
 +
Review, prioritize, and discuss which might merit a Task Force (to work between Process Cmte Meetings)
 +
 
 +
* NEXT - What will "Process" look like after Dec 2023
 +
** NEED/ASK description of how QUIC will be organized and work
 +
*** Continuity of existing process vs "Clean Break" and start over?
 +
*** What Stage is the focus of QUIC? Need deployment. Not clear if QUIC is looking to deploy tested profiles or untested profiles (and let the adopters work things out)
 +
** Which Biomarker Committees will continue to work?  Who do they submit their work to?
 +
** Is there any reason to expect different processes?
 +
** Is the current process description/documentation/details adequate to support such ongoing activities
 +
*** How do we support "externally developed" profiles?
 +
** How does wiki and process maintenance work after Dec 2023?
 +
*** Which Cmte would do the maintenance work? (Note that as tech evolves, profiles will become outdated)
 +
** Process Cmte has typically laid the groundwork of "what's next", should continue
 +
** Status Quo - existing processes continue unless an authoritative organization revises or defines new processes
 +
** TODO Consider an "MOU/FAQ/Handbook" for a society that is "adopting" a Biomarker Committee, pointing to the existing processes/templates, etc.
 +
*** ISMRM - PDFF (and others?); AIUM - VBF, PEQUS, maybe CE & SWS; EIBALL - ASL & SLN?; AAPM - various?; some others tentative;
 +
*** What are the expectations of what a hosting society does/provides
 +
*** Maybe also provide a framework for each BC to understand where they're at, and what are the options going forward.
 +
**** What stage is your profile at; will it reach the next by Dec; do you have people to continue work; what org is willing to host the work; etc.
 +
**** Maybe update the dashboard to reflect this? (Copy/revise)
 +
*** Will lose the oversight ballot of Coordinating Cmte?
 +
**
 +
* NOW - What support do the current biomarker committees need during July-Dec 2023
 +
** Do we describe "accelerated approvals"?
 +
*** Note that CC Ballots can be voice vote during a call (but circulate doc 2 weeks before meeting) and that BC Ballots can be as short as 2 weeks (but make sure you're going to have enough reviewers/voters who can review it in that time)
 +
** Is there a mechanisms for ballots to be run/completed after Dec 2023? (RSNA Staff just for ballots? AAPM?)
 +
*** Q. Can we think of a way to publish work that is part way to the next stage to formally log the "final" state of the document.
 +
** Do we need to review the library and given no maintenance process, any that we want to deprecate
 +
** Continue to support usage/understanding of the Requirements Criteria and Streamlined Template.
 +
** Try to help complete SLN V2 release?
 +
* Wiki Cleanup
 +
** Mike: Document some of the additional criteria that seemed helpful during the recent approvals and get it on the wiki
 +
** Resolution Template: A bit of wiki cleanup and also highlight the value to transparency and closing the loop (things don't fall through the cracks)
 +
** Stage 4 guidance - make sure the current criteria are clear, and the thinking behind them.
 +
* Editors Meetings
 +
:* Put in Current work - consider TF - eventually will be a separate meeting track for the actual meetings anyway - would be nice to convene by start of summer
 +
:* Perhaps Quarterly
 +
:* 1) Identify the editors (See Dashboard - ask CC's to confirm Row 12 if their dashboards are up to date) - email to CC cochairs
 +
:* 2) Heads-up email to editors - explain intentions, ask for suggestions of topics/issues/questions and logistics/timing
 +
:* 3) Consider face-to-face time when possible (QIBA Annual Meeting, RSNA Annual Mtg) - happy hour
 +
 
 +
* Committee Expertise Roster
 +
:* Dashboard item to confirm representative(s) for major stakeholder groups
 +
::* Radiologists (incl. academic, private practice (might challenging in terms of time) but if we get ACR traction, and QIBs are billable, interest might grow), Physicists, Technologists, Scanner vendors, SW vendors, CRO (implications for recruitment, burden for conducting), Pharma (biological use of the metric, claim details), Statisticians, Regulatory (device regulators, biologic regulators), ...
 +
::* Q. If there are multiple, who do you list?
 +
:* Stakeholder representatives are liaisons responsible for engaging with their stakeholder community
 +
:* If the BC has a roster "gap", need extra engagement effort during public comment, or periodically on a focused call, invite to face-to-face meetings
 +
 
 +
* Q. What does the testing & conformance process look like for a Clinical Trial to be QIBA Profile Conformant? (Andy, Gudrun)
 +
 
 +
===Current Work===
 +
 
 +
====Maintenance Process and Profile Edition & Version Guidance====
 +
* New Steering Committee Priority?
 +
* Discuss some basic concepts then spawn TF if needed
 +
:* Conventions for Published Profile edition/version names
 +
::*[[Profile Editions]]
 +
::* [https://docs.google.com/spreadsheets/d/1_T8MXNkkgFQ7jQmrLMjtuGVqOs-AgA2vU745RMZa1d4/edit#gid=0 Examples]
 +
::* Address same-stage updates, not just stage transitions
 +
::* This is important - when in a stage, how do we update (change requirements) prior to moving to new stage.
 +
::* Highlight the Change Log as a place to point readers to key areas to review (if they were familiar with the old) and perhaps note the implications/significance (release notes)
 +
:* Conventions for internal filenames during Profile development
 +
::* [[Change Tracking and File Naming]]
 +
::* Lower priority but relevant
 +
:* Tracked Change Process
 +
::*[[Maintenance Process]]
 +
::* This is probably needed for the Profile Editions to ensure managed change not arbitrary.
 +
::* Describe what constitutes "editorial change" (that doesn't require re-approval), what requires going through approval again (maybe just at BC level, notify CC chairs and allow them to decide if they want to weigh in?), and what that looks like
 +
::* ISO has a "systematic review" process every 5 years for its standards. Do we want to introduce a similar process, e.g. as part of CC portfolio management. (TODO Write this up as a proposal to the Steering Cmte - '''May 9th''')
 +
::** Profile Renewal Process (WIP Proposal)
 +
::*** Each Modality Coordinating Committee is responsible for managing their portfolio of Profiles
 +
::*** Profiles have the potential to become “stale”
 +
::*** QIBA Staff will notify CC Co-chairs when a Profile is approaching 5 years <u>since most recent publication</u>
 +
::**** If a BC is actively progressing a Profile, it would be getting republished "regularly" and would not trigger this review
 +
::**** The CC also has the responsibility to do such a review earlier if they have the sense that technology or clinical practice has evolved
 +
::*** The CC should notify the BC (if that committee/mailing list is still active)
 +
::*** The CC may request a formal assessment/recommendation from the BC
 +
::*** The CC will vote to Revise (modify, re-approve, re-publish), Renew (re-publish unchanged), or Retire (withdraw from current publication) the Profile
 +
::**** Retired Profiles will still be available on the website, but won’t be on the page of current Profiles
 +
::*** Suggested criteria/considerations (TODO Add text that these are not If-Then criteria, but rather things to spur discussions. It's OK to renew an unadopted Profile, might need more time)
 +
::**** Is there work underway in the BC? If so, it likely makes sense to allow that to proceed (effectively a “Revise” decision)
 +
::**** Is there known adoption of the Profile? If so, Renew or Revise are likely appropriate
 +
::**** Does the Claim performance meet current clinical needs? If not, consider Revise or Retire
 +
::**** Has technology advanced to the point where conformance could be made easier, or performance could be better? If so, consider Revise
 +
::**** Have new clinical practices or consensus emerged that the Profile could align to? If so, consider Revise
 +
::***** Consensus about "best practices" and guidelines may have emerged/shifted and the Profile should take into consideration/harmonize/promote
 +
::***** Also the clinical expectations and usage may have evolved and we should harmonize
 +
::***** Partnership with other organizations and specifications means we may have "convergence" activities to do (e.g. EANM)
 +
::**** Has the regulatory/certification/site conformance criteria environment changed in ways we should harmonize with
 +
::**** Have any new publications or trials come out that inform changes in our Profile?
 +
* Do as one work item or divide into multiple - some complexity
 +
:* Key people - MRE (Kay), FDG (Gudrun will ask Jeff to recommend), DWI (Mike)
 +
 
 +
====Streamlined Profile Template====
 +
* Mike & Kevin taking first pass at streamlining Profile document (some additional points in the draft template)
 +
:* Revisit the topic of dropping requirements post-TechConf to see how feedback informs
 +
:* Flavors of possible drops: (Some things are always being done, others are not affecting the claim even if not done)
 +
:* Reluctance to discarding information that took effort/time to develop (keep? preserve in appendix?)
 +
:* Streamlining is partly moving things around for better ordering, some is taking things out (or moving to appendix)
 +
:* Plan a small call on DWI - Mike/Kevin
 +
::* Are there structures we could think of to deal with the multi-organ usage of DWI? Optional modules? Multi-profiles with common parts?
 +
:* Once we vet it internally, we can make it available for voluntary use/conversion by committees.
 +
:* Don't want to distract committees, or force "unnecessary" work. 
 +
:* Plan to publicize it in the CC meetings and promote the benefits/concepts.
 +
::* Don't want to blindside any BCs. Maybe start telegraphing the situation now... Reassure we're not going to force rewrites.
 
::* Harmonize assessment procedures across profiles
 
::* Harmonize assessment procedures across profiles
::* Embed the checklist as an appendix
 
  
:* Profile Disclaimer
+
====Estimates of Precision (Wrap)====
::* '''Consult RSNA about what disclaimer should address''' (need soon since we're starting to promote/distribute Profiles)
+
* TODO Need some guidance text (like '''[[Vetting Requirements|Criteria page]]''') for BCs to understand; keep as a high priority item. Need to tidy up following text
::* Draft standardized disclaimer text for profiles
+
* Nancy will work on some guidance text in Word for later in March; after review can fold into Wiki.
 +
* Homework for Nancy & Kevin & (Nancy designee)(Nick?)
 +
:* Estimates of Precision when BC Stages Profiles and when Sites Conform to Profiles
 +
::* This came out of issues raised by Nancy about when/where/who should do test/retest type estimates of precision
 +
::* The following rough notes are from the 4/5 meeting
 +
:::* Address such Estimation as part of conformance assessment of each site and/or actor
 +
:::* Discuss BC choice to include assessment of actors/site precision as profile conformance requirement
 +
:::* Detail situations that would necessitate such profile requirements
 +
:::* Made all BC put in a Section 4 procedure to test linearity and bias with phantoms to ensure estimate is under the claim.
 +
:::* Q. Do we require the BC to do it once? Or do we require each site to do it as part of conformance?
 +
:::* At Stage 3, we might not need it as BC, but if we suspect we’re going to need it, we should test the practicality.
 +
:::* How much of a burden is test/retest? It varies depending on the amount of data required. When phantom data captures the variability you are looking for, it can be fairly easy (assuming access to the phantom is easy and the time is short).
 +
:::* BC also chooses the pass/fail threshold that provides reasonable confidence in meeting the claim.
 +
:::* If we see profiles mostly stopping at Stage 3, does it make sense to include a test/retest
 +
:::* Given that Stage 4 is a lighter weight Stage 5, What if we had an even “lighter-weight” that is not enough to reach Stage 3 but is somehow better.
 +
:::* Gap: we’re not doing groundwork with the procedures we have made in the profile (Basically that’s Stage 4) – it’s better if there have been Stage 1 groundwork that are roughly following the requirements, but most profiles do not have this.
 +
::* Key Point is Communication of what the conformance means at each level
 +
:::* The profile might state at in/near the claim what conformance means
 +
:::* There is value to all levels of conformance
 +
:::* Stage 2 - clearly(?) the claim is off the table. Stage 4 - clearly the claim is on the table.
 +
:::* Stage 3 is the current "danger" area.
 +
:::* So conformance to Stage 3 does not require 95% testing, but if a site is willing to do that (and thus help the BC on it's way to getting the profile to Stage 4 where everyone who then conforms can invoke the claim) how do we document/acknowledge/credit/thank them for that.
 +
::::* Guidance for how to design the Stage 3 to Stage 4 study.  Note that the BC can decide to either tighten requirements or loosen claim if they two don't match. - NOTE this changes the design of the study.  BC might need to weigh in which way they want to go before designing the study.
 +
::::* Some profiles have very stringent testing (e.g. claim says wcv is 10%, the profile/actor must show with 95% CI that wcv <=10%) in that we are requesting they confirm the claim directly as part of conformance. Need to better distinguish what BC does for Stage 4 vs what a Profile requires for conformance.
  
:* Committee Operations
+
====Stage 3 Resolution Template (Wrap)====
::* '''Coordinating Cmtes need to remind/confirm BC committees keep their page up to date (especially links to current draft documents)'''
+
* Have the templates '''TODO''' need to finish cleaning up the Process Page, check above bullets, then close out.
::* Add as standing agenda item on the Coordinating Cmte call to check with their Biomarker Cmte chairs
+
* Homework - Kevin - links/pointers
::* Sketch a Sunset procedure for retiring Task Forces and Biomarker Committees that have completed their work.
+
* Map out how to collate practical feedback from sites into a sheet for resolution similar to public comments.
::* Document some guidance for selecting leadership of various QIBA committees (different stakeholders, expected duties?)
+
* Use the checklists - it's what they'd see in the field and it's "simple" - they can scan and we'll transcribe
::* Propose policy/process to consider Prior Project completion when Steering Cmte reviews new Proposals from the same PI.
+
* Additionally, the overall questions solicit broader comments which is really useful as well.
:::* timing overlap of prior cycle completion period with new proposal period needs to be one considered.
+
* Don't want identification being a barrier to feedback. But it's nice to be able to followup.
:::* possible solution would require final reports for prior COMPLETED funding cycles before considering a new project proposal
+
* Be VERY clear that we don't intend to broadcast the site details
 
+
* Do some clean up and run it around the coordinating/biomarker committees for feedback.
:* QIBA Wiki
+
* Cover letter to solicit broad feedback, and the checklists both feed material into the resolution sheet.
::* [[QIBA Wiki Improvements]]
+
* <See notes on Process Page for Tech Conf>
 +
* '''Discussion Point''': To what degree are we collecting feedback (survey) vs doing a dry run of site conformance process vs both
 +
:* Consider starting some Blog threads e.g. feedback on the Tech Conf
  
 
:* Conformance Process
 
:* Conformance Process
 +
::* What should go into a Conformance Record? - (e.g. findings from Technical Confirmation tests)
 
::* Need a common view of what conformance entails, how it is achieved, what it looks like to a product, how it is documented, etc.
 
::* Need a common view of what conformance entails, how it is achieved, what it looks like to a product, how it is documented, etc.
 
::* Then we need to ensure that the QIBA Templates/Process supports those things clearly.
 
::* Then we need to ensure that the QIBA Templates/Process supports those things clearly.
 
::* Kevin will put some initial thoughts on a Wiki page and we can review/add
 
::* Kevin will put some initial thoughts on a Wiki page and we can review/add
 +
::* How often should conformance assessment be done, who will assess, who will keep records?
 
::* Should QIBA get into hosting the Conformance Statements on our site (and then we could link to them from the Profiles page which would be very handy)
 
::* Should QIBA get into hosting the Conformance Statements on our site (and then we could link to them from the Profiles page which would be very handy)
 
::* Consider the RSNA Image Share Conformance Assessment Program and whether we should do something similar for QIBA  
 
::* Consider the RSNA Image Share Conformance Assessment Program and whether we should do something similar for QIBA  
 
:::* Process committee can think through the details of a process and confer with RSNA whether they would be interested
 
:::* Process committee can think through the details of a process and confer with RSNA whether they would be interested
  
:* Literature Search
+
===Priority (Next)===
::* Process/best practices for initial literature search around a new biomarker/profile
+
 
::* Does someone have a draft set of guidance to kick this off? (Nancy, Anna Wu, Hendrik Lau, Andy)
+
====Profile Selection Process (SCP)====
 +
* Move into Current Work - Consider setting up a TF - gauge participants - below Version/Naming
 +
* Review/update review criteria/evaluations for new BC proposals
 +
:* Harvest from past experiences
 +
::* [https://docs.google.com/document/d/1PmWlLZE8lRmH4gZXi_TQA3wtDRvrEyX_iDLfEX3L5Zg/edit?usp=sharing Profile Success Factors and Challenges Survey Planning]
 +
:* Given limited resources, how to approve not just good proposals but the best proposals
 +
::* It's not just about saying "Yes". It's about When should we say "No". When should we say "Not Yet"
 +
:* Evidence that the biomarker already has vendor and user adoption and just needs the "last mile" improvements that QIBA brings.
 +
* Consider Prior Project completion when Steering Cmte reviews new Proposals from the same PI.
 +
:* timing overlap of prior cycle completion period with new proposal period needs to be one considered.
 +
:* possible solution would require final reports for prior COMPLETED funding cycles before considering a new project proposal
 +
* Discuss which profiles have been most successful, which have hit bumps, which have foundered
 +
:* What characteristics of each contributed to the success/problems? Can we look for those during selection?
 +
:* As we refine criteria for new proposals, also see how they do/don't apply well to existing profile work
 +
* Discuss Nancy's criteria for ultimate Claim Confirmation?
 +
:* BCs should understand what they are getting into and start planning for it
 +
:* If the profile will depend on a large test/retest being completed and it seems highly unlikely that would ever be doable, should that weigh on the SC approving the BC?
 +
 
 +
===ToDo===
 +
 
 +
====Profile Format Harmonization====
 +
* Various profiles differ in their layout and content which makes it harder for users
 +
:* Use of New Templates has not been mandated, but rather left to committee discretion so as not to be disruptive
 +
:* Various committees have deviated from the template and/or introduced variations without discussing with the Process Cmte
 +
* Consider starting with a table showing which template each profile is using
 +
:* Process makes table; Tags for Informal template; Formal#1, Formal#2 (Streamlined) and other divergence notes
 +
:* CCs get it populated; SC decides on priority/mandate? of harmonizing
 +
:* Use to inform "harmonization pressure" efforts?
 +
 
 +
====Communicating Uncertainty to Radiologists====
 +
::* "No measurement is complete without a statement of it's uncertainty" - NIST
 +
::* Measurement uncertainty is at the heart of what QIBA does
 +
::* If people don't recognize/appreciate measurement uncertainty they can't grasp the value of QIBA fully (or at all?)
 +
::* How do we get radiologists to appreciate the uncertainty of each measurement and incorporate it into their thinking and decision making?
 +
::* What should best practice be for communicating the uncertainty of each measurement to radiologists?
 +
:::* Always give a confidence interval rather than a value?
 +
::* Very Important Problem, not clear we could make a dent on solution in 5 months (but maybe problem definition?)
 +
::** And is this the Process Cmte job? Note really. Find a way to hand off to QUIC. Need to put more punch behind the message.
 +
::** Get it on the wiki for posterity and consultation
 +
 
 +
====On-boarding Process====
 +
* Goal: Help new committees, new members, new authors, new reviewers, new adopters
 +
* Communication Committee might shoulder some of this too and only come to Process when gaps are found.
 +
* Reviewed "How to develop a Profile" Guidance
 +
:* Email How-To guide to current authors and ask them to read/feedback
 +
:* Then email to the current community since it is helpful for all contributors
 +
* Maybe update Profiles and Protocols page to focus less on UPICT and more on QIBA Profiles today.
 +
:* Linear layout
 +
:* Explain the mechanics of who does what with a profile (vendors, rads, techs, regulators, etc.)
 +
* Maybe add some "How to Read a Profile" guidance (also useful for reviewers), e.g. focus on Spec tables. Look at your relevant Activities/Procedures. Read the Discussion sections for more background.
 +
:* Explain about the Claims, the Actors, the Requirements and the Assessment Procedures structure of a Profile
 +
:* Advice may vary depending on viewpoint of the reader.
 +
:* Consider/discuss relative merits of moving the checklists from Annex E into Section 5 of the template
 +
* Joe's intro email, current template and stage docs, QIBA Fact Sheet
 +
:* Find a way to link directly into the "current" version of documents without having to update the links. Now we link to the Profile template page then you have to click a second time put pull up the template.
 +
* Could use a "fresh eyes"/newcomer commentary - find a newcomer guinea pig
 +
:* Kevin will work with Joe to get it into a Google Doc for revision and linking from the Wiki.
 +
:* https://docs.google.com/document/d/1jB1CPy1Mll_v-yzvSZk7acYv_SfC3VDAgS_WJ3y2pm8/edit?usp=sharing
 +
:* Include link to How-To guide
 +
:* Some people might like videos/webinars
 +
* Pictures and diagrams would help a lot for people reading what is "dry" text.
 +
* Types of newcomers/stakeholders - link from an "intro to QIBA - mother page" - '''[[Stakeholder Viewpoints]]'''
 +
:* Practicing [[QIBA for Radiologists]] (Dan), [[QIBA for Physicists]] (Tom Chenevert, Sam Armato, Paul K.), [[QIBA for Technologists]] (Mike), [[QIBA for Imaging Vendors]] (Kevin), analysis SW vendors/developers (Cathy?), researchers, clinical trialists, pharma (Gudrun?), [[QIBA for Core Labs]] (Pat?), [[QIBA for Regulators]] (both device and drug?) (Nick), patients/advocates/lay public, government policy, payers, [[QIBA for Statisticians]] (Nancy)
 +
:* DONE targeted intro to each?groups? of those viewpoints
 +
::* What is QIBA basically about, what is the key value of QIBA to them, how do they "use"/"interact with" QIBA (some of them are "actors", some are not)
 +
::* easy language, a few paragraphs, and links to specific wiki pages/documents/slides that would be a good next step for them
 +
:* Maybe add a "First Steps" section for each page (see [[QIBA for Statisticians]] for example) telling them the first things they could/should do
 +
:* Might be good to also have "stories from your colleagues" who are already in QIBA and their experiences.
 +
 
 +
====Publication Process====
 +
* Ask Steering Cmte to determine whether having others publish is a necessity or not (Mike to draft some pro/con points - Kevin can help)
 +
::* Do the vendors and sites and trials that would be involved in using Profiles have an issue with these "standards" being published by QIBA (RSNA)?
 +
::* Would it be better if QIBA Profiles were balloted/published by another organization? IEC? IHE? AAPM? MITA?
 +
::* Would there be an impact in switching to a different document structure, formatting conventions, review/approval processes?
 +
 
 +
====Clinical Confirmation Process====
 +
::* Methodology/Study Design guidance/requirements for achieving "Clinically Confirmed"
 +
 
 +
====QIBA Tooling====
 +
::* How to use Google Docs?
 +
:::* Issues with references, access restricted by federal agencies and some companies
 +
::* Round trip fidelity between Word-Google-Word
 +
 
 +
====QIBA Wiki====
 +
* [[QIBA Wiki Improvements]]
 +
* Wiki serves QIBA Committee work. Consider a new user oriented site (clinicians, administrators)?
 +
* Wiki vs RSNA.org
 +
:* Address relationship between wiki content (current, easy to update) and website content (authoritative, stable)
 +
::* Likely RSNA staff will periodically mirror wiki content up onto the website; address this in publication process.
 +
:* Consider how to handle handoffs between RSNA website
 +
::* RSNA website is controlled by the RSNA Marketing Department, must meet certain style requirements, and require resources beyond QIBA staff
 +
::* QIBA would still like to find a way for the more formal publications (e.g. later stage profiles) to be accessible from the RSNA website.
 +
 
 +
====Literature Search Guidance====
 +
::* Process/best practices for review of literature around a new biomarker/profile (search is relatively straight forward)
 +
::* Assemble draft guidance to kick this off (Hendrik Laue, Ona Wu, Caroline? Chung)
 +
:::* See existing material - http://qibawiki.rsna.org/index.php/Tools_and_recommendation_for_structured_literature_review
 
::* Where do you store references, what kind of search works best, what exactly are you looking for?
 
::* Where do you store references, what kind of search works best, what exactly are you looking for?
 
::* Also meta-analysis guidance to determine sources and levels of variance
 
::* Also meta-analysis guidance to determine sources and levels of variance
 +
::* PDF/DWI - using Google Sheet to track/tabulate/organize - inherently input from many sources so nice to have centralized, commonly edited, accessible
 +
 +
====Product Reference Guidelines====
 +
* Draft Guidelines for Reference Implementations and commercial products in Profiles
 +
:* e.g., the underlying algorithm should be open/public/available/documented, QIBA will list all comers, non-commercial?, etc)
 +
* Level playing field, no favorites
 +
 +
====Public Comment Attribution====
 +
::* don't push for anonymity. Encourage people to identify themselves (deserve credit and we want to be able to followup)
 +
::* form can accept anonymous, but encourage constructive criticism that will be taken in the spirit given.
  
:* Profile Selection Process
+
===Hold===
::* Consider additional criteria/evaluation based on experiences
+
Todo items that are on hold pending some trigger:
  
:* Profile Maintenance Process
+
====Claim Guidance====
::* Propose change tracking process
+
::* Hold pending people with questions/clarification needs on current text
::* Propose conventions for Profile editions/versions
 
  
:* Profile Retirement Process
+
====[[Guidance Document Process]]====
 +
* Hold pending interest in "lightweight" QIBA output without claims/conformance
 +
* Basically "best practice" recommendations
 +
* Less rigor; Much easier to write,
 +
 
 +
====Profile Retirement Process====
 +
::* Hold pending a profile we want to retire
 
::* When do we "withdraw" or at least stop maintaining/promoting a Profile
 
::* When do we "withdraw" or at least stop maintaining/promoting a Profile
 
::* Review/borrow from corresponding IHE Process - http://wiki.ihe.net/index.php/Evaluation_of_Published_Profiles
 
::* Review/borrow from corresponding IHE Process - http://wiki.ihe.net/index.php/Evaluation_of_Published_Profiles
 
::* Review DICOM retirement concept (stays available in archives, not maintained/promoted)
 
::* Review DICOM retirement concept (stays available in archives, not maintained/promoted)
  
:* Publication Process
+
====Profile Disclaimer====
::* Sketch up publication process for Official Docs (CC approval vote, send to RSNA Staff)
+
::* Hold pending revist of Discriminatory Claims
::* Write up Standard Approval Practices for committee documents
+
::* For now QIBA addresses technical performance. Getting into the clinical performance associated with Discriminatory Claims would open a lot of issues.
:::* Quality check mechanism, voting mechanism
 
::* Start simple with this and add complexity only as needed.
 
::* Address relationship between wiki content (current, easy to update) and website content (authoritative, stable)
 
:::* Likely RSNA staff will periodically mirror wiki content up onto the website; address this in publication process.
 
  
:* Clinical Confirmation Process
+
====Statistical Assumption Testing Guidance====
::* Methodology/Study Design guidance/requirements for achieving "Clinically Confirmed"
+
::* Conformance with the statistical assumptions is required at the various QIBA profile stages. 
 +
::* Need guidance on the assumptions in the profile, validating the assumptions and testing actors for meeting those assumptions.
 +
::* Symmetrical vs Assymetrical change intervals?
 +
::* Questions about the numbers in "Academic Radiology: ?? Paper"
 +
 
 +
===Past Work===
 +
This isn't all of it but here's some notes...
 +
 
 +
====Conflict of Interest Policy====
 +
* Should have a policy statement on the wiki on QIBA expectations (e.g. what kind of things might come up and how might handle, e.g. recusal from votes or ballots)
 +
:* Dan has extracted some example wording used elsewhere (e.g. protocol approval committees, other orgs, AAPM)
 +
:* Is there a personal (financial?) benefit to the individual
 +
:* This may link into the question of getting cochairs to sign RSNA conflict of interest policy
 +
::* AGREE - guidance for guidances.
 +
* DONE - prepped language with examples and forwarded to SC/EC for approval and posting to the wiki
 +
 
 +
====Public Comment Resolution====
 +
* DONE Set up Wiki page for holding all the comment resolution records from past public comment. - [[Profiles]]
 +
* Work with RSNA on a boilerplate email to send to commenters (who gave their email on the comment form) pointing to the resolutions document for their submitted comments. (Staff will draft some proposed text for review)
 +
:* (DONE) Could build it into the automatic confirmation message that the confirmation form sends out. 
 +
* DONE Revised process to highlight circulating resolutions with ballots and posting by RSNA Staff when complete
 +
* DONE Updated resolution page
 +
* ONGOING get additional profiles to post their resolutions
 +
 
 +
====Coordinating Committee Membership Criteria====
 +
* Review the current criteria [[Committee_Organization#Committee_Membership]]
 +
* Feedback to SC/EC
 +
:* Remove Modality Scientific Liaison (can bring in SMEs as voting/non-voting)
 +
:* Remove explicit cap on voting membership
 +
:* Flag "additional voting" as "At Large Members - suggest 2-4 people"
 +
:* Keep all Co-chairs of BCs
 +
:* Suggest adding 3-year term (renewable) for CC xChairs - RSNA Staff will think through logistics - currently doing a CC membership review - will be some turnover. Staggered rotations is desirable.
 +
:* Process Cmte participation (periodic education agenda item like for BC) is useful, but can fit easily under the non-voting SME umbrella.
 +
 
 +
====Profile Ballot Reminders====
 +
* Consider something like the following:
 +
: ''Please indicate below whether this Profile''
 +
::* ''meets the criteria for this stage'' [link to criteria]
 +
::* ''conforms to profile guidelines'' [link to guidelines]
 +
::* ''is of sufficient quality to publish''
 +
:: ''Note: if you are unable to read through the profile, you may Abstain.''
  
:* On-boarding process
+
====Requirement Criteria====
::* Help new committees, new members, new authors, new reviewers, new adopters
+
* Making profiles shorter...
::* Add some "readers guide" text for reviewers, e.g. focus on Spec tables. Look at your relevant Activities/Procedures. Read the Discussion sections for more background.
+
:* Drop requirements that aren't critical
::* "How to develop a Profile" Guidance
+
:* DONE - devised, documented and communicated an approach to [[Vetting Requirements]]
::* Joe's intro email, current template and stage docs, QIBA Fact Sheet
+
::* Impact Criteria Assessment: Asking existing profiles to go back and fill in a column may invoke some resistance to the effort required.
::* Could use a "fresh eyes"/newcomer commentary
+
::* One approach: Have the BC go through all the requirements and do an impact pruning just before Pub Cmte release
:::* Dan will send the current Fact Sheet to UCSF for feedback on contents
+
:::* Don't require long winded justifications, a short clear statement should be sufficient
:::* Kevin will work with Joe to get it into a Google Doc for revision and linking from the Wiki.
+
* QIB Guidance documents (not Profiles) can have a role since they don't have a claim so dropping "requirements" is less of an issue
  
:* Guidelines for Reference Implementations and commercial products in Profiles (underlying algorithm available, list all comers, non-commercial?, etc).
+
====Driving Profile Adoption====
:* Guidelines for assessment procedures to vet SW in Profiles
+
* Adoption of Profiles
:* Clarify QIBA Profile vs UPICT Protocol (Venn Diagram)
+
:* Maybe a new TF to support Adoption (can include some Process people)
 +
::* Ed, Brad, Joe, Kevin, Dan, RSNA Webperson
 +
::* Start by looking at what is on the RSNA QIBA pages,
 +
* [https://docs.google.com/document/d/1YM0mreBRLNNQZicDatx1IE3Zi1NZeaojQJczrEIbvsk/edit?usp=sharing Biomarker Adoption Steps] - Framework for when/how site stakeholders are engaged
 +
:* Basis for reviewing organization/content/structure of current QIBA documents/deliverables
 +
* Ultimately addressed by formation of [[QIBA Sustainability Implementation Committee (QSIC)]]
 +
:* For further details, see [[QIBA Sustainability Implementation Committee (QSIC)|QSIC page]]
 +
:* Process Cmte can support QSIC when process questions/refinements come up.
  
==Working Documents==
+
====Committee Leadership Process====
 +
* Address BC and CC leadership
 +
* Continue with variations of '''co-chair/chair/vice-chair'''? - Maybe call everything below Steering Cmte as co-chairs and let them work out working patterns.
 +
* Describe process for '''nominating & selecting''' that is transparent, allows time for nominations & self-nominations, encourages diversity
 +
:* Mostly current system has been working without major issues, but would like to have efficient flow rather than everyone re-thinking/re-inventing a process
 +
* Process for recognizing cases where cochair availability/activity has decreased and need to call-the-question and trigger "replacement".
 +
:* Having '''"terms"''' would help trigger. E.g. 3-year terms, and limit of two terms to promote turnover, new faces, new ideas in some committees, on the other hand keeping experienced people and having continuity is good and there may be a limited supply of motivated leadership.
 +
:* CC term limits might be OK, but BC should maybe not have limits because they are intended to a have a limited life to start, and the chair is a key leader and change could falter
 +
:* If we stick with 3 year terms, might want to have a procedure where a cochair missing 8 meetings in a row triggers the secretariat doing a checkin to confirm that they still have the bandwidth/availability, and give them the opportunity to step aside if their other responsibilities have intruded.
 +
* '''Stakeholder diversity''' (silent, recommend, or require)
 +
:* Having "only academic representation" is an adoption risk to QIBA, so there is a value to making some effort to have diversity
 +
:* Variability in the size of some committees so tough to enforce
 +
:* Lets Strongly Recommend (and maybe make it a review point in the Coord Cmte and the Steering Cmte to ask about attempts to improve?)
 +
:* Also consider this when forming a Biomarker Committee - require? At least formally build into the evaluation process.
 +
:* Consider handling committee stakeholder diversity in the committee formation and dashboard process, not the leadership process
 +
:* Define Stakeholder diversity; do we make user/vendor classes? or is one academic radiologist and one clinical trial radiologist the intended degree of diversity?
  
===Claim Guidance===
+
* For comparison - DICOM:
* [[Media:QIBAProfileClaimGuidance-2017_02_17.docx| QIBA Profile Claim Guidance 2017.02.17]]
+
:* For Working Groups it's required but unconstrained "Working Groups shall elect a chair or co-chairs."
 +
:* For the DSC (Steering Cmte) it's more constrained
 +
::* There shall be two co-chairs – one representing a producer and one representing a biomedical professional organization.
 +
::* Each co-chair shall serve a two-year term and may serve no more than two consecutive terms. The terms of the co-chairs shall expire in alternate years.
 +
::* At the meeting preceding the meeting before the last Committee meeting each year, the co-chairs shall appoint a three-member nominating subcommittee consisting of at least one representative of a producer , one representative of a biomedical professional organization and one former committee officer (if one is available). The former officer (if one is available) shall chair the nominating subcommittee. Members of the nominating subcommittee shall develop and submit to the secretariat a slate of candidates. The names of the candidates should be submitted to the secretariat no later than 30 days prior to the meeting preceding the last meeting of the year so that their names may be included in the published agenda. Additional nominations may be made from the floor at this meeting.
 +
::* Prior to the last meeting of the year the secretariat shall conduct a letter ballot. The name of the person elected shall be announced at the last meeting of the year. That person shall assume office immediately following the last meeting of the year.
 +
::* The Committee has the right to recall a co-chair.
  
===Profile Stages===
+
* For comparison - IHE:
* [[Media:QIBA_Profile_Stages-20160412.docx| QIBA Profile Stages 2016.04.12]]
+
:* There are general cochair guidelines in section 12.2.7 of the Governance: https://www.ihe.net/wp-content/uploads/2018/07/IHE-International-Principles-of-Governance.pdf
* [[QIBA Profile Stages]] page
+
:* The Board adds the constraint "The Board shall elect as co-chairs, two Board Members drawn from Member Organizations in the User category. They will serve as co-chairs for renewable two-year terms."
 +
:* The Domain Planning Cmtes adds the recommendation "It is recommended that one Domain Planning Committee co-chair be selected from the User member category and one from the Developer member category."
  
===Wiki Layout===
+
* For comparison - RSNA:
* Use Cases - https://docs.google.com/spreadsheets/d/1bVP9pSjxtCVinlASCAeGDf5vjc2lCfj16qEg7hkft0Q/edit?usp=sharing
+
:* A nomination announcement contains a link to an online nomination form and deadline
 +
::* A comment box provides for nominators or self-nominators to state why they wanted to serve/would be a good addition to the leadership
 +
:* Once the nomination period ended, another announcement contains a link to an eballot listing nominees and their qualifications
 +
::* Joe helpfully pointed out that we need to clearly define voting eligibility (i.e. do voting privileges apply to chair selection or can everyone vote)
  
 
==See Also==
 
==See Also==

Latest revision as of 16:22, 17 January 2024

Chairs: Kevin O'Donnell, MASc (Chair); Michael Boss, PhD (Vice Chair)

Scope

The Process Committee facilitates the QIBA Coordinating Committees and their profiling activities by defining processes and tools to promote consistent quality work product.

  • Develop common Templates & Processes
  • Support & mentor adoption of above
  • Drive consistent content & format of Profiles
  • Support infrastructure for Committees

Meeting Agendas/Summaries

  • Quarterly agenda topic: What to highlight during next CC call slots. See Process Education for potential topics.

Agendas:

Process Committee Agenda Archive

Approved call summaries:

Process Committee Call Summaries Archive

Working Documents


New Topics

Review, prioritize, and discuss which might merit a Task Force (to work between Process Cmte Meetings)

  • NEXT - What will "Process" look like after Dec 2023
    • NEED/ASK description of how QUIC will be organized and work
      • Continuity of existing process vs "Clean Break" and start over?
      • What Stage is the focus of QUIC? Need deployment. Not clear if QUIC is looking to deploy tested profiles or untested profiles (and let the adopters work things out)
    • Which Biomarker Committees will continue to work? Who do they submit their work to?
    • Is there any reason to expect different processes?
    • Is the current process description/documentation/details adequate to support such ongoing activities
      • How do we support "externally developed" profiles?
    • How does wiki and process maintenance work after Dec 2023?
      • Which Cmte would do the maintenance work? (Note that as tech evolves, profiles will become outdated)
    • Process Cmte has typically laid the groundwork of "what's next", should continue
    • Status Quo - existing processes continue unless an authoritative organization revises or defines new processes
    • TODO Consider an "MOU/FAQ/Handbook" for a society that is "adopting" a Biomarker Committee, pointing to the existing processes/templates, etc.
      • ISMRM - PDFF (and others?); AIUM - VBF, PEQUS, maybe CE & SWS; EIBALL - ASL & SLN?; AAPM - various?; some others tentative;
      • What are the expectations of what a hosting society does/provides
      • Maybe also provide a framework for each BC to understand where they're at, and what are the options going forward.
        • What stage is your profile at; will it reach the next by Dec; do you have people to continue work; what org is willing to host the work; etc.
        • Maybe update the dashboard to reflect this? (Copy/revise)
      • Will lose the oversight ballot of Coordinating Cmte?
  • NOW - What support do the current biomarker committees need during July-Dec 2023
    • Do we describe "accelerated approvals"?
      • Note that CC Ballots can be voice vote during a call (but circulate doc 2 weeks before meeting) and that BC Ballots can be as short as 2 weeks (but make sure you're going to have enough reviewers/voters who can review it in that time)
    • Is there a mechanisms for ballots to be run/completed after Dec 2023? (RSNA Staff just for ballots? AAPM?)
      • Q. Can we think of a way to publish work that is part way to the next stage to formally log the "final" state of the document.
    • Do we need to review the library and given no maintenance process, any that we want to deprecate
    • Continue to support usage/understanding of the Requirements Criteria and Streamlined Template.
    • Try to help complete SLN V2 release?
  • Wiki Cleanup
    • Mike: Document some of the additional criteria that seemed helpful during the recent approvals and get it on the wiki
    • Resolution Template: A bit of wiki cleanup and also highlight the value to transparency and closing the loop (things don't fall through the cracks)
    • Stage 4 guidance - make sure the current criteria are clear, and the thinking behind them.
  • Editors Meetings
  • Put in Current work - consider TF - eventually will be a separate meeting track for the actual meetings anyway - would be nice to convene by start of summer
  • Perhaps Quarterly
  • 1) Identify the editors (See Dashboard - ask CC's to confirm Row 12 if their dashboards are up to date) - email to CC cochairs
  • 2) Heads-up email to editors - explain intentions, ask for suggestions of topics/issues/questions and logistics/timing
  • 3) Consider face-to-face time when possible (QIBA Annual Meeting, RSNA Annual Mtg) - happy hour
  • Committee Expertise Roster
  • Dashboard item to confirm representative(s) for major stakeholder groups
  • Radiologists (incl. academic, private practice (might challenging in terms of time) but if we get ACR traction, and QIBs are billable, interest might grow), Physicists, Technologists, Scanner vendors, SW vendors, CRO (implications for recruitment, burden for conducting), Pharma (biological use of the metric, claim details), Statisticians, Regulatory (device regulators, biologic regulators), ...
  • Q. If there are multiple, who do you list?
  • Stakeholder representatives are liaisons responsible for engaging with their stakeholder community
  • If the BC has a roster "gap", need extra engagement effort during public comment, or periodically on a focused call, invite to face-to-face meetings
  • Q. What does the testing & conformance process look like for a Clinical Trial to be QIBA Profile Conformant? (Andy, Gudrun)

Current Work

Maintenance Process and Profile Edition & Version Guidance

  • New Steering Committee Priority?
  • Discuss some basic concepts then spawn TF if needed
  • Conventions for Published Profile edition/version names
  • Profile Editions
  • Examples
  • Address same-stage updates, not just stage transitions
  • This is important - when in a stage, how do we update (change requirements) prior to moving to new stage.
  • Highlight the Change Log as a place to point readers to key areas to review (if they were familiar with the old) and perhaps note the implications/significance (release notes)
  • Conventions for internal filenames during Profile development
  • Tracked Change Process
  • Maintenance Process
  • This is probably needed for the Profile Editions to ensure managed change not arbitrary.
  • Describe what constitutes "editorial change" (that doesn't require re-approval), what requires going through approval again (maybe just at BC level, notify CC chairs and allow them to decide if they want to weigh in?), and what that looks like
  • ISO has a "systematic review" process every 5 years for its standards. Do we want to introduce a similar process, e.g. as part of CC portfolio management. (TODO Write this up as a proposal to the Steering Cmte - May 9th)
    • Profile Renewal Process (WIP Proposal)
      • Each Modality Coordinating Committee is responsible for managing their portfolio of Profiles
      • Profiles have the potential to become “stale”
      • QIBA Staff will notify CC Co-chairs when a Profile is approaching 5 years since most recent publication
        • If a BC is actively progressing a Profile, it would be getting republished "regularly" and would not trigger this review
        • The CC also has the responsibility to do such a review earlier if they have the sense that technology or clinical practice has evolved
      • The CC should notify the BC (if that committee/mailing list is still active)
      • The CC may request a formal assessment/recommendation from the BC
      • The CC will vote to Revise (modify, re-approve, re-publish), Renew (re-publish unchanged), or Retire (withdraw from current publication) the Profile
        • Retired Profiles will still be available on the website, but won’t be on the page of current Profiles
      • Suggested criteria/considerations (TODO Add text that these are not If-Then criteria, but rather things to spur discussions. It's OK to renew an unadopted Profile, might need more time)
        • Is there work underway in the BC? If so, it likely makes sense to allow that to proceed (effectively a “Revise” decision)
        • Is there known adoption of the Profile? If so, Renew or Revise are likely appropriate
        • Does the Claim performance meet current clinical needs? If not, consider Revise or Retire
        • Has technology advanced to the point where conformance could be made easier, or performance could be better? If so, consider Revise
        • Have new clinical practices or consensus emerged that the Profile could align to? If so, consider Revise
          • Consensus about "best practices" and guidelines may have emerged/shifted and the Profile should take into consideration/harmonize/promote
          • Also the clinical expectations and usage may have evolved and we should harmonize
          • Partnership with other organizations and specifications means we may have "convergence" activities to do (e.g. EANM)
        • Has the regulatory/certification/site conformance criteria environment changed in ways we should harmonize with
        • Have any new publications or trials come out that inform changes in our Profile?
  • Do as one work item or divide into multiple - some complexity
  • Key people - MRE (Kay), FDG (Gudrun will ask Jeff to recommend), DWI (Mike)

Streamlined Profile Template

  • Mike & Kevin taking first pass at streamlining Profile document (some additional points in the draft template)
  • Revisit the topic of dropping requirements post-TechConf to see how feedback informs
  • Flavors of possible drops: (Some things are always being done, others are not affecting the claim even if not done)
  • Reluctance to discarding information that took effort/time to develop (keep? preserve in appendix?)
  • Streamlining is partly moving things around for better ordering, some is taking things out (or moving to appendix)
  • Plan a small call on DWI - Mike/Kevin
  • Are there structures we could think of to deal with the multi-organ usage of DWI? Optional modules? Multi-profiles with common parts?
  • Once we vet it internally, we can make it available for voluntary use/conversion by committees.
  • Don't want to distract committees, or force "unnecessary" work.
  • Plan to publicize it in the CC meetings and promote the benefits/concepts.
  • Don't want to blindside any BCs. Maybe start telegraphing the situation now... Reassure we're not going to force rewrites.
  • Harmonize assessment procedures across profiles

Estimates of Precision (Wrap)

  • TODO Need some guidance text (like Criteria page) for BCs to understand; keep as a high priority item. Need to tidy up following text
  • Nancy will work on some guidance text in Word for later in March; after review can fold into Wiki.
  • Homework for Nancy & Kevin & (Nancy designee)(Nick?)
  • Estimates of Precision when BC Stages Profiles and when Sites Conform to Profiles
  • This came out of issues raised by Nancy about when/where/who should do test/retest type estimates of precision
  • The following rough notes are from the 4/5 meeting
  • Address such Estimation as part of conformance assessment of each site and/or actor
  • Discuss BC choice to include assessment of actors/site precision as profile conformance requirement
  • Detail situations that would necessitate such profile requirements
  • Made all BC put in a Section 4 procedure to test linearity and bias with phantoms to ensure estimate is under the claim.
  • Q. Do we require the BC to do it once? Or do we require each site to do it as part of conformance?
  • At Stage 3, we might not need it as BC, but if we suspect we’re going to need it, we should test the practicality.
  • How much of a burden is test/retest? It varies depending on the amount of data required. When phantom data captures the variability you are looking for, it can be fairly easy (assuming access to the phantom is easy and the time is short).
  • BC also chooses the pass/fail threshold that provides reasonable confidence in meeting the claim.
  • If we see profiles mostly stopping at Stage 3, does it make sense to include a test/retest
  • Given that Stage 4 is a lighter weight Stage 5, What if we had an even “lighter-weight” that is not enough to reach Stage 3 but is somehow better.
  • Gap: we’re not doing groundwork with the procedures we have made in the profile (Basically that’s Stage 4) – it’s better if there have been Stage 1 groundwork that are roughly following the requirements, but most profiles do not have this.
  • Key Point is Communication of what the conformance means at each level
  • The profile might state at in/near the claim what conformance means
  • There is value to all levels of conformance
  • Stage 2 - clearly(?) the claim is off the table. Stage 4 - clearly the claim is on the table.
  • Stage 3 is the current "danger" area.
  • So conformance to Stage 3 does not require 95% testing, but if a site is willing to do that (and thus help the BC on it's way to getting the profile to Stage 4 where everyone who then conforms can invoke the claim) how do we document/acknowledge/credit/thank them for that.
  • Guidance for how to design the Stage 3 to Stage 4 study. Note that the BC can decide to either tighten requirements or loosen claim if they two don't match. - NOTE this changes the design of the study. BC might need to weigh in which way they want to go before designing the study.
  • Some profiles have very stringent testing (e.g. claim says wcv is 10%, the profile/actor must show with 95% CI that wcv <=10%) in that we are requesting they confirm the claim directly as part of conformance. Need to better distinguish what BC does for Stage 4 vs what a Profile requires for conformance.

Stage 3 Resolution Template (Wrap)

  • Have the templates TODO need to finish cleaning up the Process Page, check above bullets, then close out.
  • Homework - Kevin - links/pointers
  • Map out how to collate practical feedback from sites into a sheet for resolution similar to public comments.
  • Use the checklists - it's what they'd see in the field and it's "simple" - they can scan and we'll transcribe
  • Additionally, the overall questions solicit broader comments which is really useful as well.
  • Don't want identification being a barrier to feedback. But it's nice to be able to followup.
  • Be VERY clear that we don't intend to broadcast the site details
  • Do some clean up and run it around the coordinating/biomarker committees for feedback.
  • Cover letter to solicit broad feedback, and the checklists both feed material into the resolution sheet.
  • <See notes on Process Page for Tech Conf>
  • Discussion Point: To what degree are we collecting feedback (survey) vs doing a dry run of site conformance process vs both
  • Consider starting some Blog threads e.g. feedback on the Tech Conf
  • Conformance Process
  • What should go into a Conformance Record? - (e.g. findings from Technical Confirmation tests)
  • Need a common view of what conformance entails, how it is achieved, what it looks like to a product, how it is documented, etc.
  • Then we need to ensure that the QIBA Templates/Process supports those things clearly.
  • Kevin will put some initial thoughts on a Wiki page and we can review/add
  • How often should conformance assessment be done, who will assess, who will keep records?
  • Should QIBA get into hosting the Conformance Statements on our site (and then we could link to them from the Profiles page which would be very handy)
  • Consider the RSNA Image Share Conformance Assessment Program and whether we should do something similar for QIBA
  • Process committee can think through the details of a process and confer with RSNA whether they would be interested

Priority (Next)

Profile Selection Process (SCP)

  • Move into Current Work - Consider setting up a TF - gauge participants - below Version/Naming
  • Review/update review criteria/evaluations for new BC proposals
  • Harvest from past experiences
  • Given limited resources, how to approve not just good proposals but the best proposals
  • It's not just about saying "Yes". It's about When should we say "No". When should we say "Not Yet"
  • Evidence that the biomarker already has vendor and user adoption and just needs the "last mile" improvements that QIBA brings.
  • Consider Prior Project completion when Steering Cmte reviews new Proposals from the same PI.
  • timing overlap of prior cycle completion period with new proposal period needs to be one considered.
  • possible solution would require final reports for prior COMPLETED funding cycles before considering a new project proposal
  • Discuss which profiles have been most successful, which have hit bumps, which have foundered
  • What characteristics of each contributed to the success/problems? Can we look for those during selection?
  • As we refine criteria for new proposals, also see how they do/don't apply well to existing profile work
  • Discuss Nancy's criteria for ultimate Claim Confirmation?
  • BCs should understand what they are getting into and start planning for it
  • If the profile will depend on a large test/retest being completed and it seems highly unlikely that would ever be doable, should that weigh on the SC approving the BC?

ToDo

Profile Format Harmonization

  • Various profiles differ in their layout and content which makes it harder for users
  • Use of New Templates has not been mandated, but rather left to committee discretion so as not to be disruptive
  • Various committees have deviated from the template and/or introduced variations without discussing with the Process Cmte
  • Consider starting with a table showing which template each profile is using
  • Process makes table; Tags for Informal template; Formal#1, Formal#2 (Streamlined) and other divergence notes
  • CCs get it populated; SC decides on priority/mandate? of harmonizing
  • Use to inform "harmonization pressure" efforts?

Communicating Uncertainty to Radiologists

  • "No measurement is complete without a statement of it's uncertainty" - NIST
  • Measurement uncertainty is at the heart of what QIBA does
  • If people don't recognize/appreciate measurement uncertainty they can't grasp the value of QIBA fully (or at all?)
  • How do we get radiologists to appreciate the uncertainty of each measurement and incorporate it into their thinking and decision making?
  • What should best practice be for communicating the uncertainty of each measurement to radiologists?
  • Always give a confidence interval rather than a value?
  • Very Important Problem, not clear we could make a dent on solution in 5 months (but maybe problem definition?)
    • And is this the Process Cmte job? Note really. Find a way to hand off to QUIC. Need to put more punch behind the message.
    • Get it on the wiki for posterity and consultation

On-boarding Process

  • Goal: Help new committees, new members, new authors, new reviewers, new adopters
  • Communication Committee might shoulder some of this too and only come to Process when gaps are found.
  • Reviewed "How to develop a Profile" Guidance
  • Email How-To guide to current authors and ask them to read/feedback
  • Then email to the current community since it is helpful for all contributors
  • Maybe update Profiles and Protocols page to focus less on UPICT and more on QIBA Profiles today.
  • Linear layout
  • Explain the mechanics of who does what with a profile (vendors, rads, techs, regulators, etc.)
  • Maybe add some "How to Read a Profile" guidance (also useful for reviewers), e.g. focus on Spec tables. Look at your relevant Activities/Procedures. Read the Discussion sections for more background.
  • Explain about the Claims, the Actors, the Requirements and the Assessment Procedures structure of a Profile
  • Advice may vary depending on viewpoint of the reader.
  • Consider/discuss relative merits of moving the checklists from Annex E into Section 5 of the template
  • Joe's intro email, current template and stage docs, QIBA Fact Sheet
  • Find a way to link directly into the "current" version of documents without having to update the links. Now we link to the Profile template page then you have to click a second time put pull up the template.
  • Could use a "fresh eyes"/newcomer commentary - find a newcomer guinea pig
  • Pictures and diagrams would help a lot for people reading what is "dry" text.
  • Types of newcomers/stakeholders - link from an "intro to QIBA - mother page" - Stakeholder Viewpoints
  • What is QIBA basically about, what is the key value of QIBA to them, how do they "use"/"interact with" QIBA (some of them are "actors", some are not)
  • easy language, a few paragraphs, and links to specific wiki pages/documents/slides that would be a good next step for them
  • Maybe add a "First Steps" section for each page (see QIBA for Statisticians for example) telling them the first things they could/should do
  • Might be good to also have "stories from your colleagues" who are already in QIBA and their experiences.

Publication Process

  • Ask Steering Cmte to determine whether having others publish is a necessity or not (Mike to draft some pro/con points - Kevin can help)
  • Do the vendors and sites and trials that would be involved in using Profiles have an issue with these "standards" being published by QIBA (RSNA)?
  • Would it be better if QIBA Profiles were balloted/published by another organization? IEC? IHE? AAPM? MITA?
  • Would there be an impact in switching to a different document structure, formatting conventions, review/approval processes?

Clinical Confirmation Process

  • Methodology/Study Design guidance/requirements for achieving "Clinically Confirmed"

QIBA Tooling

  • How to use Google Docs?
  • Issues with references, access restricted by federal agencies and some companies
  • Round trip fidelity between Word-Google-Word

QIBA Wiki

  • QIBA Wiki Improvements
  • Wiki serves QIBA Committee work. Consider a new user oriented site (clinicians, administrators)?
  • Wiki vs RSNA.org
  • Address relationship between wiki content (current, easy to update) and website content (authoritative, stable)
  • Likely RSNA staff will periodically mirror wiki content up onto the website; address this in publication process.
  • Consider how to handle handoffs between RSNA website
  • RSNA website is controlled by the RSNA Marketing Department, must meet certain style requirements, and require resources beyond QIBA staff
  • QIBA would still like to find a way for the more formal publications (e.g. later stage profiles) to be accessible from the RSNA website.

Literature Search Guidance

  • Process/best practices for review of literature around a new biomarker/profile (search is relatively straight forward)
  • Assemble draft guidance to kick this off (Hendrik Laue, Ona Wu, Caroline? Chung)
  • Where do you store references, what kind of search works best, what exactly are you looking for?
  • Also meta-analysis guidance to determine sources and levels of variance
  • PDF/DWI - using Google Sheet to track/tabulate/organize - inherently input from many sources so nice to have centralized, commonly edited, accessible

Product Reference Guidelines

  • Draft Guidelines for Reference Implementations and commercial products in Profiles
  • e.g., the underlying algorithm should be open/public/available/documented, QIBA will list all comers, non-commercial?, etc)
  • Level playing field, no favorites

Public Comment Attribution

  • don't push for anonymity. Encourage people to identify themselves (deserve credit and we want to be able to followup)
  • form can accept anonymous, but encourage constructive criticism that will be taken in the spirit given.

Hold

Todo items that are on hold pending some trigger:

Claim Guidance

  • Hold pending people with questions/clarification needs on current text

Guidance Document Process

  • Hold pending interest in "lightweight" QIBA output without claims/conformance
  • Basically "best practice" recommendations
  • Less rigor; Much easier to write,

Profile Retirement Process

Profile Disclaimer

  • Hold pending revist of Discriminatory Claims
  • For now QIBA addresses technical performance. Getting into the clinical performance associated with Discriminatory Claims would open a lot of issues.

Statistical Assumption Testing Guidance

  • Conformance with the statistical assumptions is required at the various QIBA profile stages.
  • Need guidance on the assumptions in the profile, validating the assumptions and testing actors for meeting those assumptions.
  • Symmetrical vs Assymetrical change intervals?
  • Questions about the numbers in "Academic Radiology: ?? Paper"

Past Work

This isn't all of it but here's some notes...

Conflict of Interest Policy

  • Should have a policy statement on the wiki on QIBA expectations (e.g. what kind of things might come up and how might handle, e.g. recusal from votes or ballots)
  • Dan has extracted some example wording used elsewhere (e.g. protocol approval committees, other orgs, AAPM)
  • Is there a personal (financial?) benefit to the individual
  • This may link into the question of getting cochairs to sign RSNA conflict of interest policy
  • AGREE - guidance for guidances.
  • DONE - prepped language with examples and forwarded to SC/EC for approval and posting to the wiki

Public Comment Resolution

  • DONE Set up Wiki page for holding all the comment resolution records from past public comment. - Profiles
  • Work with RSNA on a boilerplate email to send to commenters (who gave their email on the comment form) pointing to the resolutions document for their submitted comments. (Staff will draft some proposed text for review)
  • (DONE) Could build it into the automatic confirmation message that the confirmation form sends out.
  • DONE Revised process to highlight circulating resolutions with ballots and posting by RSNA Staff when complete
  • DONE Updated resolution page
  • ONGOING get additional profiles to post their resolutions

Coordinating Committee Membership Criteria

  • Remove Modality Scientific Liaison (can bring in SMEs as voting/non-voting)
  • Remove explicit cap on voting membership
  • Flag "additional voting" as "At Large Members - suggest 2-4 people"
  • Keep all Co-chairs of BCs
  • Suggest adding 3-year term (renewable) for CC xChairs - RSNA Staff will think through logistics - currently doing a CC membership review - will be some turnover. Staggered rotations is desirable.
  • Process Cmte participation (periodic education agenda item like for BC) is useful, but can fit easily under the non-voting SME umbrella.

Profile Ballot Reminders

  • Consider something like the following:
Please indicate below whether this Profile
  • meets the criteria for this stage [link to criteria]
  • conforms to profile guidelines [link to guidelines]
  • is of sufficient quality to publish
Note: if you are unable to read through the profile, you may Abstain.

Requirement Criteria

  • Making profiles shorter...
  • Drop requirements that aren't critical
  • DONE - devised, documented and communicated an approach to Vetting Requirements
  • Impact Criteria Assessment: Asking existing profiles to go back and fill in a column may invoke some resistance to the effort required.
  • One approach: Have the BC go through all the requirements and do an impact pruning just before Pub Cmte release
  • Don't require long winded justifications, a short clear statement should be sufficient
  • QIB Guidance documents (not Profiles) can have a role since they don't have a claim so dropping "requirements" is less of an issue

Driving Profile Adoption

  • Adoption of Profiles
  • Maybe a new TF to support Adoption (can include some Process people)
  • Ed, Brad, Joe, Kevin, Dan, RSNA Webperson
  • Start by looking at what is on the RSNA QIBA pages,
  • Basis for reviewing organization/content/structure of current QIBA documents/deliverables
  • For further details, see QSIC page
  • Process Cmte can support QSIC when process questions/refinements come up.

Committee Leadership Process

  • Address BC and CC leadership
  • Continue with variations of co-chair/chair/vice-chair? - Maybe call everything below Steering Cmte as co-chairs and let them work out working patterns.
  • Describe process for nominating & selecting that is transparent, allows time for nominations & self-nominations, encourages diversity
  • Mostly current system has been working without major issues, but would like to have efficient flow rather than everyone re-thinking/re-inventing a process
  • Process for recognizing cases where cochair availability/activity has decreased and need to call-the-question and trigger "replacement".
  • Having "terms" would help trigger. E.g. 3-year terms, and limit of two terms to promote turnover, new faces, new ideas in some committees, on the other hand keeping experienced people and having continuity is good and there may be a limited supply of motivated leadership.
  • CC term limits might be OK, but BC should maybe not have limits because they are intended to a have a limited life to start, and the chair is a key leader and change could falter
  • If we stick with 3 year terms, might want to have a procedure where a cochair missing 8 meetings in a row triggers the secretariat doing a checkin to confirm that they still have the bandwidth/availability, and give them the opportunity to step aside if their other responsibilities have intruded.
  • Stakeholder diversity (silent, recommend, or require)
  • Having "only academic representation" is an adoption risk to QIBA, so there is a value to making some effort to have diversity
  • Variability in the size of some committees so tough to enforce
  • Lets Strongly Recommend (and maybe make it a review point in the Coord Cmte and the Steering Cmte to ask about attempts to improve?)
  • Also consider this when forming a Biomarker Committee - require? At least formally build into the evaluation process.
  • Consider handling committee stakeholder diversity in the committee formation and dashboard process, not the leadership process
  • Define Stakeholder diversity; do we make user/vendor classes? or is one academic radiologist and one clinical trial radiologist the intended degree of diversity?
  • For comparison - DICOM:
  • For Working Groups it's required but unconstrained "Working Groups shall elect a chair or co-chairs."
  • For the DSC (Steering Cmte) it's more constrained
  • There shall be two co-chairs – one representing a producer and one representing a biomedical professional organization.
  • Each co-chair shall serve a two-year term and may serve no more than two consecutive terms. The terms of the co-chairs shall expire in alternate years.
  • At the meeting preceding the meeting before the last Committee meeting each year, the co-chairs shall appoint a three-member nominating subcommittee consisting of at least one representative of a producer , one representative of a biomedical professional organization and one former committee officer (if one is available). The former officer (if one is available) shall chair the nominating subcommittee. Members of the nominating subcommittee shall develop and submit to the secretariat a slate of candidates. The names of the candidates should be submitted to the secretariat no later than 30 days prior to the meeting preceding the last meeting of the year so that their names may be included in the published agenda. Additional nominations may be made from the floor at this meeting.
  • Prior to the last meeting of the year the secretariat shall conduct a letter ballot. The name of the person elected shall be announced at the last meeting of the year. That person shall assume office immediately following the last meeting of the year.
  • The Committee has the right to recall a co-chair.
  • For comparison - IHE:
  • There are general cochair guidelines in section 12.2.7 of the Governance: https://www.ihe.net/wp-content/uploads/2018/07/IHE-International-Principles-of-Governance.pdf
  • The Board adds the constraint "The Board shall elect as co-chairs, two Board Members drawn from Member Organizations in the User category. They will serve as co-chairs for renewable two-year terms."
  • The Domain Planning Cmtes adds the recommendation "It is recommended that one Domain Planning Committee co-chair be selected from the User member category and one from the Developer member category."
  • For comparison - RSNA:
  • A nomination announcement contains a link to an online nomination form and deadline
  • A comment box provides for nominators or self-nominators to state why they wanted to serve/would be a good addition to the leadership
  • Once the nomination period ended, another announcement contains a link to an eballot listing nominees and their qualifications
  • Joe helpfully pointed out that we need to clearly define voting eligibility (i.e. do voting privileges apply to chair selection or can everyone vote)

See Also

This page is based on the Committee Template. Add any good ideas you have to the template.