Difference between revisions of "Process Coordinating Committee"
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:* Technical Confirmation Resolution Template
:* Technical Confirmation Resolution Template
::* Map out how to collate practical feedback from sites into a sheet for resolution similar to public comments.
::* Map out how to collate practical feedback from sites into a sheet for resolution similar to public comments.
:* Conformance Process
:* Conformance Process
Revision as of 20:07, 16 February 2021
- Chairs: Kevin O'Donnell (Chair); Michael Boss, PhD (Vice Chair)
- RSNA Staff Support: Susan Stanfa
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
- Upcoming: Biweekly Tcons, 1st and 3rd Wednesdays of each month @ 3-4pm Central Time (Contact email@example.com for details)
Approved call summaries:
- Basis for reviewing organization/content/structure of current QIBA documents/deliverables
- Update/Iterate Profile Writing Guidance
- Ideas on what to add/review
- Making profiles shorter...
- Variants that are more "accessible" - need to keep the requirements correct/complete.
- Drop requirements that aren't critical
- Guidance documents can have a role since they don't have a claim so dropping requirements is less of an issue
- Technical Confirmation Resolution Template
- Map out how to collate practical feedback from sites into a sheet for resolution similar to public comments.
- 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
- Process Education
- Status : Standing CC agenda item (5-10 minute slot) has been working well.
- BCs would be Really Challenging. Maybe selected spot visits. (Who selects? Hmmm think on this)
- List of Reminders
- Expecting BC Chairs to take Process topics from CC back to their BCs. A BC can ask for additional participation from Process Cmte as needed.
- BCs should keep their BC Wiki page up to date (especially links to current draft documents)
- BCs put "recent" working draft of profiles at least quarterly on the BC Cmte Page. (i.e. don't leave them on TF pages)
- Identify any topics you'd like a future Process update about
- Change to the voting procedures (BC gets a "pass" on the CC vote)
- Note CC membership/voting changes (Scientific Liaisons deprecated, At Large members added, etc.)
- Do internal reviews of sections by dedicated Cmte Members before release (see Review Process Page)
- Consider resolution process "quality check" at the end.
- Consider "Profile Shortening methods" (larger topic?)
- Should we consider a page limit? At the least make it a review criteria to discuss/defend
- To avoid taking over the CC agenda - note that Process is working on this, think, contribute, we'll get back to you
- Claim statistics - particularly new BC's
- How to make/use/ a checklist with a Profile - avoid heterogeneity, its a re-sort, not different content, not a superset, not a subset
- Thoughts about process improvements
- 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), ...
- When you have a "gap", get them during public comment, or periodically on a focused call, invite to face-to-face meetings,
- Q. If there are multiple, who do you list?
- On-boarding process
- Goal: Help new committees, new members, new authors, new reviewers, new adopters
- 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
- TODO 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.)
- TODO 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.
- Include link to How-To guide
- 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
- TODO First Steps for each page (see QIBA for Statisticians for example)
- TODO Might be good to also have "stories from your colleagues" who are already in QIBA and their experiences.
- Contact page on wiki? Point to firstname.lastname@example.org for questions/info on any committee, QIDW, etc.
- Profile Selection Process
- 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
- 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
- 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.
- Consiider 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)
- 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?
- 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,
- 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
- 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?
- 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
- Profile Maintenance Process
- Propose change tracking process
- Propose conventions for Profile editions/versions
- Guidelines for Reference Implementations and commercial products in Profiles
- (underlying algorithm available, list all comers, non-commercial?, etc)
- TODO add detail
- 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.
Todo items that are on hold pending some trigger:
- Claim Guidance
- Hold pending people with questions/clarification needs on current text
- Profile Template
- Hold pending new suggestions/clarification needs
- Harmonize assessment procedures across profiles
- Profile Retirement Process
- Hold pending a profile we want to retire
- 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 DICOM retirement concept (stays available in archives, not maintained/promoted)
- 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"
- 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
- Coord Cmte 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.
- Ballot text
- 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.
This page is based on the Committee Template. Add any good ideas you have to the template.