Difference between revisions of "Process Coordinating Committee"
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:* Profile Selection Process
:* Profile Selection Process
Revision as of 23:24, 19 November 2019
- Chairs: Kevin O'Donnell (Chair); Dan Sullivan, MD (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 Susan for details)
Approved call summaries:
- Wiki Use Cases - https://docs.google.com/spreadsheets/d/1bVP9pSjxtCVinlASCAeGDf5vjc2lCfj16qEg7hkft0Q/edit?usp=sharing
- Draft standing agenda item for Coordinating Cmtes to remind/confirm BC committees keeping their BC Wiki page up to date (especially links to current draft documents)
- Advise - put "recent" working draft of profiles at least quarterly on the BC Cmte Page. (i.e. don't leave them on TF pages)
- Process Cmte will do a survey about every 6 mo and feed results to the Steering and Coordinating Cmtes. (Could add row to dashboard)
- Dashboard item to confirm representative(s) for major stakeholder groups: Radiologists, Physicists, Technologists, Scanner vendors, SW vendors, ...
- Public Comment resolution
- Set up Wiki page for holding all the comment resolution records from past public comment. - DONE 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)
- Could build it into the automatic confirmation message that the confirmation form sends out. (DONE)
- Sketch Committee Sunset Process for Task Forces and Biomarker Committees - DONE
- 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"
- 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)
- TODO 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
- Review Executive Cmte charter to look for any process changes/additions
- Contact page on wiki? Point to email@example.com for questions/info on any committee, QIDW, etc.
- Pathway to Performance (Biomarker)
- Quantitation sounds interesting
- Initial points of contact - people will go to RSNA.org, not the wiki in most cases
- <Convince me I should do this> - what are the benefits - for now see Stakeholders
- Select a Biomarker/Profile (product manager, "activist" radiologist (possibly head of section or dept), core lab or principle investigator (pitch it to the trial since there are costs)
- Read the Executive Summary (which includes a "simple" summary of the Claim), then the Claims - decide if it "merits" doing
- Biostatistician weighs in on the benefits (can translate technical performance into study design terms)
- Cross sectional claims are likely more directly useful to the radiologist (detectable change, minimum detectable difference)
- Skim the requirements to see if the "cost" sounds reasonable (physicist and tech will also estimate "costs")
- Implement a Profile ("the actors", product engineers, physicists, radiologists, technologists, ...)
- read, understand, and implement/follow the requirements on themselves.
- Two avenues:
- Checklists are short, might be handy to have the assessment procedure extracted too
- Profiles show more context (what others are doing) and provide background discussion.
- Proper implementation needs some interaction/coordination between the actors... is there an "ultimately responsible actor"? Site? Chief Radiologist?
- <Are there ways for us to piggy back on current hospital methods for implementing standard processes>
- Test your conformance
- Select Self-attestation or Certification
- Checklists, spreadsheets, metric generating software, semi-automated assessments, fully automated assessments
- <what should be recorded (and made available) when testing?>
- Results need to be recorded and perhaps reported. Some procedures ask you to record certain values.
- What about the image datasets (and the characteristics of the phantom or dataset, especially if they were given choice)? The test data used? Who stores it? Who can ask to look at it?
- Want to know What Was Done, and perhaps be able to Validate and/or Reproduce the results
- When sites conform, they may want to reproduce the vendors tests.
- Probably need some cross-QIBA guidelines, but some of these details will be profile-specific, and documented in the assessment procedures.
- Document your conformance (with test results) and submit (who is looking at these and why?)(Sites before buying from vendor)(Clinical Trials to qualify sites and vet incoming data)
- Conformance statements
- QIBA Registered vs QIBA Certified
- Frequency (check yearly? monthly?) & granularity of conformance (Site can do it? Site did it for each patient?)
- Use regularly
- How do you audit? How do you do recurrent training/refresher?
- 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,
- 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
- 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"
This page is based on the Committee Template. Add any good ideas you have to the template.