Sub-Committee Meetings
Individual meetings of the Methods, Topics and Products subcommittees were held from 8:30 – 9:30 am, allowing the subcommittee chairs and members to finalize recommendations and presentations for the full Working Group.
Welcome and Introductions
The EGAPP Working Group (WG) meeting was convened by Al Berg, Chair. Working Group members participating were Jeff Botkin, Ned Calonge, James Haddow (via teleconference), Maxine Hayes, Celia Kaye, Kathryn Phillips (via teleconference), Margaret Piper, Sue Richards, Joan Scott and Ora Strickland, and Steve Teutsch (via teleconference). Consultants present were Toby Citrin, Karen Edwards, Glenn Palomaki and Lynn Short. Dr. Berg reported that he and Linda Bradley had reviewed the Conflict of Interest forms from the WG members and determined that there were no conflicts for this meeting.
Opening Remarks
Dr. Muin Khoury, Director of CDC's Office of Genomics and Disease Prevention thanked the WG for their hard work. He discussed the need for building partnerships to achieve sustainability of this process. Dr. Bradley provided an update on project activities. She reported that evidence reviews were progressing as scheduled, survey instruments were in development for the project evaluation involving stakeholders, and that options for an independent website to post WG products were being explored.
Products Subcommittee Report
Dr. Kaye described the subcommittee’s charge, which is to ensure consistent tone and format in WG communications and products, and to review the work of the other Working Group subcommittees and suggest and coordinate creation of needed products. Current subcommittee activities include: consideration of WG materials that could be posted on an EGAPP website to provide a more transparent process, development of WG recommendation formats, and coordination of academic products. Products considered for web posting included more detailed descriptions of EGAPP processes, materials related to the topic review and selection process, and interim products related to the evidence reviews. Dr. Kaye raised issues considered fundamental to their work, including the importance of making EGAPP a sustainable process, the need to clearly articulate the WG’s role in the EGAPP process, and the need for the WG to be consistent in communicating their scientific approach and philosophy.
Outcomes Discussion
Dr. Botkin provided a brief overview of the lexicon of outcomes that had been presented at the October Working Group Meeting (see October WG Meeting Summary) along with an outcomes matrix designed to aid in definition of outcomes for specific topics. The matrix addresses whether the outcomes are relevant to the patient and/or the physician, whether they should be considered in the context of the individual, family, and/or society, and the WG’s ranking of relevance of specific outcomes to the topic. Discussion also occurred about the prioritization of outcomes included in the lexicon, and the anticipated difficulty in addressing intermediate outcomes.
Topics Subcommittee Report and Discussion
Joan Scott reviewed the current process for reviewing and selecting topics. Short summaries are prepared by CDC staff that include a description of the disease, the test, and the clinical scenario(s) in which the test will be offered. Preliminary assessment of topics based on WG criteria is then done. Currently, 36 topics are under consideration. The Topics subcommittee reviews short summaries and recommends those to be moved forward for further review. Full Summaries are more in-depth reviews that specifically address what is known with regard to each of the WG criteria. The Topics subcommittee reviews full summaries and recommends their best candidates for evidence review to the full WG. The full WG reviews all summaries, discusses the recommendations, and votes to select topics for review.
The WG discussed the need for further systematizing processes to update information on current topics and to horizon scan for topics. In addition, they considered again the scope of topics and the need to make clear when topics are not being addressed because sufficient evidence is not yet available. The WG also discussed which materials related to topics should be posted on the web to facilitate transparency, given that many of their topic related processes and products were developed for internal purposes and are still being piloted.
Discussion on Possible Topics for Review in Year 3
It is anticipated that the WG will select two topics for full evidence review in Year 3. The WG discussed potential areas of focus in order to develop a portfolio that exercises the methods and approach in the pilot phase. Suggestions for categories to consider included population screening tests, pediatric tests, tests for inherited versus somatic mutations, disorder categories (e.g., pharmacogenetic, cancer), established versus emerging tests, and types of test (e.g., predictive, diagnostic).
Full summaries were requested on: Connexin, breast cancer multigene panel, cardiovascular disease multigene or genomic panels, and testing for cardiac channelopathies. A short summary was requested on diabetes/TCF7L2 gene. Additional requests will be considered. The WG will aim to vote on topics via email or conference call prior to the next WG meeting.
Stakeholder Engagement and Dissemination
Dr. Karen Edwards and Toby Citrin each gave short presentations to update the WG on their work related to stakeholder engagement and dissemination. Both Centers have conducted a series of informal discussions to investigate stakeholder perceptions of EGAPP, the types of information that would help stakeholders better understand the EGAPP process and WG products, and stakeholder interest in helping to disseminate the products and translate materials. The Centers will use the information from these discussions and a planned informal advisory group of leaders from key stakeholder groups to guide them in assisting the project on dissemination and translation of results for stakeholders.
Methods Subcommittee
Dr. Calonge presented an overview of Methods subcommittee work to date, focusing on definitions, checklists for reporting studies, hierarchy of data sources or study designs, and grading schemes. Based on the recommendations of the Methods Subcommittee, the WG decided to modify the grading scheme for analytic validity. In their discussion, the WG recognized the need to publish their methodology so that others would understand the WG processes, but also the need to wait until some reports were completed to assess progress.
Evidence Reviews in Progress
The WG received status updates by teleconference from Agency for Healthcare Research and Quality Evidence-based Practice Centers currently conducting reviews on depression/CYP450 testing, colorectal cancer/HNPCC testing, and genetic tests for detection and management of ovarian cancer. The WG also discussed scope and key questions for a planned targeted review on colorectal cancer and UGT1A1 testing.
Discussion of Draft Documents
The WG discussed potential draft documents that they would like to submit for publication. Included in this discussion was an overview paper on EGAPP, a paper describing their overall methodology, and papers describing processes related to selection of topics and relevant outcomes to be considered. The WG felt it would be important to include general discussion of the need for an evidence-based process for reviewing genetic tests and issues related to genetic testing.
For the next meeting:
- The Topics subcommittee will review summaries prepared by staff and will recommend topics for consideration by the full WG.
- The Products subcommittee will review existing recommendation formats and will develop suggested formats to be presented to the full WG.
- The Methods subcommittee will begin work on draft protocols.
Dr. Berg thanked everyone for their participation and adjourned the meeting.
The next meeting is planned for June 5-6, 2006 in Atlanta, GA |
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