Working Group Meeting June 5-6, 2006
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Sheraton Hotel – Atlanta, GA
Individual meetings of the Methods, Topics and Products Subcommittees (SC) were held from 8:30 – 9:30 am, allowing the subcommittee chairs and members to finalize recommendations and presentations for the full EGAPP Working Group (WG).
The EGAPP WG meeting was convened by Al Berg, Chair. Working Group members participating were Katrina Armstrong, Ned Calonge, James Haddow, Maxine Hayes, Celia Kaye, Kathryn Phillips, Margaret Piper, Sue Richards, Ora Strickland, and SteveTeutsch.
Consultants present were Siobhan Dolan, Judith Johnson, and Glenn Palomaki. Dr. Berg reported that he and Linda Bradley had reviewed the conflict of interest forms that the WG members submitted in May, 2006. Two potential conflicts of interest were identified and discussed. All were noted in the record; none were considered to require action.
Opening Remarks and Introductions
Dr. Berg called the meeting to order at 9:30 am, and thanked everyone for their participation. He announced that two subcommittees would be rotating chairpersons. The Methods SC will now be chaired by Dr. Steve Teutsch and a new chair will be selected for the Topics SC. He thanked Dr. Ned Calonge, Dr. Jeffrey Botkin, and Dr. Kathryn Phillips for their service as chairs of the Methods, Outcomes and Topics SCs. The Outcomes SC has completed its work, and the newly formed Products SC will continue to be chaired by Dr. Celia Kaye.
Dr. Berg outlined the meeting objectives:
- WG discussion of the two draft reviews and development of responses
- Selection of topics for year 3
- Decisions on authorship criteria and publication plans
- Discussion on development of recommendation formats
- Discussion on development of the EGAPP Protocol Manual
- Addressing website and clearance issues
Ovarian Cancer Draft Report
Dr. Berg provided an overview (including the analytic framework, key questions, search outlines, results and conclusions) of the draft evidence report on Genomic Testing for Detection and Management of Ovarian Cancer submitted by the EPC. Dr. Armstrong described the proposed modeling approach, which includes clinical decision making and identifying strategies that might result in reduction of mortality. The Evidence-based Practice Center (EPC) representative presented the results for each key question in the draft evidence report. Following the presentation, the EPC representative answered questions from the WG.
Cytochrome P450 Draft Report
The EPC representative presented results for each key question in the draft evidence report on Testing for Cytochrome P450 Polymorphisms in Adults with Non-Psychotic Depression Treated with Selective Serotonin Reuptake Inhibitors (SSRIs) and answered questions from the WG.
Commentary and Working Group Responses to Draft Evidence Reports
Dr. Berg outlined the feedback from a May 25 conference call of staff and WG members of the Technical Expert Panel (TEP) about the Ovarian Cancer draft evidence report, and then led the full WG discussion. Written comments have already been forwarded to the EPC; any further comments from this discussion will be collated and submitted after the meeting.
Dr. Piper outlined the feedback from a May 19 conference call of staff and WG members of the TEP about the CYP450 draft evidence report, and then led the full WG discussion. Written comments have already been forwarded to the EPC; any further comments from this discussion will be forwarded after the meeting.
Dr. Bradley provided an update on project activities:
- CDC staff have submitted several abstracts and meeting proposals related to EGAPP activities (included in the Briefing Book for this meeting)
- Dr. Bradley introduced Dr. Judith Johnson, an evaluation consultant who will be overseeing the stakeholder surveys and other year 3 and 4 evaluation activities. She gave a brief overview of the status of the submission of the stakeholder survey plan to the Office of Management and Budget (OMB), including Institutional Review Board (IRB) submission and required Federal Register notices.
- After OMB approval, surveys of healthcare providers and payers will begin about six months after the first evidence report and recommendations are published. Surveying of policy makers, healthcare purchasers, and targeted consumers/website visitors will begin about six months later. Each of these groups will be resurveyed about one year later.
- The composition of these stakeholder groups and the plan for reaching each was briefly described.
- WG members confirmed that the evaluation report will include both quantitative estimates and, when informative, anecdotal (qualitative) reports about response and usefulness of the process and reports/recommendations.
Topics Subcommittee Report
Dr. Phillips presented a report of Topics SC activities and the morning subcommittee meeting. Their recent work has focused on the reviewing potential topics, reassessing criteria for selecting topics, and recommending high priority topics for consideration by the full WG. Considerations for topic selection include weighting by criteria and thinking about portfolio balance from the contextual and substantive points of view (e.g., somatic vs. inherited, disorder categories, established vs. emerging tests, type of test, testing the evidence review methodology).
With some concern about beginning new reviews without having completed one or more of the ongoing reviews, the WG conducted a comprehensive discussion of proposed topics. Straw polls were conducted to identify a short list of top-ranked topics; seven topics received sufficient votes to qualify for further discussion.
Final recommendation: 1) Genomic profiling for cardiovascular disease to identify management or prevention strategies; 2) Gene expression profiling for managing breast cancer treatment
Products Subcommittee Report
Dr. Kaye presented an update and recommendations from the Products SC on authorship and development of recommendation formats.
- Recommended that recommendations/papers should reflect the range of opinion within the group. If this is not possible, an author may opt out or a “minority report” could be considered. In all cases, all materials for publication should be reviewed by the full WG. The Products SC will maintain a list of all EGAPP products that includes status.
- Recommended publishing all EGAPP recommendations in two formats, a full recommendation (6-8 pages) and a summary of recommendation (1-2 pages).
- They preferred a journalistic format, consisting of the recommendations followed by narrative that includes clinical considerations, technology (test description and method), a brief summary of the evidence, research gaps, and reference to existing recommendations from other groups. Characteristics of other recommendation formats were reviewed and discussed (e.g., US Preventive Services Task Force, Community Guide, National Institute of Clinical Evidence).
- It was also suggested to consider an appendix that contains suggested information for patients.
- EGAPP would like to publish an evidence report and the WG recommendations simultaneously. In circumstances in which they cannot be published simultaneously (i.e., early reviews), the evidence report can be published prior to the recommendations.
Dr. Bradley presented updates:
- Among the journals considered for possible publication of evidence report summaries and WG recommendations, Genetics in Medicine (GIM) and the Morbidity and Mortality Weekly Report (MMWR) have been contacted and expressed interest in working with EGAPP.
- The WG agreed to move forward with discussions with these journals, with further discussion on specific points (e.g., open access to recommendations).
- The WG also agreed that exclusivity should not be a requirement for publication, as there could be topics that would need a different venue.
- A domain waiver request for an independent EGAPP website (e.g., EGAPPonline.org, EGAPPreview.org) was submitted to CDC in early April 2006, and has been approved at all CDC levels. Additional work is needed prior to submission of the waiver to Health and Human Services (HHS) for approval – this is a high priority.
- Dr. Bradley presented flow diagrams representing the current understanding of the processes for publication and web posting of evidence reports and recommendations. The clearance process is likely to be streamlined based on two peer review processes built into the development of evidence reports and recommendations (i.e., peer/expert review, peer review by journals).
Methods Subcommittee Report
Dr. Teutsch presented an update from the Methods SC that included: 1) Overview of a proposed “Question Set Template” for different categories of tests (e.g., diagnostic, predictive); 2) standardized language for recommendation categories; 3) clinical decision-making for recommendations; and 4) plans for an EGAPP Procedure Manual.
- Suggested developing a “question set template” that could be used to develop all recommendations by test category (e.g., screening, diagnosis, treatment/management decisions, prognosis prediction).
- Suggested using 4- or 5-tiered Standard Language Recommendation categories.
- There was concern about presenting a topic that may be premature with a positive or negative connotation.
- WG members agreed that any reviews resulting in “I”-type (insufficient evidence) recommendations should provide as much information as possible rather than just a “don’t know” recommendation without any guidance. Guidance for the clinician might include alternative services, costs, and patient value of potential harm/benefit trade-offs (patient-centered outcomes).
- Working with staff to outline a proposed EGAPP Procedure Manual based on outlines from the USPSTF and Community Guide Procedure Manuals as examples. Work will begin with a section on Topic Selection.
- The full WG briefly discussed using decision-modeling to assist in making a recommendation.
Update on UGT1A1 and HNPCC Reviews
Dr. Bradley reported that the UGT1A1 review is progressing, with delivery of data tables and some summary information in mid-August 2006. CDC staff and consultants plan a draft report for the September 2006 meeting.
Dr. Bradley reported the full-text literature review is completed for the HNPCC review. A TEP call is planned for late-June or early-July 2006. A draft report is expected by September 2006.
Recommendation Titles and Structuring Recommendations
- Dr. Berg led discussion about structuring recommendations with a discussion on developing clear recommendation titles.
- Other considerations when drafting a recommendation included:
- Addressing the patient and the public health perspectives
- Being clear that a recommendation is intended for a defined clinical setting, especially when targeted to a specific group of patients, but not to the general public.
- It was proposed that the WG look at cost effectiveness in future reviews, including its overall value to systematic reviews as well as looking at specific data (e.g., dollar costs, charge for tests, opportunity costs). This is going to be particularly important for tests that are recommended.
Action Items for the next meeting:
- The Products SC will continue work on the format and layout for recommendation documents, continue to review project products and documents, and work with staff on website development.
- The Topics SC will be evaluating additional topics for future consideration and also working on format and content for the EGAPP website (e.g., topic list, topic selection methodology).
- The Methods SC will use the discussed five-category recommendation theory to draft a rules proposal based on consideration of the first two current draft reports, and will also continue work with staff on the Procedure Manual.
Dr. Berg thanked everyone for their participation and attendance. The meeting was adjourned at 12:00 PM.
Monday & Tuesday, September 25 – 26, 2006 in Atlanta, GA.
Future meetings are scheduled for:
Monday & Tuesday, January 29 – 30, 2007
Monday & Tuesday, April 30 – May 1, 2007