Working Group Meeting February 2-3, 2009

Hilton Garden Inn Atlanta Airport / Millenium Center - Atlanta, GA

 

MEETING SUMMARY

View Agenda

 

Monday, February 2, 2009

 

Subcommittee Meetings
Topics, Methods and Products Subcommittee (SC) meetings were held from 8:30 – 9:30 am to finalize deliberations and presentations for the full EWG.

 

Welcome and Opening Statement
Al Berg welcomed the EGAPP Working Group (EWG) members and asked each EWG member to introduce themselves. 

 

Al Berg outlined a few housekeeping items including the sign in sheet, lunch selection cards for Tuesday and a letter received from the EGAPP Stakeholders Group (ESG).

 

Al Berg also mentioned that the EWG would be getting an update on where EGAPP may fit strategically in the CDC and new administration.

 

EGAPP Working Group members present: 
Al Berg, MD, MPH, Chair; Ned Calonge, MD, MPH; Doug Campos-Outcalt, MD, MPA; James Haddow, MD; Maxine Hayes, MD, MPH; Celia Kaye, MD, PhD; Roger D. Klein, MD, JD; Kenneth Offit MD, MPH; Stephen Pauker, MD, MACP, FACC, ABMH; Margaret Piper, PhD, MPH; Sue Richards, PhD, FACMG  (via teleconference); Joan Scott, MS, CGC; Ora Strickland, PhD; and David L. Veenstra, PharmD, PhD.

 

Core consultants in attendance were: Cecile Janssens, PhD; Judy Johnson, PhD; and Glenn Palomaki, BS were also present. 

 

Status Updates
Dave Dotson updated the EWG on the new issue of Genetics in Medicine (GIM).  The issue contained 3 new recommendation statements, an evidence review and a supplemental report, as well as the EWG Methods article.

 

Dave Dotson also outlined the status of the Factor V review; the final report is due in March and a representative from the EPC is expected to be at the next meeting to present.

 

He also presented the statistics on the web site.  The most the hits were on the Breast Cancer Gene Expression Profiling topic page, followed by the Lynch Syndrome topic page.

 

Dave introduced Cecelia Bellcross, who is an ASHG fellow working with CDC’s Office of Public Health Genomics (OPHG).

 

OPHG and EGAPP Transition Planning
Muin Khoury presented to the EWG on the forward progress with EGAPP.  He focused on:

• The changing environment: the need for a translation roadmap;
• Translation research; and
• The extent to which genomics translation has attracted attention

 

Muin Khoury emphasized the need to conduct the evidence reviews in a faster and nimbler method.  This would allow the EWG to make more recommendations and the office to produce more related translated products on individual tests. 

 

Muin Khoury advised the EWG of collaboration with the National Cancer Institute (NCI) to aid in this effort.

 

The CDC translation research team is being led by Shelley Reyes with the goal to support research needed for evidence-based clinical and public health promotion. 

 

The GAPPNet planning group, comprised of individuals from CDC, NHGRI, and NCI, is planning to convene a collaboration meeting in early Spring 2009.  A second meeting will occur in the Fall of 2009.

 

Muin Khoury asked for ideas on how might the EWG evolve to support GAPPNet.

 

Topic Selection
The Topics SC presented their top recommendations for the next set of reviews.  Their recommendations were as follows:

• CGH array
• Lung Cancer EGFR/KRAS
• CYP2D6 Tamoxifen Breast Cancer
• SNP Panels for various cancers

 

The EWG discussed how each of the following issues would affect their topic portfolio considerations:

• CGH array with a focus on children
• A “positive” recommendation could be beneficial
• Current marketing of CYP2D6 for patients undergoing treatment with tamoxifen
• Tamoxifen could be of potential benefit if a positive recommendation could be made

 

The EWG voted and determined that it would be beneficial to review each of these topics. The EWG members requested that CDC staff provide feedback on the type of review and resources needed to conduct each of these reviews.  The EWG would then create an ordered priority. 

 

OPHG’s GAPPnet Horizon Scanning
Marta Gwinn from CDC’s OPHG, presented on the office’s GAPPNet Initiative for information management.  The purpose of the presentation was to introduce the horizon scanning process of GAPPNet that is being conducted by OPHG staff. 

 

Cardiovascular Disease Review Update
Glenn Palomaki presented the current status of the Cardiovascular Disease review.   This included a brief review of the past presentation, what’s new since the last presentation and a report on the recent 9p21 studies.

 

The EWG had a breakout session on this topic in the afternoon and further discussion occurred.

 

Lynch Syndrome Cost Effective Analysis – Scott Grosse
Scott Grosse presented the recent results of a collaborative effort to use modeling to determine the most cost effective testing strategy for family members of Lynch syndrome patients. 

 

The details will be available in an upcoming journal article.

 

Afternoon Breakout Sessions
Al Berg charged the members with using this time to move ahead the objectives that were outlined in the Briefing Book for two topics.

Lynch Syndrome Cost Effectiveness Breakout Session Report
Glenn Palomaki led the breakout session and presented the results of the discussion to the full EWG.

 

Overall the results of the discussion on the most cost effective approach were inconclusive for the EWG.  There was some evidence of one strategy being more cost effective than the other.  Therefore, the EWG recommendation wouldn’t change, but the rationale for the recommendation itself may change. It was determined that there would be no changes to the current recommendation at this time.

 

CVD Breakout Session Report
During the last meeting the EWG voted on a recommendation statement.  The EWG elected not to relook at their draft recommendation. 

 

The EWG discussed separating the evidence report into two articles, the first being on the majority of the genes, while the other would be on 9p21.  However, it was determined the evidence review would be in 2 articles and the recommendation in 1 article. 

 

A new additional paper using 9p21 as an example for an article on GWAS studies would be appropriate to draft. 

EGAPP Stakeholders Group  (ESG) Meeting Report
The EWG was represented by Ora Strickland at the January 2009 ESG meeting.

 

The EWG is in receipt of a list of comments on the various reviews/recommendations and on the interactions of the EWG and ESG. 

 

The EWG would like to allow ESG members to have more input by incorporating more as peer reviewers.  The EWG suggested the ESG use an existing recommendation to provide a “model recommendation” in the format they would like to see.

 

It was suggested that a method to establish a confidential way to give the ESG a recommendation statement in the earlier phases to get their feedback. 

 

The current roles include the potential for ESG involvement on the front end with horizon scanning, topic selection and helping frame contextual issues, and on the back end with formatting the recommendation, and in dissemination of secondary products.

 

Debrief on January Publications
Dave Dotson provided a debrief on the GIM publications and evidence reviews, as well as the efforts to maximize the press coverage.  Overview of the processes involved in coordinating the special issue of GIM:

• The issue contained 3 EWG recommendation statements, 2 evidence reviews, and the methods paper
• The format of GIM articles was changed between the time the manuscripts were submitted and published
• Two rounds of proof corrections were required, and proofs were received in batches
• The content was posted online early, although it had been agreed that there would be no publish ahead of print for this issue

 

The National Guidelines Clearing House (NGC) is abstracting the recommendations for their web site.  CDC Staff should have them to review shortly and will be soliciting comments from the EWG Products SC.

 

Appreciation for the Genetics in Public Policy Center, for their collaborative effort in helping the EWG to plan for press coverage, was expressed. 

 

There are many ways to meet the need of the audience by use of the Products SC, open access publications, and with ESG.

 

There may be a need to develop a more clear idea of who the target audiences are for EWG recommendations and related products, and to assess whether the current publication plan will always reach those audiences most effectively. 

 

Topics SC Report
Joan Scott presented to the EWG the report from the Topics SC.  The main points were the vote on topic priorities and the status of the Topics SC work.

 

The EWG voted on 4 topic categories for their next round of reviews.  The EWG requested further information on these categories including the type of review that could be done, the amount of staff time and the financial resources to conduct the reviews.  CDC Staff will provide this information to the Topics SC for their recommendation to the full EWG and a formal vote on the next topic.

 

The Topics SC has completed the following activities since the last EWG Meeting:

• Rankings of topics from Dec 2007 completed binning.
• Annual Horizon scan report – Dec 2008
• Long summary format finalized
• Gathered suggestions from the ESG as to their priorities for topic reviews

 

The Topics SC efforts before the next meeting

• Updating ranking of Dec 2008 HS report and complete binning in next call
• Gather next set of  suggestions from ESG as to their priorities for topics
• Formal meeting with methods SC to go through the process and formalize it.

 

The Topics SC was concerned about Information Management considering the amount of topics we are watching, the revised summary format, lots of files/folders going here and there. The Topics SC and full WG thought there was a need for a formal site/function to do this.  The CDC staff will look into using the www.egappreviews.org web site to do this.

 

Methods Subcommittee Report
Jim Haddow presented the report of the Methods SC.  The report consisted of an update on the EGAPP Update Process & Decision Modeling for selecting topics for a full evidence review.

 

The EGAPP Update Process was discussed and includes a detailed flow diagram for scanning for updates, identifying gaps in knowledge, and time intervals and reporting of information structure along with responsible parties.

 

The EWG discussed decision modeling for selection topics for a full evidence review.  A draft potential modified review process using a modeling process to identify topics that would make a topic worth reviewing.  This process addresses:

• Concept of using other evidence reviews?

• Seems to be interest in pursuing this process

• Concept of getting a rough estimate of clinical associations?
• Concept of getting an estimate of clinical utility?

 

Products Subcommittee Report
Celia Kaye presented the report of the Products SC.  The report consisted of a discussion on drafting an ESG clarification letter, vetting of topic summaries for the web site, and the ESG comments on the published recommendation statements.

 

The Products SC discussed the letter received from ESG and their response.  A letter will be drafted from the entire EWG to the CDC in response to the ESG’s letter.  In general, the CDC has to determine which roles the ESG and the EWG is responsible for completing.

 

The Products SC suggested the vetting of topic summaries for web site. 

 

In terms of the comments from the ESG on the recommendation statements, the EWG suggested the ESG identify a recommendation statement and redraft it in a manner to their liking and provide it as an example for the consideration bythe EWG. 

Closing Statement
Al Berg thanked everyone for their participation and the meeting was adjourned at 12:30pm

The next EGAPP Working Group Meeting is scheduled for Monday & Tuesday, 
June 15-16, 2009 in Atlanta.