Working Group Meeting February 1-2, 2010

Horton Grand Hotel, San Diego, California

 

MEETING SUMMARY

View Agenda

 

Welcome and EGAPP Future
Muin Khoury welcomed the EGAPP Working Group (EWG) members to the meeting.  He presented on EGAPP topics for review, Comparative Effectiveness Research Network, AHRQ process, OPHG and CDC’s organizational structure, GAPPNet, and plans for an online journal.

 

EGAPP Working Group members present included:

Al Berg, MD, MPH, Chair; Ned Calonge, MD, MPH; James Haddow, MD; Roger D. Klein, MD, JD; Kenneth Offit MD, MPH; Stephen Pauker, MD, MACP, FACC, ABMH; Margaret Piper, PhD, MPH; Sue Richards, PhD, FACMG; Joan Scott, MS, CGC (via telephone); Ora Strickland, PhD; and David L. Veenstra, PharmD, PhD

 

EWG choice of topics should effect larger segments of the population and focus on prevention and early detection. 

NCI is funding a 2 year project on comparative effectiveness research in genomics and personalized medicine and some of the studies will involve systematic reviews which could benefit from EWG involvement.

 

AHRQ is supportive of the EWG submission of topics for review in their Effective Health Care Program. 

 

OPHG will continue to fund knowledge synthesis to support EWG and GAPPNet. 
The development of an online journal is being supported by OPHG.

 

Welcome and Retreat Focus/Goals
Al Berg welcomed the EWG members and outlined the focus/goals of the retreat, which included consideration of::

• EWG’s current role,
• Opportunities in the comparative effectiveness research network,
• Opportunities for additional AHRQ reviews, and
• Future of the EWG.

 

Welcome and opening statement
Al Berg called the EWG meeting to order.

 

Since 3 members have rolled off the group, votes from 9 of the remaining 13 members would constitute a quorum of two thirds. 

 

Status Update
Dave Dotson provided an update from the staff.  The update included information on pending manuscripts, reports, recommendations and EWG recruitment.

 

The CVD report will be undergoing peer review.

 

The CVD and Factor V recommendations will be discussed today and target dates set for peer review, and submission to Genetics in Medicine.

 

The EWG Outcomes manuscript was published online-ahead-of-print in Genetics in Medicine.

 

The chosen topic, Testing for CYP2D6 Polymorphisms in Pre- or Postmenopausal Women to Inform Use of Tamoxifen in Breast Cancer Treatment or Prevention, was submitted to AHRQ for a full evidence review.  However, this topic has been the subject of a recent evidence review conducted by an AHRQ EPC.  CDC Staff is comparing the Analytic Framework and Key Questions developed by the EWG and those already conducted by the EPC.  Some of the key questions were answered but others were not.  A full review is not needed and the EWG decided to wait until the next CU studies come out and then request an update to the review.  The EWG decided we should request a change of topic for the review for AHRQ.  The topics available were discussed and the EWG suggested the submission of the Breast and Prostate Cancer risk assessment using SNP panels.    

 

The CDC Staff has been busy with the EWG recruitment for new members.  There are 51 unique nominees being considered and selections will be focused on the following areas – ethics, public health, public health practice, evidence-based methodologies, epidemiology, and policy.  The selection of the new EWG members should be reflective of goals for the upcoming year(s).  For future nomination requests the specialty pool could be increased by sending the nominee request to additional specialty organizations. Selections should be made by mid-February and notifications sent to those selected by the end of February.

 

It was decided that in order to promote stability within the group, scheduled roll-offs would be halted until further clarity has been established on the future roles and responsibilities of the EWG.   Individuals may still resign from the panel if they have other reasons to do so.

 

The near future goals for EGAPP are:

• To work on a number of methods issues that could further the science behind evidence-based medicine
• To finish the ongoing reviews and add new review(s) that would add value in the refinement of EGAPP methodology.
• To consider what comes next in order to further develop recommendations.

 

The next EWG meeting will be held in Atlanta, GA.  A request for availability for the May/June and August/September timeframes has been sent.

 

Topics
Sue Richards led a discussion on Topics to be submitted to AHRQ’s Effective Health Care Program.  One suggestion was an AHRQ EPC review on CRC and KRAS/BRAF.  Topics of new interest for CDC staff to develop or update topic summaries on include:

• Markers for lung cancer in smoking
• BRAF testing for melanoma
• Age-related macular degeneration testing
• Scoliosis testing
• Fetal abnormalities
• miRNA testing for several cancers
• CRC and fecal DNA testing
• PCA3 and prostate cancer

 

The Oregon EPC is conducting a review on KRAS/BRAF and CRC.  Sue Richards and Ned Colonge are serving on the project as consultants.  Some facts on the review include:

• Review would meet EGAPP’s requirements for making a recommendation
• AF is fairly complete and includes a  frame work for intermediate outcomes
• Key questions include both KRAS/BRAFapproached inversely. 
• Good example of a large amount of studies (retrospective) came out and the clinical community turned on a dime.  The overarching question has been answered for KRAS.

 

To what degree could EGAPP be involved in the reviews for the awardees of the Comparative Effectiveness Research Network (CERN)?

• CERNs would like to connect with EGAPP again in the future about planned work in developing/extending systematic review methods in genomics.
• EGAPP would like to be involved, then conduct any supplements to the review and make a recommendation on this topic.
• This would be a good way to test alternative approaches using an outside review. 

 

Breakout Sessions
Al Berg charged the EWG with carrying out the objectives of each of the breakout sessions.  The two breakout sessions are Cardiovascular Disease recommendation and Factor V recommendation.

 

Factor V Recommendation Report
The EWG voted on consensus to the wording changes in the Recommendation Statement.  The vote was 9 unanimous in favor of the changes as described.  The EWG suggested the changes be made and the recommendation statement be sent to external reviewers.

 

CVD Recommendation Report
The EWG discussed some editorial changes to clean up the language throughout the manuscript and tables.  The EWG voted on consensus to the wording changes in the Recommendation Statement.  The vote was 9 unanimous in favor of the changes as described.  The EWG suggested the changes be made by Ned Calonge, the head of the writing group, followed by it being sent to external reviewers.

 

Process to manage AHRQ Topics
The EWG will be submitting topics to the AHRQ Effective Health Care Program for reviews.  These reviews are not paid but are suggested topics for their review.  The more details we can send to AHRQ the better.  The Topics SC suggested a call to select new topics for review.

 

The EWG made the following suggestions and selected point persons to develop the analytic framework and key questions in conjunction with CDC Staff, who will contact the point person:

• cGH array and developmental delay – Sue Richards
• fecal DNA testing and colon cancer– Ken Offit
• CYP450 and pain management with codeine –Jim Haddow
• CYP2C19 and Plavix – Dave Veenstra
• PCA3 and prostate cancer – Ned Calonge
• BRAF Testing and melanoma – Roger Klein

 

Outline of letter to OPHG and Steering Committee
The EWG reviewed a draft letter summarizing the outcomes of the EWG Retreat held the previous day.  Al Berg is going to polish the language and then send to the full EWG for comment prior to sending to OPHG leadership and EGAPP Steering Committee.

 

Liability Insurance
The EWG members reviewed the policy and no red flags came up.  CDC Staff will explore and report back on coverage limit options.

 

Wrap up

The EWG meeting was successful in finalizing the Factor V and CVD recommendation statements.  The retreat letter will be good to address the current status of the EWG and the EGAPP Initiative.

The next EGAPP Working Group Meeting will be held on
May 24-25, 2010 in Atlanta, GA.