Working Group Meeting May 24-25, 2010

Marriott Century Center, Atlanta, Georgia

 

MEETING SUMMARY

View Agenda

 

Monday, May 24, 2010

Welcome and Opening Statement
Al Berg welcomed the EGAPP Working Group (EWG) members to the meeting.  Working Group Members

 

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

 

Al Berg announced the names of two additional new WG members, Donald Lyman, MD, DTPH and Theodore Ganiats MD.

 

He introduced a third new EWG member, Nancy Fisher RN, MD, MPH from the University of Washington.  A full bio can be found on the EWG website located at www.egappreviews.org.

 

Dr. Berg reviewed a letter that was sent to Dr. Khoury and the OPHG office from the EWG and the response from Dr. Khoury.  The letter addressed the direction of the EWG and the EGAPP Initiative.

 

Dr. Berg expressed desire to resign as chair and transition to a co-chair role for the August meeting.  He thought the EWG would benefit of having a Chair and co-chair in the future.  The CDC staff will be accepting nominations for chair and co-chair in the near future from existing EWG members.

 

NOPHG and EGAPP Update
Dr. Khoury presented an update on EGAPP and NOPHG. 

 

NOPHG strategic Planning Priorities for Alignment with CDC mission

• Nations honest broker for evidence-based genomic applications to improve health
• Partner with CDC, state and other organizations to develop and implement model programs
• Use genomic tools to evaluate benefits and harms of public health interventions and assess  added value of these tools for future efforts

 

Dr. Khoury attended a meeting on Genomics at Ickworth, UK.  The key meeting topics included:

• Implications of direct-to-consumer genetic testing
• Importance of genomics for developing countries
• Unrealistic expectations surrounding the use of genomics for prediction of complex diseases
• Lack of evidence of clinical effectiveness upon which to make decisions regarding implementation
• Mounting tension between individual choice and societal responsibility
• Ethical issues surrounding the use of data; and the respective roles of public and private institutions.

 

EWG follow up from EWG February Retreat: thoughts about evolution of EGAPP

• Ramping up efforts in next 24 months (KSC, AHRQ, GAPPNet)
• Need for EWG to explore novel and rapid methods and approaches for triaging genomic applications into tiers (the problem of insufficient evidence)
• Transformation of EGAPP over next 24 months (including new chair by September, 2010)

 

EGAPP and NOPHG discussion
Al Berg led a discussion about the EGAPP Initiative and WG in relation to the NOPHG.

• Need to increase in throughput and timeframe

• It is necessary to look at the process from a process improvement standpoint.  It is critical to decrease the turnaround time while keeping the integrity of the EGAPP products.

• At the time of selecting a topic, would it be possible to triage the topic into a potential category of recommendation?
  • Push out the list of tests that should not be done and use indirect counseling
  • Maintain the integrity of the group and increase the speed of recommendations
  • Methodology needs to be defensible and thorough.

 

Status Update
Dave Dotson presented an update on the status of CDC staff projects. 

• Factor V recommendation edits need to be addressed at the meeting. 
• Multi-gene panels for breast/prostate cancer – proposals have been received and will be selected in a month.
• Topics submitted to AHRQ
• Nominations for new EWG members
• Go Grantees update
  • Oregon – evidence review on CRC and kras – hope to add to methods as well as provide an evidence review
  • Duke – evidence review on breast cancer and tamoxifen – awaiting retrospective trials
  • Penn – pilot project for evidence generation for egfr and lung cancer – not a formal evidence review.

 

Cardiovascular Disease Final Data Presentation
Glenn Palomaki presented a review of the final data from the contracted evidence review on Cardiovascular Risk Prediction Panels.  The main focus of the presentation is data support reclassifying risk categories to high or low risk effective.

 

Cardiovascular Disease Recommendation
Ned Calogne presented a final version of the cardiovascular disease risk prediction review for review by the EWG.  He opened the floor for discussion. 

 

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

 

Breakout reports

CVD report
Ned Calonge provided a report from the breakout session.  The EWG made a few changes to the recommendation statement and then voted unanimously to accept the statement as written.

 

Suggestions for external reviewers include: Eric Topol, Donna Arnet, and Tim Whilt.

 

Factor V lieden Recommendation
Jim Haddow provided a report from the breakout session.  He also reviewed the revisions suggested by the external reviewers.  All the changes were accepted.

 

Topics New Topics Report
Sue Richards led a discussion on the new topics found in the horizon scan.  A very extensive list was found some of which are duplicates.  CDC Staff will sort the topics list by disorder in order to remove and consolidate duplicates.

 

At the next meeting the Topics SC should determine which topics the Knowledge Synthesis Center should conduct reviews on.

 

Products SC report 
The chair of the Products SC has been passed to Doug Campos-Outcalt. Doug led a discussion from the Products SC breakout session.

 

Translation materials

• Producing for providers and patients (maybe for state legislature too)
• Engage with professional associations for additional materials
  • EWG materials as tools
  • EWG members can be available to answer questions or clarify language.
• NOPHG translation team can assist but we need to further discussion.
• Test cases for Factor V and for CVD for next meeting.

Considerations

• Ideal to start creating translation materials  concurrently with recommendations
  • Can we provide draft recommendations?
  • How flexible can Genetics in Medicine be with the embargo? What about other journals?
  • What can be gained by loosening the embargo? What can be lost?

Direction of the Products SC

• What are the public health implications of the EWG?
• Consideration for a Public Health related Manuscript
• What would it look like?
• Central to EGAPP Initiative.

 

Methods SC Report – Dave Veenstra
Dave Veenstra presented the report from the Methods SC.  The focus of the discussion was update on newer approach to speed process and bottlenecks and solutions. 

 

Update on newer approach to speed process

• Use existing reviews
• Evaluation clinical validity first
• Bounds estimates using modeling

Bottlenecks and solutions

• Interactions with AHRQ EPC
  • Some reviews work and others don’t
  • Increased flexibility to all midstream corrections
  • More open to communication and interactivity
  • Meeting with AHRQ, EPCs and EWG members
  • Dedicated ER group is essential to EGAPP’s success
  • We need a complete list from AHRQ of which reviews they are doing
• Quick no’s
  • Conduct a pilot test for tests with very little supporting data could lead to quick no recommendations
    • Feasible to identify these
    • What do we do with these? New recommendation statement? Can we publish on EGA?
    • CDC staff should do this project…

 

Public Comment
Pamela Seefeld, Clearwater, FL representing hospital pharmacy

• Patients (elderly, altered mental status, taking SSRI and anti-psychotics) – poor metabolism when other drugs are being taken (poly-pharmacy – drug interactions).
• 2007 decision – insufficient evidence for SSRI. 
  • What is the process for looking at a review/recommendation again? Update?
    • Want to encourage the update
  • New question including SSRI and antipsychotics together and different indication (elderly population)
• Horizon scan on literature for CYP450 and drug metabolisms (pain medications, SSRI and antipsychotics)

 

Status Reports and Closing Statement

 

Discussion on selecting a new chair
Process of selecting a new chair and co-chairs will be to have nominations from existing EWG members.  The CDC will review the nominations and select the appropriate individuals for each position.

 

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,
August 16 - 17, 2010 in Denver, CO.