Working Group Meeting August 16-17, 2010

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Denver, Colorado

MEETING SUMMARY

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EGAPP Working Group members present:

Al Berg, MD, MPH, Chair; Ned Calonge, MD, MPH; Doug Campos-Outcalt, MD, MPA; Nancy Fisher, RN, MD, MPH; Ted Ganiats, MD; James Haddow, MD; Roger D. Klein, MD, JD; Don Lyman, MD, DTPH; 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

Opening Statement

Al Berg welcomed the EGAPP Working Group (EWG) to Denver, CO and to the August EWG meeting.  He asked for introductions for new EWG members, Ted Ganiats and Don Lyman, in attendence.

EGAPP and OPHG Update

Shelley Reyes presented an update on CDC, Office of Public Health Genomics (OPHG) and EGAPP transitions.  The OPHG is now located in the Office of Surveillance, Epidemiology and Laboratory Science (OSELS).
The structure of the OPHG has changed.  There are now four teams

  • Knowledge Synthesis – Ralph Coates
  • Epidemiology and Surveillance – Nicole Dowling
  • Program Development and Implementation – Shelley Reyes
  • Communications  – Jeanette St. Pierre

Ned Calonge has been selected as the new chair of the EWG.  Nancy Fisher has been selected as the newly created co-chair of the EWG.

Status Update and Review of Briefing Book Material

Dave Dotson provided an update on the Staff activities.  The rest of the meeting agenda was reviewed.  Including:

  • The first phase of the EGAPP Evaluation will be presented by Judy Johnson.
  • A review of the current data for the Type II Diabetes Risk Prediction panels will be presented.
  • There will be several Breakout Sessions
  • The AHRQ “effective health care” program topics will be reviewed.
  • Subcommittee reports will be given
  • AHRQ funded review will only include the SNP panels for prostate cancer.  The breast cancer portion was removed due to funding.

The status of the current manuscripts was reviewed.  The CVD 9p21 meta-analysis was published in JAMA.  The outcomes manuscript was published in GIM.  The Topics and Public Health manuscripts are pending.  The CVD review and recommendation are accepted by GIM and the Factor V recommendation has been accepted by GIM.

The hits on the www.egappreviews website have been about 1-10 hits per topic page.

The EGAPP Working Group has established a working nomination pool for candidates.  Currently the pool has 46 individuals.

EGAPP Evaluation Report

Judy Johnson presented the final review of the final survey round pertaining to EGAPP CYP450 Review and Recommendation.  She reviewed the data from all participants.  She also presented a review of findings for the first round of lynch syndrome and UGT1A1 surveys thru August 2010.

Type II Diabetes

Glenn Palomaki presented a preliminary report on the Type II Diabetes Risk Prediction Review.  The report included a disorder background, treatment of Type II Diabetes and clinical scenarios to be reviewed.

There are 3 clinical scenarios to be investigated.  The first pertains to the use of a multi-gene panel to determine increased or decreased lifetime risk in non-symptomatic individuals.  The second involves the use of a either a single gene or multi-gene panel (slightly unclear on DeCode’s web site) to determine chances of progression to diabetes in an at-risk population. The third involves the use of a single gene test to determine effectiveness of sulfonylureas to control diabetes.

Glenn Palomaki, Stephanie Melillo, Michael Marrone and Michael Douglas are the primary reviewers.  The TEP includes Maggie Piper, Nancy Fisher and Doug Campos-Outcalt volunteered to join the TEP.

Methods/Topics Subcommittee

Dave Veenstra presented the report of a joint Methods SC and Topics SC breakout session whose purpose is to develop methods and processes to apply criteria to more quickly provide guidance on topics where the evidence is insufficient. It was suggested three categories of recommendation be considered to categorize topics:

  • “Do” –requires a systematic review;
  • “Don’t do” –requires a systematic review, note that the current CDC/OPHG tiers don’t include this category; and
  • Insufficient evidence – with two sub-categories below:
    • “Needs review” – these would be topics where the Topics Committee believes there may be a reasonable use but more research is needed.
    • “Not ready for review” – – these would be topics that, based on specific criteria, the Topics Subcommittee feels might likely never be useful because of lack of clinical validity data, no intervention and/or no reasonable/feasible clinical scenario.

Responsibilities and Next Steps

  • Methods SC will develop criteria for CDC Staff to conduct preliminary searches to identify the appropriate materials
  • Topics SC will make the decisions on the category and confirm the decision with the EWG
  • Topics SC will provide 6 test topics to CDC staff for consideration (10 were previously discussed and selected)
  • CDC Staff will test these and report back after receiving feedback on the methodology from the Methods SC
Translation Products Subcommittee

Doug Campos-Outcalt presented the report from the OPHG Program Development and Implementation Team and EWG Products SC breakout session.  The report includes suggestions for step-wise process, OPHG Program Development and Implementation Team and EWG interactions, Products SC and Recommendation Writing Team requirements, Review process for OPHG Program Development and Implementation Team Products, and Dissemination Plan.

The stepwise process below was agreed to between the Products SC and OPHG Program Development and Implementation Team.

  • Suggest each recommendation writing group have a member of the EWG Products SC
  • Request Draft recommendation statement to OPHG Program Development and Implementation Team.  The idea is to obtain a general direction (for, neutral, against) when available
  • Request Evidence at a Glance table from writing team (should be sent with the first recommendation statement).  See http://www.cdc.gov/genomics/gtesting/EGAPP/recommend/index.htm
  • Suggestions on emphasis in translation products from writing team from recommendation
  • Request Final Draft Recommendation Statement when submitted to GIM

The time frame to create a final set of CDC Translation Topics is:

  • 2-3 weeks to create drafts
  • 2-3 weeks for internal and Product SC review
  • 2-3 weeks for CDC clearance

General process for review of translation products from translation team

  • Products SC will receive draft of translation products from Translation Team with timeframe to provide comments
  • Products SC will provide comments within the timeframe specified
  • OPHG Program Development and Implementation Team will incorporates comments
  • OPHG Program Development and Implementation Team submits to CDC clearance/cross-clearance
  • OPHG Program Development and Implementation Team reconciles any changes from final GIM recommendation with translation product

Dissemination of Translation Products

  • Current (first 5 are consistently done)
    • CDC.gov web site
    • Weekly update (~30k subscribers)
    • Cancer control planet for cancer topics
    • EGAPPreviews.org emailing
    • Guidelines.gov
    • CDC homepage feature possible
    • Focus panels in the future
    • Collaborative groups
  • Future dissemination of Translation Products will occur in the future
AHRQ topics Submitted

Dave Dotson reviewed the topics submitted to AHRQ for evidence review.  Breast Cancer/Prostate Cancer SNPs for risk prediction was submitted as a paid review and subsequently the topic was shortened to include only Prostate Cancer SNPs for Risk Prediction.

The following topics were submitted to AHRQ’s Effective Health Care Program (EHC) for review

  • Use of PCA3 Assay in the Diagnosis of Prostate Cancer
  • Genetic Testing for CYP450 Polymorphisms to Predict Response to Clopidogrel (Plavix)
  • Analysis of Fecal DNA for Colorectal Cancer Screening and Surveillance
Topics SC Report

Sue Richards presented the report from the Topics SC breakout session.  The report included comments on topics added to the spreadsheet, the Topics Manuscript, Horizon Scanning and topics for the Knowledge Synthesis Center.

The Topics SC suggested adding to the spreadsheet

  • Color code new topics (Need to mark where old ends and the new starts)
  • Identify the latest additions to the list
  • Add the reason why some are no longer being considered

Topics SC manuscript

  • Should include methodology for identifying topics and how they are selected for review
  • Consider if a standalone article, back to back article (with methods) or combined article

Horizon Scanning

  • Need more information that what comes out of GAPP finder to prioritize topics
    • In GAPP finder, request more info in summaries and links

The soon to be funded Knowledge Synthesis Center will be responsible for 2 products relating to the Topics SC – evidence reviews, topics briefs.

Products Subcommittee

Doug Campos-Outcalt presented the report from the Product SC breakout session.  He welcomed the new subcommittee members – Nancy Fisher and Ted Ganiats. He reminded the EWG to send any abstracts they presented at meetings regarding EGAPP to Michael Douglas.

The Products SC reviewed translation products provided by the OPHG Program Development and Implementation Team.  These translation products entitled: background/summary, health professional, more health professionals, and general public; and were related to reviews/recommendations for the EWG.  Examples can be found on the CDC web site with links from www.egappreviews.org. These are an attempt by OPHG Program Development and Implementation Team to provide standardized translation products and some of the format was a result of the Cancer Control Planet collaboration.
The Products SC provided feedback specifically on the Lynch Syndrome Example.  The timeframe to develop Lynch syndrome translation products was difficult to complete due to a time intensive Health Message Testing component.  The others should be easier to complete since the structural framework is complete.
Future Translation Products Discussion emphasized the need to have a process.  Program Development and Implementation Team and EWG Products SC will work together to develop future pages in order to maintain integrity of message true to the recommendation and ensure translation products are released at the same time as reviews/recommendations.
Lynch syndrome genetic testing translation demonstration project is being hosted on September 9th by the OPHG Program Development and Implementation Team with the goal of bring together various individuals from varying backgrounds to create additional translation products for further dissemination.  The EWG suggested ensuring a pathologist(s) is in attendance.

Methods Subcommittee Report

Dave Veenstra presented the report from the Methods SC breakout session.  The report included: observations on a recent AHRQ call, AHRQ topics, and revised EGAPP evaluation framework testing, and test cases for using existing reviews.

The Methods SC had a conference call with AHRQ to discuss the option for reviews to be completed through the Effective Health Care review process.  The outcomes include:

  • Not possible to assign a designated EPC
  • EWG members can participate in AF/KQ, Kickoff calls, TEPs, peer review
  • Similar interactions to that of past reviews
  • Other stakeholders may participate in review process
  • The Methods SC thought it might not be beneficial to identify ourselves (EWG) as stakeholders in each EHC topic without assurance to obtain the thorough and complete report to address all of their questions.
  • It was suggested to:
    • No plan for more commissioned reviews through AHRQ
    • Limit EHC submissions to ~ 5 reasonably good ones with full AF/KQs
    • Monitor EHC topics submission website regularly to see if genetics related topics from other groups/individuals are proposed and/or selected

Knowledge Synthesis Center topics may be able to be used in a revised EGAPP evaluation framework testing.  These methods may include:

  • Use of existing reviews
  • Often very limited data – use to make rapid “no’s”
  • Modeling techniques to assess plausibility of clinical utility

Cases to test framework for other existing reviews may include the following:

  • CYP2D6 and tamoxifen
    • Recent AHRQ review
    • Duke GO project
    • Use review, slight update, give recommendation
  • KRAS/BRAF in CRC
    • Oregon GO Project
  • EGFR/Lung Cancer
    • Penn GO project
  • Array cGH
    • Limited evidence from BCBS Tec statement, challenging review
Adjourn

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,
December 6 – 7, 2010 in Atlanta, GA.