Implementing GRADE in Guideline Development: Real-World Experiences (Text Version)

On September 15, 2009, Dr. Matthew Fenton made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (122 KB) (Plugin Software Help).

Slide 1

Implementing GRADE in Guideline Development: Real-World Experiences
NIAID Guidelines for the Diagnosis and Management of Food Allergy

Dr. Matthew Fenton
Asthma Allergy & Inflammation Branch
DAIT, NIAID, NIH
September 15, 2009
 

Slide 2

Food Allergy Guidelines: Background

• July 2007 workshop assessed the need for clinical guidelines that could be used by health care providers across various medical specialties.
• More than 30 professional organizations, federal agencies, and advocacy groups unanimously agreed that NIAID should develop the guidelines.
• Guidelines should be developed using both evidence-based data and expert opinion.
• Wide dissemination of the guidelines by participating organizations would be needed.

Slide 3

Food Allergy Guidelines: Process Overview

• Literature Review and Evidence Grading (RAND Corp.)
  • Comprehensive literature search
  • Prepares evidence tables
  • Assesses quality of body of evidence using GRADE
• Expert Panel (Chair: Dr. Joshua Boyce)
  • Drafts the guidelines based on RAND's literature review and expert clinical opinion
  • Identifies both knowledge gaps and areas of agreement*
• Drafting, Review and Final Guidelines
  • Guidelines draft prepared by the Expert Panel to be edited based on Coordinating Committee# review and public comment

*across medical specialties
#Committee comprised of professional organizations, Federal agencies, and advocacy groups

Slide 4

Guidelines Timeline

• July 2007: Meeting highlighting the need for Guidelines
• September 2008: First meeting of the Coordinating Committee & award of RAND contract for evidence based review
• July 2009: First draft of RAND report given to Expert Panel
• October 2009: Expert Panel meets to review first draft of the guidelines
• Dec 2009: Final draft of Expert Panel guidelines to be completed and forwarded to the Coordinating Committee
• Jan-Feb 2010: 60 day public comment period
• May 2010: Final guidelines document ready for release

Slide 5

Food Allergy Guidelines: Implementing GRADE

• Training the Expert Panel Members
  • Dissemination of papers from the GRADE Working Group
  • GRADE presentation at March 18, 2009 Expert Panel Kick Off Meeting
  • Ongoing discussion to refine recommendations for grading/strength
  • RAND provides additional training

Slide 6

Food Allergy Guidelines: Implementing GRADE (Cont'd)

• Preliminary Scoring plan:
  • 5 distinct writing groups to prepare guidelines "chapters"
  • Each small group will propose the strength of a recommendation based on RAND evidence and expert opinion using GRADE
  • Vote by entire EP upon integration will determine final grading strengths
• Tentative plan to assess agreement by Panel members
  • Each section of the guidelines will contain a "agreement" score to compliment the evidence grade and recommendation strength
    • Uniform (100% agree), Substantial majority (80%), majority (50-80%), No agreement (<50%)
    • Agreement will be assessed upon integration of the 5 guideline chapters using the GRADE grid

Slide 7

Food Allergy Guidelines & GRADE: Potential Difficulties

• Nature of food allergy and state of the science
  • Few DBPC clinical trials (ethical issues)
  • No existing treatments for food allergy
  • Relatively few population-based studies
  • Reported trials use different endpoints
  • Potential population & environmental differences

Slide 8

Food Allergy Guidelines & GRADE: Potential Difficulties

• Difficult to rate some evidence highly, leading to a lack of strong recommendations
  • Example: Oral food challenge as a study endpoint
    • Oral food challenges, the gold standard for food allergy diagnosis, can be very risky for those with severe food allergies
    • Many clinical trials use oral preparations to desensitize patients, but, to minimize risk, do not use oral food challenge as the endpoint to test the success of the intervention
    • Such studies are not considered the highest quality, due to lack of the gold standard endpoint
    • Does GRADE work where the body of evidence is considered weak, but expert opinion is strong?