Implementing GRADE in Guideline Development: Real-World Experiences

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

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.

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

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

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

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

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

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?