Clinical Practice Guidelines
The development of clinical guidelines for the diagnosis and management of food allergies is based on a systematic review of the scientific and clinical literature, as well as consensus expert opinion. The steps used to develop Guidelines for the Diagnosis and Management of Food Allergy include:
Literature Review and Ranking of Evidence
- completing a comprehensive search of the literature to include an in-depth review of relevant abstracts and articles;
- preparing evidence tables to assess the weight of current evidence with respect to new and unresolved issues;
- ranking and grading the strength of evidence underlying the recommendations that are made;
- discussing and interpreting the literature review findings;
- analyzing the literature review, and as needed, providing expert opinion;
- identifying both knowledge gaps and areas of consensus;
Drafting, Review, and Final Report
- circulating a draft of the draft guidelines for review by the Coordinating Committee, as well as making the draft guidelines available for public comment;
- preparing a final report based on consideration of comments raised in the review process.
Literature Review and Ranking of Evidence
The NIAID plans to use an independent, systematic literature review and report on the state of science in food allergy, in conjunction with consensus expert opinion, to develop clinical guidelines for the diagnosis and management of food allergy.
The literature review will focus on peer reviewed medical journals in the MEDLINE database. In cases where non-primary literature is used (non-primary literature is defined as review articles, meta-analyses, data collected for other purposes or from other sources, including industry surveys, compilations from computerized databases and information systems, results from computerized or mathematical models) it will be accompanied by justification and reflected in the grading of the evidence.
Evidence tables will be prepared for selected topics. It will not be feasible to generate evidence tables for every topic in the guidelines and many topics do not have a sufficient body of evidence or a sufficient number of high-quality studies to warrant the preparation of a table.
The data will be evaluated and graded based on factors such as study relevance, bias, study size, applicability to the majority population, and data quality. A report summarizing the state-of-the-science, including knowledge gaps and areas in which consensus has not been reached will guide the formulation of the clinical guidelines.
On September 26, 2008, the NIAID awarded a contract to the RAND Corporation based on its response to RFQ NIH AI2008035, “Systematic Literature Review and Evidence Based Report on Food Allergy.”
RAND Health, a division within the RAND Corporation, includes the Southern California Evidence-Based Practice Center (EPC), which conducts systematic reviews and technology assessments of all aspects of health care, performs research on improving the methods of synthesizing the scientific evidence, developing evidence reports and technology assessments, and provides technical assistance to other organization in their efforts to translate evidence reports and technology assessments into guidelines, performance measures, and other quality-improvement tools. The Southern California Evidence-Based Practice Center (EPC) has 10 years of experience in this field, and has performed work for clients including the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs (VA).
The principal investigator on the contract is Dr. Paul G. Shekelle, MD, PhD, an internationally recognized expert in the fields of practice guidelines and meta-analysis. Dr. Shekelle has experience leading dozens of systematic reviews and meta-analyses.
Topics for Literature Review
Define: Food allergy.
- What definitions of food allergy are currently being used?
- Describe conditions which are described as non-immunologic adverse reactions to food.
- Describe conditions which are described as immunologic, but not IgE-mediated, adverse reactions to food.
- Describe conditions which are described as immunologic and IgE-mediated adverse reactions to food (and which are considered by some authorities to be equivalent to food allergy).
- Compare adverse reactions to food which are non-immunologic, immunologic and not IgE-mediated, and immunologic and IgE-mediated.
What is the prevalence of IgE-mediated food allergy?
- What is the prevalence of IgE-mediated food allergy in the pediatric and adult populations? Provide a comparison.
- Describe the prevalence of IgE mediated allergy to specific foods in the pediatric and adult populations.
- What is the prevalence of co-morbid conditions among the food allergic population? Co-morbid conditions should include, but are not limited to, atopic dermatitis, asthma and eosinophilic gastroenteritis.
What is the prevalence of immunologic, but non-IgE-mediated adverse reactions to foods?
- What is the prevalence of immunologic but non-IgE-mediated adverse reactions to food in the pediatric and adult populations? Provide a comparison.
- Describe the prevalence of immunologic but non-IgE-mediated adverse reactions to specific foods in the pediatric and adult populations
- What is the prevalence of co-morbid conditions among this population?
What is the natural history of IgE-mediated food allergy?
- Describe the natural history of IgE-mediated food allergy in the pediatric and adult populations. Provide a comparison.
- What is the relationship between IgE-mediated food allergy and co-morbid conditions such as, but not limited to, atopic dermatitis, asthma, and eosinophilic gastroenteritis?
- Where do health disparities in the food allergic population exist?
What is the natural history of immunologic but non-IgE-mediated adverse reactions to food?
- Describe the natural history of immunologic but non-IgE-mediated adverse reactions to food in the pediatric and adult populations. Provide a comparison.
- What is the relationship between immunologic but non-IgE-mediated adverse reactions to foods and co-morbid conditions?
- Where do health disparities in this population exist?
What tools are currently used to diagnose IgE-mediated food allergy?
- Patient history and physical examination
- Total serum IgE as a diagnostic test
- Immediate skin testing (for IgE antibody)
- In vitro testing: (specific IgE antibody levels in serum [including different tests of specific IgE antibody], basophil histamine release)
- Elimination diets used for diagnosis
- Oral food challenges used for diagnosis
Additional diagnostic tests besides the ones listed above
Diagnostic tools used by different groups of doctors to make the diagnosis of food allergy (primary physicians and physicians from several different specialties)
- Foods used
- Method of challenge
- Criteria for positive and negative result
What tools are currently used to diagnose immunologic but non-IgE-mediated adverse reactions to food, and how is a differential diagnosis made?
What approaches are currently used to manage patients diagnosed with IgE-mediated food allergy?
- Dietary avoidance (including cross-reacting allergens and issues of breast feeding and delay of solids)
- What is the effect of delayed introduction of allergens into an infant’s diet on the development of, and clinical course of, food allergy?
- What is the effect of breast feedings infants on the development of, and clinical course of, food allergy?
- What is the effect of delayed introduction of solid foods into an infant's diet on the development of, and clinical course of, food-allergy?
- Do different recommendations on strictness of allergen avoidance affect clinical course of food allergy?
- How effective are current standards for food labeling for prevention of food allergic reactions?
- What are the allergenic cross-reactivities (with other foods or non-food allergens) of foods (i.e. other legumes in peanut allergic patients, tree nuts in peanut allergic patients, etc)? What are the clinical consequences?
- What are the recommendations by professional organizations regarding the avoidance of allergens (food and non-food) by people with food allergy?
- What are effects on co-morbid conditions such as, but not limited to, atopic dermatitis, asthma, and eosinophilic gastroenteritis, of food allergen avoidance or other approaches to manage food allergy.
What methods are currently used to manage patients diagnosed with non-IgE-mediated reactions to food?
- How do these methods differ from those used to manage patients diagnosed with IgE-mediated food allergy?
What are the appropriate methods of diagnosis and treatment of acute and life-threatening, IgE-mediated food allergic reactions?
- Describe symptoms and diagnostic tests that distinguish food-induced acute allergic reactions and anaphylaxis from asthma or other diseases within the differential diagnosis.
- What are differences on the severity and ultimate outcome of acute food allergic reactions, of administration of epinephrine auto-injections by self administration vs. by a bystander?
- What are the effects of medication administration by different patient care personnel (e.g., trained ambulance personnel vs. untrained EMTs vs. personnel in hospital emergency rooms, etc.) on the severity and ultimate outcome of acute food allergic reactions?
- What is the time course of acute food allergic reactions, and what are the effects of delays between onset of acute food allergic reaction and seeking medical care on the severity and ultimate outcome of acute food allergic reactions?
- What medications treat or prevent delayed or biphasic food allergic reactions?
- Describe all medications used to treat acute food allergic reactions, including their documented effectiveness in treating specific symptoms.
Creation of an Expert Panel
The NIAID will establish an Expert Panel that includes representation by specialists in a variety of relevant clinical, scientific, public health, and policy areas. The panel will develop draft Guidelines for the Diagnosis and Management of Food Allergy. The panelists will use both the evidence-based report and consensus expert opinion as the basis for developing draft guidelines.
Review and Oversight by a Coordinating Committee
The NIAID has established a Coordinating Committee to oversee the process of guidelines development, to provide advice to NIAID throughout the process, to review the guidelines draft(s), and to approve the final version of the guidelines. The Coordinating Committee will review the drafts for accuracy, practicality, clarity, and broad utility of the recommendations in clinical practice. The Coordinating Committee will also develop a plan for the dissemination of the final guidelines.
Coordinating Committee members are professional organizations, advocacy groups, and Federal agencies who appoint one or more representatives to serve on the committee. Each organization, group, or agency holds a single voting position on the committee.
Public Review and Comment
Draft guidelines will be made available for public review and comment prior to completing the final guidelines. The NIAID, Coordinating Committee, and Expert Panel will consider the comments and recommendations from the public and make changes, as appropriate, that add value and utility to the draft guidelines.
The Expert panel will develop the final set of guidelines based on its review of the draft guidelines, public comment, and endorsement by the participating organizations. The final guidelines will be disseminated to healthcare practitioners and the public by the NIAID and the participating organizations.
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