In response to the public health burden that food allergy presents in the United States, NIAID worked with 34 professional organizations, federal agencies, and patient advocacy groups to develop the Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-sponsored Expert Panel. The guidelines are intended to provide healthcare professionals with concise recommendations on the diagnosis and management of food allergy and the treatment of acute food allergy reactions. Below are answers to some frequently asked questions about the guidelines.
"Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" (Institute of Medicine, 1990). Guidelines define the role of specific diagnostic and treatment methods in the diagnosis and management of patients. The statements contain recommendations that are based on evidence from a rigorous systematic evaluation of the published medical literature and may also rely on clinical expert opinion. The purpose of guidelines is to help clinicians and patients make appropriate decisions about healthcare. Guidelines attempt to do this in the following ways:
- Describing a range of generally accepted approaches for the diagnosis, management, treatment, or prevention of specific diseases or conditions
- Defining practices that meet the needs of most patients in most circumstances
The recommendations are not fixed protocols that must be followed. Responsible clinicians’ judgment on the management of patients remains paramount. Clinicians and patients need to develop individual treatment plans that are tailored to the specific needs and circumstances of the patient.
Guidelines are primarily intended for use by clinicians, physicians, nurses, managed care organizations and other groups that define benefit plans for patients or handle healthcare resources, and other health professionals.
Food allergy affects adults and children in the United States and appears to be increasing in prevalence. Food allergy is associated with severe allergic reactions and is the most common cause of emergency room visits for anaphylaxis. Even though persons with food allergies attempt to avoid known allergens, reactions from unintentional exposure are relatively common.
Despite the risk of severe, potentially life-threatening allergic reactions, there is no current treatment other than allergen avoidance and treating the symptoms associated with severe reactions. Moreover, the diagnosis of food allergy may be problematic given that non-allergic food reactions, such as food intolerance, are frequently misclassified as food allergies.
On March 13-14, 2006, at the request of Congress, an expert panel of national and international food allergy experts was convened by NIH on behalf of the HHS Secretary to address issues in food allergy research. In its report, the panel examined the current state of NIH-funded food allergy research and developed and prioritized a list of recommendations to the HHS Secretary on key opportunities and research directions.
The decision to develop the guidelines came from a one-day workshop entitled “Guidelines for the Diagnosis and Management of Food Allergy,” co-organized by NIAID, the American Academy of Allergy, Asthma & Immunology, and the Food Allergy & Anaphylaxis Network. Held in July 2007, this workshop brought together representatives from more than 20 professional organizations, patient advocacy groups, and several NIH Institutes.
The primary purpose of the workshop was to determine the need for clinical guidelines on the diagnosis and management of food allergy and acute food allergy reactions that could be used in a variety of healthcare settings. The participants agreed that there was a significant need for such guidelines, and recommended a process to bring this concept to fruition. In addition, the participants recommended that a coordinating committee be established to provide oversight, to review the draft guidelines, and to approve the final version of the guidelines. The coordinating committee would also develop a plan for disseminating the final guidelines.
The guidelines provide 43 concise clinical recommendations for healthcare professionals on how to diagnose and manage food allergy and how to treat acute food allergy reactions. They also identify gaps in the current scientific knowledge to be addressed through future research. The guidelines contain an introduction and five additional sections that address the following major topics:
- Definitions, prevalence, and epidemiology of food allergy (Section 2)
- Natural history of food allergy and associated disorders (Section 3)
- Diagnosis of food allergy (Section 4)
- Management of non-acute food allergic reactions and prevention of food allergy (Section 5)
- Diagnosis and management of food-induced anaphylaxis and other acute allergic reactions to foods (Section 6)
The guidelines are not an official regulatory document of any U.S. government agency.
The guidelines are intended as a resource to guide clinical practice and help with developing educational materials for patients, their families, and the public. The goal of the guidelines is to bring existing knowledge from the scientific literature together with clinical expert opinion to generate recommendations for use by healthcare professionals. The guidelines focus on immunoglobulin E (IgE)-mediated reactions to food, as well as some non-IgE-mediated reactions to food. The recommendations in the guidelines are not fixed protocols that must be followed. Clinical judgment regarding the management of individual patients remains paramount.
In summary, the guidelines do the following:
- Provide 43 concise recommendations to a wide variety of healthcare professionals on how to diagnose food allergy, manage ongoing food allergy, and treat acute food allergy reactions
- Identify gaps in the current scientific knowledge to be addressed through future research
- Identify and provide guidance to help standardize patient management
The guidelines do not address celiac disease. Although celiac disease is an important immunologic, non-IgE-mediated reaction to food, it is not discussed in detail because clinical guidelines for celiac disease have been previously published and were not re-evaluated in this project:
- American Gastroenterological Association (AGA) Institute Medical Position Statement on the Diagnosis and Management of Celiac Disease
- AGA Institute Technical Review on the Diagnosis and Management of Celiac Disease
- Guideline for the Diagnosis and Treatment of Celiac Disease in Children: Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition
The guidelines also do not address the clinical management of food allergy in public spaces (e.g., schools, restaurants) and related public health issues. A discussion of healthcare public policy as it relates to food allergy is beyond the scope of this effort.
These guidelines are intended to assist various healthcare professionals (physicians, nurses, and others) in making appropriate decisions about patient care. They are designed for both generalists and specialists in areas such as allergy, pediatrics, family medicine, internal medicine, dermatology, gastroenterology, emergency medicine, pulmonary, and critical care medicine.
The following three documents are available free-of-charge to view or download on the NIAID food allergy guidelines home page:
- Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-sponsored Expert Panel
- Guidelines for the Diagnosis and Management of Food Allergy in the United States: Summary of the NIAID-sponsored Expert Panel Report
- Guidelines for the Diagnosis and Management of Food Allergy in the United States: Summary for Patients, Families, and Caregivers
Healthcare professionals are the intended audience of these guidelines, but patients and their families are the ultimate beneficiaries. The guidelines will enable healthcare professionals to diagnose food allergy and develop treatment plans that are tailored to the specific needs and circumstances of each patient. In addition, NIAID adapted the guidelines into a patient- and family-friendly document that explains food allergy diagnosis and management. The goal of creating such a document is to educate patients and families so they are better able to understand and discuss healthcare decisions in partnership with their healthcare professionals.
One of the important outcomes of the guidelines development process was identifying gaps in the current scientific knowledge of food allergy. NIAID plans to use this information to guide the development of future funding initiatives for food allergy research.
The Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-sponsored Expert Panel were based on an independent, systematic review of the scientific literature, supplementary documents identified by the expert panel charged with writing the guidelines, and consensus expert opinion.
NIAID established a coordinating committee to oversee development of the guidelines; review drafts of the guidelines for accuracy, practicality, clarity, and broad utility of the recommendations in clinical practice; and help disseminate the final guidelines.
NIAID also contracted with the RAND Corporation to conduct a systematic literature review on the state of the science in food allergy.
The coordinating committee identified and approved a 25-member expert panel responsible for using the systematic literature review and their expert clinical opinions to develop draft guidelines for review by NIAID, the coordinating committee, and the public.
In October 2009, the expert panel discussed the first written draft version of the guidelines and their recommendations. Following the meeting, the expert panel incorporated any panel-wide changes to the recommendations within the draft guidelines. These revised recommendations were then subject to an initial panel-wide vote. Following discussion and revision as necessary, a second vote was held. All recommendations that received 90 percent or higher agreement were included in the draft guidelines for review by the coordinating committee and public review and comment.
The draft guidelines were posted on the NIAID Web site in March 2010 for a period of 60 days to allow for public review and comment. More than 550 comments were collected and reviewed by the expert panel and NIAID. The expert panel revised the guidelines in response to some of these comments. All new recommendations were subjected to a panel-wide vote and achieved 90 percent consensus or more.
The expert panel submitted the draft guidelines to the coordinating committee and NIAID for review and finalization. The final Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-sponsored Expert Panel were published and made publicly available in December 2010.
A literature review focuses on peer-reviewed medical journals in a variety of databases, such as the MEDLINE database, the Cochrane Database of Systematic Reviews, the Cochrane Database of Abstracts of Reviews of Effects (DARE), the Cochrane Central Register of Controlled Trials (Central), and in other peer-reviewed journals that may not be included in such databases.
When non-primary literature is used, it is accompanied by justification and reflected in the grading of the evidence. Non-primary literature is defined as review articles, meta-analyses, and data collected for other purposes or from other sources (i.e., industry surveys, compilations from computerized databases and information systems, and results from computerized or mathematical models).
Topics for the literature review are identified to guide the search, and limits on the age of articles searched may also be identified. The search for articles for the food allergy guidelines literature review was limited to articles published in 1988 and later.
The evidence can be reported in several forms. Evidence tables are prepared for selected topics and include detailed descriptions of identified studies. For topics that do not have a sufficient body of evidence or a sufficient number of high-quality studies, an evidence table is not generated. Narrative text is also used to summarize the findings and can give a qualitative analysis of the key questions and topic areas.
The data is evaluated and graded based on factors such as study relevance, bias, study design, 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 is the result of such a literature review.
NIAID and the expert panel developed an extensive set of key questions that were further refined in discussions with the RAND Corporation. Literature searches were performed using databases of biomedical articles from life science and medical journals, including PubMed, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and the World Allergy Organization Journal.
RAND screened more than 12,300 titles, reviewed more than 1,200 articles, abstracted nearly 900 articles, and included 348 articles in the final RAND report. Data were abstracted and incorporated into a full report on the state of the science in food allergy.
On September 26, 2008, NIAID awarded a contract to the RAND Corporation to conduct a systematic literature review and evidence based report on food allergy.
The key questions used to perform the literature review included:
- What is the definition of food allergy?
- What are the incidence/prevalence of IgE-mediated food allergy and immunologic but non-IgE-mediated adverse reactions to food?
- What are the symptoms and natural history of IgE-mediated and of immunologic but non-IgE-mediated adverse reactions to food?
- What tools are currently used to diagnose IgE-mediated and non-IgE-mediated food allergies?
- What methods are currently used to manage patients diagnosed with IgE-mediated food allergy?
- What methods are currently used to manage patients diagnosed with non-IgE-mediated reactions to food, and how do they differ from methods 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?
A complete list of the questions used to perform the literature review is available as part of the final literature review.
NIAID established a coordinating committee to oversee the development of the guidelines; review drafts of the guidelines for accuracy, practicality, clarity, and broad utility of the recommendations in clinical practice; review the final guidelines; and assist with the dissemination of the guidelines. Members were from 34 professional organizations, advocacy groups, and federal agencies, and each member was vetted for financial conflict of interest by NIAID staff.
The coordinating committee convened an expert panel in March 2009 that was chaired by Joshua Boyce, M.D., of Brigham and Women's Hospital in Boston. Panel members were specialists from a variety of relevant clinical, scientific, and public health areas. Each member was vetted for financial conflict of interest by NIAID staff and approved by the coordinating committee.
The charge to the expert panel was to use an independent, systematic literature review, in conjunction with consensus expert opinion and panel-identified supplementary documents, to develop guidelines that provide a comprehensive approach for diagnosing and managing food allergy based on the current state of the science.
RAND Corporation prepared an independent, systematic literature review and evidence report on the state of the science in food allergy. NIAID and the expert panel developed an extensive set of questions and topics for the literature review, which were further refined in discussions with RAND.
The public also contributed to development of the guidelines. The draft guidelines were posted to the NIAID website in March 2010 for a period of 60 days to allow for public review and comment. More than 550 comments were collected and reviewed by the coordinating committee, the expert panel, and NIAID. The expert panel revised the guidelines in response to some of these comments.
The coordinating committee included representatives from 34 professional organizations, patient advocacy groups, and federal healthcare agencies, including NIAID. The expert panel included 25 specialists from a variety of relevant clinical, scientific, public health, and policy areas. A complete list of coordinating committee and expert panel members appears in the published guidelines.
Members of the coordinating committee and expert panel submitted voluntary written statements on relevant significant financial interests to NIAID for review. NIAID staff reviewed this information to ensure that no participants had financial conflicts that precluded them from serving and to determine whether any members needed to remove themselves from the drafting/approving of one or more specific recommendations because of a real, potential, or perceived conflict of interest.
Expert panel members with perceived conflicts of interest were requested to remove themselves from voting on any recommendations relevant to the conflicted topic.
In addition to performing the systematic literature review, RAND advised the coordinating committee, expert panel, and NIAID on search strategies, standard methodology for literature reviews and guidelines, and recommendations on the use of the final systematic literature review.
The expert panel used the terms “recommends” or “suggests” in each clinical guideline. These words convey the strength of the guideline and the evidence that underpins it, defined as follows:
- The term “recommends” is used when the expert panel strongly recommended for or against a particular course of action.
The term “suggests” is used when the expert panel weakly recommended for or against a particular course of action.