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Questions on the 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 sections that address the following major topics:
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.
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:
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:
Printed copies of the summary report and summary for patients, families, and caregivers may be ordered online through the NIAID Publication Order Form.
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.
Questions on the guidelines development process
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.
The public was invited to submit comments and questions on the draft guidelines during a public review period, which began on March 5, 2010, and closed on May 6, 2010. These comments were distributed to the expert panel to consider during revision of the draft guidelines.
The expert panel wrote, discussed, and voted on the draft guidelines; revised them based on responses made during the public comment period; and submitted them to the coordinating committee and NIAID for review and finalization.
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.
View or download the literature review.
The coordinating committee included representatives from 34 professional organizations, patient advocacy groups, and federal healthcare agencies, including NIAID. View the complete list of coordinating committee representatives.
The expert panel included 25 specialists from a variety of relevant clinical, scientific, public health, and policy areas. View the complete list of expert panelists.
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. See the financial and other disclosures for the expert panel and coordinating committee.
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.
Read about the contractor conducting the literature review for additional information on RAND’s role.
The expert panel has 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:
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Questions on the public comment period
Public comments were sought from both the scientific community and the general public on the draft Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report by the NIAID-sponsored Expert Panel.
All submitted comments received by the closing date were compiled and sorted by topic. Comments that had the potential to add value and utility to the draft guidelines were given priority and distributed for consideration to three groups―the expert panel, the coordinating committee, and NIAID.
These three groups decided which ideas warranted a modification to the guidelines document.
Comments related to public health policies for food allergy management in schools and public places, NIAID research funding policies, and celiac disease were not considered because these topics are beyond the scope of the guidelines.
Personal information of individuals submitting comments (name, e-mail address, affiliation) was not forwarded to the three groups listed above. Thus, the final document does not list names of individuals who submitted comments, irrespective of whether their submitted comments were used to modify the document.
The public comment period lasted for 60 days after the draft guidelines were made available for review. This period extended from March 8, 2010, to May 6, 2010.
Following an editing period, the finalized guidelines were made publicly available in December 2010. A summary of the guidelines, highlighting the clinical recommendations, was released at the same time. View or read the complete guidelines and the summary guidelines.
In addition, NIAID developed a summary of the complete guidelines for patients, families, and caregivers. This summary highlights the most important information from the guidelines for a lay audience and provides a starting point for patient-doctor conversations about food allergy. View or read the summary.
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Last Updated February 16, 2012