Food allergy quality of life questionnaires (FAQLQ) are the most common instruments used in food allergy research to assess health-related quality of life (HRQL). With the increase in food allergy treatment trials, it is important to determine which items within the FAQLQ are most and least useful in this context. We sought to assess which items of the FAQLQ-child form (CF) were most discriminative, using item response theory (IRT), which examines relations between item responses and underlying construct (in this case, HRQL). METHODS: PEPITES was a phase 3 randomised, placebo-controlled trial that studied the safety and efficacy of Viaskin Peanut 250 mg in children aged 4-11 years. Children who participated in PEPITES, aged ≥8 years, completed the FAQLQ-CF at baseline and at 12 months. FAQLQ-CF items were analysed using IRT, considering items' discrimination values, difficulty levels, and item information curve. RESULTS: 92 children (mean age 5 8.47 years, SD 1.7) completed the FAQLQ-CF. By IRT analysis, 14 of 30 total items contained in the FAQLQ presented very high discrimination levels (a > 1.7), with the highest levels relating to items that assessed 'fear'. All the items presented difficulty level within the recommended range (mean across b1-b6 < 2+1.5), being neither too easy, nor too difficult. CONCLUSIONS: We have identified 14 items contained within the FAQLQ-CF by IRT approach that best discriminate and assess HRQL in a treatment context. These findings may provide a novel and reliable framework for measurement of changes in HRQL in future food immunotherapy clinical trials.
Shrimp allergy is the second most common food allergy in the U.S.A., affecting up to 1.2% of the pediatric population. Oral immunotherapy (OIT) to food allergy decreases the threshold of clinical reactivity to the specific food. Given the risk of clinical reactions to shrimp allergen with accidental exposures, shrimp OIT may be an effective treatment. Identification of the appropriate OIT product, major shrimp allergen, tropomyosin (Pen a 1) is critical. METHODS: Identification and characterization in a shrimp OIT product of major shrimp allergen tropomyosin (Pen a 1), compared to placebo, oat. Evaluation was made by SDS-PAGE and mass spectrometry analysis performed with digested peptides utilizing nanoHPLC-Q Exactive Mass Spectrometer. Proteome Discoverer1.4 interface with Mascot algorithm utilized to identify recovered peptides. Imunological analysis was made by western blot with anti-shrimp tropomyosin. RESULTS: SDS-PAGE gel identified shrimp tropomyosin at 37kD in the OIT shrimp but not oat product. The tropomyosin database was generated from NCBI database by selecting proteins which have tropomyosin in protein description regardless taxa (283 entries). In the oat sample, two shrimp tropomyosin peptides were identified. Data indicated,based on the area under the curve, oat has 0.01% of tropomyosin concentration compared to shrimp. Recovered tropomyosin peptides from oat may be due to contamination of insects around oat grains. Western blot analysis indicated exclusive signal of tropomyosin from the shrimp sample. CONCLUSIONS: Identification and quantification of Pen a 1 from a potential shrimp OIT product resulted in the confirmation of this product to be a potential candidate for OIT in shrimp allergy.
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