OBJECTIVES

: Food allergy (FA) poses a substantial burden on patients and their families, with reported physical and emotional impacts that can significantly influence daily life. Multiple disease-specific patient-reported outcome measures (PROMs) have been developed to measure the impact of FA on health-related quality of life (HRQoL). This review aimed to identify suitable PROMs to enable the assessment of interventions on the HRQoL impacts of patients with FAs.

METHODS

: A literature search was performed in Medline and Embase from Jan 2010-April 2020. Key words like “food allergy” and “HRQoL” identified PROMs developed or used in patients with FA. Psychometric properties including content validity, reliability, validity, responsiveness and interpretability, were evaluated in accordance with the FDA PRO Guidance (2009).

RESULTS

: A total of 1028 abstracts were identified and 241 were selected for full-text review resulting in a list of 46 PROMs. They were classified as generic (n=22), allergy specific (n=2), FA-specific (n=19), and treatment satisfaction-specific (n=3). From the FA-specific PROMs, only 7 were conceptually relevant for further evaluation— Food Allergy Quality of Life Questionnaire (FAQLQ), Food Allergy Independent Measure (FAIM), Food-Pet-Allergy in Children Questionnaire (PFAC), Food Allergy Quality of Life Assessment Tool for Adolescents (FAQL-teen), You and Your Food Allergy, Food Intolerance Quality of Life Questionnaire (FIQLQ) and Pediatric Food Allergy Quality of Life Questionnaire (PFA-QL). You and Your Food Allergy, FAQLQ, PFAC, FAQL-teen involved patient’s qualitative inputs to establish content validity. All measures showed internal consistency (reliability) to be above 0.70 threshold; in terms of validity, PROMs moderately (0.30-0.70) correlated with existing measures. Only the FAQLQs showed both responsiveness to change and interpretability, key attributes for use in clinical trials.

CONCLUSIONS

: The FAQLQs validated for measuring HRQoL in FA have relevant conceptual coverage and adequate psychometric strength. Therefore, FAQLQs are suitable for further exploration of the impact of interventions within FA clinical trials.