Developing a patient-centered instrument to assess quality of life among food allergen immunotherapy participants

Food allergies affect millions of children and adults in the United States, with many patients experiencing severe reactions requiring hospitalization or emergency treatment. The constant stress and anxiety of allergen avoidance has been found to adversely impact quality of life of patients and their families. The large demonstrated burden of disease and increasing availability of immunotherapies has led growing numbers of affected patients to seek treatments aiming to increase the threshold that triggers a reaction, thereby achieving desensitization to the treated food. In some cases patients can achieve sustained unresponsiveness, wherein therapy-related gains are maintained without ongoing exposure to the allergenic trigger. Previous work suggests that patients differ substantially with respect to their motivations for pursuing immunotherapy. While recent work shows that the majority desire eventual ad-lib allergen consumption, a substantial minority express that their desired outcome is protection from accidental ingestion. While individuals in the latter group are likely to continue allergen avoidance even upon achieving desensitization, they would nevertheless be likely to experience substantial reductions in stress and anxiety if they believe that they are protected against accidental exposure in daily life. However, current food allergy quality of life instruments may be ill-suited for assessing the quality of life domains most likely to improve during the course of immunotherapy, particularly among the majority of patients who achieve desensitization, but not tolerance. This issue is compounded by the fact that most immunotherapies are food-allergen specific, while extant instruments prompt patients to respond about “their food allergy” in general, which is likely to further obscure immunotherapy-related improvements in quality of life. Given the growing number of patients receiving food allergy immunotherapy treatments and the absence of a food allergy quality of life instrument that is both sensitive and specific to key patient-reported outcomes, we propose to systematically develop and validate an immunotherapy-related quality of life (IQoL) questionnaire for use in pediatric populations.