Study procedures
After to identify the patients meeting the inclusion criteria, a physician administered a structured questionnaire. The interview could be conducted in person or with the telephone.
The questionnaire included an explanatory cover letter reporting the aim of the study. Experts designed the questions in the field.
The structured questionnaire was prepared as a specific form to be fulfilled online (open-ended format questions) on the website. Responses were anonymous, but general information (initials of name and surname, age, gender, allergen for which SLIT was administered, drug administration schedule) was requested.
In accordance with the diagnosis (allergic rhinitis, allergic asthma, allergic rhinitis and asthma), three different questionnaires were administered. Patients who have practiced multiple cycles of SLIT were evaluated for each treatment, via a specific questionnaire for the allergen taken.
Each questionnaire included twenty questions in a multiple-choice format. Moreover, each questionnaire was split into four timing: T0: period prior to the start of therapy with monomeric carbamyl allergy; T1: first year of therapy with monomeric carbamyl allergy; T2: conclusion of the treatment with monomeric carbamyl allergoid; and T3: period following the suspension of treatment with monomeric carbamyl allergy. Specifically, each questionnaire contained questions on:
1. perceived efficacy: measured using a visual analog scale (VAS) that has been proven to be a valid tool in evaluating allergic rhinitis for patient satisfaction [9]. Using the VAS, patients assessed their level of satisfaction by indicating a position along a continuous line between two points from 0 (absence of symptoms) to 10 (bothersome or severe symptoms). VAS was referring to T0, T1, T2, and T3.
2. rescue medication (antihistamines, inhaled or systemic corticosteroids) use in patients with allergic rhinitis measured using a VAS [9]. Using the VAS, patients assessed the rescue medication use by indicating a position along a continuous line between two points from 0 (never used) to 10 (widely used). VAS was referring to T0, T1, T2, and T3.
3. perceived efficacy: measured using a visual analog scale (VAS) that has been proven to be a valid tool in evaluating asthma for patient satisfaction [8, 10, 11]. Using the VAS, patients assessed their level of satisfaction by indicating a position along a continuous line between two points from 0 (absence of symptoms) to 10 (bothersome or severe symptoms). VAS was referring to T0, T1, T2, and T3.
4. allergic rhinits control and its impact on quality of life assessed through standardized questionnaire according to ARIA guidelines [7]. The questionnaire was referring to T0 and T3.
5. asthma control and its impact on quality of life assessed through standardized questionnaire according to GINA guidelines [8]. The questionnaire was referring to T0, T1, T2, and T3.
6. number of asthma exacerbations requiring the use of rescue therapy (salbutamol or systemic corticosteroids) or hospitalization in the last 12 months. This item was numerically measured by a scale ranging from 0 to 8.
7. perceived satisfaction expressed in terms of “very dissatisfied”, “dissatisfied”, “satisfied”, and “very satisfied”. The perceived satisfaction was referring to T0, T1, T2, and T3.
One answer for each question was provided. The questionnaire was administered in Italian and translated into English for publication. The English version of the questionnaire is enclosed in Appendix 1 (a, b, a and b).
Safety was defined as the number and the type (mild, moderate, and severe) of adverse events (AEs) recorded by physician and/or children’s parents and/or patients.
Collected data were securely stored and managed using the electronic data capture tools (server: PHP; Web: HTML, CSS, JS; Framework: Bootstrap; Libraries JS: jquery, noUiSlider).
Written informed consent was obtained before entering the study, and in the case of minors was obtained from next of kin, caregivers, or guardians [12]. Patient privacy was protected in compliance with the European Union General Data Protection Regulation (GDPR). Institutional Review Board of University of Catania approved the study.