Validation of Patient-Reported Outcomes for Clinical Trials in Allergic Rhinitis: A Systematic Review

The Journal of Allergy and Clinical Immunology. in Practice
Moises A CalderónP Demoly

Abstract

Although regulatory authorities have recently recommended the use of a combined symptom-medication score as a primary efficacy end point, none has been psychometrically validated. Here, we sought to determine to what extent allergic rhinitis (AR)-related patient-reported outcomes (symptom scores, medication scores, disease control scores, and satisfaction or quality-of-life scales) have been assessed for construct, content, and/or criterion validity, reliability, responsiveness, and the minimal clinically important difference. We searched the PubMed database from January 1997 to June 2018 with logical combinations of key words related to validation, AR, and patient-rated outcomes and scales. From a total of 1705 potentially relevant publications, 55 were reviewed. Despite the current emphasis on a combined symptom-medication score for evaluating the efficacy of allergen immunotherapy in AR, symptom scores have not been extensively validated, and we did not find any publications describing the validation of a medication score. Disease control scales (mainly the Rhinitis Control Assessment Test, the Control of Allergic Rhinitis and Asthma Test, and the Allergic Rhinitis Control Test) and health-related quality-of-life scales (mai...Continue Reading

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Citations

May 22, 2020·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·Montserrat Alvaro-LozanoMarta Vazquez-Ortiz
Dec 5, 2020·Nature Reviews. Disease Primers·Jean BousquetSanna Toppila-Salmi
May 19, 2020·The Journal of Allergy and Clinical Immunology. in Practice·Moisés A CalderonHendrik Nolte
May 25, 2021·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Susan WasermanErnie Avilla
Feb 27, 2021·Journal of Pediatric Gastroenterology and Nutrition·Erica J BrennerMichael D Kappelman
Jun 29, 2021·The World Allergy Organization Journal·Lei ChengUNKNOWN Rhinology Group of the Chinese Society of Otorhinolaryngology-Head and Neck Surgery

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