Patient-reported outcomes and quality-of-life questionnaires in the assessment of rhinoconjunctivitis in childhood.
OBJECTIVE
Rhinoconjunctivitis, and especially allergic rhinoconjunctivitis (ARC) are increasing in prevalence, progressively affecting the well being of more and more adults and children. Clinical trials using allergen immunotherapy (AIT), the sole causal treatment of allergies, are being conducted, but discussions on optimal patient-related outcomes (PROs) are still ongoing.


RESULTS
Almost all publications discussing PROs relate to adults. The authors comment on the importance of broader PROs when assessing the results of AIT trials, as focusing on only nasal symptom improvement and medication reduction does not capture the full benefit of AIT. Such intervention also improves comorbid allergic diseases and general well being. In studies on rhinoconjunctivitis in children, using medical treatment or immunotherapy published between November 2012 - February 2014 nasal symptom (and medication) scores were primary outcomes in 18 of 20 trials. Only two trials applied quality-of-life questionnaires.


CONCLUSIONS
Clinical trials conducted in children with ARC should be interpreted with caution, as most currently used PROs give a restricted view, by not considering disease manifestations beyond nasal/ocular symptoms. To correctly estimate the full benefit of AIT in pediatric patients with ARC, broader PROs should be investigated, including disease control and quality of health.
aHospital Médica Sur, Mexico DF, Mexico bDepartment of Otorhinolaryngology, Head and Neck Surgery, Center for Rhinology and Allergology, University Hospital Mannheim, Wiesbaden, Germany.
Désirée
D
Larenas-Linnemann
Oliver
O
Pfaar
D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003233:Conjunctivitis, Allergic / Q000453:epidemiology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D015995:Prevalence; D011788:Quality of Life; D065631:Rhinitis, Allergic / Q000453:epidemiology / Q000628:therapy*; D011795:Surveys and Questionnaires
D000485:Allergens