Validation of the Danish National Tympanostomy Tube Insertion Questionnaires.

INTRODUCTION: The objective of the present study was to validate two questionnaires (the Danish National Tympanostomy Tube Insertion Questionnaires (DANTIQ)) intended for use by the DONHO database in the investigation of the effect or tympanic tube (TT) insertion on ear-related symptoms and the adherence or ear nose & throat (ENT) specialists in Danish private practice to the Danish National Clinical Guideline on treatment of otitis media (OM) with 7 insertion using electronic patient-reported outcome (ePRO) data. METHODS: The content validity of the questionnaires was assessed through discussion in a group of four active ENT specialists. Face and content validity analyses were conducted using data from semi structured, single person interviews with nine subjects. Reliability analysis was conducted as a three-day test/re-test study involving two groups of 117 individuals receiving and answering the same questionnaire twice. RESULTS: The overall face validity or both questionnaires was satisfactory. The reliability of the answers for both questionnaires was considered acceptable with a proportion or agreement ranging from 1.00 to 0.77. The correlation between first and second scores or the total number or symptoms reported in the test/re-test setup was acceptable with results ranging from 0.93 to 0.84. CONCLUSIONS: The DANTIQ are valid and reliable for measuring ear-related symptoms in children with OM undergoing TT insertion and for investigating Danish private ENT specialists' adherence to guidelines concerning TT insertion by use of ePRO data.