92 Chapter 5 During this assessment a new COSMIN guideline was published in 2021.10 This Reporting Guideline was developed for research groups reporting on studies that evaluate the measurement properties of existing PROMS. This reporting guideline was incorporated were possible and parts of our assessment were adjusted. All questionnaires were assessed on general design and concept elicitation; content validity (CV); Internal structure with its structural validity, internal consistency (Cronbach’s Alfa) and cross-cultural validity; (test-retest) reliability; measurement error; criterion validity; hypothesis testing for construct validity and responsiveness; Interpretability assessing distribution scores, missing items, floor and ceiling effects, scores and change scores, minimal important change or –difference scores (MIC or MID) and feasibility . Results The systematic mapping review on all otology questionnaires was conducted in an earlier stage by Viergever et al. This mapping review extracted 13.345 record and identified 155 unique otology questionnaires. The additional search performed on the 27th of April 2021 resulted in 909 new records. After removal of duplicates 898 unique records remained. One additional multiple complaint ear PROM, the ZCMEI-21 was eligible for inclusion and identified through this search. The mapping review and of the repeated search thus revealed 16 multiple complaint questionnaires. Four out of these sixteen questionnaires were not eligible for methodological assessment and excluded. The CEDRA11 and SOFI12 questionnaire were excluded as they are not PROMs for complaint evaluation, but were developed as a risk assessment. The dizziness symptom profile13 (DSP) was excluded because difference in overall design. The objective of the DSP is to generate a differential diagnosis and not to evaluate complaints over time. The Dizziness, tinnitus and taste disturbances questionnaire14 was excluded since this was developed for persons with a cochlear implant. The development paper of the included COMOT-1515 was in German language, and although a non-English development paper was an exclusion criteria, this questionnaire was included. This inclusion was deemed necessary to assess the ZCMEI-21 which is developed based on de COMOT-15 and CES. The Stapesplasty Outcome Test (SPOT-25) was found by reference checking, but excluded as It was not validated in English literature.16 The SPOT-25 is a disease-specific HRQOL PROM questionnaire for patients undergoing stapes surgery for otosclerosis. After this large mapping review eventually twelve questionnaires were eligible for quality assessment. The included questionnaires and their basis characteristics are
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