94 Chapter 5 two questionnaire were already designed to be ear domain specific and considered as potentially useful for any patient with one or more ear-complaints presenting at the ENT surgeon. All but one questionnaires were developed, translated or cross-cultural validated in the English language. The number of items in the questionnaires ranges between 7 in the EDTQ-717 to 68 items in the Gopen-Yang Superior Semi-circular Canal Dehiscence Questionnaire.22 The number of subscales in the questionnaires ranged from three to nine. Most of the subscales were based on the different complaints, but impact, use of medical resources and a more general subscale were mentioned as well. PROM design Total PROM design was assessed as ‘inadequate’ in eight out of twelve questionnaires. The most frequent reason for this unsatisfactory result was development of the questions without consulting patients affected by the complaint or disease. The other four questionnaires scored an adequate score and are the COQOL26, ETDQ-717, OQUA27 and ZCMEI24. The ETDQ-7 and ZCMEI24 are disease specific questionnaires whereas the other two are more domain-specific otology questionnaires. The complete assessment leading to these score is listed in Appendix 5.1. Content validity Content Validity scores are listed in Table 3. The GYSSCDQ22 is based on other validated questionnaires, for this reason relevance, comprehensiveness and comprehensibility was adapted from ‘inadequate’ to doubtful in the assessment of content validity. The COMQ-12 and ZCMEI-21 are also based on other questionnaires (CES and COMOT-15), but since the content validity of these questionnaires is inadequate, the assessment of ZCMEI-21 and COMQ-12 was also inadequate. Six studies performed a pilot test and made adaptations to their first version of the questionnaire. Six questionnaires did not perform a pilot test. This often resulted in using their first and only version of the questionnaire in the study population. The complete assessment leading to these score is listed in Appendix 5.2. Internal structure Structural validity is a parameter that can only be performed if the PROM is based on a reflective model. Most of the studies do not elaborate on this. If a formative model is used or if the model is not mentioned, then an exploratory factor analysis (EFA) is best applicable. A confirmatory factor analysis (CFA) can thus only be performed if the questionnaire is designed is based on a reflective model. There are no included studies describing a confirmatory factor analysis accept for the OQUA27. This study
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