Introduction
Chronic obstructive sialadenitis (COS) is a benign disorder characterized by repeated episodes of inflammation of the major salivary glands[1–3]. Clinical presentation includes painful swelling of the affected gland, usually trigged by meals or other means of salivary stimulation. After years in which the disorder received scant attention in research, the last decades have seen a growth in interest in the results of minimally invasive treatment with sialendoscopy.
Patient-reported outcomes (PROs) can simplify patient involvement in decision-making and may help healthcare professionals identify patientconcerns[4]. PROs are also essential indicators in clinical research and are frequently used as study endpoints[5]. Therefore, there is an unmet need to develop a specific PRO to assess COS[6].
To our knowledge, there are no existing Spanish questionnaires with which to assess quality of life (QOL) in COS. We identified 3 English-language questionnaires specifically designed for COS and sialendoscopy: Chronic Obstructive Sialadenitis Symptoms (COSS)[2, 7–10], Modified Oral Health Impact Profile-14 (OHIP-14)[11], and patient satisfaction questionnaire[12].
We are aware that for a QOL questionnaire to be used in clinical practice or research, the instrument must be rigorously validated in order to avoid incorrect interpretations.
Our purpose is to develop and validate a questionnaire to assess QOL in COS – called CSOC (Spanish acronym for Cuestionario sobre Calidad de vida en Sialoadenitis Obstructiva Crónica ). The overall goal of CSOC is to assess the impact of COS on QOL and the extent to which QOL improves with sialendoscopy.