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.