Study Population
The “Blinded for review” approved all study proceedings (code Blinded for review ).
In the pilot study,the target for total enrolment was 30 participants in order to achieve a reasonably high power (80%), to detect a problem that occurs in 5% of the population, and pinpoint a repeat occurrence of a problem that affects 10% of the respondents[17]. Convenience sampling was used to recruit subjects older than 18 years of age among those patients with diagnosis of COS by an otolaryngologist and indication for sialendoscopy evaluated at the department of otorhinolaryngology at “Blinded for review ” between June 2017 and March 2018. COS was defined as at least 2 episodes of salivary gland swelling and discomfort in the previous 3 months. We excluded patients with a previous diagnosis of salivary glands tumour and those with insufficient proficiency in the Spanish language.
Eight otolaryngologists experienced in sialadenitis management and sialendoscopy from different hospitals and cities in “Blinded for review ”agreed to form part of the expert panel; members of the research group were excluded. The size of the committee of experts was determined based on recommendations contained in the literature[18].
One hundred twenty patients were recruited for the validation study. The sample size was calculated using the literature recommendationsof including at least 5 subjects per item and not fewer than 100 subjects[19]. The inclusion and exclusion criteria were the same used to assemble the sample for the pilot study. Patient were recruited between July 2018 and July 2020.