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.