Statistical analysis
The patients were grouped into two groups randomly; one using
trans-nasal approach and the other using the trans-oral approach. Both
groups were compared for all demographic variables as well as
clinic-pathologic variables.
The primary outcome of this study is to compare the diagnostic accuracy
of both trans-oral and trans-nasal approaches of taking a biopsy. The
secondary outcome variables were the safety, tolerance and how easy is
each approach. Also, evaluation of visualization approaches and methods
of anesthesia were among the secondary outcome variables.
Recorded data were coded, entered, cleaned, and analyzed using the
statistical package for social sciences, version 25.0 (SPSS Inc.,
Chicago, Illinois, USA). Quantitative data were expressed as mean±
standard deviation (SD). Qualitative data were expressed as frequency
and percentage. Chi-square (x2) test of significance
was used in order to compare proportions between two qualitative
parameters, and the student t-test was used for the numerical parametric
data. The confidence level was set to 95% and the margin of error
accepted was set to 5%. So, the p-value was considered significant if< 0.05. The Cohen kappa index for agreement was
calculated to evaluate agreement between methods of biopsies.
Sensitivity, specificity, positive predictive value, negative predictive
value and diagnostic accuracy of the two different approaches of
office-based based biopsy were calculated.
Results
Ninety-nine patients were invited to participate in the study; 35
refused to participate, 14 were ineligible; thus, 60 enrolled to the
study signed a consent form and randomized into two groups: 30
trans-nasal group and 30 trans-oral group.