Sample size
As a brand-new device, there was no RCTs to assess the diagnostic
efficiency of this fluorescence colposcope previously. However, based on
the reported sensitivity and
specificity of
conventional colposcope in
detecting cervical lesions, we calculated the sample size of
the conventional colposcopy group
and set the sample size of the fluorescence colposcope group to be
consistent with it. We estimated a sensitivity of 88% and a specificity
of 85% in conventional colposcopy group, and set both the sensitivity
and specificity error range to be ±0.1, type 1 error α as 0.05. The
number of subjects required for each group was 90. Assuming a dropout
rate of 10%, the total number of subjects for recruitment was set as
200.