Strengths and limitations
Randomization was one of the strengths of this study. In this way, the
fluorescence colposcope group and the conventional colposcopy group
could be more objectively compared in the same population. In addition,
we sampled the cervix at multiple sites, regardless of the result of
fluorescent dye or acetic acid and iodine staining. Previous research
had shown that the strength of correlations between colposcopic
impression and biopsy histology was poor, with an agreement rate of only
37%10. A recent study in China indicated the
consistency between colposcopy and biopsy pathology was 59.35% with the
moderate strength of kappa coefficient of 0.464 in detecting high‑grade
squamous intraepithelial lesion and cervical cancer11.
Multiple biopsies increased the detection of histologic HSIL, regardless
of patient characteristics12. Therefore,
multi-site sampling was
recommended as a standard practice of colposcopic biopsy and applied in
several researches13-15. And multi-site sampling also
increases the sample size, which was helpful for statistical analysis.
In addition to these, we quantitatively calculated the SBRs at the
lesions when evaluating the results of fluorescence colposcopy, so that
the results would be more objective and convenient.
This study also had some limitations or implementation challenges.
Firstly, all the findings were based on our single-center data, which
may cause a certain degree of bias. Secondly, neither patients nor
colposcopists were blinded to the colposcopy. The colposcopy operation
process of the fluorescence colposcope group was different from that of
the conventional group, so the
double-blind design cannot be achieved at present. Thirdly, this was a
preliminary study of a new device with a relatively small sample size.
Fourthly, the sampled tissue was too small to additional histological
examination, and there were not enough samples for immunohistochemistry
to detect the expression level of TMTP1’s potential receptor XPNPEP2. As
a result, we could not evaluate the consistency of the levels of SBR and
XPNPEP2 expression in the fluorescence colposcope group. In the future,
the large sample multi-center clinical research should be further
performed to evaluate the application potential of this fluorescence
colposcope in the secondary screening of cervical cancer.