Sunday, October 21, 2007

Number of Cervical Biopsies and Sensitivity of Colposcopy.

Currently, colposcopy is recommended for women with low-grade squamous intraepithelial lesion (LSIL) or worse cytology, or atypical squamous cells of undetermined significance (ASC-US) that persists or is associated with high-risk human papillomavirus (HPV) infection. The major purpose of colposcopy in the United States is to diagnose precancerous lesions (cervical intraepithelial neoplasia [CIN] 3, especially) that can be treated to prevent cancer. However, colposcopy is a subjective procedure with limited reliability and, in particular, is not optimally sensitive for detection of CIN 3. Reasons for the poor reproducibility of colposcopic impression and limited accuracy of colposcopically directed biopsy have been questioned for decades. One measure of the accuracy of colposcopically guided biopsy—concordance between cervical biopsy and subsequent, complete histologic diagnosis by conization, loop electrosurgical excision procedure (LEEP), or total hysterectomy—is known to be influenced by the severity of referral Pap test, patient age and menopausal status, visibility of the squamocolumnar junction, lesion size, and endocervical extension.



Recent research has suggested that the limitations of the colposcopic examination can be reduced by taking additional biopsies. Two studies found that taking additional biopsies in quadrants where no lesion was visualized improved sensitivity of the overall colposcopic procedure. These studies were conducted in underscreened populations and are perhaps not fully applicable to the United States. Additional concern has been expressed regarding the importance of training and experience in colposcopic examinations and the possibility of differences in accuracy among various types of clinicians ranging from primary care to referral practices.



Within the context of a large clinical trial with several thousand colposcopic examinations and 2 years of follow-up, we were able to study the influences on sensitivity of colposcopic impression and colposcopically guided biopsy relative to a reference disease standard of histologic CIN 3+. In particular we evaluated the importance of varying types of medical training: nurse practitioners, general gynecologists, gynecologic oncology fellows, and gynecologic oncologists. We also examined the extent to which confounding or mediating factors such as the number of biopsies and patient characteristics could explain any differences or similarities in accuracy among types of medical training.



DISCUSSION

We found substantial improvement of colposcopically guided biopsy sensitivity when clinicians took more biopsies from colposcopically abnormal areas. This trend was observed across all types of medical training. While these findings suggest an important strategy to improve the accuracy of colposcopically guided biopsy with minimal effort, the appropriate location for additional biopsies remains unknown, because limited data are available to guide placement of additional biopsies. As a result of variation in the sensitivity of colposcopy, several authors have suggested taking multiple biopsies. Some studies suggest that high-grade lesions might not always be at the point of maximal colposcopic abnormality. The question of whether to take additional biopsies around the worst visualized lesion, from abnormal areas outside the worst lesion, from normal areas outside the lesion, or random biopsies of all quadrants even when no lesion is visualized, merits further research in a randomized controlled trial specifically designed to evaluate these aspects. The ALTS was not designed to examine the influence of biopsy-taking practices on sensitivity of colposcopically guided biopsy.



In addition, the best way to optimize taking of biopsies remains an issue. Colposcopy instructors can suggest ways to overcome concerns about taking multiple biopsies because instruments vary in size and sharpness. Frequent sharpening of the biopsy forceps decreases pain and tissue trauma. Proper waiting time after application of topical anesthesia and use of verbal reassurance seem to be helpful in reducing pain. Because the biopsies can be submitted in one vial, multiple sampling would not need to increase the cost of pathology. As an extreme, it would be wrong to conclude that LEEP should be used instead of biopsy because it provides the largest surface area for histology, because the procedure has been associated with uncommon, but significant, short-term and pregnancy complications.



We have found in our clinical colposcopy instruction that most training does not specify if, or when, more than one biopsy should be taken. Although the ALTS protocol encouraged all clinicians to take additional directed biopsies of any suspected lesions, not all clinicians were equally likely to take additional biopsies. The nurse practitioners received training that encouraged additional biopsy-taking. Our data suggest that certain clinicians such as gynecologic oncologists, gynecologist fellows, and to a less degree, general gynecologists feel a greater assurance in their ability to adequately capture the worst lesions with one biopsy. In fact, gynecologic oncologists and gynecologic oncology fellows did have a relatively higher sensitivity on the first biopsy sample (data not shown), although this did not translate into higher sensitivity of the colposcopy procedure as a whole, because general gynecologists and in particular nurse practitioners took more biopsies resulting in comparable overall sensitivities.
There is a belief that clinicians take more biopsies in the beginning of their training and take fewer later in their career as the skill of colposcopic evaluation improves. Another common assumption is that types of medical training, from nurse practitioners to general oncologists to gynecologic oncologists, form a continuum that corresponds to expertise in performing colposcopy. Our findings contradict these notions, because the overall sensitivity of the colposcopy procedure was similar across types of medical training.



This study involved colposcopic examination of women with ASCUS or LSIL cytology and may not be generalizable among women with rarer cytology results such as atypical glandular cells, HSIL or atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion. Another limitation of this study is the infrequency with which clinicians other than nurse practitioners took two or more biopsies. However, there were consistent trends of increased sensitivity when taking two or more biopsies across types of clinician training and overall, a significant increase in overall sensitivity when taking two or more biopsies. We found that sensitivity was higher among women who were younger, with lower parity, worse cytology, HPV-DNA positivity, and high-grade colposcopic impression. Within levels of each of these variables, the sensitivity of the colposcopic examination still increased with more biopsies taken (although the trends were not always statistically significant). Although we cannot absolutely rule out that differences in sensitivity were due to unmeasured differences in clinic populations such as lesion size, visibility of squamocolumnar junction, or endocervical extension, the patterns were consistent across levels of measured, possible confounding variables.



These results show that across various types of medical training, colposcopic impressions and colposcopically guided biopsies demonstrate similar sensitivities. Colposcopy, like cytology and histology, is subjective, and the number of colposcopically guided biopsies taken is most strongly associated with sensitivity. As women are referred to colposcopy based on increasingly sensitive screening tests, there is a need to have a diagnostic examination with the best accuracy possible.

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