Increase In Number Of Biopsies Research Articles

Effective cervical neoplasia detection with a novel optical detection system: A randomized trial

To assess whether the use of a novel optical detection system (ODS) as an adjunct to colposcopy increases the detection of biopsy-confirmed CIN 2,3. This is a multicenter two-arm randomized trial comparing colposcopy alone with colposcopy plus a pre-commercial ODS system that utilizes fluorescence, white light tissue reflectance, and cervical video imaging. Patients were recruited from 13 colposcopy clinics in a variety of practice settings. 2299 women referred for the evaluation of an abnormal cervical cytology were randomized with stratification by cytology; subsequently 113 women were excluded for a variety of reasons. The main study outcomes were differences in true-positive rates (CIN 2,3 and cancer identified) and false-positive rates between the study arms. The true-positive (TP) rates were 14.4% vs. 11.4% (p=0.035, one-sided) for the combined colposcopy and ODS arm compared to colposcopy-only arm, respectively, in women with either an atypical squamous cell (ASC) or low-grade squamous intraepithelial lesion (LSIL) cytology result. TP rates were similar between the two arms among women referred for the evaluation of HSIL. The 26.5% gain in true-positives observed with the use of ODS and colposcopy among women referred for an ASC or LSIL cytology was achieved with only a fractional increase in number of biopsies obtained per patient (0.30) and a modest increase in false-positive rate (4%). In the combined colposcopy and ODS arm among women with ASC or LSIL, the PPV of biopsies indicated by ODS was 15.0% and the PPV of biopsies indicated by colposcopy was 15.2%. Joint hypothesis testing indicates that ODS and colposcopy provides benefit compared to colposcopy alone among women with ASC or LSIL. Combining ODS with colposcopy provides a clinically meaningful increase in the detection of CIN 2,3 in women referred for the evaluation of mildly abnormal cytology results.

Pathology

The lowered index of suspicion on the part of clinicians, occasioned by the decrease in the number of cases of syphilis seen in practice in comparison with former times, has combined with a reduction in emphasis on the disease in medical school curricula to produce an increase in number of biopsies taken for diagnostic purposes from unrecognized early lesions of the disease. Also contributing to this problem are the diagnostic difficulties generated by the appearance of increasing numbers of exotic extragenital chancres, a phenomenon that is the natural consequence of the new sexual adventurousness among heterosexuals and the high incidence of the disease among male homosexuals noted in recent years. Biopsies are being submitted under cover of a wide variety of mistaken clinical diagnoses—psoriasis, lichen planus, pityriasis rosea, Kaposi's sarcoma, sarcoidosis, swimming pool granuloma, drug eruptions, leukemia cutis, mycosis fungoides, carcinoma, and many others. It is, therefore, incubent upon pathologists dealing with this material to be more aware than ever that their clinical colleagues are having difficulties along these lines.