[The PAPNET system in the rescreening of negative cervical/vaginal smears. A study from the Imola cytology laboratory]. / Il sistema PAPNET nel rescreening degli strisci cervico/vaginali negativi. Uno studio del laboratorio di citologia di Imola.

The rescreening of negative cervical/vaginal smears is one of the potential areas of utilization of the systems for computer-assisted cytology diagnosis. In the Imola cytology laboratory, a random sample of 1309 conventionally prepared smears that had been originally reported as negative was rescreened with the PAPNET System (Neuromedical Systems, Inc., Suffern, NY). Smears with a PAPNET diagnosis other than negative were further and independently evaluated by the staff of the laboratory and classified according to the majority report. The PAPNET rescreening confirmed the original negative diagnosis for 1188 smears (907.6/1000) and led to the detection of 46 ASCUS/LGSIL cases (35.1/1000) and 2 AGUS/HGSIL cases (1.5/1000). Seventy-three smears (55.8/1000) were interpreted as unsatisfactory. The majority report confirmed the original negative diagnosis for 42 (91%) of the 46 PAPNET diagnoses of ASCUS/LGSIL and 50 (68%) of the 73 smears interpreted as unsatisfactory. The 2 cases of AGUS/HGSIL diagnosed by PAPNET were confirmed. The detection rate of ASCUS/LGSIL decreased from 35.1/1000 to 3.1/1000 (rate ratio 0.09, 95% confidence interval [95% CI] 0.02-0.22). The rate of unsatisfactory smears decreased from 55.8/1000 to 17.6/1000 (rate ratio 0.31, 95% CI 0.20-0.47). The rate of negative smears increased from 907.6/1000 to 977.9/1000 (rate ratio 1.08, 95% CI 1.02-1.14). In conclusion, the PAPNET rescreening of negative smears brought about a low detection rate of severe cellular changes. Though greater, the detection rate of low grade changes was substantially and significantly reduced by the majority reports. At our laboratory, the PAPNET rescreening does not appear to improve the performance of conventional cytodiagnosis.

Accuracy comparison between PAPNET diagnoses and conventional diagnoses in an Italian cervical cytology laboratory.

In a population-based cervical screening laboratory with a controlled workload, a retrospective PAPNET review of 1,654 Pap smears was performed. The series included a random sample of smears originally and conventionally classified as negative (no. 1,309) and unsatisfactory (no. 43), and 299 consecutive smears originally classified as abnormal. The PAPNET diagnoses and the original diagnoses were compared for accuracy. For smears with discordant classification, a majority diagnosis as obtained on manual review was used as a gold standard. The PAPNET testing showed a greater proportion of negative smears classified as unsatisfactory (3.7% vs. 0.2%; ratio, 16.7; 95% CI 12.4-22.0); a reduced proportion of ASCUS/LGSIL cases correctly identified as positive (i.e., a reduced sensitivity for such lesions) (76.3% vs. 97.9%; ratio, 0.78; 95% CI 0.66-0.91); an equal proportion (96.2%) of AGUS/HGSIL cases correctly identified as positive (i.e., an equal sensitivity for such lesions); and an equal proportion of negative smears correctly identified as such (i.e., an equal specificity). In conclusion, the PAPNET testing did not improve the diagnostic performance of the manual screening.

[Analysis of the intralaboratory diagnostic variability in the Imola cervical screening program]. / Analisi della variabilità diagnostica intralaboratorio nel programma di screening cervicale di Imola.

The value of the assessment of intralaboratory variability as a method for quality control of cervical screening is an ill-defined one. This model has been advocated and utilized by some Authors and only indirectly addressed by others. In Italy, only occasional studies have been published. The present analysis is part of a series of studies for the evaluation and quality control of the population cervical screening programme in the area of Imola. The agreement between the 5 cytologists was tested over a series of 150 smears selected from the routine material. The data were analyzed with the k statistic and the degree and direction of discrepancies were assessed by the percent distribution of paired diagnoses. The k values for agreement between the 10 possible pairs of cytologists varied between 0.25 and 0.49 (average value, 0.37). The indexes for agreement as based on three classes ('Negative'/ASCUS + LGSIL + HGSIL/'Unsatisfactory') varied from 0.35 to 0.56 (average value, 0.46). The cytologist-specific k values (as based on five classes) ranged from 0.29 to 0.43. For the observer with the lowest specific coefficient (designated as C4), the excess disagreement was restricted to the ASCUS class and the 'Unsatisfactory' notation. In particular, C4 diagnosed more often 'Negative' smears (74% vs. 44-55%) and less frequently ASCUS (11% vs. 22-31%) and 'Unsatisfactory' smears (3% vs. 6-11%). ASCUS was the least reproducible diagnosis (k = 0.22). The evaluation of the degree and direction of the diagnostic discrepancies between the five cytologists showed that the frequency of concordant diagnoses of ASCUS was as low as 39.7%. However, the discrepancies were almost always of one degree and were directed towards the 'Negative' class. Conversely, ASCUS was associated with considerable proportions of the 'Negative' diagnoses (17.3%) and those of LGSIL (31.8%). In the occasions when one observer interpreted a smear as 'Unsatisfactory' the paired diagnoses were almost evenly distributed among 'Unsatisfactory' (49.2%) and 'Negative' (43.0%). In absolute terms, the k coefficients in this study were compatible with moderate agreement. However, they were unfavourably influenced by the modalities for smear selection. The study specimens were selected by all cytologists from the routine material over a short time period and did not include smears interpretable as showing carcinoma. A comprehensive evaluation of the diagnostic performance of C4 showed that the disagreement with other cytologists was restricted to the diagnosis of ASCUS and the 'Unsatisfactory' notation and was accounted for by a lower frequency of such reports coupled with a greater frequency of the 'Negative' diagnoses. A conservative approach to lesions of minor significance is the most likely explanation for that pattern of disagreement. Although characterized by the poorest k value, the ASCUS diagnosis proved to be generally matched with reports of minor cytology changes. This was consistent with the formal definition for ASCUS in the original Bethesda System. The observation that the ASCUS diagnosis is applied to those changes is a prerequisite for a more conservative utilization of such report. In conclusion, the study revealed important correlates of the k coefficients and provided an encouraging picture of the cytologic substrates of the diagnosis of ASCUS.