A randomized comparison of the 3 Papanicolaou smear collection methods

The purpose of this study was to compare the effectiveness of 3 cervical smear sampling devices for obtaining acceptable yields of endocervical cells in Papanicolaou smears. In a randomized, controlled clinical trial, we collected 346 smears over a 6-month period, 110 with the Cervex brush, 125 with the cotton swab plus Ayre spatula and 111 with the Cytobrush plus Ayre spatula. The Cytopathology Laboratory, blinded to the Papanicolaou smear method, screened the smears using the Bethesda system guidelines. Statistical analyses were performed using the Pearson X2 and analysis of variance tests. There was an increased detection of endocervical cells in the Cytobrush plus Ayre spatula and the Cervex brush methods, compared with the cotton swab plus Ayre spatula group (p = 2.39 x 10(-6), p = 4.49 x 10(-7) respectively). There was no statistically significant difference between the Cytobrush-Ayre spatula and the Cervex brush sampling methods were equally effective in obtaining endocervical cells in Papanicolaou smears.     

Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies

OBJECTIVE: To assess the diagnostic yield of different sampling devices used in cervical screening. DESIGN: Meta-analysis of randomised and quasi-randomised studies. SETTING: All randomised and quasi-randomised studies comparing the yield of cytological or histological abnormalities when two or more different sampling devices were used. SUBJECTS: 85,000 patients included in 29 studies reported in 28 papers. MAIN OUTCOME MEASURES: Pooled relative risk and 95% confidence interval of the yield of mild dysplasia or worse in smears recovered by each sampling method versus each other method with which it was compared; sensitivity or positive predictive value, or both, of cytological versus histological results in six studies from which sufficient data were available. RESULTS: There were no substantial differences in the yield of cytological abnormalities between the Ayre spatula, the Cytobrush, and the cotton swab used alone. There were also no substantial differences in the yield of cytological abnormalities between the extended tip spatula, the Ayre spatula combined with the Cytobrush or cotton swab, or the Cervex brush. The Ayre spatula, Cytobruah, or cotton swab used alone generally performed significantly worse than the combinations, the extended tip spatula, or the Cervex brush. There were no substantial differences in sensitivity or positive predictive value between the sampling methods. CONCLUSIONS: These results support the use of either the extended tip spatula, a combination of any spatula plus the Cytobrush or cotton swab, or the Cervex brush for cervical screening.     

Order of endocervical and ectocervical cytologic sampling and the quality of the Papanicolaou smear

OBJECTIVE: To determine whether the order of cell collection, endocervical or ectocervical cells first, has an effect on the quality of the Papanicolaou smear. METHODS: One thousand smears were obtained using an Ayre spatula and an endocervical brush. In 500 cases the endocervical brush was used first, and in 500 cases the spatula was used first. All Papanicolaou smears were collected by resident physicians in our university hospital gynecologic clinics. A smear was considered limited for interpretation for the following reasons: 1) lack of endocervical component, 2) obscured by blood, 3) obscured by inflammation, 4) drying artifact, and 5) too thick. RESULTS: The brush-first group had 405 (81%) adequate smears compared with 410 (82%) adequate smears in the spatula-first group. More smears were obscured by blood when the brush was used first (22 or 4.4% compared with three or 0.6%, P < .001). No endocervical component (ie, metaplastic cells, endocervical cells, or mucus) was found in 29 (5.8%) smears from the brush-first group compared with 45 (9.0%) of the spatula-first group, an insignificant difference. More squamous intraepithelial lesions were found when the spatula was used first (55 or 11% compared with 35 or 7.0%, P < .05). CONCLUSION: The quality of the Papanicolaou smear can be improved by using the Ayre spatula first followed by the endocervical brush. Fewer smears will be obscured by blood, which could result in more squamous intraepithelial lesions being detected.     

Cervex-Brush vs. spatula and Cytobrush. A cytohistologic evaluation

OBJECTIVE: To compare the efficacy of two cervical smear instruments, Cervex-Brush and spatula plus Cytobrush. STUDY DESIGN: Cervical smears were taken before laser ring biopsies in 213 women, who were randomized for the Cervex-Brush or spatula plus Cytobrush (S+C). The cytologic diagnosis was compared to the histologic diagnosis after laser ring biopsy. RESULTS: The correlation between cytology and histology showed comparable concordance (54% and 42%) for the two devices. In 130 (74 with Cervex-Brush and 56 S+C) patients, histology revealed moderate dysplasia or more advanced lesions. Those cases were further analyzed for smear failures. Negative smears were found in 13 cases (10 in the Cervex-Brush and 3 in the S+C group). This difference in favor of S+C was not, however, statistically significant. Significantly more false negative smears were found when endocervical cells were absent and in patients 30-39 years of age. CONCLUSION: Modern sampling devices, such as the Cervex-Brush and S+C, seem to be equally efficient in obtaining dysplastic squamous cells. Other factors of importance for nonrepresentative cervical smears should be studied in order to improve efficacy.     

Safety, efficacy and cost of three cervical cytology sampling devices in a prenatal clinic

OBJECTIVE: To evaluate and compare the safety, efficacy and cost of three cervical cytology sampling devices in pregnant women presenting for prenatal care to the obstetrics clinic, at Medical College of Pennsylvania Hospital. STUDY DESIGN: From September 7, 1993, to November 5, 1993, 61 cervical cytologic smears were obtained using the Cell-Sweep. From November 8, 1993, to January 7, 1994, 66 smears were obtained using the Ayre spatula/Cytobrush, and from January 10, 1994, to February 18, 1994, 55 smears were obtained using the Ayre spatula/cotton swab. The rate of smears with no endocervical component or with epithelial cell abnormality was determined for each group. The patients' medical records were reviewed retrospectively to determine complications occurring within two weeks of smear collection. RESULTS: Fifteen (25%) smears in the Cell-Sweep group, one (1.5%) in the Cytobrush group and nine (16%) in the cotton swab group were satisfactory but limited by absence of an endocervical component (P < .0006). None of the smears were unsatisfactory. Eleven (18%) smears in the Cell-Sweep group, eight (12%) in the Cytobrush group and nine (16%) in the cotton swab group revealed an epithelial cell abnormality (P = .643). For all three groups there was a low rate of spontaneous abortion, preterm spontaneous rupture of membranes or preterm labor occurring within two weeks of collection. There was no statistically significant difference in these complications between the three groups (P = .7). The Ayre spatula/cotton swab is the least expensive device. CONCLUSION: The Ayre spatula/cotton swab was the most satisfactory of the three methods tested for obtaining cervical cytology during pregnancy. It is safe and cost-effective and identifies the same proportion of epithelial cell abnormalities as the Ayre spatula/Cytobrush and the Cell-Sweep.     

Quality grading for cervical smears

Three thousand five hundred and eighty cervical smears were taken in 1990-1992 at a Genitourinary Medicine Clinic with various spatula or spatula brush combinations. The unsatisfactory rate and the detection of cellular abnormalities showed some relation to spatula type. However, the satisfactory smears screened in the laboratory are routinely assigned a quality grade-good, fair or poor. Analysis shows higher rate of detection of cellular abnormalities in good quality smears, the detection of dyskaryosis being twice as high, in contrast to the fair or poor quality smears. It is suggested that quality grade is a better way of classifying smear quality in the cervical screening programmes rather than the presence or absence of endocervical and/or metaplastic cells.     

Frequency of endocervical cells in cervical smears and hysterectomy rate of the patients

In gynecologic cytology, different reporting schemes suggest mentioning the presence of endocervical cells or asking for a statement on adequacy. We were interested in the question whether our data could provide a possible basis for discussing a sampling technique with smear takers. At the time of writing, in all cases, both the presence of endocervical cells and hysterectomy are recorded in our laboratory information system. Most smears are taken with cotton swabs, but the sampling technique is often modified according to the clinical situation. In a series of 20,471 cervical/vaginal smears, 2,152 (10.5%) were taken from hysterectomy patients. Among the non-hysterectomy patients, endocervical cells were found in 65% of the cases. Typically, there was a lower frequency of endocervical cells in smears stemming from older women. The frequency decreased from a maximum of 75% in the age group of 40-44 years to 45% in the age group of 65-69 years. With regard to the smear takers, some differences were evident, with age distribution and frequency of hysterectomy being different among the smear takers. In a setting where many smears of hysterectomized patients are examined by cytology, good data quality is required to evaluate the sampling techniques of different smear takers. The age dependence of endocervical cell yield is confirmed. Different age distribution of the patients from different smear takers suggests that the percentage of smears showing endocervical cells cannot be considered an optimal estimator.     

A continuous quality improvement project to improve the quality of cervical Papanicolaou smears

OBJECTIVE: To improve the quality of cervical Papanicolaou smears by continuous quality improvement techniques. METHODS: The study used a Papanicolaou smear data base of over 200,000 specimens collected between June 1988 and December 1992. A team approach employing techniques such as process flow-charting, cause and effect diagrams, run charts, and a randomized trial of collection methods was used to evaluate potential causes of Papanicolaou smear reports with the notation "inadequate" or "less than optimal" due to too few or absent endocervical cells. Once a key process variable (method of collection) was identified, the proportion of Papanicolaou smears with inadequate or absent endocervical cells was determined before and after employment of a collection technique using a spatula and Cytobrush. We measured the rate of less than optimal Papanicolaou smears due to too few or absent endocervical cells. RESULTS: Before implementing the new collection technique fully by June 1990, the overall rate of less than optimal cervical Papanicolaou smears ranged from 20-25%; by December 1993, it had stabilized at about 10%. CONCLUSION: Continuous quality improvement can be used successfully to study a clinical process and implement change that will lead to improvement.     

Efficacy of ThinPrep preparation of cervical smears: a 1,000-case, investigator-sponsored study

The diagnoses of 1,000 pairs of conventional Papanicolaou (Pap) smears and ThinPrep preparations were compared. Cervical cells were collected using an Ayre spatula and endocervical brush. The conventional smear was made first, the collection devices were rinsed into PreservCyt solution, and the slides were prepared using the ThinPrep Processor. The diagnoses of the paired smears agreed in 988 of the 1,000 cases (98.8%), including 949 negatives, 28 atypicals, 9 low grade squamous intraepithelial lesions (LGSIL), and 2 high grade squamous intraepithelial lesions (HGSIL). Five cases where LGSIL or HGSIL was found on the ThinPrep slide were negative or atypical on the conventional smear. No conventional smear abnormalities were missed on the ThinPrep slide. Although not statistically significant, this difference indicates that the ThinPrep method gives a better diagnosis of abnormalities than the conventional method. The ThinPrep method was acceptable to participating physicians and ThinPreps were easier and faster to screen than conventional smears.     

Reducing the threat: an experiential exercise to introduce role play to student nurses

OBJECTIVE: To determine if cervical smears obtained with an Ayre spatula and a cytobrush are better detectors of atypia and dysplasia than the modified Ayre spatula alone, as determined by a 2-year clinical follow-up study. METHOD: Paired cervical samples were obtained, one using a modified Ayre spatula and the other a cytobrush. In those smears with any abnormality, follow-up after 2 years documented subsequent cytologic and/or histologic diagnosis. The statistical relationship between the screening tests and follow-up cytologic diagnosis was investigated. SETTING: Seven hundred ninety-two women, aged 18 years and older, who presented to a family practice residency clinic for Papanicolaou tests. RESULTS: The correlation coefficient for the diagnoses obtained using the modified Ayre spatula and the clinical follow-up was .40 (P = .0008), while the correlation coefficient between the cytobrush samples and the clinical follow-up diagnoses was .25 (P = .04). The kappa statistics indicate statistically significant concordance only between the spatula and the follow-up diagnoses. CONCLUSIONS: Cervical smears obtained with a modified Ayre spatula correlated significantly with the follow-up diagnoses. As cervical sampling tools emerge, they need to be evaluated on the basis of accurate identification of significant clinical disease, not only on the basis of obtaining endocervical cells to avoid unnecessary repetition of screening tests and diagnostic workups.     

Knowledge of the utilization of preventive practices through a telephone survey

OBJECTIVES: To determine knowledge and use of preventive practices (cervical cytology, mammography and taking blood pressure) through a telephone survey. DESIGN: Crossover study. SETTING: Billabona Health Centre (Guipúzcoa). PARTICIPANTS: People over 15 in the Health Centre's catchment area. MAIN RESULTS: The sample size was 800 people. It reached 80% telephone coverage with a reply rate of 86.09% (278 men and 273 women). 76.5% of women stated they had heard of cervical cytology; and 80.2% mammography. 87.5% had had their blood pressure taken on some occasion. CONCLUSIONS: Both cervical cytology and mammography are well-known preventive procedures, although they could always be improved, whereas taking blood pressure is a widespread practice in all age-groups.     

Evolution of atypical gynecological cervical smears in a captive population

BACKGROUND: An atypical cervical smear may represent a wide variety of lesions, from banal diseases to invasive neoplastic lesions. AIM: To study the evolution of atypical cervical smears in a highly controlled women population. MATERIAL AND METHODS: A retrospective analysis of 117 women with atypical cervical smears, diagnosed between 1985 and 1994, was performed at the institutional hospital of a mining corporation in Chile. RESULTS: Patients age ranged from 25 to 65 years. Six percent of atypical cervical smears were associated to Papillomavirus infection and 25% to unspecific infectious agents. In the second smear, during follow up, 22.2% of women had some degree of squamous intraepithelial lesion or signs of Papillomavirus infection. A cervical biopsy was performed to 69 women, confirming the presence of a squamous intraepithelial neoplasia or signs of Papillomavirus infection in 38.4% of them. Only one patient had microinvasion. CONCLUSIONS: All patients with atypical gynecological cervical smears should be closely followed to ascertain the diagnosis.     

Cervical cytology screening: experience of a general hospital

At Henderson General Hospital, Hamilton, a program was introduced whereby cervical smears were taken routinely for cytologic study from all women admitted aged 17 years or older. The procedure was performed by a specially trained nurse. In a 5-year period 53% of eligible patients were screened. Of these, 32% had not had a cervical smear taken before. In 7681 smears nine instances of invasive disease were discovered: three of the cervix, three of the endometrium and three metastatic. There were 20 cases of carcinoma in situ and 2 of severe dysplasia. Evidence of infection was present in a high percentage of the smears. Hospital admission affords an excellent opportunity of applying this valuable screening procedure.     

The significance of endometrial cells in the cervical smear

Presence of atypical endometrial cells in a cervical smear is quite unusual; but if they are found the woman needs extra attention because of the risk of adenocarcinoma of the uterus. Postmenopausal women sometimes also have endometrial cells without atypia in the cervical smear, as a sign of endometrial pathology. We conducted a retrospective follow-up study of these women. From 1978 to 1989, 52 smears from a total of about 50,000 postmenopausal women were classified as Pap IIIA, due to the presence of normal endometrial cells. Histological follow-up was performed in 25 cases and 3 times an adenocarcinoma of the endometrium was diagnosed (6%). The smears from 142 women (pre- and postmenopausal) contained atypical endometrial cells and therefore were classified as Pap IIIA or higher. Histological follow-up was performed in 104 cases. In 48% (n = 68) an adenocarcinoma was diagnosed. In 75% of these cases (n = 51) the atypical cells were graded as severe or worse (> or = Pap IIIB). Cervical smears are not taken to detect pathology of the endometrium, but whenever atypical cells are found in the smear there is a strong indication for further (gynaecological) examination.     

Follow-up of non-negative cervical cytological smears in the county of Funen

The outcome of screening for cervical cancer in the county of Funen was evaluated in two sequential periods (1.7.-31.12.1989 and 1.7.-31.12.1992), comprising 17,493 and 18,135 respectively. About 10.5% of the screened women had a define non-negative smear. From the first and the second period 80% and 85.1% of the non-negative smears respectively were followed up within six months. The follow-up of positive smears was 96% in both periods. Four point nine percent and 3.3% respectively of the non-negative smears were not followed up within 18 months. No women were actually lost in the screening system, unless they renounced further follow-up themselves. The follow-up was improved from the first to the second period, presumably as a result of a better general acquaintance with the screening procedures. The study indicates that reorganization of a screening programme requires both time and adjustment. Moreover, it is important that a successful screening programme frequently adjusts its procedures.     

Human papillomavirus in normal cervical smears from Cape Town

OBJECTIVE: To determine the prevalence of human papillomavirus (HPV) types in South African women with normal cervical cytology and to determine whether our results are comparable to what has been found elsewhere in the world. DESIGN: Cervical smears were collected from 262 women. SETTING: The Cape Town metropolitan area. PARTICIPANTS: A total of 262 women, aged 19-85 years. Eighty-five women attended the family planning clinic of the Gynaecology Department at Groote Schuur Hospital and 177 women consulted private gynaecological practices. MAIN OUTCOME MEASURES: The prevalence and types of HPV in 192 women with normal cervical cytology. RESULTS: The incidence of HPV DNA in cervical smears from Cape Town women with normal cytology was found to be 13% (25/192) using Southern blot hybridisation. The types of HPV found in normal cervical tissue from Cape Town did not differ significantly from those found elsewhere in the world. Nine per cent (17/192) were positive for "high-risk' HPV types which are associated with premalignant and malignant cervical lesions. In the age group 20-39 years, 15 of 92 (16%) were positive for HPV DNA, while in the age group above 39 years, 3 of 53 (6%) women were positive for HPV DNA. CONCLUSIONS: In this study, 25 of 192 (13%) women with normal cytology were positive for HPV.     

Hantavirus pulmonary syndrome treated with inhaled nitric oxide

BACKGROUND: A retrospective study was done to assess the correlation between endometrial cells on routine cervical cytology and carcinoma of the endometrium. METHODS: In a 4-year period, endometrial cells of some type were identified on the Papanicolaou (Pap) smears of 61 women, of whom 52 had further diagnostic evaluation of the endometrium. Data were analyzed with a multivariate stepwise logistic regression. RESULTS: The results indicated an association of endometrial cells in Pap smears with carcinoma of the endometrium in seven patients (13.5%). In 45 patients (86.5%), the final diagnosis was benign. Factors that impacted the diagnosis of carcinoma were the findings of atypical or cancerous endometrial cells on Pap smear and abnormal vaginal bleeding. CONCLUSIONS: These data indicate the importance of further diagnostic evaluation with endometrial sampling in postmenopausal patients with endometrial cells seen in Pap smears, especially those with abnormal bleeding.     

Organised cervical cancer screening still leads to higher coverage than spontaneous screening in The Netherlands

In The Netherlands, early detection of cervical cancer by programme and spontaneous screening has been common practice for more than two decades. Both types of screening are mainly performed by general practitioners. Therefore, the question is raised of whether programme screening still enhances screening uptake. To answer this question, we analysed the national health interview survey in the years 1992-1996. The coverage rate, defined as the percentage of women with at least one smear taken in the previous 5 years, was 91% for women invited for programme screening compared with 68% for women not invited. The performance of the organised programme in reducing excessive screening, i.e. smears taken in excess of the recommended age and interval range, was not clear and the effect seemed small. Furthermore, we found that half the non-attenders were 'protected' by a recent smear or a hysterectomy, and of the unprotected women, 72% showed a positive attitude towards the programme. We conclude that even after a long history of cervical cancer screening, an organised programme is still required to ensure a high coverage.     

Significance of a first-time atypical Papanicolaou smear in a young, high-risk African-American and Latino-American population

The first atypical Papanicolaou smear in young, sexually active Latino and African-American women of low socioeconomic status may be predictive of underlying cervical neoplasia and human papillomavirus infection of significant quantity. The optimal management of first-time atypia on routine Pap smear has not been established. In many clinics, colposcopically directed sampling of the cervix is recommended only if atypia persists following specific or nonspecific treatment of cervicitis or after an arbitrarily determined time interval. Others recommend immediate colposcopic evaluation. To determine the best approach to the first-time atypical Pap smear in young minority women at high risk for the development of cervical cancer, 250 such patients were evaluated with colposcopically directed biopsy of the cervix prior to any form of therapy. Pap smears were repeated at the time of colposcopy. Histologically, there was evidence of cervical intraepithelial neoplasia in 41% of patients and human papillomavirus infection in 86%. Repeat Pap smears predicted the presence of cervical intraepithelial neoplasia in only 24% of patients. Immediate colposcopic evaluation represents the most prudent approach to the first-time atypical Pap smear in young, high-risk minority women.