A randomized control trial of two cervical spatulas

Summary. The sampling efficacy of the Ayre and Rocket cervical spatulas was compared in a randomized controlled trial involving 533 women who were attending a colposcopy clinic either for investigation of cytological abnormality or for review after treatment of CIN. Smears were compared with respect to the presence of cytological abnormality and two types of normal cervical epithelial cells (endocervical and immature metaplastic cells) which are considered indicators of adequate cytological sampling. Smears taken with the Rocket spatula were significantly less likely to contain immature metaplastic cells (95% CI on difference in proportion; 5–30%), but more likely to contain endocervical cells (95% CI 16–36%). No significant difference was found in the proportion of smears containing one or other type of indicator cell or in the yield of abnormal smears. It is concluded that the Rocket spatula offered no advantage when used in these circumstances. This study illustrates how spurious conclusions of sampling efficacy can be drawn if only one type of indicator cell is used as an endpoint.     

The cytological detection of persistent cervical intraepithelial neoplasia after local ablative treatment: a comparison of sampling devices.

OBJECTIVE: To determine whether the cytological detection of persistent cervical intraepithelial neoplasia (CIN) after local ablative treatment is improved by the use of sampling devices other than the Ayre's spatula. DESIGN: A randomized controlled study. SETTING: Lothian Area Colposcopy Clinic. SUBJECTS: 856 patients who had received local therapy (CO2 laser or cold coagulation) for CIN II or III between 9 and 30 months earlier. INTERVENTION: Each patient had three consecutive cervical smears taken, one with the Ayre's spatula, one with either the Aylesbury, the Rocket or the Multispatula device, and finally one with the Cytobrush. The allocation of which spatula and the order of the first two was randomized. Each patient had a colposcopic examination immediately after the smears were taken. MAIN OUTCOME MEASURES: A comparison of the detection of histologically proven persistent CIN by the Ayre's spatula with the detection of persistent disease by alternative sampling devices. RESULTS: Of the 856 patients 130 had histologically proven persistent CIN. Another 98 had suspicious findings on colposcopy but punch biopsies reported as histologically normal. Of the remaining patients with normal colposcopy 130 were randomly selected to form a control group. The cervical smears from these 358 women were reported. Significantly fewer Ayre's samples contained endocervical cells than Aylesbury samples (47% vs 59%, difference 12%; 95% CI 3%-21%; P less than 0.001), Rocket samples (47% vs 67%; difference 20%, 95% CI; 12%-32%; P less than 0.001) or Multispatula samples (47% vs 76%; difference 29%, 95% CI 19-38%; P less than 0.001). When punch biopsies contained CIN, dyskaryotic cells were seen in 10% of Ayre's samples, 4.3% of Aylesbury samples, 8.3% of Rocket samples, and in no smear taken with the Multispatula. Obtaining a third smear with the Cytobrush did not substantially improve the detection rate of dyskaryosis. Neither the order of use of the spatulas, the form of initial treatment nor the size of the transformation zone had any apparent effect on the cytological detection of persistent CIN. CONCLUSIONS: We recommend that surveillance of patients who have received local ablative therapy for CIN should be by both cytology and colposcopy, and that cytological samples should be obtained using the Ayre's spatula.     

The efficiency of the cytobrush and cotton swab in obtaining endocervical cells in smears taken after conization of the cervix

Summary In a randomised study of cervical smears after conization, the efficacy of the combined wooden spatula and cytobrush was compared with that of the combined wooden spatula and cotton swab. The conization technique involved a could knife and two Sturmdorf sutures. A total of 75 women participated, 57 had smears taken with both methods. Eigtheen with only one of the methods. Out of 66 taken with a wooden spatula and a cytobrush. 48 (72.7%) contained endocervical cells and 53 (80.3%) contained either endocervical or metaplastic cells. Out of 66 smears taken with a wooden spatula and a cotton swab, only 25 (37.9%) contained endocervical cells and 40 (60.6%) contained endocervical or metaplastic cells. Both differences were significant (P<0.001 andP<0.05, respectively). The combined use of a wooden spatula and cytobrush is recommended for cytological smears after conization.     

Improving the quality of cervical screening

OBJECTIVE: To compare the adequacy of cervical cytology sampling by a newly designed cervical cell sampler (the implement) with a commonly used, extended tip cervical scraper, namely the Jordan's spatula, by assessing the quality of cervical smears obtained. DESIGN: Prospective randomised controlled trial, with the approval of the local Ethics Committee after informing the Medical Devices Agency in the UK. SETTING: Colposcopy Clinic in a District General NHS Trust Hospital in London. POPULATION: Women attending the Colposcopy Clinic and having a good command of the English language (to avoid any misinterpretation of the information and enabling them to give informed consent) were invited to take part. Two hundred and twenty patients were recruited. METHODS: The women were randomised into two groups, each of them having two smears at the same time, half of them having their first smear with the Jordan's spatula and the other half having the first smear with the new implement. MAIN OUTCOME MEASURE: Good quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. RESULTS: Fifty-four percent of smears taken by the new implement showed good quality smears, compared with 37% taken by Jordan's spatula, a statistically significant result with P value <0.001. CONCLUSION: A larger number of good quality smears, judged by evidence of sampling of transformation zone and presence of endocervical cells, were obtained with the new implement. The difference was statistically significant. This would enhance the ability to detect dyskaryosis and increase adequate smear rates, reducing unnecessary recall of patients for repeat smears.     

Nylon brush improves collection of cervical cytologic specimens

A prospective, randomized study was performed to compare the efficacy of a combined endocervical and ectocervical nylon brush with the cotton-tipped swab and wooden spatula for obtaining cervical cytologic specimens. Strict objective criteria were used to determine the adequacy of Papanicolaou smears on the basis of the number of cells present. The two methods were equally effective in collecting ectocervical smears. However, 96% of endocervical smears obtained with the nylon brush contained greater than 50 cells, compared with 58% of swab and spatula smears. Only 1.4% of brush samples contained no endocervical cells, versus 19% of swab and spatula smears. The presence of endocervical cells confirms adequate sampling of the transitional zone. Use of the cytologic Papanicolaou brush may result in fewer false negative and inadequate Papanicolaou smears.     

Geographical variations in the sampling quality of cervical smears.

It is generally accepted that cervical smears are adequately sampled when they contain endocervical and/or metaplastic cells. An extensive literature search via MEDLINE and FAMLI for papers on cervical smears yielded 33 articles providing explicit information both on the country where the study was executed and on the relationship between the adequate sampling of smears and the sampling method used. The correlation between the geographic origin of cervical smears and the proportion of those smears that were adequately sampled was examined. The results were controlled for the sampling method. It was found that the proportion of adequately sampled smears reported in studies in the U.K. is exceedingly low, in contrast with the proportion reported from The Netherlands. The differences between the various countries studied are stable over different sampling methods. It is suggested that, in order to ameliorate the sampling quality of cervical smears, factors associated with the working conditions in particular regions also need be considered.     

Should the Cytobrush be used in routine screening for cervical pathology?

In 632 women visiting a family planning clinic, paired cervical smears were taken using a wooden spatula and a Cytobrush. Of the spatula smears 7.8% were unreliable with too little or scanty material to allow a cytologic diagnosis (class 0); 17.7% of spatula smears were inadequate, lacking endocervical cells. Combined spatula/Cytobrush cytology reduced these figures significantly; 4.3% unreliable smears and 3.2% inadequate specimens. Seventy-three (11.6%) of the smears revealed some abnormality, in most cases Papanicolaou class IIIA, suggestive of mild dysplasia. In 10 cases, dysplastic cells were found only in the Cytobrush cytology. It is concluded that the Cytobrush adds to the improvement of smear quality and the accuracy of routine cervical cytology obtained by relatively inexperienced smear takers.     

Comparación del cepillo endocervical y la torunda de algodón para la toma citológica cervical

ObjectiveTo compare the quality and diagnostic yield of cervical cytologic sampling according to the Bethesda System 1988–1991 based on the use of an endocervical brush or cotton swab.Material and methodsWe performed a randomized study of 595 women distributed in two groups. Cervical sampling was performed with a cotton swab and wooden spatula in group A (305 women) and with a cervical brush and wooden spatula in group B (290 women).ResultsThere were no statistically significant differences in the clinical or demographic features of the two groups. No differences were found in the effectiveness of the two sampling methods in detecting cytological alterations or collection of endocervical cells. Satisfactory smears for interpretation were obtained using both methods.ConclusionNo change in the traditional method of cervical sampling is required. Attempts to improve the quality and false-negative rate of samples should focus on other features.     

Importance of endocervical cells in the diagnosis of CIN]

BACKGROUND AND AIM: The authors performed a comparative study to define the role played by the presence of endocervical cells on the smear in the correct diagnosis of CIN. METHODS: The study was performed from January to December 1996 at the Clinic of Obstetrics and Gynecology of the Second University of Naples and involved 67 women with a histological diagnosis of CIN made in the two previous months of the study. The smears taken earlier were re-examined to assess the endocervical component regarding columnar and metaplastic cells and a comparison was made between smears which were CIN-positive and negative. RESULTS: The difference between positive and negative CIN smears was statistically non-significant for columnar cells (66% vs 56%), unlike the findings for metaplastic cells (82% vs 61%). This demonstrated that CIN smears are more likely to include metaplastic cells compared to negative smears and the two types of smear do not differ significantly with regard to columnar cells. CONCLUSIONS: In order to make a cytological diagnosis of CIN, attention must predominantly be focused on the metaplastic component of endocervical cells.     

Comparison of cervical smears secured with different instruments

BACKGROUND: In this presentation we have compared the results from cytologic samples obtained with the cervical brush and Ayre's wooden spatula, against samples obtained with Acellon Combi. METHODS: One thousand cervical smears were collected. This was a cross-sectional study, where it was decided randomly to use cervical brush for sampling of the endocervix and Ayre's wooden spatula for exocervix or Acellon Combi for both. RESULTS: The combination of the cervical brush and the wooden spatula yielded an acceptable quantity of columnar cells in 71.6% of the cases, during both endocervical and exocervical sampling, while the Acellon Combi yielded an acceptable quantity in 61.7% of the cases (p<0.01). The combination of brush/spatula yielded an acceptable quantity of squamous cells from samples of endocervix and exocervix in 87.5% cases, while with the Acellon device amounted to 77.4% (p<0.001). Highly significant differences in the state of cellular preservation of samples from endocervix obtained with cervical brush technique were found upon comparison to Acellon group. CONCLUSIONS: Henceforth, we believe that the use of the cervical brush and the Ayre wooden spatula increases the quantity and preservation of the cells retrieved during cervical smears compared to Acellon Combi.     

A Randomized Comparison of the 3 Papanicolaou Smear Collection Methods

Summary: 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 × 10^-6, p=4.49 × 10^-7 respectively). There was no statistically significant difference between the Cytobrush-spatula and Cervex brush groups (p=0.0779). We concluded that the Cytobrush-Ayre spatula and the Cervex brush sampling methods were equally effective in obtaining endocervical cells in Papanicolaou smears.     

Evaluation of smears obtained by cervical scraping and an endocervical swab in the diagnosis of neoplastic disease of the uterine cervix.

A study of the supplementary value of an endocervical swab smear in addition to cervical scraping in the cytological diagnosis of cervical neoplasias is presented. The two sampling techniques were applied to a population with a high prevalence of neoplastic cervical disease. The endocervical swab smear was a useful adjunct in the detection of mild and moderate dysplasia, and a combination of the two sampling methods decreased the false negative rate in the diagnosis of intraepithelial, as well as invasive neoplasia. In the sphere of specific cytological diagnosis cervical scraping was found to be the more accurate method for diagnosing severe dysplasia and carcinoma in situ, while endocervical swab smears were more useful in diagnosing mild and moderate dysplasia. Differences between the results obtained in our study and comparable studies are discussed. It is concluded that the endocervical swab smear is a valuable adjunct to cervical scraping in the diagnosis of malignant cervical disease. It should not, however, be used as the only sampling method as it produces a higher proportion of unsatisfactory smears, and also because the severity of the epithelial lesion is more likely to be underestimated.     

The quality of the Pap smear.

Three methods of cervical Pap smear have been studied: the classical spatula, the combination of spatula and cytobrush, and the Cervex-Brush. Thirty-two percent of the spatula smears did not provide endocervical cylinder cells. Significantly better results can be achieved by performing the smear with a combination of spatula and cytobrush (11% without cylinder cells), or with Cervex-Brush (15% without cylinder cells). Cervical smears using a spatula alone are therefore discouraged.     

The screening Papanicolaou smear: contribution of the endocervical brush

Between September 1984 and February 1985, cervical cytologic smears were collected from 510 patients using a spatula and an endocervical swab. These smears were compared with those collected from 510 patients between September 1985 and February 1986 using a spatula and an endocervical brush. The use of the endocervical brush increased the number of smears that contained endocervical cells, for both reproductive-age and postmenopausal women. In women without previous radiation therapy, the rate of suboptimal smears (those without endocervical cells) fell from 12.0 to 1.7% when the endocervical brush was used. This modified smear collection technique improved the quality of the cytologic material.     

A randomized clinical trial comparing the Cytobrush and cotton swab for Papanicolaou smears.

OBJECTIVE: We sought to determine whether use of the Cytobrush/spatula or the cotton swab/spatula is better in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. METHODS: This 1-year randomized trial was performed at the Los Angeles County + University of Southern California Women's Hospital colposcopy clinic. Participants were all nonpregnant patients referred to the colposcopy clinic for abnormal Papanicolaou smears. The main outcome measurement was the effectiveness in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. Data were analyzed using the Pearson chi 2 test. RESULTS: The sampling methods had similar abilities to obtain a satisfactory smear (Cytobrush/spatula 63%, cotton swab/spatula 57%; P = .23). Less-than-optimal smears accounted for 28% of the Cytobrush group and 38% of the cotton-swab group. The Cytobrush was superior in its ability to obtain endocervical cells (Cytobrush 80%, cotton swab 60%; P less than .01). Both sampling methods had similar rates of correlation with histologic diagnosis. No complications were associated with either technique. CONCLUSIONS: The Cytobrush/spatula is superior to the cotton swab/spatula in obtaining endocervical cells. There appears to be no difference in each method's ability to obtain satisfactory smears. Application of the Bethesda System results in a significant number of less-than-optimal smears using either technique.     

Glandular abnormalities on cervical smear: a study to compare the accuracy of cytological diagnosis with underlying pathology

The interpretation of glandular abnormalities detected by cervical smear provides a diagnostic dilemma. This study aims to compare the accuracy of cytological diagnosis with underlying pathology so that guidelines for the investigation and management of abnormal glandular smears may be formulated. A retrospective review of 150 women with glandular abnormalities reported on cervical smear collected over 12 months from 1996 in a University hospital was performed. Smears were graded by the initial report into 3 groups, dependent on the severity of abnormality. Investigation, treatment and subsequent 3-year follow-up were recorded. The accuracy of prediction for a significant neoplastic or preneoplastic glandular pathology only was 0% with mild, 9% (3/35) with moderate, and 24% (9/38) with severe abnormalities. When squamous lesions were included, the chance of finding any dysplastic squamous or glandular abnormality was 16% (12/77), 51% (18/35) and 82% (31/38), respectively, following a smear showing a suspected glandular abnormality only. Our results highlight the poor specificity of predicting glandular neoplasia or preneoplasia from cervical smears, with a final diagnosis of high grade CIN in 35% (17/49) of patients with dyskaryotic glandular cytological changes only and 83% (20/24) where concomitant squamous dyskaryosis was reported. The reporting of reactive or minor changes in endocervical cells was of no diagnostic value. Management protocols for moderate and severe glandular abnormalities should include visualisation and biopsy of the uterine cavity to exclude endometrial neoplasia.     

Performance of the Cytobrush in patients at risk for cervical pathology: does it add anything to the wooden spatula?

In 130 high-risk patients for cervical pathology paired smears were obtained with a wooden spatula and a Cytobrush. The Cytobrush was useful in lowering the amount of inadequate smears (2 vs 22%, p less than or equal to 0.01), and detected more abnormal cytology in combination with the spatula compared to the spatula smear alone (27 vs 35%, p less than or equal to 0.05). In 6 cases, adequate false-negative spatula smears, containing endocervical cells, were corrected by the Cytobrush. It is concluded that the Cytobrush is useful in lowering the amount of inadequate smears and false-negative cytology, while there is little evidence of false-positive cytology. The use of the wooden spatula/Cytobrush-combination is recommended in high risk populations.     

A comparative study of two devices used for cervical cell sampling raises some doubts about liquid-based cytology

The objective of this study was to compare the quality of smears obtained by a newly designed cervical cell sampler (the implement) to those obtained with the cervex brush, using liquid-based cytology (LBC). A prospective randomized controlled trial with the approval of the local ethics committees after informing the Medical Devices Agency in the UK was used in this study. The study was carried out in colposcopy clinics in two district general NHS Trust Hospitals in London. A total of 200 women were recruited (100 from each hospital). The women were randomized into two groups, each of them having two smears at the same time. One hundred (50%) of the women had their first smear with the new implement, and the other 100 (50%) had their first smear with the cervex brush. The main outcome of this study is good-quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. Eighty-five percent of the smears taken by the new implement showed good-quality smears compared to 91% of those taken by the cervex brush, a statistically marginally nonsignificant result, with P value = 0.052 (McNemar exact test). A larger number of good-quality smears, judged by evidence of sampling of transformation zone, were obtained with the cervex brush, though the difference was statistically marginally nonsignificant, using the British society for clinical cytology criteria. Surprisingly, despite the use of LBC, there was a higher rate of inadequate smears obtained with both the devices (8% with each) compared to our previous study using the conventional slide test (1.3% with the new implement and 1.8% with the Jordan's spatula).     

Evaluation of atypical glandular cells of undetermined significance: Is age important?

OBJECTIVE: Our purpose was to assess the effect of age on the incidence of significant pathologic findings in patients with atypical glandular cells of undetermined significance.Study Design: This retrospective study evaluated nonreferred patients with Papanicolaou smears showing atypical glandular cells of undetermined significance over a 5-year period. RESULTS: Two hundred eighty-one women (91%) with Papanicolaou smears showing atypical glandular cells of undetermined significance were available for follow-up. Significant abnormality was found in 90 subjects (32%), including 31 women (11%) with cancer. Older patients (> or =50 years old) have lower odds of high-grade cervical dysplasia (odds ratio = 0.21; 95% CI: 0.32-0.40) and higher odds of uterine cancer (odds ratio = 12.88; 95% CI: 1.78-567.60) compared with younger patients. CONCLUSIONS: Women with Papanicolaou smears showing atypical glandular cells of undetermined significance have a 1 in 3 chance of having significant abnormality. Evaluation includes colposcopy, endocervical curettage, and appropriate cervical biopsies. Patients >45 years require endometrial biopsies.     

Comparison of the ThinPrep monolayer technique and conventional cervical Pap smears in a high-risk population using the Munich II nomenclature

OBJECTIVE: In this prospective study using the Munich II nomenclature for cervical cytology. Pap smear results obtained by the ThinPrep monolayer technique and those obtained by the conventional method were compared. METHODS: Pap smears were obtained from 1,000 women using an Ayre spatula/endocervical brush combination. Following transfer of the cell sample onto a slide, the same collection devices were rinsed in a liquid medium and processed using ThinPrep-2000 processor (split-sample technique). RESULTS: Specimen inadequacies due to drying artefacts, cell overlap or low number of epithelial cells were rare with both methods without any significant differences. However, ThinPrep slides were significantly less often compromised by red or white blood cells or by cytolysis. In contrast, endocervical cells were missing in 11.6% of slides compared to only 2.3% in conventional Pap smears. ThinPrep yielded results of unknown significance (Pap III) significantly less often (4.2 vs 6.3%). CONCLUSIONS: ThinPrep slides are less frequently compromised by blood components or cytolysis. Inconclusive results of Pap III are slightly less frequent when using ThinPrep. However, there is a significant percentage of slides lacking the endocervical component. Using a combination of spatula and cytobrush, this may not necessarily be due to non-representative cell sampling.