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PubMed2005

Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel.

BACKGROUND: An expanded Phase I trial was performed to assess the safety and acceptability of 6% cellulose sulfate gel (CS) in comparison with K-Y Jelly. METHODS: Sexually abstinent (cohort I) and sexually active (cohort II) women in India, Nigeria and Uganda applied 3.5 ml of either 6% CS gel or K-Y Jelly for seven consecutive days. Safety was assessed by symptoms and signs (including colposcopy) of genital irritation, review of adverse events, and by changes in vaginal health as assessed by microscopy. RESULTS: One hundred and eighty women (90 on CS and 90 on K-Y Jelly) were enrolled. Baseline characteristics of women in both gel groups were similar. In cohort I, six (14%) women on CS and 12 (27%) on K-Y Jelly reported genital symptoms, two (in K-Y Jelly group) of whom withdrew from the study. New colposcopy findings or findings showing deterioration were detected in four (9%) women on CS and nine (21%) women on K-Y Jelly in cohort I. Two women on CS and three on K-Y Jelly in cohort II reported genital symptoms. Five women (11%) in each gel group in cohort II had new colposcopy findings or findings showing deterioration. The differences between the gel groups were not statistically significant. The majority of women had no problem with their assigned product. CONCLUSION: A vaginal application of 6% cellulose sulfate twice daily for seven consecutive days is as safe and well tolerated as a similar regimen of K-Y Jelly. Further development of 6% CS for prevention of HIV and pregnancy is recommended.

Administration, Intravaginal↗
PubMed2004

Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening.

Human papillomavirus (HPV) DNA testing was recently approved by the Food and Drug Administration for use as an adjunct to cytology for cervical cancer screening. To help provide guidance to clinicians and patients when using HPV DNA testing as an adjunct to cervical cytology for screening, a workshop was cosponsored by the National Institutes of Health-National Cancer Institute, American Society of Colposcopy and Cervical Pathology (ASCCP), and American Cancer Society. Consensus was reached based on a literature review, expert opinion, and unpublished results from large ongoing screening studies. The conclusions of the workshop were that HPV DNA testing may be added to cervical cytology for screening in women aged 30 years or more. Women whose results are negative by both HPV DNA testing and cytology should not be rescreened before 3 years. Women whose results are negative by cytology, but are high-risk HPV DNA positive, are at a relatively low risk of having high-grade cervical neoplasia, and colposcopy should not be performed routinely in this setting. Instead, HPV DNA testing along with cervical cytology should be repeated in these women at 6 to 12 months. If test results of either are abnormal, colposcopy should then be performed. This guidance should assist clinicians in utilizing HPV DNA testing in an effective manner, while minimizing unnecessary evaluations and treatments.

Adult↗
PubMed2005

Adherence to guidelines for follow-up of low-grade cytologic abnormalities among medically underserved women.

OBJECTIVE: To determine whether women in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) who had findings on a Papanicolaou (Pap) test of atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL) were followed up in accordance with the interim guidelines for management of abnormal cervical cytology. METHODS: For this study period, the guidelines for a Pap result of ASC-US or LSIL specified follow-up by Pap tests repeated every 4 to 6 months for 2 years. If a second report of ASC-US or LSIL was made, the patient was to have colposcopy. We analyzed data from 10,004 women who had a result of ASC-US or LSIL followed by a second ASC-US or LSIL from 1991-2000. RESULTS: As judged by the guidelines, 44% of women who had 2 low-grade abnormalities were followed up appropriately with colposcopy. Among women with 2 ASC-US results, those aged less than 30 years were more likely to receive colposcopy than the other age groups, while women who were aged 60 years and older were more likely to be followed up with a third Pap test. For each of the 4 result groups, American Indian or Alaska Native women had the highest percentages of a third Pap test, whereas Black or African-American women had a higher percentage of no follow-up. CONCLUSION: More than one half of the women studied were not followed up in accordance with the established guidelines for managing abnormal cervical cytology. Factors such as age and race or ethnicity influence whether women with cytologic abnormalities receive appropriate follow-up.

Adult↗
PubMed2005

Risk of high-grade cervical intraepithelial neoplasia among young women with abnormal screening cytology.

OBJECTIVE: To estimate the risk of high-grade cervical disease among teenage women with abnormal cytology. METHODS: Retrospective analysis of a prospectively collected database of females undergoing colposcopy for abnormal screening cytology in an urban dysplasia clinic. RESULTS: Among 211 eligible teens, high-grade squamous intraepithelial lesions were found in 17 (8%) on referral cytology and 4 (2%) on repeat cytology. High-grade cervical intraepithelial neoplasia was found in colposcopic biopsy specimens 30 (15%) of young women; no patient had cancer. Age, referral Pap, ethnicity, parity, HIV serostatus, history of other sexually transmitted infections, smoking, oral contraceptive use condom use, use of medroxyprogesterone, age at first intercourse, and the number of years since first intercourse did not predict increasing risk of high-grade cervical intraepithelial neoplasia (CIN). In logistic regression, both number of partners > or = 5 (p = 0.003) and a finding of any squamous intraepithelial lesion in a Pap test repeated at colposcopy (p = 0.025) were significant predictors of CIN 2,3, though the predictive value of the model was weak (R = 0.12). CONCLUSION: Only 15% of teens with abnormal cytology have high-grade CIN. Colposcopy may be most appropriate for those with multiple partners and squamous intraepithelial lesions on repeat Pap.

Adolescent↗
PubMedDate not supplied

Visual inspection with acetic acid as a feasible screening test for cervical neoplasia in Iran.

The aim of this study was to estimate the sensitivity and specificity of visual inspection of the uterine cervix with acetic acid (VIA) as a screening test for cervical carcinoma and its precursors. One thousand and two hundred eligible women were screened by VIA and Papanicolaou smear. Those positive on one or both of these screening tests (n = 308) or those who had clinically suspicious lesions, even if the tests were negative [25% of remainders (n = 290)], were referred for colposcopy. Three hundred and fifty five of 598 women at colposcopy underwent biopsies or endocervical curettage. Those with cervical intraepithelial neoplasia I (CIN I) or worse lesions, diagnosed by histology, were considered true positive. VIA was positive in 191 women (16.1%). In 175 true-positive cases, VIA detected 130 cases, yielding a sensitivity of 74.3% and a specificity of 94%. By considering atypical squamous cell of undetermined significance or worse lesions on Papanicolaou smear as referring threshold for colposcopy, the sensitivity and specificity of cytology were 72 and 90.2%, respectively. In conclusion, the sensitivity and specificity of VIA is high and comparable with that of cytology. Hence, VIA can be undertaken as a feasible method of screening in cervical cancer in countries where access to cytopathology is limited.

Acetic Acid↗
PubMed2006

Balancing uncertainty and acceptance: understanding Chinese women's responses to an abnormal cervical smear result.

AIMS AND OBJECTIVES: The aims of this study were to examine the responses of Hong Kong Chinese women receiving an abnormal smear result and to compare any differences in responses depending on the diagnosis of the abnormal smear. BACKGROUND: The implementation of cervical screening programmes has resulted in an increasing number of women receiving an abnormal smear result requiring cytological surveillance or referral for colposcopy. Evidence suggests that women frequently misunderstood such results, believing that they already have cancer. However, little is known about the responses of Chinese women in this situation. DESIGN: An exploratory qualitative study. METHODS: Face-to-face semi-structured tape-recorded interviews were undertaken with 66 women sampled opportunistically from an urban centre of a major non-governmental service provider. Amongst this sample, 22 women required cytological surveillance, 20 required treatment for vaginitis and 24 were referred for colposcopy. Thematic analysis was undertaken of the translated interviews within and across groups to identify categories and themes illustrating women's responses to an abnormal smear result. FINDINGS: An important difference in the comparison of the data sets was that of women's understanding of the cause of the abnormal result. Women with vaginitis understood the cause of their abnormality, whereas those in the other groups remained unclear about their abnormality, generating feelings of fear and uncertainty. Trust in practitioners influenced women's acceptance of the result. CONCLUSIONS: Although responses of Chinese women are similar to those in other population groups, with those referred for colposcopy experiencing greater anxiety than those undergoing cytological surveillance, balancing feelings of uncertainty and acceptance influenced Chinese women's responses to their abnormal results and allowed them to make sense of their result in their everyday life. Trust in the practitioner was essential to the acceptance of their result. RELEVANCE TO CLINICAL PRACTICE: Such findings highlight implications for nursing practice, in particular developing information-giving strategies and targeted information to help women manage feelings of uncertainty. The importance of trusting professional relationships in determining women's acceptance of an abnormal result is also highlighted. The findings suggest nurses working with Chinese women should consider the underlying influence of culture on women's beliefs and actions.

Adaptation, Psychological↗
PubMed1992

Patterns and implications of subclinical vulval human papillomavirus infection: the impact of PCR analysis.

This study was performed to elucidate the presence of human papillomavirus (HPV) infection of the vulva by colposcopy, histology and the polymerase chain reaction (PCR). Colposcopy defined 5 patterns of vulval epithelial lesions inconspicuous to the naked eye. Of these 75 subclinical vulval lesions, HPV infection was diagnosed by histology in 20.0% of minor epithelial changes with faint acetowhitening, 52.2% of conspicuous acetowhite lesions, 63.0% of acetowhite areas with satellite lesions, 84.6% of villous lesions, and 85.7% of villous lesions with surrounding acetowhitening. The corresponding HPV DNA positivity rates by PCR were 60.0%, 73.9%, 70.4%, 84.6% and 100% respectively. The oncogenic HPV type 16 was detected by PCR in 37.3% of the samples. These results provide firm evidence for the prevalent existence of subclinical HPV lesions of the vulva. Some of these infections may not produce significant morphologic changes detectable by colposcopy or histology. Subclinical vulval lesions are common and may constitute a reservoir for repeated cervical HPV infections, as well as a source of contamination of cervical samples for HPV DNA detection by sensitive molecular techniques.

Base Sequence↗
PubMed1997

Dense acetowhite: a high grade lesion?

To describe the ability of colposcopy in predicting the high grade squamous intraepithelial lesion (SIL) a retrospective, descriptive study was undertaken from January 1, 1993 until November 30, 1995. Agreement between colposcopy and histology results was described in unweighted Kappa. Agreement between colposcopy diagnosis and histology results taken from the dense acetowhitening areas was poor (Kappa 0.5). This agreement will be higher in areas of acetowhite that has an abrupt peeling margin in 72/74 cases. It seems that dense acetowhite areas showed high grade lesions in most of cases observed especially if they had also abrupt peeling margin.

Cervix Uteri↗
PubMed1992

Cone biopsy: has endocervical sampling a role?

OBJECTIVE: To investigate the sensitivity, specificity and predictive value of endocervical sampling in women with abnormal cervical smears. DESIGN: A randomized study of two methods of endocervical sampling. SETTING: Colposcopy clinic at Aberdeen Royal Infirmary. SUBJECTS: 100 women with abnormal cervical smears selected for cone biopsy according to current colposcopy criteria. INTERVENTIONS: 53 women were randomized to have endocervical sampling with the Kevorkian curette and 47 to have sampling with the Medscand endocervical brush. MAIN OUTCOME MEASURES: Cytology and histology results from endocervical sampling compared with cone biopsy histology. RESULTS: The overall sensitivity of endocervical sampling was 56%, with a false negative rate of 44% and a negative predictive value of 26%. CONCLUSIONS: Endocervical sampling should not influence management when colposcopy is unsatisfactory.

Adult↗
PubMed2005

Detection of cervical intraepithelial neoplasia using impedance spectroscopy: a prospective study.

OBJECTIVE: To compare cervical impedance spectrometry in the cervical epithelium of women with cervical intraepithelial neoplasia (CIN) and normal epithelium. DESIGN: Prospective observational study. SETTING: Colposcopy clinic, Jessop Wing, Royal Hallamshire Hospital, Sheffield, UK. POPULATION: Eighty-seven women referred to colposcopy with a moderate or severely dyskaryotic smear. METHODS: A pencil probe incorporating four gold electrodes was used to measure an electrical impedance spectrum from cervical epithelium. Colposcopy examinations, including probe positioning, were recorded by video to allow for correlation between results obtained from colposcopic impression, histopathological examination of colposcopically directed punch biopsies and the impedance measurements. MAIN OUTCOME MEASURES: Cervical impedance derived parameters R, S and C were assessed to see if there was a significant difference in values obtained in CIN and normal squamous epithelium. Analysis was based upon matching the electrical components measured to those identified by cellular modelling as being most sensitive for premalignancy. RESULTS: From normal epithelium through CIN 1 to CIN 2/3, R decreased by a factor of 4.5, S increased by a factor of 2.5 but C remained unchanged. CONCLUSIONS: Cervical impedance spectrometry provides a potentially promising screening tool with similar sensitivity and specificity to currently used screening tests, but with the potential advantage of providing instant results. Further work is currently being undertaken to improve the probe in its clinical use.

Area Under Curve↗
PubMed1995

The significance of mild squamous atypia on cytology.

Between January, 1991 and February, 1993 inclusive, 396 Papanicolaou smears were reported to show Mild Squamous Atypia with or without Human Papilloma Virus (MSA +/- HPV). All women with MSA +/- HPV smears were routinely recalled for colposcopy. To determine the significance of MSA +/- HPV on routine smear screening, the records of all patients were reviewed. Three hundred and thirty-seven women (85.1%) attended the colposcopy clinic and are the subjects analyzed for this report. The remaining 59 (14.9%) failed to attend. Intraepithelial neoplasia was found in 61 patients (18.1%), of whom 27 (8.0%) had a high grade lesion (CIN 2 or 3 or GIN 2). No patient had invasive cancer of the cervix. Only 1 of the 45 pregnant women had a significant lesion. It is concluded that all asymptomatic women with MSA +/- HPV on cervical smear may be managed in accordance with the current NH and MRC recommendations (1) and have a repeat smear in 6 months and colposcopy if the abnormality persists at 12 months.

Adult↗
PubMed2001

Notification of Papanicolaou smear results: a survey of women's experiences and preferred means of notification.

In a population of Australian women attending a colposcopy clinic, we aimed to establish the method by which they were notified of their Pap smear result, who notified them of their result, and if given the choice, how they would prefer to be notified. Of women attending a colposcopy clinic between October 1998 and June 1999, 59.7% participated in the survey. There was a final sample of 210 women after exclusion of questionnaires with missing data. The doctor most often notified women of their Pap smear result (81.7%). The usual methods of notification were by a follow-up appointment (43.1%), by a telephone call (35.8%) or with a letter (13.8%); 42% of women preferred to be notified with a mailed copy of the report and explanation of follow-up; 29.6% preferred to be telephoned with the result, and 11.3% would prefer a follow-up appointment. Women preferred methods of notification which were initiated by the doctor. Women have varying preferences, which commonly differ from the current services provided by both GPs and colposcopy clinic. To overcome this, women could be asked to nominate their preferred method of notification when completing the cervical smear request form.

Adolescent↗
PubMed2005

Comparison of a self-administered tampon ThinPrep test with conventional pap smears for cervical cytology.

AIM: To assess a self-administered tampon specimen as an alternative method of detecting cytological abnormalities and its acceptability in comparison with a conventional Papanicolou (pap) smear. DESIGN: Comparative observational study. SETTING/POPULATION: Two hundred and seventeen women were recruited from the colposcopy clinic of an outer urban public teaching hospital and from sexual health clinics at suburban and major metropolitan hospital clinics. METHODS: Participants inserted and immediately withdrew a tampon, then placed it into a vial of ThinPrep PreservCyt fluid. This was analysed by a local private pathology laboratory. Results were compared to a pap smear performed the same day or within the previous 6 months. All women with an abnormal result (tampon or pap smear) underwent a colposcopy, with or without biopsy as necessary. Participants completed a questionnaire after performing the tampon test. OUTCOME MEASURES: Probabilities of tampon test detecting (i) a high grade abnormality (pHG), (ii) any cervical intraepithelial neoplasia (CIN) changes (pCINany), and (iii) any abnormalities (pabn) compared to the conventional pap smear and, if abnormal, compared to the biopsy taken at colposcopy. Acceptability of the tampon test and conventional pap smear were also measured. RESULTS: Probabilities of the tampon test compared to pap smear: pabn sensitivity 33%, specificity 89%, PPV 59%, NPV 73%; pCINany sensitivity 23%, specificity 97%, PPV 71%, NPV 79%; pHG sensitivity 19%, specificity 98%, PPV 63%, NPV 89%. Acceptability for tampon test was 91.21% and for pap smear, 45.85%. CONCLUSIONS: Although the self-administered tampon ThinPrep method is a poor detector of cervical abnormalities compared to pap smear, it is highly acceptable to women. It has a relatively good negative predictive value (NPV). Our study suggests that if a more acceptable, sensitive method of cervical screening was found, which removed some of the existing barriers to conventional pap testing, screening rates for cervical cancer may improve.

Adolescent↗
PubMed2000

Image analysis for discrimination of cervical neoplasia.

Colposcopy involves visual imaging of the cervix for patients who have exhibited some prior indication of abnormality, and the major goals are to visually inspect for any malignancies and to guide biopsy sampling. Currently colposcopy equipment is being upgraded in many health care centers to incorporate digital image acquisition and archiving. These permanent images can be analyzed for characteristic features and color patterns which may enhance the specificity and objectivity of the routine exam. In this study a series of images from patients with biopsy confirmed cervical intraepithelia neoplasia stage 2/3 are compared with images from patients with biopsy confirmed immature squamous metaplasia, with the goal of determining optimal criteria for automated discrimination between them. All images were separated into their red, green, and blue channels, and comparisons were made between relative intensity, intensity variation, spatial frequencies, fractal dimension, and Euler number. This study indicates that computer-based processing of cervical images can provide some discrimination of the type of tissue features which are important for clinical evaluation, with the Euler number being the most clinically useful feature to discriminate metaplasia from neoplasia. Also there was a strong indication that morphology observed in the blue channel of the image provided more information about epithelial cell changes. Further research in this field can lead to advances in computer-aided diagnosis as well as the potential for online image enhancement in digital colposcopy.

Adolescent↗
PubMed1989

Diagnosis and treatment of cervical intraepithelial neoplasia in general practice.

OBJECTIVE: To audit the first five years of a colposcopy and treatment service for cervical dysplasia established within a general practice. DESIGN: A cervical smear register was established to determine which women were "at risk" of dysplasia. The results of colposcopy and treatment of dysplasia were analysed. SETTING: A large rural general practice with community hospital facilities in mid-Wales. PATIENTS: 4437 Women at risk in a total practice population of 14,100. INTERVENTIONS: Colposcopy of women with dyskaryotic smear results, persistent inflammatory smear results, or vulval warts. Treatment of women with proved dysplasia by electrodiathermy of the cervix or cone biopsy. RESULTS: 138 Women with dysplasia were diagnosed over five years: 36 mild, 97 moderate or severe, and five with microinvasion. Despite a 78% smear rate of at risk women over five years, nine invasive cancers still occurred. CONCLUSIONS: The results of treatment are acceptable. Cervical dysplasia has become very common, the risk of a dysplasia in women aged 20-39 who had smear tests being one in 14 over five years.

Adolescent↗
PubMed1990

Implications of inflammatory changes on cervical cytology.

OBJECTIVE: To assess premenopausal women with inflammatory changes on cervical cytology for genital infections and cervical abnormalities. DESIGN: Prospective study of women attending general practice and family planning clinics who had a recent cervical cytology result with inflammatory changes. SETTING: Department of genitourinary medicine. PATIENTS: 102 Premenopausal women with recent cytology result showing inflammatory changes and with no history of antibiotic or antifungal treatment since their smear. INVESTIGATIONS: Genital examination and microbiological screening for genital infections; colposcopic examination about six weeks later. MAIN OUTCOME MEASURES: Detection of genital infections, particularly those sexually acquired, and abnormalities on colposcopy. RESULTS: Genital infections were isolated in 77 patients, and one or more sexually acquired infections were found in 22. Prevalence of sexually acquired infections was significantly correlated with younger age (particularly being under 25), being single, separated, or divorced; using non-barrier contraception; and recent change of sexual partner. An abnormality on colposcopy was found in 36 women. There was a strong correlation of a sexually acquired infection with an abnormality at colposcopy; hence younger women were more likely to have a colposcopic abnormality. CONCLUSIONS: Inflammatory changes on cytology are often associated with the presence of a sexually acquired infection and premalignant disease of the cervix, particularly in younger, single women using non-barrier contraception.

Adolescent↗
PubMed2006

Effect of testing for human papillomavirus as a triage during screening for cervical cancer: observational before and after study.

OBJECTIVE: To assess the effect of introducing testing for human papillomavirus combined with liquid based cytology in women with low grade cytological abnormalities. DESIGN: Observational before and after study. SETTING: Three cervical screening laboratories, England. PARTICIPANTS: 5654 women aged 20-64 with low grade cytological abnormalities found at routine cervical screening in a pilot; 5254 similar women in the period before the pilot. INTERVENTIONS: Human papillomavirus testing combined with liquid based cytology in the management of women with borderline or mildly dyskaryotic cervical smear results compared with conventional smear tests, with immediate referral to colposcopy of women positive for human papillomavirus. RESULTS: 57.9% (3187/5506) of women tested in the pilot were positive for human papillomavirus. The rate of repeat smears fell by 74%, but the rate of referral to colposcopy for low grade cytological abnormalities more than doubled. The estimated negative predictive value of human papillomavirus testing varied between 93.8% and 99.7%. CONCLUSION: The addition of testing for human papillomavirus in women with low grade cytological abnormalities resulted in a reduction in the rate of repeat smears, but an increase in rates of referral to colposcopy.

Adult↗
PubMed1992

A colposcopic case-control study of cervical squamous intraepithelial lesions in women with anogenital warts.

OBJECTIVE: To assess whether anogenital warts, present or past, are an indication for women to be referred for colposcopy. DESIGN: A case control study comparing patients with and without a history of anogenital warts. SETTING: A department of genitourinary medicine in West London. PATIENTS: 468 patients examined by colposcopy between January 1985 and December 1987 of whom 147 (31%) had abnormal cytology, 163 (35%) had anogenital warts and 158 (34%) had both. MAIN OUTCOME MEASURES: Colposcopic findings and histology of cervical biopsies compared with behavioural and disease variables. RESULTS: Human papillomavirus infection (HPVI) of the cervix showed no relationship with a life time history of vulval warts, or with the presence of anogenital warts on clinical examination, or with any parameter of sexual behaviour included in the study. Cervical intraepithelial neoplasia (CIN) was strongly associated with current IUCD usage (RR = 7.75) and coitarche under 16 years of age (RR = 3.72), but a history of vulval warts yielded a negative association (RR = 0.34), suggesting a protective effect. This relationship held true when cytological dyskaryosis was made the dependent variable (RR = 0.24). CONCLUSIONS: Anogenital warts are not a risk for subclinical cervical HPVI or for CIN and therefore not an indication for colposcopy.

Adult↗