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1.
BJOG ; 130(2): 210-213, 2023 01.
Article En | MEDLINE | ID: mdl-36054732

OBJECTIVE: To understand the effect of changing from cytology-based to primary HPV screening on the positive predictive value (PPV) of colposcopy referrals for cervical intraepithelial neoplasia (CIN) in a cohort offered HPV vaccination. DESIGN: Retrospective pre/post observational cohort study. SETTING: Scotland. POPULATION OR SAMPLE: 2193 women referred to colposcopy between September 2019 and February 2020 from cytology-based screening and between September 2020 and February 2021 from primary high-risk HPV (hrHPV) screening. METHODS: Calculating positive predictive values (PPVs) for two cohorts of women; one having liquid-based cytology screening and the other, the subsequent hrHPV cervical screening as a pre/post observational study. MAIN OUTCOME MEASURES: Positive predictive values of LBC and hrHPV cut-offs for colposcopy referral for CIN at colposcopy. RESULTS: Three papers fitted our criteria; these reported results only for cytology-based screening. The PPV was lower for women in HPV-vaccinated cohorts indicating a lower prevalence of disease. Vaccination under the age of 17 had the lowest PPV reported. Scottish colposcopy data concerning hrHPV and cytology showed a non-significant difference between PPV (17.5%, 95% CI 14.3-20.7, and 20.6, 95% CI 16.7-24.5, respectively) for referrals with a cut-off of low grade dyskaryosis (LGD); both met the standard set of 8-25%. The hrHPV PPV (66.7, 95% CI 56.8-76.6) was comparable to cytology (64.1, 95% CI 55.8-72.4) for referrals with a cut-off of high grade dyskaryosis (HGD) but neither met the standard set of 77-92%. CONCLUSIONS: Current literature only provides PPVs for LBC and, overall, the vaccinated cohort had lower PPVs. Only LG dyskaryosis met PHE criteria. The PPV for HPV-vaccinated women undergoing either LBC or HR-HPV screening were not statistically different. However, similar to papers in the current literature, HG dyskaryosis (HGD) PPVs of both techniques did not meet the PHE threshold of 76.6-91.6% outlined in the cervical standards data report.


Papillomavirus Infections , Uterine Cervical Dysplasia , Uterine Cervical Neoplasms , Female , Humans , Pregnancy , Colposcopy , Papillomavirus Infections/diagnosis , Papillomavirus Infections/prevention & control , Papillomavirus Infections/epidemiology , Early Detection of Cancer/methods , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control , Retrospective Studies , Mass Screening/methods , Referral and Consultation , Papillomaviridae , Uterine Cervical Dysplasia/diagnosis , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Dysplasia/prevention & control
3.
J Low Genit Tract Dis ; 26(3): 229-244, 2022 Jul 01.
Article En | MEDLINE | ID: mdl-35763611

ABSTRACT: The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) developed consensus statements on pre-invasive vulvar lesions in order to improve the quality of care for patients with vulvar squamous intraepithelial neoplasia, vulvar Paget disease in situ, and melanoma in situ. For differentiated vulvar intraepithelial neoplasia (dVIN), an excisional procedure must always be adopted. For vulvar high-grade squamous intraepithelial lesion (VHSIL), both excisional procedures and ablative ones can be used. The latter can be considered for anatomy and function preservation and must be preceded by several representative biopsies to exclude malignancy. Medical treatment (imiquimod or cidofovir) can be considered for VHSIL. Recent studies favor an approach of using imiquimod in vulvar Paget's disease. Surgery must take into consideration that the extension of the disease is usually wider than what is evident in the skin. A 2 cm margin is usually considered necessary. A wide local excision with 1 cm free surgical margins is recommended for melanoma in situ. Following treatment of pre-invasive vulvar lesions, women should be seen on a regular basis for careful clinical assessment, including biopsy of any suspicious area. Follow-up should be modulated according to the risk of recurrence (type of lesion, patient age and immunological conditions, other associated lower genital tract lesions).


Carcinoma in Situ , Melanoma , Paget Disease, Extramammary , Squamous Intraepithelial Lesions , Vulvar Neoplasms , Carcinoma in Situ/pathology , Colposcopy , Female , Humans , Imiquimod/therapeutic use , Pregnancy , Skin Neoplasms , Vulvar Neoplasms/diagnosis , Vulvar Neoplasms/pathology , Vulvar Neoplasms/surgery , Melanoma, Cutaneous Malignant
4.
Int J Gynecol Cancer ; 32(7): 830-845, 2022 07 04.
Article En | MEDLINE | ID: mdl-35728950

The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) developed consensus statements on pre-invasive vulvar lesions in order to improve the quality of care for patients with vulvar squamous intraepithelial neoplasia, vulvar Paget disease in situ, and melanoma in situ. For differentiated vulvar intraepithelial neoplasia (dVIN), an excisional procedure must always be adopted. For vulvar high-grade squamous intraepithelial lesion (VHSIL), both excisional procedures and ablative ones can be used. The latter can be considered for anatomy and function preservation and must be preceded by several representative biopsies to exclude malignancy. Medical treatment (imiquimod or cidofovir) can be considered for VHSIL. Recent studies favor an approach of using imiquimod in vulvar Paget's disease. Surgery must take into consideration that the extension of the disease is usually wider than what is evident in the skin. A 2 cm margin is usually considered necessary. A wide local excision with 1 cm free surgical margins is recommended for melanoma in situ. Following treatment of pre-invasive vulvar lesions, women should be seen on a regular basis for careful clinical assessment, including biopsy of any suspicious area. Follow-up should be modulated according to the risk of recurrence (type of lesion, patient age and immunological conditions, other associated lower genital tract lesions).


Carcinoma in Situ , Genital Neoplasms, Female , Melanoma , Paget Disease, Extramammary , Vulvar Neoplasms , Carcinoma in Situ/pathology , Cidofovir , Colposcopy , Female , Humans , Imiquimod , Paget Disease, Extramammary/pathology , Pregnancy , Skin Neoplasms , Vulvar Neoplasms/pathology , Melanoma, Cutaneous Malignant
5.
Health Expect ; 23(1): 202-211, 2020 02.
Article En | MEDLINE | ID: mdl-31659850

BACKGROUND: Young women's attendance at cervical screening in the UK is continuing to fall, and the incidence of invasive cervical cancer is rising. OBJECTIVES: We assessed the preferences of non-attending young women for alternative ways of delivering cervical screening. DESIGN: Postal discrete choice experiment (DCE) conducted during the STRATEGIC study of interventions for increasing cervical screening uptake. Attributes included action required to arrange a test, location of the test, availability of a nurse navigator and cost to the National Health Service. SETTING AND PARTICIPANTS: Non-attending young women in two UK regions. MAIN OUTCOME MEASURES: Responses were analysed using a mixed multinomial logit model. A predictive analysis identified the most preferable strategy compared to current screening. Preferences from the DCE were compared with observed behaviours during the STRATEGIC trial. RESULTS: The DCE response rate was 5.5% (222/4000), and 94% of respondents agreed screening is important. Preference heterogeneity existed around attributes with strong evidence for test location. Relative to current screening, unsolicited self-sampling kits for home use appeared most preferable. The STRATEGIC trial showed this same intervention to be most effective although many women who received it and were screened, attended for conventional cytology instead. CONCLUSIONS: The DCE and trial identified the unsolicited self-sampling kit as the most preferred/effective intervention. The DCE suggested that the decision of some women receiving the kit in the trial to attend for conventional cytology may be due to anxieties around home testing coupled with a knowledge that ignoring the kit could potentially have life-changing consequences.


Early Detection of Cancer , Patient Preference , Uterine Cervical Neoplasms , Adult , Choice Behavior , Female , Health Services Accessibility , Humans , State Medicine , Surveys and Questionnaires , United Kingdom/epidemiology , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/epidemiology , Young Adult
6.
J Obstet Gynaecol ; 40(5): 694-698, 2020 Jul.
Article En | MEDLINE | ID: mdl-31609146

Vaginal intraepithelial neoplasia (VaIN) is less common than intraepithelial neoplasia at other non-cervical sites and can be challenging to manage. This survey describes current clinical practice by colposcopists in the UK. An online questionnaire was emailed to all the lead colposcopists in U.K. A total of 86 (43%) responses were obtained. The median number of cases of VaIN seen in a year was five (range 0-100. Most clinics (95%) managed low grade VaIN conservatively. Local vaginal mucosal excision was the most common surgical procedure. Half of respondents adopted observation, although 64% of the units referred cases to a cancer centre. More than half used a combination of cytology and colposcopy for follow-up; only two reported using Human papilloma virus testing. Seventy-seven of eighty-six lead colposcopists did not have a local guideline and would support national guidance. Treatment differed across the UK with no agreed management guidelines.Impact statementWhat is already known on the subject? Vaginal intraepithelial neoplasia (VaIN) is a pre-cancerous condition of lower genital tract and usually co-exists with cervical intraepithelial neoplasia (CIN) rather than in isolation. Unlike CIN, VaIN can be extremely challenging to manage in view of its anatomical proximity to bladder and bowel and also difficulty in accessing fornices. If diagnosed during the definitive management of CIN at the time of hysterectomy and confined to the upper vagina, it could be surgically treated at the same time. VaIN can be more challenging post-hysterectomy, especially following a failed medical and conservation option. Various treatment options are adopted for management of VaIN with no standardisation of care.What do the results of this study add? A national survey was conducted to assess the management of VaIN amongst lead colposcopists. The national survey has added valuable results, despite a response rate of only 43%. The survey confirmed conservative approach to low grade VaIN but differing treatment for high grade VaIN.What are the implications of these findings for clinical practice and/or further research? This clearly calls for the implementation of a national guideline in the UK to standardise management of VaIN, though it may be quite challenging. The survey could help inform implementation of HrHPV testing in recurrent or persistent VaIN.


Carcinoma in Situ/therapy , Precancerous Conditions/therapy , Vaginal Neoplasms/therapy , Carcinoma in Situ/diagnosis , Carcinoma in Situ/pathology , Colposcopy , Female , Humans , Precancerous Conditions/diagnosis , Precancerous Conditions/pathology , Pregnancy , Prospective Studies , Surveys and Questionnaires , United Kingdom , Vaginal Neoplasms/diagnosis , Vaginal Neoplasms/pathology
7.
Int J Cancer ; 145(2): 427-434, 2019 07 15.
Article En | MEDLINE | ID: mdl-30650180

To assess the excess risk of HPV-associated cancer (HPVaC) in two at-risk groups-women with a previous diagnosis of high grade cervical intraepithelial neoplasia (CIN3) and both men and women treated for non-cervical pre-invasive anogenital disease. All CIN3 cases diagnosed in 1989-2015 in Scotland were extracted from the Scottish cancer registry (SMR06). All cases of pre-invasive penile, anal, vulval, and vaginal disease diagnosed in 1990-2015 were identified within the NHS pathology databases in the two largest NHS health boards in Scotland. Both were linked to SMR06 to extract subsequent incidence of HPVaC following the diagnosis of CIN3 or pre-invasive disease. Standardised incidence ratios were calculated for the risk of acquiring HPVaC for the two at-risk groups compared to the general Scottish population. Among 69,714 females in Scotland diagnosed with CIN3 (890,360.9 person-years), 179 developed non-cervical HPVaC. CIN3 cases were at 3.2-fold (95% CI: 2.7 to 3.7) increased risk of developing non-cervical HPVaC, compared to the general female population. Among 1,235 patients diagnosed with non-cervical pre-invasive disease (9,667.4 person-years), 47 developed HPVaC. Individuals with non-cervical pre-invasive disease had a substantially increased risk of developing HPVaC - 15.5-fold (95% CI: 11.1 to 21.1) increased risk for females and 28-fold (11.3 to 57.7) increased risk for males. We report a significant additional risk of HPV-associated cancer in those have been diagnosed with pre-invasive HPV-associated lesions including but not confined to the cervix. Uncovering the natural history of pre-invasive disease has potential for determining screening, prevention and treatment.


Genital Neoplasms, Female/virology , Genital Neoplasms, Male/virology , Papillomavirus Infections/epidemiology , Precancerous Conditions/epidemiology , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Neoplasms/epidemiology , Adult , Aged , Anal Canal/pathology , Female , Genital Neoplasms, Female/epidemiology , Genital Neoplasms, Male/epidemiology , Humans , Incidence , Male , Middle Aged , Papillomavirus Infections/complications , Penis/pathology , Retrospective Studies , Scotland/epidemiology , Vagina/pathology , Vulva/pathology
8.
J Low Genit Tract Dis ; 22(2): 110-114, 2018 Apr.
Article En | MEDLINE | ID: mdl-29474235

OBJECTIVE: In United Kingdom., test of cure after treatment of any grade of cervical intraepithelial neoplasia (CIN) incorporates high-risk human papillomavirus (Hr-HPV) test and cytology at 6-month follow-up. The aims of the study were to determine the rate of recurrent CIN in women who are Hr-HPV positive and cytology negative and to explore possible associated risk factors. METHODS: A retrospective observational cohort study was performed in women treated for any grade CIN between 2010 and 2015 from a regional population, who were Hr-HPV positive and cytology negative at first follow-up. RESULTS: A total of 2729 women were identified as treated for any grade CIN, and 213 (7.8%) were re-referred to colposcopy having Hr-HPV-positive test and negative cytology at test of cure. Their mean age was 31.56 years (range = 19-62 years). The mean time of follow-up per woman was 30.50 months (range = 2-63 months). At colposcopy, 171 (80.3%) had colposcopy examination only and 42 women (19.7%) had a biopsy. Twenty-four cases (11.3%) of CIN were identified of which 4 (1.9%) were CIN 2/3. Eleven women (5.2%) in total had a repeat treatment. Five women (2.3%) had biopsy-proven CIN 2/3 within 12-months after treatment. No cases of CIN 3+ after negative colposcopy were identified during the follow-up period. CONCLUSIONS: The incorporation of Hr-HPV testing yielded a very small number of women with residual CIN within 12 months of treatment. Our results suggest that women who are Hr-HPV positive and cytology negative after treatment of CIN with normal and adequate colposcopy could be discharged to routine recall if confirmed by larger national data.


Colposcopy/statistics & numerical data , Papillomaviridae/isolation & purification , Uterine Cervical Dysplasia/pathology , Uterine Cervical Dysplasia/therapy , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/therapy , Adult , Female , Humans , Middle Aged , Papillomavirus Infections/complications , Recurrence , Retrospective Studies , Risk Factors , Treatment Outcome , United Kingdom , Uterine Cervical Neoplasms/virology , Young Adult , Uterine Cervical Dysplasia/virology
9.
Lancet Infect Dis ; 16(10): 1154-1168, 2016 Oct.
Article En | MEDLINE | ID: mdl-27373900

BACKGROUND: Although the risk of human papillomavirus (HPV) infection is greatest in young women, women older than 25 years remain at risk. We present data from the VIVIANE study of the HPV 16/18 AS04-adjuvanted vaccine in adult women after 7 years of follow-up. METHODS: In this phase 3, double-blind, randomised controlled trial, healthy women older than 25 years were enrolled (age stratified: 26-35 years, 36-45 years, and ≥46 years). Up to 15% in each age stratum had a history of HPV infection or disease. Women were randomly assigned (1:1) to receive HPV 16/18 vaccine or aluminium hydroxide control, with an internet-based system. The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or greater (CIN1+) associated with HPV 16/18. We did analyses in the according-to-protocol cohort for efficacy and total vaccinated cohort. Data for the combined primary endpoint in the according-to-protocol cohort for efficacy were considered significant when the lower limit of the 96·2% CI around the point estimate was greater than 30%. For all other endpoints and cohorts, data were considered significant when the lower limit of the 96·2% CI was greater than 0%. This study is registered with ClinicalTrials.gov, number NCT00294047. FINDINGS: The first participant was enrolled on Feb 16, 2006, and the last study visit took place on Jan 29, 2014. 4407 women were in the according-to-protocol cohort for efficacy (n=2209 vaccine, n=2198 control) and 5747 women in the total vaccinated cohort (n=2877 vaccine, n=2870 control). At month 84, in women seronegative for the corresponding HPV type in the according-to-protocol cohort for efficacy, vaccine efficacy against 6-month persistent infection or CIN1+ associated with HPV 16/18 was significant in all age groups combined (90·5%, 96·2% CI 78·6-96·5). Vaccine efficacy against HPV 16/18-related cytological abnormalities (atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion) and CIN1+ was also significant. We also noted significant cross-protective efficacy against 6-month persistent infection with HPV 31 (65·8%, 96·2% CI 24·9-85·8) and HPV 45 (70·7%, 96·2% CI 34·2-88·4). In the total vaccinated cohort, vaccine efficacy against CIN1+ irrespective of HPV was significant (22·9%, 96·2% CI 4·8-37·7). Serious adverse events related to vaccination occurred in five (0·2%) of 2877 women in the vaccine group and eight (0·3%) of 2870 women in the control group. INTERPRETATION: In women older than 25 years, the HPV 16/18 vaccine continues to protect against infections, cytological abnormalities, and lesions associated with HPV 16/18 and CIN1+ irrespective of HPV type, and infection with non-vaccine types HPV 31 and HPV 45 over 7 years of follow-up. FUNDING: GlaxoSmithKline Biologicals SA.


Adjuvants, Immunologic/administration & dosage , Human papillomavirus 16/immunology , Human papillomavirus 18/immunology , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Adult , DNA, Viral , Double-Blind Method , Female , Follow-Up Studies , Humans , Middle Aged , Papillomaviridae/immunology , Papillomaviridae/isolation & purification , Papillomavirus Vaccines/immunology , Papillomavirus Vaccines/therapeutic use , Uterine Cervical Neoplasms/prevention & control , Uterine Cervical Neoplasms/virology
10.
Womens Health Issues ; 25(5): 517-27, 2015.
Article En | MEDLINE | ID: mdl-26051021

BACKGROUND: A colposcopy examination is the main management option for women with an abnormal cervical screening test result. Although some women experience adverse psychological effects after colposcopy, those at greatest risk are unknown. We investigated predictors of worries about cervical cancer, sex, future fertility and general health during 12 to 30 months after colposcopy. METHODS: We invited 1,515 women, aged 20 to 59 years with low-grade cervical cytology who attended colposcopy to complete questionnaires at recruitment (∼8 weeks after cytology result) and after 12, 18, 24, and 30 months of follow up. Outcomes were worries about having cervical cancer, having sex, future fertility, and general health at any time during follow-up. Factors significantly associated with each outcome were identified using multiple logistic regression. RESULTS: At one or more time points during follow-up, 40% of women reported worries about having cervical cancer, 26% about having sex, 24% about future fertility, and 60% about general health. For all outcomes except sex, worries reported at recruitment were associated with significantly increased risk of worries during follow-up. Significant anxiety at recruitment was associated with all worries during follow-up. Women diagnosed with CIN2+ had significantly higher risks of worries about cervical cancer and future fertility. Management received was associated significantly with worries about cervical cancer and having sex. Younger women significantly more often reported worries about future fertility, whereas women who had children had reduced risk of future fertility worries but increased risk of cervical cancer worries. CONCLUSION: Clinical, sociodemographic, lifestyle, and psychological factors predicted risk of reporting worries after colposcopy.


Anxiety/psychology , Cervix Uteri/pathology , Colposcopy/psychology , Stress, Psychological/psychology , Uterine Cervical Dysplasia/pathology , Uterine Cervical Neoplasms/pathology , Adult , Anxiety Disorders/psychology , Depression/psychology , Early Detection of Cancer/psychology , Female , Follow-Up Studies , Humans , Internal-External Control , Logistic Models , Mass Screening , Middle Aged , Pregnancy , Surveys and Questionnaires , Uterine Cervical Neoplasms/psychology , Vaginal Smears , Uterine Cervical Dysplasia/psychology
11.
Lancet ; 384(9961): 2213-27, 2014 Dec 20.
Article En | MEDLINE | ID: mdl-25189358

BACKGROUND: Although adolescent girls are the main population for prophylactic human papillomavirus (HPV) vaccines, adult women who remain at risk of cervical cancer can also be vaccinated. We report data from the interim analysis of the ongoing VIVIANE study, the aim of which is to assess the efficacy, safety, and immunogenicity of the HPV 16/18 AS04-adjuvanted vaccine in adult women. METHODS: In this phase 3, multinational, double-blind, randomised controlled trial, we randomly assigned healthy women older than 25 years to the HPV 16/18 vaccine or control (1:1), via an internet-based system with an algorithm process that accounted for region, age stratum, baseline HPV DNA status, HPV 16/18 serostatus, and cytology. Enrolment was age-stratified, with about 45% of participants in each of the 26-35 and 36-45 years age strata and 10% in the 46 years and older stratum. Up to 15% of women in each age stratum could have a history of HPV infection or disease. The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or higher (CIN1+) associated with HPV 16/18. The primary analysis was done in the according-to-protocol cohort for efficacy, which consists of women who received all three vaccine or control doses, had negative or low-grade cytology at baseline, and had no history of HPV disease. Secondary analyses included vaccine efficacy against non-vaccine oncogenic HPV types. Mean follow-up time was 40·3 months. This study is registered with ClinicalTrials.gov, number NCT00294047. FINDINGS: The first participant was enrolled on Feb 16, 2006, and the last study visit for the present analysis took place on Dec 10, 2010; 5752 women were included in the total vaccinated cohort (n=2881 vaccine, n=2871 control), and 4505 in the according-to-protocol cohort for efficacy (n=2264 vaccine, n=2241 control). Vaccine efficacy against HPV 16/18-related 6-month persistent infection or CIN1+ was significant in all age groups combined (81·1%, 97·7% CI 52·1-94·0), in the 26-35 years age group (83·5%, 45·0-96·8), and in the 36-45 years age group (77·2%, 2·8-96·9); no cases were seen in women aged 46 years and older. Vaccine efficacy against atypical squamous cells of undetermined significance or greater associated with HPV 16/18 was also significant. We also noted significant cross-protective vaccine efficacy against 6-month persistent infection with HPV 31 (79·1%, 97·7% CI 27·6-95·9) and HPV 45 (76·9%, 18·5-95·6]) Serious adverse events occurred in 285 (10%) of 2881 women in the vaccine group and 267 (9%) of 2871 in the control group; five (<1%) and eight (<1%) of these events, respectively, were believed to be related to vaccination. INTERPRETATION: In women older than 25 years, the HPV 16/18 vaccine is efficacious against infections and cervical abnormalities associated with the vaccine types, as well as infections with the non-vaccine HPV types 31 and 45. FUNDING: GlaxoSmithKline Biologicals SA.


Adjuvants, Immunologic/administration & dosage , Human papillomavirus 16/immunology , Human papillomavirus 18/immunology , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Adult , Cross Reactions , DNA, Viral/genetics , Double-Blind Method , Female , Human papillomavirus 16/genetics , Human papillomavirus 18/genetics , Humans , Middle Aged , Papillomavirus Vaccines/immunology , Uterine Cervical Neoplasms/prevention & control , Uterine Cervical Neoplasms/virology , Uterine Cervical Dysplasia/prevention & control , Uterine Cervical Dysplasia/virology
12.
Expert Rev Vaccines ; 13(4): 533-44, 2014 Apr.
Article En | MEDLINE | ID: mdl-24606579

Human papillomavirus (HPV) is the primary cause of cervical cancer and genital warts. The development of HPV vaccines has been a major advance in the prevention of these diseases. Recent studies have shown promising early effects of HPV immunization programs on cervical abnormalities and genital warts, with evidence of herd immunity against genital warts also emerging in Australia. Further studies are required to not only continue monitoring the effect of the HPV immunization on the incidence of these diseases, but also to establish the effect the immunization will have on cervical screening programs and the performance of colposcopy.


Condylomata Acuminata/epidemiology , Papillomaviridae/isolation & purification , Papillomavirus Infections/epidemiology , Papillomavirus Vaccines/immunology , Uterine Cervical Neoplasms/epidemiology , Australia/epidemiology , Condylomata Acuminata/prevention & control , Female , Humans , Immunity, Herd , Immunization/methods , Incidence , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Neoplasms/prevention & control
13.
J Low Genit Tract Dis ; 18(3): 203-9, 2014 Jul.
Article En | MEDLINE | ID: mdl-24270198

OBJECTIVES: This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), among women with histologically proven CIN 1. MATERIALS AND METHODS: This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed. RESULTS: A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17% were HPV-16 positive, and 11% were HPV-18 positive. Overall, 21 women (12%) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95% CI = 1.09-8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95% CI = 1.60-9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58% and 78%, respectively. CONCLUSIONS: Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.


Colposcopy/methods , Uterine Cervical Dysplasia/diagnosis , Uterine Cervical Dysplasia/therapy , Adult , Biopsy , Disease Progression , Female , Follow-Up Studies , Humans , Middle Aged , Papillomaviridae/isolation & purification , Papillomavirus Infections/diagnosis , Papillomavirus Infections/virology , Prospective Studies , Treatment Outcome , Young Adult
14.
Article En | MEDLINE | ID: mdl-25767846

Background: There is a need for an instrument to measure the psychosocial burden of receiving an abnormal cervical cytology result which can be used regardless of the clinical management women receive.Methods: 3331 women completed the POSM as part of baseline psychosocial assessment in a trial of management of low grade cervical cytological abnormalities. Factor analysis and reliability assessment of the POSM were conducted.Results: Two factors were extracted from the POSM: Factor 1, containing items related to worry; and Factor 2 containing items relating to satisfaction with information and support received and change in the way women felt about themselves. Factor 1 had good reliability (Cronbach's alpha 0.769), however reliability of the Factor 2 was poorer(0.482). Data collected at four subsequent time points demonstrated that the factor structure was stable over time.Conclusion: This study demonstrates the presence and reliability of a scale measuring worries within the POSM. This analysis will inform its future use in this population and in other related contexts.


Anxiety/epidemiology , Cost of Illness , Outcome and Process Assessment, Health Care/statistics & numerical data , Psychometrics/instrumentation , Stress, Psychological/epidemiology , Uterine Cervical Diseases/epidemiology , Uterine Cervical Diseases/psychology , Adult , Anxiety/psychology , Causality , Comorbidity , Factor Analysis, Statistical , Female , Humans , Middle Aged , Quality of Life , Reproducibility of Results , Self Concept , United Kingdom , Young Adult
15.
J Low Genit Tract Dis ; 16(4): 403-8, 2012 Oct.
Article En | MEDLINE | ID: mdl-22659775

UNLABELLED: The incidence of microinvasive cervical cancers seems to be increasing as a result of screening. However, there is little national or international guidance on best management or follow-up of women treated with conservation of the cervix. OBJECTIVE: The study aimed to assess the current management and follow-up of women with stage IA cervical cancer, according to the International Federation of Gynecology and Obstetrics, within the United Kingdom. DESIGN/SETTING: This study is a multicenter national audit of a clinical practice in the United Kingdom. MATERIALS AND METHODS: A structured questionnaire was sent and returned electronically to all lead colposcopists in the United Kingdom on the management and follow-up of women with stage IA cervical cancer according to the International Federation of Gynecology and Obstetrics. The study was approved by the British Society for Colposcopy and Cervical Pathology. RESULTS: Of the 210 lead colposcopists, 110 (52%) responded. All reported that women with stage IA cervical cancer are discussed at a gynecologic multidisciplinary team meeting. Women who managed conservatively with their cervix in situ are followed up for at least 5 years. There is a wide variation in clinical management of cases with lymphovascular space involvement (LVSI) and depth of invasion greater than 3 mm (stage IA2). CONCLUSIONS: The pattern and practice of follow-up for stage IA cervical cancer is highly variable. The development of national guidance should be considered.


Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/therapy , Adult , Clinical Audit , Female , Humans , Middle Aged , Practice Guidelines as Topic , Surveys and Questionnaires , United Kingdom
16.
Eur J Obstet Gynecol Reprod Biol ; 162(1): 79-82, 2012 May.
Article En | MEDLINE | ID: mdl-22397746

OBJECTIVE: To review the surgical procedures used to treat the complications of vulval lichen sclerosus at a single tertiary referral institution in north-east Scotland over a ten year period. STUDY DESIGN: A retrospective case note review of women who had surgery for ano-genital lichen sclerosus at Aberdeen Royal Infirmary between January 1999 and December 2009. RESULTS: The total number of women was 25 and the two most common procedures were Fenton's procedure (median perineotomy) and laser division of adhesions. Initial surgery resulted in an improvement of symptoms for 80% of women. CONCLUSIONS: When surgery for vulval lichen sclerosus is reserved for highly selected cases where there are complications secondary to adhesions, the proportion of women benefiting is high.


Vulva/surgery , Vulvar Lichen Sclerosus/complications , Adult , Aged , Female , Humans , Middle Aged , Retrospective Studies , Tissue Adhesions/etiology , Tissue Adhesions/surgery , Treatment Outcome
17.
J Low Genit Tract Dis ; 16(3): 306-12, 2012 Jul.
Article En | MEDLINE | ID: mdl-22460272

OBJECTIVES: Vaginal intraepithelial neoplasia (VaIN) accounts for 0.4% of the lower genital tract intraepithelial disease. Various treatments have been reported often as small case series or reports. MATERIALS AND METHODS: An electronic search of the Ovid MEDLINE (from 1948 to present) and PubMed was performed, and only articles written in English were reviewed. All articles ranging from case reports to randomized controlled trials were included. This review critically appraises the published evidence for different treatment modalities and gives an overview of these options. RESULTS: The 3 main modalities reported were surgery, brachytherapy, and medical management. Surgery included local excision, laser ablation, vaginectomy, and cavitational ultrasonic ablation. Medical management included topical 5% imiquimod, 5-fluorouracil, and tricholoroacetic acid. All treatments had good success rates for disease clearance with low rates of progression to cancer. Prerequisites for ablative treatments are the lesion is fully visible and adequately examined by biopsy to exclude invasion. Where invasion is suspected or cannot be excluded (e.g., at the vault suture line), surgical excision is essential. Brachytherapy and vaginectomy, although effective, have a limited place because of their related morbidity. Treatment choice may depend on the availability of equipment and expertise. CONCLUSIONS: Conservative options in the form of laser ablation and topical agents are useful as first-line treatment methods especially in young women and for multifocal disease. Radical options like brachytherapy and vaginectomy should be reserved for highly selected cases. Evidence from a randomized controlled trial of first-line treatment with surgical and medical therapies is needed to compare treatment success and impact on quality of life.


Carcinoma in Situ/pathology , Carcinoma in Situ/therapy , Vaginal Neoplasms/pathology , Vaginal Neoplasms/therapy , Adult , Aged , Aminoquinolines/therapeutic use , Antineoplastic Agents/therapeutic use , Biological Products/therapeutic use , Biopsy, Needle , Brachytherapy/methods , Carcinoma in Situ/epidemiology , Female , Humans , Imiquimod , Immunohistochemistry , Laser Therapy/methods , Middle Aged , Neoplasm Invasiveness/pathology , Neoplasm Staging , Prognosis , Randomized Controlled Trials as Topic , Risk Assessment , Treatment Outcome , Ultrasonic Therapy/methods , Vaginal Neoplasms/epidemiology
18.
J Low Genit Tract Dis ; 14(3): 196-9, 2010 Jul.
Article En | MEDLINE | ID: mdl-20592554

OBJECTIVE: To evaluate the outcome of women referred to colposcopy with the clinical finding of suspected cancer ("clinically suspicious cervix"). MATERIALS AND METHODS: A prospective cohort study of women referred to a dedicated colposcopy clinic serving a regional population with a clinically suspicious cervix was conducted. All referral letters were reviewed, and women were identified prospectively when the letter stated "referral for a clinically suspicious cervix." Relevant data were collected subsequently by case note review. RESULTS: One hundred four women were identified, and 95 attended for colposcopy from September 2006 to January 2008. Nine women defaulted. Seventy-six (80%) had a normal cervix or a benign cervical pathological result. Cervical intraepithelial neoplasia was detected in 15 patients (16%), and only 4 women (4%) had invasive cancer confirmed. CONCLUSIONS: We believe that women referred with a clinically suspicious cervix should be assessed in a general gynecology clinic rather than colposcopy because most will not have cancer. The small number of women with a clinical cancer can then be referred onto colposcopy, whereas women with benign pathological result can be treated appropriately in the general clinic.


Colposcopy/methods , Early Detection of Cancer/methods , Uterine Cervical Dysplasia/diagnosis , Uterine Cervical Neoplasms/diagnosis , Adult , Aged , Cohort Studies , Female , Humans , Middle Aged , Prevalence , Prospective Studies , Uterine Cervical Neoplasms/epidemiology , Uterine Cervical Dysplasia/epidemiology
19.
Int J Gynecol Cancer ; 20(1): 154-7, 2010 Jan.
Article En | MEDLINE | ID: mdl-20130517

OBJECTIVES: Conservative management of women with microinvasive cervical cancer (International Federation of Gynecologists and Obstetricians stage IA) has led to prolonged and intensive cytological follow-up. We conducted a retrospective study to assess human papillomavirus status and genotypes at diagnosis and to find out whether there is an association between the persistence of high-risk human papillomavirus during follow-up and the detection of recurrent disease. STUDY DESIGN: Paraffin-embedded cervical biopsies in the pathology archives were identified from women with an initial large loop excision of the transformation zone or cone specimen diagnostic of microinvasive disease since 1991. RESULTS: We identified 45 women with a diagnosis of microinvasive cervical cancer. Human papillomavirus was detected in 87% of the initial diagnostic specimens. Human papillomavirus testing showed a negative predictive value of 100% for recurrent disease with a sensitivity of 100%. CONCLUSION: Human papillomavirus testing has an important role in the follow-up of women treated conservatively for stage IA cervical cancer.


Alphapapillomavirus/genetics , Carcinoma, Squamous Cell/surgery , Carcinoma, Squamous Cell/virology , Minimally Invasive Surgical Procedures/methods , Papillomavirus Infections/virology , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/virology , Adult , Carcinoma, Squamous Cell/etiology , Carcinoma, Squamous Cell/pathology , DNA, Viral/analysis , Female , Follow-Up Studies , Genotype , Gynecologic Surgical Procedures/methods , Human papillomavirus 16/genetics , Human papillomavirus 16/isolation & purification , Human papillomavirus 18/genetics , Human papillomavirus 18/isolation & purification , Humans , Infertility, Female/prevention & control , Middle Aged , Neoplasm Invasiveness , Neoplasm Recurrence, Local/diagnosis , Neoplasm Recurrence, Local/virology , Papillomavirus Infections/complications , Papillomavirus Infections/genetics , Predictive Value of Tests , Retrospective Studies , Risk Factors , Uterine Cervical Neoplasms/etiology , Uterine Cervical Neoplasms/pathology , Young Adult
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