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Background: Previous studies have shown that woman attending their first cervical screening or colposcopy appointment experience negative emotions, primarily anxiety and fear. With the introduction of the Human Papillomavirus (HPV) vaccine, it is unknown whether these emotions will have altered or whether the information needs of vaccinated women will have changed. The objective of this study is to determine the knowledge, understanding and concerns that young women have about HPV when attending colposcopy and whether their information needs are met., Methods: This is a qualitative study using semi-structured interviews which were audiotaped and transcribed. Data was analysed thematically, with recruitment until data saturation was reached. Women born after 01/09/1990 and attending colposcopy as a result of abnormal cytology were eligible to join the study. Recruitment took place in an out-patient regional colposcopy clinic, Aberdeen, Scotland., Results: Fifteen women were interviewed. The majority of participants had some knowledge and understanding of HPV, cervical screening and colposcopy. Knowledge about the HPV vaccine was more limited; a third of participants misunderstood the effectiveness of the vaccine believing that is provided complete protection, and were left feeling that it had failed them. Some also felt that they were "test cases" for the vaccine., Conclusion: With the introduction of the HPV vaccine, the information and support needs of young women attending colposcopy are not fully met, leaving women with unanswered questions. With increasing numbers of vaccinated women entering the screening programme, it is timely to review the information available to these women.

Objective: To measure patterns of clinical activity at colposcopy before and after vaccinated women entered the Scottish Cervical Screening Programme (SCSP)., Design: Population-based observational study using nationally collected data., Setting: Scottish colposcopy clinics., Sample: All women with a date of birth on or after 1 January 1985 who attended colposcopy in Scotland between 2008 and 2014., Methods: Routinely collected data from the Scottish National Colposcopy Clinical Information Audit System (NCCIAS) were extracted, including: referral criteria, referral cervical cytology, colposcopic findings, clinical procedures, and histology results. Analysis was restricted to those referred to colposcopy at age 20 or 21 years., Main Outcome Measures: Referral criteria, positive predictive value of colposcopy, default rates, and rates of cervical biopsies and treatments., Results: A total of 7372 women referred for colposcopy at age 20 or 21 years were identified. There was a downward trend in the proportion of those referred with abnormal cytology (2008/9, 91.0%; 2013/14, 90.3%; linear trend P = 0.03). Women were less likely to have diagnostic or therapeutic interventions. The proportion with no biopsy (2008/9, 19.5%; 2013/14, 26.9%; linear trend P < 0.0001) and no treatment (2008/9, 74.9%; 2013/14, 91.8%; linear trend P < 0.0001) increased over the period of observation., Conclusions: A reduction in clinical activity related to abnormal screening referrals is likely to be associated with the human papillomavirus (HPV) catch-up immunisation programme. Referral criteria and the service provision of colposcopy needs to be planned carefully, taking account of the increasing number of women who have been immunised against HPV that will be entering cervical screening programmes worldwide., Tweetable Abstract: Colposcopy referral criteria and service planning need attention following HPV immunisation programme., (© 2017 Royal College of Obstetricians and Gynaecologists.)

Objective: To determine whether human papillomavirus (HPV) immunisation has affected the prevalence of HPV genotypes and colposcopic features of cervical intraepithelial neoplasia (CIN) in young women referred for colposcopy., Design: A two-centre observational study including vaccinated and unvaccinated women., Setting: Colposcopy clinics serving two health regions in Scotland, UK., Population: A total of 361 women aged 20-25 years attending colposcopy following an abnormal cervical cytology result at routine cervical screening., Methods: Cervical samples were obtained from women for HPV DNA genotyping and mRNA E6/E7 expression of HPV 16, 18, 31, 33, and 45. Demographic data, cytology, and histology results and colposcopic features were recorded. Chi-square analysis was conducted to identify associations between vaccine status, HPV genotypes, and colposcopic features., Main Outcome Measures: Colposcopic features, HPV genotypes, mRNA expression, and cervical histology., Results: The prevalence of HPV 16 was significantly lower in the vaccinated group (8.6%) compared with the unvaccinated group (46.7%) (P = 0.001). The number of cases of CIN2+ was significantly lower in women who had been vaccinated (P = 0.006). The HPV vaccine did not have a statistically significant effect on commonly recognised colposcopic features, but there was a slight reduction in the positive predictive value (PPV) of colposcopy for CIN2+, from 74% (unvaccinated) to 66.7% (vaccinated)., Conclusions: In this group of young women with abnormal cytology referred to colposcopy, HPV vaccination via a catch-up programme reduced the prevalence of CIN2+ and HPV 16 infection. The reduced PPV of colposcopy for the detection of CIN2+ in women who have been vaccinated is at the lower acceptable level of the UK national cervical screening programme guidelines., Tweetable Abstract: Reduction of hrHPV positivity and CIN in immunised women consistent with lower PPV of colposcopy for CIN2+., (© 2017 Royal College of Obstetricians and Gynaecologists.)

Objective: To compare psychosocial outcomes (follow-up related worries and satisfaction with follow-up related information and support) over 30 months of two alternative management policies for women with low-grade abnormal cervical cytology., Methods: Women aged 20-59 years with low-grade cytological abnormalities detected in the National Health Service Cervical Screening Programme were randomised to cytological surveillance or initial colposcopy. A total of 3399 women who completed psychosocial questionnaires at recruitment were invited to complete questionnaires at 12, 18, 24 and 30 months. Linear mixed models were used to investigate differences between arms in the two psychosocial outcomes. Each outcome had a maximum score of 100, and higher scores represented higher psychosocial morbidity., Results: On average, over 30 months, women randomised to colposcopy scored 2.5 points (95%CI -3.6 to -1.3) lower for follow-up related worries than women randomised to cytological surveillance. Women in the colposcopy arm also scored significantly lower for follow-up related satisfaction with information and support (-2.4; -3.3 to -1.4) over 30 months. For both outcomes, the average difference between arms was greatest at 12th- and 18th-month time points. These differences remained when the analysis was stratified by post-school education., Conclusions: Women with low-grade cytology, irrespective of their management, have substantial initial psychosocial morbidity that reduces over time. Implementation of newer screening strategies, which include surveillance, such as primary HPV screening, need to consider the information and support provided to women. © 2016 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd., (© 2016 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Background: Effective cervical screening reduces cancer incidence and mortality. However, these benefits may be accompanied by some harms, potentially including, adverse psychological impacts. Studies suggest women may have concerns about various specific issues, such as cervical cancer., Aim: To compare worries about cervical cancer, future fertility, having sex, and general health between women managed by alternative policies at colposcopy., Design: Multicentre individually-randomised controlled trial, nested within the National Health Service Cervical Screening Programmes., Setting: UK., Methods: 1515 women, aged 20-59 years, with low-grade cytology who attended colposcopy during February 2001-October 2002, were randomised to immediate loop excision or punch biopsies with recall for treatment if cervical intraepithelial neoplasia (CIN)2/3 was confirmed. Women completed questionnaires at recruitment and after 12, 18, 24 and 30 months. Outcomes were prevalence of worries at each time-point (point prevalence) and at any time-point during follow-up (12-30 months; cumulative prevalence). Primary analysis was by intention-to-treat (ITT); secondary per-protocol analysis compared groups according to management received among women with an abnormal transformation zone., Results: Cumulative prevalence of worries was: cervical cancer 40%; having sex 26%, future fertility 24%, and general health 60%. In ITT analyses, there were no statistically significant differences between management arms in cumulative or point prevalence of any of the worries. In per-protocol analyses, between-group differences were significant only for future fertility; cumulative prevalence was highest in women who underwent punch biopsies and treatment., Conclusions: There is no difference in the prevalence of specific worries in women randomised to alternative post-colposcopy management policies., Isrctn: 34841617., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: Worldwide, each year, large numbers of women are referred for colposcopy following low-grade abnormal cervical cytology. Many have no visible abnormality on examination. The risk of cervical intra-epithelial neoplasia grade 2/3 (CIN2/3) in these women is low. It is unknown whether, for women, a normal colposcopy resolves the anxiety which often follows the receipt of an abnormal cytology result. We investigated the prevalence of adverse psychological outcomes over 30 months following a normal colposcopy., Methods: This cohort study was nested within the UK TOMBOLA randomized controlled trial. Women aged 20-59 years, with recent low-grade cytology, who had a satisfactory colposcopy examination and normal transformation zone, completed the Hospital Anxiety and Depression Scale (HADS) and Process Outcome Specific Measure (POSM) at recruitment and during follow-up (12, 18, 24 and 30 months post-recruitment). Outcomes included percentages reporting significant anxiety (HADS anxiety subscale score ≥11), significant depression (HADS depression subscale score ≥8) or worries about the result of the next cytology test, cervical cancer, having sex, future fertility and general health at each time point (point prevalence) and during follow-up (cumulative prevalence)., Results: The study included 727 women. All psychological measures (except depression) had high prevalence at recruitment, falling substantially by 12 months. During follow-up, the cumulative prevalence of significant anxiety was 27% and significant depression was 21%. The most frequently reported worry was that the next cytology test would be abnormal (cumulative prevalence of 71%; point prevalence of ≥50% at 12 and 18 months). The cumulative prevalence values of worries about cervical cancer, having sex and future fertility were 33%, 20% and 16%, respectively., Conclusions: For some women who have low-grade cytology, a normal colposcopy does not appear to provide psychological reassurance., (© 2014 John Wiley & Sons Ltd.)

Objectives: To determine the rate of cervical intraepithelial neoplasia grade 2 (CIN2+) in women with low grade cervical cytology and a normal colposcopy examination over 3 years of follow-up., Design: Cohort study within a randomised controlled trial., Setting: NHS Cervical Screening Programmes in Grampian, Tayside and Nottingham., Population: Eight hundred and eighty-four women aged 20-59 years with borderline nuclear abnormalities (BNA) or mild dyskaryosis with a normal and adequate colposcopy examination., Methods: Samples at baseline were tested for 14 high-risk (Hr) types using GP5+6+ methodology and for HPV 16 and 18 using type-specific primers. Women were followed up post-colposcopy by cervical cytology at 6-month intervals in primary care. After 3 years, women were invited for an exit colposcopy examination and underwent LLETZ if any colposcopic abnormality was identified., Main Outcome Measures: Absolute and relative risks of CIN2+ during follow-up and/or at exit colposcopy., Results: The median age was 36 years. The absolute risk of developing CIN2+ within 3 years was 1.86 per 100 woman years and for CIN3+, 0.64 per 100 woman years. One microinvasive cancer was identified. The relative risk (RR) was highest for women with initial mild dyskaryosis who were HrHPV-positive (RR 5.86, 95% confidence interval 2.53-13.56) compared with women with BNA who were HrHPV-negative., Conclusion: For women with low grade cervical cytology, the risk of a high grade CIN within 3 years of a normal colposcopy examination is low. Women can be reassured that, even with a positive HPV test, the risk of developing CIN2 or worse is sufficiently low to return to the routine 3-year recall., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Background: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination., Methods: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance., Results: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points., Conclusions: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost., Trial Registration: Controlled-Trials.com ISRCTN 34841617.

Objective: The success of cervical screening relies on women with abnormal cervical cytology attending for follow-up by colposcopy and related procedures. Failure to attend for colposcopy, however, is a common problem in many countries. The objective of this study was to identify factors associated with non-attendance at an initial colposcopy examination among women with low-grade abnormal cervical cytology., Study Design: A cohort study was conducted within one arm of a multi-centre population-based randomised controlled trial nested within the UK NHS Cervical Screening Programmes. The trial recruited women aged 20-59 years with recent low-grade cervical cytology; women randomised to immediate referral for colposcopy were included in the current analysis (n=2213). At trial recruitment, women completed a socio-demographic and lifestyle questionnaire; 1693 women in the colposcopy arm were also invited to complete a psychosocial questionnaire, including the Hospital Anxiety and Depression Scale. Women were sent up to two colposcopy appointments. A telephone number was provided to reschedule if necessary. Defaulters were defined as those who failed to attend after two appointments. Logistic regression methods were used to compute multivariate odds ratios (OR) to identify variables significantly associated with default., Results: 148 women defaulted (6.7%, 95%CI 5.7-7.8%). In multivariate analysis, risk of default was significantly raised in those not in paid employment (OR=2.70, 95%CI 1.64-4.43) and current smokers (OR=1.62, 95%CI 1.12-2.34). Default risk deceased with increasing age and level of post-school education/training and was lower in women with children (OR=0.59, 95%CI 0.35-0.98). Among the sub-group invited to complete psychosocial questionnaires, women who were not worried about having cervical cancer were significantly more likely to default (multivariate OR=1.56, 95%CI 1.04-2.35). Anxiety and depression were not significantly associated with default., Conclusions: Women at highest risk of default from colposcopy are younger, not in paid employment, smoke, lack post-school education, have not had children and are not worried about having cervical cancer. Findings such as these could inform the development of tools to predict the likelihood that an individual woman will default from follow-up. Interventions to minimise default also deserve consideration, but a better understanding of reasons for default is needed to inform intervention development., (Copyright © 2012. Published by Elsevier Ireland Ltd.)

Background: The debate continues regarding the best management for women with low-grade abnormal cervical cytology attending colposcopy. We compared psychosocial outcomes of alternative management policies in these women., Methods: In all, 989 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to immediate large loop excision (LLETZ) or two to four targeted punch biopsies taken immediately with recall for LLETZ if these showed cervical intra-epithelial neoplasia 2/3. At 6 weeks after the last procedure, women completed the hospital anxiety and depression scale (HADS) and the impact of event scale (IES). At 12, 18, 24 and 30 months post recruitment, women completed the HADS and process outcome specific measure (POSM). Prevalence of significant depression (≥ 8), significant anxiety (≥ 11) and distress (≥ 9) and median POSM scores were compared between arms. Multivariate odds ratios (ORs) for immediate LLETZ vs biopsy and recall were computed., Results: Over the entire follow-up, there was no significant difference between arms in cumulative prevalence or risk of significant depression (OR=0.78, 95% CI 0.52-1.17) or significant anxiety (OR=0.83, 95% CI 0.57-1.19). At 6 weeks post procedure, distress did not differ significantly between arms. At later time points, 8-11% had significant depression and 14-16% had significant anxiety but with no differences between arms. The POSM scores did not differ between the arms., Conclusions: There is no difference in long- or short-term psychosocial outcomes of immediate LLETZ and punch biopsies with selective recall.

Objective: Few studies have investigated physical after-effects of colposcopy. We compared post-colposcopy self-reported pain, bleeding, discharge and menstrual changes in women who underwent: colposcopic examination only; cervical punch biopsies; and large loop excision of the transformation zone (LLETZ)., Design: Observational study nested within a randomised controlled trial., Setting: Grampian, Tayside and Nottingham., Population: Nine hundred-and-twenty-nine women, aged 20-59, with low-grade cytology, who had completed their initial colposcopic management., Methods: Women completed questionnaires on after-effects at approximately 6-weeks, and on menstruation at 4-months, post-colposcopy., Main Outcome Measures: Frequency of pain, bleeding, discharge; changes to first menstrual period post-colposcopy., Results: Seven hundred-and-fifty-one women (80%) completed the 6-week questionnaire. Of women who had only a colposcopic examination, 14-18% reported pain, bleeding or discharge. Around half of women who had biopsies only and two-thirds treated by LLETZ reported pain or discharge (biopsies: 53% pain, 46% discharge; LLETZ: 67% pain, 63% discharge). The frequency of bleeding was similar in the biopsy (79%) and LLETZ groups (87%). Women treated by LLETZ reported bleeding and discharge of significantly longer duration than other women. The duration of pain was similar across management groups. Forty-three percent of women managed by biopsies and 71% managed by LLETZ reported some change to their first period post-colposcopy, as did 29% who only had a colposcopic examination., Conclusions: Cervical punch biopsies and, especially, LLETZ carry a substantial risk of after-effects. After-effects are also reported by women managed solely by colposcopic examination. Ensuring that women are fully informed about after-effects may help to alleviate anxiety and provide reassurance, thereby minimising the harms of screening.

Objective: To determine whether human papillomavirus (HPV) immunisation has affected the prevalence of HPV genotypes and colposcopic features of cervical intraepithelial neoplasia (CIN) in young women referred for colposcopy.Design: A two-centre observational study including vaccinated and unvaccinated women.Setting: Colposcopy clinics serving two health regions in Scotland, UK.Population: A total of 361 women aged 20-25 years attending colposcopy following an abnormal cervical cytology result at routine cervical screening.Methods: Cervical samples were obtained from women for HPV DNA genotyping and mRNA E6/E7 expression of HPV 16, 18, 31, 33, and 45. Demographic data, cytology, and histology results and colposcopic features were recorded. Chi-square analysis was conducted to identify associations between vaccine status, HPV genotypes, and colposcopic features.Main Outcome Measures: Colposcopic features, HPV genotypes, mRNA expression, and cervical histology.Results: The prevalence of HPV 16 was significantly lower in the vaccinated group (8.6%) compared with the unvaccinated group (46.7%) (P = 0.001). The number of cases of CIN2+ was significantly lower in women who had been vaccinated (P = 0.006). The HPV vaccine did not have a statistically significant effect on commonly recognised colposcopic features, but there was a slight reduction in the positive predictive value (PPV) of colposcopy for CIN2+, from 74% (unvaccinated) to 66.7% (vaccinated).Conclusions: In this group of young women with abnormal cytology referred to colposcopy, HPV vaccination via a catch-up programme reduced the prevalence of CIN2+ and HPV 16 infection. The reduced PPV of colposcopy for the detection of CIN2+ in women who have been vaccinated is at the lower acceptable level of the UK national cervical screening programme guidelines.Tweetable Abstract: Reduction of hrHPV positivity and CIN in immunised women consistent with lower PPV of colposcopy for CIN2+. [ABSTRACT FROM AUTHOR]

Objective: To measure patterns of clinical activity at colposcopy before and after vaccinated women entered the Scottish Cervical Screening Programme (SCSP).Design: Population-based observational study using nationally collected data.Setting: Scottish colposcopy clinics.Sample: All women with a date of birth on or after 1 January 1985 who attended colposcopy in Scotland between 2008 and 2014.Methods: Routinely collected data from the Scottish National Colposcopy Clinical Information Audit System (NCCIAS) were extracted, including: referral criteria, referral cervical cytology, colposcopic findings, clinical procedures, and histology results. Analysis was restricted to those referred to colposcopy at age 20 or 21 years.Main Outcome Measures: Referral criteria, positive predictive value of colposcopy, default rates, and rates of cervical biopsies and treatments.Results: A total of 7372 women referred for colposcopy at age 20 or 21 years were identified. There was a downward trend in the proportion of those referred with abnormal cytology (2008/9, 91.0%; 2013/14, 90.3%; linear trend P = 0.03). Women were less likely to have diagnostic or therapeutic interventions. The proportion with no biopsy (2008/9, 19.5%; 2013/14, 26.9%; linear trend P < 0.0001) and no treatment (2008/9, 74.9%; 2013/14, 91.8%; linear trend P < 0.0001) increased over the period of observation.Conclusions: A reduction in clinical activity related to abnormal screening referrals is likely to be associated with the human papillomavirus (HPV) catch-up immunisation programme. Referral criteria and the service provision of colposcopy needs to be planned carefully, taking account of the increasing number of women who have been immunised against HPV that will be entering cervical screening programmes worldwide.Tweetable Abstract: Colposcopy referral criteria and service planning need attention following HPV immunisation programme. [ABSTRACT FROM AUTHOR]

Background: To document the effect of bivalent HPV immunisation on cervical cytology as a screening test and assess the implications of any change, using a retrospective analysis of routinely collected data from the Scottish Cervical Screening Programme (SCSP).Methods: Data were extracted from the Scottish Cervical Call Recall System (SCCRS), the Scottish Population Register and the Scottish Index of Multiple Deprivation. A total of 95 876 cytology records with 2226 linked histology records from women born between 1 January 1988 and 30 September 1993 were assessed. Women born in or after 1990 were eligible for the national catch-up programme of HPV immunisation. The performance of cervical cytology as a screening test was evaluated using the key performance indicators used routinely in the English and Scottish Cervical Screening Programmes (NHSCSP and SCSP), and related to vaccination status.Results: Significant reductions in positive predictive value (16%) and abnormal predictive value (63%) for CIN2+ and the mean colposcopy score (18%) were observed. A significant increase (38%) in the number of women who had to be referred to colposcopy to detect one case of CIN2+ was shown. The negative predictive value of negative- or low-grade cytology for CIN2+ increased significantly (12%). Sensitivity and specificity, as used by the UK cervical screening programmes, were maintained.Conclusions: The lower incidence of disease in vaccinated women alters the key performance indicators of cervical cytology used to monitor the quality of the screening programme. These findings have implications for screening, colposcopy referral criteria, colposcopy practice and histology reporting. [ABSTRACT FROM AUTHOR]

Please cite this paper as: Cotton S, Sharp L, Little J, Cruickshank M, Seth R, Smart L, Duncan I, Harrild K, Neal K, Waugh N, The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group. The role of human papillomavirus testing in the management of women with low-grade abnormalities: multicentre randomised controlled trial. BJOG 2010; DOI: 10.1111/j.1471-0528.2010.02519.x. Objective To assess the value of a single human papillomavirus (HPV) test in making decisions on management of women with cervical cytology showing borderline nuclear abnormality (BNA) or mild dyskaryosis. In particular, to determine whether information on high-risk (hr) HPV status would be valuable in the choice between (1) cytological surveillance versus immediate referral to colposcopy, and (2) at colposcopy, between biopsy and recall versus immediate large loop excision of the transformation zone (LLETZ). Design Multicentre individually randomised controlled trial, nested within the NHS Cervical Screening Programmes, investigating the value of HPV testing by testing for interactions between HPV status and (1) cytological surveillance versus colposcopy, and (2) biopsy and recall versus immediate LLETZ. Setting Grampian, Tayside and Nottingham. Population Women ( n = 4439), aged 20–59 years, with a cytology test showing borderline nuclear abnormalities or mild dyskaryosis during October 1999 to October 2002. Methods High-risk HPV status was determined at recruitment using the polymerase chain reaction assay with the GP5+/6+ general primer system. The results of this HPV testing were not disclosed to either the participating women or to those involved in their management. Women were randomised to either (1) 6-monthly cytological screening in primary care or (2) referral for colposcopy. Human papillomavirus status was used to stratify both randomisations. All women were followed for 3 years, concluding with an invitation to an exit appointment at which colposcopic examination was undertaken. In addition, in women who were randomised to initial colposcopy and underwent colposcopy, the association between hrHPV status and presence of cervical intraepithelial neoplasia (CIN) grade 2 or more severe disease (henceforth CIN2 or worse) was examined. Main outcome measures Sensitivity, specificity, positive and negative predictive values of the HPV test for predicting CIN2 or worse and the implications for the choice of management between cytological surveillance and immediate referral for colposcopy. Results There were no significant interactions between management and HPV status. Hence, in women with mild dyskaryosis or BNA who are HPV positive, there is no advantage of (1) immediate colposcopy over cytological surveillance ( P = 0.76) or (2) immediate LLETZ over biopsy and recall ( P = 0.27). The sensitivity of HPV testing for detection of CIN2 or worse was 75.2% (95% CI 68.8–81.0%) among women with mild dyskaryosis and 69.9% (95% CI 61.7–77.3%) among those with BNA. Specificity was higher in those with BNA (71.3%; 95% CI 68.5–74.1%) than in those with mild dyskaryosis (46.9%; 95% CI 42.2–51.6%). Sensitivity decreased with increasing age whereas specificity increased. The negative predictive value was high, particularly among women with BNA (94.5%; 95% CI 92.9–96.0%). Across all ages, 22% of women who had CIN2 or worse were HPV negative. Conversely, 40% of those who were HPV positive did not have CIN. HPV was a much more reliable predictor in women aged over 40 years. Conclusions We conclude that in younger women with low-grade cytological abnormalities, a single HPV test would not be useful in determining who should be referred for colposcopy or the most effective management at colposcopy. In women over 40, a negative HPV test could be used to rule out further investigation. [ABSTRACT FROM AUTHOR]

Background Better understanding of motivators for, and barriers to, participation in randomized controlled trials (RCTs) in different study populations and settings has the potential to improve participation of historically under-represented groups (eg, women) in future trials. Purpose To investigate reasons why women agreed, or declined, to participate in a RCT. Methods In two postal questionnaire-based studies, we investigated women's reasons for participation or non-participation in TOMBOLA, a RCT comparing management policies for low-grade cervical abnormalities. Four-hundred and ninety-two TOMBOLA participants (response rate 56%) completed questionnaires on reasons for participation. One-hundred and thiry-seven women (38%) who declined TOMBOLA participation completed questionnaires on reasons for this. Results Eighty percent of women reported that one of their reasons for attending their TOMBOLA recruitment appointment was worries about their smear result. Ninety-four percent participated in the RCT because it was a worthwhile contribution to the cervical screening programme and other women; for 70% this was the most important reason. These proportions did not vary by socio-demographic factors. Thirty-two percent thought participation would result in better care. The most common reason for non-participation was preference for follow-up from the woman's GP. Logistical issues (eg, inconvenient appointments, travel time, arranging time off work or child-care) were commonly cited. Fourteen percent were too frightened to participate; this was unrelated to the grade of the recruitment smear. Limitations Response rates were not high, but there was little evidence of response bias. Structured questionnaires were used. Conclusions Future research should address how best to deliver information to ensure different social groups appreciate potential benefits of RCT participation and provide reassurance regarding fears about participation. Simple strategies (eg, appealing to the altruism of potential participants or offering flexible recruitment clinic locations and times) might enhance RCT recruitment rates. This in turn would ensure best use of research resources thus bringing the greatest benefits to participants and the population. [ABSTRACT FROM AUTHOR]

Annually in the UK around 250 000 cervical smears show low-grade abnormalities. Alternative management policies following a low-grade smear are cytological surveillance or referral for colposcopy. Their effectiveness and cost-effectiveness, and the potential for human papillomavirus (HPV) testing to triage women to either management, has been debated. Trial of management of borderline and other low-grade abnormal smears (TOMBOLA) (a large RCT) addresses these uncertainties, considering clinical, psychosocial and economic outcomes. 4439 women aged 20–59, resident in Grampian, Tayside or Nottingham with a low-grade smear were randomised to cytological surveillance (six-monthly smears in primary care) or hospital-based colposcopy. At colposcopy, women with visible abnormality were randomised to immediate treatment or biopsy and recall for treatment if necessary. Recruitment HPV status was assessed using PCR techniques. Women were followed for three years to an exit colposcopy. Cumulative incidence of CIN2 or more severe disease (CIN2+) in the colposcopy arm was 7.9% per year, higher than in cytological surveillance (5.8%; OR = 1.43, 95% CI 1.23–1.67). This difference was less marked for CIN3+ (OR = 1.27, 1.04–1.55), suggesting spontaneous regression of some CIN2, and that initial colposcopy can lead to over-treatment. There was little difference in psychosocial outcomes between arms. In comparison of biopsy and recall versus immediate treatment, there was no difference in cumulative incidence of CIN2+ or psychosocial outcomes. There was over-treatment and increased frequency/duration of bleeding with immediate treatment. There was no compelling economic reason to favour any one management method. Testing for HPV does not appear to be effective in triage. Based on these findings, we make management recommendations for women with low-grade smears. [ABSTRACT FROM AUTHOR]