[Guidelines for application of molecular tests identyfying HR HPV DNA in the prevention of cervical cancer. Statement of experts from PGS (PTG) and NCLD (KIDL)]. / Wytyczne dotyczace aplikacji testów molekularnych identyfikujacych DNA HPV HR w profilaktyce szyjki macicy. Stanowisko ekspertów PTG i KIDL.

DNA from high risk types of human papillomavirus (HPV-HR) is detected in virtually all cervical cancer samples. Most of HPV infections are transient, some persist and lead to development of neoplastics or even cervical cancer lesions. Cervical cancer screening programs are designed to detect early precancerous changes, which should decrease the cancer morbidity and mortality and reduce the costs of diagnosis and treatment. The most effective are screening programs that use cytological and HPV testing. Screening with this method are proven to reduce both the incidence and mortality from cervical cancer WOMEN AGED 21-29 YEARS: HPV testing should not be used to screen women aged 21-29 years, either as a stand-alone test or as a cotest with cytology DNA HPV HR testing in this group of women is recommended in diagnostics ofASCUS. Women DNA HPV positive with ASCUS should be referred to colposcopy WOMEN AGED 30-65 YEARS: Screening by HPV testing alone is not recommended. Women should be screened with cytology and HPV testing every 5 years or cytology alone every 3 years (acceptable). DNA HPV HR /+/, PAP /-/: Two options are recommended. Option 1: 12-months follow-up with contesting (PAP and DNA HPV HR tests). Option 2: Test for HPV16 or HPV16/18 genotypes. If HPV16 or HPV16/18 positive: refer to colposcopy If HPV16 or HPV16/18 negative:12-months follow-up with cotesting. DNA HPV HR /-/, ASC-US: Repetition of cytology in 12 moths is recommended. WOMEN AGED >65 YEARS: No screening is recommended following adequate negative prior to screening. Women with a history of CIN2 or a more severe diagnosis should continue routine screening for at least 20 years. WOMEN HPV VACCINATED: Follow age-specific recommendations (same as unvaccinated women). REQUIREMENTS OF DNA HPV HR TESTS IN CERVICAL SCREENING: The DNA HPV tests used in cervical screening should detect as much as possible of 14 HPV HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 i 68) and genotyping HPV 16/18. Candidates' tests should have control of DNA HPV purification and amplification processes and be preserved against contaminations. Clinical sensitivity for CIN 2 + should be no less than 90%. HPV tests and specimen collection system should fulfill the requirements of the act on medical devices.

Colposcopic management of high-grade referral smears: a retrospective audit supporting 'see and treat'?

OBJECTIVE: The National Health Service Cervical Screening Programme monitors the quality of colposcopy services through the annual KC65 returns. The 2002 returns demonstrated that Standard 7c, which specifies a biopsy rate > or = 90% at first colposcopy visit for high-grade referrals, was not met in the assessed 3-month period. This was investigated along with the other standards. METHODS: Retrospective colposcopy records were accessed for the 597 new referrals, excluding 10 pregnant patients, seen at the colposcopy clinic at the Royal Victoria Infirmary between 1 July 2001 and 31 December 2002, following an abnormal high-grade smear. Cytology and histopathology computer records were checked for confirmation. The results were assessed against the colposcopy standards applicable at that time and the revised standards (2004). RESULTS: Biopsies were taken from 94.47% (Standard > or = 90%) of women at index colposcopy visit including wire loop excision biopsies from 66.16% (87.97% of high-grade colposcopic appearances). Cervical intraepithelial neoplasia (CIN) on histology was found in 91.79% in the study group (Standard > or = 85%) and in 96.71% of index visit biopsies (Standard > or = 90%), meeting the applicable colposcopy standards. The revised 2004 standards specify a biopsy in > or = 95% of high-grade referrals and excision biopsies in 95% if colposcopic appearances are also high-grade, if colposcopy is low grade but the smear is severely dyskaryotic, or when the lesion extends into the canal. The positive predictive value of high-grade cytology for this entire group was 75.54% with CIN present in 90.95%. CONCLUSION: From this study it appears that high-grade cytology in this centre reliably indicates high-grade CIN. Therefore, in women referred for colposcopy following a high-grade smear, excision biopsies should be performed in a higher proportion at the first visit to comply with the revised standards.

Assessing the wellbeing of cytoscreeners: experience in two NHS cytology laboratories.

OBJECTIVE: Cervical screening programmes in England are in transition as the liquid-based cytology (LBC) method replaces conventional Papanicolaou screening and staff in NHS laboratories are trained to analyse LBC smears. Cytoscreeners and biomedical scientists undertake routine microscopy of slides, but the scientists usually have a wider professional role. Attitudinal surveys were carried out in laboratories where LBC was partially introduced. METHODS: Staff in two cytology laboratories in Greater Manchester were surveyed twice over 6 months. The questionnaire assessed work pressures using scales from the Measures of Work Characteristics instrument, work-related stress using the General Survey version of the Maslach Burnout Inventory, job intentions and job satisfaction. RESULTS: Cytoscreeners, many aged over 50 years, formed over 60% of respondents in both surveys (27/42 in the first survey), and biomedical scientists and doctors, 30%. Both groups were under moderate pressure from work demands in each survey, but cytoscreeners had significantly less autonomy over their working methods (P < 0.001). Although both groups experienced similar levels of exhaustion, cytoscreeners were much more cynical or indifferent towards work in the second survey (P = 0.008) and had lower expectations of being effective (P < 0.001). For the cytoscreeners, there were strong negative correlations in both surveys between cynicism and the work characteristics of influencing decisions and autonomy/control. CONCLUSIONS: The strength of the relationship between work performance and wellbeing serves to emphasize the importance of the new LBC technology in ameliorating low morale where it exists. Further attitudinal research involving larger samples of laboratories is warranted to assess the full impact of this innovation.

Quality control assurance in national screening programmes for cervical cancer.

The United Kingdom established a centrally controlled formal screening programme for cervical cancer in 1988. The programme has been an unprecedented success, with the incidence of cervical cancer falling by an accelerated rate of 7% a year. Underlying the success of the programme is a rigorous system of quality assurance at all levels of activity. Quality assurance assessment in performed for coverage of the target population, cytology reporting laboratories and colposcopy services. Each component in the system is examined annually by mandatory returns, and by regular on-site review of the clinical services by independent authorities. Processes also exist to establish and maintain the competency of all clinical and non-clinical staff involved in the programme. Using nationally published figures from the financial year 2001/2002, the different quality assurance strategies are described. The future development of quality assurance in the programme is then discussed.

Design and methods of the evaluation of an HPV-based cervical cancer screening strategy in Mexico: The Morelos HPV Study.

OBJECTIVE: The purpose of this paper is to describe the design and methodology of the Morelos HPV Study. The main objective of this study is to examine the use of two different methods for obtaining HPV DNA specimens, self-collected vaginal and clinician-collected cervical, to detect pre-invasive cervical lesions and cancer. MATERIAL AND METHODS: This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) cervical cancer screening program in Morelos. A total of 7,868 women were recruited between May and October 1999 and are representative of the population of women attending cervical cancer screening services at the 23 IMSS clinics in the state of Morelos in 1999. Women were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all participants using a standard IMSS registration form. During the initial recruitment visit, a randomly selected subsample of 1,069 participants were interviewed to collect additional information about cervical cancer risk factors, acceptability of the HPV and Pap tests, as well as patient costs. Before the pelvic exam, participants were asked to provide a self-collected vaginal specimen for HPV testing. All participants underwent a pelvic examination that involved collecting a cervical sample for the Pap smear and a clinician-collected HPV specimen. Data were evaluated from 7,732 women with complete information for the three tests. The 1,147 women who received at least one positive result (Pap, self- and/or clinician-HPV tests) were invited to return for a colposcopic examination. During colposcopy, biopsies were taken as appropriate, to histologically confirm a diagnosis of cervical intraepithelial neoplasia (CIN) 2/3 or invasive cancer. A total of 1,015 women attended colposcopy, and 101 women received a histologically-confirmed CIN 2/3 or cervical cancer diagnosis. CONCLUSIONS: The initial enrollment activities of the Morelos HPV study are the basis for a prevalent case-control study and a prospective cohort study that will investigate the natural history of HPV infections and determine if an HPV-based screening strategy is a safe and cost-effective alternative to Pap screening. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.

Quality of care from a patient perspective in population-based cervical cancer screening.

In Stockholm, population-based cervical cancer screening is offered free of charge to all women between 23 and 60 years of age. A survey to assess satisfaction with care using a previously validated questionnaire was conducted with 73 women receiving abnormal Pap smear results through the screening program. Thirty-seven women received results of screening within a feasibility project, in which they had extra contact with a midwife prior to receiving standard information and medical follow-up by a gynaecologist. The other 36 women were a matched sample receiving standard information. The results indicate generally high perceptions of quality of care, with particularly high ratings of perceived gynaecological knowledge and medical information provision. Low perceptions of quality were found regarding several aspects of psychosocial care. Higher levels of self-reported psychological well-being were found among the women who had extra midwifery contact. The results indicate that more attention to psychosocial aspects might optimize the screening program.

Design and methods of the evaluation of an HPV-based cervical cancer screening strategy in Mexico: The Morelos HPV Study

OBJECTIVE: The purpose of this paper is to describe the design and methodology of the Morelos HPV Study. The main objective of this study is to examine the use of two different methods for obtaining HPV DNA specimens, self-collected vaginal and clinician-collected cervical, to detect pre-invasive cervical lesions and cancer. MATERIAL AND METHODS: This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) cervical cancer screening program in Morelos. A total of 7,868 women were recruited between May and October 1999 and are representative of the population of women attending cervical cancer screening services at the 23 IMSS clinics in the state of Morelos in 1999. Women were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all participants using a standard IMSS registration form. During the initial recruitment visit, a randomly selected subsample of 1,069 participants were interviewed to collect additional information about cervical cancer risk factors, acceptability of the HPV and Pap tests, as well as patient costs. Before the pelvic exam, participants were asked to provide a self-collected vaginal specimen for HPV testing. All participants underwent a pelvic examination that involved collecting a cervical sample for the Pap smear and a clinician-collected HPV specimen. Data were evaluated from 7,732 women with complete information for the three tests. The 1,147 women who received at least one positive result (Pap, self- and/or clinician-HPV tests) were invited to return for a colposcopic examination. During colposcopy, biopsies were taken as appropriate, to histologically confirm a diagnosis of cervical intraepithelial neoplasia (CIN) 2/3 or invasive cancer. A total of 1,015 women attended colposcopy, and 101 women received a histologically-confirmed CIN 2/3 or cervical cancer diagnosis. CONCLUSIONS: The initial enrollment activities of the Morelos HPV study are the basis for a prevalent case-control study and a prospective cohort study that will investigate the natural history of HPV infections and determine if an HPV-based screening strategy is a safe and cost-effective alternative to Pap screening.

Rapid screening: a comparative study.

Although rapid screening of negative and inadequate cervical smears is a quality assurance requirement for all UK laboratories, there has been little attempt to standardize the method and laboratories make use of a number of different techniques and times. The aim of this study was to assess the sensitivity of these various techniques by measuring their ability to pick out known false-negative smears. Completed questionnaires from 123 laboratories across England revealed that 52% of laboratories use a "step" technique, 19% use "turret", 15% use random paths and 34% attempt to rescreen the whole slide quickly. Twenty-two percent of laboratories use a mixture of techniques. Timings are also variable, with the majority of laboratories allowing screeners to review slides at a pace decided by themselves but usually between 1 and 2 min. The study involved 120 participants who performed a total of 24 000 rapid screens. The results showed that, of the 90 abnormal slides used in the study, 62 cases (69%) were identified as abnormal or needing review by more than 50% of participants. Overall rapid screening picked out 58% of high-grade squamous abnormalities, 59% of low-grade abnormalities and 72% of glandular lesions. Step screening performed best, followed by whole slide/random and then turret. One minute was the optimum time and there was a significant fall in performance once individuals attempted to rescreen large numbers (>50). The most significant finding was the marked variation in the performance of individuals using the same slide sets.