RESUMEN
INTRODUCTION: Colposcopy is an important part of the diagnostic work-up of women with an abnormal cervical screening test as it is used to guide the collection of biopsies. Although quality assurance has been used in the evaluation of screening programs, not much is known about quality indicators for the diagnostics and treatment of screen-positive women. Therefore, the European Federation for Colposcopy developed quality indicators aiming to support colposcopy practice across Europe. We performed a survey of colposcopy cases to determine if the quality indicators are understandable, relevant, and reproducible. MATERIAL AND METHODS: We conducted a survey among all members of the European Federation for Colposcopy Quality and Standards Group from November 2022 to March 2023. Members were asked to collect information on a total of 17 quality indicators for 50 women who had been newly referred for colposcopy due to an abnormal screening test between January 1, 2020 to December 31, 2021. Results were reported descriptively. RESULTS: We included data on 609 cases from 12 members across Europe. The majority of the quality indicators were either achieved or within reach of the agreed standard, often due to few countries with outlying data. One quality indicator had very low performance, although stratified results indicated that two countries had different clinical management of the patient type thereby skewing the results. In addition, discrepancies between the number of cases included in each quality indicator raised concerns regarding potential misunderstanding of the quality indicator and its objective. CONCLUSIONS: Quality indicators on colposcopy must be understandable to those collecting data, highlighting the importance of validating quality indicators before data collection.
Asunto(s)
Colposcopía , Indicadores de Calidad de la Atención de Salud , Neoplasias del Cuello Uterino , Humanos , Colposcopía/normas , Colposcopía/estadística & datos numéricos , Femenino , Europa (Continente) , Reproducibilidad de los Resultados , Adulto , Neoplasias del Cuello Uterino/diagnóstico , Encuestas y Cuestionarios , Persona de Mediana Edad , Sociedades Médicas , Detección Precoz del Cáncer/normasRESUMEN
The aim of our analysis was the assessment of the qualitative and performance indicators of a pilot program for health visitors' cervical cancer screening. The analysis involved the data from the Communication module of the Office of the National Chief Medical Officer. In the examined period (October, 2013 - September, 2015) the participation indicators of women aged 25-65, the prevalence rates of human papillomavirus and the cervical intraepithelial neoplasia were determined. In the screening period, the call-in rate was 32.45% nationally, with the compliance of 8.26%. The occurrence of a positive result was 1.85% nationally, with the highest rate in Hajdú-Bihar county (7.24%). HPV infection was detected in 113 cases (0.45%) nationally, HPV prevalence was 37.44/100,000 persons. The willingness for participation among women was low concerning the indicators. Their raising should be an emphasized task for public health in favor of reducing mortality from morbidities.
Asunto(s)
Detección Precoz del Cáncer/métodos , Enfermeros de Salud Comunitaria/organización & administración , Infecciones por Papillomavirus/diagnóstico , Displasia del Cuello del Útero/diagnóstico , Neoplasias del Cuello Uterino/diagnóstico , Adulto , Factores de Edad , Anciano , Femenino , Humanos , Hungría , Persona de Mediana Edad , Infecciones por Papillomavirus/epidemiología , Cooperación del Paciente/estadística & datos numéricos , Proyectos Piloto , Prevalencia , Evaluación de Programas y Proyectos de Salud , Investigación Cualitativa , Indicadores de Calidad de la Atención de Salud/organización & administración , Neoplasias del Cuello Uterino/epidemiología , Displasia del Cuello del Útero/epidemiologíaRESUMEN
Two main considerations played roles in creation of new cervical screening system. One was the proven fact that high-risk human papilloma virus infection plays a role in the development of cervical cancer and pre-cancerous lesions. The other was the implementation of the HPV infection's biological behavior in the new screening strategy. The new screening procedure faithfully reflects the cervical carcinogenesis. An organised, population-based and age differentiated screening method could increase attendance of screening and could decrease the possibility of interval cancer rate due to increased sensitivity. Orv Hetil. 2017; 158(52): 2062-2067.
Asunto(s)
Detección Precoz del Cáncer/métodos , Tamizaje Masivo/organización & administración , Infecciones por Papillomavirus/diagnóstico , Displasia del Cuello del Útero/diagnóstico , Factores de Edad , Femenino , Humanos , Hungría , Infecciones por Papillomavirus/prevención & control , Neoplasias del Cuello Uterino/diagnóstico , Frotis Vaginal , Displasia del Cuello del Útero/prevención & controlRESUMEN
INTRODUCTION: Within the tender (6.1.3.A-13/1-2013-0001) supported by the European Union, we wished to involve health visitors into the organized cervical cancer screening program. AIM: The aim of our survey was to assess the satisfaction of health visitors, instructors, and that of the teaching aids. Furthermore, we wished to assess whether the teaching materials met the expectations. METHOD: Satisfaction of the health visitors was assessed by a survey, in four groups of questions. These involved the assessment of the instructors, the teaching aids, evaluation of the further training day, and the compliance with the knowledge of training. Period for completion of the questionnaires lasted from October to December in 2014. We used descriptive statistics for data evaluation. RESULTS: Data of 2148 health visitors was evaluated. They rated the performance of gynecologist-obstetricians 4.65, that of health visitors 4.61, that of public health professionals 4.56, and that of IT specialists 4.52. 98% of the teaching aids were useful for them and the acquired knowledge was appropriate with their expectations. CONCLUSION: The health visitors were satisfied with the theoretical instruction within the pilot program. The professionally well prepared health visitors may contribute to the success of the cervical cancer screening program. Orv. Hetil, 2017, 158(12), 461-467.
Asunto(s)
Detección Precoz del Cáncer/métodos , Conocimientos, Actitudes y Práctica en Salud , Neoplasias del Cuello Uterino/diagnóstico , Enfermería en Salud Comunitaria/educación , Unión Europea , Femenino , Humanos , Evaluación de Necesidades , Proyectos Piloto , Neoplasias del Cuello Uterino/psicologíaRESUMEN
In the era of primary vaccination against HPV and at the beginning of the low prevalence of cervical lesions, introduction of screening methods that can distinguish between low- and high-grade lesions is necessary in order to maintain the positive predictive value of screening. This case-control study included 562 women who attended cervical screening or were referred for colposcopy and 140 disease free controls, confirmed by histology and/or cytology. The cases were stratified by age. Using routine exfoliated liquid based cytological samples RT-PCR measurements of biomarker genes, high-risk HPV testing and liquid based cytology were performed and used to evaluate different testing protocols including sets of genes/tests with different test cut-offs for the diagnostic panels. Three new panels of cellular biomarkers for improved triage of hrHPV positive women (diagnostic panel) and for prognostic assessment of CIN lesions were proposed. The diagnostic panel (PIK3AP1, TP63 and DSG3) has the potential to distinguish cytologically normal hrHPV+ women from hrHPV+ women with CIN2+. The prognostic gene panels (KRT78, MUC5AC, BPIFB1 and CXCL13, TP63, DSG3) have the ability to differentiate hrHPV+ CIN1 and carcinoma cases. The diagnostic triage panel showed good likelihood ratios for all age groups. The panel showed age-unrelated performance and even better diagnostic value under age 30, a unique feature among the established cervical triage tests. The prognostic gene-panels demonstrated good discriminatory power and oncogenic, anti-oncogenic grouping of genes. The study highlights the potential for the gene expression panels to be used for diagnostic triage and lesion prognostics in cervical cancer screening.
Asunto(s)
Biomarcadores de Tumor/genética , Papillomaviridae/genética , Infecciones por Papillomavirus/patología , Infecciones por Papillomavirus/virología , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/virología , Adulto , Estudios de Casos y Controles , Línea Celular Tumoral , Colposcopía/métodos , ADN Viral/genética , Progresión de la Enfermedad , Detección Precoz del Cáncer/métodos , Femenino , Células HeLa , Humanos , Sensibilidad y Especificidad , Triaje/métodos , Frotis Vaginal/métodos , Displasia del Cuello del Útero/genética , Displasia del Cuello del Útero/patologíaRESUMEN
The ongoing Triage and Risk Assessment of Cervical Precancer by Epigenetic Biomarker (TRACE) prospective, multicenter study aimed to provide a clinical evaluation of the CONFIDENCE™ assay, which comprises a human papillomavirus (HPV) DNA and a human epigenetic biomarker test. Between 2013 and 2015 over 6,000 women aged 18 or older were recruited in Hungary. Liquid-based cytology (LBC), high-risk HPV (hrHPV) DNA detection and single target host gene methylation test of the promoter sequence of the POU4F3 gene by quantitative methylation-specific polymerase chain reaction (PCR) were performed from the same liquid-based cytology sample. The current analysis is focused on the baseline cross-sectional clinical results of 5,384 LBC samples collected from subjects aged 25 years or older. The performance of the CONFIDENCE HPV™ test was found to be comparable to the cobas® HPV test with good agreement. When applying the CONFIDENCE Marker™ test alone in hrHPV positives, it showed significantly higher sensitivity with matching specificity compared to LBC-based triage. For CIN3+ histological endpoint in the age group of 25-65 and 30-65, the methylation test of POU4F3 achieved relative sensitivities of 1.74 (95% CI: 1.25-2.33) and 1.64 (95% CI: 1.08-2.27), respectively, after verification bias adjustment. On the basis of our findings, POU4F3 methylation as a triage test of hrHPV positives appears to be a noteworthy method. We can reasonably assume that its quantitative nature offers the potential for a more objective and discriminative risk assessment tool in the prevention and diagnostics of high-grade cervical intraepithelial neoplasia (CIN) lesions and cervical cancer.
Asunto(s)
Carcinoma de Células Escamosas/química , Proteínas de Homeodominio/análisis , Infecciones por Papillomavirus/metabolismo , Lesiones Precancerosas/metabolismo , Factor de Transcripción Brn-3C/análisis , Displasia del Cuello del Útero/metabolismo , Neoplasias del Cuello Uterino/química , Adolescente , Adulto , Anciano , Biomarcadores , Biomarcadores de Tumor , Carcinoma de Células Escamosas/virología , Metilación de ADN , Sondas de ADN de HPV , ADN Viral/análisis , Femenino , Proteínas de Homeodominio/genética , Humanos , Hungría/epidemiología , Persona de Mediana Edad , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/virología , Lesiones Precancerosas/virología , Regiones Promotoras Genéticas , Estudios Prospectivos , Reacción en Cadena en Tiempo Real de la Polimerasa , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Factor de Transcripción Brn-3C/genética , Triaje , Displasia del Cuello del Útero/virología , Displasia del Cuello del Útero/química , Neoplasias del Cuello Uterino/virología , Adulto JovenRESUMEN
Several immunochemistry tests are used for triaging human papilloma virus (HPV) and cytology positive cases in cervical cancer screening and as an adjunct test to diagnose cervical cancer. Claudin-1 (CLDN1) protein is a major component of the tight junction, shown to have altered expression in cervical cancer. In this study, value of CLDN1 was analysed as a screening and triage immunochemistry test compared to cytology and HPV testing. A population of 352 women attending colposcopic referral visits resulting in cervical conisation and a second population of 150 women attending routine gynaecological visits with negative cervical cytology were enrolled in a multi-centre clinical study in Hungary. Cytology and HPV (Genoid Full Spectrum HPVAmplification and Detection System) testing were carried out along with immunocytochemistry for CLDN1, and as a reference, using CINtec p16 Cytology Kit. Three different evaluation protocols were used which assessed immunostaining characteristics with or without cytological readings. High correlation observable between p16INK4a and CLDN1 established CLDN1 as a competing marker in cervical cancer. Concordance of CLDN1 immunostaining of cervical intraepithelial neoplasia 2 and above (CIN2+) positives was 84.0 % (73.889.3); concordance of CIN2+ negatives was 69.0 % (59.675.8). In conclusion, CLDN1 has similar diagnostic potential as p16INK4a, our results established it as a histological and cytological biomarker with the potential to improve the clinical performance of cervical cytology and histology.
Asunto(s)
Biomarcadores de Tumor/metabolismo , Claudina-1/metabolismo , Citodiagnóstico , Neoplasias de Células Escamosas/patología , Infecciones por Papillomavirus/patología , Displasia del Cuello del Útero/patología , Neoplasias del Cuello Uterino/patología , Estudios de Casos y Controles , Colposcopía , Detección Precoz del Cáncer , Femenino , Estudios de Seguimiento , Humanos , Hungría , Técnicas para Inmunoenzimas , Clasificación del Tumor , Neoplasias de Células Escamosas/metabolismo , Neoplasias de Células Escamosas/virología , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/metabolismo , Infecciones por Papillomavirus/virología , Pronóstico , Neoplasias del Cuello Uterino/metabolismo , Neoplasias del Cuello Uterino/virología , Frotis Vaginal , Displasia del Cuello del Útero/metabolismo , Displasia del Cuello del Útero/virologíaRESUMEN
Cervical glandular neoplasias (CGN) present a challenge for cervical cancer prevention due to their complex histopathology and difficulties in detecting preinvasive stages with current screening practices. Reports of human papillomavirus (HPV) prevalence and type-distribution in CGN vary, providing uncertain evidence to support prophylactic vaccination and HPV screening. This study [108288/108290] assessed HPV prevalence and type-distribution in women diagnosed with cervical adenocarcinoma in situ (AIS, N = 49), adenosquamous carcinoma (ASC, N = 104), and various adenocarcinoma subtypes (ADC, N = 461) from 17 European countries, using centralised pathology review and sensitive HPV testing. The highest HPV-positivity rates were observed in AIS (93.9%), ASC (85.6%), and usual-type ADC (90.4%), with much lower rates in rarer ADC subtypes (clear-cell: 27.6%; serous: 30.4%; endometrioid: 12.9%; gastric-type: 0%). The most common HPV types were restricted to HPV16/18/45, accounting for 98.3% of all HPV-positive ADC. There were variations in HPV prevalence and ADC type-distribution by country. Age at diagnosis differed by ADC subtype, with usual-type diagnosed in younger women (median: 43 years) compared to rarer subtypes (medians between 57 and 66 years). Moreover, HPV-positive ADC cases were younger than HPV-negative ADC. The six years difference in median age for women with AIS compared to those with usual-type ADC suggests that cytological screening for AIS may be suboptimal. Since the great majority of CGN are HPV16/18/45-positive, the incorporation of prophylactic vaccination and HPV testing in cervical cancer screening are important prevention strategies. Our results suggest that special attention should be given to certain rarer ADC subtypes as most appear to be unrelated to HPV.
Asunto(s)
Carcinoma Adenoescamoso/epidemiología , Infecciones por Papillomavirus/epidemiología , Displasia del Cuello del Útero/epidemiología , Neoplasias del Cuello Uterino/epidemiología , Adulto , Anciano , Carcinoma Adenoescamoso/virología , Estudios Transversales , Europa (Continente)/epidemiología , Femenino , Papillomavirus Humano 16/genética , Humanos , Persona de Mediana Edad , Infecciones por Papillomavirus/virología , Prevalencia , Estudios Retrospectivos , Neoplasias del Cuello Uterino/virología , Adulto Joven , Displasia del Cuello del Útero/virologíaRESUMEN
Knowledge of differences in human papillomavirus (HPV)-type prevalence between high-grade cervical intraepithelial neoplasia (HG-CIN) and invasive cervical cancer (ICC) is crucial for understanding the natural history of HPV-infected cervical lesions and the potential impact of HPV vaccination on cervical cancer prevention. More than 6,000 women diagnosed with HG-CIN or ICC from 17 European countries were enrolled in two parallel cross-sectional studies (108288/108290). Centralised histopathology review and standardised HPV-DNA typing were applied to formalin-fixed paraffin-embedded cervical specimens dated 2001-2008. The pooled prevalence of individual HPV types was estimated using meta-analytic methods. A total of 3,103 women were diagnosed with HG-CIN and a total of 3,162 with ICC (median ages: 34 and 49 years, respectively), of which 98.5 and 91.8% were HPV-positive, respectively. The most common HPV types in women with HG-CIN were HPV16/33/31 (59.9/10.5/9.0%) and in ICC were HPV16/18/45 (63.3/15.2/5.3%). In squamous cell carcinomas, HPV16/18/33 were most frequent (66.2/10.8/5.3%), and in adenocarcinomas, HPV16/18/45 (54.2/40.4/8.3%). The prevalence of HPV16/18/45 was 1.1/3.5/2.5 times higher in ICC than in HG-CIN. The difference in age at diagnosis between CIN3 and squamous cervical cancer for HPV18 (9 years) was significantly less compared to HPV31/33/'other' (23/20/17 years), and for HPV45 (1 year) than HPV16/31/33/'other' (15/23/20/17 years). In Europe, HPV16 predominates in both HG-CIN and ICC, whereas HPV18/45 are associated with a low median age of ICC. HPV18/45 are more frequent in ICC than HG-CIN and associated with a high median age of HG-CIN, with a narrow age interval between HG-CIN and ICC detection. These findings support the need for primary prevention of HPV16/18/45-related cervical lesions.