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Background Cervical cancer is the second most common cancer in women world-wide and affects about 300 women in Norway each year. Cervical cancer develops through cellular abnormalities in the cervix that can be detected by cytological tests. With the introduction of organized cervical cytologic screening programs, the incidence of cervical cancer has been dramatically reduced. However, cytologic screening tests also have limitations, especially their limited sensitivity. Because infection with oncogenic human papillomavirus (HPV) has been identified as the underlying cause of cervical cancer, there is interest in the use of HPV testing as a screening test for cervical cancer. The overall prevalence of HPV among cervical cancers is more than 99%. We have evaluated HPV RNA testing for cervical pre cancer lesions by assessing the diagnostic accuracy of the HPV RNA tests compared with cytology and HPV DNA testing. Methods We have systematically searched the following databases for studies that fulfilled our criteria:1. Medline (Ovid) 1966 - 2007, September week 12. Embase (Ovid) 1980 - 2007 week 373. CRD databases (DARE, NHS EED, HTA) 2007, September Relevant topics and text words were combined. We also composed a search filter for diagnostic studies. NorChip AS who has developed a HPV mRNA test was invited to dispatch documentation. We included published literature based on the following criteria: Population: Women Index test: HPV RNA tests Comparators: HPV DNA tests or cytology for screening of cervical cancer Reference standard: Histology Study design: No limit Outcome: Test sensitivity and specificity, positive and negative predictive value or other values that describe diagnostic accuracy Development of cancer Test reliability Language: English and Scandinavian We did not include publications from conferences or abstracts. Relevance and quality was assessed according to our handbook. We used GRADE to assess the documentation for diagnostic accuracy. The results are presented in tables and in a descriptive summary. This work has been carried out by two researchers at NOKC and the report has been externally reviewed. We calculated diagnostic accuracy using 2 x 2 tables for each study. Results We identified 2498 references and assessed 31 full-text articles. Five studies were included in the report and results were extracted and pooled from three of them. Details of each study are presented in evidence tables. Two of the studies were sponsored by the producers of the tests. We have assessed the quality of the documentation of diagnostic accuracy using GRADE. For HPV RNA testing, the quality is very low which means that the results are very uncertain. It is not known whether HPV RNA testing give a better diagnostic accuracy than HPV DNA testing and cytology. In summary these results showed:1. The HPV RNA tests had slightly lower sensitivity compared with HPV DNA tests (77 % 95 % CI 73-81) versus 92 % (95 % CI 89-94), while cytology had lowest sensitivity (61 %). The sensitivity states the probability of a positive test result if you have the disease.2. The HPV RNA tests had slightly higher specificity compared with HPV DNA tests (64 % 95 % CI 60-68) versus 45 % (95 % CI 41-49), while cytology had highest specificity (81 %). The specificity states the probability of a negative test result if you are healthy.3. The HPV RNA tests had comparable positive predictive value with the HPV DNA tests (63 % 95 % CI 59-67) versus 57 % (95 % CI 53-60), while cytology had the highest positive predictive value (91 %). Positive predictive value states the probability of illness among people with a positive test.4. The HPV RNA tests had slightly lower negative predictive value compared with the HPV DNA tests (78 % 95 % CI 74-82) versus 87 % (95 % CI 83-91), while cytology had the lowest negative predictive value (39 %). Negative predictive value states the probability of illness among people with a negative test. Conclusions Due to spare and low quality documentation, we do not know if HPV RNA tests have a better diagnostic accuracy compared to HPV DNA tests and cytology for detection of cervical pre cancer lesions. Norwegian Knowledge Centre for the Health Services summarizes and disseminates evidence concerning the effect of treatments, methods, and interventions in health services, in addition to monitoring health service quality. Our goal is to support good decision making in order to provide patients in Norway with the best possible care. The Centre is organized under The Directorate for Health and Social Affairs, but is scientifically and professionally independent. The Centre has no authority to develop health policy or responsibility to implement policies.

Papillomavirus diseases.

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Background Cervical cancer is the second most common cancer in women world-wide and affects about 300 women in Norway each year. Cervical cancer develops through cellular abnormalities in the cervix that can be detected by cytological tests. With the introduction of organized cervical cytologic screening programs, the incidence of cervical cancer has been dramatically reduced. However, cytologic screening tests also have limitations, especially their limited sensitivity. Because infection with oncogenic human papillomavirus (HPV) has been identified as the underlying cause of cervical cancer, there is interest in the use of HPV testing as a screening test for cervical cancer. The overall prevalence of HPV among cervical cancers is more than 99%. We have evaluated HPV RNA testing for cervical pre cancer lesions by assessing the diagnostic accuracy of the HPV RNA tests compared with cytology and HPV DNA testing. Methods We have systematically searched the following databases for studies that fulfilled our criteria:1. Medline (Ovid) 1966 - 2007, September week 12. Embase (Ovid) 1980 - 2007 week 373. CRD databases (DARE, NHS EED, HTA) 2007, September Relevant topics and text words were combined. We also composed a search filter for diagnostic studies. NorChip AS who has developed a HPV mRNA test was invited to dispatch documentation. We included published literature based on the following criteria: Population: Women Index test: HPV RNA tests Comparators: HPV DNA tests or cytology for screening of cervical cancer Reference standard: Histology Study design: No limit Outcome: Test sensitivity and specificity, positive and negative predictive value or other values that describe diagnostic accuracy Development of cancer Test reliability Language: English and Scandinavian We did not include publications from conferences or abstracts. Relevance and quality was assessed according to our handbook. We used GRADE to assess the documentation for diagnostic accuracy. The results are presented in tables and in a descriptive summary. This work has been carried out by two researchers at NOKC and the report has been externally reviewed. We calculated diagnostic accuracy using 2 x 2 tables for each study. Results We identified 2498 references and assessed 31 full-text articles. Five studies were included in the report and results were extracted and pooled from three of them. Details of each study are presented in evidence tables. Two of the studies were sponsored by the producers of the tests. We have assessed the quality of the documentation of diagnostic accuracy using GRADE. For HPV RNA testing, the quality is very low which means that the results are very uncertain. It is not known whether HPV RNA testing give a better diagnostic accuracy than HPV DNA testing and cytology. In summary these results showed:1. The HPV RNA tests had slightly lower sensitivity compared with HPV DNA tests (77 % 95 % CI 73-81) versus 92 % (95 % CI 89-94), while cytology had lowest sensitivity (61 %). The sensitivity states the probability of a positive test result if you have the disease.2. The HPV RNA tests had slightly higher specificity compared with HPV DNA tests (64 % 95 % CI 60-68) versus 45 % (95 % CI 41-49), while cytology had highest specificity (81 %). The specificity states the probability of a negative test result if you are healthy.3. The HPV RNA tests had comparable positive predictive value with the HPV DNA tests (63 % 95 % CI 59-67) versus 57 % (95 % CI 53-60), while cytology had the highest positive predictive value (91 %). Positive predictive value states the probability of illness among people with a positive test.4. The HPV RNA tests had slightly lower negative predictive value compared with the HPV DNA tests (78 % 95 % CI 74-82) versus 87 % (95 % CI 83-91), while cytology had the lowest negative predictive value (39 %). Negative predictive value states the probability of illness among people with a negative test. Conclusions Due to spare and low quality documentation, we do not know if HPV RNA tests have a better diagnostic accuracy compared to HPV DNA tests and cytology for detection of cervical pre cancer lesions. Norwegian Knowledge Centre for the Health Services summarizes and disseminates evidence concerning the effect of treatments, methods, and interventions in health services, in addition to monitoring health service quality. Our goal is to support good decision making in order to provide patients in Norway with the best possible care. The Centre is organized under The Directorate for Health and Social Affairs, but is scientifically and professionally independent. The Centre has no authority to develop health policy or responsibility to implement policies.

Papillomavirus diseases.

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Papillomavirus diseases --- Papillomavirus diseases --- Papillomavirus diseases --- Immunological aspects. --- Diagnosis. --- Treatment.

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Cervical cancer is the second most prevalent cancer among women worldwide, and infection with Human Papilloma Virus (HPV) has been identified as the causal agent for this condition. The natural history of cervical cancer is characterized by slow disease progression, rendering the condition in essence preventable and even treatable when diagnosed in early stages. Pap smear and the recently introduced prophylactic vaccines are the most prominent prevention options, but despite the availability of these primary and secondary screening tools, the global burden of disease is unfortunately still very high This book will focus on the clinical and diagnostic aspects of HPV and related disease, highlighting the latest developments in this field.

Papillomavirus diseases. --- Papillomavirus infections --- Virus diseases --- Oncology

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Genital Infection with Human Papillomavirus (HPV) is one of the most common sexually transmitted infectious diseases.
About 70% of cervix cancers in the world are caused by HPV types 16 and 18, while HPV types 6 and Il cause about 90% of genital warts.
Since 2007, a bivalent vaccine, Cervarix®, developed to prevent HPV types 16 and 18, and a quadrivalent vaccine, Gardasil®, for HPV 6, 11, 16 and 18 are available on the Belgian market.
Although these vaccines are both made of virus-like particles (VLP) , they differ on many points such as their indications, the additives used, their immunogenicity and the cross protection induced.
Their clinical studies point to the same conclusion : an excellent clinical efficacy on the injuries caused by HPV types 16 and 18, a high level of tolerance and an immunity extended towards other HPV types.
Sespite the broader indication and a promising clinical efficacy of Gardasil®, immunogenicity studies have demonstrated that antibody levels induced by Cervarix® are significantly higher than those of Gardasil® and persist for at least 6,4 years.
However, observation show, that vaccination with Gardasil® causes a gradual decrease in antibody anti-HPV 6, 11 and 18 to finally reach serum levels equivalent to natural infection levels (non protective).
The aim of prophylactic vaccination being to induce specifie types of antibodies to be maintained throughout the period in which women are likely to be contaminated, we can easily understand the importance of local rate and immune memory system.
With an innovative adjuvant in Cervarix®, that allows higher and more constant neutralizing antibody levels, we can only but recommend this as preferred treatment L'infection génitale aux Papillomavirus Humains (HPV) est l'une des maladies infectieuses sexuellement transmissibles les plus fréquentes.
Environ 70% des cancers du col de l'utérus dans le monde sont provoqués par les HPV de types 16 et 18 tandis que les HPV de types 6 et 11 sont responsables d'environ 90% des verrues génitales.
Depuis 2007, le Cervarix®, vaccin bivalent, dirigé contre les types d'HPV 16 et 18 et le Gardasil®, vaccin quadrivalent dirigé contre les HPV de type 6, Il, 16 et 18 sont disponibles sur le marché belge.
Bien que ces vaccins soient tous deux constitués de pseudo-particules virales (VLP), ils diffèrent en de multiples points tels que leurs indications, les adjuvants utilisés, leurs immunogénicités et protections croisées induites.
Leurs études cliniques aboutissent à la même conclusion: une excellente efficacité clinique sur les lésions causées par les HPV de types 16 et 18, une bonne tolérance et une immunité élargie à l'égard d'autres types d'HPV.
Malgré une indication plus large et une efficacité clinique tout aussi prometteuse du Gardasil®, les études d'Immunogénicité ont pu démontrer que les titres d'anticorps induits par le Cervarix® sont nettement supérieurs à ceux du Gardasil® et se maintiennent durant au moins 6,4 ans. Après vaccination du Gardasil®, on observe, par contre, une diminution progressive des titres d'anticorps anti-HPV 6, 11 et 18 jusqu'à atteindre finalement des taux sériques équivalents à ceux d'une infection naturelle (non protectrice).
Le but de la vaccination prophylactique étant d'induire des anticorps spécifiques de types qui seront maintenus pendant toute la durée où les femmes sont susceptibles d'être contaminées, on comprend aisément l'importance du taux local et de la mémoire immunitaire.
Puisque le nouvel adjuvant contenu dans le Cervarix® permet un taux d'anticorps neutralisants plus élevé et plus soutenu dans le temps, nous affichons une préférence pour le Cervarix®.

Papillomavirus Infections --- Papillomavirus Vaccines --- Uterine Cervical Neoplasms