PubTransformer

A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

Health technology assessment report: HPV DNA based primary screening for cervical cancer precursors.

Abstract OBJECTIVE OF THE PROJECT: The introduction of the HPV test as a primary screening test will cause important changes in the screening system based on cytology. The purposes of this report are: to define the best screening policies with HPV-based screening on the basis of the resulting efficacy and of undesired effects; comparing them to cytology-based screening; to identify their best conditions of application; to evaluate economic cost, feasibility and impact on the organisation of services of such policy in the Italian situation.
PMID
Related Publications

Age-specific evaluation of primary human papillomavirus screening vs conventional cytology in a randomized setting.

Results and cost evaluation of triage with high risk HPV test in cervical cancer screening. A pilot study in Piedmont (North-West Italy).

Health technology assessment report: Computer-assisted Pap test for cervical cancer screening.

The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds.

Health technology assessment report. Use of liquid-based cytology for cervical cancer precursors screening.

Authors

Mayor MeshTerms
Keywords
Journal Title epidemiologia e prevenzione
Publication Year Start




PMID- 22828243
OWN - NLM
STAT- MEDLINE
DA  - 20120725
DCOM- 20121205
LR  - 20120725
IS  - 1120-9763 (Print)
IS  - 1120-9763 (Linking)
VI  - 36
IP  - 3-4 Suppl 1
DP  - 2012 May-Aug
TI  - [Health technology assessment report: HPV DNA based primary screening for
      cervical cancer precursors].
PG  - e1-72
AB  - OBJECTIVE OF THE PROJECT: The introduction of the HPV test as a primary screening
      test will cause important changes in the screening system based on cytology. The 
      purposes of this report are: to define the best screening policies with HPV-based
      screening on the basis of the resulting efficacy and of undesired effects;
      comparing them to cytology-based screening; to identify their best conditions of 
      application; to evaluate economic cost, feasibility and impact on the
      organisation of services of such policy in the Italian situation. CONTENTS: This 
      report contains a section on efficacy and undesired effects based on a systematic
      review of literature conducted in strict coordination with the preparation of a
      supplement to the European Guidelines for quality assurance in cervical cancer
      screening. This chapter corresponds to a preliminary version of the chapter of
      the European Guidelines on primary screening with HPV. The sections on costs,
      impact on organisation, and social, ethical and legal impact reflect the Italian 
      situation; they are based on a review of the available Italian data (including
      unpublished data, mainly from on-going pilot projects) and on a structured
      analysis of what will result if the proposed protocol is applied to the Italian
      situation. RESULTS: Efficacy and undesired effects. There is clear scientific
      evidence that a screening based on validated tests for the DNA of oncogenic HPV
      as primary test and applying an appropriate protocol is more effective than
      screening based on cytology in preventing invasive cancers of the uterine cervix.
      In addition, it entails a limited--if any--increase of the undesired effects both
      in terms of unneeded referral to diagnostic work-up and in terms of
      over-diagnosis and consequent overtreatment of spontaneously regressive lesions. 
      The crucial elements of such protocol are the followings: HPV-positive women are 
      not to be directly referred to colposcopy, but the use of triage systems is
      essential. The currently recommendable method is based on performing cytology in 
      HPV positive women. If the result of this test is abnormal, the woman is
      immediately referred to colposcopy; if cytology is normal, the woman is invited
      to repeat a new HPV test after one year. In case such a test is still positive,
      the woman is referred to colposcopy; in case of negative result, the woman will
      be re-invited for a new screening round at the regular interval. In organised
      population-based screening programmes the interval after a negative primary HPV
      test should be at least 5 years. There is evidence that the 5-year cumulative
      risk of high-grade CIN after a negative HPV test is lower than the 3-year risk
      after a normal cytology. On the other hand, the probability of unneeded
      colposcopies and treatments would plausibly be relevant with 3-year intervals
      after a negative HPV test. HPV-based screening should not start before 30-35
      years. There is evidence that below 30 years HPV-based screening leads to an
      increased overdiagnosis of CIN2 that would regress spontaneously, with consequent
      overtreatment. Some increase in overdiagnosis is plausible also between 30 and 34
      years. Below such ages, cytological screening is the recommended test. Only tests
      for the DNA of oncogenic HPV, validated according to the European guidelines as
      for sensitivity and specificity for high-grade lesions, should be applied. There 
      is no evidence that double testing with cytology and HPV is more protective than 
      stand-alone HPV as primary test, although it entails a small and not relevant
      increase in sensitivity vs stand-alone HPV. On the contrary, there is evidence
      that double testing causes a substantial increase in referral to colposcopy and a
      decrease in its PPV. For this reason, if HPV is used as primary screening test,
      it is recommended not to add cytology in parallel. Cost and economic evaluation. 
      It is estimated that, if the protocol described is applied, in the current
      Italian situation the overall costs of HPV-based screening are lower than those
      of conventional cytological screening applied at the current 3-year intervals,
      although the cost of each screening round is higher. Impact on organization. For 
      reasons of quality and cost, both the interpretation of cytology and HPV testing 
      require a centralisation. This need is particularly strong, in terms of costs,
      for HPV test execution. It is therefore recommended to perform the HPV test in a 
      limited number of reference laboratories of large size. This also makes
      monitoring and evaluating the spontaneous activity easier. HPV-based screening
      entails problems of organisation related to the need of triage, to complex
      protocols and to reconversion of the activities of cytological interpretation.
      Social, ethical and legal impact. The communication of the result of the HPV test
      to women, particularly if positive, is a further crucial aspect in order to
      reduce not only the emotional impact, but also the possible risks that women are 
      inappropriately managed or lost to follow-up. Great efforts must be put in the
      education of healthcare professionals, both directly involved in organised
      programmes or not, particularly private gynaecologists and general practitioners.
      RECOMMENDATIONS: In conclusion, the crucial requirement to introduce HPV-based
      screening programmes is the capacity to guarantee the application of appropriate 
      screening protocols. If protocols do not respect the criteria described above
      they can cause relevant increase of undesired effects and costs compared to
      cytology-based screening. Therefore they should be avoided, except in studies
      able to provide clear evidence about human and economic costs. For this purpose, 
      correct education and information both to healthcare professionals and to the
      population is needed. In the Italian situation, where organised screening and a
      relevant spontaneous activity coexist, their interaction is crucial. Actions
      directed to integrate them and to guarantee as more uniformity of interventions
      as possible are needed, in particular through the integration of registries and
      thorough monitoring and a progressive homogenization of protocols. In order to
      grant the safety of transition, it is needed that the HPV-based organised
      screening activities are strictly monitored and that the National Centre for
      Screening Monitoring (ONS) ensures coordination. Knowledge about HPV based
      screening is still rapidly evolving. It is possible that currently on-going
      researches suggest changes to the optimal protocols in the next few years,
      particularly as for the management of HPV positive women. In addition, studies on
      the validation of new assays were recently published and others are expected. It 
      is suggested to exploit the organised screening activity to produce scientific
      evidence, in order to clarify the still uncertain aspects of optimal protocols.
      Different protocols in terms of screening intervals, age of application and
      management of HPV positive women should be studied in the frame of controlled
      implementation, through multicentre projects coordinated by ONS. Finally, it is
      suggested the creation of a National working group to promptly update the
      recommendations for screening and the list of assays to be considered as
      validated. On the bases of the results obtained in the first vaccinated cohorts
      reaching the screening age, for the future, it will be crucial to deliver
      specific recommendations to the population vaccinated against HPV during
      adolescence.
FAU - Ronco, Guglielmo
AU  - Ronco G
AD  - Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in
      Piemonte, Via San Francesco da Paola 31, 10123 Torino.
FAU - Biggeri, Annibale
AU  - Biggeri A
FAU - Confortini, Massimo
AU  - Confortini M
FAU - Naldoni, Carlo
AU  - Naldoni C
FAU - Segnan, Nereo
AU  - Segnan N
FAU - Sideri, Mario
AU  - Sideri M
FAU - Zappa, Marco
AU  - Zappa M
FAU - Zorzi, Manuel
AU  - Zorzi M
FAU - Calvia, Maria
AU  - Calvia M
FAU - Accetta, Gabriele
AU  - Accetta G
FAU - Giordano, Livia
AU  - Giordano L
FAU - Cogo, Carla
AU  - Cogo C
FAU - Carozzi, Francesca
AU  - Carozzi F
FAU - Gillio Tos, Anna
AU  - Gillio Tos A
FAU - Arbyn, Marc
AU  - Arbyn M
FAU - Mejier, Chris J L M
AU  - Mejier CJ
FAU - Snijders, Peter J F
AU  - Snijders PJ
FAU - Cuzick, Jack
AU  - Cuzick J
FAU - Giorgi Rossi, Paolo
AU  - Giorgi Rossi P
LA  - ITA
PT  - English Abstract
PT  - Journal Article
TT  - Health technology assessment report: ricerca del DNA di papillomavirus umano
      (HPV) come test primario per lo screening dei precursori del cancro del collo
      dell'utero.
PL  - Italy
TA  - Epidemiol Prev
JT  - Epidemiologia e prevenzione
JID - 8902507
SB  - IM
MH  - Adult
MH  - Alphapapillomavirus/genetics/isolation & purification
MH  - Cervical Intraepithelial Neoplasia/*diagnosis/epidemiology/virology
MH  - Colposcopy
MH  - Cost-Benefit Analysis
MH  - Female
MH  - Guidelines as Topic
MH  - Health Policy
MH  - Human Papillomavirus DNA Tests/economics/*statistics & numerical data/utilization
MH  - Humans
MH  - Italy/epidemiology
MH  - Mass Screening/economics/legislation & jurisprudence/organization &
      administration/*statistics & numerical data
MH  - Papillomavirus Infections/*diagnosis/epidemiology/virology
MH  - Precancerous Conditions/*diagnosis/epidemiology/virology
MH  - Predictive Value of Tests
MH  - Program Evaluation
MH  - Truth Disclosure
MH  - Uterine Cervical Neoplasms/diagnosis/epidemiology/*prevention & control/virology
MH  - Uterine Cervicitis/*diagnosis/epidemiology/virology
EDAT- 2012/08/01 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/07/26 06:00
AID - 1439 [pii]
PST - ppublish
SO  - Epidemiol Prev. 2012 May-Aug;36(3-4 Suppl 1):e1-72.

<?xml version="1.0" encoding="UTF-8"?>
<b:Sources SelectedStyle="" xmlns:b="http://schemas.openxmlformats.org/officeDocument/2006/bibliography"  xmlns="http://schemas.openxmlformats.org/officeDocument/2006/bibliography" >
</b:Sources>