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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.

Abstract The ARTISTIC (A Randomised Trial In Screening To Improve Cytology) trial originally reported after two rounds of primary cervical screening with human papillomavirus (HPV). Extended follow-up of the randomised trial cohort through a third round could provide valuable insight into the duration of protection of a negative HPV test, which could allow extended screening intervals. If HPV primary screening is to be considered in the national programme, then determining its cost-effectiveness is key, and a detailed economic analysis using ARTISTIC data is needed.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title health technology assessment (winchester, england)
Publication Year Start




PMID- 24762804
OWN - NLM
STAT- MEDLINE
DA  - 20140425
DCOM- 20141222
LR  - 20160323
IS  - 2046-4924 (Electronic)
IS  - 1366-5278 (Linking)
VI  - 18
IP  - 23
DP  - 2014 Apr
TI  - 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.
PG  - 1-196
LID - 10.3310/hta18230 [doi]
AB  - BACKGROUND: The ARTISTIC (A Randomised Trial In Screening To Improve Cytology)
      trial originally reported after two rounds of primary cervical screening with
      human papillomavirus (HPV). Extended follow-up of the randomised trial cohort
      through a third round could provide valuable insight into the duration of
      protection of a negative HPV test, which could allow extended screening
      intervals. If HPV primary screening is to be considered in the national
      programme, then determining its cost-effectiveness is key, and a detailed
      economic analysis using ARTISTIC data is needed. AIMS/OBJECTIVES: (1) To
      determine the round 3 and cumulative rates of cervical intraepithelial neoplasia 
      (CIN) grade 2 or worse (2+) and CIN grade 3 or worse (CIN3+) between the revealed
      and concealed arms of ARTISTIC after three screening rounds over 6 years. (2) To 
      compare the cumulative incidence of CIN2+ over three screening rounds following
      negative screening cytology with that following negative baseline HPV. (3) To
      determine whether or not HPV screening could safely extend the screening interval
      from 3 to 6 years. (4) To study the potential clinical utility of an increased
      cut-off of 2 relative light unit/mean control (RLU/Co) for Hybrid Capture 2 (HC2)
      and HPV genotyping in primary cervical screening. (5) To determine the potential 
      impact of HPV vaccination with Cervarix in terms of preventing abnormal cytology 
      and CIN2+. (6) To determine the cost-effectiveness of HPV primary screening
      compared with current practice using cervical cytology in England. DESIGN: The
      ARTISTIC study cohort was recalled for a third round of screening 3 years after
      round 2 and 6 years following their enrolment to the study. Both arms of the
      original trial used a single protocol during round 3. SETTING: ARTISTIC study
      cohort undergoing cervical screening in primary care in Greater Manchester, UK.
      PARTICIPANTS: Between July 2007 and September 2009, 8873 women participated in
      round 3; 6337 had been screened in round 2 and 2536 had not been screened since
      round 1. INTERVENTIONS: All women underwent liquid-based cytology and HPV testing
      and genotyping. Colposcopy was offered to women with moderate dyskaryosis or
      worse and with HPV-positive mild dyskaryosis/borderline changes. Women with
      negative cytology or HPV-negative mild dyskaryosis/borderline changes were
      returned to routine recall. MAIN OUTCOME MEASURES: Principal outcomes were
      cumulative rates of CIN2+ over three screening rounds by cytology and HPV status 
      at entry; HPV type specific rates of CIN2+; effect of age on outcomes correlated 
      with cytology and HPV status; comparison of HC2 cut-off RLU/Co of both 1 and 2;
      and cost-effectiveness of HPV primary screening. RESULTS: The median duration of 
      follow-up was 72.7 months in round 3. Over the three screening rounds, there was 
      no significant difference in CIN2+ [odds ratio (OR): 1.06, 95% confidence
      interval (CI) 0.89 to 1.26, p = 0.5)] or CIN3+ (OR: 0.90, 95% CI 0.72 to 1.14, p 
      = 0.4) rates between the trial arms (revealed vs. concealed). Overall, 16% of
      women were HC2 positive at entry, decreasing from 40% in women aged 20-24 years
      to around 7% in women aged over 50 years. Abnormal cytology rates at entry were
      13% for borderline+ and 2% for moderate+ cytology. Following positive cytology at
      entry, the cumulative rate of CIN2+ was 20.5%, and was 20.1% following a
      HPV-positive result at baseline. The cumulative CIN2+ rate for women who were HPV
      negative at baseline was only 0.87% (95% CI 0.70% to 1.06%) after three rounds of
      screening, significantly lower than that for women with negative cytology, which 
      was 1.41% (95% CI 1.19% to 1.65%). Women who were HPV negative at baseline had
      similar protection from CIN2+ after 6 years as women who were cytology negative
      at baseline after 3 years. Women who were HPV positive/cytology negative at
      baseline had a cumulative CIN2+ rate at 6 years of 7.7%, significantly higher
      than that for women who were cytology positive/HPV negative (3.2%). Women who
      were HPV type 16 positive at baseline had a cumulative CIN2+ rate over three
      rounds of 43.6% compared with 20.1% for any HPV-positive test. Using a HC2
      cut-off of RLU/Co >/= 2 would maintain acceptable sensitivity and result in 16%
      fewer HPV-positive results. Typing data suggested that around 55-60% of
      high-grade cytology and CIN2+, but less than 25% of low-grade cytology, would be 
      prevented by HPV vaccine given current rates of coverage in the UK national
      programme. For the cost-effectiveness analysis, most of the primary HPV
      strategies examined where HPV was used as the sole primary test were cost saving 
      in both unvaccinated and vaccinated cohorts under baseline cost assumptions, with
      a 7-18% reduction in annual screening-associated costs in unvaccinated cohorts
      and a 9-22% reduction for vaccinated cohorts. Utilising partial genotyping at the
      primary screening stage to identify women with HPV 16/18 and referring them to
      colposcopy was the most effective strategy (barring co-testing, which is
      significantly more costly than any other strategies considered), resulting in 83 
      additional life-years per 100,000 women for unvaccinated women when compared with
      current practice, and similar life-years saved compared with current practice for
      vaccinated women. In unvaccinated cohorts, however, this genotyping strategy is
      predicted to result in a 20% increase in the number of colposcopies performed in 
      England, although in vaccinated cohorts the number of colposcopy referrals was
      predicted to be lower than in current practice. For all strategies in which HPV
      is used as the sole primary screening test, decreasing the follow-up interval for
      intermediate-risk women from 24 to 12 months increased the overall effectiveness 
      of primary HPV screening. In exploratory analysis, strategies for which cytology 
      screening was retained until either age 30 or 35 years, and for which HPV testing
      was used at older ages, were predicted to be of higher costs and intermediate
      effectiveness than those associated with full implementation of primary HPV
      screening from age 25 years. However, this finding should be interpreted with
      caution as it depends on assumptions made about screening behaviour and
      compliance with recommendations at the 'switch over' point. CONCLUSIONS: HPV
      testing as an initial screen was significantly more protective over three rounds 
      (6 years) than the current practice of cytology and the use of primary HPV
      screening could allow a safe lengthening of the screening interval. A substantial
      decrease in high-grade cytology and CIN2+ can be expected as a consequence of the
      HPV vaccination programme. A HC2 cut-off of 2RLU/Co instead of the manufacturer's
      recommended cut-off of 1 would be clinically beneficial in terms of an optimal
      balance between sensitivity and specificity. Modelled analysis predicts that
      primary HPV screening would be both more effective and cost saving compared with 
      current practice with cervical cytology for a number of potential strategies in
      both unvaccinated and vaccinated cohorts. Compliance with surveillance and
      optimal management of HPV-positive/cytology-negative women after primary HPV
      screening is of key importance. Limitations of the economic investigation
      included the need to make assumptions around compliance with screening attendance
      and follow-up for longer screening intervals in the future, assumptions regarding
      maintenance of current uptake vaccination in the future, and assumptions
      regarding the stability of cost of HPV and cytology tests in the future. Detailed
      sensitivity analysis across a range of possible assumptions was conducted to
      address these issues. This study and the economic evaluation lend support to
      convert from cytology to HPV-based screening. Future work should include
      researching (i) the attitudes of women who test HPV positive/cytology negative,
      (ii) the value of complementary biomarkers and (iii) activities relevant to
      primary HPV screening in unvaccinated and vaccinated populations from the point
      of view of QALY assessment. STUDY REGISTRATION: Current Controlled Trials
      ISRCTN25417821.
FAU - C Kitchener, Henry
AU  - C Kitchener H
AD  - Institute of Cancer Sciences, University of Manchester, Manchester, UK.
FAU - Canfell, Karen
AU  - Canfell K
AD  - Lowy Cancer Research Centre, Prince of Wales Clinical School, University of New
      South Wales, Sydney, NSW, Australia.
FAU - Gilham, Clare
AU  - Gilham C
AD  - Non-Communicable Disease Epidemiology Unit, London School of Hygiene and Tropical
      Medicine, London, UK.
FAU - Sargent, Alexandra
AU  - Sargent A
AD  - Department of Virology, Central Manchester University Hospitals NHS Foundation
      Trust, Manchester, UK.
FAU - Roberts, Chris
AU  - Roberts C
AD  - Institute of Population Health, University of Manchester, Manchester, UK.
FAU - Desai, Mina
AU  - Desai M
AD  - Manchester Cytology Centre, Central Manchester University Hospitals NHS
      Foundation Trust, Manchester, UK.
FAU - Peto, Julian
AU  - Peto J
AD  - Non-Communicable Disease Epidemiology Unit, London School of Hygiene and Tropical
      Medicine, London, UK.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Health Technol Assess
JT  - Health technology assessment (Winchester, England)
JID - 9706284
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adult
MH  - Age Distribution
MH  - Aged
MH  - Aged, 80 and over
MH  - Cause of Death
MH  - Cervical Intraepithelial Neoplasia/*diagnosis/economics/epidemiology
MH  - Colposcopy/*economics/standards/statistics & numerical data
MH  - Cost-Benefit Analysis
MH  - England/epidemiology
MH  - Female
MH  - Follow-Up Studies
MH  - Genotype
MH  - Humans
MH  - Incidence
MH  - Logistic Models
MH  - Mass Screening/*economics/standards/statistics & numerical data
MH  - Middle Aged
MH  - Papillomaviridae/genetics/isolation & purification
MH  - Papillomavirus Infections/complications/*diagnosis/epidemiology
MH  - Papillomavirus Vaccines/administration & dosage/*economics
MH  - Quality-Adjusted Life Years
MH  - Sensitivity and Specificity
MH  - State Medicine/economics/standards
MH  - Time Factors
MH  - Uterine Cervical Neoplasms/diagnosis/economics/etiology/*prevention & control
MH  - Young Adult
PMC - PMC4781243
OID - NLM: PMC4781243
EDAT- 2014/04/26 06:00
MHDA- 2014/12/23 06:00
CRDT- 2014/04/26 06:00
AID - 10.3310/hta18230 [doi]
PST - ppublish
SO  - Health Technol Assess. 2014 Apr;18(23):1-196. doi: 10.3310/hta18230.

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