Randomised healthcare policy evaluation of organised primary human papillomavirus screening of women aged 56-60.
OBJECTIVE
The aim of this research is to implement and reliably evaluate primary human papillomavirus (HPV) screening in an established and routinely running organised, large-scale population-based screening programme.


PARTICIPANTS
Resident women in the Stockholm/Gotland region of Sweden, aged 56-60 years were randomised to either (1) screening with cervical cytology, with HPV test in triage of low-grade cytological abnormalities (old policy) or (2) screening with HPV testing, with cytology in triage of HPV positives (new policy).


OUTCOME
The primary evaluation was the detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).


RESULTS
During January 2012-May 2014, the organised screening programme sent 42 752 blinded invitations with a prebooked appointment time to the women in the target age group. 7325 women attended in the HPV policy arm and 7438 women attended in the cytology arm. In the new policy, the population HPV prevalence was 5.5%, using an accredited HPV test (Cobas 4800). HPV16 prevalence was 1.0% (73/7325) and HPV18 prevalence was 0.3% (22/7325). In the HPV policy arm, 78/405 (19%) HPV-positive women were also cytology positive. There were 19 cases of CIN2+ in histopathology, all among women who were both HPV positive and cytology positive. The positive predictive value for CIN2+ in this group was 33.3% (19/57). In the cytology policy, 153 women were cytology positive and there were 18 cases of CIN2+ in histopathology. Both the total number of cervical biopsies and the number of cervical biopsies with benign histopathology were much lower in thepositive predictive value policy (49 benign, 87 total vs 105 benign, 132 total).


CONCLUSION
Primary HPV screening had a similar detection rate for CIN2+ as cytology-based screening, already before follow-up of HPV-positive, cytology-negative women with new HPV test and referral of women with persistence.


TRIAL REGISTRATION NUMBER
NCT01511328.
['Lamin|Helena|H|', 'Eklund|Carina|C|', 'Elfström|Klara Miriam|KM|', 'Carlsten-Thor|Agneta|A|', 'Hortlund|Maria|M|', 'Elfgren|Kristina|K|', 'Törnberg|Sven|S|', 'Dillner|Joakim|J|']
D000328:Adult D001706:Biopsy D018290:Cervical Intraepithelial Neoplasia D002584:Cervix Uteri D055088:Early Detection of Cancer D005260:Female D006291:Health Policy D052162:Human papillomavirus 16 D052161:Human papillomavirus 18 D006801:Humans D007231:Infant, Newborn D008875:Middle Aged D030361:Papillomavirus Infections D011237:Predictive Value of Tests D015995:Prevalence D012017:Referral and Consultation D013548:Sweden D014218:Triage D002583:Uterine Cervical Neoplasms D014626:Vaginal Smears D055815:Young Adult
organised screening programme HPV primary screening cervical cancer