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Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening : A randomised controlled trial

Hellsten, Caroline LU ; Ernstson, Avalon LU orcid ; Bodelsson, Gunilla LU ; Forslund, Ola LU and Borgfeldt, Christer LU (2021) In European Journal of Cancer Prevention 30(4). p.334-340
Abstract

Objectives HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer. Methods Vaginal HPV self-sampling kits were sent by regular mail to 14 765 randomly selected women aged 30-64 years old in the screening programme. HPV-positive women were invited for a follow-up examination by their midwife in which they provided a cervical sample for cytological and HPV... (More)

Objectives HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer. Methods Vaginal HPV self-sampling kits were sent by regular mail to 14 765 randomly selected women aged 30-64 years old in the screening programme. HPV-positive women were invited for a follow-up examination by their midwife in which they provided a cervical sample for cytological and HPV co-testing. The control arm consisted of 14 839 women who met the same inclusion criteria and were invited to have cervical sampling by midwives for primary HPV screening. All HPV samples were analysed by the Aptima HPV assay (Hologic Inc.). Main results The participation rate was 33.5% in the self-sampling arm and 47.5% in the cervical sampling arm, (P < 0.0001). HPV was detected in 17.1% (95% confidence interval (CI), 16.1-18.23%) in the self-sampling arm and 4.5% (95% CI, 4.0-5.0%) in the cervical sampling arm. Histological, severe dysplasia was observed among 0.48% (95% CI, 0.3-0.72%) and 0.47% (95% CI, 0.3-0.66%) of the self-sampling and the cervical sampling groups, respectively. Conclusion The self-sampling approach detects a similar proportion of severe dysplasia as regular screening. Thus, our study indicates that self-sampling could replace primary HPV screening of cervical samples.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cervical cancer, HPV, human papillomavirus, self-sampling, vaginal human papillomavirus
in
European Journal of Cancer Prevention
volume
30
issue
4
pages
7 pages
publisher
Lippincott Williams & Wilkins
external identifiers
  • scopus:85108021370
  • pmid:34010238
ISSN
0959-8278
DOI
10.1097/CEJ.0000000000000693
language
English
LU publication?
yes
id
6cd2ae4b-f91d-4bcb-af6a-13c95cd48b51
date added to LUP
2021-07-13 14:58:42
date last changed
2024-06-15 13:31:30
@article{6cd2ae4b-f91d-4bcb-af6a-13c95cd48b51,
  abstract     = {{<p>Objectives HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer. Methods Vaginal HPV self-sampling kits were sent by regular mail to 14 765 randomly selected women aged 30-64 years old in the screening programme. HPV-positive women were invited for a follow-up examination by their midwife in which they provided a cervical sample for cytological and HPV co-testing. The control arm consisted of 14 839 women who met the same inclusion criteria and were invited to have cervical sampling by midwives for primary HPV screening. All HPV samples were analysed by the Aptima HPV assay (Hologic Inc.). Main results The participation rate was 33.5% in the self-sampling arm and 47.5% in the cervical sampling arm, (P &lt; 0.0001). HPV was detected in 17.1% (95% confidence interval (CI), 16.1-18.23%) in the self-sampling arm and 4.5% (95% CI, 4.0-5.0%) in the cervical sampling arm. Histological, severe dysplasia was observed among 0.48% (95% CI, 0.3-0.72%) and 0.47% (95% CI, 0.3-0.66%) of the self-sampling and the cervical sampling groups, respectively. Conclusion The self-sampling approach detects a similar proportion of severe dysplasia as regular screening. Thus, our study indicates that self-sampling could replace primary HPV screening of cervical samples.</p>}},
  author       = {{Hellsten, Caroline and Ernstson, Avalon and Bodelsson, Gunilla and Forslund, Ola and Borgfeldt, Christer}},
  issn         = {{0959-8278}},
  keywords     = {{cervical cancer; HPV; human papillomavirus; self-sampling; vaginal human papillomavirus}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{334--340}},
  publisher    = {{Lippincott Williams & Wilkins}},
  series       = {{European Journal of Cancer Prevention}},
  title        = {{Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening : A randomised controlled trial}},
  url          = {{http://dx.doi.org/10.1097/CEJ.0000000000000693}},
  doi          = {{10.1097/CEJ.0000000000000693}},
  volume       = {{30}},
  year         = {{2021}},
}