Clinical yield and operational cost-threshold analysis of HPV self-sampling send-outs for long-term non-attenders in cervical cancer screening: a population-based, real-world, registry study in Sweden
Year: 2026
Type: article
Study design: Observational Study
Abstract: Objectives To evaluate the clinical yield and operational costs of a targeted ‘send-to-all’ human papillomavirus (HPV) self-sampling strategy for long-term non-attenders in cervical cancer screening. Design Population-based, real-world observational registry study. Setting The regional organised cervical cancer screening programme in Region Örebro County, Sweden. Participants A total of 9123 women identified as long-term non-attenders. Long-term non-attendance was defined as having no recorded cervical screening test for at least one routine screening interval plus an additional 4 years. Interventions A total of 11 283 vaginal HPV self-sampling kits were dispatched via direct mail to the registered home addresses of all 9123 eligible women between 2022 and 2024. Primary and secondary outcome measures Clinical yield was evaluated using the number of tests analysed (NTA) and number of kits dispatched (NKD) to detect one case of high-grade squamous intraepithelial lesion or worse (HSIL+). Resource utilisation was measured as the average cost per screened woman/detected HSIL+, and the economic break-even point against standard letter invitations was established using a deterministic threshold analysis. Results Of the 11 283 self-sampling kits dispatched, 1826 kits were returned and analysed. This direct response yielded 27 HSIL+ cases (NTA: 68; NKD: 418), at an average cost of 2031 SEK (€183) per screened woman and 134 103 SEK (€12,114) per histologically confirmed HSIL+ case. Incorporating an additional 190 long-term non-attenders who underwent clinical screening within 1 year of dispatch yielded a total of 32 HSIL+ cases. This cumulative response decreased the NTA to 63 and the NKD to 353, with an average cost of 2045 SEK (€185) per screened woman and 126 068 SEK (€11 388) per HSIL+ case. To match the cost per screened woman of the self-sampling strategy, standard letter invitations must achieve a participation rate of 9.5% (based on kit returns alone) or 6.4% (based on cumulative participation). Conclusions Direct mailing of HPV self-sampling kits effectively identifies high-grade lesions in a hard-to-reach population. From an operational perspective, previous research indicates that participation from standard letters rarely reaches the calculated 6.4%–9.5% break-even points, suggesting self-sampling is a resource-efficient initial outreach strategy for long-term non-attenders. However, full economic evaluations incorporating long-term health outcomes are required to establish comprehensive cost-effectiveness.
Source: BMJ Open
Institution: Örebro University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W7223203760