Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter
Open accessAbstract
BACKGROUND: We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter. METHODS: Women aged 30-64 non-responding to screening invitation were eligible. Response rate to first invitation ranged from 30% to 60% between centres. The control was the standard reminder letter to undergo the test used by the programme (Pap test in three centres and HPV DNA test in three other centres). Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV. The analysis was intention-to-treat. RESULTS: In all, 14 041 women were randomised and recruited: 5012 in the control arm, 4516 to receive the self-sampler at home, and 4513 to pick up the self-sampler at a pharmacy. Participation was 11.9% in the control, 21.6% (relative participation: 1.75; 95% CI 1.60-1.93) in home, and 12.0% (relative participation: 0.96; 95% CI 0.86-1.07) in the pharmacy arms, respectively. The heterogeneity between centres was high (excess heterogeneity of that expected due to chance, i.e., I(2), 94.9% and 94.1% for home and pharmacy arm, respectively). The estimated impact on the overall coverage was +4.3% for home mail self-sampling compared with +2.2% for standard reminder. CONCLUSIONS: Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes, even in those with HPV as primary testing. Picking up at pharmacies showed effects varying from centre to centre.
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Participation was not significantly different when hrHPV testing was performed versus when cytology was performed in two Italian studies (P=0.60 v P=0.76).
“The participation was not significantly different when hrHPV testing was performed versus when cytology was performed (P=0.60 v P=0.76).104 117”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [117]
The Results (page unavailable) report no difference in participation between the cytology and HPV clinic-control groups at one centre. However, the reported P value is 0.9, not 0.60 or 0.76; this source does not support the quoted figures or the claim about two studies. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThree (12%) of the 25 trials met the criteria for low risk of bias in all categories.
“Three (12%) of the 25 trials met the criteria for low risk of bias in all categories.114 115 117”
From Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses (2018) · cites this paper as [117]
The Methods (Analysis and Study design; page unavailable) describe this paper’s own randomized trial, not an assessment of 25 trials. Searches for “25 trials,” “low risk of bias,” and “three trials 12%” found no passage reporting the claimed count or bias rating. (LLM, conf=0.75)
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Ronco, G., Dillner, J., Elfström, K. M., Tunesi, S., Snijders, P. J. F., Arbyn, M., Kitchener, H., Segnan, N., Gilham, C., Giorgi-Rossi, P., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62218-7 · Cited by 1,810 · see citing works
the Self-Sampling Study Working Group, Giorgi Rossi, P., Marsili, L. M., Camilloni, L., Iossa, A., Lattanzi, A., Sani, C., Di Pierro, C., Grazzini, G., Angeloni, C., et al. (2011) · British Journal of Cancer · doi:10.1038/sj.bjc.6606040 · Cited by 125 · see citing works
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- Authors
- the HPV Self-sampling Italian Working Group, Giorgi Rossi, P., Fortunato, C., Barbarino, P., Boveri, S., Caroli, S., Del Mistro, A., Ferro, A., Giammaria, C., Manfredi, M., Moretto, T., Pasquini, A., Sideri, M., Tufi, M. C., Cogo, C., & Altobelli, E.
- Affiliations
- Azienda Sanitaria Unità Locale di Reggio Emilia (IT)
- University of L'Aquila (IT)
- ASL Roma (IT)
- European Institute of Oncology (IT)
- Azienda USL di Bologna (IT)
- Corresponding author
- Altobelli, E
- Venue
- British Journal of Cancer
- Published
- 2015-01-29
- Volume
- 112
- Issue
- 4
- Pages
- 667-675
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC4333501
- OpenAlex
- W2017554996
- Cited by
- 101
- References
- 2
- Citations by year
- 2026: 7 · 2025: 10 · 2024: 10 · 2023: 7 · 2022: 14 · 2021: 8 · 2020: 7 · 2019: 4 · 2018: 13 · 2017: 8 · 2016: 11 · 2015: 2
- FWCI
- 8.89
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- www.springer.com/tdm (unspecified)
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi dell Aquila (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
- Keywords
- cervical cancer screening, self-sampling, pharmacy distribution, screening uptake, HPV testing, Pap smear, screening reminders
- MeSH terms
- Adult, Uterine Cervical Neoplasms, Data Collection, Female, Humans, Italy, Middle Aged, Patient Participation, Pharmacies, Postal Service, Self Care, Specimen Handling, Vaginal Smears, Correspondence as Topic, Early Detection of Cancer
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