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., I2, 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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Patients diagnosed with low-grade squamous intraepithelial lesion ((L-SIL) or atypical squamous cells of undetermined significance (ASC-US) are subjected to additional investigations, such as colposcopy and biopsy, to rule out cervical intraepithelial neoplasia 2+ (CIN 2+). Especially in young patients, lesions tend to regress spontaneously, and many human papilloma virus (HPV) infections are transient. Dual-staining p16/Ki-67 has been proposed for the triage of patients with ASC-US or L-SIL, but no prospective study addressing only this subgroup of patients has been conducted so far. We performed a prospective study including all eligible patients referred for a loop electrosurgical excision procedure (LEEP) in the Department of Obstetrics and Gynecology of Timișoara University City Hospital. HPV genotyping and dual-staining for p16/Ki-67 were performed prior to LEEP, at 6 and 12 months after LEEP. A total of 60 patients were included in the study and completed the follow-up evaluation. We analyzed the sensitivity and specificity for biopsy-confirmed CIN2+ using the 95% confidence interval (CI) of high-risk human papilloma virus (HR-HPV), dual-staining p16/Ki-67, colposcopy, and combinations of the tests on all patients and separately for the ASC-US and L-SIL groups. Dual-staining p16/Ki-67 alone or in combination with HR-HPV and/or colposcopy showed a higher specificity that HR-HPV and/or colposcopy for the diagnosis of biopsy confirmed CIN2+ in patients under 30 years. Colposcopy + p16/Ki-67 and HR-HPV + colposcopy + p16/Ki-67 showed the highest specificity in our study.