title: Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter.
abstract: 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.
authors: 1] Servizio Interaziendale di Epidemiologia, Azienda Unità Sanitaria Locale, via Amendola 2, Reggio Emilia 42122, Italy [2] IRCCS-Arcispedale S. Maria Nuova, 42122 Reggio Emilia, Italy.
authors: P
authors: P
authors: Giorgi Rossi
authors: Department of Life, Health and Environmental Sciences, University of L'Aquila, Viale San Salvatore, Edificio Delta 6, 67100 L'Aquila, Italy.
authors: C
authors: C
authors: Fortunato
authors: UOC Screening e prevenzione ASL Roma G, 00019 Tivoli (Rome), Italy.
authors: P
authors: P
authors: Barbarino
authors: Preventive Gynaecology Unit, European Institute of Oncology, 20141 Milano, Italy.
authors: S
authors: S
authors: Boveri
authors: 1] Servizio Interaziendale di Epidemiologia, Azienda Unità Sanitaria Locale, via Amendola 2, Reggio Emilia 42122, Italy [2] IRCCS-Arcispedale S. Maria Nuova, 42122 Reggio Emilia, Italy.
authors: S
authors: S
authors: Caroli
authors: Istituto Oncologico Veneto IOV-IRCCS, 35128 Padova, Italy.
authors: A
authors: A
authors: Del Mistro
authors: Dipartimento di Prevenzione Azienda ULSS 17, 35042 Este-Monselice (PD), Italy.
authors: A
authors: A
authors: Ferro
authors: UOC Ginecologia e Ostetricia, Screening Oncologici Regionali Ospedale Cardarelli, 86100 Campobasso (CB), Italy.
authors: C
authors: C
authors: Giammaria
authors: Programma Screening Oncologici AUSL di Bologna, 40068 San Lazzaro di Savena (BO), Italy.
authors: M
authors: M
authors: Manfredi
authors: Dipartimento di Prevenzione Azienda ULSS 7 Pieve di Soligo - Conegliano, 31053 Pieve di Soligo (TV), Italy.
authors: T
authors: T
authors: Moretto
authors: Programma Screening Oncologici AUSL di Bologna, 40068 San Lazzaro di Savena (BO), Italy.
authors: A
authors: A
authors: Pasquini
authors: Preventive Gynaecology Unit, European Institute of Oncology, 20141 Milano, Italy.
authors: M
authors: M
authors: Sideri
authors: UOC Screening e prevenzione ASL Roma G, 00019 Tivoli (Rome), Italy.
authors: M C
authors: MC
authors: Tufi
authors: Registro tumori del Veneto, 35131 Padova, Italy.
authors: C
authors: C
authors: Cogo
authors: Department of Life, Health and Environmental Sciences, University of L'Aquila, Viale San Salvatore, Edificio Delta 6, 67100 L'Aquila, Italy.
authors: E
authors: E
authors: Altobelli
mesh_terms: D000328:Adult; D015709:Correspondence as Topic; D003625:Data Collection; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D010358:Patient Participation / Q000379:methods / Q000706:statistics & numerical data; D010594:Pharmacies; D011177:Postal Service; D012648:Self Care; D013048:Specimen Handling / Q000295:instrumentation / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology; D014626:Vaginal Smears / Q000295:instrumentation* / Q000379:methods
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