Henry C Kitchener1, Matthew Gittins2, Oliver Rivero-Arias3, Apostolos Tsiachristas4, Margaret Cruickshank5, Alastair Gray4, Loretta Brabin1, David Torgerson6, Emma J Crosbie1, Alexandra Sargent7, Chris Roberts2. 1. Institute of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, UK. 2. Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, UK. 3. National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. 4. Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. 5. Department of Obstetrics and Gynaecology, Aberdeen Maternity Hospital, Aberdeen, UK. 6. Department of Health Sciences, University of York, York, UK. 7. Virology Department, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
Abstract
BACKGROUND: Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience. OBJECTIVES: To measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women. DESIGN: A cluster randomised trial based on general practices performed in two phases. SETTING: Primary care in Greater Manchester and the Grampian region in Scotland. PARTICIPANTS: Phase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months. INTERVENTIONS: Phase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices. MAIN OUTCOME MEASURES: Uplift in screening compared with control practices, cost-effectiveness of interventions, and the women's preferences explored in a discrete choice experiment. RESULTS: The pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06; p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20; p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53; p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91; p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74; p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%. CONCLUSION: Women receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52303479. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.
RCT Entities:
BACKGROUND:Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience. OBJECTIVES: To measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women. DESIGN: A cluster randomised trial based on general practices performed in two phases. SETTING: Primary care in Greater Manchester and the Grampian region in Scotland. PARTICIPANTS: Phase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months. INTERVENTIONS: Phase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices. MAIN OUTCOME MEASURES: Uplift in screening compared with control practices, cost-effectiveness of interventions, and the women's preferences explored in a discrete choice experiment. RESULTS: The pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06; p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20; p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53; p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91; p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74; p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%. CONCLUSION:Women receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52303479. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.
Authors: Amelia Acera; Josep Maria Manresa; Diego Rodriguez; Ana Rodriguez; Josep Maria Bonet; Marta Trapero-Bertran; Pablo Hidalgo; Norman Sànchez; Silvia de Sanjosé Journal: PLoS One Date: 2017-01-24 Impact factor: 3.240
Authors: H Kitchener; M Gittins; M Cruickshank; C Moseley; S Fletcher; R Albrow; A Gray; L Brabin; D Torgerson; E J Crosbie; A Sargent; C Roberts Journal: J Med Screen Date: 2017-05-22 Impact factor: 2.136