A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

Henry C. Kitchener, Matthew Gittins, Oliver Rivero-Arias, Apostolos Tsiachristas, Margaret Cruickshank, Alastair Gray, Loretta Brabin, David Torgerson, Emma J. Crosbie, Alexandra Sargent, Chris Roberts

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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.

Original languageEnglish
Pages (from-to)1-138
Number of pages138
JournalHealth Technology Assessment
Volume20
Issue number68
DOIs
Publication statusPublished - Sep 2016

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A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC). / Kitchener, Henry C.; Gittins, Matthew; Rivero-Arias, Oliver; Tsiachristas, Apostolos; Cruickshank, Margaret; Gray, Alastair; Brabin, Loretta; Torgerson, David; Crosbie, Emma J.; Sargent, Alexandra; Roberts, Chris.

In: Health Technology Assessment, Vol. 20, No. 68, 09.2016, p. 1-138.

Research output: Contribution to journalArticle

Kitchener, HC, Gittins, M, Rivero-Arias, O, Tsiachristas, A, Cruickshank, M, Gray, A, Brabin, L, Torgerson, D, Crosbie, EJ, Sargent, A & Roberts, C 2016, 'A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)', Health Technology Assessment, vol. 20, no. 68, pp. 1-138. https://doi.org/10.3310/hta20680
Kitchener, Henry C. ; Gittins, Matthew ; Rivero-Arias, Oliver ; Tsiachristas, Apostolos ; Cruickshank, Margaret ; Gray, Alastair ; Brabin, Loretta ; Torgerson, David ; Crosbie, Emma J. ; Sargent, Alexandra ; Roberts, Chris. / A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC). In: Health Technology Assessment. 2016 ; Vol. 20, No. 68. pp. 1-138.
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title = "A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)",
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.",
author = "Kitchener, {Henry C.} and Matthew Gittins and Oliver Rivero-Arias and Apostolos Tsiachristas and Margaret Cruickshank and Alastair Gray and Loretta Brabin and David Torgerson and Crosbie, {Emma J.} and Alexandra Sargent and Chris Roberts",
note = "Acknowledgements The STRATEGIC study research team thanks Sara Rodgers and Laura Clark at the University of York for their input conducting qualitative interviews. We are grateful to Maggie Redshaw at the National Perinatal Epidemiology Unit (NPEU) for helpful suggestions to attempt to improve the response rate in our study. We also would like to thank the NPEU design team who significantly improved the look of our final questionnaire, and the NPEU administration team for their assistance preparing the mail-out material. Special thanks are given to our data entry team Sissi Hernandez-Quesada, Jacob Stevens and Pamela White. The authors would also like to thank Zeinab Abbas for her valuable assistance in the economic evaluation. We would like to express our gratitude to the teams at the English and Scottish screening agencies for their willingness to collaborate in this study. Finally, we thank all women who participated and completed the DCE survey. Any errors or omissions are entirely our own. We are indebted to the support provided by the Lancashire and South Cumbria Agency, without whom we could not have provided the interventions. We also wish to thank Linsey Nelson for her painstaking work in helping to compile this report. Funding Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.",
year = "2016",
month = "9",
doi = "10.3310/hta20680",
language = "English",
volume = "20",
pages = "1--138",
journal = "Health Technology Assessment",
issn = "1366-5278",
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TY - JOUR

T1 - A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

AU - Kitchener, Henry C.

AU - Gittins, Matthew

AU - Rivero-Arias, Oliver

AU - Tsiachristas, Apostolos

AU - Cruickshank, Margaret

AU - Gray, Alastair

AU - Brabin, Loretta

AU - Torgerson, David

AU - Crosbie, Emma J.

AU - Sargent, Alexandra

AU - Roberts, Chris

N1 - Acknowledgements The STRATEGIC study research team thanks Sara Rodgers and Laura Clark at the University of York for their input conducting qualitative interviews. We are grateful to Maggie Redshaw at the National Perinatal Epidemiology Unit (NPEU) for helpful suggestions to attempt to improve the response rate in our study. We also would like to thank the NPEU design team who significantly improved the look of our final questionnaire, and the NPEU administration team for their assistance preparing the mail-out material. Special thanks are given to our data entry team Sissi Hernandez-Quesada, Jacob Stevens and Pamela White. The authors would also like to thank Zeinab Abbas for her valuable assistance in the economic evaluation. We would like to express our gratitude to the teams at the English and Scottish screening agencies for their willingness to collaborate in this study. Finally, we thank all women who participated and completed the DCE survey. Any errors or omissions are entirely our own. We are indebted to the support provided by the Lancashire and South Cumbria Agency, without whom we could not have provided the interventions. We also wish to thank Linsey Nelson for her painstaking work in helping to compile this report. Funding Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.

PY - 2016/9

Y1 - 2016/9

N2 - 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.

AB - 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.

U2 - 10.3310/hta20680

DO - 10.3310/hta20680

M3 - Article

C2 - 27632816

VL - 20

SP - 1

EP - 138

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 68

ER -