Impact of post-colposcopy management on women's long-term worries

results from the UK population-based TOMBOLA trial

Linda Sharp, Seonaidh Cotton, Margaret Cruickshank, Nicola Gray, Louise Smart, David Whynes, Julian Little, The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Effective cervical screening reduces cancer incidence and mortality. However, these benefits may be accompanied by some harms, potentially including, adverse psychological impacts. Studies suggest women may have concerns about various specific issues, such as cervical cancer.

AIM: To compare worries about cervical cancer, future fertility, having sex, and general health between women managed by alternative policies at colposcopy.

DESIGN: Multicentre individually-randomised controlled trial, nested within the National Health Service Cervical Screening Programmes.

SETTING: UK.

METHODS: 1515 women, aged 20-59 years, with low-grade cytology who attended colposcopy during February 2001-October 2002, were randomised to immediate loop excision or punch biopsies with recall for treatment if cervical intraepithelial neoplasia (CIN)2/3 was confirmed. Women completed questionnaires at recruitment and after 12, 18, 24 and 30 months. Outcomes were prevalence of worries at each time-point (point prevalence) and at any time-point during follow-up (12-30 months; cumulative prevalence). Primary analysis was by intention-to-treat (ITT); secondary per-protocol analysis compared groups according to management received among women with an abnormal transformation zone.

RESULTS: Cumulative prevalence of worries was: cervical cancer 40%; having sex 26%, future fertility 24%, and general health 60%. In ITT analyses, there were no statistically significant differences between management arms in cumulative or point prevalence of any of the worries. In per-protocol analyses, between-group differences were significant only for future fertility; cumulative prevalence was highest in women who underwent punch biopsies and treatment.

CONCLUSIONS: There is no difference in the prevalence of specific worries in women randomised to alternative post-colposcopy management policies.

CLINICAL TRIAL REGISTRATION: ISRCTN:34841617.

Original languageEnglish
Pages (from-to)43-51
Number of pages9
JournalJournal of Family Planning and Reproductive Health Care
Volume42
Issue number1
Early online date16 Sep 2015
DOIs
Publication statusPublished - Jan 2016

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Colposcopy
Population
Uterine Cervical Neoplasms
Fertility
Intention to Treat Analysis
Biopsy
Cervical Intraepithelial Neoplasia
National Health Programs
Women's Health
Early Detection of Cancer
Cell Biology
Randomized Controlled Trials
Clinical Trials
Psychology
Mortality
Incidence
Health
Therapeutics

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Sharp, L., Cotton, S., Cruickshank, M., Gray, N., Smart, L., Whynes, D., ... The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group (2016). Impact of post-colposcopy management on women's long-term worries: results from the UK population-based TOMBOLA trial. Journal of Family Planning and Reproductive Health Care, 42(1), 43-51. https://doi.org/10.1136/jfprhc-2015-101170

Impact of post-colposcopy management on women's long-term worries : results from the UK population-based TOMBOLA trial. / Sharp, Linda; Cotton, Seonaidh; Cruickshank, Margaret; Gray, Nicola; Smart, Louise; Whynes, David; Little, Julian; The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group.

In: Journal of Family Planning and Reproductive Health Care, Vol. 42, No. 1, 01.2016, p. 43-51.

Research output: Contribution to journalArticle

Sharp, L, Cotton, S, Cruickshank, M, Gray, N, Smart, L, Whynes, D, Little, J & The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group 2016, 'Impact of post-colposcopy management on women's long-term worries: results from the UK population-based TOMBOLA trial', Journal of Family Planning and Reproductive Health Care, vol. 42, no. 1, pp. 43-51. https://doi.org/10.1136/jfprhc-2015-101170
Sharp, Linda ; Cotton, Seonaidh ; Cruickshank, Margaret ; Gray, Nicola ; Smart, Louise ; Whynes, David ; Little, Julian ; The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group. / Impact of post-colposcopy management on women's long-term worries : results from the UK population-based TOMBOLA trial. In: Journal of Family Planning and Reproductive Health Care. 2016 ; Vol. 42, No. 1. pp. 43-51.
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title = "Impact of post-colposcopy management on women's long-term worries: results from the UK population-based TOMBOLA trial",
abstract = "BACKGROUND: Effective cervical screening reduces cancer incidence and mortality. However, these benefits may be accompanied by some harms, potentially including, adverse psychological impacts. Studies suggest women may have concerns about various specific issues, such as cervical cancer.AIM: To compare worries about cervical cancer, future fertility, having sex, and general health between women managed by alternative policies at colposcopy.DESIGN: Multicentre individually-randomised controlled trial, nested within the National Health Service Cervical Screening Programmes.SETTING: UK.METHODS: 1515 women, aged 20-59 years, with low-grade cytology who attended colposcopy during February 2001-October 2002, were randomised to immediate loop excision or punch biopsies with recall for treatment if cervical intraepithelial neoplasia (CIN)2/3 was confirmed. Women completed questionnaires at recruitment and after 12, 18, 24 and 30 months. Outcomes were prevalence of worries at each time-point (point prevalence) and at any time-point during follow-up (12-30 months; cumulative prevalence). Primary analysis was by intention-to-treat (ITT); secondary per-protocol analysis compared groups according to management received among women with an abnormal transformation zone.RESULTS: Cumulative prevalence of worries was: cervical cancer 40{\%}; having sex 26{\%}, future fertility 24{\%}, and general health 60{\%}. In ITT analyses, there were no statistically significant differences between management arms in cumulative or point prevalence of any of the worries. In per-protocol analyses, between-group differences were significant only for future fertility; cumulative prevalence was highest in women who underwent punch biopsies and treatment.CONCLUSIONS: There is no difference in the prevalence of specific worries in women randomised to alternative post-colposcopy management policies.CLINICAL TRIAL REGISTRATION: ISRCTN:34841617.",
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note = "Date of Acceptance: 12/08/2015 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",
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T2 - results from the UK population-based TOMBOLA trial

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AU - Cotton, Seonaidh

AU - Cruickshank, Margaret

AU - Gray, Nicola

AU - Smart, Louise

AU - Whynes, David

AU - Little, Julian

AU - The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group

N1 - Date of Acceptance: 12/08/2015 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2016/1

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N2 - BACKGROUND: Effective cervical screening reduces cancer incidence and mortality. However, these benefits may be accompanied by some harms, potentially including, adverse psychological impacts. Studies suggest women may have concerns about various specific issues, such as cervical cancer.AIM: To compare worries about cervical cancer, future fertility, having sex, and general health between women managed by alternative policies at colposcopy.DESIGN: Multicentre individually-randomised controlled trial, nested within the National Health Service Cervical Screening Programmes.SETTING: UK.METHODS: 1515 women, aged 20-59 years, with low-grade cytology who attended colposcopy during February 2001-October 2002, were randomised to immediate loop excision or punch biopsies with recall for treatment if cervical intraepithelial neoplasia (CIN)2/3 was confirmed. Women completed questionnaires at recruitment and after 12, 18, 24 and 30 months. Outcomes were prevalence of worries at each time-point (point prevalence) and at any time-point during follow-up (12-30 months; cumulative prevalence). Primary analysis was by intention-to-treat (ITT); secondary per-protocol analysis compared groups according to management received among women with an abnormal transformation zone.RESULTS: Cumulative prevalence of worries was: cervical cancer 40%; having sex 26%, future fertility 24%, and general health 60%. In ITT analyses, there were no statistically significant differences between management arms in cumulative or point prevalence of any of the worries. In per-protocol analyses, between-group differences were significant only for future fertility; cumulative prevalence was highest in women who underwent punch biopsies and treatment.CONCLUSIONS: There is no difference in the prevalence of specific worries in women randomised to alternative post-colposcopy management policies.CLINICAL TRIAL REGISTRATION: ISRCTN:34841617.

AB - BACKGROUND: Effective cervical screening reduces cancer incidence and mortality. However, these benefits may be accompanied by some harms, potentially including, adverse psychological impacts. Studies suggest women may have concerns about various specific issues, such as cervical cancer.AIM: To compare worries about cervical cancer, future fertility, having sex, and general health between women managed by alternative policies at colposcopy.DESIGN: Multicentre individually-randomised controlled trial, nested within the National Health Service Cervical Screening Programmes.SETTING: UK.METHODS: 1515 women, aged 20-59 years, with low-grade cytology who attended colposcopy during February 2001-October 2002, were randomised to immediate loop excision or punch biopsies with recall for treatment if cervical intraepithelial neoplasia (CIN)2/3 was confirmed. Women completed questionnaires at recruitment and after 12, 18, 24 and 30 months. Outcomes were prevalence of worries at each time-point (point prevalence) and at any time-point during follow-up (12-30 months; cumulative prevalence). Primary analysis was by intention-to-treat (ITT); secondary per-protocol analysis compared groups according to management received among women with an abnormal transformation zone.RESULTS: Cumulative prevalence of worries was: cervical cancer 40%; having sex 26%, future fertility 24%, and general health 60%. In ITT analyses, there were no statistically significant differences between management arms in cumulative or point prevalence of any of the worries. In per-protocol analyses, between-group differences were significant only for future fertility; cumulative prevalence was highest in women who underwent punch biopsies and treatment.CONCLUSIONS: There is no difference in the prevalence of specific worries in women randomised to alternative post-colposcopy management policies.CLINICAL TRIAL REGISTRATION: ISRCTN:34841617.

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DO - 10.1136/jfprhc-2015-101170

M3 - Article

VL - 42

SP - 43

EP - 51

JO - Journal of Family Planning and Reproductive Health Care

JF - Journal of Family Planning and Reproductive Health Care

SN - 1471-1893

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