Abstract
Objective
To compare psychosocial outcomes (follow-up related worries, and satisfaction with follow-up related information and support) over 30 months of two alternative management policies for women with low-grade abnormal cervical cytology.
Methods
Women aged 20-59 years with low-grade cytological abnormalities detected in the NHS Cervical Screening Programme were randomised to cytological surveillance or initial colposcopy. 3399 women who completed psychosocial questionnaires at recruitment, were invited to complete questionnaires at 12, 18, 24 and 30 months. Linear mixed models were used to investigate differences between arms in the two psychosocial outcomes. Each outcome had a maximum score of 100 and higher scores represented higher psychosocial morbidity.
Results
On average, over 30 months women randomised to colposcopy scored 2.5 points (95%CI -3.6 to -1.3) lower for follow-up related worries than women randomised to cytological surveillance. Women in the colposcopy arm also scored significantly lower for follow-up related satisfaction with information and support (-2.4; -3.3 to -1.4) over 30 months. For both outcomes, the average difference between arms was greatest at 12 and 18 month time-points. These differences remained when the analysis was stratified by post-school education.
Conclusions
Women with low-grade cytology, irrespective of their management, have substantial initial psychosocial morbidity that reduces over time. Implementation of newer screening strategies which include surveillance, such as primary HPV screening, need to consider the information and support provided to women.
To compare psychosocial outcomes (follow-up related worries, and satisfaction with follow-up related information and support) over 30 months of two alternative management policies for women with low-grade abnormal cervical cytology.
Methods
Women aged 20-59 years with low-grade cytological abnormalities detected in the NHS Cervical Screening Programme were randomised to cytological surveillance or initial colposcopy. 3399 women who completed psychosocial questionnaires at recruitment, were invited to complete questionnaires at 12, 18, 24 and 30 months. Linear mixed models were used to investigate differences between arms in the two psychosocial outcomes. Each outcome had a maximum score of 100 and higher scores represented higher psychosocial morbidity.
Results
On average, over 30 months women randomised to colposcopy scored 2.5 points (95%CI -3.6 to -1.3) lower for follow-up related worries than women randomised to cytological surveillance. Women in the colposcopy arm also scored significantly lower for follow-up related satisfaction with information and support (-2.4; -3.3 to -1.4) over 30 months. For both outcomes, the average difference between arms was greatest at 12 and 18 month time-points. These differences remained when the analysis was stratified by post-school education.
Conclusions
Women with low-grade cytology, irrespective of their management, have substantial initial psychosocial morbidity that reduces over time. Implementation of newer screening strategies which include surveillance, such as primary HPV screening, need to consider the information and support provided to women.
| Original language | English |
|---|---|
| Pages (from-to) | 476–483 |
| Number of pages | 8 |
| Journal | Psycho-Oncology |
| Volume | 26 |
| Issue number | 4 |
| Early online date | 14 Jun 2016 |
| DOIs | |
| Publication status | Published - 1 Apr 2017 |
Bibliographical note
We are grateful for the co-operation and assistance that we received from NHS staff in the co-ordinating centres and clinical sites. We thank the women who participated in TOMBOLA.The TOMBOLA trial was supported by the Medical Research Council (G9700808) and the NHS in England and Scotland.
The TOMBOLA Group comprises the following:
Grant-holders: University of Aberdeen and NHS Grampian, Aberdeen, Scotland: Maggie Cruickshank, Graeme Murray, David Parkin, Louise Smart, Eric Walker, Norman Waugh (Principal Investigator 2004–2008)
University of Nottingham and Nottingham NHS, Nottingham, England: Mark Avis, Claire Chilvers, Katherine Fielding, Rob Hammond, David Jenkins, Jane Johnson, Keith Neal, Ian Russell, Rashmi Seth, Dave Whynes
University of Dundee and NHS Tayside, Dundee, Tayside: Ian Duncan, Alistair Robertson (deceased)
University of Ottawa, Ottawa, Canada: Julian Little (Principal Investigator 1999–2004)
National Cancer Registry, Cork, Ireland: Linda Sharp
Bangor University, Bangor, Wales: Ian Russell
University of Hull, Hull, England: Leslie G Walker
Staff in clinical sites and co-ordinating centres
Grampian
Breda Anthony, Sarah Bell, Adrienne Bowie, Katrina Brown (deceased), Joe Brown, Kheng Chew, Claire Cochran, Seonaidh Cotton, Jeannie Dean, Kate Dunn, Jane Edwards, David Evans, Julie Fenty, Al Finlayson, Marie Gallagher, Nicola Gray, Maureen Heddle, Alison Innes, Debbie Jobson, Mandy Keillor, Jayne MacGregor, Sheona Mackenzie, Amanda Mackie, Gladys McPherson, Ike Okorocha, Morag Reilly, Joan Rodgers, Alison Thornton, Rachel Yeats
Tayside
Lindyanne Alexander, Lindsey Buchanan, Susan Henderson, Tine Iterbeke, Susanneke Lucas, Gillian Manderson, Sheila Nicol, Gael Reid, Carol Robinson, Trish Sandilands
Nottingham
Marg Adrian, Ahmed Al-Sahab, Elaine Bentley, Hazel Brook, Claire Bushby, Rita Cannon, Brenda Cooper, Ruth Dowell, Mark Dunderdale, Dr Gabrawi, Li Guo, Lisa Heideman, Steve Jones, Salli Lawson, Zoë Philips, Christopher Platt, Shakuntala Prabhakaran, John Rippin, Rose Thompson, Elizabeth Williams, Claire Woolley
Statistical analysis
Seonaidh Cotton, Kirsten Harrild, John Norrie, Linda Sharp
External Trial Steering Committee
Nicholas Day (chair, 1999–2004), Theresa Marteau (chair 2004-), Mahesh Parmar, Julietta Patnick and Ciaran Woodman.
Keywords
- cancer
- oncology
- colonoscopy
- cytology
- psychosocial morbidity
Access to Document
- Accepted Manuscript
"This is the peer reviewed version of the following article: Fielding, S., Rothnie, K., Gray, N. M., Little, J., Cruickshank, M. E., Neal, K., Walker, L. G., Whynes, D., Cotton, S. C., Sharp, L., and In association with the TOMBOLA group (2017) Psychosocial morbidity in women with abnormal cervical cytology managed by cytological surveillance or initial colposcopy: longitudinal analysis from the TOMBOLA randomised trial. Psycho-Oncology, 26: 476–483, which has been published in final form at doi: 10.1002/pon.4163. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving."
- Psychosocial morbidity in women with abnormal cervical cytology managed by cytological surveillance or initial colposcopy
© 2016 The Authors. Psycho-Oncology published by John Wiley & Published online 14 June 2016 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/pon.4163 This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/
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Seonaidh Cotton
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Senior Trial Manager
- School of Medicine, Medical Sciences & Nutrition, Centre for Healthcare Randomised Trials (CHaRT)
Person: Academic Related - Management