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Psychosocial impact of alternative management policies for low-grade cervical abnormalities : results from the TOMBOLA randomised controlled trial
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Sharp, Linda, Cotton, Seonaidh, Little, Julian, Gray, Nicola M., Cruickshank, M., Smart, Louise, Thornton, Alison, Waugh, Norman and Walker, Leslie C. (2013) Psychosocial impact of alternative management policies for low-grade cervical abnormalities : results from the TOMBOLA randomised controlled trial. PLoS One, Volume 8 (Number 12). Article number e80092. doi:10.1371/journal.pone.0080092 ISSN 1932-6203.
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WRAP_Waugh_journal.pone.0080092.pdf - Published Version Available under License Creative Commons Attribution. Download (1299Kb) | Preview |
Official URL: http://dx.doi.org/10.1371/journal.pone.0080092
Abstract
Background: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.
Methods: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20–59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥8) and significant anxiety (≥11; “30-month percentages”). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.
Results: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80–1.21) or anxiety (OR = 0.97, 95% CI 0.81–1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38–0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54–0.84). Neither anxiety nor depression differed between arms at subsequent time-points.
Conclusions: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.
Item Type: | Journal Article | ||||
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Subjects: | R Medicine > R Medicine (General) R Medicine > RG Gynecology and obstetrics |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) > Warwick Evidence Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Cervix uteri -- Diseases -- Treatment -- Psychological aspects, Clinical trials, Cervix uteri -- Diseases -- Diagnosis, Colposcopy | ||||
Journal or Publication Title: | PLoS One | ||||
Publisher: | Public Library of Science | ||||
ISSN: | 1932-6203 | ||||
Official Date: | 30 December 2013 | ||||
Dates: |
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Volume: | Volume 8 | ||||
Number: | Number 12 | ||||
Page Range: | Article number e80092 | ||||
DOI: | 10.1371/journal.pone.0080092 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Open Access (Creative Commons) | ||||
Date of first compliant deposit: | 26 December 2015 | ||||
Date of first compliant Open Access: | 26 December 2015 |
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