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Psychosocial Impact of Alternative Management Policies for Low-Grade Cervical Abnormalities: Results from the TOMBOLA Randomised Controlled Trial
Abstract
<div><p>Background</p><p>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.</p><p>Methods</p><p>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.</p><p>Results</p><p>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.</p><p>Conclusions</p><p>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.</p><p>Trial Registration</p><p>Controlled-Trials.com <a href="http://www.controlled-trials.com/ISRCTN34841617/tombola" target="_blank">ISRCTN 34841617</a></p></div- Dataset
- Dataset
- Medicine
- Sociology
- Clinical research design
- clinical trials
- Prospective studies
- Mental health
- psychiatry
- Anxiety disorders
- Mood disorders
- psychology
- Psychological stress
- Non-clinical medicine
- Health care policy
- Psychological and psychosocial issues
- Screening guidelines
- Treatment guidelines
- Health services research
- Obstetrics and gynecology
- Gynecologic cancers
- oncology
- Cancer detection and diagnosis
- Cancer screening
- Cancers and neoplasms
- Gynecological tumors
- Cervical cancer
- Cancer prevention
- Public health
- Health screening
- urology
- Genitourinary cancers
- women's health
- policies
- low-grade
- cervical
- tombola
- randomised
- controlled