title: Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial.
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.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN 34841617.
authors.affiliation: National Cancer Registry Ireland, Cork Airport Business Park, Kinsale Road, Cork, Ireland.
authors.forename: Linda
authors.initials: L
authors.lastname: Sharp
authors.affiliation: Obstetrics & Gynaecology, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
authors.forename: Seonaidh
authors.initials: S
authors.lastname: Cotton
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Julian
authors.initials: J
authors.lastname: Little
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
authors.forename: Nicola M
authors.initials: NM
authors.lastname: Gray
authors.affiliation: Obstetrics & Gynaecology, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
authors.forename: Margaret
authors.initials: M
authors.lastname: Cruickshank
authors.affiliation: Department of Pathology, Aberdeen Royal Infirmary, Aberdeen, Scotland.
authors.forename: Louise
authors.initials: L
authors.lastname: Smart
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
authors.forename: Alison
authors.initials: A
authors.lastname: Thornton
authors.affiliation: Medical School, University of Warwick, Coventry, England.
authors.forename: Norman
authors.initials: N
authors.lastname: Waugh
authors.affiliation: University of Hull, Hull, England.
authors.forename: Leslie
authors.initials: L
authors.lastname: Walker
mesh_terms: D000328:Adult; D001007:Anxiety / Q000523:psychology; D002584:Cervix Uteri / Q000473:pathology*; D003127:Colposcopy / Q000523:psychology*; D003863:Depression / Q000523:psychology; D005260:Female; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D002577:Uterine Cervical Diseases / Q000175:diagnosis / Q000523:psychology*; D014626:Vaginal Smears / Q000523:psychology*