title: Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trial.
abstract: OBJECTIVE
  To assess which of three triage strategies for women with borderline abnormal cervical smear results in the best psychosocial outcomes.
  
  
  METHODS
  Pragmatic, non-blinded, multicentre, randomised controlled trial.
  
  
  METHODS
  18 family planning clinics across Australia, covering both urban and rural areas, between January 2004 and October 2006.
  
  
  METHODS
  Women aged 16-70 years (n=314) who attended routine cervical screening and received a borderline cervical smear.
  
  
  METHODS
  Patients were randomly assigned to human papillomavirus (HPV) DNA testing (n=104), a repeat smear test at six months (n=106), or the patient's informed choice of either test supported by a decision aid (n=104). Psychosocial outcomes were assessed at multiple time points over 12 months by postal questionnaire.
  
  
  METHODS
  We assessed health related quality of life (SF36 mental health subscale), cognitive effects (such as perceived risk of cervical cancer, intrusive thoughts), affective outcomes (general anxiety [state-trait anxiety inventory]), specific anxiety about an abnormal smear (cervical screening questionnaire), and behavioural outcomes (sexual health behaviour and visits to the doctor) over 12 months of follow-up.
  
  
  RESULTS
  At two weeks, some psychosocial outcomes were worse for women allocated to HPV testing compared with those in the smear testing group (SF36 vitality subscale: t=-1.63, df=131, P=0.10; intrusive thoughts chi(2)=8.14, df=1, P<0.01). Over 12 months, distress about the abnormal smear was lowest in women allocated to HPV testing and highest in the repeat smear testing group (t=-2.89, df=135, P<0.01). Intrusive thoughts were highest in patients allocated to HPV testing (25%, compared with 13% in the informed choice group; difference=12%, 95% CI -1.1% to 25.1%). Women in the HPV DNA group and the informed choice group were more satisfied with their care than women allocated to repeat smear testing.
  
  
  CONCLUSIONS
  Although the psychosocial effect was initially worse for women allocated to HPV triage, over the full year of follow-up this intervention was better for women's psychosocial health than repeat smear testing. Offering informed choice could have a small advantage for cognitive outcomes, but in view of the additional effort and logistical complexity that this intervention requires, HPV testing alone can be justified for most women.
  
  
  BACKGROUND
  actr.org.au Identifier: 12605000111673.
authors.affiliation: Screening and Test Evaluation Program, School of Public Health, University of Sydney, NSW 2006, Australia. kirstenm@health.usyd.edu.au
authors.forename: Kirsten J
authors.initials: KJ
authors.lastname: McCaffery
authors.forename: Les
authors.initials: L
authors.lastname: Irwig
authors.forename: Robin
authors.initials: R
authors.lastname: Turner
authors.forename: Siew Foong
authors.initials: SF
authors.lastname: Chan
authors.forename: Petra
authors.initials: P
authors.lastname: Macaskill
authors.forename: Mary
authors.initials: M
authors.lastname: Lewicka
authors.forename: Judith
authors.initials: J
authors.lastname: Clarke
authors.forename: Edith
authors.initials: E
authors.lastname: Weisberg
authors.forename: Alex
authors.initials: A
authors.lastname: Barratt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology; D003072:Cognition Disorders / Q000209:etiology; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D017060:Patient Satisfaction; D010465:Perception; D011379:Prognosis; D011788:Quality of Life; D012735:Sexual Dysfunction, Physiological / Q000209:etiology; D013315:Stress, Psychological / Q000209:etiology; D011795:Surveys and Questionnaires; D014218:Triage / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D014626:Vaginal Smears / Q000523:psychology*; D055815:Young Adult