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.

Design: Pragmatic, non-blinded, multicentre, randomised controlled trial.

Setting: 18 family planning clinics across Australia, covering both urban and rural areas, between January 2004 and October 2006.

Participants: Women aged 16-70 years (n=314) who attended routine cervical screening and received a borderline cervical smear.

Interventions: 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.

Main outcome measures: 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.

Trial registration: actr.org.au Identifier: 12605000111673.

Fig 1 Randomised trial design and psychosocial assessment

Fig 2 Framework for understanding and assessing psychosocial effects.

Fig 3 Patient recruitment and retention

Fig 4: Mean satisfaction with health care in general for period 1 (90-160 days), period 2 (161-320 days) and period 3 (321-365 days) and mean satisfaction with health care in general for the entire study period

Fig 5: Mean cervical screening questionnaire (CSQ) distress scores for the period 1 (90-160 days), period 2 (161-320 days) and period 3 (321-365 days) and mean CSQ distress scores for the entire study period