Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trialBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.b4491 (Published 24 February 2010) Cite this as: BMJ 2010;340:b4491
- Kirsten J McCaffery, senior research fellow1,
- Les Irwig, professor of epidemiology1,
- Robin Turner, research fellow, biostatistics1,
- Siew Foong Chan, statistician1,
- Petra Macaskill, associate professor in biostatistics 1,
- Mary Lewicka, research assistant1,
- Judith Clarke, research assistant1,
- Edith Weisberg, director research 2,
- Alex Barratt, associate professor in epidemiology1
- 1Screening and Test Evaluation Program, School of Public Health, University of Sydney, NSW 2006, Australia
- 2Sydney Centre for Reproductive Health Research, Family Planning NSW, Sydney, Australia
- Correspondence to: Kirsten McCaffery
- Accepted 9 September 2009
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 χ2=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
We thank Elizabeth Davey for her advice and assistance with clinical aspects of the IMAP trial; FPA Health (NSW), Illawarra Women’s Health Centre (NSW), Family Planning Queensland (FPQ), Family Planning ACT, SHINE (South Australia), and Family Planning WA (FPWA) for their assistance with the recruitment and testing of IMAP study participants; Julie Cayley, Ruth Terwijn, Julie Adrian, Shane Jasiak, Ann Hutchings, Pauline Lee, Wendy Jarrett, Marilyn Grey, Lynn Wray, Caroline Harvey, Sally Page, Jacqui McLelland, Sonya Melgram, Jody Monroe, Judith Collision, Angela Cooney, Katrina Allen, Sue Plume, Sue Opie, Robin Pretty, Edith Melgarejo, Mary Poole, Elizabeth Bowen, Libby Knight, Catherine Turnbull, Jane Newman and Angela Triggs, and staff at Symbion Laverty Pathology.
Contributors: KM and LI conceived the study. KM, LI, PM and AB all contributed to the study design. KM led the research team, data collection, and writing of the manuscript. ML and JC assisted with the all aspects of running the study and coordination the data collection. SFC developed the study database and assisted with the initial analysis. RT carried out the statistical analysis with advice from PM and LI. EW advised on clinical aspects of the study. All authors contributed to the interpretation of the analysis and the writing of the manuscript. KM, LI, RT, and PM are guarantors.
Funding: This work was supported by an Australian National Health and Medical Research Council (NHMRC) Grant 402764 to the Screening and Test Evaluation Program. KM is supported by a NHMRC Career Development Award 402836. The NHMRC has played no role in the writing of this paper.
Competing interests: KM has received a speaker’s fee from CSL (producers of the HPV quadrivalent vaccine Gardasil) and a consultancy fee from GlaxoSmithKline (producers of the bivalent HPV vaccine, Cevarix). EW has received honoraria and research funding from GSK and CSL for her research in the area of HPV vaccination. All other authors have no conflict of interest.
Ethical approval: Ethical approval was granted by the University of Sydney human research ethics committee and all ethics committees governing the participating family planning clinics.
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