HPV testing versus repeat Pap testing for the management of a minor abnormal Pap smear: Evaluation of a decision aid to support informed choice
Introduction
The management of minor cervical abnormalities (borderline smears, atypical cells of undetermined significance ASCUS, possible LSIL) remains contentious and difficult for clinicians and women. There are two main approaches to management available, repeat Pap testing or Human papillomavirus (HPV) testing. We designed and evaluated a patient decision aid to support an evidence-based informed choice between the two options for women with a minor abnormal Pap smear.
Minor abnormalities on Pap smear are common with over 100,000 women affected annually in Australia [1], a similar number in England [2], and approximately 3 million women affected each year in the US. Although the vast majority of cases are clinically insignificant, 5–10% [3] represent a more serious abnormality (CIN2+) that may benefit from treatment [4], [5]. The two principal management approaches involve: (i) follow-up by repeat Pap tests at 6–12 monthly intervals with referral to colposcopy if more serious abnormalities are found. This strategy is currently adopted in the UK and Australian screening programmes [6], [7], [8] and shown to be highly effective [4]. (ii) The new alternate management is Human Papillomavirus (HPV) testing (Digene Hybrid Capture II) which checks for the presence of high-risk types of HPV associated with cervix cancer. It is now recommended practice for women with ASCUS in the US [5], [6] and is being considered for inclusion in the UK and Australian cervical screening programmes. HPV testing is also offered privately or reimbursed through health funds in several countries worldwide. Women who test positive for HPV are referred for colposcopy examination and those testing negative are recalled for a repeat Pap smear at 12 months [5].
In a previous paper we compared evidence on the health and psychological outcomes of each management strategy [6] to inform a patient decision aid. We determined that both HPV testing and repeat Pap smear testing are highly effective at preventing serious cervical abnormalities and cancer [4], [7], [8]. However, the tests hold different advantages and disadvantages for women practically and psychologically (as summarised in Fig. 1).
The advantages of HPV testing are that the test can be done immediately after an abnormal result (as an additional test or by reflex testing if the original Pap smear used liquid based cytology). Women are referred directly for further examination if they test positive, or a repeat Pap smear at an extended interval if they test negative. Immediate testing may have practical and psychological benefits for women and there is evidence that some women prefer a more rapid follow-up and resolution of their abnormality [7]. In contrast, management by repeat Pap testing is a long process of repeat tests until 2 or 3 consecutive Pap smears are normal (in Australia and UK, respectively). Waiting for repeat testing and uncertainty about whether the abnormality will clear or worsen can result in raised levels of anxiety which remain until the abnormality has resolved [15], [16].
The disadvantages of HPV triage are that it may increase the distress experienced by women with an abnormal Pap smear; first through the increased referral of women to colposcopy [8], [9] and the detection and treatment of cytological lesions which may regress naturally if left [10]. Both colposcopy and treatment are associated with increased anxiety among women [11]. Second, distress may be increased through the explicit diagnosis of HPV. Women have been shown to be concerned and confused about the sexually transmitted nature of HPV following a positive test result, albeit a very common infection. This appears to contribute additional psychosocial burden to an already stressful experience [12], [13], [14].
The balance of benefits and harms of each management strategy inevitably varies between women. For some women the advantages of immediate testing offered by HPV triage will outweigh the disadvantages whereas for others the reverse holds. In this paper we investigate which management option women preferred when offered an evidenced based informed choice and the socio-demographic, health, and psychological factors associated with choice of management. We examined the impact of the decision aid and choice on women's short-term psychological wellbeing.
Section snippets
Participants
Participants were women aged 16–70 years who were attending routine cervical screening at Family Planning clinics across Australia. All women had received a minor abnormal Pap smear result, categorised according to the Australian terminology current at that time, as non-specific minor changes (NSMCs) with or without HPV effect (koilocytosis).1
Results
A total of 106 women were randomised to receive the decision aid. Of these, 94 women (89%) made a management choice by returning their preference form. Ninety-one (91/106, 86%) women returned a baseline questionnaire and slightly fewer women (n = (81/106), 76%) a completed follow-up questionnaire (the decision evaluation questionnaire). Twelve of the total 106 women did not make a choice. Of these 1 withdrew from the study, 2 completed a baseline questionnaire but nothing further and the
Discussion
The study examined the effect of a decision aid to support an informed choice for the management of a minor abnormal Pap smear result. It is the first study to examine informed preferences among women facing the management decision. Over two-thirds of women made an informed choice and 65% of women chose HPV triage testing. We expected that preferences for HPV testing would in fact be higher since it is a new test which might be perceived as better by virtue of it being more recently developed.
Conflict of interest
None.
Acknowledgments
We would like to thank 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. In particular we are grateful to 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
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