Our findings suggest that although psychosocial outcomes for women receiving HPV triage are worse in the short term, over 12 months the outcomes seem to be better than those seen with conventional management by repeat smear testing. Two weeks after triage testing, psychosocial outcomes were poorer for women who received HPV testing than for those in the repeat smear testing or informed choice groups, with lower health related quality of life scores on the SF36 vitality subscale, and with a small effect size of 0.27 (small <0.3). Women allocated to HPV testing also had more intrusive thoughts about the abnormal result than the other groups. However, when outcomes were assessed over a full year, the psychosocial burden was worse for those participants who waited six months for a repeat smear. The HPV and informed choice groups had better psychosocial outcomes than the repeat smear group, with a significant effect on the specific distress measure for the HPV testing group compared with the smear group. Both the HPV and informed choice groups also rated satisfaction with management consistently higher than did women in the smear testing group.
Our findings suggest that HPV triage has an initial negative effect on psychosocial wellbeing but that this effect is quickly resolved. By contrast, the psychosocial burden of triage by repeat smear testing remained higher for longer and resulted in a greater total burden on the specific measure of distress for cervical screening. In a cross sectional study, Maissi et al 5 35
indicated that short term effects of management (assessed at four weeks after triage) were worse for women receiving HPV testing than for those who were not tested (receiving a repeat smear test only). At six months, this difference had disappeared. Maissi found a higher level of concern about sexual health in the HPV positive group at six months, but concerns about the test result itself were highest in the group with an abnormal smear who were not tested for HPV. However, these findings are limited by the use of a cross sectional design. Our study showed, using a randomised trial method and comparing psychosocial outcomes for a year, that HPV triage actually caused less screening specific distress overall and resulted in greater satisfaction with management than repeat testing. This finding highlights the importance of long term follow-up of psychosocial outcomes.
Multiple outcomes were included in this study in order to comprehensively assess the various psychosocial effects of management. Examination of multiple independent outcomes can lead to spurious significant findings, and increase type I errors. However, P value adjustment when items are correlated, as the psychosocial variables were in this study, is likely to be overly conservative and also lead to an increase in type II errors resulting in a loss of power to detect true effects. Hence, we did not adjust for multiple outcomes in the current study.36
We highlight that the cognitive and emotional items that show significant differences between groups in the one year analysis were highly specific to the experience and concerns of an abnormal cervical smear result, as assessed by the cervical screening questionnaire measure (which includes concerns about fertility, gynaecological health, and cervical cancer), and the intrusive thoughts measure, which assessed frequency of thoughts women had about their abnormal smear results.
A randomised trial by Kitchener et al37
examined the psychological effect of primary HPV testing. The authors compared short term psychological and psychosexual outcomes at two weeks between women who were either given or not given their HPV test results. There were almost no differences in outcomes between the two groups. The findings indicated a net neutral effect of HPV testing in the short term; however, there are currently no long term data available for the outcomes from this trial.
Our results suggest that the effect of informed choice of management supported by a decision aid is uncertain. At two weeks after testing, the informed choice group had significantly better psychosocial outcomes than the HPV testing group, as measured by the SF36 vitality subscale, with a moderate effect size (0.33). However, although scores in the informed choice arm were better on many of the psychosocial measures over 12 months compared to the other trial arms, scores were not significantly different, and effect sizes all fell within the small range (<0.3). The cognitive measure, intrusive thoughts, showed a notable difference compared with HPV testing (12%) over 12 months. Although not significant, the confidence intervals indicate that informed choice could offer an advantage to this outcome over HPV testing. Worry about cervical cancer demonstrated a similar although weaker pattern.
We conclude that offering women an informed choice offers uncertain benefit compared with HPV triage over 12 months, with the caveat that there might potentially be an advantage of informed choice on the cognitive outcomes, intrusive thoughts, and worry. Informed choice is also likely to be better than allocating women directly to repeat smear testing, which had the worst psychosocial outcomes. Women in the informed choice group had significantly higher overall knowledge scores than the other groups, which might be an important benefit. However, in view of the extra effort and cost that informed choice requires with respect to providing alternative services, it may or may not be seen as worthwhile for these outcomes.
Importantly, the knowledge measure also indicated that women in the HPV arm became well informed about HPV triage and the important characteristics of HPV and its association with cervical cancer. All women testing HPV positive in the study were provided with a high quality information leaflet (see web appendix 3) provided by the New South Wales Cervical Screening Program. This factor might have reduced some of the anxiety in the HPV group. Previous research has found anxiety and distress about the HPV test result is associated with poor understanding and confusion about HPV infection, and that poor understanding is often widespread among women undergoing HPV testing.5 38 39
We know of only one previous study offering women choice in management of borderline cervical abnormalities. This study offered women the choice between a repeat smear test or immediate colposcopy, and assessed psychological outcomes over 12 months. The authors found that there were no differences in outcomes between women offered a choice and those who were not.40
However, the details of how women made their choice and what information they were given are unclear. Participants were informed in a discussion with their clinician and appeared to make their choice immediately. There was no attempt to give women standardised evidence based information on the advantages and disadvantages of each management. In our study, women were given an evidence based decision aid that clearly described the advantages and disadvantages of each option. Our previous analyses of women in the informed choice arm showed that 78% of women were knowledgeable (scored over 50% on the knowledge scale) and 68% of women made an informed choice.14
This finding suggests that most women were aware of the options and were able to make an informed choice.
Although our findings are informative, there are limitations to the study. The area based method used to analyse the psychological outcomes over a year of follow-up involved both the interpolation and extrapolation of data. We tried to minimise extrapolation where possible and carefully excluded participants where substantial extrapolation was required. Sensitivity analysis, adopting both less stringent exclusion criteria, and including all data for analysis, as well as analyses by three periods of follow-up time encompassing the three key events of the HPV triage, the smear triage and the post triage follow-up showed similar results and interpretation, indicating that the analysis method chosen is robust. The area based method is necessary to capture the inherent time differences between the two triage managements. Although more complex than selecting arbitrary points in time for comparison, it allows us to compare the entire period of management for both arms (including the six month waiting time in the smear triage arm) and make maximum use of the longitudinal data.
As with all randomised trials, there are questions about generalisability. Our study included participants in the national cervical screening programme from across Australia with a range of educational backgrounds. Women participating in the study might possibly have been more interested in HPV testing and the opportunity to choose management. However, we note that preference for HPV testing in the informed choice arm was 65%, whereas in a nationally representative sample of Australian women we surveyed, 85% preferred HPV triage testing (data not shown). We also highlight that the offer of choice might be best suited to those women who want a choice in their health care, which would make our sample appropriate.
All women in our study had conventional cytology and therefore had to re-attend the family planning clinic for another swab to be taken for their HPV test. For women who undergo liquid based cytology, a further test is not required, since the HPV triage procedure can be performed on the original cytology specimen. Our findings showed a clear overall preference for HPV triage among women in the informed choice group (65% v
35%). The use of liquid based cytology and reflex testing would probably further increase preferences for HPV test among women than we have recorded in the current study. Similarly, in the UK HPV Sentinel Sites Implementation Project, women testing HPV negative are returned to routine screening, rather than a 12 month smear test, as used in the study and the ALTS protocol.18
This change would be further likely to favour management by HPV triage and adds further support to this triage strategy.