Should health-related quality of life and patient choice be incorporated into evidence-based guidelines in the treatment of cervical dysplasia?
STUDY 1: Health-related quality of life outcomes and patient preferences of follow-up, post treatment of CIN 2 and CIN 3. OBJECTIVE: To identify patient preferences and investigate whether type of follow-up was associated with differences in Health-related Quality of Life (HrQOL), adherence to screening, or cost benefits in patients who have undergone large loop excision of the transformation zone (LLETZ) procedures for cervical intraepithelial neoplasia (CIN) stages two and three. STUDY DESIGN: Three arm, parallel-group, open label randomised controlled trial of women aged 18 70, with a new diagnosis of CIN 2-3, at Christchurch Women’s Hospital. The control group (n= 69) had routine follow-up with colposcopy review at the hospital, six months post treatment (6). Two intervention groups were also examined: one having follow-up by high-risk human papilloma virus (HrHPV) and smear testing in the community (n = 66), and the second group who selected their follow-up regime (either hospital-based colposcopy or HrHPV and smear tests in the community, n = 65). Assessments were conducted at time of treatment and at 6 months by questionnaire. The two intervention groups were compared with the control group. Comparisons between the choice versus no-choice groups were also made. The primary outcome of the study was an analysis of HrQOL scores using the Short Form Health Survey 12 version 2 (SF12v2). Additional questions to investigate patient preferences, sexual function, anxiety, and insight into condition were also asked. Intention to treat analysis was performed. The secondary outcomes of the study include percentage of normal follow-up tests, detection of recurrent disease, patient preferences, adherence to screening recommendation, and cost analysis with comparison between the groups. RESULTS: This study investigated 200 women who received LLETZ treatment at Christchurch Women’s Hospital between 2013 and 2015. The baseline characteristics of the groups were similar. Seventy-six women (38%) were randomised to the control group in the study, 63 (32%) were randomised to follow-up in the community with smear and HrHPV testing, and 61 (31%) were offered the choice to select their follow-up regime. Of those given a choice of follow-up, 22 (36%) chose to have their follow-up in the community and 39 (64%) chose to have follow-up in the colposcopy department. This illustrates a preference for follow-ups in the colposcopy department. Of the 200 women enrolled in the study, 196 (98%) completed their baseline questionnaires and 128 (65%) returned their questionnaires after 6 months. We found no significant difference in HrQOL between the follow-up regimes. At 6 months, the SF12v2 scores for HrQOL were not significantly different between the groups. There was, however, a four times greater likelihood that patients in the choice group would adhere to follow-up. There are cost benefits to both community and choice of follow-up (with savings of $59 and $33 dollars per person, respectively). Of the participants, 122 women (61%) had no evidence of disease by 6 months (had normal smears and negative HrHPV tests). Although there were no significant correlations with smoking status or OCP use, the trends were in the expected direction. One patient experienced treatment failure and required a repeat LLETZ, while another was found to have a 1A1 squamous cell carcinoma and was referred for Gynaecology Oncology follow-up.CONCLUSION: We found no statistically significant differences in HrQOL between the groups as measured by the SF12v2. A preference for follow-up in colposcopy was observed. Community follow-up was the most cost effective but was also associated with the highest non-adherence to follow-up. Choice of follow-up has a cost benefit of $33 per patient and was associated with the lowest non-adherence to follow-up. A larger randomised trial would help determine whether these results are representative of the diversity of women in the New Zealand population, notably among ethnic minorities and women living rurally, who are not well represented in this study. Within the limitations of the study there is evidence that women who were given choice in follow-up were less likely to miss future appointments. This, together with the economic benefit, suggests that even though there is no QOL difference between follow-up methods, changes should be made to the screening guidelines to accomodate patient preference. STUDY 2: Does conservative management of cervical intraepithelial neoplasia reduce quality of life in young women? OBJECTIVE: To assess health-related quality of life (HrQOL) in women under 25 years of age with cervical intraepithelial neoplasia (CIN) grade 2 receiving conservative management (colposcopy follow-up, with treatment if necessary) compared with those receiving immediate excisional treatment with large loop excision of the transformation zone (LLETZ).STUDY DESIGN: A cross-sectional observational study evaluating HrQOL was conducted at Christchurch Women’s Hospital, New Zealand. Women undergoing conservative management for CIN 2 were compared with those undergoing immediate excisional treatment in an age-matched sample. The Short Form Health Survey 12 version 2 (SF-12v2) was used, measuring Physical Component Summary scores (PCS) and Mental Component Summary scores (MCS) to evaluate quality of life (QOL). Secondary outcomes of anxiety and sexual function were also assessed. RESULTS: 104 women with CIN 2 participated in the study. Of these, 63 women (60%) received conservative management and 41 (40%) received immediate excisional treatment with LLETZ. The demographic features of the groups were similar. We found no significant difference in HrQOL between the groups in a multivariate regression analysis adjusted for parity, smoking, and socioeconomic status. There were also no significant differences in sexual function or anxiety.CONCLUSION: We found no difference in HrQOL by management strategy. Conservative management of CIN 2 in women under 25 is unlikely to have an adverse impact on self-reported health-related quality of life, anxiety, or sexual functioning compared with conventional management.
Advisor: Sykes, Peter; Innes, Carrie
Degree Name: Master of Medical Science
Degree Discipline: Obstetrics and Gynaecology
Publisher: University of Otago
Keywords: HrQOL; Patient-choice; New-Zealand; Cervical-screening
Research Type: Thesis