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Both patient-centred care and evidence-based medicine are central to the practice of modern healthcare. The former is focused on individualising a patient’s care; the latter requires standardisation of care. Creating an alliance between these concepts is a major challenge for clinicians and researchers alike. For New Zealand gynaecological clinicians, adapting evidence-based information to foster a woman’s sense of being respected and able to participate in their own health decisions is critical in the evolution of cervical screening guidelines. Women who have received treatment for cervical intraepithelial neoplasia (CIN) grades 2 to 3 are a high-risk population for developing cervical cancer, particularly if they do not attend follow-up screening. Until recently, all women were recalled back to the hospital colposcopy clinic for their initial post-treatment assessment, which enabled standardisation of care. However, since 2020 the National Screening Guidelines of New Zealand have allowed either colposcopic or community follow-up in the post-treatment setting.[[1]] This new approach promotes patient-centred care, and is consistent with many international healthcare policies where, for the initial follow-up after treatment, HPV screening and cytology alone are allowed, and may also take place in either the community or hospital settings.[[2,3]]

Successful cervical screening programmes rely heavily on long-term patient participation, and studies from other fields show that participation is dependent on factors such as patient choice.[[4,5]] Allowing patients a choice of follow-up is a patient-centred approach that has potential advantages.[[5]] Despite research in other medical fields showing a positive relationship between patient choice and health outcomes, this “preference effect” is largely overlooked in the literature informing CIN screening guidelines.[[1–3]] To date, there are no studies investigating health-related quality of life (HrQOL) and patient preferences in the post-treatment setting, and there are no specific data informing the updated New Zealand screening guidelines.[[1]] Considering that the new guidelines now offer patient choice, this information may be particularly useful to practitioners offering follow-up to women who are at greater risk of developing cancer (ie, CIN 2–3 post-treatment) or becoming lost to follow-up.[[6]] Other potential advantages are improved HrQOL, decreased patient anxiety and greater adherence to the screening programme.[[4,5,7]]

Colposcopy follow-up requires women to visit the hospital and see a specialised doctor or nurse for a minor procedure. Often the practitioner will be seeing the woman for the first time. The advantages of colposcopy include the possibility of a diagnostic test, with a potentially shorter time to treatment. With regards to patient perspective, some studies have shown a long-lasting negative effect on HrQOL in women following colposcopy, whereas others suggest a high satisfaction rate, due to specialist reassurance.[[8,9]] The disadvantages of colposcopy in this setting include inter-observer variability, poor cost-effectiveness, and less flexibility for appointment times.

Smear and HrHPV testing can be done in the community by a GP or nurse specialist. To the practitioner, these tests have the advantage of being objective, and they require less specialised training to administer. Triaging colposcopy visits with this preceding step, allows colposcopy with a specialist to be reserved for women who need it most. For many women, community smear and HrHPV testing offers more flexibility of appointments, which may confer a quality-of-life advantage. Disadvantages of this approach include a delay in diagnostic testing (by way of colposcopy-directed biopsy), and some women reporting a preference towards attending a specialist hospital clinic.[[10,11]]

The primary aim of this study was to determine whether a significant quality of life difference exists among women receiving treatment for CIN 2–3 who are followed up in either a hospital-based colposcopy clinic, in the community, or given a choice. The secondary aims of this study were to estimate costs for the different follow-up options.

Methods

This three-arm, parallel-group, randomised controlled trial was conducted at Christchurch Women’s Hospital between 2013 and 2015 (Trial registration: ACTRN12617000931370). Currently, there is no core outcome set (COS) that addresses the topic of measuring and comparing quality of life for women receiving treatment for CIN 2–3 with different follow-up options. Approval for this study was obtained through the New Zealand HDEC (Ref: URA/11/10/056). Potential participants were sent information about the study by mail, prior to their appointment for large loop excision of the transformation zone (LLETZ) treatment. Women aged between 18 and 70 with a new diagnosis of CIN 2–3 appropriate for LLETZ treatment and capable of giving informed consent were eligible. The exclusion criteria included those with a history of immunosuppression, cancer or associated vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN) and anal intraepithelial neoplasia (AIN), as, in New Zealand, these women would be recommended to continue regular colposcopic follow-up.

At their attendance for LLETZ treatment, consenting women were allocated to one of the three study groups by computer-generated block randomisation. Randomisation was prepared by a statistician external to the study team. A folder was arranged with patient packs identified by study number. The randomisation was concealed in the patient packs prior to enrolment. Due to the nature of the intervention, blinding of participants following enrolment was not possible. Following LLETZ, if the patient was found to have cancer or positive endocervical boundary, the gynaecologist could override the randomised follow-up: the women was allocated to the colposcopy review (group a) and the results analysed in an intention-to-treat analysis. All clinical data were collected in the clinic by treating clinicians and later transferred to an electronic database by a study team member.

All groups were followed until six-months post-treatment. The control group (group a) underwent the routine follow-up in a hospital-based colposcopy clinic. The community follow-up group (group b) had HPV and cytological testing at their GP or family planning clinic. The patient choice group (group c) was given the choice of either colposcopy or community-based follow-up.

Participants were twice asked to complete identical questionnaires, initially at enrolment and again at their six-month follow-up. The Medical Outcomes Study Short Form version 2 (SF12v2) survey was used to measure HrQOL. This uses two scores to evaluate HrQOL: mental (MCS) and physical (PCS) component scores. A higher score indicates a better health status. Participants also received questions about baseline characteristics, cost associated with visit, preferences for place of follow-up, as well as barriers and facilitators associated with each follow-up option. Follow-up attendance was measured through review of medical records. The primary outcome of the study was self-reported HrQOL measured using the SF12v2 survey at six months. Secondary outcomes included attendance to follow-up, patient preferences, and costs.

Statistical analysis

A target of 200 participants was set (at least 64 per group) allowing for loss to follow-up, which would achieve greater than 80% power to detect a difference of at least d=0.5 with {{2}}=0.05. In a previous study the effect sizes (measured as standard deviations between the means) of 0.5 were found.[[12]] This study looked at HrQOL differences in screening comparing colposcopy and HPV/smear.[[12]] Since colposcopy is more invasive, we expected that the differences in this study would be greater. Therefore, we planned the study to detect a difference of d=0.5 between arms.

For each follow-up group, the primary outcome was analysed using a one-way ANOVA test to assess for differences in mean SF12v2 scores between baseline and follow-up at six months. We obtained all SF12v2 questionnaires at baseline, and 64.0% (n=128) at six months. Using colposcopy as the control, a pairwise analysis of mean HrQOL scores from both the community and choice groups (groups b and c) was made using a t-test with a significance level of p<0.05 (Table 2). Adherence to follow-up was measured using the risk ratio, risk difference and associated 95% confidence intervals of non-attendance between different follow-up methods. Preferences of follow-up were summarised using proportions and analysed using a one-sample test for binomial proportions. Cost analysis of the groups was performed, including the costs of missed appointments, recalls, re-referrals and subsequent appointments by different means and analysed descriptively. No imputations were performed for the management of missing data—these participants were excluded from the HrQOL analysis. Patient preferences were assessed by both the analysis of the choice group responses and through the questionnaire. We used Stata version 14 (StataCorp, College Station, TX, USA) for the analyses. We estimated the costs of a colposcopy at Christchurch Women’s Hospital to be $140 per patient, and the average cost of a smear in the community as $50 in Christchurch. The total costs per group were calculated as shown in the below tables and an average cost estimated. Costs of missed appointments, recall, re-referral and subsequent appointment by different means were included in the calculation.

Figure 1: CONSORT flow diagram—participant allocation. View Figure 1.

Results

A total of 458 women at Christchurch Women’s Hospital were assessed for eligibility, of which 200 patients were enrolled in the study between 2013 and 2105. Patient characteristics for age, gravidity, parity, contraception method or smoking are shown in Table 1. The most common contraception used was the combined oral contraceptive pill (COCP) although a quarter of women used no contraception. Of the data available, a high proportion of women had not received the HPV vaccine, which may be justified by the age distribution of study participants—Gardasil only became part of the New Zealand immunisation schedule in 2009.[[13]]

Attendance to clinical follow-up was a secondary analysis (Table 3). The greatest non-attendance (of 17 patients) was observed in the community group (Figure 1), despite nine of these patients reporting community follow-up as feasible. In the colposcopy group, three patients did not receive their allocated intervention despite self-reported feasibility of follow-up allocation. Among the women not attending follow-up (“NA”), the total number was, therefore, twelve patients. In the choice group, only one patient did not attend follow-up. Our analysis showed a trend for higher rate of non-attendance among women who were assigned a follow-up option (8.9%) compared with women who chose their follow-up option (1.5%, risk difference=7%, 95% CI 2%–13%, p=.06).  

Table 1: Baseline characteristics of participants by randomised follow-up group. View Table 1.

Table 2: Comparison of health-related quality of life scores§ in follow-up groups: colposcopy versus community/choice.

Table 3: Observed frequencies of attendance to follow-up: choice versus no choice.

Assessing patient preferences for method of follow-up found 63.1% of the choice group (41/65, Figure 1) electing to have follow-up at the colposcopy clinic compared to 36.4% (24/65) who elected follow-up in the community. A one-sample test for binomial proportions suggests there may be a true difference favouring colposcopy (63.1% [95% CI 50.2–74.7]). Patient preference was also assessed in the questionnaire and showed differences over time. Those preferring the choice group increased by 5% and the community group by 4%. However, those preferring the colposcopy group decreased by 7% (Supplementary Material 2).

The average cost of the follow-up options per person was $147 for colposcopy, $88 for community and $114 for choice. This would result in savings of $59 per person if all patients were initially referred to the community and a saving of $33 if women were given the choice of follow-up.

Discussion

Health-related quality of life

We found no objective HrQOL difference associated with follow-up type in patients after LLETZ treatment for CIN 2–3. This supports the newly introduced guidelines, which recommend that clinicians offer both hospital and community options to women for post-treatment follow-up.

Attendance

Attendance at follow-up in cervical screening programmes is of paramount importance. It is well-established that women with a history of high-grade (CIN 2+) disease are at high risk of developing cervical cancer. Among women who have developed cancer following a previous abnormality, 50% have been lost to follow-up.[[9]] Factors that impact on cervical screening uptake include timing of appointments, economic factors, education/knowledge, fear/embarrassment and the gender of the smear taker. However, to date, the cervical screening literature has not identified patient choice as a factor contributing to attendance.[[15,16]] Studies in other medical fields demonstrate a “preference effect,” whereby choice itself may have an outcome advantage.[[20]] Other studies also observe a high correlation between women’s choice of management type and their attendance at follow-up.[[21]] In our study, women that were given the option of either hospital or community follow-up type (group c) had better attendance at cervical screening services (risk difference=7%, 95% CI 2%–13%, p=.06) than those given no choice of follow-up type (groups a and b). Therefore, offering a choice of follow-up type may improve women’s adherence and attendance.

Cost-effectiveness

Community follow-up was the most cost-effective but least adhered-to option. When compared to routine colposcopy, the group given a choice of follow-up (group c) had a cost benefit of $33 per patient and was associated with the highest rates of adherence.

Limitations

We acknowledge that this was a secondary analysis with the limitation of small numbers informing a potential association. Nonetheless, this highlights the importance of patient choice in medical decision-making, which is often overlooked in research and guideline development.

We acknowledge that study designs that allow participants to choose their treatment are susceptible to confounding factors. For example, a more anxious group of women at baseline may be more inclined to choose colposcopy. In order to minimise this in the analysis of the primary outcome, the choice group was analysed separately and not according to the follow-up chosen.

The potential for information bias requires consideration. For the collection of data, we considered several options. We identified four specific cervical screening questionnaires in our literature search: the Process Outcome Specific Measure (POSM) from the Trial of Management of Borderline and Other Low-Grade Abnormal Smears (TOMBOLA) group,[[17]] Psychological Effects of Abnormal Pap Smears Questionnaire (PEAPS-Q),[[18]] Cervical Dysplasia Distress Questionnaire (CDDQ)[[16]] and the HPV Impact Profile (HIP).[[19]] However, none of these have been widely used or validated. Therefore, we chose to use a generic HrQOL tool, the SF12v2, for which there is a large body of supporting evidence. As a generic assessment tool, the SF12v2 allows comparison of health status between groups, including those suffering from different diseases. Such a tool also allows analysis of a wide range of populations, ascertaining any deviations from a “healthy norm.”[[5]] As such, a broader range of comparison is possible. However, use of the SF12v2 in the context of this study may be criticised for its potential imprecision in assessing disease-specific effects.[[7]] Furthermore, since a small number of women completed the questionnaire at home with return by post, the day and location of survey completion has the potential to bias survey outcomes.

Strengths

One of the strengths of the current study lies in its randomised design and intention to treat analysis which supports the internal validity of the trial. All participants completed their clinical care, and we had no missing clinical data for baseline and follow-up. We obtained all HrQOL questionnaires at baseline, and 64.0% (n=128) at six months.

Further research

This study highlights that patient choice, where equivalent management options exist, may warrant further research due to associations with improved adherence and cost benefits. Larger studies are warranted to examine the potential effects of patient choice on follow-up type in cervical screening, and to test these findings in a wider clinical setting. A larger study involving different centres throughout New Zealand would also better represent the wider New Zealand population because choice options and the costs associated with follow-up type are likely to vary between regions. Patient choice of colposcopy or community follow-up type depends on numerous factors, such as perceived standard of care, geographical factors, financial considerations and patient experience. For example, women living in rural areas may feel more comfortable with their own general practitioner and access to colposcopy services should also not be assumed to be homogenous throughout New Zealand.

Additionally, although the importance of adherence to follow-up is well-documented in women who have had previous high-grade disease, a study with a longer follow-up period would provide more certainty of potential long-term effects.

Finally, future management and research decisions should consider costs to the patient. In New Zealand, screening services are free for patients in the hospital but not in the community. Although costs to patients were subsidised in this study, the increased personal costs associated with screening was an important issue raised by some patients and may be a major deterrent to follow-up for some women.

Conclusion

In New Zealand, guidelines for cervical screening have recently been amended to allow either colposcopic or community follow-up in the post-treatment setting, thus presenting the clinician and patient with a choice. Although it is known that patient choice can influence participation—and thus health outcome—this has not yet been explored with regards to cervical screening. We investigated whether patient choice of follow-up screening type improves HrQOL and attendance for women who have undergone LLETZ for CIN 2–3. Using a randomised control trial study design, we found no significant difference in HrQOL between three study groups of hospital follow-up, community follow-up or patience choice of follow-up type. However, attendance was greater in patients allocated to a group where they could choose their follow-up type. Larger and longer-term studies examining these potential effects are warranted.

Supplementary material

Supplementary Material 1: Comparison of health-related quality of life between groups baseline and six month (MCS and PCS scores).

Supplementary Material 2: Patient follow-up preferences.

Summary

Abstract

Aim

We investigated whether patient choice of follow-up type improves health-related quality of life (HrQOL) and follow-up attendance in women who have undergone large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia grade 2 to 3 (CIN 2–3).

Method

A three-armed randomised controlled trial including women with newly diagnosed CIN 2–3 post-LLETZ treatment was performed. Consenting women were randomised (1:1:1) to either: (a) colposcopy review at the hospital, (b) follow-up with high-risk human papilloma virus (HrHPV) and smear test in the community or (c) a choice of the aforementioned follow-up options, six months post-treatment. HrQOL was measured and participants were surveyed at baseline and six months regarding preferences for follow-up.

Results

Sixty-eight participants were randomised to follow-up (a), 67 to follow-up (b) and 65 to follow-up (c) (n=200). At six months post-treatment, 47% of patients indicated a preference for (a), 24% for (b) and 26% for (c). We found no significant difference in HrQOL between the study arms. Attendance was greater among patients who chose their follow-up (95.5% vs 91.1%, p=0.06).

Conclusion

Choice of follow-up was associated with greater attendance. However, larger studies examining the effects of HrQOL and attendance to different follow-ups are warranted.

Author Information

Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital. Jillian Lanb: RN, Colposcopy Nurse Specialist, Christchurch Women’s Hospital. Helene MacNab: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Carrie Innes: PhD, Post-doctoral Fellow, Department of Obstetrics and Gynaecology, University of Otago David Peddie: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Diane Harker: MA, RN, Department of Obstetrics and Gynaecology, University of Otago, Christchurch. Jonathan Williman: PhD MBiostat, Research Fellow, Department of Population Health, University of Otago, Christchurch. Peter Sykes: FRANZCOG, DGO, Associate Professor, Christchurch Women’s Hospital. Bryony Simcock: FRANZCOG, Gynaecologic Oncologist at Christchurch Women’s Hospital.

Acknowledgements

We would like to acknowledge the contribution of the administrative and nursing staff of the Colposcopy Department at Christchurch Women’s Hospital. Their support and assistance was instrumental to the success of the project. We would also like to thank the Gynaecology Cancer Research Trust and The Canterbury Initiative for their support.

Correspondence

Dr Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital, Private Bag 4711, Christchurch 8140, New Zealand, +41 79 8556214

Correspondence Email

katayoun.taghavi@gmail.com

Competing Interests

The authors declare grants and funding from the Gynaecology Cancer Research Trust and the Canterbury Initiative to support this manuscript.

1. Ministry of Health. Guidelines for cervical screening New Zealand. Ministry of Health New Zealand: National Screening Unit. 2020.

2. Colposcopy and Programme Management Guidelines for the NHS Cervical Screening Programme. NHS cervical screening unit. 2010

3. Wright TC J, Cox JT, Massad LS, Carlson J, Twiggs LB, Wilkinson EJ. Consensus guidelines for the management of women with cervical intraepithelial neoplasia. AJOG. 2003;189(1):295-304.

4. Lambert MF, Wood J. Incorporating patient preferences into randomized trials. Journal of clinical epidemiology. 2000;53:163-6.

5. Preference Collaborative Review G. Patients' preferences within randomised trials: systematic review and patient level meta-analysis. BMJ. 2008;337:a1864.

6. Soutter WP, Sasieni P, Panoskaltsis T. Long-term risk of invasive cervical cancer after treatment of squamous cervical intraepithelial neoplasia. International journal of cancer. 2006;118(8):2048-55.

7. Clark NM, Janz NK, Dodge JA, Schork MA, Fingerlin TE, Wheeler JR, et al. Changes in functional health status of older women with heart disease: evaluation of a program based on self-regulation. The journals of gerontology Series B, Psychological sciences and social sciences. 2000;55(2):S117-26.

8. Korfage IJ, van Ballegooijen M, Wauben B, Looman CW, Habbema JD, Essink-Bot ML. Having a Pap smear, quality of life before and after cervical screening: a questionnaire study. BJOG : an international journal of obstetrics and gynaecology. 2012;119(8):936-44.

9. Korfage IJ, Essink-Bot ML, Westenberg SM, Helmerhorst T, Habbema JD, van Ballegooijen M. How distressing is referral to colposcopy in cervical cancer screening?: a prospective quality of life study. Gynecologic oncology. 2014;132(1):142-8.

10. Orbell S, Hagger M, Brown V, Tidy J. Appraisal theory and emotional sequelae of first visit to colposcopy following an abnormal cervical screening result. British journal of health psychology. 2004;9(Pt 4):533-55.

11. Balasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Do women with high-grade cervical intraepithelial neoplasia prefer a see and treat option in colposcopy? BJOG : an international journal of obstetrics and gynaecology. 2007;114(1):39-45.

12. McCaffery KJ, Irwig L, Turner R, et al. Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trial. BMJ. 2010;340:b4491.

13. Ministry of Health New Zealand. The HPV (Human Papillomavirus) Immunisation Programme, HPV Project Team PHD. June 2008.

14. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Medical care. 1989;27(3 Suppl):S217-32.

15. van der Heijden E, Lopes AD, Bryant A, Bekkers R, Galaal K. Follow-up strategies after treatment (large loop excision of the transformation zone (LLETZ)) for cervical intraepithelial neoplasia (CIN): Impact of human papillomavirus (HPV) test. The Cochrane database of systematic reviews. 2015;1:CD010757.

16. O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L, et al. Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG : an international journal of obstetrics and gynaecology. 2016;123(1):24-38.

17. Gray NM, Sharp L, Cotton SC, Avis M, Philips Z, Russell I, et al. Developing a questionnaire to measure the psychosocial impact of an abnormal cervical smear result and its subsequent management: the TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) trial. Quality of Life Research. 2005;14(6):1553-62.

18. Bennetts A, Irwig L, Oldenburg B, Simpson JM, Mock P, Boyes A, et al. Peaps-Q - a Questionnaire to Measure the Psychosocial Effects of Having an Abnormal Pap Smear. Journal of clinical epidemiology. 1995;48(10):1235-43.

19. Shinn E, Basen-Engquist K, Le T, Hansis-Diarte A, Bostic D, Martinez-Cross J, et al. Distress after an abnormal Pap smear result: scale development and psychometric validation. Preventive medicine. 2004;39(2):404-12.

20. Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality-of-life instruments. Pharmacoeconomics. 2000;17(1):13-35.

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Both patient-centred care and evidence-based medicine are central to the practice of modern healthcare. The former is focused on individualising a patient’s care; the latter requires standardisation of care. Creating an alliance between these concepts is a major challenge for clinicians and researchers alike. For New Zealand gynaecological clinicians, adapting evidence-based information to foster a woman’s sense of being respected and able to participate in their own health decisions is critical in the evolution of cervical screening guidelines. Women who have received treatment for cervical intraepithelial neoplasia (CIN) grades 2 to 3 are a high-risk population for developing cervical cancer, particularly if they do not attend follow-up screening. Until recently, all women were recalled back to the hospital colposcopy clinic for their initial post-treatment assessment, which enabled standardisation of care. However, since 2020 the National Screening Guidelines of New Zealand have allowed either colposcopic or community follow-up in the post-treatment setting.[[1]] This new approach promotes patient-centred care, and is consistent with many international healthcare policies where, for the initial follow-up after treatment, HPV screening and cytology alone are allowed, and may also take place in either the community or hospital settings.[[2,3]]

Successful cervical screening programmes rely heavily on long-term patient participation, and studies from other fields show that participation is dependent on factors such as patient choice.[[4,5]] Allowing patients a choice of follow-up is a patient-centred approach that has potential advantages.[[5]] Despite research in other medical fields showing a positive relationship between patient choice and health outcomes, this “preference effect” is largely overlooked in the literature informing CIN screening guidelines.[[1–3]] To date, there are no studies investigating health-related quality of life (HrQOL) and patient preferences in the post-treatment setting, and there are no specific data informing the updated New Zealand screening guidelines.[[1]] Considering that the new guidelines now offer patient choice, this information may be particularly useful to practitioners offering follow-up to women who are at greater risk of developing cancer (ie, CIN 2–3 post-treatment) or becoming lost to follow-up.[[6]] Other potential advantages are improved HrQOL, decreased patient anxiety and greater adherence to the screening programme.[[4,5,7]]

Colposcopy follow-up requires women to visit the hospital and see a specialised doctor or nurse for a minor procedure. Often the practitioner will be seeing the woman for the first time. The advantages of colposcopy include the possibility of a diagnostic test, with a potentially shorter time to treatment. With regards to patient perspective, some studies have shown a long-lasting negative effect on HrQOL in women following colposcopy, whereas others suggest a high satisfaction rate, due to specialist reassurance.[[8,9]] The disadvantages of colposcopy in this setting include inter-observer variability, poor cost-effectiveness, and less flexibility for appointment times.

Smear and HrHPV testing can be done in the community by a GP or nurse specialist. To the practitioner, these tests have the advantage of being objective, and they require less specialised training to administer. Triaging colposcopy visits with this preceding step, allows colposcopy with a specialist to be reserved for women who need it most. For many women, community smear and HrHPV testing offers more flexibility of appointments, which may confer a quality-of-life advantage. Disadvantages of this approach include a delay in diagnostic testing (by way of colposcopy-directed biopsy), and some women reporting a preference towards attending a specialist hospital clinic.[[10,11]]

The primary aim of this study was to determine whether a significant quality of life difference exists among women receiving treatment for CIN 2–3 who are followed up in either a hospital-based colposcopy clinic, in the community, or given a choice. The secondary aims of this study were to estimate costs for the different follow-up options.

Methods

This three-arm, parallel-group, randomised controlled trial was conducted at Christchurch Women’s Hospital between 2013 and 2015 (Trial registration: ACTRN12617000931370). Currently, there is no core outcome set (COS) that addresses the topic of measuring and comparing quality of life for women receiving treatment for CIN 2–3 with different follow-up options. Approval for this study was obtained through the New Zealand HDEC (Ref: URA/11/10/056). Potential participants were sent information about the study by mail, prior to their appointment for large loop excision of the transformation zone (LLETZ) treatment. Women aged between 18 and 70 with a new diagnosis of CIN 2–3 appropriate for LLETZ treatment and capable of giving informed consent were eligible. The exclusion criteria included those with a history of immunosuppression, cancer or associated vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN) and anal intraepithelial neoplasia (AIN), as, in New Zealand, these women would be recommended to continue regular colposcopic follow-up.

At their attendance for LLETZ treatment, consenting women were allocated to one of the three study groups by computer-generated block randomisation. Randomisation was prepared by a statistician external to the study team. A folder was arranged with patient packs identified by study number. The randomisation was concealed in the patient packs prior to enrolment. Due to the nature of the intervention, blinding of participants following enrolment was not possible. Following LLETZ, if the patient was found to have cancer or positive endocervical boundary, the gynaecologist could override the randomised follow-up: the women was allocated to the colposcopy review (group a) and the results analysed in an intention-to-treat analysis. All clinical data were collected in the clinic by treating clinicians and later transferred to an electronic database by a study team member.

All groups were followed until six-months post-treatment. The control group (group a) underwent the routine follow-up in a hospital-based colposcopy clinic. The community follow-up group (group b) had HPV and cytological testing at their GP or family planning clinic. The patient choice group (group c) was given the choice of either colposcopy or community-based follow-up.

Participants were twice asked to complete identical questionnaires, initially at enrolment and again at their six-month follow-up. The Medical Outcomes Study Short Form version 2 (SF12v2) survey was used to measure HrQOL. This uses two scores to evaluate HrQOL: mental (MCS) and physical (PCS) component scores. A higher score indicates a better health status. Participants also received questions about baseline characteristics, cost associated with visit, preferences for place of follow-up, as well as barriers and facilitators associated with each follow-up option. Follow-up attendance was measured through review of medical records. The primary outcome of the study was self-reported HrQOL measured using the SF12v2 survey at six months. Secondary outcomes included attendance to follow-up, patient preferences, and costs.

Statistical analysis

A target of 200 participants was set (at least 64 per group) allowing for loss to follow-up, which would achieve greater than 80% power to detect a difference of at least d=0.5 with {{2}}=0.05. In a previous study the effect sizes (measured as standard deviations between the means) of 0.5 were found.[[12]] This study looked at HrQOL differences in screening comparing colposcopy and HPV/smear.[[12]] Since colposcopy is more invasive, we expected that the differences in this study would be greater. Therefore, we planned the study to detect a difference of d=0.5 between arms.

For each follow-up group, the primary outcome was analysed using a one-way ANOVA test to assess for differences in mean SF12v2 scores between baseline and follow-up at six months. We obtained all SF12v2 questionnaires at baseline, and 64.0% (n=128) at six months. Using colposcopy as the control, a pairwise analysis of mean HrQOL scores from both the community and choice groups (groups b and c) was made using a t-test with a significance level of p<0.05 (Table 2). Adherence to follow-up was measured using the risk ratio, risk difference and associated 95% confidence intervals of non-attendance between different follow-up methods. Preferences of follow-up were summarised using proportions and analysed using a one-sample test for binomial proportions. Cost analysis of the groups was performed, including the costs of missed appointments, recalls, re-referrals and subsequent appointments by different means and analysed descriptively. No imputations were performed for the management of missing data—these participants were excluded from the HrQOL analysis. Patient preferences were assessed by both the analysis of the choice group responses and through the questionnaire. We used Stata version 14 (StataCorp, College Station, TX, USA) for the analyses. We estimated the costs of a colposcopy at Christchurch Women’s Hospital to be $140 per patient, and the average cost of a smear in the community as $50 in Christchurch. The total costs per group were calculated as shown in the below tables and an average cost estimated. Costs of missed appointments, recall, re-referral and subsequent appointment by different means were included in the calculation.

Figure 1: CONSORT flow diagram—participant allocation. View Figure 1.

Results

A total of 458 women at Christchurch Women’s Hospital were assessed for eligibility, of which 200 patients were enrolled in the study between 2013 and 2105. Patient characteristics for age, gravidity, parity, contraception method or smoking are shown in Table 1. The most common contraception used was the combined oral contraceptive pill (COCP) although a quarter of women used no contraception. Of the data available, a high proportion of women had not received the HPV vaccine, which may be justified by the age distribution of study participants—Gardasil only became part of the New Zealand immunisation schedule in 2009.[[13]]

Attendance to clinical follow-up was a secondary analysis (Table 3). The greatest non-attendance (of 17 patients) was observed in the community group (Figure 1), despite nine of these patients reporting community follow-up as feasible. In the colposcopy group, three patients did not receive their allocated intervention despite self-reported feasibility of follow-up allocation. Among the women not attending follow-up (“NA”), the total number was, therefore, twelve patients. In the choice group, only one patient did not attend follow-up. Our analysis showed a trend for higher rate of non-attendance among women who were assigned a follow-up option (8.9%) compared with women who chose their follow-up option (1.5%, risk difference=7%, 95% CI 2%–13%, p=.06).  

Table 1: Baseline characteristics of participants by randomised follow-up group. View Table 1.

Table 2: Comparison of health-related quality of life scores§ in follow-up groups: colposcopy versus community/choice.

Table 3: Observed frequencies of attendance to follow-up: choice versus no choice.

Assessing patient preferences for method of follow-up found 63.1% of the choice group (41/65, Figure 1) electing to have follow-up at the colposcopy clinic compared to 36.4% (24/65) who elected follow-up in the community. A one-sample test for binomial proportions suggests there may be a true difference favouring colposcopy (63.1% [95% CI 50.2–74.7]). Patient preference was also assessed in the questionnaire and showed differences over time. Those preferring the choice group increased by 5% and the community group by 4%. However, those preferring the colposcopy group decreased by 7% (Supplementary Material 2).

The average cost of the follow-up options per person was $147 for colposcopy, $88 for community and $114 for choice. This would result in savings of $59 per person if all patients were initially referred to the community and a saving of $33 if women were given the choice of follow-up.

Discussion

Health-related quality of life

We found no objective HrQOL difference associated with follow-up type in patients after LLETZ treatment for CIN 2–3. This supports the newly introduced guidelines, which recommend that clinicians offer both hospital and community options to women for post-treatment follow-up.

Attendance

Attendance at follow-up in cervical screening programmes is of paramount importance. It is well-established that women with a history of high-grade (CIN 2+) disease are at high risk of developing cervical cancer. Among women who have developed cancer following a previous abnormality, 50% have been lost to follow-up.[[9]] Factors that impact on cervical screening uptake include timing of appointments, economic factors, education/knowledge, fear/embarrassment and the gender of the smear taker. However, to date, the cervical screening literature has not identified patient choice as a factor contributing to attendance.[[15,16]] Studies in other medical fields demonstrate a “preference effect,” whereby choice itself may have an outcome advantage.[[20]] Other studies also observe a high correlation between women’s choice of management type and their attendance at follow-up.[[21]] In our study, women that were given the option of either hospital or community follow-up type (group c) had better attendance at cervical screening services (risk difference=7%, 95% CI 2%–13%, p=.06) than those given no choice of follow-up type (groups a and b). Therefore, offering a choice of follow-up type may improve women’s adherence and attendance.

Cost-effectiveness

Community follow-up was the most cost-effective but least adhered-to option. When compared to routine colposcopy, the group given a choice of follow-up (group c) had a cost benefit of $33 per patient and was associated with the highest rates of adherence.

Limitations

We acknowledge that this was a secondary analysis with the limitation of small numbers informing a potential association. Nonetheless, this highlights the importance of patient choice in medical decision-making, which is often overlooked in research and guideline development.

We acknowledge that study designs that allow participants to choose their treatment are susceptible to confounding factors. For example, a more anxious group of women at baseline may be more inclined to choose colposcopy. In order to minimise this in the analysis of the primary outcome, the choice group was analysed separately and not according to the follow-up chosen.

The potential for information bias requires consideration. For the collection of data, we considered several options. We identified four specific cervical screening questionnaires in our literature search: the Process Outcome Specific Measure (POSM) from the Trial of Management of Borderline and Other Low-Grade Abnormal Smears (TOMBOLA) group,[[17]] Psychological Effects of Abnormal Pap Smears Questionnaire (PEAPS-Q),[[18]] Cervical Dysplasia Distress Questionnaire (CDDQ)[[16]] and the HPV Impact Profile (HIP).[[19]] However, none of these have been widely used or validated. Therefore, we chose to use a generic HrQOL tool, the SF12v2, for which there is a large body of supporting evidence. As a generic assessment tool, the SF12v2 allows comparison of health status between groups, including those suffering from different diseases. Such a tool also allows analysis of a wide range of populations, ascertaining any deviations from a “healthy norm.”[[5]] As such, a broader range of comparison is possible. However, use of the SF12v2 in the context of this study may be criticised for its potential imprecision in assessing disease-specific effects.[[7]] Furthermore, since a small number of women completed the questionnaire at home with return by post, the day and location of survey completion has the potential to bias survey outcomes.

Strengths

One of the strengths of the current study lies in its randomised design and intention to treat analysis which supports the internal validity of the trial. All participants completed their clinical care, and we had no missing clinical data for baseline and follow-up. We obtained all HrQOL questionnaires at baseline, and 64.0% (n=128) at six months.

Further research

This study highlights that patient choice, where equivalent management options exist, may warrant further research due to associations with improved adherence and cost benefits. Larger studies are warranted to examine the potential effects of patient choice on follow-up type in cervical screening, and to test these findings in a wider clinical setting. A larger study involving different centres throughout New Zealand would also better represent the wider New Zealand population because choice options and the costs associated with follow-up type are likely to vary between regions. Patient choice of colposcopy or community follow-up type depends on numerous factors, such as perceived standard of care, geographical factors, financial considerations and patient experience. For example, women living in rural areas may feel more comfortable with their own general practitioner and access to colposcopy services should also not be assumed to be homogenous throughout New Zealand.

Additionally, although the importance of adherence to follow-up is well-documented in women who have had previous high-grade disease, a study with a longer follow-up period would provide more certainty of potential long-term effects.

Finally, future management and research decisions should consider costs to the patient. In New Zealand, screening services are free for patients in the hospital but not in the community. Although costs to patients were subsidised in this study, the increased personal costs associated with screening was an important issue raised by some patients and may be a major deterrent to follow-up for some women.

Conclusion

In New Zealand, guidelines for cervical screening have recently been amended to allow either colposcopic or community follow-up in the post-treatment setting, thus presenting the clinician and patient with a choice. Although it is known that patient choice can influence participation—and thus health outcome—this has not yet been explored with regards to cervical screening. We investigated whether patient choice of follow-up screening type improves HrQOL and attendance for women who have undergone LLETZ for CIN 2–3. Using a randomised control trial study design, we found no significant difference in HrQOL between three study groups of hospital follow-up, community follow-up or patience choice of follow-up type. However, attendance was greater in patients allocated to a group where they could choose their follow-up type. Larger and longer-term studies examining these potential effects are warranted.

Supplementary material

Supplementary Material 1: Comparison of health-related quality of life between groups baseline and six month (MCS and PCS scores).

Supplementary Material 2: Patient follow-up preferences.

Summary

Abstract

Aim

We investigated whether patient choice of follow-up type improves health-related quality of life (HrQOL) and follow-up attendance in women who have undergone large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia grade 2 to 3 (CIN 2–3).

Method

A three-armed randomised controlled trial including women with newly diagnosed CIN 2–3 post-LLETZ treatment was performed. Consenting women were randomised (1:1:1) to either: (a) colposcopy review at the hospital, (b) follow-up with high-risk human papilloma virus (HrHPV) and smear test in the community or (c) a choice of the aforementioned follow-up options, six months post-treatment. HrQOL was measured and participants were surveyed at baseline and six months regarding preferences for follow-up.

Results

Sixty-eight participants were randomised to follow-up (a), 67 to follow-up (b) and 65 to follow-up (c) (n=200). At six months post-treatment, 47% of patients indicated a preference for (a), 24% for (b) and 26% for (c). We found no significant difference in HrQOL between the study arms. Attendance was greater among patients who chose their follow-up (95.5% vs 91.1%, p=0.06).

Conclusion

Choice of follow-up was associated with greater attendance. However, larger studies examining the effects of HrQOL and attendance to different follow-ups are warranted.

Author Information

Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital. Jillian Lanb: RN, Colposcopy Nurse Specialist, Christchurch Women’s Hospital. Helene MacNab: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Carrie Innes: PhD, Post-doctoral Fellow, Department of Obstetrics and Gynaecology, University of Otago David Peddie: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Diane Harker: MA, RN, Department of Obstetrics and Gynaecology, University of Otago, Christchurch. Jonathan Williman: PhD MBiostat, Research Fellow, Department of Population Health, University of Otago, Christchurch. Peter Sykes: FRANZCOG, DGO, Associate Professor, Christchurch Women’s Hospital. Bryony Simcock: FRANZCOG, Gynaecologic Oncologist at Christchurch Women’s Hospital.

Acknowledgements

We would like to acknowledge the contribution of the administrative and nursing staff of the Colposcopy Department at Christchurch Women’s Hospital. Their support and assistance was instrumental to the success of the project. We would also like to thank the Gynaecology Cancer Research Trust and The Canterbury Initiative for their support.

Correspondence

Dr Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital, Private Bag 4711, Christchurch 8140, New Zealand, +41 79 8556214

Correspondence Email

katayoun.taghavi@gmail.com

Competing Interests

The authors declare grants and funding from the Gynaecology Cancer Research Trust and the Canterbury Initiative to support this manuscript.

1. Ministry of Health. Guidelines for cervical screening New Zealand. Ministry of Health New Zealand: National Screening Unit. 2020.

2. Colposcopy and Programme Management Guidelines for the NHS Cervical Screening Programme. NHS cervical screening unit. 2010

3. Wright TC J, Cox JT, Massad LS, Carlson J, Twiggs LB, Wilkinson EJ. Consensus guidelines for the management of women with cervical intraepithelial neoplasia. AJOG. 2003;189(1):295-304.

4. Lambert MF, Wood J. Incorporating patient preferences into randomized trials. Journal of clinical epidemiology. 2000;53:163-6.

5. Preference Collaborative Review G. Patients' preferences within randomised trials: systematic review and patient level meta-analysis. BMJ. 2008;337:a1864.

6. Soutter WP, Sasieni P, Panoskaltsis T. Long-term risk of invasive cervical cancer after treatment of squamous cervical intraepithelial neoplasia. International journal of cancer. 2006;118(8):2048-55.

7. Clark NM, Janz NK, Dodge JA, Schork MA, Fingerlin TE, Wheeler JR, et al. Changes in functional health status of older women with heart disease: evaluation of a program based on self-regulation. The journals of gerontology Series B, Psychological sciences and social sciences. 2000;55(2):S117-26.

8. Korfage IJ, van Ballegooijen M, Wauben B, Looman CW, Habbema JD, Essink-Bot ML. Having a Pap smear, quality of life before and after cervical screening: a questionnaire study. BJOG : an international journal of obstetrics and gynaecology. 2012;119(8):936-44.

9. Korfage IJ, Essink-Bot ML, Westenberg SM, Helmerhorst T, Habbema JD, van Ballegooijen M. How distressing is referral to colposcopy in cervical cancer screening?: a prospective quality of life study. Gynecologic oncology. 2014;132(1):142-8.

10. Orbell S, Hagger M, Brown V, Tidy J. Appraisal theory and emotional sequelae of first visit to colposcopy following an abnormal cervical screening result. British journal of health psychology. 2004;9(Pt 4):533-55.

11. Balasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Do women with high-grade cervical intraepithelial neoplasia prefer a see and treat option in colposcopy? BJOG : an international journal of obstetrics and gynaecology. 2007;114(1):39-45.

12. McCaffery KJ, Irwig L, Turner R, et al. Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trial. BMJ. 2010;340:b4491.

13. Ministry of Health New Zealand. The HPV (Human Papillomavirus) Immunisation Programme, HPV Project Team PHD. June 2008.

14. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Medical care. 1989;27(3 Suppl):S217-32.

15. van der Heijden E, Lopes AD, Bryant A, Bekkers R, Galaal K. Follow-up strategies after treatment (large loop excision of the transformation zone (LLETZ)) for cervical intraepithelial neoplasia (CIN): Impact of human papillomavirus (HPV) test. The Cochrane database of systematic reviews. 2015;1:CD010757.

16. O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L, et al. Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG : an international journal of obstetrics and gynaecology. 2016;123(1):24-38.

17. Gray NM, Sharp L, Cotton SC, Avis M, Philips Z, Russell I, et al. Developing a questionnaire to measure the psychosocial impact of an abnormal cervical smear result and its subsequent management: the TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) trial. Quality of Life Research. 2005;14(6):1553-62.

18. Bennetts A, Irwig L, Oldenburg B, Simpson JM, Mock P, Boyes A, et al. Peaps-Q - a Questionnaire to Measure the Psychosocial Effects of Having an Abnormal Pap Smear. Journal of clinical epidemiology. 1995;48(10):1235-43.

19. Shinn E, Basen-Engquist K, Le T, Hansis-Diarte A, Bostic D, Martinez-Cross J, et al. Distress after an abnormal Pap smear result: scale development and psychometric validation. Preventive medicine. 2004;39(2):404-12.

20. Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality-of-life instruments. Pharmacoeconomics. 2000;17(1):13-35.

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Both patient-centred care and evidence-based medicine are central to the practice of modern healthcare. The former is focused on individualising a patient’s care; the latter requires standardisation of care. Creating an alliance between these concepts is a major challenge for clinicians and researchers alike. For New Zealand gynaecological clinicians, adapting evidence-based information to foster a woman’s sense of being respected and able to participate in their own health decisions is critical in the evolution of cervical screening guidelines. Women who have received treatment for cervical intraepithelial neoplasia (CIN) grades 2 to 3 are a high-risk population for developing cervical cancer, particularly if they do not attend follow-up screening. Until recently, all women were recalled back to the hospital colposcopy clinic for their initial post-treatment assessment, which enabled standardisation of care. However, since 2020 the National Screening Guidelines of New Zealand have allowed either colposcopic or community follow-up in the post-treatment setting.[[1]] This new approach promotes patient-centred care, and is consistent with many international healthcare policies where, for the initial follow-up after treatment, HPV screening and cytology alone are allowed, and may also take place in either the community or hospital settings.[[2,3]]

Successful cervical screening programmes rely heavily on long-term patient participation, and studies from other fields show that participation is dependent on factors such as patient choice.[[4,5]] Allowing patients a choice of follow-up is a patient-centred approach that has potential advantages.[[5]] Despite research in other medical fields showing a positive relationship between patient choice and health outcomes, this “preference effect” is largely overlooked in the literature informing CIN screening guidelines.[[1–3]] To date, there are no studies investigating health-related quality of life (HrQOL) and patient preferences in the post-treatment setting, and there are no specific data informing the updated New Zealand screening guidelines.[[1]] Considering that the new guidelines now offer patient choice, this information may be particularly useful to practitioners offering follow-up to women who are at greater risk of developing cancer (ie, CIN 2–3 post-treatment) or becoming lost to follow-up.[[6]] Other potential advantages are improved HrQOL, decreased patient anxiety and greater adherence to the screening programme.[[4,5,7]]

Colposcopy follow-up requires women to visit the hospital and see a specialised doctor or nurse for a minor procedure. Often the practitioner will be seeing the woman for the first time. The advantages of colposcopy include the possibility of a diagnostic test, with a potentially shorter time to treatment. With regards to patient perspective, some studies have shown a long-lasting negative effect on HrQOL in women following colposcopy, whereas others suggest a high satisfaction rate, due to specialist reassurance.[[8,9]] The disadvantages of colposcopy in this setting include inter-observer variability, poor cost-effectiveness, and less flexibility for appointment times.

Smear and HrHPV testing can be done in the community by a GP or nurse specialist. To the practitioner, these tests have the advantage of being objective, and they require less specialised training to administer. Triaging colposcopy visits with this preceding step, allows colposcopy with a specialist to be reserved for women who need it most. For many women, community smear and HrHPV testing offers more flexibility of appointments, which may confer a quality-of-life advantage. Disadvantages of this approach include a delay in diagnostic testing (by way of colposcopy-directed biopsy), and some women reporting a preference towards attending a specialist hospital clinic.[[10,11]]

The primary aim of this study was to determine whether a significant quality of life difference exists among women receiving treatment for CIN 2–3 who are followed up in either a hospital-based colposcopy clinic, in the community, or given a choice. The secondary aims of this study were to estimate costs for the different follow-up options.

Methods

This three-arm, parallel-group, randomised controlled trial was conducted at Christchurch Women’s Hospital between 2013 and 2015 (Trial registration: ACTRN12617000931370). Currently, there is no core outcome set (COS) that addresses the topic of measuring and comparing quality of life for women receiving treatment for CIN 2–3 with different follow-up options. Approval for this study was obtained through the New Zealand HDEC (Ref: URA/11/10/056). Potential participants were sent information about the study by mail, prior to their appointment for large loop excision of the transformation zone (LLETZ) treatment. Women aged between 18 and 70 with a new diagnosis of CIN 2–3 appropriate for LLETZ treatment and capable of giving informed consent were eligible. The exclusion criteria included those with a history of immunosuppression, cancer or associated vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN) and anal intraepithelial neoplasia (AIN), as, in New Zealand, these women would be recommended to continue regular colposcopic follow-up.

At their attendance for LLETZ treatment, consenting women were allocated to one of the three study groups by computer-generated block randomisation. Randomisation was prepared by a statistician external to the study team. A folder was arranged with patient packs identified by study number. The randomisation was concealed in the patient packs prior to enrolment. Due to the nature of the intervention, blinding of participants following enrolment was not possible. Following LLETZ, if the patient was found to have cancer or positive endocervical boundary, the gynaecologist could override the randomised follow-up: the women was allocated to the colposcopy review (group a) and the results analysed in an intention-to-treat analysis. All clinical data were collected in the clinic by treating clinicians and later transferred to an electronic database by a study team member.

All groups were followed until six-months post-treatment. The control group (group a) underwent the routine follow-up in a hospital-based colposcopy clinic. The community follow-up group (group b) had HPV and cytological testing at their GP or family planning clinic. The patient choice group (group c) was given the choice of either colposcopy or community-based follow-up.

Participants were twice asked to complete identical questionnaires, initially at enrolment and again at their six-month follow-up. The Medical Outcomes Study Short Form version 2 (SF12v2) survey was used to measure HrQOL. This uses two scores to evaluate HrQOL: mental (MCS) and physical (PCS) component scores. A higher score indicates a better health status. Participants also received questions about baseline characteristics, cost associated with visit, preferences for place of follow-up, as well as barriers and facilitators associated with each follow-up option. Follow-up attendance was measured through review of medical records. The primary outcome of the study was self-reported HrQOL measured using the SF12v2 survey at six months. Secondary outcomes included attendance to follow-up, patient preferences, and costs.

Statistical analysis

A target of 200 participants was set (at least 64 per group) allowing for loss to follow-up, which would achieve greater than 80% power to detect a difference of at least d=0.5 with {{2}}=0.05. In a previous study the effect sizes (measured as standard deviations between the means) of 0.5 were found.[[12]] This study looked at HrQOL differences in screening comparing colposcopy and HPV/smear.[[12]] Since colposcopy is more invasive, we expected that the differences in this study would be greater. Therefore, we planned the study to detect a difference of d=0.5 between arms.

For each follow-up group, the primary outcome was analysed using a one-way ANOVA test to assess for differences in mean SF12v2 scores between baseline and follow-up at six months. We obtained all SF12v2 questionnaires at baseline, and 64.0% (n=128) at six months. Using colposcopy as the control, a pairwise analysis of mean HrQOL scores from both the community and choice groups (groups b and c) was made using a t-test with a significance level of p<0.05 (Table 2). Adherence to follow-up was measured using the risk ratio, risk difference and associated 95% confidence intervals of non-attendance between different follow-up methods. Preferences of follow-up were summarised using proportions and analysed using a one-sample test for binomial proportions. Cost analysis of the groups was performed, including the costs of missed appointments, recalls, re-referrals and subsequent appointments by different means and analysed descriptively. No imputations were performed for the management of missing data—these participants were excluded from the HrQOL analysis. Patient preferences were assessed by both the analysis of the choice group responses and through the questionnaire. We used Stata version 14 (StataCorp, College Station, TX, USA) for the analyses. We estimated the costs of a colposcopy at Christchurch Women’s Hospital to be $140 per patient, and the average cost of a smear in the community as $50 in Christchurch. The total costs per group were calculated as shown in the below tables and an average cost estimated. Costs of missed appointments, recall, re-referral and subsequent appointment by different means were included in the calculation.

Figure 1: CONSORT flow diagram—participant allocation. View Figure 1.

Results

A total of 458 women at Christchurch Women’s Hospital were assessed for eligibility, of which 200 patients were enrolled in the study between 2013 and 2105. Patient characteristics for age, gravidity, parity, contraception method or smoking are shown in Table 1. The most common contraception used was the combined oral contraceptive pill (COCP) although a quarter of women used no contraception. Of the data available, a high proportion of women had not received the HPV vaccine, which may be justified by the age distribution of study participants—Gardasil only became part of the New Zealand immunisation schedule in 2009.[[13]]

Attendance to clinical follow-up was a secondary analysis (Table 3). The greatest non-attendance (of 17 patients) was observed in the community group (Figure 1), despite nine of these patients reporting community follow-up as feasible. In the colposcopy group, three patients did not receive their allocated intervention despite self-reported feasibility of follow-up allocation. Among the women not attending follow-up (“NA”), the total number was, therefore, twelve patients. In the choice group, only one patient did not attend follow-up. Our analysis showed a trend for higher rate of non-attendance among women who were assigned a follow-up option (8.9%) compared with women who chose their follow-up option (1.5%, risk difference=7%, 95% CI 2%–13%, p=.06).  

Table 1: Baseline characteristics of participants by randomised follow-up group. View Table 1.

Table 2: Comparison of health-related quality of life scores§ in follow-up groups: colposcopy versus community/choice.

Table 3: Observed frequencies of attendance to follow-up: choice versus no choice.

Assessing patient preferences for method of follow-up found 63.1% of the choice group (41/65, Figure 1) electing to have follow-up at the colposcopy clinic compared to 36.4% (24/65) who elected follow-up in the community. A one-sample test for binomial proportions suggests there may be a true difference favouring colposcopy (63.1% [95% CI 50.2–74.7]). Patient preference was also assessed in the questionnaire and showed differences over time. Those preferring the choice group increased by 5% and the community group by 4%. However, those preferring the colposcopy group decreased by 7% (Supplementary Material 2).

The average cost of the follow-up options per person was $147 for colposcopy, $88 for community and $114 for choice. This would result in savings of $59 per person if all patients were initially referred to the community and a saving of $33 if women were given the choice of follow-up.

Discussion

Health-related quality of life

We found no objective HrQOL difference associated with follow-up type in patients after LLETZ treatment for CIN 2–3. This supports the newly introduced guidelines, which recommend that clinicians offer both hospital and community options to women for post-treatment follow-up.

Attendance

Attendance at follow-up in cervical screening programmes is of paramount importance. It is well-established that women with a history of high-grade (CIN 2+) disease are at high risk of developing cervical cancer. Among women who have developed cancer following a previous abnormality, 50% have been lost to follow-up.[[9]] Factors that impact on cervical screening uptake include timing of appointments, economic factors, education/knowledge, fear/embarrassment and the gender of the smear taker. However, to date, the cervical screening literature has not identified patient choice as a factor contributing to attendance.[[15,16]] Studies in other medical fields demonstrate a “preference effect,” whereby choice itself may have an outcome advantage.[[20]] Other studies also observe a high correlation between women’s choice of management type and their attendance at follow-up.[[21]] In our study, women that were given the option of either hospital or community follow-up type (group c) had better attendance at cervical screening services (risk difference=7%, 95% CI 2%–13%, p=.06) than those given no choice of follow-up type (groups a and b). Therefore, offering a choice of follow-up type may improve women’s adherence and attendance.

Cost-effectiveness

Community follow-up was the most cost-effective but least adhered-to option. When compared to routine colposcopy, the group given a choice of follow-up (group c) had a cost benefit of $33 per patient and was associated with the highest rates of adherence.

Limitations

We acknowledge that this was a secondary analysis with the limitation of small numbers informing a potential association. Nonetheless, this highlights the importance of patient choice in medical decision-making, which is often overlooked in research and guideline development.

We acknowledge that study designs that allow participants to choose their treatment are susceptible to confounding factors. For example, a more anxious group of women at baseline may be more inclined to choose colposcopy. In order to minimise this in the analysis of the primary outcome, the choice group was analysed separately and not according to the follow-up chosen.

The potential for information bias requires consideration. For the collection of data, we considered several options. We identified four specific cervical screening questionnaires in our literature search: the Process Outcome Specific Measure (POSM) from the Trial of Management of Borderline and Other Low-Grade Abnormal Smears (TOMBOLA) group,[[17]] Psychological Effects of Abnormal Pap Smears Questionnaire (PEAPS-Q),[[18]] Cervical Dysplasia Distress Questionnaire (CDDQ)[[16]] and the HPV Impact Profile (HIP).[[19]] However, none of these have been widely used or validated. Therefore, we chose to use a generic HrQOL tool, the SF12v2, for which there is a large body of supporting evidence. As a generic assessment tool, the SF12v2 allows comparison of health status between groups, including those suffering from different diseases. Such a tool also allows analysis of a wide range of populations, ascertaining any deviations from a “healthy norm.”[[5]] As such, a broader range of comparison is possible. However, use of the SF12v2 in the context of this study may be criticised for its potential imprecision in assessing disease-specific effects.[[7]] Furthermore, since a small number of women completed the questionnaire at home with return by post, the day and location of survey completion has the potential to bias survey outcomes.

Strengths

One of the strengths of the current study lies in its randomised design and intention to treat analysis which supports the internal validity of the trial. All participants completed their clinical care, and we had no missing clinical data for baseline and follow-up. We obtained all HrQOL questionnaires at baseline, and 64.0% (n=128) at six months.

Further research

This study highlights that patient choice, where equivalent management options exist, may warrant further research due to associations with improved adherence and cost benefits. Larger studies are warranted to examine the potential effects of patient choice on follow-up type in cervical screening, and to test these findings in a wider clinical setting. A larger study involving different centres throughout New Zealand would also better represent the wider New Zealand population because choice options and the costs associated with follow-up type are likely to vary between regions. Patient choice of colposcopy or community follow-up type depends on numerous factors, such as perceived standard of care, geographical factors, financial considerations and patient experience. For example, women living in rural areas may feel more comfortable with their own general practitioner and access to colposcopy services should also not be assumed to be homogenous throughout New Zealand.

Additionally, although the importance of adherence to follow-up is well-documented in women who have had previous high-grade disease, a study with a longer follow-up period would provide more certainty of potential long-term effects.

Finally, future management and research decisions should consider costs to the patient. In New Zealand, screening services are free for patients in the hospital but not in the community. Although costs to patients were subsidised in this study, the increased personal costs associated with screening was an important issue raised by some patients and may be a major deterrent to follow-up for some women.

Conclusion

In New Zealand, guidelines for cervical screening have recently been amended to allow either colposcopic or community follow-up in the post-treatment setting, thus presenting the clinician and patient with a choice. Although it is known that patient choice can influence participation—and thus health outcome—this has not yet been explored with regards to cervical screening. We investigated whether patient choice of follow-up screening type improves HrQOL and attendance for women who have undergone LLETZ for CIN 2–3. Using a randomised control trial study design, we found no significant difference in HrQOL between three study groups of hospital follow-up, community follow-up or patience choice of follow-up type. However, attendance was greater in patients allocated to a group where they could choose their follow-up type. Larger and longer-term studies examining these potential effects are warranted.

Supplementary material

Supplementary Material 1: Comparison of health-related quality of life between groups baseline and six month (MCS and PCS scores).

Supplementary Material 2: Patient follow-up preferences.

Summary

Abstract

Aim

We investigated whether patient choice of follow-up type improves health-related quality of life (HrQOL) and follow-up attendance in women who have undergone large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia grade 2 to 3 (CIN 2–3).

Method

A three-armed randomised controlled trial including women with newly diagnosed CIN 2–3 post-LLETZ treatment was performed. Consenting women were randomised (1:1:1) to either: (a) colposcopy review at the hospital, (b) follow-up with high-risk human papilloma virus (HrHPV) and smear test in the community or (c) a choice of the aforementioned follow-up options, six months post-treatment. HrQOL was measured and participants were surveyed at baseline and six months regarding preferences for follow-up.

Results

Sixty-eight participants were randomised to follow-up (a), 67 to follow-up (b) and 65 to follow-up (c) (n=200). At six months post-treatment, 47% of patients indicated a preference for (a), 24% for (b) and 26% for (c). We found no significant difference in HrQOL between the study arms. Attendance was greater among patients who chose their follow-up (95.5% vs 91.1%, p=0.06).

Conclusion

Choice of follow-up was associated with greater attendance. However, larger studies examining the effects of HrQOL and attendance to different follow-ups are warranted.

Author Information

Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital. Jillian Lanb: RN, Colposcopy Nurse Specialist, Christchurch Women’s Hospital. Helene MacNab: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Carrie Innes: PhD, Post-doctoral Fellow, Department of Obstetrics and Gynaecology, University of Otago David Peddie: FRANZCOG, Gynaecologist, Christchurch Women’s Hospital. Diane Harker: MA, RN, Department of Obstetrics and Gynaecology, University of Otago, Christchurch. Jonathan Williman: PhD MBiostat, Research Fellow, Department of Population Health, University of Otago, Christchurch. Peter Sykes: FRANZCOG, DGO, Associate Professor, Christchurch Women’s Hospital. Bryony Simcock: FRANZCOG, Gynaecologic Oncologist at Christchurch Women’s Hospital.

Acknowledgements

We would like to acknowledge the contribution of the administrative and nursing staff of the Colposcopy Department at Christchurch Women’s Hospital. Their support and assistance was instrumental to the success of the project. We would also like to thank the Gynaecology Cancer Research Trust and The Canterbury Initiative for their support.

Correspondence

Dr Katayoun Taghavi: FRANZCOG, Registrar in Obstetrics and Gynaecology Christchurch Women’s Hospital, Private Bag 4711, Christchurch 8140, New Zealand, +41 79 8556214

Correspondence Email

katayoun.taghavi@gmail.com

Competing Interests

The authors declare grants and funding from the Gynaecology Cancer Research Trust and the Canterbury Initiative to support this manuscript.

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