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Janesh K Gupta 1,2, Jane P Daniels 3,*, Lee J Middleton 3, Helen M Pattison 4, Gail Prileszky 5, Tracy E Roberts 6, Sabina Sanghera 6, Pelham Barton 6, Richard Gray 7, Joe Kai 5,

1 School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK
2 Birmingham Women’s Hospital NHS Foundation Trust, Edgbaston, Birmingham, UK
3 Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
4 School of Health and Life Sciences, Aston University, Birmingham, UK
5 Division of Primary Care, University of Nottingham, Nottingham, UK
6 Health Economics Unit, University of Birmingham, Birmingham, UK
7 Clinical Trials Service Unit, University of Oxford, Oxford, UK
* Corresponding author Email: j.p.daniels@bham.ac.uk

{{metadata.Journal}} Volume: {{metadata.Volume}}, Issue:{{metadata.Issue}}, Published in {{metadata.PublicationDate | date:'MMMM yyyy'}}

https://dx.doi.org/{{metadata.DOI}}

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The full text of this issue is available as a PDF document from the Toolkit section on this page.

The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.

OBJECTIVES

To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women's perspectives on treatment.

DESIGN

A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.

SETTING

Women who presented in primary care.

PARTICIPANTS

A total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment.

INTERVENTIONS

LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.

OUTCOME MEASURES

The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost-utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses.

RESULTS

The MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points; pâ <â 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI -0.6 to 8.3 points; pâ =â 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women's experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments.

CONCLUSIONS

The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86566246.

FUNDING

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information.

Abstract

BACKGROUND

Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.

OBJECTIVES

To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women's perspectives on treatment.

DESIGN

A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.

SETTING

Women who presented in primary care.

PARTICIPANTS

A total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment.

INTERVENTIONS

LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.

OUTCOME MEASURES

The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost-utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses.

RESULTS

The MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points; pâ <â 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI -0.6 to 8.3 points; pâ =â 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women's experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments.

CONCLUSIONS

The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86566246.

FUNDING

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information.

If you would like to receive a notification when this project publishes in the NIHR Journals Library, please submit your email address below.

 

Responses to this report

 

Response by Paul Kind on 2 February 2017 at 3:19 PM
Unacceptable practice?
An account is given of the methods used to estimate utility weights for QALY computation. As stated the text reads: Utility values for the individual states were calculated by averaging the EQ-5D and SF-6D values obtained by each woman in the given state at any given. This is completely lacking in any sustainable methodology. EQ-5D weights are generated using TIme Trace-Off (TTO) and SF-6D weights are generated using Standard Gamble. TTO utility weights and SG weights are systematically different (even NICE Guidance recognises this widely accepted fact). It is not possible to convert TTO weights into SG weights since the relationship between the two systems is unknown. The arithmetic aggregation of two numeric values from wholly different metrics defies credibility - would anyone take the average of a height expressed in terms of cms and inches? There must have been a reason behind this heroic assumption that the two utility weights should be aggregated in this way. That in turn suggests that the researchers were aware of differences that might emerge if the two systems were applied independently. It is imperative that a proper account is given of the justification for the current practice. Without such an explanation the entire economic evaluation risks being little short of meaningless.

Response by Tracy Roberts on 2 February 2017 at 10:42 AM
Response by author

The sentence quoted is at the start of the second paragraph under the heading “Quality-of-life measures”. We agree that, taken in isolation, the sentence quoted could be interpreted in the way the commenter says. However, it should be clear from the rest of the chapter that what we actually did was carry out completely separate analysis first using EQ-5D values only and secondly using SF-6D values only. For example, at the beginning of the Results section we said “The results of the base-case analysis and sensitivity analyses are presented in two parts. Part 1 depicts the results using the EQ-5D for the outcome at 2 years and 5 years. Part 2 shows the results using the SF-6D for 2 years and 5 years.” In the sentence quoted, we should perhaps have said “averaging the EQ-5D or SF-6D values” as we did in the sentence immediately before the one quoted.

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