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      The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost‐effectiveness analysis

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          Abstract

          Objective

          To evaluate the costs and non‐inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG‐IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB).

          Design

          Cost‐effectiveness analysis from a societal perspective alongside a multicentre randomised non‐inferiority trial.

          Setting

          General practices and gynaecology departments in the Netherlands.

          Population

          In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child.

          Methods

          Randomisation to a strategy starting with the LNG‐IUS ( n = 132) or EA ( n = 138). The incremental cost‐effectiveness ratio was estimated.

          Main outcome measures

          Direct medical costs and (in)direct non‐medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)‐score (non‐inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC‐score ≤75 points).

          Results

          Total costs per patient were €2,285 in the LNG‐IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC‐scores were 64.8 in the LNG‐IUS group ( n = 115) and 14.2 in the EA group ( n = 132); difference 50.5 points (95% CI 4.3–96.7). In the LNG‐IUS group, 87% of women had a PBAC‐score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85–1.01). The ICER was €23 (95% CI €5–111) per PBAC‐point.

          Conclusions

          A strategy starting with the LNG‐IUS was cheaper than starting with EA, but non‐inferiority could not be demonstrated. The LNG‐IUS is reversible and less invasive and can be a cost‐effective treatment option, depending on the success rate women are willing to accept.

          Tweetable abstract

          Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation.

          Tweetable abstract

          Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation.

          Related collections

          Most cited references42

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          The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

          A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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            The estimation of a preference-based measure of health from the SF-36.

            This paper reports on the findings of a study to derive a preference-based measure of health from the SF-36 for use in economic evaluation. The SF-36 was revised into a six-dimensional health state classification called the SF-6D. A sample of 249 states defined by the SF-6D have been valued by a representative sample of 611 members of the UK general population, using standard gamble. Models are estimated for predicting health state valuations for all 18,000 states defined by the SF-6D. The econometric modelling had to cope with the hierarchical nature of the data and its skewed distribution. The recommended models have produced significant coefficients for levels of the SF-6D, which are robust across model specification. However, there are concerns with some inconsistent estimates and over prediction of the value of the poorest health states. These problems must be weighed against the rich descriptive ability of the SF-6D, and the potential application of these models to existing and future SF-36 data set.
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              Assessment of menstrual blood loss using a pictorial chart.

              Objective menstrual blood loss measurements (in ml) were compared with the score obtained from a pictorial blood loss assessment chart (PBAC) which took into account the degree to which each item of sanitary protection was soiled with blood as well as the total number of pads or tampons used. Twenty eight women used the chart during 55 menstrual cycles and a single observer assessed 122 cycle collections in a similar manner. A pictorial chart score of 100 or more, when used as a diagnostic test for menorrhagia, was found to have a specificity and sensitivity of greater than 80%. Demonstration of the relation between self assessed pictorial chart scores and the objective measurement of blood loss enables us to provide a simple, cheap and reasonably accurate method of assessing blood loss before embarking upon treatment.
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                Author and article information

                Contributors
                M.J.van.den.Brink@umcg.nl
                Journal
                BJOG
                BJOG
                10.1111/(ISSN)1471-0528
                BJO
                Bjog
                John Wiley and Sons Inc. (Hoboken )
                1470-0328
                1471-0528
                27 July 2021
                November 2021
                : 128
                : 12 ( doiID: 10.1111/bjo.v128.12 )
                : 2003-2011
                Affiliations
                [ 1 ] Department of General Practice and Elderly Care Medicine University of Groningen University Medical Centre Groningen Groningen The Netherlands
                [ 2 ] Department of General Practice University of Maastricht Maastricht University Medical Centre Maastricht The Netherlands
                [ 3 ] Department of Obstetrics and Gynaecology Máxima Medical Centre Veldhoven The Netherlands
                [ 4 ] Department of Epidemiology University of Groningen University Medical Centre Groningen Groningen The Netherlands
                [ 5 ] Department of Obstetrics and Gynaecology Grow Research School for Oncology and Developmental Biology University of Maastricht Maastricht The Netherlands
                Author notes
                [*] [* ] Correspondence: MJ van den Brink, Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, PO Box 196, 9700 AD Groningen, The Netherlands. Email: M.J.van.den.Brink@ 123456umcg.nl

                [*]

                M.J. van den Brink and P. Beelen contributed equally to this paper.

                Author information
                https://orcid.org/0000-0001-9805-5015
                Article
                BJO16836
                10.1111/1471-0528.16836
                8518490
                34245652
                34107a51-2d11-4acc-8265-3d8ca94b1160
                © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 22 March 2021
                Page count
                Figures: 1, Tables: 3, Pages: 9, Words: 6485
                Funding
                Funded by: ZonMw
                Award ID: 171202001
                Categories
                Research Article
                Research Articles
                Health Economics
                Custom metadata
                2.0
                November 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.8 mode:remove_FC converted:15.10.2021

                Obstetrics & Gynecology
                cost‐effective analysis,economic evaluation,excessive uterine bleeding,intrauterine device,menorrhagia,menstruation,mirena,noninferiority trial,novasure

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