Janesh K. Gupta
A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial
Gupta, Janesh K.; Daniels, Jane P.; Middleton, Lee J.; Pattison, Helen M.; Prileszky, Gail; Roberts, Tracy E.; Sanghera, Sabina; Barton, Pelham; Gray, Richard; Kai, Joe
Jane P. Daniels
Lee J. Middleton
Helen M. Pattison
Tracy E. Roberts
Professor JOE KAI email@example.com
Professor of Primary Care
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; p
|Journal Article Type||Article|
|Publication Date||Oct 1, 2015|
|Journal||Health Technology Assessment|
|Publisher||NIHR Journals Library|
|Peer Reviewed||Peer Reviewed|
|APA6 Citation||Gupta, J. K., Daniels, J. P., Middleton, L. J., Pattison, H. M., Prileszky, G., Roberts, T. E., …Kai, J. (2015). A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial. Health Technology Assessment, 19(88), https://doi.org/10.3310/hta19880|
|Keywords||Clinical Effectiveness; Cost-Effectiveness; levonorgestrel-releasing intrauterine system; Menorrhagia; Randomised Controlled Trial; ECLIPSE trial; Primary Care|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf|
Gupta Health Tech Assess 2015.pdf
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf
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