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

Abstract

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 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 and Joe Kai 5 on behalf of the ECLIPSE Collaborative Group This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was funded by the HTA programme as project number 02/06/02. The contractual start date was in November 2004. The draft report began editorial review in February 2015 and was accepted for publication in May 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publicati...

Factors predicting self-reported medication low adherence in a large sample of adults in the US general population: a cross-sectional study

“…It has been widely used in adherence research for multiple disease states and medications across numerous countries. [14][15][16][17] In this study, the MMAS-8 was used to assess for self-reported low adherence in general and was not grounded in any specific conditions or medications. MMAS-8 scores can range from 0 to 8 with low adherence defined as a score <6, medium adherence as scores of 6 or 7 and high adherence with a score of 8.…”

Expanding Access to a New, More Affordable Levonorgestrel Intrauterine System in Kenya: Service Delivery Costs Compared With Other Contraceptive Methods and Perspectives of Key Opinion Leaders

“…Additional cost–benefit analyses of the LNG IUS conducted in Kenya and other developing countries are needed to compare the use of the product with other therapeutic interventions, including for treatment of heavy menstrual bleeding. 28 - 30 …”

New developments in intrauterine device use: focus on the US

“… 98 A more recent 5-year comparative trial (ECLIPSE), which compared LNG-IUS with usual medical therapies, found that at 2 years women’s assessments of their bleeding was better with the LNG-IUS, but at 5 years, no difference was detected. 99 As a result of its impact on having heavy menstrual bleeding, this LNG-IUS is also helpful in treating women with menstrually related iron deficiency anemia. 100 …”