Details of HTA project
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Secondary Research (e.g. systematic review) |
Project title: |
Effectiveness and cost effectiveness of hysterectomy, microwave endometrial ablation and thermal balloon ablation for the treatment of menorrhagia |
 Outputs in journals arising from this project
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Project ref: |
05/45/02 |
Cost: |
£329,532 |
Chief Investigator : |
Professor Siladitya Bhattacharya, Professor of Reproductive Medicine, School of Medicine and Dentistry, University of Aberdeen |
Start Date: |
September 2007 |
Estimated date of publication in HTA journal series: |
February 2011. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
Heavy menstrual bleeding is a common problem in women of child bearing age. Long term medical treatment is unsuccessful or unacceptable in many and surgery is required. Over the last decade a number of conservative alternatives to hysterectomy have been developed and evaluated. Current guidelines now recommend their use before proceeding to hysterectomy which is a more invasive treatment with a higher risk of complications. Two common techniques of endometrial ablation in use are microwave endometrial ablation (MEA) and thermal balloon ablation (TBA). We believe that a trial comparing these three treatments would be difficult to execute and instead propose to evaluate the clinical and cost effectiveness of hysterectomy, MEA and TBA by means of analysis of the considerable body of existing literature (including randomised trials). We also plan to use a large national dataset to investigate the long term outcomes of these treatments. Analytical models of clinical effectiveness and cost effectiveness based on these will be used to define a treatment pathway for women with heavy menstrual bleeding which combines maximum efficiency with minimum risk. The output from this project will inform the devlopment of a clinical algorithm for the treatment of menorrhagia with the help of clinical and consumer representatives. As no patients are directly involved in this research, the ethical issues are those relating to the use of already collected data for a new purpose. This will be addressed by obtaining the necessary approvals and ensuring that all data are anonymised. This research brings together a team from a number of UK and overseas centres, including clinicians, epidemiologists, statisticians, health economists and lay representatives with expertise in a number of areas of Health Services Research. These include systematic reviews of trial data, analysis of large datasets and development of clinical and cost effectiveness models. In addition, the collaborators have access to large national databases. In line with Research Council guidance, the proposal has been subjected to full economic costing. In addition to research expenses, the support requested reflects the costs of travel as well as access to datasets from national registers and individual randomised trials. |
Project Abstract: |
PRIMARY RESEARCH DESIGN: The clinical effectiveness element of this project will be conducted using analysis of existing data from two sources: (1) Anonymised pooled data record linkage of relevant national datasets and randomised cohorts in Scotland, (2) Individual patient data (IPD) meta-analysis of existing randomised controlled trials. The output from these two analyses will be used to inform the development of cost effectiveness models incorporating UK based cost data. SETTING: Analysis of existing data from the Scottish national clinical database and existing randomised controlled trials both from UK and elsewhere. TARGET POPULATION: Women with heavy menstrual bleeding who have not responded to or do not wish medical treatment. HEALTH TECHNOLOGIES: Second-generation ablative techniques (microwave endometrial ablation and thermal balloon ablation) and hysterectomy. MEASUREMENT OF COSTS AND OUTCOMES: (1) Using pooled anonymised data from the Information and Statistics Division -( ISD) Scotland, the analyses will determine the characteristics of women which predict the likelihood of long term treatment failure with endometrial ablation. (2) Using individual patient data meta-analysis of relevant RCTs the likelihood of treatment success will be determined. This second analysis has the advantage of detailed information relating to predictive characteristics of the women and the opportunity to perform subgroup analyses. Thus the PRIMARY CLINICAL OUTCOMES of interest are: 1) treatment failure as demonstrated by the need to undergo a subsequent ablation or a hysterectomy, 2) complications - early and late. THE COSTS AND ECONOMIC OUTCOMES : The economic evaluation will take the form of a cost effectiveness analysis within a decision analytic framework based on an outcome of cost per woman successfully treated and hysterectomy avoided. If quality of life data are available then the economic evaluation will present results in terms of cost per QALY. The model will be populated using data derived from the analysis of national registers and existing randomised controlled trials (as above). Resource use will be estimated from the existing published evidence and additional costs data will be sought from other sources such as the national schedule for reference costs. ALGORITHM GENERATION: These results will be used to develop a parsimonious algorithm to guide clinical decision making regarding the appropriate choice of first line surgical treatment for women with menorhagia. SAMPLE SIZE: From the Scottish Information and Statistics Division (1990-2004) alone, we envisage assembling a cohort of at least 13,000 women post-ablation and 40,000 post-hysterectomy. With a dataset of 13,000 ablations, the two-sided 95% confidence interval around an estimated prevalence of re-treatment of 25% would be (24.3%, 25.7%). In addition, we anticipate that we can access IPD on 90% of 1,600 women randomised to alternative ablation techniques and 400 randomised to hysterectomy versus ablation. PROJECT TIMETABLE: An 18 month project is envisaged: (1) Aggregation and cleaning of national cohort dataset and IPD data aggregation; identification of cost data (months 1-6); (2) Analysis of cohort data and IPD meta-analysis (months 7-12); (3) Cost-effectiveness modelling (months 12-16); (4) Final algorithm development and report writing (months 17-18). |
NRR* number, if applicable: |
N0484196287 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
Project Protocol: |
Project protocol (pdf format, 256 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1616 |
Outputs from this project
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