Title: Economic evaluation feasibility study: A randomised controlled trial comparing treatment of only the blocked (heart attack-causing) artery to treatment of the blocked and other significantly narrowed arteries.
Funder: Department of Health (England)

Abstract: Background There is uncertainty with regard to the best management (in terms of clinical and cost-effectiveness) of people who have had a heart attack and present with multiple narrowed arteries. Some patients currently have significantly narrowed arteries treated, as well as the blocked (heart attack-causing) artery, while others only have the blocked artery treated during the initial hospital admission. Given this uncertainty as to which of these two options is most appropriate, it would be timely to estimate the costs and benefits associated with each option to assess which is most cost-effective. A pilot trial [2] comparing these two treatment options has recently started and here we request funding to conduct a feasibility cost-effectiveness analysis alongside this study. Conducting such a study is consistent with MRC Guidance that recommends pilot studies be undertaken to address uncertainties in study design, and that argues that the inclusion of an economic evaluation will make evaluation results more useful for decision makers [3]. Aims 1. To monitor levels of resource use and quality of life, for two different treatment options, with a view to inform the decision as to how costs and benefits would be measured as part of a future more definitive study. 2. To undertake a preliminary cost-effectiveness analysis to assess which of the two treatment options would represent best value for money for provision by the UK National Health Service. The level of uncertainty associated with this decision will also be estimated. The treatment options to be compared are for people who have had a heart attack and present with multiple narrowed arteries. One group will have the blocked (heart attack-causing) artery, plus any other significantly narrowed artery, treated within the same hospital admission. Those receiving the second treatment option will only have the blocked artery treated (other narrowing arteries may be treated post-discharge, depending upon symptoms). Plan of investigation This will be a feasibility economic evaluation study for people who have had a heart attack and present with multiple narrowed arteries. Patients will be randomly allocated to one of the two aforementioned treatment options and information on resource use and quality of life will be collected for each patient for the 12 month follow-up period. We propose to recruit 250 patients across four centres, which will take an estimated 12 months. This will firstly enable us to assess whether, and how, the methods used to collect this data should be modified within a larger more definitive study. Secondly, we will also use the collected resource use and quality of life data to estimate the costs and benefits associated with the two treatment options. This will enable a preliminary cost effectiveness analysis to be conducted to estimate which option provides the best value for money and the level of uncertainty associated with that decision. Potential benefits to patients and the NHS This study can be added onto a trial which has already been funded and started (enhancing the value of the trial), and as such it can provide information for a relatively low cost. The information will be used to inform the decision as to how cost and benefit data can be collected in a larger more definitive study, ensuring such a study will be appropriately designed, deliver it’s proposed aims and does not waste valuable research money. A preliminary cost-effectiveness analysis, from this study, and a more definitive one in any subsequent study, will seek to estimate which treatment option provides the greatest benefit for a given cost. Thus, aiming to ensure that scarce NHS resources are used efficiently and provide the greatest possible benefit to patients.


Research activity codes: 6.4 SURGERY
Health categories: CARDIOVASCULAR