Title: Better assessment of patient reported outcome measures in cardiac catheter ablation
Funder: Barts Charity

Abstract: Key Aim To determine whether more frequent measurement of patient reported outcome measures (PROMs) ? specifically health related quality of life (HRQL) ? can improve the evaluation of the effectiveness and cost-effectiveness of interventions used in cardiology. For the specific purpose of this pilot study, we will focus on catheter ablation of ventricular tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD). Background Randomised clinical trials (RCTs) in cardiology have been criticised for failing to include PROMs, with a call for action from the European Society of Cardiology (ESC) in 2014 proposing their mandatory integration into all future trials. This is critical for cost effectiveness analyses and formation of NICE guidance. In the field of cardiac electrophysiology, catheter ablation has become established as an intervention used to treat many cardiac arrhythmias. The evidence to date supports reductions in arrhythmic events for VT ablation but not overall mortality. Contribution to improvements in healthcare provision Our study hypothesis contends that more frequent measurement of patient HRQL will help better capture the true benefits of ablation. Patients who have VT often experience clinical events regardless of either VT ablation or medical therapy treatment strategy. These events may affect their health status quite dramatically. Hence, this intervention clearly illustrates the more general concern that studies often miss the changes in health status by measuring HRQL irregularly. This also has the potential to change the current consent process for patients of the future, moving away from presenting interventions and operations only in terms of risks and likely clinical outcomes, but also in terms of patient reported outcomes and impact on quality of life. In the UK, cost-effectiveness analyses (CEAs) are used to help inform decisions regarding which treatments the NHS should fund. Patient-reported HRQL is a central component of such CEAs. However, a previous systematic review showed only 16% of RCTs in cardiology featured them. Our own work due to be presented at the ESC Congress in 2019 has highlighted how brittle patient HRQL can be in patients with an ICD undergoing VT ablation, a particularly disabling arrhythmia. Data from RCTs support a reduction in VT events and decreased admissions to hospitals, though no difference in mortality. It is concerning that from a patient?s perspective, these trials have measured readmissions with great diligence but often failed to make the final step in actually asking those patients who were readmitted how they were affected by such circumstances. By sampling HRQL more frequently, we could potentially detect a more meaningful difference in quality of life for patients undergoing VT ablation and thus improve the evaluation of the relative effectiveness and cost-effectiveness of this intervention. Methods Design: Prospective cohort study Intended sample size: Aim of 140 patients [70 undergoing VT ablation and 70 matched controls]. Based on annual caseload of VT ablation and an attrition rate of 30%. This sample size compares favourably to other pilot studies. Duration of study: 18 months Treatment group: Patients who receive catheter ablation of VT Control group: Patients who receive AAD therapy for their VT Measurement: Assessment of HRQL using a standardised questionnaire (EQ-5D) at months 0 (baseline), 1, 2, 3, 4, 6, 9, 12. This will be administered via paper initially with further assessment of electronic capture in a sub-study. The selection of 8 points of HRQL assessment (vs. 2 in most RCTs) is a compromise between feasibility and minimising bias due to repeated sampling. Data storage and analysis: Questionnaires will be held securely in the research unit. Calculation of the QALY and analysis using an increasing number of data points of HRQL inputs to see the overall effect on the QALY. Benefit to organisation This study would be the first in the literature to examine the effect of frequency of sampling of HRQL. The preliminary data generated will subsequently be used to support a larger application to a major funding body. The output of the study will place Barts Health NHS Trust and Barts Charity at the head of a body of research that is truly patient-centred, with scope to influence policy decisions by NICE on a national level. The main PI, Dr. Yang Chen, graduated from Oxford University in 2013. He has considerable experience in publications (n=15) and is supported by a prestigious NIHR academic clinical fellowship and a scholarship from the ESC to study a part-time MSc in Health Economics (2018-2020) that is directly relevant to the study idea. He intends to pursue a career in academia with a focus on health economics and decision-making with patients at the heart of a future PhD. He led a patient focus day in March, with the study receiving unanimous support from the 9 patients in attendance. Lay summary A patient-centred approach involves providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensures that patient values guide all clinical decisions. This approach should also guide decisions about which treatments are funded by the NHS. Cardiology uses many costly technologies and devices and not enough work has been done to assess their affordability. The measurement of patient-reported health related quality of life (HRQL) is crucial in determining whether a treatment is good value for taxpayers money. HRQL is measured using questionnaires that patients complete in their own time, with questions including level of pain, functionality and emotional and physical wellbeing. Many studies in cardiology do not measure HRQL, and even when they do, they do so infrequently. This has the risk of missing out the true health benefits that patients experience when undergoing an intervention, particularly in areas such as reducing symptoms and readmissions to hospital. We intend to conduct a study in patients with severe heart failure who have ventricular tachycardia (VT) - a life-threatening and disabling arrhythmia. We wish to examine whether increased assessment of HRQL in patients undergoing either medical therapy or VT ablation can better capture the relative merits of each treatment and thus affect the calculation of both effectiveness and cost-effectiveness of such treatments.


Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CARDIOVASCULAR