Improving patient reported outcome measures in catheter ablation v1.1

• Research type

  Research Study

• Full title

  Use of patient reported outcome measures (PROMs) to assess quality of life and economic evaluation of cardiac catheter ablation of ventricular tachycardia: a feasibility study and cohort study

• IRAS ID

  264743

• Contact name

  Mays Jawad

• Contact email

  research.governance@qmul.ac.uk

• Sponsor organisation

  Barts Health NHS Trust

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  TITLE: Improving patient reported outcome measures in catheter ablation

  AIM
  What is the optimal frequency of health related quality of life (HRQL) measurement in patients with severe heart failure, an implantable cardioverter defibrillator (ICD) and previous VT (ventricular tachycardia) that accurately reflects quality of life without being burdensome or redundant

  PATIENTS
  The focus of this study will be catheter ablation of an arrhythmia called ventricular tachycardia (VT) in patients with severe heart failure and an Implantable Cardioverter Defibrillator (ICD).

  BACKGROUND:
  Cardiology uses many costly technologies and devices. For catheter ablation, most of the research evidence supports improvement in quality and not quantity of life. HRQL is measured using questionnaires that patients complete in their own time yet many research studies omit HRQL from their study outcomes. Even when used, HRQL are measured infrequently, which risks missing the true impact different treatments can have on patient
  HRQL is additionally a tool used to help assess the cost-effectiveness of an intervention.

  METHODOLOGY:
  We intend to conduct a study in a specific group of patients with severe heart failure, an ICD and VT. These patients are particularly prone to suffering the disabling and life-threatening heart rhythm VT. Their ICD protects them from sudden death however in doing so, they may receive shocks from their device.

  Ablation of VT represents an invasive intervention that can relieve episodes of VT and thus symptoms either from the rhythm itself or the shocks from their ICD. This observational cohort study will be conducted at St. Bartholomew's hospital, Barts Health NHS Trust and is intended to run for 18 months. The study is funded by Barts Charity. We will ask HRQL at 8 separate time points during the 12month follow up - far greater than existing published studies in the field and monitor the completion rate during the study.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  20/ES/0080

• Date of REC Opinion

  25 Sep 2020

• REC opinion

  Further Information Favourable Opinion