Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Study Overview
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Brief Summary
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A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias

Detailed Description
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This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research. Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure. The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.

Official Title
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A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Other: Interview
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic cardiac arrhythmias Consented to and awaiting a cardiac ablation procedure Able to read, write and understand English or Welsh Capable of giving informed written consent Exclusion Criteria: Not able to read, write and understand English or Welsh Not able to provide informed written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac arrhythmia patients<br>Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation. | Other: Interview<br>* Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire<br>* Other names: EQ5D5L;Other: Questionnaires<br>* Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure<br>* Other names: EQ5D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias? | This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods. | Up to 5 years post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Do replies to the questionnaires show that the tool is responsive to change following ablation treatment? |  | Average 10 weeks post ablation | 
| Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes? |  | Up to 5 years post-ablation. | 
| Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias? |  | Average 10 weeks post ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Outcome Measures, PROMs, Cardiac arrhythmia, Cardiac ablation