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| ID | Type | Description | Link |
|---|---|---|---|
| RRK 4429 | Other Identifier | Birmingham R&D | |
| 6125 | Other Identifier | Newcastle R&D |
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| Name | Class |
|---|---|
| National Institute for Health and Clinical Excellence | UNKNOWN |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac arrhythmia patients | Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire |
|
| 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 |
| 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? |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac arrhythmia clinic
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| Name | Affiliation | Role |
|---|---|---|
| Grace Carolan-Rees, PhD | Cardiff and Vale University Health Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham Foundation Trust | Birmingham | B15 2PR | United Kingdom | |||
| Cardiff and Vale University Health Board |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26104746 | Derived | Withers KL, Wood KA, Carolan-Rees G, Patrick H, Lencioni M, Griffith M. Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias. Health Qual Life Outcomes. 2015 Jun 24;13:86. doi: 10.1186/s12955-015-0282-9. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| University College, London |
| OTHER |
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| Questionnaires | Other | Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure |
|
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| 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 |
| Cardiff |
| CF14 7XB |
| United Kingdom |
| Newcastle Upon Tyne Hospitals NHS Trusts | Newcastle | NE7 7DN | United Kingdom |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |