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During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.
The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Surgery | Procedure | Routine or urgent cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life using Questionnaire EQ-5D | Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life using Questionnaire SF-12 | Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life using Questionnaire LOT | Conduct questionnaire LOT to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. | 12 months |
| Change in Quality of Life using Questionnaire PANAS |
Inclusion Criteria:
Exclusion Criteria:
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All adults able to understand the patient information sheet written in English.
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| Name | Affiliation | Role |
|---|---|---|
| Samer Nashef | Chief Investigator Royal Papworth Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Papworth Hospital | Cambridge | Cambridgeshire | CB2 0AY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42118099 | Derived | Nashef SAM, Willard J, Mills C, Chiu YD, Noyes P, Petch MC, Couturier DL, Large SR. Quality of Life After Cardiac Surgery: The QUACS Study and Benefit Prediction Model. Eur J Cardiothorac Surg. 2026 May 11;68(5):ezag159. doi: 10.1093/ejcts/ezag159. |
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Participant data is not to be shared with researchers
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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Conduct questionnaire PANAS to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure. |
| 12 months |
| D014694 |
| Ventricular Outflow Obstruction |
| D014652 | Vascular Diseases |