Title : Nature and Intensity of Angina Symptoms: Association between Seattle Angina Questionnaire, Canadian Cardiovascular Class and Rose Angina Questionnaire in the Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina Trial
Abstract:
Background: Current angina questionnaires have been validated with data from unblinded trials of percutaneous coronary intervention (PCI) in stable angina. ORBITA, the first placebo-controlled trial of PCI, provides an opportunity to validate existing angina assessments.
Methods: Symptoms were assessed at enrolment, pre-randomization, and follow-up. Evaluation of physician-assessed symptom severity, patient-reported symptom severity and frequency, nature of symptoms and quality of life were performed using the Canadian Cardiovascular Society (CCS) Class, Seattle Angina Questionnaire (SAQ), Rose Angina Questionnaire (Rose) and EuroQol 5 Dimensions (EQ5D-5L) questionnaire respectively. We tested the associations of these assessments intended to measure similar constructs. A linear regression model was used for continuous variables and proportional odds ordinal logistic model for ordinal variables.
Results: Physician-assessed symptom severity using CCS was associated with patient-reported SAQ angina frequency at enrolment, pre-randomization and follow-up (R2 = 0.046, p = 0.0026; R2 = 0.213, p < 0.0001 and R2 = 0.266, p < 0.0001 respectively). Similar associations were seen with SAQ physical limitation. Rose was associated with SAQ physical limitation at enrolment and follow up, but not at pre-randomization (R2 = 0.065, p = 0.0003; R2 = 0.075, p = 0.0002 and R2 = 0.005, p = 0.3307 respectively). EQ5D-5L Visual Analogue Score was associated with SAQ quality of life at enrolment, pre-randomization and follow-up (R2 = 0.369, p < 0.0001; R2 = 0.240, p < 0.0001 and R2 = 0.316, p < 0.0001 respectively).
Conclusion: The association between CCS and SAQ physical limitation was strong, supporting their convergent validity. Similarly, the association between EQ5D-5L and SAQ quality of life was strong, suggesting they measure similar construct in assessing quality of life in patients with angina.
Keywords: angina pectoris, coronary artery disease, percutaneous coronary intervention (PCI), symptom management
What will audience learn from your presentation?
- ORBITA- the first placebo-controlled trial of percutaneous coronary intervention (PCI), enabled the validation of existing angina metrics (Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) Class and Rose Angina Questionnaire (RAQ)) for the first time with placebo-controlled data. The existing metrics, which are used in trials of PCI, were previously validated with unblinded data. Our blinded data is therefore important for the use of angina symptom assessments in future PCI trials.
- Validation of angina symptom assessments with blinded evidence is important as it may improve the accuracy of study methods in trials which utilize these assessments to capture patients’ angina symptoms.
- Our data will be insightful, as the first blinded evidence, for faculties who utilize these angina metrics in their study design to capture patients’ angina symptoms in PCI trials.
