Key result
The ITALY questionnaires are the first specific patient-reported outcome measures for ATTR-CA, demonstrating feasibility and close correlations with non-specific quality of life measures like KCCQ and SF-36.
Why the study?
Transthyretin cardiac amyloidosis has a major impact on quality of life, but no specific patient-reported outcome measures for the condition exist.
Observational (n=140)
Yes
Answers are grounded in this paper and cite their sources.
The ITALY questionnaires are the first specific, feasible patient-reported outcome measures for wild-type and variant transthyretin cardiac amyloidosis, showing strong correlation with generic quality of life tools.
BACKGROUND: Transthyretin cardiac amyloidosis (ATTR-CA) has a deep impact on the quality of life (QoL), yet no specific patient-reported outcome measures (PROMs) for ATTR-CA exist. METHODS: The ITALY study involved 5 Italian referral centres (Pisa, Pavia, Ferrara, Florence, Messina) enrolling consecutive outpatients with ATTR-CA. RESULTS: Two 30-item questionnaires were created for wild-type (wt) and variant (v) ATTR-CA. Scores ranged from 100 (best condition) to 0 (worst condition). Out of 140 patients enrolled (77% with ATTRwt-CA), 115 repeated the re-evaluation at 6 months. At baseline, only 30% of patients needed help to fill out the questionnaires. Among baseline variables, all KCCQ and SF-36 domains were univariate predictors of ITALY scores in ATTRwt-CA patients, with the KCCQ Symptom Summary score (beta coefficient 0.759), Social Limitations (0.781), and Overall summary score (0.786) being the strongest predictors. The SF-36 Emotional well-being score (0.608), the KCCQ Overall summary score (0.656), and the SF-36 Energy/fatigue score (0.669) were the strongest univariate predictors of ITALY scores in ATTRv-CA. Similar results were found at 6 months. CONCLUSIONS: The ITALY questionnaires are the first specific PROMs for ATTRwt- and ATTRv-CA. Questionnaire completion is feasible. ITALY scores display close relationships with non-ATTR-specific measures of QoL.
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Aimo et al. (2023) conducted an observational in Transthyretin cardiac amyloidosis (ATTR-CA) (n=140). ITALY questionnaires (disease-specific PROMs) vs. KCCQ and SF-36 was evaluated on Correlation of ITALY scores with KCCQ and SF-36 scores. The ITALY questionnaires are the first specific patient-reported outcome measures for ATTR-CA, demonstrating feasibility and close correlations with non-specific quality of life measures like KCCQ and SF-36.
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