This methodological study aims to develop and validate a questionnaire named for the Assessment of Patient Knowledge in Pulmonary Arterial Hypertension. The study will be conducted in four phases: (1) questionnaire development based on guidelines and literature; (2) content validation by expert judges; (3) semantic validation with patients; and (4) psychometric testing in a sample of up to 200 patients with confirmed pulmonary arterial hypertension (PAH).
In addition to validation, the study will collect clinical and functional data from medical records, including risk stratification using the COMPERA 2.0 method The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.
Adults aged 18 years or older
Confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH)
Ability to read and understand the questionnaire language
Provided informed consent to participate in the study
Cognitive, visual, or auditory impairments that hinder questionnaire comprehension
Refusal to participate or withdrawal of informed consent
Inability to complete the questionnaire due to clinical instability
Single group
Application of Patient Knowledge Questionnaire on Pulmonary Hypertension
Other interventionParticipants will complete one version of the SAVOIR questionnaire, developed to assess patient knowledge about pulmonary arterial hypertension. Depending on the study phase, participants will contribute to content validation (expert judges), semantic validation (patients), or psychometric validation (patients). In the final phase, additional data including risk stratification (COMPERA 2.0) will be collected for correlational analysis.
Content Validity Index (CVI) of the Questionnaire Items
Proportion of agreement among expert judges regarding the relevance and clarity of each item. Items with CVI ≥ 0.80 will be considered valid.
Semantic Clarity Rating by Patients
Assessment of the clarity and comprehension of each item by patients using a structured form. Items with ≥ 85% of patients rating them as clear or very clear will be considered semantically valid.
Internal Consistency of the Questionnaire (Cronbach's Alpha)
Psychometric evaluation of the final version of the SAVOIR questionnaire using Cronbach's alpha. A coefficient ≥ 0.70 will be considered acceptable. The analysis will be conducted in a sample of up to 200 patients.
Test-Retest Reliability (Intraclass Correlation Coefficient - ICC)
Stability of the questionnaire scores over time will be assessed by reapplying the instrument after 1 to 2 weeks in a subsample of patients. ICC ≥ 0.80 will be considered acceptable.
Completion Rate and Acceptability of the Questionnaire
Percentage of participants who complete the questionnaire without missing data and report that the items are clear and easy to understand.
6. Association Between questionnaire Score and Risk Stratification (COMPERA 2.0)
Association between total DICTA score and patient risk status based on the COMPERA 2.0 stratification tool.
Association Between questionnaire Score and Number of PAH-related Hospitalizations
Correlation between questionnaire score and number of PAH-related hospitalizations in the 12 months prior to questionnaire administration.
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