Validating a Quality of Life Questionnaire for Brazilians With Pulmonary Hypertension
Checks a Portuguese quality of life questionnaire in adults with pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation
Key facts
- Where
- Porto Alegre, BrazilSee the site
Where in Brazil
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital de Clinicas de Porto Alegre
- Trial code
- NCT07822997
- Record updated
- 16 September 2026
- Original description
Pulmonary hypertension (PH) is a severe and heterogeneous condition associated with poor prognosis and significant impairment in quality of life. Patient-reported outcome questionnaires are useful, low-cost tools for clinical assessment and risk stratification. The EmPHasis-10 questionnaire is a brief and easy-to-administer instrument that has demonstrated good correlation with clinical outcomes across different PH populations; however, a validated Brazilian Portuguese version is not yet available.Read full original descriptionShow less
Cultural Adaptation, Validation, and Reliability of the EMPHASIS-10 Questionnaire for Assessing Quality of Life in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: Brazilian Version
Pulmonary hypertension (PH) is a severe and heterogeneous condition associated with poor prognosis and significant impairment in quality of life. Patient-reported outcome questionnaires are useful, low-cost tools for clinical assessment and risk stratification. The EmPHasis-10 questionnaire is a brief and easy-to-administer instrument that has demonstrated good correlation with clinical outcomes across different PH populations; however, a validated Brazilian Portuguese version is not yet available.
This study aims to translate, culturally adapt, and validate the EmPHasis-10 questionnaire for Brazilian patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The investigators designed a cross-sectional observational study including 50 adult patients with a confirmed diagnosis of PAH (group 1) or CTEPH (group 4), followed at the Pulmonary Circulation Outpatient Clinic of Hospital de Clínicas de Porto Alegre. The EmPHasis-10-BR will be administered alongside the SF-36 questionnaire for concurrent validity analysis, as well as frailty assessment instruments. Reliability will be evaluated through test-retest analysis in both in-person and remote settings.
Clinical, functional, and hemodynamic variables will also be collected to investigate associations between EmPHasis-10-BR scores and risk stratification parameters recommended by international guidelines. Statistical analyses will include Cronbach's alpha to assess internal consistency, Spearman's correlation coefficients for test-retest reliability, and comparisons with previously validated instruments.
The investigators expect that the validation of the EmPHasis-10-BR will provide a practical, reliable, and culturally appropriate tool for quality-of-life assessment in Brazilian patients with PH, supporting standardized clinical follow-up, risk stratification, and potentially contributing to therapeutic decision-making.
Inclusion: Willingness to participate in the study after being informed and having provided written informed consent; Age ≥ 18 years; Diagnosis of precapillary pulmonary hypertension from groups 1 and 4, confirmed by right heart catheterization; Clinically stable patients with no changes in therapy for at least 3 months; Native speaker of Brazilian Portuguese; Literate patient.
Exclusion: Diagnosis of pulmonary hypertension from groups 2, 3, and/or 5; Severe communication impairment, including major cognitive deficit or severe hearing or visual impairment, resulting in inability to respond to the questionnaires or to understand the study procedures; Spirometry showing forced vital capacity (FVC) ≤ 70% predicted and/or forced expiratory volume in the first second (FEV₁) ≤ 60% predicted; Patients who experience clinical exacerbation or worsening between the days on which the questionnaires are administered; Refusal to participate in the study.