Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Internal consistency of the EmPHasis-10-BR questionnaire measured by Cronbach's alpha — 7-28 days
  EmPHasis-10 Brazilian Portuguese version (EmPHasis-10-BR): Evaluates health-related quality of life in pulmonary hypertension. Scores range from 0 to 50, where higher scores indicate a worse outcome (greater disease impact/lower quality of life).
• Test-retest reliability measured by Spearman's correlation coefficient — 7-28 days
• Concurrent validity assessed by correlation with SF-36 questionnaire — 7-28 days
  Concurrent validity considering the SF-36 (Brazilian Portuguese version), a generic questionnaire of 36 items evaluating health-related quality of life across 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and 2 summary component scores (PCS and MCS). Transformed scores for each domain/component range from 0 to 100, where higher scores indicate a better outcome (better overall health status and higher quality of life).

Trial sites (1)

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