Development and validation of patient-reported outcomes scale for hypertension

To validate a patient-reported outcomes (PROs) measure for patients with hypertension.

This was a validation study that employed mixed methods including classical test theory, item response theory, and reliability and validity evaluation.

The community health centers in two Chinese cities.

Fifteen patients participated in the pilot survey, and 641 patients completed the PRO survey.

Classical test theory and item response theory were applied to the item selection. Evaluations and adjustments were based on results of reliability, validity, responsiveness and feasibility analyses.

The item selection process produced a final scale with 4 domains (physiology, psychology, society and treatment), 12 subdomains and 56 items. According to confirmatory factor analysis, the construct validity was adequate. The split-half reliability, Cronbach's α coefficients and responsiveness both in each subdomain and in the whole scale were also acceptable, as was feasibility.

Mixed methods were beneficial for developing this scale and could be applied to PROs in other health areas. The instrument provides a means for comprehensive assessment of the impact of hypertension, and for quantification of benefits of hypertension interventions from the patients' perspective.