Development and validation of patient-reported outcomes scale for hypertension.
OBJECTIVE
To validate a patient-reported outcomes (PROs) measure for patients with hypertension.


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


METHODS
The community health centers in two Chinese cities.


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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
School of Public Health, Shanxi Medical University, Taiyuan, China.
Li
L
Zhi
School of Public Health, Shanxi Medical University, Taiyuan, China.
Liu
L
Qiaojun
School of Public Health, Shanxi Medical University, Taiyuan, China.
Zhang
Z
Yanbo
D002681:China; D003071:Cognition; D003151:Community Health Centers / Q000458:organization & administration* / Q000592:standards; D005163:Factor Analysis, Statistical; D006304:Health Status; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D007398:Interpersonal Relations; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D011594:Psychometrics; D011787:Quality of Health Care / Q000458:organization & administration* / Q000592:standards; D015203:Reproducibility of Results
classical test theory; confirmatory factor analysis; hypertension; item response theory; patient-reported outcomes