| Objective:According to the principle and processes of PRO instrument which is made by U.S. Food and Drug Administration (FDA), under the guidance of CTT, from the perspective of patients, an instrument based on patient-reported outcomes for hypertension was developed. And through the clinical investigation with large samples, the reliability, validity and responsibility of the scale were revised, tested. It will make the hypertension evaluation of curative effect to be quantified. Besides it can offer doctors reference and evaluation, so as to formulate therapeutic regimen and direct clinical medication.Methods:Following the procedures norms of International Scale Development, combining with the theoretical knowledge of hypertension, the item pool in 4 domains were established by reviewing a large number of literatures, referring to related instruments, and interviewing the hypertension patients. The established item pool can be modified by number of multidisciplinary experts. An initial instrument was made by some language modifications in pre-survey. The data was obtained from hypertension patients in hospitals and community health centers. The eventually instrument was analyzed by a variety of statistical methods. The validity, reliability and responsiveness of the Hy-PRO instrument were evaluated.Results:1. The initial Hy-PRO instrument composed of 4 domains,10 facets and 65 items, including 16-items physical domain with three facets of somatic symptoms, independence and cognition; 9-items psychological domain with three facets of anxiety, depression and hostile; 8-items social domain with two facets of social support and support by degrees; and 11-items therapeutic domain with two facets of compliance and satisfaction.2. The valid data was collected from 583 Hy-patients. The results showed that the instrument had good reliability, validity, responsiveness and clinical feasibility. Test-retest Spearman correlation coefficient of the domains were between 0.957 and 0.983(P=0.000), as well as total scale’s Spearman coefficient correlation was 0.983, which showed a good test-retest reliability. The Split-half reliability coefficient was 0.88. In addition to the Split-half reliability of social dimension was low (0.66), the rest of the Split-half reliability of the dimensions were ideal. Cronbach’s a was 0.925, and four domains’Cronbach’s a were 0.910,0.925,0.715 and 0.882, which showed the instrument had a good internal consistency. Faction analysis showed that 7 common factors were extracted with 70.76% cumulative variance contribution rate. After theoretical varimax orthogonal rotation, the results showed fit-well with the theoretical structure model. With respect to dimension correlation, the correlations of the facets and every item-domains correlation coefficient was better(r>0.5, except the economic burden facet was 0.407), and it was inferred from the correlation analysis that there were strong correlation between items and their own domains, which showed a good structure validity; the first and third points of paired t test results showed that the social domain was no significant difference (P=0.091), with the rest of the fields had a significant difference (P<0.05), which showed the instrument can basically reflect QOL for patients with hypertension after treatment. It showed Hy-PRO instrument had a good responsiveness.Conclusion:The result showed that the instrument had a good reliability, validity, responsiveness and clinical feasibility, and can be applied in clinical evaluation. |
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