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Development of a patient-reported outcome scale for stable chronic obstructive pulmonary disease and its clinical applicability

Author(s): Yan-bo Zhu

Journal: Zhong Xi Yi Jie He Xue Bao
ISSN 1672-1977

Volume: 9;
Issue: 8;
Start page: 857;
Date: 2011;
Original page

Keywords: pulmonary disease | chronic obstructive | program evaluation | patient-reported outcome | controlled clinical trial

Objective: To develop a patient-reported outcome (PRO) scale for patients with stable chronic obstructive pulmonary disease (sCOPD) and to study its clinical applicability in traditional Chinese medicine (TCM).Methods: According to standardized procedures, the test version of PRO scale for sCOPD (sCOPD-PRO scale) was developed based on the theory of “unity of body and spirit” and was used to test 324 patients selected from six clinical centers. Five methods were used to analyze the items; the reliability, validity and responsiveness of the remaining items of the scale were evaluated. Results: (1) sCOPD-PRO consisted of 23 items after item analysis, and according to the content of each item, these items could be grouped into four domains, namely, lung and kidney deficiency symptom, spleen deficiency symptom, functional activities and emotional impact. (2) Cronbach’s alpha coefficient for sCOPD-PRO scale was more than 0.75 in four domains and total scores. (3) sCOPD-PRO scale and St. George’s Respiratory Questionnaire (SGRQ) were moderately correlated or highly correlated in corresponding domains: the correlation coefficient between the total score of sCOPD-PRO scale and the total score of SGRQ was 0.72 (P

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