Li Jian-sheng, Wang Ming-hang, Yu Xue-qing, Li Su-yun, Xie Yang
Geriatric Department, Henan University of Traditional Chinese Medicine, Zhengzhou, 450046, China.
Department of Respiratory, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, 450000, China.
Chin J Integr Med. 2015 Sep;21(9):667-75. doi: 10.1007/s11655-014-1982-4. Epub 2014 Sep 24.
To develop and validate a specific patient reported outcome (PRO) for chronic obstructive pulmonary disease (COPD) patients (COPD-PRO) at a set of standardized procedures.
Literature analysis, interview and group discussion were performed to draft an initial model of COPD-PRO. Thereafter, 65 clinicians and experts throughout China reviewed the draft scale. Then cognitive debriefing interviews with 40 patients were conducted to assess respondent comprehension of the scale. After that, the revised scale was validated through pre-testing and field-testing. Finally, the psychometric properties of the COPD-PRO were evaluated by indicators such as validity, reliability and responsiveness based on the data from 230 patients.
The COPD-PRO contained 17 items in 3 domains: amelioration of clinical symptoms, satisfaction of health condition and satisfaction of treatment effect. The Cronbach's α, Split-half coefficient and test-retest coefficient were 0.806, 0.744, 0.703, respectively; the correlation coefficients between domains and overall scale were 0.835-0.963; 5 factors were extracted according to the conceptual model. The differences of the scale scores before and after treatment were statistically significant (P=0.000).
The COPDPRO has good validity, reliability and responsiveness. The COPD-PRO could provide patients' response to the treatments and then evaluate the effect of treatment in a standardized way.
通过一系列标准化程序开发并验证一种针对慢性阻塞性肺疾病（COPD）患者的特定患者报告结局（PRO）（COPD-PRO）。
进行文献分析、访谈和小组讨论以起草COPD-PRO的初始模型。此后，来自中国各地的65名临床医生和专家对该量表草案进行了评审。然后对40名患者进行了认知反馈访谈，以评估受访者对该量表的理解。之后，通过预测试和现场测试对修订后的量表进行验证。最后，基于230名患者的数据，通过有效性、可靠性和反应性等指标评估COPD-PRO的心理测量特性。
COPD-PRO包含3个领域的17个条目：临床症状改善、健康状况满意度和治疗效果满意度。Cronbach's α系数、分半系数和重测系数分别为0.806、0.744、0.703；各领域与总量表的相关系数为0.835 - 0.963；根据概念模型提取了5个因子。治疗前后量表得分差异有统计学意义（P = 0.000）。
COPD-PRO具有良好的有效性、可靠性和反应性。COPD-PRO能够提供患者对治疗的反应，进而以标准化方式评估治疗效果。
