Item Screening of Patient-reported Outcomes Instrument for Chronic Obstructive Pulmonary Disease_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

LiMinjie ¹ , LvHongmei ² , LuoYanhong ¹ , LiuXiaoying ² ,  ZhangYanbo ¹

1. Department of Health Statistics, School of Public Health, Shanxi Medical University, Taiyuan, Shanxi, 030001, China;
2. ;

Corresponding?author：

ZhangYanbo, Email: sxmuzyb@126.com

Keywords：

Chronic obstructive pulmonary disease; Patient reported outcomes; Item screening

DOI：

10.7507/1671-6205.2016027

Video：

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Objective To developapatient-reported outcomes scale of chronic obstructive pulmonary disease used for Chinese, thus offering tools for clinical efficacy assessment. Methods According to the development standard of International Patient-Reported Outcomes, the item pool was established and the preliminary scale was prepared. Then, 100 patients with chronic obstructive pulmonary disease and 50 healthy subjects were face-to-face interviewed with preliminary scale by well-trained investigators.Those copies were collected, surveys were analyzed and items were selected with 5 methods including measure of discrete tendency method, factor analysis, correlation coefficient method, Cronbach’s alpha coefficient method and item response Theory. Finally, the final scale was gained. Results The eventual scale contains 4 areas(physiological dimain, psychological dimension, social dimension, treatment), 11 dimensions(specific symptoms, general symptoms, individual, anxiety, depression, disease cognization, disease influence on social pctivity, social support, compliance, drug adverse reaction, satisfactory), and 52 items. Conclusion The ultimate scale coincides with the theoretical framework and reflects the connotation of the quality of life of patients with chronic obstructive pulmonary disease.

Citation： LiMinjie, LvHongmei, LuoYanhong, LiuXiaoying, ZhangYanbo. Item Screening of Patient-reported Outcomes Instrument for Chronic Obstructive Pulmonary Disease. Chinese Journal of Respiratory and Critical Care Medicine, 2016, 15(2): 105-108. doi: 10.7507/1671-6205.2016027 Copy

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2.	Zhong N, Wang C, Yao W, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med, 2007, 176:753-760.
3.	呂宏梅, 張巖波.患者報告結局(PRO)在臨床療效評價體系中的應用與思考.醫學與哲學:臨床決策論壇版, 2011, 32:1-3.
4.	Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics, 2008, 26:363-370.
5.	Guidance for industry:patient-reported outcome measures:use in medical product development to support labeling claims:draft guidance.Health Qual Life Outcomes, 2009, 4:79.
6.	郝元濤, 孫希鳳, 方積乾, 等.量表條目篩選的統計學方法研究.中國衛生統計, 2004, 21:209-211.
7.	呂靜, 薛江平, 羅艷虹, 等.慢性心衰PRO量表條目的初步篩選.中國衛生統計, 2014, 31:379-382.
8.	曾憲華, 馬瑞, 郭小玲, 等.IRT等級反應模型在冠心病PRO量表編制中的應用.中國衛生統計, 2012, 29:639-641.

1. Meneze AM, Perez-Padilla R, Jardim JR, et al. Chronic obstructive pulmonary disease in five Latin America cities (the PLATI-NO study):a prevalence study. Lancet, 2005, 366:1875-1881.
2. Zhong N, Wang C, Yao W, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med, 2007, 176:753-760.
3. 呂宏梅, 張巖波.患者報告結局(PRO)在臨床療效評價體系中的應用與思考.醫學與哲學:臨床決策論壇版, 2011, 32:1-3.
4. Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics, 2008, 26:363-370.
5. Guidance for industry:patient-reported outcome measures:use in medical product development to support labeling claims:draft guidance.Health Qual Life Outcomes, 2009, 4:79.
6. 郝元濤, 孫希鳳, 方積乾, 等.量表條目篩選的統計學方法研究.中國衛生統計, 2004, 21:209-211.
7. 呂靜, 薛江平, 羅艷虹, 等.慢性心衰PRO量表條目的初步篩選.中國衛生統計, 2014, 31:379-382.
8. 曾憲華, 馬瑞, 郭小玲, 等.IRT等級反應模型在冠心病PRO量表編制中的應用.中國衛生統計, 2012, 29:639-641.

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