Current Situation of the Revision of Clinical Outcome Assessment Tools and Consideration on the Procedure：with the COPD-PRO as an Example

doi:10.12114/j.issn.1007-9572.2020.00.360

Abstract

Abstract: Efficient assessment tools are needed in assessing clinical outcomes.The development of assessment tools is a cyclical process，and revision is a necessary way to optimize.At present，there is a lack of uniform norms for the revision process of such tools.According to the development standard of international scales，important achievements of domestic research，and the revision of COPD-PRO，this paper proposes a preliminary revision process of clinical outcome assessment tools，with a view to providing guidance for relevant research.

Key words: Clinical outcome, Outcome assessment （health care）, Assessment tools, Revision process

摘要： 临床结局的测评需借助有效的测评工具。测评工具的研制是一个循环反复的过程，修订是优化测评工具的必要途径。当前临床结局测评工具的修订流程尚缺乏统一规范。本文参照国际量表研制规范，借鉴国内研究重要成果，并结合慢性阻塞性肺疾病患者报告结局量表（COPD-PRO）修订工作，初步提出临床结局测评工具修订流程，以期为相关研究提供指导。

关键词: 临床结局, 结果评价（卫生保健）, 测评工具, 修订流程

WANG Jiajia,XIE Yang,LI Jiansheng. Current Situation of the Revision of Clinical Outcome Assessment Tools and Consideration on the Procedure：with the COPD-PRO as an Example　[J]. Chinese General Practice, 2020, 23(29): 3644-3648. DOI: 10.12114/j.issn.1007-9572.2020.00.360.
王佳佳,谢洋,李建生. 临床结局测评工具修订的现状及流程思考：以慢性阻塞性肺疾病患者报告结局量表修订为例[J]. 中国全科医学, 2020, 23(29): 3644-3648. DOI: 10.12114/j.issn.1007-9572.2020.00.360.

References

［1］刘炳林.药物临床试验中有效性指标的分类［J］．中国新药杂志，2016，25（10）：1103-1107.
LIU B L.Classification of efficacy endpoints in a clinical trial of the new drug［J］．Chinese Journal of New Drugs，2016，25（10）：1103-1107.
［2］张艳宏，刘保延，李君，等．医生报告结局研究进展［J］．中国中西医结合杂志，2014，34（6）：764-768．DOI：10.7661/CJIM.2014.06.0764.http://www.cnki.com.cn/Article/CJFDTotal-ZZXJ201406034.htm.
［3］POWERS J H 3rd，PATRICK D L，WALTON M K，et al．Clinician-reported outcome assessments of treatment benefit：report of the ISPOR clinical outcome assessment emerging good practices task force［J］．Value Health，2017，20（1）：2-14．DOI：10.1016/j.jval.2016.11.005.
［4］U.S.Food and Drug Administration.Guidance for industry：patient-reported outcome measures：use in medical product development to support labeling claims［EB/OL］．［2020-02-06］．https：//www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
［5］TERWEE C B，BOT S D，DE BOER M R，et al．Quality criteria were proposed for measurement properties of health status questionnaires［J］．J Clin Epidemiol，2007，60（1）：34-42．DOI：10.1016/j.jclinepi.2006.03.012.
［6］刘保延.患者报告结局的测量：原理、方法与应用［M］．北京：人民卫生出版社，2011：71-197.
［7］方积乾，陆盈.现代医学统计学［M］．2版.北京：人民卫生出版社，2015：144-174.
［8］万崇华，禹玉兰，谭健烽，等．生命质量研究导论：测定?评价?提升［M］．北京：科学出版社，2016：34-72.
［9］李鲁，王红妹，沈毅.SF-36健康调查量表中文版的研制及其性能测试［J］．中华预防医学杂志，2002，36（2）：109-113.
LI L，WANG H M，SHEN Y.Development and psychometric tests of a Chinese Version of the SF-36 Health Survey Scales［J］．Chinese Journal of Preventive Medicine，2002，36（2）：109-113.
［10］郝元涛，方积乾.世界卫生组织生存质量测定量表中文版介绍及其使用说明［J］．现代康复，2000，4（8）：1127-1129，1145．DOI：10.3321/j.issn:1673-8225.2000.08.002.
HAO Y T，FANG J Q.The introduce and usage of WHOQOL instrument in Chinese［J］．Modern Rehabilitation，2000，4（8）：1127-1129，1145．DOI：10.3321/j.issn:1673-8225.2000.08.002.
［11］戴海崎，张锋.心理与教育测量［M］．4版.广州：暨南大学出版社，2018：307-332.
［12］侯政昆，刘凤斌，陈新林，等．基于条目反应理论、计算机自适应测试及数据模拟的胃痞患者报告结局量表简短版的研制与评价［J］．中国中西医结合杂志，2015，35（7）：806-815．DOI：10.7661/CJIM.2015.07.0806.
HOU Z K，LIU F B，CHEN X L，et al．Development and evaluation of GS-SF for gastric stuffiness （Wei pi） patients based on item response theory，computerized adaptive testing，and data simluation［J］．Chinese Journal of Integrated Traditional and Western Medicine，2015，35（7）：806-815．DOI：10.7661/CJIM.2015.07.0806.
［13］陈新林，程皖琴，王蕾，等．鼻咽癌患者生存质量简短版量表的研制和评价［J］．中华肿瘤防治杂志，2016，23（2）：79-83．DOI：10.16073/j.cnki.cjcpt.2016.02.007.
CHEN X L，CHENG W Q，WANG L，et al．Development and evaluation of the Short Quality of Life Scales for nasopharyngeal carcinoma［J］．Chinese Journal of Cancer Prevention and Treatment，2016，23（2）：79-83．DOI：10.16073/j.cnki.cjcpt.2016.02.007.
［14］朱燕波，虞晓含，王琦，等．简短版中医体质量表的初步设置与考评［J］．中国全科医学，2017，20（7）：879-885.
ZHU Y B，YU X H，WANG Q，et al．Preliminary development and evaluation of the Short-version Constitution in Chinese Medicine Questionnaire［J］．Chinese General Practice，2017，20（7）：879-885.
［15］朱燕波，王琦，虞晓含，等．中医体质量表-41条目简短版的结构效度和反应度评价［J］．中国全科医学，2017，20（26）：3282-3286．DOI：10.3969/j.issn.1007-9572.2017.07.y15.
ZHU Y B，WANG Q，YU X H，et al．Construct validity and responsiveness of the 41-item Short Version of Constitution in Chinese Medicine Questionnaire［J］．Chinese General Practice，2017，20（26）：3282-3286．DOI：10.3969/j.issn.1007-9572.2017.07.y15.
［16］朱燕波，王琦，史会梅，等．中医体质量表-30条目简短版的制定与评价［J］．中医杂志，2018，59（18）：1554-1559．DOI：10.13288/j.11-2166/r.2018.18.006.
ZHU Y B，WANG Q，SHI H M，et al．Formulation and evaluation on Short Version of Chinese Medical Constitution Questionnaire with 30 Items［J］．Journal of Traditional Chinese Medicine，2018，59（18）：1554-1559．DOI：10.13288/j.11-2166/r.2018.18.006.
［17］MEGURO M，BARLEY E A，SPENCER S，et al．Development and validation of an improved，COPD-specific version of the st.George respiratory questionnaire［J］．Chest，2007，132（2）：456-463．DOI：10.1378/chest.06-0702.
［18］李佳玲，赵艳霞，顾菁，等．基于项目反应理论修订生存质量测定量表简表WHOQOL-BREF［J］．中山大学学报（医学科学版），2015，36（2）：284-293．DOI：10.13471/j.cnki.j.sun.yat-sen.univ（med.sci）.2015.0047.
LI J L，ZHAO Y X，GU J，et al．Modify WHOQOL-BREF by item response theory［J］．Journal of Sun Yat-Sen University（Medical Sciences），2015，36（2）：284-293．DOI：10.13471/j.cnki.j.sun.yat-sen.univ（med.sci）.2015.0047.
［19］VISPOEL W P，MORRIS C A，KILINC M.Applications of generalizability theory and their relations to classical test theory and structural equation modeling［J］．Psychol Methods，2018，23（1）：1-26．DOI：10.1037/met0000107.
［20］WU J Y，HU L R，ZHANG G H，et al．Development and validation of the nasopharyngeal cancer scale among the system of quality of life instruments for cancer patients （QLICP-NA V2.0）：combined classical test theory and generalizability theory［J］．Qual Life Res，2016，25（8）：2087-2100．DOI：10.1007/s11136-016-1251-4.
［21］MENG Q，YANG Z，WU Y，et al．Reliability analysis of the Chinese version of the Functional Assessment of Cancer Therapy - Leukemia （FACT-Leu） scale based on multivariate generalizability theory［J］．Health Qual Life Outcomes，2017，15（1）：93．DOI：10.1186/s12955-017-0664-2.
［22］LEI P G，LEI G H，TIAN J J，et al．Development and validation of the irritable bowel syndrome scale under the system of quality of life instruments for chronic diseases QLICD-IBS：combinations of classical test theory and generalizability theory［J］．Int J Colorectal Dis，2014，29（10）：1245-1255．DOI：10.1007/s00384-014-1976-x.
［23］WAN C H，LI H Z，FAN X J，et al．Development and validation of the coronary heart disease scale under the system of quality of life instruments for chronic diseases QLICD-CHD：combinations of classical test theory and Generalizability Theory［J］．Health Qual Life Outcomes，2014，12：82．DOI：10.1186/1477-7525-12-82.
［24］TAN Q R，CAI Y，LI Q Y，et al．Development and validation of an item bank for depression screening in the Chinese population using computer adaptive testing：a simulation study［J］．Front Psychol，2018，9：1225．DOI：10.3389/fpsyg.2018.01225.
［25］KOPEC J A，BADII M，MCKENNA M，et al．Computerized adaptive testing in back pain：validation of the CAT-5D-QOL［J］．Spine，2008，33（12）：1384-1390．DOI：10.1097/BRS.0b013e3181732a3b.
［26］YOUNT S E，CHOI S W，VICTORSON D，et al．Brief，valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease （COPD）［J］．Value Heal，2011，14（2）：307-315．DOI：10.1016/j.jval.2010.11.009.
［27］TURNER-BOWKER D M，DEROSA M A，SARIS-BAGLAMA R N，et al．Development of a computerized adaptive test to assess health-related quality of life in adults with asthma［J］．J Asthma，2012，49（2）：190-200．DOI：10.3109/02770903.2011.633674.
［28］CHEVILLE A L，YOST K J，LARSON D R，et al．Performance of an item response theory-based computer adaptive test in identifying functional decline［J］．Arch Phys Med Rehabil，2012，93（7）：1153-1160．DOI：10.1016/j.apmr.2012.02.008.
［29］李筱颖.胃痛PRO计算机自适应试验的初步构建研究［D］．广州：广州中医药大学，2011.
LI X Y.The pilot study of development of gastralgia PRO computerized adaptive testing［D］．Guangzhou：Guangzhou University of Chinese Medicine，2011.
［30］侯政昆.基于计算机自适应测试的胃痞患者报告结局量表研制［D］．广州：广州中医药大学，2012.
HOU Z K.Development of a patient reported outcomes instrument for patients with gastric stuffiness based on computer adaptive test（GS-CAT）［D］．Guangzhou：Guangzhou University of Chinese Medicine，2012.
［31］李晓.便秘患者报告结局量表的研制及心理测量学考评［D］．广州：广州中医药大学，2014.
LI X.Constipation patients report development and psychometric outcome scale of science evaluation［D］．Guangzhou：Guangzhou University of Chinese Medicine，2014.
［32］李建生，王明航，余学庆，等．慢性阻塞性肺疾病稳定期患者报告结局量表的研制及初步考核［J］．中医学报，2011，26（3）：270-274．DOI：10.16368/j.issn.1674-8999.2011.03.004.
LI J S，WANG M H，YU X Q，et al．Study and preliminary assessment of chronic obstructive pulmonary disease patients report circulating ending scale［J］．China Journal of Chinese Medicine，2011，26（3）：270-274．DOI：10.16368/j.issn.1674-8999.2011.03.004.
［33］LI J S，WANG M H，YU X Q，et al．Development and validation of a patient reported outcome instrument for chronic obstructive pulmonary diseases［J］．Chin J Integr Med，2015，21（9）：667-675．DOI：10.1007/s11655-014-1982-4.
［34］王佳佳.基于项目反应理论的COPD-PRO量表的初步修订与评价［D］．郑州：河南中医药大学，2016.
［35］王佳佳.基于病证结合理论的COPD-PRO量表的修订与评价［D］．北京：北京中医药大学，2019.

[1]	CHEN Qiulong, CHEN Jia, FANG Jing, DAI Wei, YANG Qing. Application Status and Research Progress of Observer-reported Outcome [J]. Chinese General Practice, 2026, 29(18): 2561-2570.
[2]	ZHOU Hongmei, HE Lin, XU Hui, WANG Ning. A Systematic Review of Fatigue Assessment Tools for Cancer Patients Based on the COSMIN Guidelines [J]. Chinese General Practice, 2026, 29(08): 965-973.
[3]	LUO Qi, CHEN Xiaolei, ZHAO Linlin, DU Juan, SHAO Shuang. Systematic Evaluation of Social Capital Assessment Tools for Elderly Based on COSMIN Guidelines [J]. Chinese General Practice, 2025, 28(31): 3974-3980.
[4]	LI Jingling, LIU Ning, GUO Jun. Methodological Quality and Metrological Characteristics of Palliative Care Quality Assessment Tools for Cancer Patients: a Systematic Evaluation Based on COSMIN [J]. Chinese General Practice, 2025, 28(31): 3981-3988.
[5]	WEN Yongxia, SUN Hai, CHEN Xiaoju, CAI Wanjing, LI Shuni, GUO Honghua. A Systematic Review of the Assessment Tools for Maternal Psychological Birth Trauma [J]. Chinese General Practice, 2025, 28(20): 2555-2561.
[6]	YU Yuemin, MO Feifei, LI Lesi, PAN Jiyang. The Assessment Tools and Influencing Factors of Insomnia in Chinese Adolescents: a Scoping Review [J]. Chinese General Practice, 2025, 28(10): 1213-1219.
[7]	LI Chunyang, WANG Jiajia, WEI Mengyu, LI Jiansheng. Research Status of Patient-reported Outcome Measurements for Acute Exacerbation of Chronic Obstructive Pulmonary Disease [J]. Chinese General Practice, 2024, 27(31): 3896-3904.
[8]	CHEN Muxin, LIANG Hao, ZHAO Yidi, YANG Xiaomin, FANG Jiamin, ZHOU Chunjiao, FU Xiuzhen, WEI Lin. Effectiveness Comparison of Different Frailty Assessment Tools in Preoperative Frailty Screening in the Elderly [J]. Chinese General Practice, 2024, 27(30): 3790-3796.
[9]	JIANG Xiaoli, PENG Haibo, XU Lingfeng, XU Na, YIN Chengliang, MENG Wenqi, LIU Songyi, YIN Wenqiang, CHEN Zhongming, MA Dongping, YU Qianqian. Effectiveness Evaluation of Contracted Residents' First Contact in Primary Care in the Context of Contracted Family Doctor Services [J]. Chinese General Practice, 2024, 27(10): 1231-1237.
[10]	HE Yufu, TONG Wenying, WANG Fang, LI Lixia, HE Junbing, SHAO Yiming. Effects of Pre-hospital Metformin Use on Clinical Outcomes in Patients with Diabetes and Sepsis [J]. Chinese General Practice, 2024, 27(09): 1034-1041.
[11]	WANG Qingyu, LIN Zheng, LEI Yang, SUN Caiyun, WANG Mi, GU Junyi, ZHU Zhanhui, TANG Lichen. Assessment and Treatment of Avoidant/Restrictive Food Intake Disorder in Children and Adolescents [J]. Chinese General Practice, 2024, 27(09): 1028-1033.
[12]	WEI Mengyu, WANG Jiajia, ZHANG Yingying, LI Chunyang, LI Jiansheng. Research Status of Patient-reported Outcome Assessment Tools for Obstructive Sleep Apnea [J]. Chinese General Practice, 2023, 26(30): 3725-3733.
[13]	WANG Xinyuan, WANG Xiaolei, LIU Yanli, AN Ran, LUO Jiao, LIU Xiaofei, LI Yangyang, HU Chongdie, HOU Fuwen. Advances in Evaluation Tools for Resistiveness to Care in Patients with Dementia [J]. Chinese General Practice, 2023, 26(22): 2816-2822.
[14]	WANG Tong, QUAN Haishan, TIAN Bowen, LI Ying, CUI Qianqian, LIU Yao, ZHU Huahua. Fatigue in Chronic Obstructive Pulmonary Disease: a Scoping Review [J]. Chinese General Practice, 2023, 26(07): 893-902.
[15]	SHI Zhao, DOU Lei, LI Shunping. Patient-reported Outcome: Recent Advances in Applications and Research at Home and Abroad [J]. Chinese General Practice, 2023, 26(04): 401-408.