A methodological study of the validation of psychometric properties of patient-reported outcome measurement_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Xiaolu ¹ , LI Rui ¹ , WANG Peimeng ¹ , ZHANG Yuzheng ¹ , XIAO Feiyi ¹ , GAO Xin ¹ , ZHAO Kun ² , XIE Feng ³ ,  GUO Wudong ¹ ,  LI Xue ¹

1. China National Health Development Research Center, Beijing 100191, P. R. China;
2. Vanhe School of Public Health, Tsinghuua University, Beiing 100044, P. R. China;
3. Department of Health Research Methods, Evidence and Impact, Centre for Health Economics and Policy Analysis, McMaster University, Hamilton L8S4K1, P. R. Canada;

Corresponding author：

GUO Wudong, Email: guowudong@hotmail.com; LI Xue, Email: lx0204@126.com

Keywords：

COSMIN; Patient-reported outcome measures; Reliability; Validity; Responsiveness; Interpretability

DOI：

10.7507/1672-2531.202411178

Video：

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Patient-reported outcome measures (PROM) measure attribute studies refer to studies conducted by investigators to validate the measurement attributes of PROM. The consensus-based standards for the selection of health measurement instruments (COSMIN), an international consensus standard for the selection of health measurement instruments, divides this attribute into three aspects: reliability, validity and responsiveness, and adds interpretability as an additional important feature for evaluating PROM. The purpose of this paper is to introduce the verification methods and principles of the three major measurement attributes in the COSMIN consensus, as well as the significance and direction of interpretability evaluation, and to provide international methodological experience and reference for the development of high-quality PROM psychometric attribute verification in China.

1.	Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res, 2018, 27(5): 1147-1157.
2.	de Vet HC, Terwee CB, Mokkink LB, et al. Measurement in medicine: a practical guide. Cambridge: Cambridge University Press, 2011.
3.	COSMIN. COSMIN tools. 2024.
4.	彭健, 沈蓝君, 陈祎婷, 等. 对COSMIN-RoB清单中测量工具稳定性、测量误差和效标效度研究偏倚风险的清单解读. 中国循证医学杂志, 2020, 20(11): 1340-1344.
5.	彭健, 沈蓝君, 陈祎婷, 等. COSMIN-RoB清单简介及测量工具内部结构研究的偏倚风险清单解读. 中国循证医学杂志, 2020, 20(10): 1234-1240.
6.	郝元涛, 孙希凤, 方积乾, 等. 量表条目筛选的统计学方法研究. 中国卫生统计, 2004, 21(4): 209-211.
7.	何庆勇, 王阶, 张允岭, 等. 基于患者报告的临床结局评价量表的条目筛选方法. 中华中医药杂志, 2011, 26(1): 112-114.
8.	茅范贞, 韩耀风, 方亚. 量表条目的统计学筛选方法研究进展. 现代预防医学, 2015, 42(1): 1-3.
9.	Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol, 2010, 63(7): 737-745.
10.	陈祎婷, 彭健, 沈蓝君, 等. COSMIN方法介绍: 制作患者报告结局测量工具的系统评价. 护士进修杂志, 2021, 36(8): 699-703.
11.	乔舰. 组内相关系数的理论基础及建模应用. 统计与信息论坛, 2016, 31(11): 44-48.
12.	Nunnally JC. Psychometric theory. Tata McGraw-Hill Education, 1994.
13.	Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull, 1968, 70(4): 213-220.
14.	邓建华. Kappa值在Nottingham健康量表信度测量中的应用. 中国卫生统计, 1997, 14(1): 19-21.
15.	Koch LGG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1): 159-174.
16.	Fleiss JL. Statistical methods for rates and proportions. Hoboken: John Wiley & Sons, 1973.
17.	王惠慈. 现代医院管理综合统计学. 北京: 中国统计出版社, 1993.
18.	张晓路, 李睿, 彭馨, 等. 基于COSMIN共识标准的患者报告结局测量理论与概念模型研究. 中国卫生经济, 2024, 43(12): 1-6.
19.	樊嵘, 孟大志, 徐大舜. 统计相关性分析方法研究进展. 数学建模及其应用, 2014, 3(1): 1-12.
20.	Santos JRA. Cronbach's alpha: a tool for assessing the reliability of scales. JOE, 1999, 37(2): 2TOT3.
21.	苏中华, 李四劝, 成义仁. 量表评估的内部一致性与克朗巴赫α系数的应用评价. 临床心身疾病杂志, 2009, 15(1): 85-86.
22.	Cortina JM. What is coefficient alpha. An examination of theory and applications. JAP, 1993, 78(1): 98-104.
23.	Bot SD, Terwee CB, van der Windt DA, et al. Clinimetric evaluation of shoulder disability questionnaires: a systematic review of the literature. Ann Rheum Dis, 2004, 63(4): 335-341.
24.	de Boer MR, Moll AC, de Vet HC, et al. Psychometric properties of vision-related quality of life questionnaires: a systematic review. Ophthalmic Physiol Opt, 2004, 24(4): 257-273.
25.	陈彦垒, 郭少阳. 标准误在统计与测量中的使用比较. 统计与决策, 2014, (20): 75-78.
26.	Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res, 1999, 8(2): 135-160.
27.	Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs-user manual. Amsterdam: VU University Medical Center, 2018.
28.	Lord FM, Novick MR. Statistical theory of mental test scores. New Jersey: Addison Wesley, 1968.
29.	Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol, 1991, 59(1): 12-19.

1. Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res, 2018, 27(5): 1147-1157.
2. de Vet HC, Terwee CB, Mokkink LB, et al. Measurement in medicine: a practical guide. Cambridge: Cambridge University Press, 2011.
3. COSMIN. COSMIN tools. 2024.
4. 彭健, 沈蓝君, 陈祎婷, 等. 对COSMIN-RoB清单中测量工具稳定性、测量误差和效标效度研究偏倚风险的清单解读. 中国循证医学杂志, 2020, 20(11): 1340-1344.
5. 彭健, 沈蓝君, 陈祎婷, 等. COSMIN-RoB清单简介及测量工具内部结构研究的偏倚风险清单解读. 中国循证医学杂志, 2020, 20(10): 1234-1240.
6. 郝元涛, 孙希凤, 方积乾, 等. 量表条目筛选的统计学方法研究. 中国卫生统计, 2004, 21(4): 209-211.
7. 何庆勇, 王阶, 张允岭, 等. 基于患者报告的临床结局评价量表的条目筛选方法. 中华中医药杂志, 2011, 26(1): 112-114.
8. 茅范贞, 韩耀风, 方亚. 量表条目的统计学筛选方法研究进展. 现代预防医学, 2015, 42(1): 1-3.
9. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol, 2010, 63(7): 737-745.
10. 陈祎婷, 彭健, 沈蓝君, 等. COSMIN方法介绍: 制作患者报告结局测量工具的系统评价. 护士进修杂志, 2021, 36(8): 699-703.
11. 乔舰. 组内相关系数的理论基础及建模应用. 统计与信息论坛, 2016, 31(11): 44-48.
12. Nunnally JC. Psychometric theory. Tata McGraw-Hill Education, 1994.
13. Cohen J. Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull, 1968, 70(4): 213-220.
14. 邓建华. Kappa值在Nottingham健康量表信度测量中的应用. 中国卫生统计, 1997, 14(1): 19-21.
15. Koch LGG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1): 159-174.
16. Fleiss JL. Statistical methods for rates and proportions. Hoboken: John Wiley & Sons, 1973.
17. 王惠慈. 现代医院管理综合统计学. 北京: 中国统计出版社, 1993.
18. 张晓路, 李睿, 彭馨, 等. 基于COSMIN共识标准的患者报告结局测量理论与概念模型研究. 中国卫生经济, 2024, 43(12): 1-6.
19. 樊嵘, 孟大志, 徐大舜. 统计相关性分析方法研究进展. 数学建模及其应用, 2014, 3(1): 1-12.
20. Santos JRA. Cronbach's alpha: a tool for assessing the reliability of scales. JOE, 1999, 37(2): 2TOT3.
21. 苏中华, 李四劝, 成义仁. 量表评估的内部一致性与克朗巴赫α系数的应用评价. 临床心身疾病杂志, 2009, 15(1): 85-86.
22. Cortina JM. What is coefficient alpha. An examination of theory and applications. JAP, 1993, 78(1): 98-104.
23. Bot SD, Terwee CB, van der Windt DA, et al. Clinimetric evaluation of shoulder disability questionnaires: a systematic review of the literature. Ann Rheum Dis, 2004, 63(4): 335-341.
24. de Boer MR, Moll AC, de Vet HC, et al. Psychometric properties of vision-related quality of life questionnaires: a systematic review. Ophthalmic Physiol Opt, 2004, 24(4): 257-273.
25. 陈彦垒, 郭少阳. 标准误在统计与测量中的使用比较. 统计与决策, 2014, (20): 75-78.
26. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res, 1999, 8(2): 135-160.
27. Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs-user manual. Amsterdam: VU University Medical Center, 2018.
28. Lord FM, Novick MR. Statistical theory of mental test scores. New Jersey: Addison Wesley, 1968.
29. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol, 1991, 59(1): 12-19.

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