Interpretation of the COSMIN reporting guideline 2.0 for studies on measurement properties of patient-reported outcome measures (PROMs)_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Yixuan ^1,2 , LIANG Shasha ^1,3 ,  SUN Yanan ⁴ ,  QIU Ruijin ^1,5 ,  YU Changhe ¹

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P. R. China;
2. Xinjiang Medical University Affiliated Hospital of Traditional Chinese Medicine, Urumqi 830000, P. R. China;
3. The First Clinical Medical College of Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
4. Xuanwu Hospital, Capital Medical University, Department of Traditional Chinese Medicine, Beijing 100053, P. R. China;
5. Key Laboratory of Traditional Chinese Medicine Internal Medicine, Ministry of Education, Beijing University of Chinese Medicine, Beijing 100700, P. R. China;

Corresponding?author：

SUN Yanan, Email: sunny726618@163.com; QIU Ruijin, Email: psddqxn@163.com; YU Changhe, Email: yakno2@163.com

Keywords：

Patient-reported outcome measures; Consensus-based standards for the selection of health measurement instruments; Measurement properties; Reporting guidelines; Report list

DOI：

10.7507/1672-2531.202508065

Video：

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Patient-reported outcome measures (PROMs) are instruments that capture patients’ perceptions of their health status and the benefits of treatment. The psychometric adequacy of these tools is therefore an empirical prerequisite. Nevertheless, published evaluations often omit critical details about measurement properties, and clinical trials rarely give a complete account of how PROMs were implemented. To close these gaps, the consensus-based standards for the selection of health measurement instruments (COSMIN) initiative has released version 2.0, a comprehensive update of the original COSMIN 1.0 guidance for PROMs research. This article walks readers through the COSMIN 2.0 checklist, illustrating each item with concrete examples.

Citation： GAO Yixuan, LIANG Shasha, SUN Yanan, QIU Ruijin, YU Changhe. Interpretation of the COSMIN reporting guideline 2.0 for studies on measurement properties of patient-reported outcome measures (PROMs). Chinese Journal of Evidence-Based Medicine, 2026, 26(3): 359-365. doi: 10.7507/1672-2531.202508065 Copy

1.	Gagnier JJ, de Arruda GT, Terwee CB, et al. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures: version 2.0. Qual Life Res, 2025, 34(7): 1901-1911.
2.	陳千吉, 陳紅, 張英, 等. 患者報告結局測量工具選擇路徑: 以中國腰痛患者日常生活活動能力量表的選擇為例. 中國全科醫學, 2021, 24(36): 4648-4652, 4660.
3.	于長禾, 孫亞男, 何麗云, 等. 量表研制及測量屬性評價標準的比較研究. 世界科學技術-中醫藥現代化, 2015, 17(6): 1127-1135.
4.	Gagnier JJ, Huang H, Mullins M, et al. Measurement properties of patient-reported outcome measures used in patients undergoing total hip arthroplasty: a systematic review. JBJS Rev, 2018, 6(1): e2.
5.	Jia Y, Huang H, Gagnier JJ. A systematic review of measurement properties of patient-reported outcome measures for use in patients with foot or ankle diseases. Qual Life Res, 2017, 26(8): 1969-2010.
6.	Gagnier JJ, Mullins M, Huang H, et al. A systematic review of measurement properties of patient-reported outcome measures used in patients undergoing total knee arthroplasty. J Arthroplasty, 2017, 32(5): 1688-1697.
7.	van der Vet P, Wilson S, Houwert RM, et al. Quality and reporting of patient-reported outcomes in elderly patients with hip fracture: a systematic review. BMJ Open, 2022, 12(12): e058197.
8.	Zhou J, Qi H, Hu J, et al. Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder-a meta-epidemiological review. Front Psychiatry, 2023, 14: 1246938.
9.	Moore T, Nees D, Hightower B, et al. Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2. 0. Respir Med Res, 2023, 83: 100962.
10.	梁元文, 陳紅, 陳千吉, 等. 腰痛功能障礙評價量表QBPDS、ODI、RMDQ的比較研究. 頸腰痛雜志, 2024, 45(6): 1040-1046.
11.	高藝軒, 王錫友, 陳千吉, 等. 健康調查12條目簡表與5水平歐洲5維度健康量表用于評價腰痛患者生活質量的比較. 中國康復醫學雜志, 2024, 39(11): 1710-1714.
12.	高藝軒, 王錫友, 陳千吉, 等. 基于COSMIN指南對中國腰痛患者羅蘭-莫里殘疾調查問卷測量性能證據的系統評價. 中國全科醫學, 2024, 27(29): 3672-3678.
13.	Gagnier JJ, Lai J, Mokkink LB, et al. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res, 2021, 30(8): 2197-2218.
14.	Patrick D. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Value Health, 2013, 16(4): 455-456.
15.	Gao YX, Weng ZW, Shao H, et al. Reliability, validity and minimum clinical importance difference of the Chinese version of the Zurich claudication questionnaire. Sci Rep, 2025, 15(1): 16654.
16.	Yi H, Wei X, Zhang W, et al. Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis. Spine (Phila Pa 1976), 2014, 39(10): 820-825.
17.	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.
18.	Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2. 0. Qual Life Res, 2024, 33(11): 2929-2939.
19.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol, 2010, 63(8): e1-e37.
20.	Kottner J, Audige L, Brorson S, et al. Guidelines for reporting reliability and agreement studies (GRRAS) were proposed. Int J Nurs Stud, 2011, 48(6): 661-671.
21.	Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals. A Cochrane review. Syst Rev, 2012, 1: 60.
22.	于長禾, 孫亞男, 何麗云, 等. 中醫生活質量量表心理測量性能證據的系統評價. 中華中醫藥雜志, 2015, 30(5): 1631-1635.
23.	陳千吉, 陳紅, 張英, 等. 基于中國腰痛患者Oswestry功能障礙指數測量性能證據的COSMIN系統評價. 中國康復醫學雜志, 2022, 37(1): 79-83.
24.	Dong OM, Manga N, Zhong Y, et al. Use of patient-reported outcome measures in cost-effectiveness models informing health technology assessments of non-oncology treatments: a review. J Med Econ, 2025, 28(1): 1045-1060.

1. Gagnier JJ, de Arruda GT, Terwee CB, et al. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures: version 2.0. Qual Life Res, 2025, 34(7): 1901-1911.
2. 陳千吉, 陳紅, 張英, 等. 患者報告結局測量工具選擇路徑: 以中國腰痛患者日常生活活動能力量表的選擇為例. 中國全科醫學, 2021, 24(36): 4648-4652, 4660.
3. 于長禾, 孫亞男, 何麗云, 等. 量表研制及測量屬性評價標準的比較研究. 世界科學技術-中醫藥現代化, 2015, 17(6): 1127-1135.
4. Gagnier JJ, Huang H, Mullins M, et al. Measurement properties of patient-reported outcome measures used in patients undergoing total hip arthroplasty: a systematic review. JBJS Rev, 2018, 6(1): e2.
5. Jia Y, Huang H, Gagnier JJ. A systematic review of measurement properties of patient-reported outcome measures for use in patients with foot or ankle diseases. Qual Life Res, 2017, 26(8): 1969-2010.
6. Gagnier JJ, Mullins M, Huang H, et al. A systematic review of measurement properties of patient-reported outcome measures used in patients undergoing total knee arthroplasty. J Arthroplasty, 2017, 32(5): 1688-1697.
7. van der Vet P, Wilson S, Houwert RM, et al. Quality and reporting of patient-reported outcomes in elderly patients with hip fracture: a systematic review. BMJ Open, 2022, 12(12): e058197.
8. Zhou J, Qi H, Hu J, et al. Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder-a meta-epidemiological review. Front Psychiatry, 2023, 14: 1246938.
9. Moore T, Nees D, Hightower B, et al. Underreporting of patient-reported outcomes in cystic fibrosis randomized controlled trials using CONSORT-PRO and RoB 2. 0. Respir Med Res, 2023, 83: 100962.
10. 梁元文, 陳紅, 陳千吉, 等. 腰痛功能障礙評價量表QBPDS、ODI、RMDQ的比較研究. 頸腰痛雜志, 2024, 45(6): 1040-1046.
11. 高藝軒, 王錫友, 陳千吉, 等. 健康調查12條目簡表與5水平歐洲5維度健康量表用于評價腰痛患者生活質量的比較. 中國康復醫學雜志, 2024, 39(11): 1710-1714.
12. 高藝軒, 王錫友, 陳千吉, 等. 基于COSMIN指南對中國腰痛患者羅蘭-莫里殘疾調查問卷測量性能證據的系統評價. 中國全科醫學, 2024, 27(29): 3672-3678.
13. Gagnier JJ, Lai J, Mokkink LB, et al. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res, 2021, 30(8): 2197-2218.
14. Patrick D. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Value Health, 2013, 16(4): 455-456.
15. Gao YX, Weng ZW, Shao H, et al. Reliability, validity and minimum clinical importance difference of the Chinese version of the Zurich claudication questionnaire. Sci Rep, 2025, 15(1): 16654.
16. Yi H, Wei X, Zhang W, et al. Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis. Spine (Phila Pa 1976), 2014, 39(10): 820-825.
17. 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.
18. Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2. 0. Qual Life Res, 2024, 33(11): 2929-2939.
19. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol, 2010, 63(8): e1-e37.
20. Kottner J, Audige L, Brorson S, et al. Guidelines for reporting reliability and agreement studies (GRRAS) were proposed. Int J Nurs Stud, 2011, 48(6): 661-671.
21. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals. A Cochrane review. Syst Rev, 2012, 1: 60.
22. 于長禾, 孫亞男, 何麗云, 等. 中醫生活質量量表心理測量性能證據的系統評價. 中華中醫藥雜志, 2015, 30(5): 1631-1635.
23. 陳千吉, 陳紅, 張英, 等. 基于中國腰痛患者Oswestry功能障礙指數測量性能證據的COSMIN系統評價. 中國康復醫學雜志, 2022, 37(1): 79-83.
24. Dong OM, Manga N, Zhong Y, et al. Use of patient-reported outcome measures in cost-effectiveness models informing health technology assessments of non-oncology treatments: a review. J Med Econ, 2025, 28(1): 1045-1060.

Chinese Journal of Evidence-Based Medicine

Interpretation of the COSMIN reporting guideline 2.0 for studies on measurement properties of patient-reported outcome measures (PROMs)

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