Interpretation of COSMIN systematic evaluation guidelines for patient-reported outcome measures version 2.0_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Yixuan ¹ , LIANG Shasha ¹ , SUN Yanan ² ,  QIU Ruijin ¹ ,  YU Changhe ¹

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P. R. China;
2. Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical University, Beijing 100053, P. R. China;

Corresponding author：

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

Keywords：

Systematic evaluation; patient-reported outcome measures; COSMIN guidelines

DOI：

10.7507/1672-2531.202506163

Video：

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Systematic evaluation of patient-reported outcome measures (PROMs) is crucial for identifying high-quality PROMs for research and clinical practice. It ensures reliable health outcomes data collection. But current PROMs systematic evaluation reports vary in quality and have many defects. To address this, in 2024, the guideline research team updated and published the COSMIN guideline V2.0 for PROMs systematic evaluation and two other tools in the Quality of Life Research. This paper interprets the guideline development team, method, and the core content of the COSMIN guideline V2.0. It also uses specific examples to promote standardized PROMs selection and clinical application, aiming to help domestic researchers improve the quality of such systematic evaluations.

1.	Beaton D, Maxwell L , Grosskleg S, et al. The OMERACT handbook version 2.1. OMERACT.
2.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
3.	Churruca K, Pomare C, Ellis LA, et al. Patient-reported outcome measures (PROMs): a review of generic and condition-specific measures and a discussion of trends and issues. Health Expect, 2021, 24(4): 1015-1024.
4.	Arguelles GR, Shin M, Lebrun DG, et al. The majority of patient-reported outcome measures in pediatric orthopaedic research are used without validation. J Pediatr Orthop, 2021, 41(1): e74-e79.
5.	Janssens A, Thompson Coon J, Rogers M, et al. A systematic review of generic multidimensional patient-reported outcome measures for children, part I: descriptive characteristics. Value Health, 2015, 18(2): 315-333.
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8.	MokkinkL B, De Vet HCW. COSMIN methodology for systematic reviews of patient-reported outcome measures (PROMs) - user manual. 2018.
9.	Terwee CB, Prinsen CA, et al. COSMIN methodology for assessing the content validity of patient-reported outcome measures (PROMs). 2024.
10.	Elsman EBM, Mokkink LB, Abma IL, et al. Methodological quality of 100 recent systematic reviews of health-related outcome measurement instruments: an overview of reviews. Qual Life Res, 2024, 33(10): 2593-2609.
11.	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.
12.	Langendoen-Gort M, Groeneveld L, Prinsen CAC, et al. Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: a systematic review. Rev Endocr Metab Disord, 2022, 23(5): 931-977.
13.	Terwee CB, Elders PJM, Langendoen-Gort M, et al. Content validity of patient-reported outcome measures developed for assessing health-related quality of life in people with type 2 diabetes mellitus: a systematic review. Curr Diab Rep, 2022, 22(9): 405-421.
14.	Elsman EBM, Mokkink LB, Langendoen-Gort M, et al. Systematic review on the measurement properties of diabetes-specific patient-reported outcome measures (PROMs) for measuring physical functioning in people with type 2 diabetes. BMJ Open Diabetes Res Care, 2022, 10(3): e002729.
15.	Rutters F, Elsman E, Groeneveld L, et al. Challenges in measuring what matters to patients with diabetes. Comment on "measurement properties of patient-reported outcome measures for diabetes: systematic review". J Med Internet Res, 2022, 24(3): e36876.
16.	Terwee CB, Elders PJM, Blom MT, et al. Patient-reported outcomes for people with diabetes: what and how to measure. A narrative review. Diabetologia, 2023, 66(8): 1357-1377.
17.	van Andel EM, Koopmann BDM, Crouwel F, et al. Systematic review of development and content validity of patient-reported outcome measures in inflammatory bowel disease: do we measure what we measure. J Crohns Colitis, 2020, 14(9): 1299-1315.
18.	Inhulsen MMR, van Stralen MM, Terwee CB, et al. Measuring sleep health in primary school-aged children: a systematic review of instruments and their content validity. Sleep, 2022, 45(11): zsac215.
19.	Stallwood E, Elsman EBM, Monsour A, et al. Measurement properties of patient reported outcome scales: a systematic review. Pediatrics, 2023, 152(2): e2023061489.
20.	Mokkink LB, Boers M, van der Vleuten CPM, et al. COSMIN risk of bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study. BMC Med Res Methodol, 2020, 20(1): 293.
21.	Elsman EBM, Mokkink LB, Terwee CB, et al. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Qual Life Res, 2024, 33(8): 2029-2046.
22.	HigginsJPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions(Version 6.4). 2023.
23.	Deeks JJ, Bossuyt PM. Cochrane handbook for systematic reviews of diagnostic test accuracy(Version 2.0). 2023.
24.	Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650): 924-926.
25.	赵茜, 王钰, 卞兰峥. 基于COSMIN指南对儿童癌症相关疲劳评估工具的系统评价. 中国当代儿科杂志, 2025, 27(2): 184-191.

1. Beaton D, Maxwell L , Grosskleg S, et al. The OMERACT handbook version 2.1. OMERACT.
2. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
3. Churruca K, Pomare C, Ellis LA, et al. Patient-reported outcome measures (PROMs): a review of generic and condition-specific measures and a discussion of trends and issues. Health Expect, 2021, 24(4): 1015-1024.
4. Arguelles GR, Shin M, Lebrun DG, et al. The majority of patient-reported outcome measures in pediatric orthopaedic research are used without validation. J Pediatr Orthop, 2021, 41(1): e74-e79.
5. Janssens A, Thompson Coon J, Rogers M, et al. A systematic review of generic multidimensional patient-reported outcome measures for children, part I: descriptive characteristics. Value Health, 2015, 18(2): 315-333.
6. Mokkink L, Terwee C. The COSMIN database of systematic reviews of outcome measurement instruments. 2024.
7. 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.
8. MokkinkL B, De Vet HCW. COSMIN methodology for systematic reviews of patient-reported outcome measures (PROMs) - user manual. 2018.
9. Terwee CB, Prinsen CA, et al. COSMIN methodology for assessing the content validity of patient-reported outcome measures (PROMs). 2024.
10. Elsman EBM, Mokkink LB, Abma IL, et al. Methodological quality of 100 recent systematic reviews of health-related outcome measurement instruments: an overview of reviews. Qual Life Res, 2024, 33(10): 2593-2609.
11. 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.
12. Langendoen-Gort M, Groeneveld L, Prinsen CAC, et al. Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: a systematic review. Rev Endocr Metab Disord, 2022, 23(5): 931-977.
13. Terwee CB, Elders PJM, Langendoen-Gort M, et al. Content validity of patient-reported outcome measures developed for assessing health-related quality of life in people with type 2 diabetes mellitus: a systematic review. Curr Diab Rep, 2022, 22(9): 405-421.
14. Elsman EBM, Mokkink LB, Langendoen-Gort M, et al. Systematic review on the measurement properties of diabetes-specific patient-reported outcome measures (PROMs) for measuring physical functioning in people with type 2 diabetes. BMJ Open Diabetes Res Care, 2022, 10(3): e002729.
15. Rutters F, Elsman E, Groeneveld L, et al. Challenges in measuring what matters to patients with diabetes. Comment on "measurement properties of patient-reported outcome measures for diabetes: systematic review". J Med Internet Res, 2022, 24(3): e36876.
16. Terwee CB, Elders PJM, Blom MT, et al. Patient-reported outcomes for people with diabetes: what and how to measure. A narrative review. Diabetologia, 2023, 66(8): 1357-1377.
17. van Andel EM, Koopmann BDM, Crouwel F, et al. Systematic review of development and content validity of patient-reported outcome measures in inflammatory bowel disease: do we measure what we measure. J Crohns Colitis, 2020, 14(9): 1299-1315.
18. Inhulsen MMR, van Stralen MM, Terwee CB, et al. Measuring sleep health in primary school-aged children: a systematic review of instruments and their content validity. Sleep, 2022, 45(11): zsac215.
19. Stallwood E, Elsman EBM, Monsour A, et al. Measurement properties of patient reported outcome scales: a systematic review. Pediatrics, 2023, 152(2): e2023061489.
20. Mokkink LB, Boers M, van der Vleuten CPM, et al. COSMIN risk of bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study. BMC Med Res Methodol, 2020, 20(1): 293.
21. Elsman EBM, Mokkink LB, Terwee CB, et al. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Qual Life Res, 2024, 33(8): 2029-2046.
22. HigginsJPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions(Version 6.4). 2023.
23. Deeks JJ, Bossuyt PM. Cochrane handbook for systematic reviews of diagnostic test accuracy(Version 2.0). 2023.
24. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650): 924-926.
25. 赵茜, 王钰, 卞兰峥. 基于COSMIN指南对儿童癌症相关疲劳评估工具的系统评价. 中国当代儿科杂志, 2025, 27(2): 184-191.

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