{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T08:08:50Z","timestamp":1778486930776,"version":"3.51.4"},"reference-count":41,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T00:00:00Z","timestamp":1778112000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine","award":["ZYYCXTD-C-202006"],"award-info":[{"award-number":["ZYYCXTD-C-202006"]}]},{"name":"The National Administration of Traditional Chinese Medicine","award":["YGZXKT2024046"],"award-info":[{"award-number":["YGZXKT2024046"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Eval Health Prof"],"abstract":"<jats:p>This study aimed to analyse the application characteristics of patient-reported outcomes (PROs) in traditional Chinese medicine (TCM) clinical trials for musculoskeletal disorders in China. This study included TCM clinical trials for musculoskeletal diseases conducted in China between January 1, 2010, and August 1, 2023. Data were extracted from ClinicalTrials.gov, the Chinese Clinical Registry, and the International Traditional Medicine Clinical Trial Registry. Eligible trials were categorized as (1) explicitly specified PROs, (2) implicitly specified PROs (generic outcome concepts [e.g., pain] without naming a specific instrument), and (3) PROs not mentioned. Of 494 eligible trials, 446 (90.3%) used PROs as endpoints. Of 67,839 participants, 58,093 (85.6%) were in trials with specific PRO tools, 4,400 (6.5%) in trials with ambiguous PRO descriptions, and 5,346 (7.9%) in trials without PROs. Arthropathies (43.0%) were the most common condition among PRO-inclusive trials, and the Visual Analogue Scale was the most frequently used PRO tool. Primary sponsors showed significant regional imbalance, with most concentrated in eastern China. This study demonstrated a significant emphasis on PRO application in TCM clinical trials for musculoskeletal diseases in China, while also identifying gaps in standardization and regional distribution that require addressing.<\/jats:p>","DOI":"10.1177\/01632787261444409","type":"journal-article","created":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T03:44:56Z","timestamp":1778211896000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Application of Patient-Reported Outcome Measurements in Traditional Chinese Medicine Clinical Trials for Musculoskeletal Disorders in China: A Registry-Based Analysis"],"prefix":"10.1177","author":[{"given":"Xuanyu","family":"Chen","sequence":"first","affiliation":[{"name":"Beijing University of Chinese Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yijia","family":"Gong","sequence":"additional","affiliation":[{"name":"Beijing University of Chinese Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Lin","sequence":"additional","affiliation":[{"name":"Beijing University of Chinese Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongguo","family":"Rong","sequence":"additional","affiliation":[{"name":"Beijing University of Chinese Medicine"},{"name":"Beijing University of Chinese Medicine"},{"name":"Beijing University of Chinese Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4925-6705","authenticated-orcid":false,"given":"Yansong","family":"Zhao","sequence":"additional","affiliation":[{"name":"Beijing University of Chinese Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2026,5,7]]},"reference":[{"issue":"7","key":"e_1_3_7_2_1","first-page":"1324","article-title":"The factor subdimensions of the western Ontario and McMaster universities osteoarthritis index (WOMAC) help to specify hip and knee osteoarthritis: A prospective evaluation and validation study","volume":"32","author":"Angst F.","year":"2005","unstructured":"Angst F., Ewert T., Lehmann S., Aeschlimann A., Stucki G. (2005). The factor subdimensions of the western Ontario and McMaster universities osteoarthritis index (WOMAC) help to specify hip and knee osteoarthritis: A prospective evaluation and validation study. Journal of Rheumatology, 32(7), 1324\u20131330.","journal-title":"Journal of Rheumatology"},{"key":"e_1_3_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/eahr.500216"},{"key":"e_1_3_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hex.13254"},{"issue":"02","key":"e_1_3_7_5_1","first-page":"105","article-title":"Construction ideas and methods of a comprehensive efficacy evaluation system with TCM characteristics","volume":"33","author":"Dai X. Y.","year":"2024","unstructured":"Dai X. Y., Zi M. J., Sun M. Y., Duan H. P., Yu J. Y., Yang C. M., Sun Q. M., Zhao J. N. (2024). Construction ideas and methods of a comprehensive efficacy evaluation system with TCM characteristics. Chinese Journal of New Drugs, 33(02), 105\u2013109.","journal-title":"Chinese Journal of New Drugs"},{"key":"e_1_3_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pmr.2017.06.004"},{"key":"e_1_3_7_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/01410768211014048"},{"key":"e_1_3_7_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-2025-1"},{"key":"e_1_3_7_9_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0030-1250456"},{"key":"e_1_3_7_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-3-26"},{"key":"e_1_3_7_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000016301"},{"key":"e_1_3_7_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/jncimonographs\/lgx010"},{"issue":"10","key":"e_1_3_7_13_1","first-page":"5584997","article-title":"Therapeutic effects of traditional Chinese exercises on musculoskeletal pain: A systematic review and meta-analysis","volume":"2021","author":"Li Z.","year":"2021","unstructured":"Li Z., Zhuang J., Zhang S., He Q., Zhao R., Alima T., Fang L. (2021). Therapeutic effects of traditional Chinese exercises on musculoskeletal pain: A systematic review and meta-analysis. Pain Research and Management, 2021(10), 5584997. https:\/\/doi.org\/10.1155\/2021\/5584997","journal-title":"Pain Research and Management"},{"issue":"4","key":"e_1_3_7_14_1","first-page":"205031211667172","article-title":"SF-36 total score as a single measure of health-related quality of life: Scoping review","volume":"4","author":"Lins L.","year":"2016","unstructured":"Lins L., Carvalho F. M. (2016). SF-36 total score as a single measure of health-related quality of life: Scoping review. Sage Open Medicine, 4(4), 2050312116671725. https:\/\/doi.org\/10.1177\/2050312116671725","journal-title":"Sage Open Medicine"},{"issue":"05","key":"e_1_3_7_15_1","first-page":"268","article-title":"The current status and prospects of clinical efficacy evaluation research in traditional Chinese medicine","volume":"24","author":"Liu B. Y.","year":"2010","unstructured":"Liu B. Y. (2010). The current status and prospects of clinical efficacy evaluation research in traditional Chinese medicine. China Science Foundation, 24(05), 268\u2013274. https:\/\/doi.org\/10.16262\/j.cnki.1000-8217.2010.05.012","journal-title":"China Science Foundation"},{"issue":"22","key":"e_1_3_7_16_1","first-page":"127","article-title":"Reflections and practices on evidence-based evaluation of traditional Chinese medicine clinical practice under the disease-syndrome combination system","volume":"30","author":"Liu T. W.","year":"2024","unstructured":"Liu T. W., Shi Y. F., Wang T. W. (2024). Reflections and practices on evidence-based evaluation of traditional Chinese medicine clinical practice under the disease-syndrome combination system. Chinese Journal of Experimental Formulas, 30(22), 127\u2013136. https:\/\/doi.org\/10.13422\/j.cnki.syfjx.20242221","journal-title":"Chinese Journal of Experimental Formulas"},{"issue":"03","key":"e_1_3_7_17_1","first-page":"1688","article-title":"Clinical patient-reported outcomes and their assessment in traditional Chinese medicine","volume":"14","author":"Liu W. M.","year":"2012","unstructured":"Liu W. M., Cui X. J., He L. Y. (2012). Clinical patient-reported outcomes and their assessment in traditional Chinese medicine. World Science and Technology (Modernisation of Traditional Chinese Medicine), 14(03), 1688\u20131693.","journal-title":"World Science and Technology (Modernisation of Traditional Chinese Medicine)"},{"key":"e_1_3_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2015.03.002"},{"key":"e_1_3_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2022.106882"},{"key":"e_1_3_7_20_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.812370"},{"issue":"04","key":"e_1_3_7_21_1","first-page":"20","article-title":"The superiority and limitations of patient-reported outcome measures","volume":"21","author":"Ren J.","year":"2014","unstructured":"Ren J., Zhou F., Yang G. Y. (2014). The superiority and limitations of patient-reported outcome measures. Modern Clinical Traditional Chinese Medicine, 21(04), 20\u201323.","journal-title":"Modern Clinical Traditional Chinese Medicine"},{"key":"e_1_3_7_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01648-4"},{"key":"e_1_3_7_23_1","doi-asserted-by":"publisher","DOI":"10.1080\/17453674.2016.1181815"},{"key":"e_1_3_7_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1707537"},{"key":"e_1_3_7_25_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph16081144"},{"key":"e_1_3_7_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.09.542"},{"issue":"9","key":"e_1_3_7_27_1","first-page":"II102","article-title":"Health-related quality-of-life assessments in diverse population groups in the United States","volume":"38","author":"Stewart A. L.","year":"2000","unstructured":"Stewart A. L., N\u00e1poles-Springer A. (2000). Health-related quality-of-life assessments in diverse population groups in the United States. Medical Care, 38(9 Suppl), II102\u2013II124. https:\/\/doi.org\/10.1097\/00005650-200009001-00012","journal-title":"Medical Care"},{"key":"e_1_3_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vhri.2017.04.001"},{"key":"e_1_3_7_29_1","doi-asserted-by":"publisher","DOI":"10.51507\/j.jams.2022.15.5.281"},{"key":"e_1_3_7_30_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-4-79"},{"issue":"3","key":"e_1_3_7_31_1","first-page":"177","article-title":"Chinese expert consensus on the application of pain assessment scales (2020)","volume":"16","author":"Wan L. Z. Q.","year":"2020","unstructured":"Wan L. Z. Q., Chen J. (2020). Chinese expert consensus on the application of pain assessment scales (2020). Chinese Journal of Pain, 16(3), 177\u2013187. https:\/\/doi.org\/10.3760\/cma.j.cn101379-20190915-00075","journal-title":"Chinese Journal of Pain"},{"key":"e_1_3_7_32_1","unstructured":"World Health Organization. (2022). Musculoskeletal health [fact sheet]. 14 July 2022. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/musculoskeletal-conditions"},{"issue":"08","key":"e_1_3_7_33_1","first-page":"68","article-title":"Comparative study on the application of individualized TCM syndrome scoring and traditional TCM syndrome scoring in the evaluation of TCM clinical efficacy","volume":"42","author":"Xiao L.","year":"2024","unstructured":"Xiao L., Ou Y., Chen Z. H., Wang J. H., Li J., Jiang J. W., Min D. Y. (2024). Comparative study on the application of individualized TCM syndrome scoring and traditional TCM syndrome scoring in the evaluation of TCM clinical efficacy. Chinese Journal of Integrative Medicine, 42(08), 68\u201372. https:\/\/doi.org\/10.13193\/j.issn.1673-7717.2024.08.014","journal-title":"Chinese Journal of Integrative Medicine"},{"key":"e_1_3_7_34_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-014914"},{"key":"e_1_3_7_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/10410236.2021.1950292"},{"key":"e_1_3_7_36_1","first-page":"6099","article-title":"Further refinement is required for patient-reported outcome scales for respiratory diseases based on traditional Chinese medicine theory for applicability","volume":"23","author":"Zhang P.","year":"2023","unstructured":"Zhang P., Ren J., Xu B., Wang J., Xie Y. (2023). Further refinement is required for patient-reported outcome scales for respiratory diseases based on traditional Chinese medicine theory for applicability. International Journal of General Medicine, 23(16), 6099\u20136113. https:\/\/doi.org\/10.2147\/IJGM.S438297","journal-title":"International Journal of General Medicine"},{"issue":"03","key":"e_1_3_7_37_1","first-page":"1026","article-title":"Research status of patient reported outcome scale of traditional Chinese medicine","volume":"33","author":"Zhang S.","year":"2018","unstructured":"Zhang S., Chen Y. (2018). Research status of patient reported outcome scale of traditional Chinese medicine. Zhong Hua Zhong Yi Yao Za Zhi, 33(03), 1026\u20131029.","journal-title":"Zhong Hua Zhong Yi Yao Za Zhi"},{"issue":"08","key":"e_1_3_7_38_1","first-page":"696","article-title":"Outcome indicators and effect measurement in clinical trials","volume":"2007","author":"Zhang H. W.","year":"2007","unstructured":"Zhang H. W., Liu J. P. (2007). Outcome indicators and effect measurement in clinical trials. Journal of Traditional Chinese Medicine, 2007(08), 696\u2013698. https:\/\/doi.org\/10.13288\/j.11-2166\/r.2007.08.050","journal-title":"Journal of Traditional Chinese Medicine"},{"issue":"10","key":"e_1_3_7_39_1","first-page":"4111","article-title":"The construction ideas for the theoretical structural model of the efficacy evaluation scale of traditional Chinese medicine for diabetes","volume":"31","author":"Zhang S.","year":"2016","unstructured":"Zhang S., Lu H. (2016). The construction ideas for the theoretical structural model of the efficacy evaluation scale of traditional Chinese medicine for diabetes. Chinese J Tradit Chin Med, 31(10), 4111\u20134113.","journal-title":"Chinese J Tradit Chin Med"},{"issue":"17","key":"e_1_3_7_40_1","first-page":"1516","article-title":"Discussion on the Co-construction model of clinical outcome indicators system between doctors and patients under the concept of narrative medicine","volume":"61","author":"Zhang Y.","year":"2020","unstructured":"Zhang Y., Chen H., Wang Y. (2020). Discussion on the Co-construction model of clinical outcome indicators system between doctors and patients under the concept of narrative medicine. Journal of Traditional Chinese Medicine, 61(17), 1516\u20131520. https:\/\/doi.org\/10.13288\/j.11-2166\/r.2020.17.011.","journal-title":"Journal of Traditional Chinese Medicine"},{"key":"e_1_3_7_41_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.11644"},{"issue":"24","key":"e_1_3_7_42_1","first-page":"1330","article-title":"Impact of the COVID-19 pandemic on clinical trials: A cross-sectional questionnaire study in China","volume":"10","author":"Zhu Y.","year":"2022","unstructured":"Zhu Y., Sun Y., Jin Y., Tao T., Yi L., Li X. (2022). Impact of the COVID-19 pandemic on clinical trials: A cross-sectional questionnaire study in China. Annals of Translational Medicine, 10(24), 1330. https:\/\/doi.org\/10.21037\/atm-22-5594","journal-title":"Annals of Translational Medicine"}],"container-title":["Evaluation &amp; the Health Professions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/01632787261444409","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/01632787261444409","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/01632787261444409","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T07:17:26Z","timestamp":1778483846000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/01632787261444409"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,7]]},"references-count":41,"alternative-id":["10.1177\/01632787261444409"],"URL":"https:\/\/doi.org\/10.1177\/01632787261444409","relation":{},"ISSN":["0163-2787","1552-3918"],"issn-type":[{"value":"0163-2787","type":"print"},{"value":"1552-3918","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,7]]},"article-number":"01632787261444409"}}