Characteristics of Nursing Related Clinical Trials Registered on the Chinese Clinical Trial Registry (ChiCTR) from 2009 to 2023

Qin Li; Weixin Xiong; Meijuan  Wu

doi:10.62177/apjcmr.v2i3.1548

Authors

Qin Li The First Affiliated Hospital Sun Yat-sen University
Weixin Xiong The First Affiliated Hospital Sun Yat-sen University
Meijuan Wu The First Affiliated Hospital Sun Yat-sen University

DOI:

https://doi.org/10.62177/apjcmr.v2i3.1548

Keywords:

Nursing, Clinical Trials, Chinese Clinical Trial Registry

Abstract

Background: The retrieval and analysis of nursing-related clinical trials registered in the Chinese Clinical Trial Registry (Chi CTR) database are conducive to understanding the registration characteristics and development trends of such trials in China and can offer guidance for nursing researchers to standardize their clinical research. Objectives: This research aims to explore the registration characteristics and development trend of nursing-related clinical trials in the Chi CTR. Methods: This is a retrospective observational study. The Chi CTR database was searched for nursing-related clinical trials from its establishment until December 31, 2023. The retrieved clinical trials were re-checked and extract relevant data from retrieved clinical trials. Excel software was utilized to analyze the data of the included studies and summarize the characteristics of the clinical trials. Results: A total of 1,314 nursing-related trials were included, of which 1,102 trials were registered as prospective registration. The registered trials were distributed across 33 regional areas and 498 clinical registration institutions, The top 1 registered clinical trials regions, organization and sources of funds were Guangdong province(138, 10.50%), School of Nursing, Jilin University(73, 5.56%) and local finance (312, 23.75%) respectively. The main types of studies were intervention studies(1031, 78.46%), and randomized parallel controlled trials were the main study design(773, 58.83%) . A total of 812 studies (61.80%) used the simple randomized method, and 243 studies (18.49%) used the blind method. Discussion: The number of nurse-related clinical trial registrations in China present a tendency of increasing overall, but the experimental design, methodology and reporting quality were poor, and the regional distribution of trial registration was unbalanced, Chi CTR should strengthen the control of registration, standardize clinical trial registration, and improve the level and quality of clinical trial registration reports.

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References

Kraft M, Kästel A, Eriksson H, et,al. (2017). Global Nursing-a literature review in the field of education and practice. Nurs Open, 4(3):122-33.https://doi.org/10.1002/nop2.79 DOI: https://doi.org/10.1002/nop2.79

Ebrahim S, Huffman MD. (2022). Future for Systematic Reviews and Meta-Analysis. Systematic Reviews in Health Research, p. 463-79. https://doi.org/10.1002/9781119099369.ch24 DOI: https://doi.org/10.1002/9781119099369.ch24

De Angelis C, Drazen JM, Frizelle FA, et al. (2005). Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Stroke, 36(4):924-5. https://doi.org/10.1161/01.STR.0000162239.47724.c2 DOI: https://doi.org/10.1161/01.STR.0000162239.47724.c2

Wu T, Li Y, Liu G, et,al. (2011). Chinese Clinical Trial Registry: mission, responsibility and operation. J Evid Based Med, 4(3):165-7. https://doi.org/10.1111/j.1756-5391.2011.01137.x

Du Jie, Li Xiaobao, Ye Yun. (2025). Current situation of interventional nursing research in China based on Chinese Clinical Trial Registry. Journal of Clinical Medicine in Practice, 29(12):125-9. https://doi.org/10.7619/jcmp.20245646

Proehl JA, Alexander S, Manton AP. (2017). Integrity and Transparency in Reporting Clinical Trials. Adv Emerg Nurs J, 39(1):1-2. https://doi.org/10.1097/tme.0000000000000136 DOI: https://doi.org/10.1097/TME.0000000000000136

Shrestha B, Dunn L. (2020). The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J Nepal Health Res Counc, 17(4):548-52. https://doi.org/10.33314/jnhrc.v17i4.1042 DOI: https://doi.org/10.33314/jnhrc.v17i4.1042

Taichman DB, Backus J, Baethge C, et al. (2016). Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors. Ann Intern Med, 164(7):505-6. https://doi.org/10.7326/m15-2928 DOI: https://doi.org/10.7326/M15-2928

Costa LO, Lin CW, Grossi DB et al. (2012). Clinical trial registration in physiotherapy journals: recommendations from the International Society of Physiotherapy Journal Editors. J Orthop Sports Phys Ther, 42(12):978-81. https://doi.org/10.2519/jospt.2012.0111 DOI: https://doi.org/10.2519/jospt.2012.0111

Liang N, Zhang Y, Zhang X, et al. (2024). International Traditional Medicine Clinical Trial Registry: A meaningful initiative and its future development. J Evid Based Med, 17(3):486-9. https://doi.org/10.1111/jebm.12651 DOI: https://doi.org/10.1111/jebm.12651

Li YP, Wu TX, Li J, et al. (2006). Joint statement of establishing Chinese Clinical Trial Registration and Publishing system. Zhong Xi Yi Jie He Xue Bao, 4(4):331-2. https://doi.org/10.3736/jcim20060401 DOI: https://doi.org/10.3736/jcim20060401

Meldrum DR, Decherney AH. (2011). The WHO, WHY, WHAT, WHEN, WHERE, and HOW of clinical trial registries. Fertil Steril, 96(1):2-5. https://doi.org/10.1016/j.fertnstert.2011.05.028 DOI: https://doi.org/10.1016/j.fertnstert.2011.05.028

Wu T, Li Y, Liu G, et al. (2011). Chinese Clinical Trial Registry: mission, responsibility and operation. J Evid Based Med, 4(3):165-7. https://doi.org/10.1111/j.1756-5391.2011.01137.x DOI: https://doi.org/10.1111/j.1756-5391.2011.01137.x

Fan R, Zheng Y, Zhou R, et al. (2023). Chinese Clinical Trial Registry 13-year data collection and analysis: geographic distribution, financial support, research phase, duration, and disease categories. Front Med (Lausanne), 10:1203346. https://doi.org/10.3389/fmed.2023.1203346 DOI: https://doi.org/10.3389/fmed.2023.1203346

Xu P, Xing X, Yu K, et al. (2020). Profiles of COVID-19 clinical trials in the Chinese Clinical Trial Registry. Emerg Microbes Infect, 9(1):1695-701. https://doi.org/10.1080/22221751.2020.1791736 DOI: https://doi.org/10.1080/22221751.2020.1791736

Zhou H, Yao M, Gu X, et al. (2022). Application of Patient-Reported Outcome Measurements in Clinical Trials in China. JAMA Netw Open, 5(5):e2211644. https://doi.org/10.1001/jamanetworkopen.2022.11644 DOI: https://doi.org/10.1001/jamanetworkopen.2022.11644

Jia Y, Li Q, Zhang X, et al. (2024). Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study. J Med Internet Res, 26:e45719. https://doi.org/10.2196/45719 DOI: https://doi.org/10.2196/45719

Dong Y, Liu L, Zhang X, et al. (2023). A cross-sectional study on the application of patient-reported outcome measurements in clinical trials of traditional Chinese medicine in mainland China. Front Pharmacol, 14:1159906. https://doi.org/10.3389/fphar.2023.1159906 DOI: https://doi.org/10.3389/fphar.2023.1159906

Viergever RF, Li K. (2015). Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open, 5(9):e008932. https://doi.org/10.1136/bmjopen-2015-008932 DOI: https://doi.org/10.1136/bmjopen-2015-008932

Zhu R, Wang Y, Wu R, et al. (2020). Trends in high-impact papers in nursing research published from 2008 to 2018: A web of science-based bibliometric analysis. J Nurs Manag, 28(5):1041-52. https://doi.org/10.1111/jonm.13038 DOI: https://doi.org/10.1111/jonm.13038

Giménez-Espert MDC, Prado-Gascó VJ.(2019). Bibliometric analysis of six nursing journals from the Web of Science, 2012-2017. J Adv Nurs, 75(3):543-54. https://doi.org/10.1111/jan.13868 DOI: https://doi.org/10.1111/jan.13868

Wang C, Shi Y, Lu H, et al. (2022). Global nursing research activity from 2009 to 2020: A bibliometric analysis. Int J Nurs Pract, 28(5):e13063. https://doi.org/10.1111/ijn.13063 DOI: https://doi.org/10.1111/ijn.13063

Ndwandwe DE, Runeyi S, Pienaar E, et al. (2022). Practices and trends in clinical trial registration in the Pan African Clinical Trials Registry (PACTR): a descriptive analysis of registration data. BMJ Open, 12(1):e057474. https://doi.org/10.1136/bmjopen-2021-057474 DOI: https://doi.org/10.1136/bmjopen-2021-057474

Yanbing S, Hua L, Chao L, et al. (2021). The state of nursing research from 2000 to 2019: A global analysis. J Adv Nurs., 77(1):162-75. https://doi.org/10.1111/jan.14564 DOI: https://doi.org/10.1111/jan.14564

Fu X, You L, Liu X, et al. (2022). Developing trends of initial nursing education in China from 2006 to 2017: A descriptive analysis based on national-level data. Nurse Educ Today, 110:105271. https://doi.org/10.1016/j.nedt.2022.105271 DOI: https://doi.org/10.1016/j.nedt.2022.105271

Yao X, Zheng Z, Wang Z, et al. (2023). Nationally funded health management projects for older adults in China and the United States: Comparative analysis based on data from two principal institutions. Int J Nurs Sci, 10(1):8-15. https://doi.org/10.1016/j.ijnss.2022.12.013 DOI: https://doi.org/10.1016/j.ijnss.2022.12.013

Woo BFY, Tam WWS, Williams MY, et al. (2023). Characteristics, methodological, and reporting quality of scoping reviews published in nursing journals: A systematic review. J Nurs Scholarsh, 55(4):874-85. https://doi.org/10.1111/jnu.12861 DOI: https://doi.org/10.1111/jnu.12861

Villa M, Le Pera M, Cassina T, et al. (2023). Reporting quality of abstracts from randomised controlled trials published in leading critical care nursing journals: a methodological quality review. BMJ Open, 13(3):e070639. https://doi.org/10.1136/bmjopen-2022-070639 DOI: https://doi.org/10.1136/bmjopen-2022-070639

Huo B, Xu S, Liu Y, et al. (2024). Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study. BMC Pediatr, 24(1):364. https://doi.org/10.1186/s12887-024-04839-3 DOI: https://doi.org/10.1186/s12887-024-04839-3

Zhang J, Chen X, Zhu Q, et al. (2016). Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement. Orthop Traumatol Surg Res, 102(7):933-8. https://doi.org/10.1016/j.otsr.2016.05.018 DOI: https://doi.org/10.1016/j.otsr.2016.05.018

Serra-Aracil X, Pascua-Sol M, Badia-Closa J, et al. (2020). How to start and develop a multicenter, prospective, randomized, controlled trial. Cir Esp (Engl Ed), 98(3):119-26. https://doi.org/10.1016/j.ciresp.2019.11.012 DOI: https://doi.org/10.1016/j.cireng.2020.03.002