Analysis of research hotspots and trends in core outcome set from 2015 to 2024_Chinese Journal of Evidence-Based Medicine

Authors：

LI Tengfei ^1,2 , XU Jianguo ¹ , ZHENG Qingyong ¹ , ZHANG Bowa ¹ , YU Guihan ¹ ,  TIAN Jinhui ¹

1. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
2. School of Nursing, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100144, P. R. China;

Corresponding author：

TIAN Jinhui, Email: tjh996@163.com

Keywords：

Core outcome set; VOSviewer; Visualization analysis; Bibliometrics; Research hotspots; Research trends

DOI：

10.7507/1672-2531.202503006

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To analyze the research hotspots and development trends of core outcome set (COS) from 2015 to 2024, providing a reference for future research in this field. Methods We retrieved literature on COS research from the Web of Science Core Collection and CNKI spanning January 1, 2015 to December 31, 2024. We extracted and organized data on the number of publications, journals, citation frequency, and keywords using Excel 2021. We performed keyword clustering analysis using VOSviewer 1.6.13 and generated strategic coordinate maps using Bibliometrix 3.13 in R 4.3.1. Results We included a total of 1 288 studies, comprising 1 085 English publications and 203 Chinese publications. From 2015 to 2024, the number of COS publications showed a steady increase. English journals covered a wide range of fields, while Chinese journals were mainly focused on traditional Chinese medicine. High-impact articles primarily focused on COS methodology. Chinese literature mainly concentrated on the application of COS in traditional Chinese medicine, while English literature focused on child health, Delphi surveys, quality of life, and pain. The results of the strategic coordinate map showed that research on acupuncture core outcome indicators, qualitative studies of surgical COS, and Delphi-based COS for quality of life in patients with rheumatoid diseases were relatively weak, with significant room for improvement. Conclusion Over the past decade, COS research has shown a steady growth trend and has gradually become an important tool for improving the standardization and scientific rigor of clinical research. As COS research continues to expand, there is increasing overlap in the scope and findings of different studies. Future research could incorporate umbrella and basket study designs to optimize resource utilization and promote the application of COS in clinical practice.

1.	Kirkham JJ, Clarke M, Williamson PR. A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials. gov: findings from a review of randomised controlled trials of rheumatoid arthritis. BMJ, 2017, 357: j2262.
2.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
3.	Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
4.	Blackwood B, Marshall J, Rose L. Progress on core outcome sets for critical care research. Curr Opin Crit Care, 2015, 21(5): 439-444.
5.	邱瑞瑾, 陈诗琪, 韩松洁, 等. 基于COMET数据库的核心指标集研究现状及进展. 中国循证医学杂志, 2019, 19(5): 622-629.
6.	史纪元, 高亚, 马新萍, 等. COMET数据库核心指标集研究现状剖析. 中国医药导刊, 2020, 22(1): 53-58.
7.	van Eck NJ, Waltman L. Software survey: VOSviewer, a computer program for bibliometric mapping. Scientometrics, 2010, 84(2): 523-538.
8.	李昊, 潘宇光, 王磊. Bibliometrix: 一款新的基于R语言的文献计量软件介绍与评价. 大学图书情报学刊, 2018, 36(4): 93-104.
9.	史纪元, 罗家音, 王雪莲, 等. 国内外人工智能护理相关研究热点和趋势分析. 军事护理, 2023, 40(7): 16-19.
10.	史纪元, 田金徽, 高亚, 等. 人工智能临床研究文献科学计量学分析. 协和医学杂志, 2022, 13(5): 871-879.
11.	陈亚敏, 程露颖, 郑卿勇, 等. 人工智能与神经科学研究主题分析. 兰州大学学报(医学版), 2022, 48(3): 59-65.
12.	霍少娟, 廖婷, 田金徽, 等. 中国肺康复领域研究可视化分析. 兰州大学学报(医学版), 2021, 47(3): 8-11,16.
13.	王韵华, 陈永聪, 田金徽, 等. 海拔与老年人身心健康关系研究可视化分析. 兰州大学学报(医学版), 2021, 47(4): 7-11.
14.	龙子临, 赵厚宇, 廖星, 等. 基于Bibliometrix分析2017-2022年国内外中医药疗效评价队列研究的现状与趋势. 中医杂志, 2024, 65(7): 737-744.
15.	钟志涛, 龙琼, 赵敏. 基于Bibliometrix软件可视化分析2002至2021年百草枯中毒研究的全球趋势. 中国急救医学, 2022, 42(12): 1050-1054.
16.	Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "core outcome set" - a practical guideline. Trials, 2016, 17(1): 449.
17.	邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
18.	张明妍, 张俊华, 张伯礼, 等. 中医药临床试验核心指标集研制技术规范. 中华中医药杂志, 2021, 36(2): 924-928.
19.	张俊华, 王海南. 临床评价核心指标集研究方法与实践. 上海: 上海科学技术出版社, 2021.
20.	强晓钰, 季昭臣, 生晓迪, 等. 核心指标集方法学研究进展. 上海中医药杂志, 2022, 56(8): 113-117.
21.	赵文芳. 基于GRADE分级工具系统评价针灸临床证据质量及核心指标集构建: 肠易激综合征. 南昌: 江西中医药大学. 2024.
22.	秦懿囡, 徐天宇, 李泽鑫, 等. 初步构建针刺治疗特发性面神经麻痹核心结局指标集. 世界科学技术-中医药现代化, 2023, 25(3): 1069-1077.
23.	白杨, 宏亚丽, 陈波, 等. 针灸治疗粘连性肩关节囊炎临床研究核心结局指标集的构建方法. 中国针灸, 2023, 43(6): 701-705.
24.	崔莹. 基于GRADE分级工具系统评价针灸临床证据质量及核心指标集构建: 原发性抑郁症. 天津: 天津中医药大学, 2022.
25.	李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
26.	李心怡. 针刺治疗偏头痛临床研究核心结局指标集的建立. 北京: 北京中医药大学, 2020.
27.	秦文秀, 许军峰, 高莹, 等. 近5年针刺治疗中风后痉挛性偏瘫随机对照试验结局指标的现存问题分析. 针灸临床杂志, 2023, 39(12): 42-50.
28.	罗辉, 廖星, 王茜. 中医证候积分在疗效评价中的应用: 基于240项随机对照试验的比较研究. 中国中西医结合杂志, 2015, 35(10): 1261-1266.
29.	陈智慧, 张会永, 裴宇鹏, 等. 基于中医证候量表探讨建立智能化中医药临床决策与疗效评价模式的设想. 北京中医药大学学报, 2021, 44(3): 221-225.
30.	Li G, Han R, Lin M, et al. Developing a core outcome set for clinical trials of chinese medicine for hyperlipidemia. Front Pharmacol, 2022, 13: 847101.
31.	谢倩文, 肖晶旻, 邓雪仪, 等. 建立中医药治疗缺血性卒中核心结局指标集的初步研究. 中医杂志, 2022, 63(3): 220-228.
32.	邱幸莹, 唐淇, 曹文聪, 等. 中医药领域核心结局指标集研究的概况性评价. 中国循证医学杂志, 2023, 23(12): 1419-1427.
33.	Lei R, Shen Q, Yang B, et al. Core outcome sets in child health: a systematic review. JAMA Pediatr, 2022, 176(11): 1131-1141.
34.	Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-standardised protocol items: the COS-STAP statement. Trials, 2019, 20(1): 116.
35.	Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-standards for reporting: the COS-STAR statement. PLoS Med, 2016, 13(10): e1002148.
36.	Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol, 2018, 96: 84-92.
37.	Goren K, Monsour A, Stallwood E, et al. Pediatric core outcome sets had deficiencies and lacked child and family input: a methodological review. J Clin Epidemiol, 2023, 155: 13-21.
38.	Gargon E, Crew R, Burnside G, et al. Higher number of items associated with significantly lower response rates in COS Delphi surveys. J Clin Epidemiol, 2019, 108: 110-120.
39.	Hall DA, Smith H, Heffernan E, et al. Recruiting and retaining participants in e-Delphi surveys for core outcome set development: evaluating the COMiT'ID study. PLoS One, 2018, 13(7): e0201378.
40.	Fish R, MacLennan S, Alkhaffaf B, et al. "Vicarious thinking" was a key driver of score change in Delphi surveys for COS development and is facilitated by feedback of results. J Clin Epidemiol, 2020, 128: 118-129.
41.	Brookes ST, Macefield RC, Williamson PR, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials, 2016, 17(1): 409.
42.	Remus A, Smith V, Wuytack F. Methodology in core outcome set (COS) development: the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study. BMC Med Res Methodol, 2021, 21(1): 10.
43.	Chernyshov PV, Evers AWM, Bewley A, et al. Quality of life assessment in core outcome sets: a position statement of the EADV Task Force on quality of life and patient oriented outcomes. J Eur Acad Dermatol Venereol, 2022, 36(1): 20-23.
44.	Marron SE, Chernyshov PV, Tomas-Aragones L. Quality-of-life research in acne vulgaris: current status and future directions. Am J Clin Dermatol, 2019, 20(4): 527-538.
45.	Bova G, Domenichiello A, Letzen JE, et al. Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process. EClinicalMedicine, 2023, 66: 102340.
46.	Hughes KL, Clarke M, Williamson PR. A systematic review finds Core Outcome Set uptake varies widely across different areas of health. J Clin Epidemiol, 2021, 129: 114-123.
47.	Qiu R, Han S, Wei X, et al. Development of a Core Outcome Set for the benefits and adverse events of acute heart failure in clinical trials of traditional chinese medicine and western medicine: a study protocol. Front Med (Lausanne), 2021, 8: 677068.
48.	Qiu R, Wan S, Guan Z, et al. The key elements and application of a master protocol in the development of the core outcome set. J Evid Based Med, 2022, 15(4): 320-327.

1. Kirkham JJ, Clarke M, Williamson PR. A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials. gov: findings from a review of randomised controlled trials of rheumatoid arthritis. BMJ, 2017, 357: j2262.
2. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
3. Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
4. Blackwood B, Marshall J, Rose L. Progress on core outcome sets for critical care research. Curr Opin Crit Care, 2015, 21(5): 439-444.
5. 邱瑞瑾, 陈诗琪, 韩松洁, 等. 基于COMET数据库的核心指标集研究现状及进展. 中国循证医学杂志, 2019, 19(5): 622-629.
6. 史纪元, 高亚, 马新萍, 等. COMET数据库核心指标集研究现状剖析. 中国医药导刊, 2020, 22(1): 53-58.
7. van Eck NJ, Waltman L. Software survey: VOSviewer, a computer program for bibliometric mapping. Scientometrics, 2010, 84(2): 523-538.
8. 李昊, 潘宇光, 王磊. Bibliometrix: 一款新的基于R语言的文献计量软件介绍与评价. 大学图书情报学刊, 2018, 36(4): 93-104.
9. 史纪元, 罗家音, 王雪莲, 等. 国内外人工智能护理相关研究热点和趋势分析. 军事护理, 2023, 40(7): 16-19.
10. 史纪元, 田金徽, 高亚, 等. 人工智能临床研究文献科学计量学分析. 协和医学杂志, 2022, 13(5): 871-879.
11. 陈亚敏, 程露颖, 郑卿勇, 等. 人工智能与神经科学研究主题分析. 兰州大学学报(医学版), 2022, 48(3): 59-65.
12. 霍少娟, 廖婷, 田金徽, 等. 中国肺康复领域研究可视化分析. 兰州大学学报(医学版), 2021, 47(3): 8-11,16.
13. 王韵华, 陈永聪, 田金徽, 等. 海拔与老年人身心健康关系研究可视化分析. 兰州大学学报(医学版), 2021, 47(4): 7-11.
14. 龙子临, 赵厚宇, 廖星, 等. 基于Bibliometrix分析2017-2022年国内外中医药疗效评价队列研究的现状与趋势. 中医杂志, 2024, 65(7): 737-744.
15. 钟志涛, 龙琼, 赵敏. 基于Bibliometrix软件可视化分析2002至2021年百草枯中毒研究的全球趋势. 中国急救医学, 2022, 42(12): 1050-1054.
16. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "core outcome set" - a practical guideline. Trials, 2016, 17(1): 449.
17. 邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
18. 张明妍, 张俊华, 张伯礼, 等. 中医药临床试验核心指标集研制技术规范. 中华中医药杂志, 2021, 36(2): 924-928.
19. 张俊华, 王海南. 临床评价核心指标集研究方法与实践. 上海: 上海科学技术出版社, 2021.
20. 强晓钰, 季昭臣, 生晓迪, 等. 核心指标集方法学研究进展. 上海中医药杂志, 2022, 56(8): 113-117.
21. 赵文芳. 基于GRADE分级工具系统评价针灸临床证据质量及核心指标集构建: 肠易激综合征. 南昌: 江西中医药大学. 2024.
22. 秦懿囡, 徐天宇, 李泽鑫, 等. 初步构建针刺治疗特发性面神经麻痹核心结局指标集. 世界科学技术-中医药现代化, 2023, 25(3): 1069-1077.
23. 白杨, 宏亚丽, 陈波, 等. 针灸治疗粘连性肩关节囊炎临床研究核心结局指标集的构建方法. 中国针灸, 2023, 43(6): 701-705.
24. 崔莹. 基于GRADE分级工具系统评价针灸临床证据质量及核心指标集构建: 原发性抑郁症. 天津: 天津中医药大学, 2022.
25. 李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
26. 李心怡. 针刺治疗偏头痛临床研究核心结局指标集的建立. 北京: 北京中医药大学, 2020.
27. 秦文秀, 许军峰, 高莹, 等. 近5年针刺治疗中风后痉挛性偏瘫随机对照试验结局指标的现存问题分析. 针灸临床杂志, 2023, 39(12): 42-50.
28. 罗辉, 廖星, 王茜. 中医证候积分在疗效评价中的应用: 基于240项随机对照试验的比较研究. 中国中西医结合杂志, 2015, 35(10): 1261-1266.
29. 陈智慧, 张会永, 裴宇鹏, 等. 基于中医证候量表探讨建立智能化中医药临床决策与疗效评价模式的设想. 北京中医药大学学报, 2021, 44(3): 221-225.
30. Li G, Han R, Lin M, et al. Developing a core outcome set for clinical trials of chinese medicine for hyperlipidemia. Front Pharmacol, 2022, 13: 847101.
31. 谢倩文, 肖晶旻, 邓雪仪, 等. 建立中医药治疗缺血性卒中核心结局指标集的初步研究. 中医杂志, 2022, 63(3): 220-228.
32. 邱幸莹, 唐淇, 曹文聪, 等. 中医药领域核心结局指标集研究的概况性评价. 中国循证医学杂志, 2023, 23(12): 1419-1427.
33. Lei R, Shen Q, Yang B, et al. Core outcome sets in child health: a systematic review. JAMA Pediatr, 2022, 176(11): 1131-1141.
34. Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-standardised protocol items: the COS-STAP statement. Trials, 2019, 20(1): 116.
35. Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-standards for reporting: the COS-STAR statement. PLoS Med, 2016, 13(10): e1002148.
36. Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol, 2018, 96: 84-92.
37. Goren K, Monsour A, Stallwood E, et al. Pediatric core outcome sets had deficiencies and lacked child and family input: a methodological review. J Clin Epidemiol, 2023, 155: 13-21.
38. Gargon E, Crew R, Burnside G, et al. Higher number of items associated with significantly lower response rates in COS Delphi surveys. J Clin Epidemiol, 2019, 108: 110-120.
39. Hall DA, Smith H, Heffernan E, et al. Recruiting and retaining participants in e-Delphi surveys for core outcome set development: evaluating the COMiT'ID study. PLoS One, 2018, 13(7): e0201378.
40. Fish R, MacLennan S, Alkhaffaf B, et al. "Vicarious thinking" was a key driver of score change in Delphi surveys for COS development and is facilitated by feedback of results. J Clin Epidemiol, 2020, 128: 118-129.
41. Brookes ST, Macefield RC, Williamson PR, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials, 2016, 17(1): 409.
42. Remus A, Smith V, Wuytack F. Methodology in core outcome set (COS) development: the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study. BMC Med Res Methodol, 2021, 21(1): 10.
43. Chernyshov PV, Evers AWM, Bewley A, et al. Quality of life assessment in core outcome sets: a position statement of the EADV Task Force on quality of life and patient oriented outcomes. J Eur Acad Dermatol Venereol, 2022, 36(1): 20-23.
44. Marron SE, Chernyshov PV, Tomas-Aragones L. Quality-of-life research in acne vulgaris: current status and future directions. Am J Clin Dermatol, 2019, 20(4): 527-538.
45. Bova G, Domenichiello A, Letzen JE, et al. Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process. EClinicalMedicine, 2023, 66: 102340.
46. Hughes KL, Clarke M, Williamson PR. A systematic review finds Core Outcome Set uptake varies widely across different areas of health. J Clin Epidemiol, 2021, 129: 114-123.
47. Qiu R, Han S, Wei X, et al. Development of a Core Outcome Set for the benefits and adverse events of acute heart failure in clinical trials of traditional chinese medicine and western medicine: a study protocol. Front Med (Lausanne), 2021, 8: 677068.
48. Qiu R, Wan S, Guan Z, et al. The key elements and application of a master protocol in the development of the core outcome set. J Evid Based Med, 2022, 15(4): 320-327.

Chinese Journal of Evidence-Based Medicine

Latest ArticlesAnalysis of research hotspots and trends in core outcome set from 2015 to 2024

Abstract Full text Figures/Tables Video References Cited by

Format

Content