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：

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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, 陳詩琪, 韓松潔, 等. 基于COMET數據庫的核心指標集研究現狀及進展. 中國循證醫學雜志, 2019, 19(5): 622-629.
6.	史紀元, 高亞, 馬新萍, 等. COMET數據庫核心指標集研究現狀剖析. 中國醫藥導刊, 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語言的文獻計量軟件介紹與評價. 大學圖書情報學刊, 2018, 36(4): 93-104.
9.	史紀元, 羅家音, 王雪蓮, 等. 國內外人工智能護理相關研究熱點和趨勢分析. 軍事護理, 2023, 40(7): 16-19.
10.	史紀元, 田金徽, 高亞, 等. 人工智能臨床研究文獻科學計量學分析. 協和醫學雜志, 2022, 13(5): 871-879.
11.	陳亞敏, 程露穎, 鄭卿勇, 等. 人工智能與神經科學研究主題分析. 蘭州大學學報(醫學版), 2022, 48(3): 59-65.
12.	霍少娟, 廖婷, 田金徽, 等. 中國肺康復領域研究可視化分析. 蘭州大學學報(醫學版), 2021, 47(3): 8-11,16.
13.	王韻華, 陳永聰, 田金徽, 等. 海拔與老年人身心健康關系研究可視化分析. 蘭州大學學報(醫學版), 2021, 47(4): 7-11.
14.	龍子臨, 趙厚宇, 廖星, 等. 基于Bibliometrix分析2017-2022年國內外中醫藥療效評價隊列研究的現狀與趨勢. 中醫雜志, 2024, 65(7): 737-744.
15.	鐘志濤, 龍瓊, 趙敏. 基于Bibliometrix軟件可視化分析2002至2021年百草枯中毒研究的全球趨勢. 中國急救醫學, 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, 張俊華, 張伯禮. 中醫臨床研究核心結局指標集形成路徑. 中華中醫藥雜志, 2014, 29(5): 1352-1355.
18.	張明妍, 張俊華, 張伯禮, 等. 中醫藥臨床試驗核心指標集研制技術規范. 中華中醫藥雜志, 2021, 36(2): 924-928.
19.	張俊華, 王海南. 臨床評價核心指標集研究方法與實踐. 上海: 上海科學技術出版社, 2021.
20.	強曉鈺, 季昭臣, 生曉迪, 等. 核心指標集方法學研究進展. 上海中醫藥雜志, 2022, 56(8): 113-117.
21.	趙文芳. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 腸易激綜合征. 南昌: 江西中醫藥大學. 2024.
22.	秦懿囡, 徐天宇, 李澤鑫, 等. 初步構建針刺治療特發性面神經麻痹核心結局指標集. 世界科學技術-中醫藥現代化, 2023, 25(3): 1069-1077.
23.	白楊, 宏亞麗, 陳波, 等. 針灸治療粘連性肩關節囊炎臨床研究核心結局指標集的構建方法. 中國針灸, 2023, 43(6): 701-705.
24.	崔瑩. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 原發性抑郁癥. 天津: 天津中醫藥大學, 2022.
25.	李心怡, 石兆峰, 胡嘉元, 等. 針刺治療偏頭痛核心結局指標集的建立. 世界科學技術-中醫藥現代化, 2020, 22(1): 7-12.
26.	李心怡. 針刺治療偏頭痛臨床研究核心結局指標集的建立. 北京: 北京中醫藥大學, 2020.
27.	秦文秀, 許軍峰, 高瑩, 等. 近5年針刺治療中風后痙攣性偏癱隨機對照試驗結局指標的現存問題分析. 針灸臨床雜志, 2023, 39(12): 42-50.
28.	羅輝, 廖星, 王茜. 中醫證候積分在療效評價中的應用: 基于240項隨機對照試驗的比較研究. 中國中西醫結合雜志, 2015, 35(10): 1261-1266.
29.	陳智慧, 張會永, 裴宇鵬, 等. 基于中醫證候量表探討建立智能化中醫藥臨床決策與療效評價模式的設想. 北京中醫藥大學學報, 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.	謝倩文, 肖晶旻, 鄧雪儀, 等. 建立中醫藥治療缺血性卒中核心結局指標集的初步研究. 中醫雜志, 2022, 63(3): 220-228.
32.	邱幸瑩, 唐淇, 曹文聰, 等. 中醫藥領域核心結局指標集研究的概況性評價. 中國循證醫學雜志, 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, 陳詩琪, 韓松潔, 等. 基于COMET數據庫的核心指標集研究現狀及進展. 中國循證醫學雜志, 2019, 19(5): 622-629.
6. 史紀元, 高亞, 馬新萍, 等. COMET數據庫核心指標集研究現狀剖析. 中國醫藥導刊, 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語言的文獻計量軟件介紹與評價. 大學圖書情報學刊, 2018, 36(4): 93-104.
9. 史紀元, 羅家音, 王雪蓮, 等. 國內外人工智能護理相關研究熱點和趨勢分析. 軍事護理, 2023, 40(7): 16-19.
10. 史紀元, 田金徽, 高亞, 等. 人工智能臨床研究文獻科學計量學分析. 協和醫學雜志, 2022, 13(5): 871-879.
11. 陳亞敏, 程露穎, 鄭卿勇, 等. 人工智能與神經科學研究主題分析. 蘭州大學學報(醫學版), 2022, 48(3): 59-65.
12. 霍少娟, 廖婷, 田金徽, 等. 中國肺康復領域研究可視化分析. 蘭州大學學報(醫學版), 2021, 47(3): 8-11,16.
13. 王韻華, 陳永聰, 田金徽, 等. 海拔與老年人身心健康關系研究可視化分析. 蘭州大學學報(醫學版), 2021, 47(4): 7-11.
14. 龍子臨, 趙厚宇, 廖星, 等. 基于Bibliometrix分析2017-2022年國內外中醫藥療效評價隊列研究的現狀與趨勢. 中醫雜志, 2024, 65(7): 737-744.
15. 鐘志濤, 龍瓊, 趙敏. 基于Bibliometrix軟件可視化分析2002至2021年百草枯中毒研究的全球趨勢. 中國急救醫學, 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, 張俊華, 張伯禮. 中醫臨床研究核心結局指標集形成路徑. 中華中醫藥雜志, 2014, 29(5): 1352-1355.
18. 張明妍, 張俊華, 張伯禮, 等. 中醫藥臨床試驗核心指標集研制技術規范. 中華中醫藥雜志, 2021, 36(2): 924-928.
19. 張俊華, 王海南. 臨床評價核心指標集研究方法與實踐. 上海: 上海科學技術出版社, 2021.
20. 強曉鈺, 季昭臣, 生曉迪, 等. 核心指標集方法學研究進展. 上海中醫藥雜志, 2022, 56(8): 113-117.
21. 趙文芳. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 腸易激綜合征. 南昌: 江西中醫藥大學. 2024.
22. 秦懿囡, 徐天宇, 李澤鑫, 等. 初步構建針刺治療特發性面神經麻痹核心結局指標集. 世界科學技術-中醫藥現代化, 2023, 25(3): 1069-1077.
23. 白楊, 宏亞麗, 陳波, 等. 針灸治療粘連性肩關節囊炎臨床研究核心結局指標集的構建方法. 中國針灸, 2023, 43(6): 701-705.
24. 崔瑩. 基于GRADE分級工具系統評價針灸臨床證據質量及核心指標集構建: 原發性抑郁癥. 天津: 天津中醫藥大學, 2022.
25. 李心怡, 石兆峰, 胡嘉元, 等. 針刺治療偏頭痛核心結局指標集的建立. 世界科學技術-中醫藥現代化, 2020, 22(1): 7-12.
26. 李心怡. 針刺治療偏頭痛臨床研究核心結局指標集的建立. 北京: 北京中醫藥大學, 2020.
27. 秦文秀, 許軍峰, 高瑩, 等. 近5年針刺治療中風后痙攣性偏癱隨機對照試驗結局指標的現存問題分析. 針灸臨床雜志, 2023, 39(12): 42-50.
28. 羅輝, 廖星, 王茜. 中醫證候積分在療效評價中的應用: 基于240項隨機對照試驗的比較研究. 中國中西醫結合雜志, 2015, 35(10): 1261-1266.
29. 陳智慧, 張會永, 裴宇鵬, 等. 基于中醫證候量表探討建立智能化中醫藥臨床決策與療效評價模式的設想. 北京中醫藥大學學報, 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. 謝倩文, 肖晶旻, 鄧雪儀, 等. 建立中醫藥治療缺血性卒中核心結局指標集的初步研究. 中醫雜志, 2022, 63(3): 220-228.
32. 邱幸瑩, 唐淇, 曹文聰, 等. 中醫藥領域核心結局指標集研究的概況性評價. 中國循證醫學雜志, 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.

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