Objective  To systematically evaluate the methodological and reporting quality of domestic and international guidelines and consensus on multiple sclerosis (MS).

Methods  CNKI, WanFang, VIP, CBM, PubMed, Embase, NGC, NICE, GIN, and Medlive were searched from January 1, 2013, to May 31, 2024. Two reviewers independently assessed the methodological and reporting quality of the included guidelines and consensus using the AGREE Ⅱ and RIGHT tools, respectively. The intraclass correlation coefficient (ICC) was used to evaluate consistency.

Results  A total of 10 guidelines and 11 consensus were included. These were published between 2015 and 2024, in various countries including China, the United States, the United Kingdom and France. The ICC values for the two tools were both > 0.75. In terms of AGREE Ⅱ methodological quality assessment, the average standardized scores in the domains of scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence were 85.58%, 61.77%, 43.40%, 89.42%, 61.01%, and 68.25%, respectively. The scores across various fields are as follows: 4 guidelines rated as A, 17 guidelines rated as B, and none rated as C. Four high-quality guidelines were identified. The average reporting rate for RIGHT was 57.79%. In terms of RIGHT reporting quality, the reporting rates for basic information, background, evidence, recommendations, review and quality assurance, funding, declaration and management of interest, and other information were 80.16%, 68.90%, 24.05%, 66.67%, 19.05%, 53.27%, and 50.79%, respectively.

Conclusion  The overall quality of the included MS guidelines/consensuses is moderate, and the methodological and reporting quality needs further improvement. Future development of MS guidelines and consensus should adhere strictly to international standards to ensure high-quality guidelines that provide clear and standardized guidance for clinical practice.

1.Noseworthy JH, Lucchinetti C, Rodriguez M, et al. Multiple sclerosis[J]. N Engl J Med, 2000, 343(13): 938-952. DOI: 10.1056/NEJM200009283431307.

2.Tian DC, Zhang C, Yuan M, et al. Incidence of multiple sclerosis in China: a nationwide hospital-based study[J]. Lancet Reg Health West Pac, 2020, 1: 100010. DOI: 10.1016/j.lanwpc.2020.100010.

3.国家卫生健康委员会, 科学技术部, 工业和信息化部, 等. 关于公布第一批罕见病目录的通知[EB/OL].(2018-05-11) [2024-10-06]. http://www.gov.cn/zhengce/zhengceku/2018-12/31/content_5435167.htm

4.Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust[M]. Washington (DC): National Academies Press (US), 2011. DOI: 10.17226/13058.

5.陈耀龙,罗旭飞,王吉耀,等. 如何区分临床实践指南与专家共识[J]. 协和医学杂志, 2019, 10(4): 403-408. [Chen YL, Luo  XF, Wang JY, et al. How to distinguish between clinical practice guidelines and expert consensus[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(4): 403-408.] DOI: 10.3969/j.issn.1674-9081.2019.04.018.

6.朱迪,罗旭飞,王子君,等. 专家证据、专家意见及专家共识在指南制订中的区别与联系[J]. 协和医学杂志, 2024, 15(4): 936-941. [Zhu D, Luo XF, Wang ZJ, et al. The differences and connections among expert evidence, expert opinion and expert consensus in the development of guidelines[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(4): 936-941.] DOI: 10.12290/xhyxzz.2024-0542.

7.Guo J, Cheng C, Yan W, et al. Systematic review of clinical practice guidelines related to multiple sclerosis[J]. PLoS One, 2014, 9(10): e106762. DOI: 10.1371/journal.pone.0106762.

8.Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care[J]. CMAJ, 2010, 182(18): E839-E842. DOI: 10.1503/cmaj.090449.

9.Chen Y, Yang K, Marušic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement[J]. Ann Intern Med, 2017, 166(2): 128-132. DOI: 10.7326/M16-1565.

10.李雯燕,曾力楠,李思雨,等. 中国儿童临床指南现状分析及循证临床指南质量评价[J]. 中国循证医学杂志, 2021, 21(12): 1450-1456. [Li WY, Zeng LN, Li SY, et al. Analysis on status of clinical guidelines and evaluation of evidence-based clinical guidelines for children in China[J]. Chinese Journal of Evidence-Based Medicine, 2021, 21(12): 1450-1456.] DOI: 10.7507/1672-2531.202108191.

11.Cicchetti DV. Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology[J]. Psychological Assessment, 1994, 6: 284-290. DOI: 10.1037/1040-3590.6.4.284.

12.Scolding N, Barnes D, Cader S, et al. Association of British Neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis[J]. Pract Neurol, 2015, 15(4): 273-279. DOI: 10.1136/practneurol-2015-001139.

13.Vågberg M, Axelsson M, Birgander R, et al. Guidelines for the use of magnetic resonance imaging in diagnosing and monitoring the treatment of multiple sclerosis: recommendations of the Swedish Multiple Sclerosis Association and the Swedish Neuroradiological Society[J]. Acta Neurol Scand, 2017, 135(1): 17-24. DOI: 10.1111/ane.12667.

14.Marques VD, Passos GRD, Mendes MF, et al. Brazilian consensus for the treatment of multiple sclerosis: Brazilian Academy of Neurology and Brazilian Committee on Treatment and Research in Multiple Sclerosis[J]. Arq Neuropsiquiatr, 2018, 76(8): 539-554. DOI: 10.1590/0004-282X20180078.

15.Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology[J]. Neurology, 2018, 90(17): 777-788. DOI: 10.1212/WNL.0000000000005347.

16.Dobson R, Dassan P, Roberts M, et al. UK consensus on pregnancy in multiple sclerosis: 'Association of British Neurologists' guidelines[J]. Practical Neurology, 2019, 19(2): 106-114. DOI: 10.1136/practneurol-2018-002060.

17.Pereira DJ, Abreu P, Reis AM, et al. Consensus recommendations of the multiple sclerosis study group and the Portuguese Neuroradiological Society for the use of magnetic resonance imaging in multiple sclerosis in clinical practice: part 2[J]. Acta Med Port, 2020, 33(1): 66-75. DOI: 10.20344/amp.11532.

18.Bhatia R, Srivastava MVP, Khurana D, et al. Consensus statement on immune modulation in multiple sclerosis and related disorders during the COVID-19 pandemic: expert group on behalf of the Indian Academy of Neurology[J]. Ann Indian Acad Neurol, 2020, 23(Suppl 1): S5-S14. DOI: 10.4103/0972-2327.282442.

19.Wattjes MP, Ciccarelli O, Reich DS, et al. 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis[J]. Lancet Neurol, 2021, 20(8): 653-670. DOI: 10.1016/S1474-4422(21)00095-8.

20.Skromne-Eisenberg E, Treviño-Frenk I, Llamosa García Velázquez GL, et al. Clinical practice patterns in multiple sclerosis management: Mexican consensus recommendations[J]. Mult Scler Relat Disord, 2021, 53: 103053. DOI: 10.1016/j.msard. 2021.103053.

21.Bigaut K, Cohen M, Durand-Dubief F, et al. How to switch disease-modifying treatments in multiple sclerosis: guidelines from the French Multiple Sclerosis Society (SFSEP)[J]. Mult Scler Relat Disord, 2021, 53: 103076. DOI: 10.1016/j.msard.2021.103076.

22.Wiendl H, Gold R, Berger T, et al. Multiple Sclerosis Therapy Consensus Group (MSTCG): position statement on disease-modifying therapies for multiple sclerosis (white paper)[J]. Ther Adv Neurol Disord, 2021, 14: 17562864211039648. DOI: 10.1177/17562864211039648.

23.Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis[J]. Mult Scler, 2018, 24(2): 96-120. DOI: 10.1177/1352458517751049.

24.National Institute for Health and Clinical Excellence (NICE). Multiple sclerosis in adults: management[EB/OL]. (2022-06-22)[2024-10-06]. https://www.nice.org.uk/guidance/ng220

25.Vukusic S, Carra-Dalliere C, Ciron J, et al. Pregnancy and multiple sclerosis: 2022 recommendations from the French Multiple Sclerosis Society[J]. Mult Scler, 2023, 29(1): 11-36. DOI: 10.1177/13524585221129472.

26.中华医学会神经病学分会神经免疫学组. 运用Delphi法对多发性硬化进展评估及诊治综合调研的中国专家共识 [J]. 中华神经科杂志, 2022, 55(4): 300-305. [Neuroimmunology Group, Neurology Branch, Chinese Medical Association. Chinese expert consensus on evaluation, diagnosis and treatment of progression in multiple sclerosis using the Delphi method[J]. Chinese Journal of Neurology, 2022, 55(4): 300-305.] DOI: 10.3760/cma.j.cn113694-20210805-00542.

27.Solomon AJ, Arrambide G, Brownlee WJ, et al. Differential diagnosis of suspected multiple sclerosis: an updated consensus approach[J]. Lancet Neurol, 2023, 22(8): 750-768. DOI: 10.1016/S1474-4422(23)00148-5.

28.Rajda C, Rózsa C, Mike A, et al. Treatment of relapsing multiple sclerosis in Hungary-consensus recommendation from the Hungarian Neuroimmunology Society[J]. Orphanet J Rare Dis, 2023, 18(1): 183. DOI: 10.1186/s13023-023-02789-0.

29.中华医学会放射学分会磁共振学组, 中国医师协会神经内科医师分会. 多发性硬化MRI规范化应用专家共识[J]. 中华放射学杂志, 2023, 57(6): 592-599. [Magnetic Resonance Imaging Group of Chinese Society of Radiology Chinese Medical Association, Chinese Neurology Association of Chinese Medical Doctor Association. Expert consensus on the use of MRI in multiple sclerosis[J]. Chinese Journal of Radiology, 2023, 57(6): 592-599.] DOI: 10.3760/cma.j.cn112149-20230404-00260.

30.Yamout B, Al-Jumah M, Sahraian MA, et al. Consensus recommendations for diagnosis and treatment of multiple sclerosis: 2023 revision of the MENACTRIMS guidelines[J]. Mult Scler Relat Disord, 2024, 83: 105435. DOI: 10.1016/j.msard. 2024.105435.

31.Meca-Lallana JE, Martínez Yélamos S, Eichau S, et al. Consensus statement of the Spanish Society of Neurology on the treatment of multiple sclerosis and holistic patient management in 2023[J]. Neurologia (Engl Ed), 2024, 39(2): 196-208. DOI: 10.1016/j.nrleng. 2024.01.003.

32.中华医学会神经病学分会神经免疫学组. 多发性硬化诊断与治疗中国指南(2023版)[J]. 中华神经科杂志, 2024, 57(1): 10-23. [Neuroimmunology Group, Neurology Branch, Chinese Medical Association. Chinese guidelines for diagnosis and treatment of multiple sclerosis (2023 edition) [J]. Chinese Journal of Neurology, 2024, 57(1): 10-23.] DOI: 10.3760/cma.j.cn113694-20230918-00173.

33.杨楠, 赵巍, 潘旸, 等. 针对临床实践指南科学性、透明性和适用性的评级工具研发[J]. 中华医学杂志, 2022, 102(30): 2329-2337. [Yang N, Zhao W, Pan Y, et al. Development of a tool for evaluating the scientificity, transparency, and applicability of clinical practice guidelines[J]. National Medical Journal of China, 2022, 102(30): 2329-2337.] DOI: 10.3760/cma.j.cn112137-20220219-00340.