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Research on evidence-based social intervention guidelines and standards Ⅰ: developing standards based on evidence-based concepts

Published on Jan. 31, 2024Total Views: 14608 timesTotal Downloads: 3559 timesDownloadMobile

Author: BAI Zhenggang 1, 2# ZHU Yumeng1 2# CHEN Hao 3 GAI Qiongyan 4 ZENG Xiantao 5 SHI Nannan 6 Campbell China Network

Affiliation: 1. Evidence-Based Research Center of Social Science & Health, Nanjing University of Science and Technology, Nanjing 210094, China 2. School of Public Affairs, Nanjing University of Science and Technology, Nanjing 210094, China 3. School of Acupuncture-Moxibustionand Tuina, School of Rehabilitationand Health Preservation, Nanjing University of Chinese Medicine, Nanjing 210023, China 4. Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China 5. Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China 6. Institute of Basic Research in Clinical Medicine , China Academy of Chinese Medical Sciences, Beijing 100700, China

Keywords: Evidence-based principle Standard Methodology

DOI: 10.12173/j.issn.1004-5511.202310017

Reference: Bai ZG, Zhu YM, Chen H, Gai QY, Zeng XT, Shi NN, Campbell China Network. Research on evidence-based social intervention guidelines and standards Ⅰ: developing standards based on evidence-based concepts[J]. Yixue Xinzhi Zazhi, 2024, 34(1): 53-63. DOI: 10.12173/j.issn.1004-5511.202310017.[Article in Chinese]

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Abstract

This paper presents the procedures of the International Organization for Standardization, the National Institute for Health and Clinical Excellence, and the American Society for Testing and Materials in developing standards, and discusses how to develop standards based on evidence-based principles. The development of standards needs to be carried out by a standards development committee, a standards development group and a standards implementation evaluation group. In the process of developing standards, it is crucial to improve the transparency and scientific basis of the standard-setting process and to establish a progressive system for standard development and services. To ensure inclusion of multiple stakeholders and representative interests, there should also be an improvement in the roles of standard-setting committees and industry associations. Furthermore, standard tracking and evaluation should be carried out to continuously monitor the implementation and effectiveness of standards so that revisions and improvements can be made.

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1.中华人民共和国中央人民政府.《中国标准化发展年度报告（2022年）》发布 去年新增881项标准成为“领跑者”[EB/OL].(2023-04-20) [2023-10-27].https://www.gov.cn/lianbo/2023-04/20/content_5752306.htm.

2.Smith R, Rennie D. Evidence based medicine-an oral history[J]. JAMA, 2014, 311(4): 365-367. DOI: 10.1001/jama.2013.286182.

3.林珊,屈会起,张金钟,等. 循证医学与医疗技术标准的制定[J]. 中华医院管理杂志, 2000, 16(6): 332-334. [Lin S, Qu HQ, Zhang JZ, et al. Evidence-based medicine and the formulation of medical technology standards[J]. Chinese Journal of Hospital Administration, 2000, 16(6): 332-334.] DOI: 10.3760/j.issn:1000-6672.2000.06.004.

4.周坚锋. 对标准和标准化工作的一些认识和思考[J]. 中国标准化, 2020(5): 26-29. [Zhou JF. Some understandings and thoughts on standards and standardization work[J]. China Standardization, 2020(5): 26-29.] DOI: 10.3969/j.issn.1002-5944.2020.05.006.

5.中华人民共和国自然资源部.《国际标准化组织(ISO)简介及组织机构》[EB/OL].（2013-10-14）[2023-08-07]. https://www.mnr.gov.cn/zt/kj/kjfz/bzh/201310/t20131014_2369523.html.

6.刘荣. 小议标准的概念及标准的内涵[J]. 航天标准化, 2012(3): 46-47. [Liu R. Brief discussion on the concept and connotation of standards[J]. Aerospace Standardization, 2012(3): 46-47.] DOI: 10.3969/j.issn.1009-234X.2012.03.011.

7.黄超,孔东池,程书栋,等. 国内外对标准定义和类型的比较和思考[J]. 中国卫生标准管理,2020, 11(7):1-3. [Huang C, Kong DC, Cheng SD, et al. Comparison and reflection on the definition and types of standard at home and abroad[J]. Chin Heal standard management, 2020, 11(7): 1-3.] DOI: 10.3969/j.issn.1674-9316.2020.07.001.

8.徐延君. 全面提升标准化工作质量[J]. 中国社会保障, 2016(11): 28-29. [Xu YJ. Enhancing the quality of standardization work in all aspects[J]. China Social Security, 2016(11): 28-29.] DOI: 10.3969/j.issn.1008-4304.2016.11.008.

9.张东风.国家食药监管总局主要职责确定[J].中医药管理杂志, 2013, 21(5): 463. [Zhang DF. Determination of the main responsibilities of the National Medical Products Administration[J]. Journal of Traditional Chinese Medicine Management, 2013, 21(5): 463.] DOI: 10.16690/j.cnki.1007-9203.2013.05.007.

10.国家中医药管理局.机构职能[EB/OL].(2020-11-11) [2023-08-19].http://www.natcm.gov.cn/zhengcewenjian/zhengfuxinxigongkai/2021-12-24/23778.html

11.ISO.My ISO job - What delegates and experts need to know[EB/OL]. [2023-08-27]. https://www.iso.org/publication/PUB100037.html

12.ISO. Developing standards[EB/OL]. [2023-08-27].  https://www.iso.org/developing-standards.html

13.ISO. ISO 9001 and related standards[EB/OL]. [2023-08-27]. https://www.iso.org/iso-9001-quality-management.html

14.NICE.Timeline for developing quality standards[EB/OL]. [2023-08-27]. https://www.nice.org.uk/standards-and-indicators/timeline-developing-quality-standards

15.NICE. Standards and indicators[EB/OL]. [2023-08-27]. https://www.nice.org.uk/standards-and-indicators

16.NICE. Timeline for developing quality standards《National institute for health and care excellence: health and social care directorate quality standards process guide》[EB/OL].[2023-08-27].https://www.nice.org.uk/standards-and-indicators/timeline-developing-quality-standards

17.李悦菱,廖晓曼,旻苏. ASTM医疗器械标准分类及转化现状分析[J]. 标准科学, 2014(5): 82-86. [Li YL, Liao XM, Min S. Analysis of ASTM medical device standard classification and its conversion status[J]. Standard Science, 2014(5): 82-86.] DOI: 10.3969/j.issn.1674-5698.2014.05.021.

18.ASTM. About ASTM[EB/OL]. [2023-08-27]. https://cn.astm.org/zh/about/

19.ASTM. Key documents and forms《Form and style manual for ASTM standards or “blue book”》[EB/OL]. [2023-08-27]. https://www.astm.org/get-involved/technical-committees/key-documents.html

20.周立军,王美萍. 国外团体标准发展经验研究 ——以ASTM国际标准组织为例[J]. 标准科学, 2016(10): 106-110, 120.  [Zhou, LJ Wang MP. Study on the development experience of foreign group standards——a case study of ASTM in the United States[J]. Standard Science, 2016(10): 106-110, 120.] DOI: 10.3969/j.issn.1674-5698.2016.10.022.

21.ASTM. What is ASTM[EB/OL]. [2023-08-27]. https://www.astm.org/get-involved/consumer-participation/what-is-astm.html.

22.ASTM. Lead-based paint as a major source of childhood lead poisoning: a review of the evidence[EB/OL]. [2023-08-27]. https://www.astm.org/stp12974s.html

23.鲍玉荣,李林,何宇,等. 医院管理标准化的国际经验借鉴[J]. 中国医院, 2013(8): 13-15. [Bao YR, Li L, He Y, et al. Reference on international experience of medical management standardization[J]. Chinese Hospital, 2013(8): 13-15.] DOI: 10.3969/j.issn.1671-0592.2013.08.010.

24.Richardson WS, Wilson MC, Nishikawa J, et al. The well-built clinical question: a key to evidence-based decisions[J]. ACP journal club, 1995, 123(3): A12-13. DOI: 10.7326/ACPJC-1995-123-3-A12.

25.Dicenso A , Bayley L , Haynes RB. Pre appraised: accessing preappraised evidence: fine-tuning the 5S model into a 6S model.[J]. Evid Based Nurs, 2009, 151(6): 99-101. DOI: 10.1136/ebn.12.4.99-b.

26.Higgins JPT，Greens. Cochrane handbook for systematic reviews of interventions[DB/OL]. [2023-08-27].https://training.cochrane.org/handbook.

27.马佩芬,李玲玲,豆欣蔓.某非随机干预性研究偏倚风险评估工具及使用方法的解读[J].中华护理教育, 2021, 18(2): 187-192. [Ma PF, Li LL, Dou XM. The interpretation and its use method of a tool of risk of bias in non-randomized studies of interventions[J]. Chinese Journal of Nursing Education, 2021, 18(2): 187-192.] DOI: 10.3761/j.issn.1672-9234.2021.02.019.

28.陈匡阳,马彬, 王亚楠, 等. SYRCLE动物实验偏倚风险评估工具简介[J].中国循证医学杂志, 2014, 14(10): 1281-1285. [Chen KY, Ma B, Wang YN, et al. SYRCLE's risk of bias tool for animal studies[J]. Chin J Evid-Based Med, 2014, 14(10): 1281-1285.] DOI: 10.7507/1672-2531.20140206.

29.葛龙,潘蓓,潘佳雪, 等.解读AMSTAR-2——基于随机和(或)非随机对照试验系统评价的质量评价工具[J].中国药物评价, 2017, 34(5): 334-338. [Ge L,Pan B, Pan JX, et al. An introduction of AMSTAR-2: a quality assessment instrument of systematic reviews including randomized or non-randomized controlled trials or both[J].Chinese Journal of Drug Evaluation, 2017, 34(5): 334-338.] DOI: 10.3969/j.issn.2095-3593.2017.05.005.

30.韦当,王聪尧,肖晓娟, 等.指南研究与评价(AGREE Ⅱ)工具实例解读[J].中国循证儿科杂志, 2013, 8(4): 316-319. [Wer D, Wang CY, Xiao XJ, et al. Tools of appraisal of guidelines for research & evaluation (AGREE Ⅱ) instrument: case explanation[J]. Chin J Evid Based Pediatr, 2013, 8(4): 316-319.] DOI: 10.3969/j.issn.1673-5501.2013. 04.017.

31.李柄辉，訾豪，李路遥, 等. 医学领域一次研究和二次研究的方法学质量（偏倚风险）评价工具[J]. 医学新知, 2021, 31(1): 51-58. [Li BH, Zi H, Li LY, et al. Methodological quality(risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better?[J]. Yixue Xinzhi Zazhi, 2021, 31(1): 51-58.] DOI: 10.12173/j.issn.1004-5511.2021.01.07.

32.陈耀龙,姚亮, Susan N,等. GRADE在系统评价中应用的必要性及注意事项[J].中国循证医学杂志, 2013,  13(12): 1401-1404. [Chen YL, Yao L, Susan N, et al. Application of GRADE in systematic reviews: necessity, frequently-asked questions and concerns [J]. Chin J Evid-Based Med, 2013, 13(12): 1401-1404.] DOI: 10.7507/1672-2531.20130240.

33.NICE. Type 2 diabetes in adults[EB/OL]. [2023-08-27]. https://www.nice.org.uk/guidance/qs209

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