目的 依据描述干预措施的清单和报告规范(Template for Intervention Description and Replication,TIDieR)框架,研制针对穴位贴敷临床研究报告质量的具体化报告清单,并运用该具体化清单系统地评价穴位贴敷干预类风湿关节炎(rheumatoid arthritis, RA)临床研究的文献报告质量。为穴位贴敷干预措施报告质量提供一套针对性评估工具,并明确指引穴位贴敷干预RA临床研究报告质量的优化方向。方法 通过焦点小组讨论法、试提取、专家共识会议法,构建基于TIDieR的穴位贴敷具体化报告清单;计算机检索中国知网、万方数据知识平台、维普数据库、中国生物医学文献数据库、PubMed、Web of science、Cochrane Library、CINAHL及Embase数据库,检索时限从建库至2024年4月30日,应用上述具体化报告清单评价文献报告质量,主要包括各条目报告与否及报告清楚程度。结果 TIDieR清单12个条目经具体化后共计30个要点;共纳入125篇文献,发文数量整体呈上升趋势,评价结果显示报告率低于10%的条目为条目5、10、11,报告清楚的比例低于10%的条目为条目3、4、5、11、12。结论 根据TIDieR清单对穴位贴敷干预RA相关文献的干预措施报告质量进行评价,报告完整性有待提高,建议未来的研究应更加重视依据TIDieR标准来规范研究报告。
Abstract
Objective To develop a specific checklist for the quality of clinical studies reoirts on acupoint application therapy based on the framework of Template for Intervention Description and Replication (TIDieR) checklist, to systematically evaluate the quality of clinical studies reports on acupoint application therapy in rheumatoid arthritis (RA) using this specific checklist, to provide a targeted evaluation tool for the quality of acupoint application intervention reports, and to clarify the optimization direction for the quality of clinical studies reports on acupoint application theory in RA. Methods Using focus group discussion, trial extraction and expert consensus meetings, a specific checklist for acupoint application therapy based on TIDieR was constructed; Computer searches were conducted for clinical studies reports in CNKI, Wanfang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, CINAHL, and Embase. The retrieval period spanned from the inception of the databases to April 30, 2024. The constructed checklist was used to evaluate the quality of the reports, mainly including whether each item was reported and the clarity of the report. Results After concretizing the 12 items on the TIDieR checklist, 30 key points were identified; 125 articles were included, and the overall number of publications showed an upward trend. The evaluation results showed that items with reporting rates below 10% were 5, 10, and 11, while those with clear reporting proportions under 10% included 3, 4, 5, 11, and 12. Conclusion Based on the TIDieR checklist, the quality of reports for acupoint application therapy in RA is evaluated, and the completeness of the reports needs to be improved, suggesting future studies should pay more attention to standardize studies reports according to the TIDieR.
关键词
穴位贴敷 /
类风湿关节炎 /
报告质量 /
TIDieR
Key words
acupoint application therapy /
rheumatoid arthritis /
report quality /
TIDieR
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] Mok TC, Mok CC.Non-TNF biologics and their biosimilars in rheumatoid arthritis[J]. Expert Opin Biol Ther, 2024, 24(7):599-613. DOI:10.1080/14712598.2024.2358165.
[2] 刘秀婵. 中西医治疗类风湿关节炎的临床进展[J].内蒙古中医药,2024,43(3):152-153.DOI:10.16040/j.cnki.cn15-1101.2024.03.075.
[3] 徐晓燕. 三阴寒湿方联合中药穴位贴敷治疗类风湿性关节炎的临床研究[J].反射疗法与康复医学,2023,4(1):44-46,50. DOI: 2096-7950(2023)1(a)-0044-04.
[4] 国家中医药管理局.关于印发优势病种中医护理方案护理效果总结分析报告体例及样稿的通知[EB/OL].(2013-11-29)[2024-05-20].http://www.natcm.gov.cn/yizhengsi/gongzuodongtai/2018-03-24/2762.html.
[5] 陈珏璇,段玉婷,卞兆祥,等.更好地报告干预措施:描述干预措施的模板和报告规范[J].中国循证医学杂志, 2020,20(12):1439-1448. DOI: 10.7507/1672-2531.202008182.
[6] Hoffmann TC, Glasziou PP, Boutron I, et al.Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide[J]. BMJ, 2014(348):g1687. DOI:10.1136/bmj.g1687.
[7] 郑俊侨,张俏菊,吴欣颖,等.穴位给药作用评价及应用情况研究进展[J].中国中药杂志,2024,49(14):3706-3713. DOI: 10.19540/j.cnki.cjcmm.20240401.601.
[8] 刘莎,陈玲,张丹莉,等.依据TIDieR制订护理研究方案报告及案例解读[J].护理研究,2022,36(22):3958-3962. DOI: 10. 12102/j. issn. 1009-6493. 2022. 22. 003.
[9] 国家中医药管理局.国家中医药管理局关于加强对冬病夏治穴位贴敷技术应用管理的通知[EB/OL].(2013-07-05)[2024-07-30].http://www.natcm.gov.cn/yizhengsi/gongzuodongtai/2018-03-24/2790.html.
[10] 中华人民共和国国家标准(GB/T21709.9—2008)《针灸技术操作规范第9部分:穴位贴敷》[J].中国针灸,2009,29(4):329-331.
[11] 周芬,刘丹,梁青鑫,等.类风湿关节炎常见适宜中医护理技术操作关键点的构建研究[J].护理管理杂志,2021,21(10):717-720;746.DOI:10.3969/j.issn.1671-315x.2021.10.007.
[12] Zacharia K, Patterson AJ, English C, et al.i-Rebound after stroke-eat for health: mediterranean dietary intervention co-design using an Integrated Knowledge Translation approach and the TIDieR Checklist[J]. Nutrients, 2021, 13(4):1058. DOI:10.3390/nu13041058.
[13] Yin YH, Liu JYW, Välimäki, M.Effectiveness of non-pharmacological interventions on the management of sarcopenic obesity: a systematic review and Meta-analysis[J]. Exp Gerontol, 2020(135):110937.DOI:10.1016/j.exger.2020.110937.
[14] 王丛礼,邹华,殷明.穴位贴敷临床应用进展[J].中国中医药现代远程教育,2023,21(24):191-193.DOI:10.3969/j.issn.1672-2779.2023.24.060.
[15] 高雯雯,刘莹.中药穴位贴敷治疗小儿乳食内伤型呕吐疗效观察及护理[J].世界最新医学信息文摘,2018,18(89):152.DOI:10.19613/j.cnki.1671-3141.2018.89.112.
[16] 刘欢,李德勋,蒋自程,等.西部地区中医药与区域经济发展水平的耦合协调研究[J].卫生软科学,2023,37(6):68-74.DOI:10.3969/j.issn.1003-2800.2023.06.015.
[17] 杨阳,刘宁.支气管哮喘患者冬病夏治穴位敷贴护理评估及管理的最佳证据总结[J].护理学报,2022,29(5):15-21.DOI:10.16460/j.issn1008-9969.2022.05.015.
[18] 薛晴,丛竹凤,向泽栋,等.近十年中药穴位贴敷制剂研究评述[J].中国中医基础医学杂志,2022,28(5):785-791.DOI:10.19945/j.cnki.issn.1006-3250.2022.05.024.
[19] 路红,高明利,齐庆,等.春秋分穴位贴敷联合专业护理治疗类风湿关节炎的效果[J].中国医药导报,2015,12(4):45-47;75.
[20] 王琪,崔建英.类风湿关节炎患者穴位贴敷中医护理的临床观察[J].实用临床护理学电子杂志, 2020, 5(45):124.
[21] 黄云城. 岭南传统天灸1号方治疗类风湿性关节炎的临床研究[D].广州:广州中医药大学,2022.DOI:10.27044/d.cnki.ggzzu.2022.000237.
[22] 孙思东,边祥涛.穴位贴敷辅助五味消毒饮对类风湿性关节炎患者免疫功能、Th17/Tregs平衡的影响[J].中国医院用药评价与分析,2022,22(3):293-296.DOI:10.14009/j.issn.1672-2124.2022.03.009.
[23] 孙树松,刘洪波,王晶,等.穴位贴敷治疗风湿痹证125例临床观察[J].实用中医内科杂志,2015,29(1):48-49.DOI:10.13729/j.issn.1671-7813.2015.01.22.
[24] 聂永超,钟涵,周慧慧,等.基于CONSORT与TIDieR-Placebo评价安慰针刺治疗膝骨性关节炎随机对照试验文献的报告质量[J].中医康复, 2024, 1(8):1-8.DOI:10.19787/j.issn.2097-3128.2024.08.001.
[25] 王林嘉,李铁林,徐韬,等.基于CONSORT与TIDieR-Placebo评价安慰针刺治疗偏头痛随机对照试验的文献报告质量[J].世界科学技术-中医药现代化, 2023,25(5):1623-1636.DOI:10.11842/wst.20220220002.
基金
北京市教育科学“十四五”规划2024年度一般课题(CDDB24193)