首页|中医药相关核心结局指标集研究的文献质量评价

中医药相关核心结局指标集研究的文献质量评价

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目的 评价中医药相关核心结局指标集(COS-TCM)研究发表的方案及结果的文献质量,为提高COS-TCM研究报告水平和方法学质量提供参考.方法 计算机检索中、英文数据库,搜集从建库至2023年4月18日收录的COS-TCM研究方案或研究结果,按照纳入、排除标准筛选后采用《核心指标集研制规范》(COS-STAD)、《核心指标集报告规范》(COS-STAR)和《核心指标集研究方案报告规范》(COS-STAP)进行质量评价.此外,对发表了研究方案和研究结果的同一个研究进行一致性评价.结果 共纳入14篇研究方案和14篇研究结果报告,涉及23项COS-TCM研究.研究方案采用COS-STAP进行评价,发现报告率相对较低的两个条目为"利益相关者"和"缺失数据".基于COS-STAD对COS-TCM结果进行评价发现,条目"COS涵盖的人群"(35.7%)和"关注结局指标清单的语言描述"(28.6%)的报告率较低;而基于COS-STAR,报告率较低的条目为"方案偏离"(7.1%)、"参与者"(21.4%)和"利益冲突"(28.6%).此外,一致性评价发现,研究方案与研究结果之间存在不一致的情况,包括系统评价纳入的研究类型、定性研究的方法及共识会议的举办方式、评分方法等,且仅有1项研究报告了方案偏离及其原因.结论 COS-TCM研究仍需提高其方法学质量和报告透明度,在遵循国际规范的基础上,需结合中医特色.未来有必要研制适合COS-TCM研究的质量评价指南和报告规范.
Quality evaluation of studies on the core outcome set of Chinese medicine
Objective To evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine(COS-TCM),and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies.Methods Literature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18,2023.The Core Outcome Set-STAndards for Reporting(COS-STAR),Core Outcome Set-STAndards for Development(COS-STAD),and Core Outcome Set-STAndardised Protocol Items(COS-STAP)were used to evaluate their reporting and methodological quality.Additionally,the consistency of studies with both published protocols and results was evaluated.Results A total of 14 protocols and 14 reports(involving 23 COS-TCM studies)were included.The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of"Stakeholders"(71.4%)and"Missing data"(42.9%)were relatively low.For the reports of COS-TCM,the evaluation based on the COS-STAD found that the reporting rates of"the population(s)covered by the COS"(35.7%)and"care was taken to avoid ambiguity of language used in the list of outcomes"(28.6%)were relatively low.Based on the COS-STAR,the items with low reporting rates were"Protocol Deviation"(7.1%),"Participants"(21.4%),and"Conflicts of interest"(28.6%).Additionally,the consistency evaluation found that there were inconsistencies between protocols and their results,such as the types of research included in the systematic review,the methods of qualitative research,the way of holding consensus meetings,scoring methods,etc.Moreover,only one study reported protocol deviation and reasons for change.Conclusion COS-TCM studies need to improve their methodological quality and report transparency.When developing COS-TCM,we should pay attention to the characteristics of TCM while basing on international standards.The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.

Core outcomes setTraditional Chinese medicineQuality evaluation

邱幸莹、唐淇、曹文聪、刘冰清、温泽淮、李庚

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广州中医药大学第二临床医学院(广州 510405)

省部共建中医湿证国家重点实验室(广州中医药大学第二附属医院)(广州 510120)

广东省中医院(广州 510120)

广州中医药大学科技创新中心(广州 510405)

广东省中医证侯临床研究重点实验室(广州 510120)

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核心结局指标集 中医药 文献质量评价

省部共建中医湿证国家重点实验室课题广东省科技计划项目

SZ2021ZZ04032023B1212060063

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(2)
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