中国循证医学杂志

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抗凝药用于房颤患者队列研究的结果可信度评价工具的研发

徐畅 # , 李玲 # , 邓可 , 康德英 , 李静 , 陈进 , 谭婧 , 王雯 , 刘佳利 , 刘艳梅 , 孙鑫

四川大学华西医院中国循证医学中心 CREAT 团队（成都 610041）

收稿日期: 2018-09-17;  修回日期:2018-10-25; 

基金项目: 国家自然科学基金项目（编号：71573183）；国家“青年千人计划”项目（编号：D1024002）；拜耳医药保健有限公司基金（编号：HX-H1705065）

通讯作者: 孙鑫, Email: sunx79@hotmail.com

#共同第一作者

Development of a checklist for assessing credibility of cohort studies on effects of oral anticoagulants treatments for atrial fibrillation

XU Chang , LI Ling , DENG Ke , KANG Deying , LI Jing , CHEN Jin , TAN Jing , WANG Wen , LIU Jiali , LIU Yanmei , SUN Xin

Chinese Evidence-based Medicine Center and CREAT group, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China

Corresponding Author: SUN Xin, Email: sunx79@hotmail.com

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目的 构建抗凝药用于房颤患者队列研究的结果可信度评价工具。 方法 计算机检索 MEDLINE、EMbase 和 CBM 查找评价队列研究方法学质量和结果可信度的相关文献，检索时限由建库至 2017 年 12 月 19 日。根据检索结果，提取并收集关于观察性研究方法学质量或结果可信度的条目。通过核心小组头脑风暴，对收集的条目进行扩充和整理，形成初步量表。进一步召开内部专家讨论会，对初步量表内容进行商议、评价，同时对量表框架进行讨论。最后组织外部专家对量表进行四轮外部评价，形成最终量表。 结果 经过文献筛选纳入 17 篇文献，去除重复、意义相同的条目并整理后，建立关键词池，初步形成 46 个条目。经核心小组讨论补充潜在条目，剔除与方法学无关条目，整合部分重叠条目，形成 43 个条目的初级量表。通过 4 轮内部专家讨论会，对条目进行整合，形成 40 个条目的初级量表。进一步通过 4 轮外部专家咨询会，对条目进一步优化及整合，达成一致意见，最终形成 21 个条目的量表，包括问题定义、测量、随访、混杂、缺失、统计方法、结果评价 7 个域。 结论 本研究制定了抗凝药用于房颤患者队列研究可信度评价量表，具有实际的临床应用价值。临床医师在临床诊疗实践中，可参考本量表对队列研究可信度进行评价和循证决策；同时，在相关指南的制作中，也可采用本量表对队列研究结果可信度进行评价。

Objectives To develop a tool to assess the credibility of cohort studies regarding anticoagulants treatment for patients with atrial fibrillation. Methods MEDLINE, EMbase and CBM databases were retrieved for eligible studies on the methodological quality and credibility of the cohort study. The retrieval period was from inception to December 19th, 2017, and the languages were limited to Chinese and English. Based on the search results, the items on the methodology quality of the research or the credibility of the results were collected. Through brainstorming of the core group, the collected items were expanded and sorted out to a preliminary scale. Furthermore, we conducted 4 rounds of internal expert seminars to discuss and evaluate the preliminary scale content and discuss the scale framework. Finally, we organized domestic authoritative experts to conduct 4 external evaluations on the scale and formed the final scale. Results A total of 7 734 literatures were obtained from primary search, in which 17 of which were included. Fifty-five tools with 780 items for the quality assessment of observational studies were collected from the included studies. After removing duplicated keywords with similar meanings, we obtained the " keyword pool” with 46 keywords, which were preliminarily formed 46 items. After discussion of the core group, which aimed to supplement the potential items, eliminate the items irrelevant to methodology, and integrate the items with partial overlapping meanings, a preliminary scale of 43 items was formed. According to the four rounds of internal expert consultative meetings, these items were integrated to form a preliminary scale of 40 items. After further evaluation by four rounds of external expert consultative meetings, a consensus was reached and a scale of 21 items from seven domains (i.e., definition of question, measurement, follow-up, confounder, missing data, statistical analysis, and results assessment) was finally formed. Conclusions This study developed an assessment tool for the credibility of the results from the cohort studies regarding anticoagulants treatment in patients with atrial fibrillation, which has practical clinical value. Clinicians can refer to the results of credibility assessment by using this tool to better assist clinical decision-making in clinical practice. In addition, in the preparation of relevant guidelines, this tool can be used to assess the credibility of results from cohort studies.

关键词: 抗凝药; 房颤; 队列研究; 结果可信度; 量表开发

Key words: Anticoagulants; Atrial fibrillation; Cohort studies; Results credibility; Scale development

引用本文： 徐畅, 李玲, 邓可, 康德英, 李静, 陈进, 谭婧, 王雯, 刘佳利, 刘艳梅, 孙鑫. 抗凝药用于房颤患者队列研究的结果可信度评价工具的研发. 中国循证医学杂志, 2019, 19(2): 218-224. doi: 10.7507/1672-2531.201809087 复制

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