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
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摘要
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 19 th, 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.
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 19 th, 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.
引文
1Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006guidelines for the management of patients with atrial fibrillation—executive summary. Circulation, 2006, 114(7):700-752.
2 周自强,胡大一,陈捷,等.中国心房颤动现状的流行病学研究.中华内科杂志, 2004, 43(7):491-494.
3Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke:the Framingham study. Stroke,1991, 22(8):983-938.
4 中华医学会心血管病学分会,心律失常联盟.心房颤动抗凝治疗中国专家共识.中华内科杂志, 2012, 51(11):916-921.
5January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation.Circulation, 2014:CIR. 0000000000000041.
6 Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation:a meta-analysis of randomised trials. Lancet, 2014, 383(9921):955-962.
7Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med, 2011, 365:883-891.
8 Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med, 2011,365:981-992.
9David LS, Geoffrey RN, John C. Health measurement scales:a practical guide to their development and use(5th edition). Aust NZ J Publ Heal, 2016, 40(3):294-295.
10 Haladyna TM. Developing and validating multiple-choice test items(2nd edition). Mahwah, NJ:L. Erlbaum Associates, 2004:250.
11Devellis RF. Scale development:theory and applications(Ed.p.1-113 ). Thousand Oaks CA:SAGE publications Ltd, 2003.
12 Gerber Y, Jacobsen SJ, Killian JM, et al. Participation bias assessment in a community-based study of myocardial infarction,2002-2005. Mayo Clin Proc, 2007, 82(8):933-938.
13Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines:1.introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4):383-394.
14Sutton-Tyrrell K. Assessing bias in case-control studies. Proper selection of cases and controls. Stroke, 1991, 22(7):938-942.
15陈玉芳,王媛媛,王娟娟,等.中文护理专业病例对照研究质量的评价.中国实用护理杂志, 2014, 30(28):1-6.
16 陈泽鑫,刘慧,潘益峰,等.试验性和观察性研究相关医学文献质量评价方法.中国循证医学杂志, 2011, 11(11):1229-1236.
17邓艳华,彭唯娜,毛湄,等.针灸治疗带状疱疹后遗神经痛文献质量评价.中国循证医学杂志, 2007, 7(12):899-903.
18 刘霞,李静,艾昌林,等.国内斑点免疫金胶体渗滤法检测结核抗体诊断结核病的文献质量评价.中国循证医学杂志, 2006, 6(12):893-896.
19史美育,王剑,李洁.中医证候流行病学调查研究文献的质量评价.上海中医药杂志, 2007,(1):66-67.
20 王梅,王建华,张抗,等.中医药疗效评价队列研究的方法学质量评价.中医杂志, 2016, 57(16):1379-1383.
21王鹏,刘鲁明.中医药治疗胰腺癌临床文献质量评价.上海中医药杂志, 2007,(8):22-23.
22 杨璐,杨佳,张泽梅,等.我国老年谵妄预后队列研究的文献质量评价.护理研究, 2016, 30(1):80-82.
23张蒙,张雪梅,杨璐,等.我国老年谵妄危险因素的队列研究文献的质量评价.护理研究, 2016, 30(33):4206-4207.
24 张燕舞,蒋朱明,王杨,等.与转化医学有关的临床研究质量及研究报告质量的评价工具.中华临床营养杂志, 2011, 19(1):1-6.
25Brixner DI, Holtorf AP, Neumann PJ, et al. Standardizing quality assessment of observational studies for decision making in health care. J Manag Care Pharm, 2009, 15(3):275-283.
26 Hollerw?ger D. Methodological quality and outcomes of studies addressing manual cervical spine examinations:a review. Man Ther, 2006, 11(2):93-98.
27Lang S, Kleijnen J. Quality assessment tools for observational studies:lack of consensus. Int J Evid Based Healthc, 2010, 8(4):247.
28 Shamliyan T, Kane RL, Dickinson S. A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases. J Clin Epidemiol, 2010, 63(10):1061-1070.
2 周自强,胡大一,陈捷,等.中国心房颤动现状的流行病学研究.中华内科杂志, 2004, 43(7):491-494.
3Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke:the Framingham study. Stroke,1991, 22(8):983-938.
4 中华医学会心血管病学分会,心律失常联盟.心房颤动抗凝治疗中国专家共识.中华内科杂志, 2012, 51(11):916-921.
5January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation.Circulation, 2014:CIR. 0000000000000041.
6 Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation:a meta-analysis of randomised trials. Lancet, 2014, 383(9921):955-962.
7Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med, 2011, 365:883-891.
8 Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med, 2011,365:981-992.
9David LS, Geoffrey RN, John C. Health measurement scales:a practical guide to their development and use(5th edition). Aust NZ J Publ Heal, 2016, 40(3):294-295.
10 Haladyna TM. Developing and validating multiple-choice test items(2nd edition). Mahwah, NJ:L. Erlbaum Associates, 2004:250.
11Devellis RF. Scale development:theory and applications(Ed.p.1-113 ). Thousand Oaks CA:SAGE publications Ltd, 2003.
12 Gerber Y, Jacobsen SJ, Killian JM, et al. Participation bias assessment in a community-based study of myocardial infarction,2002-2005. Mayo Clin Proc, 2007, 82(8):933-938.
13Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines:1.introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4):383-394.
14Sutton-Tyrrell K. Assessing bias in case-control studies. Proper selection of cases and controls. Stroke, 1991, 22(7):938-942.
15陈玉芳,王媛媛,王娟娟,等.中文护理专业病例对照研究质量的评价.中国实用护理杂志, 2014, 30(28):1-6.
16 陈泽鑫,刘慧,潘益峰,等.试验性和观察性研究相关医学文献质量评价方法.中国循证医学杂志, 2011, 11(11):1229-1236.
17邓艳华,彭唯娜,毛湄,等.针灸治疗带状疱疹后遗神经痛文献质量评价.中国循证医学杂志, 2007, 7(12):899-903.
18 刘霞,李静,艾昌林,等.国内斑点免疫金胶体渗滤法检测结核抗体诊断结核病的文献质量评价.中国循证医学杂志, 2006, 6(12):893-896.
19史美育,王剑,李洁.中医证候流行病学调查研究文献的质量评价.上海中医药杂志, 2007,(1):66-67.
20 王梅,王建华,张抗,等.中医药疗效评价队列研究的方法学质量评价.中医杂志, 2016, 57(16):1379-1383.
21王鹏,刘鲁明.中医药治疗胰腺癌临床文献质量评价.上海中医药杂志, 2007,(8):22-23.
22 杨璐,杨佳,张泽梅,等.我国老年谵妄预后队列研究的文献质量评价.护理研究, 2016, 30(1):80-82.
23张蒙,张雪梅,杨璐,等.我国老年谵妄危险因素的队列研究文献的质量评价.护理研究, 2016, 30(33):4206-4207.
24 张燕舞,蒋朱明,王杨,等.与转化医学有关的临床研究质量及研究报告质量的评价工具.中华临床营养杂志, 2011, 19(1):1-6.
25Brixner DI, Holtorf AP, Neumann PJ, et al. Standardizing quality assessment of observational studies for decision making in health care. J Manag Care Pharm, 2009, 15(3):275-283.
26 Hollerw?ger D. Methodological quality and outcomes of studies addressing manual cervical spine examinations:a review. Man Ther, 2006, 11(2):93-98.
27Lang S, Kleijnen J. Quality assessment tools for observational studies:lack of consensus. Int J Evid Based Healthc, 2010, 8(4):247.
28 Shamliyan T, Kane RL, Dickinson S. A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases. J Clin Epidemiol, 2010, 63(10):1061-1070.
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