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Am J Med. 2019 Mar;132(3):354-361. doi: 10.1016/j.amjmed.2018.11.011. Epub 2018 Nov 29.
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Risk of subsequent fracture after prior fracture among older women.老年女性既往骨折后再次骨折的风险。
Osteoporos Int. 2019 Jan;30(1):79-92. doi: 10.1007/s00198-018-4732-1. Epub 2018 Nov 19.
3
Risk for Herpes Zoster in Tofacitinib-Treated Rheumatoid Arthritis Patients With and Without Concomitant Methotrexate and Glucocorticoids.接受托法替尼治疗的类风湿关节炎患者中,无论是否同时使用甲氨蝶呤和糖皮质激素,其带状疱疹风险。
Arthritis Care Res (Hoboken). 2019 Sep;71(9):1249-1254. doi: 10.1002/acr.23769. Epub 2019 Jul 29.
4
Chronic lung disease in U.S. Veterans with rheumatoid arthritis and the impact on survival.美国类风湿关节炎退伍军人的慢性肺部疾病及其对生存的影响。
Clin Rheumatol. 2018 Nov;37(11):2907-2915. doi: 10.1007/s10067-018-4314-9. Epub 2018 Oct 2.
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Tocilizumab and the Risk of Cardiovascular Disease: Direct Comparison Among Biologic Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis Patients.托珠单抗与心血管疾病风险:类风湿关节炎患者生物改善病情抗风湿药物的直接比较。
Arthritis Care Res (Hoboken). 2019 Aug;71(8):1004-1018. doi: 10.1002/acr.23737.
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Understanding practice-based research participation: The differing motivations of engaged vs. non-engaged clinicians in pragmatic clinical trials.理解基于实践的研究参与:务实临床试验中参与和未参与的临床医生的不同动机。
Contemp Clin Trials Commun. 2016 Aug 23;4:136-140. doi: 10.1016/j.conctc.2016.08.003. eCollection 2016 Dec 15.
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A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.一项比较平板电脑知情同意书与传统纸质方法用于骨质疏松症研究的实用性随机试验。
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8
Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study.带状疱疹疫苗预防带状疱疹的长期效果:一项队列研究。
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Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-to-Target Approach to Care of US Patients With Rheumatoid Arthritis.类风湿关节炎患者以目标为导向的治疗方法纳入护理的行为干预措施的聚类随机试验。
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Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.评估停用双膦酸盐治疗的有效性试验的可行性:一项初步研究。
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真实世界证据生成的工具和方法:实用临床试验、电子知情同意书和数据链接。

Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages.

机构信息

Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.

Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Rheum Dis Clin North Am. 2019 May;45(2):275-289. doi: 10.1016/j.rdc.2019.01.010.

DOI:10.1016/j.rdc.2019.01.010
PMID:30952398
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6499376/
Abstract

Real-world evidence requires use of new tools and methods to support efficient evidence generation. Among those tools are pragmatic trials, utilization of central/single institutional review board and electronic consent, and data linkages between diverse types of data sources (eg, a trial or registry to administrative claims or electronic medical record data). This article reviews these topics in the context of describing several exemplar use cases specific to rheumatology and provides perspective regarding both the promise and potential pitfalls in using these tools and approaches.

摘要

真实世界证据需要使用新的工具和方法来支持高效的证据生成。这些工具包括实用临床试验、中央/单一机构审查委员会的利用以及不同类型数据源(例如,试验或注册表与行政索赔或电子病历数据)之间的数据链接。本文在描述几个特定于风湿病学的范例用例的背景下,对这些主题进行了回顾,并就使用这些工具和方法的前景和潜在陷阱提供了观点。