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设计干预研究。

Design an Intervention Study.

机构信息

Department of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.

出版信息

Methods Mol Biol. 2024;2766:317-324. doi: 10.1007/978-1-0716-3682-4_32.

DOI:10.1007/978-1-0716-3682-4_32
PMID:38270891
Abstract

Randomized controlled trials are commonly designed to compare the effectiveness of treatments in rheumatoid arthritis (RA). In a clinical trial (intervention study), researchers apply interventions or preventive services to patients and examine outcomes. Clinical trial design consists of the following categories: choice of intervention and control, selection of patients, informed consent, baseline measurement, bank specimens, randomized allocation and blinding, and outcome measurements. Here, we discuss the design of clinical trials for RA.

摘要

随机对照试验常用于比较类风湿关节炎 (RA) 治疗方法的有效性。在临床试验(干预研究)中,研究人员将干预或预防措施应用于患者,并检查结果。临床试验设计包括以下类别:干预和对照的选择、患者选择、知情同意、基线测量、标本库、随机分配和盲法、以及结果测量。在这里,我们讨论 RA 的临床试验设计。

相似文献

1
Design an Intervention Study.设计干预研究。
Methods Mol Biol. 2024;2766:317-324. doi: 10.1007/978-1-0716-3682-4_32.
2
Design an Intervention Study.设计一项干预性研究。
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3
Audio-visual presentation of information for informed consent for participation in clinical trials.用于参与临床试验知情同意的信息视听展示。
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本文引用的文献

1
Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points.比较评估不同的美国风湿病学会/欧洲抗风湿病联盟缓解标准在类风湿关节炎临床试验终点中的应用。
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过去50年类风湿关节炎随机试验中的结局指标。
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4
A simple sample size formula for analysis of covariance in cluster randomized trials.协方差分析在整群随机临床试验中的简单样本量公式。
Stat Med. 2012 Sep 10;31(20):2169-78. doi: 10.1002/sim.5352. Epub 2012 Apr 11.
5
Canadian recommendations for clinical trials of pharmacologic interventions in rheumatoid arthritis: inclusion criteria and study design.加拿大关于类风湿关节炎药物干预临床试验的建议:纳入标准和研究设计。
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6
Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L).新的 EQ-5D 五维版本(EQ-5D-5L)的制定和初步测试。
Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
7
American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.美国风湿病学会/欧洲抗风湿病联盟类风湿关节炎临床试验缓解的临时定义。
Ann Rheum Dis. 2011 Mar;70(3):404-13. doi: 10.1136/ard.2011.149765.
8
2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative.2010年类风湿关节炎分类标准:美国风湿病学会/欧洲抗风湿病联盟合作项目
Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
9
Issues in the design of new clinical trials for rheumatoid arthritis therapeutics.类风湿关节炎治疗新临床试验设计中的问题
Nat Clin Pract Rheumatol. 2008 Dec;4(12):641-8. doi: 10.1038/ncprheum0948.
10
Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.类风湿关节炎患者临床试验中疾病活动度的报告:欧洲抗风湿病联盟/美国风湿病学会联合推荐意见
Ann Rheum Dis. 2008 Oct;67(10):1360-4. doi: 10.1136/ard.2008.091454.