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在多发性硬化症中使用实用随机试验:系统概述

Julian Hirt¹, Perrine Janiaud², Pascal Düblin³

¹Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland/Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland/Department of Health, Eastern Switzerland University of Applied Sciences, St. Gallen, Switzerland.

Multiple sclerosis (Houndmills, Basingstoke, England)

|January 22, 2024

概括

这项研究发现,在多发性硬化症 (MS) 中的实用试验很少,很少评估药物. 在那里,在那里,在那里,在那里.

科学领域:

临床研究方法论临床研究方法论
现实世界的证据生成
神经学和多发性硬化症研究神经学和多发性硬化症研究

背景情况:

实用性试验对于产生对治疗有效性的真实世界的证据至关重要.
它们在多发性硬化症 (MS) 研究中的应用正在增长,但需要进一步调查.
了解MS中现有的实用试验的特征对于未来的研究设计至关重要.

研究的目的:

在多发性硬化症 (MS) 研究中研究实用试验的利用和设计特征.
分析MS实用试验中的干预范围和参与者数量.
使用PRECIS-2工具评估MS试验中的实用主义程度.

主要方法:

进行了系统的文献搜索,寻找与2022年之前的任何干预相关的务实试验.
用PRagmatic解释连续性指标摘要-2 (PRECIS-2) 工具来评估所识别的试验的实用性.
分析了试验特征,干预措施,参与者数量,地理分布和结果的数据.

主要成果:

在MS中确定了48项实用性试验,在1967年至2022年之间发表,平均82名参与者.
大多数试验 (85%) 专注于支持性护理,只有15%评估药物干预措施.
大多数试验来自英国,意大利和美国;只有2%使用例行收集的数据,29%被认为是广泛的实用性.

结论:

多发性硬化症 (MS) 的实用试验领域的特点是有限的数量,大多是小规模的研究,对药物干预的关注度很低.
尽管有常规数据基础设施可用,但在MS实用试验中其使用仍然很少.
显著需要加强MS实用试验的设计和执行,以有效地产生有价值的现实世界证据.

关键词:

多发性硬化症是一种多发性硬化症.实用临床试验实用临床试验随机对照试验是随机对照试验.经常收集的健康数据.

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相关概念视频

Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

Randomized Experiments

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...