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| Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement | | Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement |
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− | 对两组平行随机试验的四个阶段(登记、分配、干预、随访和数据分析)的流程图(在对照试验中,其中一项干预措施作为对照) ,修改自 CONSORT (综合报告试验标准)2010年声明
| + | 据修改的2010年CONSORT (综合报告试验标准)要求,流程图包括:两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段,在对照试验中,需要其中一项干预作为对照处理措施。 |
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| A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group. | | A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group. |
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− | 随机对照试验(或随机对照试验)是一种科学实验(例如:。临床试验)或干预研究(相对于观察性研究) ,旨在减少某些来源的偏见时,测试新的治疗方法的有效性,这是通过随机分配到两个或两个以上的组,对待他们不同,然后比较他们与一个有节制的反应。一组(实验组)接受正在评估的干预措施,而另一组(通常称为对照组)接受替代治疗,如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测,以确定实验干预的有效性,并与对照组进行疗效评估。可能有一个以上的治疗组或一个以上的对照组。 | + | 随机对照试验(A randomized controlled trial ,RCT)是一种科学实验(例如:临床试验)或干预研究(相对于观察性研究) ,旨在减少偏差,测试评估的治疗方法的有效性。通过受试者随机分配到两个或两个以上的组,经过不同的处理,产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施,而另一组(通常称为对照组)接受替代治疗,如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测,以确定实验干预的有效性,并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。 |
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| The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias. | | The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias. |
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− | 试验可能是盲性的,这意味着可能影响参与者的信息在试验完成后才会公布。实验的任何参与者,包括受试者、研究人员、技术人员、数据分析人员和评估人员,都可能被强加盲目性。有效的盲法可以减少或消除某些实验偏差的来源。
| + | 试验可能采用了盲法,这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者,包括受试者、研究人员、技术人员、数据分析人员和评估人员,都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。 |
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| The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases. | | The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases. |
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− | 在分配治疗方案时,受试者被分配到不同组的随机性减少了选择偏差和分配偏差,平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。
| + | 在分配治疗方案时,受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差,平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。 |
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| A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. | | A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. |
− | | + | 一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果,并且还可能提供关于药物不良反应等不良反应的信息。随机对照试验可以提供令人信服的证据,证明研究治疗对人类健康产生了影响。 |
− | 一个良好的盲法 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果,并且还可能提供关于药物不良反应等不良反应的信息。随机对照试验可以提供令人信服的证据,证明研究治疗对人类健康产生了影响。
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| The terms "RCT" and "randomized trial" are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences. | | The terms "RCT" and "randomized trial" are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences. |
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− | “ RCT”和“随机试验”这两个术语有时被用作同义词,但后一个术语没有提到对照,因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。同样,初始论有时被扩展为“随机临床试验”或“随机比较试验”,导致科学文献中的歧义。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验,因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而,随机对照临床试验也被用于其他研究领域,包括许多社会科学。 | + | “ RCT”和“随机试验”这两个术语有时被用作同义词,但后一个术语没有提到对照,因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验,因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而,随机对照临床试验也被用于其他研究领域,包括许多社会科学。 |
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