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A cluster-randomised controlled trial is a type of randomised controlled trial in which groups of subjects (as opposed to individual subjects) are randomised. [1] Cluster randomised controlled trials are also known as cluster-randomised trials, [2] group-randomised trials, [3] [4] and place-randomized trials. [5]
The stepped-wedge design involves the collection of observations during a baseline period in which no clusters are exposed to the intervention. Following this, at regular intervals, or steps, a cluster (or group of clusters) is randomized to receive the intervention [5] [6] and all participants are once again measured. [7]
Clinical trials units (CTU) are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials , cluster randomised trials , surgical trials, and health services research.
The main CONSORT Statement is based on the "standard" two-group parallel design. Extensions of the CONSORT Statement have been developed to give additional guidance for randomized trials with specific designs (e.g., cluster randomized trials, [3] noninferiority and equivalence trials, [4] pragmatic trials [5]), data (e.g., harms, [6] abstracts [7]), type of target outcome, [8] and various ...
A randomized controlled trial (or randomized control trial; [2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices , diagnostic procedures , diets or other medical treatments.
Zelen's design is an experimental design for randomized clinical trials proposed by Harvard School of Public Health statistician Marvin Zelen (1927-2014). In this design, patients are randomized to either the treatment or control group before giving informed consent. Because the group to which a given patient is assigned is known, consent can ...
Randomized, controlled crossover experiments are especially important in health care. In a randomized clinical trial, the subjects are randomly assigned to different arms of the study which receive different treatments. When the trial has a repeated measures design, the same measures are
Randomized controlled trial [5]. Blind trial [6]; Non-blind trial [7]; Adaptive clinical trial [8]. Platform Trials; Nonrandomized trial (quasi-experiment) [9]. Interrupted time series design [10] (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi ...