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Open AccessProtocolClare Elton,1 Mark Strong,2 Mary J Renfrew,3 Kate Thomas,2 Julia Burrows,2 Barbara Wherein,1 Heather M Whit ford,3 Elaine Scott,1 Julia FoxRushby,4 Nana Anyone,4 Sabina Sanford,4

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How to fill out cluster randomised controlled trial

01

To fill out a cluster randomised controlled trial, follow these steps:

02

Define the research question or hypothesis that you want to investigate.

03

Determine the level of clustering in your study, i.e., whether the units of randomisation are individuals, groups, or organizations.

04

Design the study protocol, including the number and size of clusters, the allocation ratio, and the length of follow-up.

05

Randomly assign clusters to the intervention and control groups using an appropriate randomisation method.

06

Obtain informed consent from participants in each cluster.

07

Implement the intervention or treatment in the intervention group, while maintaining usual care or placebo in the control group.

08

Collect data on the outcome measures of interest from each cluster at the specified time points.

09

Analyze the data using appropriate statistical methods, accounting for the clustering effect.

10

Interpret the results and draw conclusions based on the findings.

11

Report the study findings in a scientific publication or other appropriate format.

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01

Cluster randomised controlled trials are useful in situations where:

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- Individual randomisation is not feasible or practical due to the nature of the intervention or control group allocation.

03

- The intervention is delivered at the group or community level and its effects are expected to differ between clusters.

04

- There is a risk of contamination between individuals within the same cluster (e.g., in a school or workplace setting).

05

- The study aims to evaluate the effectiveness of an intervention in real-world settings rather than controlled laboratory conditions.

06

- The research question pertains to the impact of policies, programs, or interventions that target groups or communities rather than individuals.

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What is cluster randomised controlled trial?

A cluster randomised controlled trial is a type of research study where groups of subjects are randomly assigned to different treatments or interventions.

Who is required to file cluster randomised controlled trial?

Researchers, scientists, or organizations conducting the trial are required to file cluster randomised controlled trial.

How to fill out cluster randomised controlled trial?

The trial should be filled out with detailed information about the study design, interventions, outcomes, and analysis plan.

What is the purpose of cluster randomised controlled trial?

The purpose of a cluster randomised controlled trial is to evaluate the effectiveness of interventions at the group level, rather than individual level.

What information must be reported on cluster randomised controlled trial?

The trial should report details about the study design, randomization procedure, interventions, outcomes, and statistical analysis plan.

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