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National Institute for Health Research Public Health Research Program PHR 10/3006/02 A cluster randomized controlled trial evaluation and cost-effectiveness analysis of the Roots of Empathy (ROE)
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How to fill out a cluster randomised controlled

01
Determine the population that will be included in the study and select clusters of participants. Clusters can be groups of people that are naturally occurring, such as schools or neighborhoods.
02
Randomly assign the clusters to either the control group or the intervention group. This can be done using random number generators or other randomization methods.
03
Collect baseline data on the outcome measures from both the control and intervention groups before the intervention is implemented.
04
Implement the intervention in the intervention group while keeping the control group unchanged.
05
Collect post-intervention data on the outcome measures from both the control and intervention groups.
06
Analyze the data using appropriate statistical methods to determine the effectiveness of the intervention.
07
Interpret the results and draw conclusions based on the findings.
08
Report the study findings in a clear and systematic manner, following the guidelines for reporting cluster randomised controlled trials.

Who needs a cluster randomised controlled?

01
Cluster randomised controlled trials are commonly used in public health and social science research.
02
They may be necessary when individual randomization is not possible or practical, such as when the intervention is targeted at a group or community level.
03
Researchers, policymakers, and program evaluators who want to assess the effectiveness of interventions in real-world settings may use cluster randomised controlled trials.
04
Cluster randomised controlled trials can also be used to study the impact of interventions on groups that naturally occur together, such as schools, workplaces, or neighborhoods.
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A cluster randomised controlled trial is a type of study in which groups of subjects, rather than individual subjects, are randomly assigned to different treatments or interventions. It is commonly used in medical research to evaluate the effectiveness of new treatments or interventions.
Researchers and institutions conducting clinical trials or research studies that involve cluster randomisation are required to file a cluster randomised controlled trial protocol.
To fill out a cluster randomised controlled trial protocol, researchers need to clearly define the clusters, interventions, and outcome measures, and provide detailed information on the study design, randomisation process, and statistical analysis plan.
The purpose of a cluster randomised controlled trial is to reduce bias and control for clustering effects that may occur when individual subjects are treated in groups. This design is useful when individual randomisation is not feasible or may lead to contamination between treatment groups.
A cluster randomised controlled trial protocol must include details on the study design, randomisation process, intervention and control group characteristics, outcome measures, statistical analysis plan, and ethical considerations.
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