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Statistical analysis planThe CORE study: A stepped wedge cluster randomised controlled trial to test a codesign technique to optimise psychosocial recovery outcomes for people affected by mental illness
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01
Define the objective of the study to understand the purpose of the stepped wedge cluster design.
02
Identify the clusters (groups) and randomly assign the order in which each cluster will receive the intervention.
03
Determine the number of time points for the intervention rollout and ensure they are spaced appropriately.
04
Develop a detailed protocol for implementing the intervention in each cluster during its designated time frame.
05
Collect baseline data before the intervention begins in the first cluster to establish a reference point.
06
Implement the intervention in the first cluster while continuing to collect data from the clusters that have not yet received it.
07
After the intervention period for the first cluster, roll out the intervention to the next cluster while maintaining data collection.
08
Repeat the rollout process for all clusters until all have received the intervention.
09
Analyze the data collected at each stage using appropriate statistical methods to assess the impact of the intervention.

Who needs a stepped wedge cluster?

01
Researchers looking to evaluate the effectiveness of an intervention in a community or population.
02
Public health organizations aiming to implement new health strategies progressively over time.
03
Administrators in healthcare settings needing to test programs in phases while continuously monitoring outcomes.
04
Policy makers interested in incremental changes and their effects before a full implementation.
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A stepped wedge cluster is a type of experimental design used primarily in public health research where participants are grouped into clusters that receive an intervention in a staggered or sequential manner over time.
Researchers and organizations conducting stepped wedge cluster trials or studies typically need to file a stepped wedge cluster, especially if required by funding agencies or regulatory bodies.
Filling out a stepped wedge cluster involves providing details about the intervention, the participating clusters, study timeline, data collection methods, and participant consent, among other specifics as defined by the study protocol.
The purpose of a stepped wedge cluster design is to evaluate the effectiveness of an intervention while allowing all participants to eventually receive the intervention, thus combining the benefits of both randomized controlled trials and real-world implementation.
Information that must be reported includes the cluster design, intervention details, participant demographics, data collection methods, outcome measures, and analysis plan, as well as ethical considerations and consent processes.
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