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Statistical analysis plan DREAM A randomized controlled trial of meniscal tears in young adultsSection 1: Administrative information Title & trial registration 1a: Danish Rct on Exercise vs Arthroscopic
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A statistical analysis plan (SAP) is a document that outlines the strategy and methodology for analyzing statistical data, particularly in clinical trials or research studies. It details the statistical techniques that will be used, the study design, and how the results will be interpreted.
Researchers, clinical trial sponsors, and organizations conducting studies involving statistical analysis are typically required to file a statistical analysis plan as part of their study submission to regulatory bodies or institutions.
To fill out a statistical analysis plan, one should clearly define the study objectives, describe the study design, outline the statistical methods to be used for data analysis, specify the data management procedures, and indicate how results will be interpreted and reported.
The purpose of a statistical analysis plan is to ensure that the data analysis is systematic, reproducible, and aligned with the study objectives. It helps to prevent data dredging and bias in interpreting results.
The SAP should report study objectives, study design details, statistical methods, data management procedures, and plans for interpretation and reporting of results, among other relevant information.
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