Benjamin Jones


The study protocol includes an outline of the statistical methods to be employed in the analysis of the trial data. The purpose of the Statistical Analysis Plan (SAP) is to provide full details of the planned statistical methods to be used in the primary report of the trial results, in line with the Consolidated Standards of Reporting Trials (CONSORT) guidelines1 and extensions for non-pharmacological trials2 and cluster randomised trials3, which provide guidelines to facilitate the complete and transparent reporting of clinical trials, as well as the ICH E9 Guidelines4. The PARTNERS2 protocol includes details of an internal pilot study within the definitive RCT. However, this SAP pertains only to the design and statistical analysis of the definitive trial. The planned health economic analyses are outlined in section 7. Details of the planned process evaluation, including detailed fidelity and adherence measures, are not discussed within this document.



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University of Plymouth

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Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.