Abstract
The statistical analysis plan (SAP) for the NAP SACC UK trial has been written in accordance with BTC standard operating procedures, the CONSORT statement, and International Conference on Harmonisation (ICH) Statistical Principles for Clinical Trials E9, by Liping Wen, NAP SACC UK study statistician, Research Associate in Medical Statistics, Bristol Trials Centre, Bristol Medical School, University of Bristol, under the supervision of Pete Blair, Professor of Epidemiology and Statistics, and covers all final statistical analyses to be performed, outlined in the study protocol within the study master file. This document details the rules proposed and the presentation that will be followed, as closely as possible, when analysing and reporting the main results from the Nutrition and Physical Activity Self-Assessment for Child Care United Kingdom (NAP SACC UK) Trial. The purpose of the plan is to:
a) Ensure that the analysis is appropriate for the aims of the trial, reflects good statistical practice, and that interpretation of a priori and post hoc analyses respectively is appropriate
b) Explain in detail how the data will be handled and analysed to enable others to perform the actual analysis in the event of sickness or other absence
Additional exploratory or auxiliary analyses of data not specified in the protocol are permitted (and will be described as exploratory) but fall outside the scope of this analysis plan (although such analyses would be expected to follow Good Statistical Practice). The analysis strategy will be made available if required for journal editors or referees when the main papers are submitted for publication. Additional analyses suggested by reviewers or editors will, if considered appropriate, be performed in accordance with the Analysis Plan, but if published the source of such a post-hoc analysis will be declared. Amendments to the statistical analysis plan will be described and justified in the final report of the trial.
a) Ensure that the analysis is appropriate for the aims of the trial, reflects good statistical practice, and that interpretation of a priori and post hoc analyses respectively is appropriate
b) Explain in detail how the data will be handled and analysed to enable others to perform the actual analysis in the event of sickness or other absence
Additional exploratory or auxiliary analyses of data not specified in the protocol are permitted (and will be described as exploratory) but fall outside the scope of this analysis plan (although such analyses would be expected to follow Good Statistical Practice). The analysis strategy will be made available if required for journal editors or referees when the main papers are submitted for publication. Additional analyses suggested by reviewers or editors will, if considered appropriate, be performed in accordance with the Analysis Plan, but if published the source of such a post-hoc analysis will be declared. Amendments to the statistical analysis plan will be described and justified in the final report of the trial.
| Original language | English |
|---|---|
| Type | NAP SACC UK Statistical Analysis Plan (SAP) |
| Publication status | Unpublished - 10 Jan 2024 |