Please use this identifier to cite or link to this item: https://hdl.handle.net/10356/105972
Title: Update on the general practice optimising structured monitoring to improve clinical outcomes in type 2 diabetes (GP-OSMOTIC) trial : statistical analysis plan for a multi-centre randomised controlled trial
Authors: Chiang, Jason
Blackberry, Irene
Thuraisingam, Sharmala
Chondros, Patty
Catchpool, Max
Dalziel, Kim
Manski-Nankervis, Jo-Anne
Speight, Jane
Holmes-Truscott, Elizabeth
Audehm, Ralph
O’Neal, David
Khunti, Kamlesh
Best, James
Furler, John
Keywords: Statistical Analysis Plan
Randomised Controlled Trial
DRNTU::Science::Medicine
Issue Date: 2019
Source: Thuraisingam, S., Chondros, P., Catchpool, M., Dalziel, K., Manski-Nankervis, J.-A., Speight, J., . . . Furler, J. (2019). Update on the general practice optimising structured monitoring to improve clinical outcomes in type 2 diabetes (GP-OSMOTIC) trial : statistical analysis plan for a multi-centre randomised controlled trial. Trials, 20, 93-. doi:10.1186/s13063-018-3126-1
Series/Report no.: Trials
Abstract: Background : General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines. Objective : To describe in detail the data management process and statistical methods that will be used to analyse the trial data. Methods : An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results. Conclusion : In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses.
URI: https://hdl.handle.net/10356/105972
http://hdl.handle.net/10220/48824
DOI: 10.1186/s13063-018-3126-1
Rights: © 2019 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:LKCMedicine Journal Articles

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