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

Thuraisingam, Sharmala, Chondros, Patty, Catchpool, Max, Dalziel, Kim, Manski-Nankervis, Jo-Anne, Speight, Jane, Holmes-Truscott, Elizabeth, Audehm, Ralph, Chiang, Jason, Blackberry, Irene, O'Neal, David, Khunti, Kamlesh, Best, James and Furler, John 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, vol. 20, pp. 1-14, doi: 10.1186/s13063-018-3126-1.

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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
Author(s) Thuraisingam, Sharmala
Chondros, Patty
Catchpool, Max
Dalziel, Kim
Manski-Nankervis, Jo-Anne
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Holmes-Truscott, ElizabethORCID iD for Holmes-Truscott, Elizabeth orcid.org/0000-0001-9139-4663
Audehm, Ralph
Chiang, Jason
Blackberry, Irene
O'Neal, David
Khunti, Kamlesh
Best, James
Furler, John
Journal name Trials
Volume number 20
Article ID 93
Start page 1
End page 14
Total pages 14
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2019-01
ISSN 1745-6215
Keyword(s) General practice
Randomised controlled trial
Retrospective continuous glucose monitoring
Statistical analysis plan
Type 2 diabetes
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Summary 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. 
Language eng
DOI 10.1186/s13063-018-3126-1
Field of Research 170106 Health, Clinical and Counselling Psychology
Socio Economic Objective 920104 Diabetes
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2019, The Author(s)
Persistent URL http://hdl.handle.net/10536/DRO/DU:30118514

Document type: Journal Article
Collections: School of Psychology
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