General Practice and Primary Care - Research Publications

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Author: Chondros, Panagiota × Author: Furler, John × Start date: 2015 × End date: 2019 ×

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    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, S ; Chondros, P ; Catchpool, M ; Dalziel, K ; Manski-Nankervis, J-A ; Speight, J ; Holmes-Truscott, E ; Audehm, R ; Chiang, J ; Blackberry, I ; O'Neal, D ; Khunti, K ; Best, J ; Furler, J (BMC, 2019-01-30)
    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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.
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    Correction.
    Palmer, VJ ; Chondros, P ; Piper, D (BMJ, 2015-07-14)
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    The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting
    Palmer, VJ ; Chondros, P ; Piper, D ; Callander, R ; Weavell, W ; Godbee, K ; Potiriadis, M ; Richard, L ; Densely, K ; Herrman, H ; Furler, J ; Pierce, D ; Schuster, T ; Iedema, R ; Gunn, J (BMJ PUBLISHING GROUP, 2015)
    INTRODUCTION: User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. METHODS: An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. ETHICS AND DISSEMINATION: The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry ACTRN12614000457640.