Statistical analysis plan of the study titled “A deprescribing programme aimed to optimize blood glucose-lowering medication in older people with type 2 diabetes mellitus — the OMED2 study: a randomized controlled trial”
Trials, vol. 27
Abstract
BACKGROUND: The OMED2 (Optimization of Medication in Elderly with Diabetes) study addresses the effect and implementation of integrating a deprescribing programme (DPP) in general practice. The aim of the DPP is to reduce glucose-lowering medication (SU/insulin) in overtreated older patients. The protocol for this study has been published previously. This statistical analysis plan (SAP) contains a more elaborate outline of the (statistical) methods we plan to use for data analysis. METHODS: The OMED2 study is a randomized mixed-methods study with a 2-year follow-up period that compares the effect of the implementation of a DPP in general practice to regular care (control). In this SAP, we report on the (statistical) approaches that we plan to use to address the study objectives. The main objective of the OMED2 study is to examine the effect of the implementation of the DPP on diabetes complications, whereby the total number of diabetes complications related to undertreatment and overtreatment will be summed. Generalized linear mixed models with a Poisson distribution and the DPP as the main determinant will be used to test whether the total number of diabetes complications occurring from the start of the 2-year follow-up until the end of follow-up differs between intervention and control. The incident rate of the number of diabetes complications will be calculated to correct for possible differences in follow-up duration. The model will also include a random effect variable to allow for possible clustering effects by general practice. We will perform intention-to-treat analyses, which include all patients eligible for deprescribing, as well as per protocol analyses, which omit patients who were not deprescribed in the intervention arm. Additionally, approaches to study the implementation of the DPP and the cost-effectiveness of the implementation are outlined in the SAP. TRIAL REGISTRATION: ISRCTN Registry ISRCTN50008265. Registered on 1 November 2024.
Authors 14
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Charlotte Andriessen corresponding
Amsterdam Public Health · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health Research Institute, Amsterdam, the Netherlands. c.andriessen@amsterdamumc.nl
Department of General Practice, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. c.andriessen@amsterdamumc.nl
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Amsterdam Public Health · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
Department of General Practice, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands
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Amsterdam Public Health · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
Department of General Practice, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care/Health Campus The Hague, LUMC, Leiden, The Netherlands
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National Institute for Public Health and the Environment · Vrije Universiteit Amsterdam
Affiliation as printed
Centre for Public Health, Healthcare and Society, National Institute of Public Health and the Environment, Bilthoven, the Netherlands
Department of Health Sciences, Faculty of Beta Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
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Affiliation as printed
PHARMO Institute for Drug Outcomes Studies, Utrecht, The Netherlands
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Amsterdam University Medical Centers · Jeroen Bosch Ziekenhuis
Affiliation as printed
Department of Clinical Pharmacology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands
Department of Elderly Care Medicine, Amsterdam University Medical Center, Amsterdam, the Netherlands
Department of Geriatric Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Center, Amsterdam, the Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Internal Medicine - Geriatrics, Amsterdam University Medical Center, Amsterdam, the Netherlands
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Amsterdam Public Health · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
Department of General Practice, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care/Health Campus The Hague, LUMC, Leiden, The Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
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Amsterdam Public Health · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
Department of General Practice, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands
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