Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 20, 2020
Date Accepted: Mar 22, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Statistical analysis plan for comparing the effectiveness of a hierarchical diabetes management intervention vs. usual care in primary care in China: the ROADMAP study
ABSTRACT
Background:
As the management of type 2 diabetes (T2D) remains suboptimal in primary care, the ROAd to hierarchical Diabetes Management At Primary care (ROADMAP) study is designed and being conducted in diverse primary care settings to test the effectiveness of a three-tiered diabetes management model of care in China.
Objective:
This paper pre-determines the detailed analytical methods for the study before completion of database lock to reduces potential bias and facilitate transparent analyses.
Methods:
The ROADMAP study adopts a community-based, cluster randomised controlled trial design which compares the effectiveness of a tiered diabetes management model on diabetes control to usual care among diabetes patients over a one-year study period. Registered adult patients with T2D were randomly selected from primary care clinics in 864 communities across 144 counties/districts of 25 provinces in China. Communities (clusters) within the same county were randomly assigned to either the intervention or control (usual care) arm in a 2:1 ratio. The centralized randomisation was stratified by provincial economic development level (developed/less-developed) and its locality (urban/rural). The primary outcome is the control rate of glycated haemoglobin (HbA1c) <7% at one year. Secondary outcomes include control rates and changes of ABC (HbA1c, blood pressure and LDL-C) targets and fasting plasma glucose, hypoglycaemia episodes, and health-related quality of life (EuroQol, EQ-5D).
Results:
Appropriate statistical comparisons between arms are planned and described in detail, including exploratory and sensitivity analyses. Five subgroup analyses are pre-specified.
Conclusions:
This article outlines the statistical analysis plan for the main publication and was written and reviewed with all authors blinded to group allocation and no access to study data. This plan has been approved and signed off by the principle investigator, co-principle investigator and lead statisticians by Nov 19-22, 2019, and made public on the institutional website, prior to completion of end-of-study assessment of last participant. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR-IOC-17011325).
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Copyright
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