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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

Authors: Johanna Taylor, Jan R. Böhnke, Judy Wright, Ian Kellar, Sarah L. Alderson, Tom Hughes, Richard I. G. Holt, Najma Siddiqi

Published in: Trials | Issue 1/2017

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Abstract

Background

People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed.

Methods

This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist.

Discussion

The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups.

Trial registration

COMET registration: http://​www.​comet-initiative.​org/​studies/​details/​911. Registered on 1 July 2016
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Metadata
Title
A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review
Authors
Johanna Taylor
Jan R. Böhnke
Judy Wright
Ian Kellar
Sarah L. Alderson
Tom Hughes
Richard I. G. Holt
Najma Siddiqi
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1805-y

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