Core Outcome Measures in Effectiveness Trials

Health Information Technologies in Paediatrics: A Protocol for the Identification of a Core Outcome Set using a Delphi Survey and Consensus Meeting

General Information

Summary:
Background
Investments in the use of Health Information Technologies (HITs) are increasing. HITs are electronic tools that enable the storage, communication or sharing, and analysis of health-related data. In paediatric healthcare settings, over forty Randomised Controlled Trials (RCTs) investigating the use of HIT interventions have been published. However, there are concerns that the quality of evidence relating to the use of these interventions may be limited by the way that the outcomes of HIT trials are selected and reported. This study therefore aims to facilitate the development of a Core Outcome Set (COS) for use in evaluations of HIT interventions implemented in paediatric healthcare settings.

Methods
We will follow recommended COS development methods (COS-STAD). We have previously identified the outcomes reported in RCTs of HIT interventions conducted in paediatric healthcare settings. These outcomes will be categorised and used as a starting point from which to conduct a two round Delphi survey involving stakeholder groups including children, young people and their parents. The results of the Delphi Survey will be presented at a consensus meeting where the final COS will be agreed.

Discussion
There is currently no published COS for evaluating the use of Health Information Technologies in paediatric healthcare settings. The development of a COS will improve the quality of future studies, help to reduce outcome reporting bias, allow easier comparison between studies, enhance opportunities for meta-analysis and will enable healthcare providers to better evaluate the effectiveness of their services.

Contributors:
Dr Matthew Neame, University of Liverpool, Principal Investigator
Dr Ian Sinha, Alder Hey Children's Hospital, Project Supervisor
Dr Dan Hawcutt, University of Liverpool, Project Supervisor

Further Study Information

Current Stage:
Ongoing
Date:
December 2018 - December 2019
Funding source(s):
No specific funding for this project. MN is funded by the NHS Digital, Global Digital Exemplar Programme. DH is part funded by the NIHR Alder Hey Clinical Research Facility.

Health Area

Disease Category
Child health

Disease Name
N/A

Target Population

Age Range
0 - 17

Sex
Either


Nature / type of Intervention
Other

Method(s)

Consensus meeting
Delphi process
Systematic review

We have completed a systematic review which has identified the categories of outcomes that have been reported in randomised controlled trials of HITs conducted in paediatric settings. We propose to use a two round Delphi survey and a consensus meeting to identify which outcome categories stakeholders would recommend for inclusion in future evaluations of the effects of HIT interventions.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Device manufacturers
Families
Journal editors
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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