Core Outcome Measures in Effectiveness Trials

Developing core economic outcome sets for asthma studies: a protocol for a systematic review

General Information

Abstract:
Introduction Core outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set.

Methods and analysis We will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a ‘realist synthesis review’ to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set.

Ethics and dissemination The review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Authors:
Natalia Hounsome, Deborah Fitzsimmons, Ceri Phillips, Anita Patel

Publication

Journal:
BMJ Open
Volume:
7
Issue:
8
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):
This study was funded by Asthma UK as part of the Asthma UK Centre for Applied Research (AUK-AC-2012-01)

Health Area

Disease Category
Lungs & airways

Disease Name
Asthma

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
N/A

Method(s)

Systematic review

Stakeholders Involved

Unknown

Study Type

Systematic review of outcomes measured in trials

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