Core Outcome Measures in Effectiveness Trials

The Core Outcome Measures for Food Allergy

General Information

Summary:
Food allergy is a major societal challenge in Europe. The disease affects 6%-8% of children under the age of 3 years, and 2-3% of adults and has a quality of life impact similar to other major chronic conditions. Food allergy is a major financial burden, with significant impact on healthcare, education, food and catering industries. New treatments for food allergy are in development. There is however no agreed set of Core Outcomes for evaluating these new treatments. This may prevent the development of effective treatments with marketing approvals from regulatory authorities, for food allergic Europeans.

Core Outcome sets ensure that trial outcomes are relevant to patients, clinicians, healthcare providers and regulators; and they allow trial outcomes to be combined in meta-analysis, so that new findings are capitalized on as soon as possible. The Core Outcome Measures for Food Allergy (COMFA) project is a multidisciplinary network involving all relevant stakeholders aiming to advance food allergy research and innovation by (a) defining the scope and applicability of food allergy Core Outcome sets; (b) developing Core Outcome sets and measurement tools for food allergy; (c) reaching a consensus on terminology and definitions of measurement properties for food allergy Core Outcomes.

This project addresses the Societal Challenges in Health by improving our understanding of health and our ability to reliably monitor health outcomes, and demonstrates new options for healthcare delivery. The outcomes will help improve the quality of clinical trials, and the Action will advance the career of young researchers, strengthening Europe's leading position in pharmaceutical sciences.

Contributors:
https://www.cost.eu/actions/CA18227/#tabs|Name:management-committee

Further Study Information

Current Stage:
Ongoing
Date:
November 2019 - November 2023
Funding source(s):
European Cooperation in Science and Technology (COST)

Health Area

Disease Category
Other

Disease Name
Food allergy

Target Population

Age Range
0 - 120

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Literature review
Semi structured discussion
Survey
Systematic review

To be confirmed.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Families
Food industry
Journal editors
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Researchers
Service providers
Service users
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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