COMET Initiative | Development of a Core Outcome Set for nutritional intervention studies focused on treating protein-energy malnutrition in malnourished older adults and those at risk

Development of a Core Outcome Set for nutritional intervention studies focused on treating protein-energy malnutrition in malnourished older adults and those at risk

Introduction
As part of the development of an agreed minimum set of outcomes or Core Outcome Set (COS) for future nutritional intervention trials in older adults with malnutrition or at risk of malnutrition, this work reports on the Delphi surveys and final consensus.

Methods
Outcomes from a scoping review were incorporated into a two-round Delphi survey. Researchers and healthcare professionals experienced in malnutrition in older adults were invited to take part in an online survey to rate 38 selected outcomes on a nine-point Likert scale ranging from ‘not important’ to ‘critical’ for their setting (community, hospital, or long-term care). Consensus for inclusion was reached when =75% (or =60% if a patient-reported outcome) of the participants scored the outcome as ‘critical’ and <15% as ‘not important’. Resulting outcomes were voted for inclusion or exclusion in the COS in a final online consensus meeting.

Results
Ninety-three and 72 participants from diverse professional backgrounds and countries participated in the 1st and 2nd Delphi round, respectively. After both rounds eleven outcomes met the inclusion criteria, largely irrespective of setting. Fifteen participants, representing academia, health care, health policy, industry, and PPI, voted in a final online consensus meeting resulting in ten outcomes: malnutrition status, dietary intake, appetite, body weight or BMI, muscle strength, muscle mass, functional performance, functional limitations, quality of life, and acceptability of the intervention.

Conclusions
Ten outcomes will form the COS which is intended to be used by the scientific community in all future nutritional intervention studies for older adults with malnutrition or at risk of malnutrition. The subsequent phase will establish the appropriate methods to measure these outcomes.

Contributors

Nuno Mendonça, Christina Avgerinou, Sibel Çavdar, Tommy Cederholm, Alfonso J. Cruz-Jentoft, Gabriel Torbahn, Cornel Sieber, Hanna M. Siebentritt, Eva Kiesswetter, Dorothee Volkert & Marjolein Visser

Publication

Journal: European Journal of Clinical Nutrition
Volume:
Issue:
Pages: -
Year: 2024
DOI: 10.1038/s41430-024-01444-6

Further Study Information

Current Stage: Completed
Date: March 2020 - 2024
Funding source(s): NM was funded by the Fundação para a Ciência e a Tecnologia (2021.00745.CEECIND). The present publication was funded by Fundação Ciência e Tecnologia, IP national support through CHRC (UIDP/04923/2020). The work has also received support from EuGMS.

Health Area

Disease Category: Health care of older people

Disease Name: Malnutrition

Target Population

Age Range: 65 - 120

Sex:

Nature of Intervention: Diet and nutrition

Stakeholders Involved

- Clinical experts
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Delphi process
- Survey
- Systematic review

1) Scoping review
2) Delphi study