Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol.
Background Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.Methods This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.Conclusions We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.
Authors
- Lone Musaeus Poulsen (ORCID: https://orcid.org/0000-0002-7030-3395)
- Tomas Jovaiša (ORCID: https://orcid.org/0000-0002-0229-5100)
- Anne Craveiro Brøchner (ORCID: https://orcid.org/0000-0001-6453-6152)
- Rikke Faebo Larsen
- Claudia Spies (ORCID: https://orcid.org/0000-0002-1062-0495)
- Camilla Rahbek Lysholm Bruun (ORCID: https://orcid.org/0009-0004-6875-1369)
- Kristin Hofsø (ORCID: https://orcid.org/0000-0002-5854-8461)
- Martin I. Sigurðsson (ORCID: https://orcid.org/0000-0001-7054-0844)
- Louise Stenbryggen Herløv (ORCID: https://orcid.org/0000-0001-6638-1529)
- Jacob Dye (ORCID: https://orcid.org/0000-0002-3469-2792)
- Thomas Strøm (ORCID: https://orcid.org/0000-0002-1868-0978)
- Bharath Kumar Tirupakuzhi Vijayaraghavan (ORCID: https://orcid.org/0000-0002-1801-0667)
- Jon Henrik Laake (ORCID: https://orcid.org/0000-0001-6157-5359)
- Marek Nalos (ORCID: https://orcid.org/0000-0002-7977-9410)
- Carmen Andrea Pfortmueller (ORCID: https://orcid.org/0000-0003-0326-2770)
- Jade Cole
- Edward Litton (ORCID: https://orcid.org/0000-0002-5125-6829)
- Camilla Bekker Mortensen (ORCID: https://orcid.org/0000-0001-5202-3552)
- Anders Granholm (ORCID: https://orcid.org/0000-0001-5799-7655)
- Praleene Sivapalan (ORCID: https://orcid.org/0000-0002-0442-0032)
- Frederik Keus (ORCID: https://orcid.org/0000-0003-1516-1475)
- Anne‐Marie Gellert Bunzel (ORCID: https://orcid.org/0009-0002-9639-0623)
- Dale M. Needham (ORCID: https://orcid.org/0000-0002-9538-0557)
- Bodil Steen Rasmussen (ORCID: https://orcid.org/0000-0003-2190-145X)
- Aske Tøgern
- Anna Włudarczyk
- Naomi Hammond
- Eva Lærkner
- Matt P Wise
- Balasubramanian Venkatesh
- Anna Schandl
- Kimberley Haines (ORCID: https://orcid.org/0000-0002-2882-1594)
- Louise Rose
- Johanna Hästbacka
- Trine Haberlandt
- Kavita Yadav
- Wojciech Szczeklik
- Anna Holm
- Marlies Ostermann
- Sheila Nainan Myatra
- Sarah Gorst
- Maria Cronhjort
- Ingrid Egerod
- Marie O Collet
- Daniel Munblit
- Stine Estrup
- Morten Hylander Møller
- Carol Hodgson
- Bronwen Connolly
- Maurizio Cecconi
- Fredrike Blokzijl
- Maj-Brit Nørregaard Kjær
- Anders Perner
- Marja Mäkinen
Institutions
- Intensive Care Foundation (AU)
- Intensive Care Society (GB)
Publication Details
- Journal
- Open Access CRIS of the University of Bern
- Published
- 2026-06-18
- DOI
- https://doi.org/10.48620/98736
- Primary Topic
- Delphi Technique in Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00