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Developing a Core Outcome Set and a Core Outcome Measurement Set for Studies Evaluating Interventions to Minimize
Ziad Alostaz1, Wendy L Ellis1, Sangeeta Mehta2
1Faculty of Health Sciences, George Brown College, Toronto, ON, Canada.
Background:
Heterogeneity in outcome selection and measurement methods has been noted in studies examining the minimization of physical restraint use in adult intensive care units (ICUs). This variability undermines evidence synthesis, limiting the development of evidence-based approaches to minimize restraint use and improve patient outcomes.
Objective:
This protocol outlines the methods for developing international consensus on core outcomes and standardized measurement approaches for studies focused on physical restraint minimization in adult ICUs.
Methods:
We will follow the Core Outcome Measures in Effectiveness Trials Handbook. Drawing on our previous work, including a scoping review of studies on physical restraint minimization and interviews with family members, we will compile a list of potential outcomes for a 2-round Delphi survey. In round 1, stakeholders will rank outcomes using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) scale. In round 2, they will review the aggregated results for rescoring and refinement. A consensus meeting using the modified nominal group technique will finalize the core outcome set, followed by another meeting to agree on standardized measurement methods.
Results:
Research ethics board approval is in progress. Recruitment has not yet begun. Project initiation is anticipated in January 2026, with completion planned for April 2027 and publication of findings is expected by June 2027.
Conclusions:
This study will be the first to establish a core outcome set and a core outcome measurement set for minimizing restraint use in adult ICUs. Standardization will enhance comparability across future studies and support evidence synthesis. The resulting outcome and measurement sets will provide a foundation for high-quality research and guide evidence-based strategies to improve patient safety and care in ICU settings.
Trial Registration:
COMET Initiative 3368; https://tinyurl.com/yubfzre9.
International Registered Report Identifier (Irrid):
PRR1-10.2196/76405.
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