Developing a Core Outcome Set and a Core Outcome Measurement Set for Studies Evaluating Interventions to Minimize...

Area of Science:

• Critical Care Medicine
• Patient Safety Research
• Health Services Research

Background:

• Variability in outcome selection and measurement hinders evidence synthesis for physical restraint minimization in adult intensive care units (ICUs).
• This heterogeneity limits the development of evidence-based strategies to reduce restraint use and enhance patient outcomes.

Purpose of the Study:

• To develop international consensus on core outcomes for physical restraint minimization studies in adult ICUs.
• To establish standardized measurement approaches for these core outcomes.

Main Methods:

• Utilizing the Core Outcome Measures in Effectiveness Trials (COMET) Handbook.
• Conducting a 2-round Delphi survey with stakeholders, informed by a scoping review and family interviews.
• Finalizing the core outcome set and measurement methods through consensus meetings.

Main Results:

• Ethical approval is pending; recruitment and data collection are scheduled from January 2026 to April 2027.
• Project completion and publication of findings are anticipated by June 2027.

Conclusions:

• This research will establish the first core outcome and measurement sets for physical restraint minimization in adult ICUs.
• Standardization will enable cross-study comparability, support evidence synthesis, and inform high-quality research.
• The developed sets will guide evidence-based practices to improve ICU patient safety and care.