JMIR Publications

ABSTRACT

Background:

Heterogeneity in outcome selection and measurement methods has been noted in previous studies examining physical restraint minimization in adult intensive care units (ICUs). This variability undermines meaningful evidence synthesis, including systematic reviews and meta-analyses, thereby limiting the development of evidence-based clinical approaches in minimizing physical restraint use and improve patient outcomes.

Objective:

This protocol outlines the methods for developing an international consensus on priority core outcomes, along with standardized measurement approaches for these outcomes in studies focused on minimizing physical restraint use in adult ICUs.

Methods:

We will follow the guidelines outlined in the Core Outcome Measures in Effectiveness Trials Handbook. At the outset, representatives from key stakeholder groups—including former ICU survivors/ family members, ICU clinicians, and researchers—are involved in designing this protocol to enhance its relevance and applicability. Drawing on our previous work, including a scoping review of studies on physical restraint minimization that we will update, and interviews with family members about restraint use and minimization in the ICU, we will compile a comprehensive list of potential outcomes for stakeholders to use in the two-round Delphi process. In the first round, stakeholders will rank the identified outcomes using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) scale. In the second round, they will be provided with a summary of the results from Round 1 for rescoring and further refinement. A series of consensus meetings using the modified nominal group technique will be held with representatives from our stakeholder groups to finalize the core outcome set, followed by another meeting to establish standardized measurement methods for the agreed-upon outcomes.

Results:

We are in the process of finalizing the REB application for this protocol, which will be submitted shortly. The anticipated project start date is June/July 2025, with completion expected by October 2026.

Conclusions:

This study will be the first to establish both a core outcome set, and a core measurement set for minimizing physical restraint use in adult ICUs. By standardizing outcomes and measurement methods, it will enhance comparability across future research and contribute to improved patient care in ICUs Clinical Trial: This protocol is registered in the Core Outcome Measurement in Effectiveness Trials (COMET) Initiative database registration: https://cometinitiative.org/Studies/Details/3368