ArticleJMIR research protocols2025
Developing a Core Outcome Set and a Core Outcome Measurement Set for Studies Evaluating Interventions to Minimize Physical Restraint Use in Adult Intensive Care Units: Protocol for a Modified Delphi Study.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
- Erratum issued
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHeterogeneity 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.
objectiveThis 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.
methodsWe 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.
resultsResearch 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.
conclusionsThis 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 registrationCOMET Initiative 3368; https://tinyurl.com/yubfzre9. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/76405.
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