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
Bibliographic record
Abstract
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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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Qualitative | low |
| gpt | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Other design | low |
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.040 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".