Introduction: Heterogeneity in the data collected has been noted in previous studies examining physical restraint minimization in adult ICUs. This variability risks overlooking key social determinants of health that influence physical restraint use. Failing to address these determinants not only hinders the identification of patterns and disparities but may also perpetuates systemic biases, disproportionately affecting vulnerable groups and eroding trust in healthcare systems. We seek to establish an international consensus on core data elements to be collected in studies aimed at minimizing physical restraint use in adult ICUs.
Relevant Minimum Data Set (MDS) and Rationale for a New MDS
No relevant published or ongoing MDS was identified for studies evaluating physical restraint minimization interventions in adult ICUs. Given the specific and crucial data elements required for these types of intervention, there is a clear need for a dedicated MDS. Developing this MDS will standardize data collection, improve comparability across studies, and support the design of high-quality research that can influence clinical practice and policy in restraint minimization.
PI: Ziad Alostaz
Sally Horsfall Eaton School of Nursing, Daphne Cockwell Centre for Health Sciences, Waterfront Campus, George Brown College, Toronto, ON, Canada M5A 0B6
Contributors:
1. Wendy Ellis
Sally Horsfall Eaton School of Nursing, Daphne Cockwell Centre for Health Sciences, Waterfront Campus, George Brown College, Toronto, ON, Canada M5A 0B6
2. Louise Rose
Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, London, UK
3. Sangeeta Mehta
a. Department of Medicine, Interdepartmental Division of Critical Care Medicine, University of Toronto
b. Mount Sinai Hospital, 600 University Ave, Rm 18-216, Toronto, ON, Canada
Disease Category: Other
Disease Name: N/A
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Researchers
- Minimum dataset
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)
Methods and analysis: We will design a protocol to guide the development of the minimum data set, incorporating input from representatives of our key stakeholder groups—former ICU patients, family members, ICU clinicians, and researchers—to ensure a rigorous and systematic approach. Building on our prior work, which includes a scoping review of restraint minimization studies that we will update, and in-depth interviews with family members and interprofessional ICU teams, as well as a previously published EDI glossary of sociodemographic determinants of health within critical care medicine, we will compile a comprehensive list of relevant sociodemographic variables. These variables will be evaluated through a structured two-round Delphi process. In the first round, stakeholders will rank the identified outcomes and variables using the 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 final consensus meeting, using a nominal group technique, will be held with representatives from our stakeholder groups to finalize the core data set and determine the appropriate granularity of sociodemographic data collection.
Ethics and dissemination: We will obtain research ethics approval in full compliance with the requirements of local authorities. Participation will be entirely voluntary, with strict measures in place to de-identify all data and ensure confidentiality. The results will be disseminated through prominent international organizations, such as the Restraint Reduction Network, published in high-impact peer-reviewed journals, and presented at relevant conferences to maximize their reach and impact.