Comparison Between GCS and FOUR Scores

NCT06703619 | Completed DMC

• 1 other identifier: UNCOMIRB20240520
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the predictive utility of the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score in determining outcomes among patients with altered mental status admitted to the emergency room. The main questions it aims to answer are: Does the FOUR Score provide a more accurate prediction of patient outcomes than the GCS Score? Are there specific patient subgroups where one score is more effective than the other? Participants will: Undergo assessment of mental status using both the FOUR Score and the GCS Score during their emergency room admission. Have their clinical outcomes monitored during their hospital stay.

Conditions

Coma

Keywords

GCS; FOUR score; COMA

Outcome Measures

Primary Outcomes (3)

• In hospital mortality

  Mortality (death) during hospitalization

  average of 10 days through discharge

• Accuracy Assessment of the Glasgow Coma Scale (GCS)

  Glasgow Coma Scale (GCS): Range 3-15; higher scores indicate better neurological status.

  the first 12 hours after ER admission

• Accuracy Assessment of the Full Outline of UnResponsiveness (FOUR) Score

  Full Outline of Unresponsiveness (FOUR) score: Range 0-16; higher scores indicate better neurological status.

  the first 12 hours after ER admission

Secondary Outcomes (1)

• Length of Hospitalization

  average of 10 days through discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients (aged 18 years and above) presenting to the emergency room with altered mental status due to various underlying conditions, such as traumatic brain injury, metabolic encephalopathy, stroke, or central nervous system infections. Participants will be selected from a tertiary care hospital emergency room where comprehensive medical and neurological assessments are routinely conducted. This population is expected to represent a diverse range of clinical presentations and severities of altered consciousness, making it suitable for evaluating the predictive performance of the Full Outline of Unresponsiveness (FOUR) score and the Glasgow Coma Scale (GCS).

You may qualify if:

• Patients admitted to the emergency room with altered mental status.
• Patients were assessed using both the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score upon admission.
• Patients whose clinical outcomes (e.g., mortality, length of hospital stay, need for intensive care) are available for follow-up and analysis.

You may not qualify if:

• Patients with incomplete or missing data on FOUR and/or GCS assessments.
• Patients who leave against medical advice (LAMA) or are discharged before outcome data can be collected.
• Patients with pre-existing neurological conditions that might independently influence outcomes (e.g., severe dementia, long-standing neurodegenerative diseases).
• Patients in whom resuscitative measures were initiated but unsuccessful before scoring could be performed.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

Location

Related Publications (3)

• Fischer M, Ruegg S, Czaplinski A, Strohmeier M, Lehmann A, Tschan F, Hunziker PR, Marsch SC. Inter-rater reliability of the Full Outline of UnResponsiveness score and the Glasgow Coma Scale in critically ill patients: a prospective observational study. Crit Care. 2010;14(2):R64. doi: 10.1186/cc8963. Epub 2010 Apr 14.

  PMID: 20398274 RESULT

• Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.

  PMID: 16178024 RESULT

• Segatore M, Way C. The Glasgow Coma Scale: time for change. Heart Lung. 1992 Nov-Dec;21(6):548-57.

  PMID: 1447002 RESULT

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasan Azeez Al-Hamadani, Professor of Neurology

  College Of Medicine - Nahrain University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 3, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)