1. MbchB, MMED(Int Medicine), DTMH Mbarara Regional Refferal Hospital
A comparison of the predictive properties and acceptability of the Full Outline of Unresponsiveness (FOUR) score and the Glasgow Coma Score (GCS) among patients with reduced level of consciousness in a resource-limited setting
Dr. Abdallah Amir
MbchB, MMED(Int Medicine), DTMH
Mbarara Regional Refferal Hospital

2. Full list of investigators
Abdallah, Amir, Mbarara Regional Referral Hospital
Adrian, Kayanja, Mbarara University of Science and Technology
Rose, Muhindo, Mbarara University of Science and Technology
Stephen, B. Asiimwe, Mbarara Regional Referral Hospital and UCSF- CA, USA
Tony, Wilson, Mbarara University of Science and Technology
Bart M. Demaerschalk, Department of Neurology, Mayo Clinic, Arizona, USA
Nan Zhang, Mayo Clinic, Arizona, USA
E. Peter Bosch, Department of Neurology, Mayo Clinic, Arizona, USA
Cumara O’Carroll, Department of Neurology, Mayo Clinic, Arizona, USA

3. Introduction
The successful management of patients with central nervous system disorders(CNS) and reduced level of consciousness(LOC) requires a proper neurological evaluation and risk stratification.
Neurological evaluation; good history, clinical examination and all kinds diagnostic modalities.
In resource limited settings, lack of medical imaging and other diagnostic services significantly hampers the ability of clinicians to fully asses patients with LOC.

4. In the absence of good diagnostic capabilities therefore, clinical neurological scores can be used by clinicians to diagnose, risk-stratify, and measure disease severity.
Clinical scores can also be used to monitor and identify patients that are most likely to benefit from aggressive physiological support or early referral to ICU
Examples of such scores are; The Glasgow Coma Scale (GCS) and The Full Outline of Unresponsiveness (FOUR) score.

6. - able to asses for brainstem reflexes and respiratory patterns
- Has been evaluated in the US in neuro-critical care, general intensive care, and general medical emergency units, and, in all cases, found to have excellent inter-rater agreement
- Found to predict in-hospital mortality and 30-day functional status as determined by the Modified Rankin Score better than the GCS, especially at the lowest scores

7. Able to asses for brainstem reflexes and respiratory patterns
Excellent inter-rater agreement
Found to predict in-hospital mortality and 30-day functional status better than the GCS, especially at the lowest scores
Not validated in RLS
Has been evaluated in the US in neuro-critical care, general intensive care, and general medical emergency units, and, in all cases, found to have

8. Rwebembera J; Tropical doctor 2009, 39(4):240-241.
Methods
Observational cohort study
Patients presenting to the medical emergency room (ER) at MRRH with reduced LOC
MRRH; 300kms SW of Kampala; 400 bed capacity; 3 Million catchment.
It’s the teaching hospital for Mbarara University.
350 monthly admission to the medical ER, 16.1% have LOC. LOC patients have an in-hospital mortality of 44%.
Rwebembera J; Tropical doctor 2009, 39(4):

9. Specific Objectives
Objectives
To assess how the FOUR score predicts in-hospital mortality in patients admitted with reduced LOC in a resource limited setting, and to compare its performance to that of the GCS.
To determine the acceptability of the FOUR score, compared to that of GCS, as a neurological assessment tool to be used by physicians attending to patients with reduced LOC in a resource limited setting.

10. Inclusion and exclusion criteria
Aged ≥18years with reduced or altered LOC of any etiology.
drowsy, stuporous, or comatose.
Exclusion:
- Received sedating or neuromuscular blocking agents
- Patients with surgical emergencies.

11. Study procedures
Patient identification from the waiting area at the ER.
Initial consenting
Detailed evaluation; socio demographic data and contact information, history, a full clinical examination including a detailed neurological examination.
FOUR and GCS score will be done by the P.I
Investigations: CBC, HIV, RBS, electrolytes
Followed up for primary and secondary outcomes.

12. Measurements
Primary predictors: GCS and FOUR scores.
Secondary predictors of outcome: history, clinical examination, and laboratory investigations
Outcomes: primary outcome; in-hospital mortality while the secondary outcomes; 30-day mortality and the functional status of survivors at 30 days.

13. Quality assurance for neurological assessments
For all patients, both the FOUR score the GCS score will be conducted by the PI.
The PI and all those involved in the study will receive a 3-4 weeks refresher bed-side training in the use of both the GCS and FOUR scores.
This refresher training will be by neurologists from the Mayo clinic (Arizona).

14. Qualitative measurements(second objective)
Qualitative in depth interviews with clinicians at different levels of training
One FGD with clinicians and nurses at the end of the study.
(interns, senior house officers, and attending physicians) to get a preliminary view of their attitudes towards clinical neurological scores including both the GCS and the FOUR score).

15. Data analysis
Descriptive analyses
Inferential analyses
- a multivariable-adjusted logistic regression
- compare the areas under the ROC curve for the multiple logistic models for both scores.
- spearman’s rank correlation coefficient between both scores.
 Qualitative data analysis

16. Sample size calculation
Assumptions
- An estimated risk of death of 40% in the study population,
- significance of <0.05, power of 80%,
- loss to follow-up rate of 5%,
A total of 360 patients (30-40 patients per month over 9 to 12 months).

17. Ethical considerations
- Confidentiality and consent
- Minimal risk
- Ethical approval from hospital director and the MUST-REC.
Dissemination of findings
- Department of Medicine of Mbarara University
- Oral posters/presentations at the conferences
- Publication in a peer reviewed journal.

18. Acknowledgements
Conference organizers
Department of medicine at MUST
Department of neurology, Mayo clinic, AZ.