Predicting Favorable Outcome in Patients who Exhibit a Normal CT Scan after Moderate or Severe Traumatic Brain Injury Open Access

Abstract

A post hoc analysis of clinical trial data from the Progesterone for Traumatic Brain Injury Experimental Clinical Treatment (ProTECT III) clinical trial was conducted in an effort to elucidate patient characteristics that could be used to predict 6-month patient outcome as defined by an Extended Glasgow Outcome Scale stratified dichotomy. Patients in this trial were diagnosed with a moderate or severe traumatic brain injury (TBI) upon inclusion. Univariate analysis and multivariable logistic model selection was performed on the potential patient characteristics to create a prediction model for 6-month patient outcome in both the entire cohort of clinical trial patients (N = 829) as well as the cohort of patients who exhibited an initially normal CT scan (N = 105). An assessment of efficacy of the progesterone treatment was also conducted for the normal CT cohort of patients. Similar to the results of the randomized clinical trial, progesterone treatment was again not associated with the 6-month dichotomized outcome (OR: 0.571 (0.227, 1.437)) in the normal CT cohort of patients. Patient characteristics that were found to significantly predict patient outcome in the entire cohort include verbal GCS score, CT scan, age, ISS, and whether or not the patient underwent a prior TBI, non-intraventricular ICP monitor installation or ventriculostomy. In the cohort of patients with a normal CT scan, verbal GCS score, blood glucose concentration, and pupil response were found to significantly predict patient outcome at 6 months.

Table of Contents

1. 1. Acronym Key 1

2. Introduction 2

3. Methods 8

Clinical Trial Description and Results 8

Progesterone Intervention 8

Participants & Randomization 10

Data Collection 12

Outcome Measure 12

Patient Characteristics and Measurements 15

Aims of Analysis 17

Statistical Analysis Plan -Descriptive Statistics and Univariate Analysis 18

Statistical Analysis Plan - Model Selection 19

Statistical Analysis Plan - Multivariable Analysis 24

4. Results 25

Association between Patient Characteristics and CT scan 26

Predicting 6-month Outcome in Entire Cohort 29

Predicting 6-month Outcome in patients with normal CT scan 38

5. Discussion 47

Interpretation of Results & Clinical Significance 47

Limitations 50

Future Work 51

Final Conclusions 51

6. Appendix 52

7. Sources 56

About this Master's Thesis

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School	Rollins School of Public Health
Department	Biostatistics and Bioinformatics
Subfield / Discipline	Biostatistics - MPH & MSPH
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Biology, Biostatistics Health Sciences, Public Health Health Sciences, Medicine and Surgery
Keyword	Clinical Trial Traumatic Brain Injury Normal CT
Committee Chair / Thesis Advisor	Moore, Renee H, Emory University
Committee Members	Ratcliff, Jonathan J, Emory University
Partnering Agencies	Emory University schools, faculty or affiliated programs

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