Validation and Feasibility of the Coma Recovery Scale-Revised for Accelerated Standardized Assessment (CRSR-FAST): a Brief, Standardized Assessment Instrument to Monitor Recovery of Consciousness in the Intensive Care Unit
Conditions: Disorder of Consciousness, Traumatic Brain Injury
Sponsor: Massachusetts General Hospital

Validation and Feasibility of the Coma Recovery Scale-Revised for Accelerated 
Standardized Assessment (CRSR-FAST):  
a Brief, Standardized Assessment Instrument to Monitor Recovery of Consciousness in 
the Intensive Care Unit 
ClinicalTrials.Gov: NCT03549572 
February 08, 2023

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
1 
Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
PRINCIPAL/OVERALL INVESTIGATOR 
Dr. Yelena Bodien  
SITE PI 
Dr. Brian Edlow 
PROTOCOL TITLE 
The Coma Recovery Scale-Revised for Accelerated Standardized Assessment 
(CRSR-FAST): an abbreviated assessment of conscious awareness for 
patients with disorders of consciousness (DOC) 
FUNDING 
National Institute on Disability, Independent Living, and Rehabilitation 
Research, U.S. Department of Health and Human Services 
VERSION DATE 
02/08/2023 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
Specific Aims: 
Determine the reliability, validity, sensitivity/specificity and administration 
time of the CRSR-FAST in the acute care setting.  
Hypotheses: 
Hypothesis 1: Concurrent validity between CRSR-FAST and CRS-R total 
scores will be adequate.  
Hypothesis 2: Inter-rater reliability of CRSR-FAST-derived diagnostic 
ratings (conscious v. unconscious) will be adequate. 
Hypothesis 3: Test-retest reliability of CRSR-FAST-derived diagnostic 
ratings (conscious v. unconscious) will be adequate.  
Hypothesis 4: Internal consistency between the CRSR-FAST total score 
and the four subscale scores will be adequate.  
Hypothesis 5: The sensitivity of the CRSR-FAST in detecting features of 
MCS (using the CRS-R as a reference standard) will be adequate.  

Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
2 
Hypothesis 6: The average administration time for the CRSR-FAST when 
administered in the acute care setting will be ≤ 10 minutes. 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
The CRS-R1 is a standardized and validated bedside assessment of conscious 
awareness. It is used routinely for diagnosis and prognosis of patients with 
disorders of consciousness (DOC) as well as in research settings. One 
limitation of the CRS-R is the lengthy administration time required to obtain 
a total score. Administration time can vary from approximately 15-30 
minutes, depending on the patient’s level of responsiveness. For this reason, 
the CRS-R is rarely administered in the acute hospital setting. Less time-
consuming scales and metrics are used to assess conscious awareness in the 
acute hospital/ICU setting, but they lack specificity and sensitivity and have 
not been validated, increasing the potential for misdiagnosis2. In conjunction 
with the developers of the Neuroscore (an unpublished, abbreviated version 
of the CRS-R3), we have developed the CRSR-FAST and aim to test its 
validity, inter- and intra- rater reliability. We anticipate that, compared with 
the CRS-R, the CRSR-FAST will be less time-consuming to administer and 
score, but will maintain a high level of sensitivity to detecting signs of 
consciousness in severely brain injured patients. 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
Study design: prospective, cross-sectional study 
Participants: 75 subjects 
Inclusion Criteria: 
•
Age 18 or older
•
Fluent in English
•
Surrogate available to provide informed consent
•
History of severe acquired brain injury
•
Sustained a TBI (defined by damage to brain tissue caused by an
external mechanical force),
•
Be within 3 weeks of injury
•
Have a total GCS score <9 within the first 48 hours of injury,

Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
3 
•
Be unable to follow simple commands consistently at the time of
enrollment
Exclusion Criteria: 
•
History of developmental, neurologic, or major psychiatric disorder
resulting in ongoing functional disability up to the time of the current
injury
•
Physician orders for comfort measures only
The following clinical factors will necessitate deferral of enrollment until the 
condition or symptom has resolved: 
•
Evidence of a reversible medical condition or symptom that is judged
to be a safety concern or threat to the validity of the assessment, as
deemed by treating physician
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
Neurobehavioral Assessment 
Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is 
a standardized neurobehavioral rating scale that consists of 23 items 
organized into six subscales that address arousal, auditory, visual, motor, 
oromotor/verbal, and communication systems. Each subscale is organized 
hierarchically, with lower items representing reflexive behaviors and higher 
items indicative of cognitively-mediated behaviors. Reliability and validity 
have been demonstrated in multiple studies1. The CRSR-FAST consists of 10 
items organized into 4 subscales that address arousal, visual, motor and 
verbal/oromotor systems. Each subscale is organized hierarchically, with 
lower items representing reflexive behaviors and higher items indicative of 
cognitively-mediated behaviors.  
An independent member of the study team (i.e., not an examiner) will 
screen patients at MGH for eligibility through a medical chart review. When a 
patient meeting the inclusion/exclusion criteria is identified, the study PI and 
study coordinator will be notified. The study coordinator will work with the 
patient’s clinical team to determine an appropriate time to approach the 
family for consent. Consent may be conducted remotely or in-person at 
MGH. Once consent is obtained, the coordinator will work with the family and 
clinical team to determine an appropriate time to conduct the CRSR-FAST 
and CRS-R assessment(s). The study will conclude when a sample size of 
approximately 75 subjects is reached.  

Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
4 
The study will be conducted across approximately 4 sessions completed over 
one or two consecutive days and will be carried out by three independent 
examiners (A, B, and C). For example: 
Examiner A will administer the standard CRS-R and examiners B and C will 
administer the CRSR-FAST. This will enable calculation of concurrent validity 
(CRS-R v. CRSR-FAST) as well as inter-rater reliability of the CRSR-FAST 
(CRSR-FAST Rater A v. CRSR-FAST Rater B). Examiner C will administer the 
CRSR-FAST twice over a short interval to enable calculation of intra-rater 
reliability (CRSR-FAST Rater C at Time 1 v. CRSR-FAST Rater C at Time 2).  
Examiners may include Yelena Bodien, Joseph Giacino, a dedicated TBI 
Model Systems research assistant, postdoctoral fellow, and a surgical 
intensive care unit Fellow.  
The test administration order will be pseudo-randomized to prevent order 
effects and each test administration will be timed.  
We will record concomitant medications, dosages and administration times. 
Sharing Results with Surrogates and Clinicians 
After discussion of the ethical implications of sharing or not sharing the CRS-
R and CRSR-FAST with ICU clinicians, family member participants on the TBI 
Model System Advisory Board, and members of the investigator team with 
the patient’s family and/or clinical team, we have developed the following 
approach: 
-To avoid exposing families to multiple sources of information (i.e.,
information coming from the clinical team and the research team regarding
level of consciousness,) we will not share the CRS-R or the CRSR-FAST data
directly with families.
-Upon request, we will make the results of the full version of CRS-R available
to the clinical team
-We will provide an option on the consent form allowing the family to opt-out
of sharing data with the clinical team
-We will not provide the results of the CRSR-FAST to the clinical team
because this is not a validated assessment and the reliability of detecting
consciousness is unknown.
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
This study does not include treatment or diagnosis. 

Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
5 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
The CRS-R has been in use for the last 25 years and has amassed a long 
track record of clinical and research utility. An Administration and Scoring 
Manual detailing all procedures is used to guide administration and limit 
adverse events. No reports of harm to patients or subjects arising from CRS-
R administration have been reported since its inception. 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
To ensure the safety of study subjects, the attending physician will provide 
medical authorization for participation in the study and identify any potential 
contraindications. Study procedures will be terminated if there is evidence of 
extensive distress or discomfort. 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
There are no anticipated medical risks associated with the neurobehavioral 
examinations that will be conducted with the CRSR-FAST and CRS-R. 
CRS-R and CRSR-FAST exams sometimes include brief application of noxious 
stimulation to assess motor responses in the absence of command-following. 
Discomfort typically lasts approximately 20 seconds and resolves completely. 
Similar applications of noxious stimulation to elicit localizing or withdrawal 
behaviors are used routinely in clinical care and are a critical part of 
assessing brainstem and cortical function. 
To protect patient participants against this risk 
It is not possible to eliminate the risk of physical discomfort in this study as 
administration of both scales may requires application of noxious stimulation 
to assess brain function. Prior to application of noxious stimulation, the 
examiner will review the medical record and/or speak with the clinical staff 
to identify any implanted catheters or devices to avoid stimulation at these 
sites. The examiner will also ensure that there is no local tissue damage at 
the site of stimulation.  

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
6 
 
 
Privacy and Confidentiality  
Separating identifying material from data files will protect confidential 
information and securing both files in locked cabinet files and/or password 
protected electronic files. Surrogates will be informed that the Partners 
Institutional Review Board (IRB) may inspect identifying records and, 
therefore, absolute confidentiality cannot be assured.  
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
This study is not designed to be of direct benefit to the subjects. Results 
may aid diagnostic and prognostic assessment of DOC patients and may 
provide ICU clinicians with an efficient, reliable and validate tool for 
assessing conscious awareness. The minimal risks associated with this study 
are reasonable relative to the anticipated results. 
 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
The subjects are expected to be ethnically diverse and include participants of 
both genders.  
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
Non-English speakers are excluded from the study because the CRSR-FAST 
is currently available only in English.  
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
7 
 
     http://healthcare.partners.org/phsirb/nonengco.htm 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
An independent member of the study team (i.e., not an examiner) will 
screen patients at MGH (Lunder 6, Ellison 4 and Blake 12) for eligibility 
through a medical chart review. When a patient meeting the 
inclusion/exclusion criteria is identified, the study PI and study coordinator 
will be notified. The study coordinator will work with the patient’s clinical 
team to determine an appropriate time to approach the family for consent. 
Once consent is obtained, the coordinator will work with the family and 
clinical team to determine an appropriate time to conduct the CRSR-FAST 
and CRS-R assessment(s). 
 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
There will be no cost to subjects for participation in this study. Subjects will 
not be paid for participation. 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
     http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
     http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
     http://healthcare.partners.org/phsirb/remun.htm
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
8 
 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
All consent meetings for patients will be conducted either remotely (via 
telephone or Enterprise Zoom) or at MGH and will be conducted by trained 
members of the research staff. Remote consent procedures will comply with 
the MGB IRB guidance 
(https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb/Docu
ments/Policy%20on%20Conduct%20of%20Human%20Research%20Activiti
es%20During%20COVID-19%20Operations.pdf and 
https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Informed-Consent-of-Research-Subjects.pdf). Specifically, when 
verbal consent procedures are used, subjects will be provided with a copy of  
the written informed consent document, fully informed about the study and 
given the opportunity to have all questions answered. Study staff will adhere 
to the relevant sections of the remote visit guidelines provided by the MGB 
IRB (i.e., the Clinical Research Virtual Visit Checklist). A script will be used to 
obtain surrogate consent and document the verbal consent. All email 
communications with surrogates will comply with the MGB IRB guidelines 
(https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/FAQs-Email-Communication-with-Research-Participans-and-
Potential-Research-Participants.pdf).    
 
Consent will be obtained from the patient’s surrogate decision-maker as all 
subjects will, by definition, lack capacity. Surrogates approached about 
participation in the study will be clearly informed that participation is 
voluntary, that a decision not to participate will not jeopardize clinical care 
or participation in rehabilitation, and that study participation can be 
discontinued at any time during the study. If a surrogate withdraws from the 
study, they may request that the data be discarded. After discussing the 
terms of participation, procedures, and potential outcomes with the 
surrogate, consent will be obtained by a member of the research team.  
No time limit will be placed on the surrogates to consider participation, 
though only patients within 3 weeks of injury will be enrolled.  
The attending physician and nurse will be notified once the patient has been 
enrolled. 
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
     http://healthcare.partners.org/phsirb/infcons.htm

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
9 
 
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
An internal audit of all case report forms and database entries will be 
performed upon completion of study activities for each subject to ensure 
accuracy and completeness. 
 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
In the unlikely case of an adverse event, the PI will follow all steps in the 
Partners IRB Adverse Event Reporting Protocol.  
 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
10 
 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
As the PI of this study, Dr. Yelena Bodien will oversee and monitor all 
aspects of this study on an ongoing basis and will be accountable to the 
Partners IRB. In this capacity, Dr. Bodien will conduct regular (weekly) 
meetings of the research team and will notify the IRB in advance of any 
desired alterations to the study protocol or its early cessation.  
 
To monitor and assure the validity and integrity of data and adherence to 
the IRB-approved protocol, prior to opening enrollment, meetings will be 
held with all members of the research team to review the protocol and 
address questions and concerns.  
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
     http://healthcare.partners.org/phsirb/guidance.htm#13
 
          Reporting Unanticipated Problems (including Adverse Events)
     http://healthcare.partners.org/phsirb/guidance.htm#7
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
Privacy and Confidentiality  
 
Once family members sign the Informed Consent, or provide verbal consent, 
all participants will be assigned an identification number. Any identifying 
information will be stripped from study documents. A separate file will be 
maintained for cross-reference to allow for follow-up contact. Identifying 
information will be kept in a locked cabinet in a separate office accessible 
only by study staff. All research staff will have completed up-to-date CITI 
training prior to their involvement in this study.  
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
11 
 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
A limited data set (e.g., including dates of admission to MGH) will be shared with Dr. Ni 
Pengsheng, Research Associate Professor of Health Law, Policy and Management at 
Boston University who will assist with statistical analyses. 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
No data will be stored at research collaborators outside of partners. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
No data from outside of Partners will be sent to Partners investigators.  
 
RERERENCES 
1. Giacino, J., K. Kalmar, and J. Whyte, The JFK Coma Recovery Scale-
Revised: measurement characteristics and diagnostic utility. Arch Phys 
Med Rehabil, 2004. 85(12): p. 2020 - 2029. 
2. Schnakers C., Vanhaudenhuyse A., Giacino J. et al. Diagnostic 
accuracy of the vegetative and minimally conscious state: Clinical 
consensus versus standardized neurobehavioral assessment. BMC 
Neurology 2009 9:35 
3. Prisco, L., Ganau , M., and Berlot, G. Proposal of a new behavioral 
scoring system in neurointensive care unit: the NEUROSCORE. 
Abstract International Brain Injury Association’s Ninth World Congress 
on Brain Injury, 2012 
 

Statistical Analysis Plan 
 
 
Examiners documented the start and end time of each assessment to determine the 
feasibility of the CRSR-FAST (goal: mean ≤10 minutes). We tested concurrent validity by 
comparing CRS-R and CRS-FAST diagnostic ratings (conscious [MCS or eMCS] vs. 
unconscious [coma or VS/UWS]), using the simple Kappa coefficient and CRSR-FAST 
test-retest and inter-rater reliability using Mak’s ρ (Statistical Analysis System [SAS v9.4]). 
We established an a priori threshold of ≥ 0.60 to indicate substantial validity and 
reliability