Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 7/11/2015 |
| Start Date: | March 2011 |
| End Date: | March 2013 |
| Contact: | Gina Signoracci, Ph.D. |
| Email: | Gina.Signoracci@va.gov |
| Phone: | (303) 399-8020 |
Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions: The Role of The Neurobehavioral Symptom Inventory
The purpose of this study is to examine differences in post-concussive (PC) symptom
endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom
(OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury
(mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history
of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those
with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on
the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous
research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom
endorsement (Brenner et al. 2010; Terrio et al, 2009).
HYPOTHESES ARE AS FOLLOWS:
1. Individuals with a history of target, service-related, mTBI only (Group 2) and
individuals with PTSD only (Group 3) each will report significantly more PC symptoms,
as measured by NSI total scores, when compared to those with no history of
service-related mTBI or PTSD (Group 4).
2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1)
will report significantly more PC symptoms, as measured by total NSI scores, than
either those with target, service-related, mTBI only (Group 2) or those with PTSD only
(Group 3).
endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom
(OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury
(mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history
of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those
with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on
the Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous
research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom
endorsement (Brenner et al. 2010; Terrio et al, 2009).
HYPOTHESES ARE AS FOLLOWS:
1. Individuals with a history of target, service-related, mTBI only (Group 2) and
individuals with PTSD only (Group 3) each will report significantly more PC symptoms,
as measured by NSI total scores, when compared to those with no history of
service-related mTBI or PTSD (Group 4).
2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1)
will report significantly more PC symptoms, as measured by total NSI scores, than
either those with target, service-related, mTBI only (Group 2) or those with PTSD only
(Group 3).
Archival data will be collected from all OEF/OIF Veterans who were seen in the VA ECHCS TBI
Clinic by Nancy Cutter, M.D. and her team between January 1, 2009 and December 31, 2010.
Electronic Medical Record (EMR) progress note titles "OEF/OIF TBI 2nd Level Evaluation
Consult Report" and "TBI Consult Report" will be used to identify potential subjects.
Power is based on the primary hypothesis that those with PTSD only (Group 3) and those with
target, service-related mTBI only (Group 2) will have significantly more PC symptom
reporting than those with no history of target, service-related mTBI or PTSD (Group 4).
Belanger et al. (2010) reported a standard deviation of 15.3 on the NSI total score in a
sample of 134 mTBI subjects. Assuming variability similar to the Belanger study, a
significance level of 0.025 to correct for the two comparisons and 80% power, 180 subjects
per group will detect a clinically significant difference of 5 points. For simplicity, this
was calculated using a two-sided, two-sample t-test. Given that we are modeling all four
groups together, pooled standard error estimates will be used, which will result in slightly
higher power.
All analyses will assume a two-sided test of hypothesis with an overall significance level
of 0.05, unless otherwise noted, and will be performed in either Statistical Analysis
Software (SAS) v9.2 or above (SAS Institute, Inc., Cary, NC).
Demographic characteristics will be reported as means and standard deviations; medians and
ranges; and proportions, as appropriate. Likewise, characteristics will be compared between
the four aforementioned subject groups using Analysis of Variance (ANOVA), chi-square tests
and/or nonparametric tests as appropriate.
Hypothesis 1: An ANOVA with reference cell coding will be utilized to model NSI total score
as a function of the four groups (Group 1: Individuals with co-occurring target,
service-related, mTBI and PTSD; Group 2: those with target, service-related, mTBI only;
Group 3: those with PTSD only; and Group 4: those with no history of target,
service-related, mTBI or PTSD). Potential confounders will then be assessed individually by
adding them to the model with the groups. If any of the group parameter estimates changes by
more than 10% with the inclusion of the potential confounder, the variable will be utilized
in the final model. Once the final model is determined, a contrast will be set up within the
model to test (1) PTSD only vs. Neither and (2) target, service-related, mTBI only vs.
Neither, a Bonferroni correction will be employed such that the significance level will be
adjusted to 0.025 for these two primary tests. Estimated mean differences will be reported
with 95% CIs. Potential confounding variables to be considered are: age; gender; total
number of deployments; time since last deployment; time since earliest documented mTBI; time
since target, service-related, mTBI; and total number of mTBIs.
Hypothesis 2: Within the same final model above, a contrast will be used to test (1) those
with co-occurring target, service-related, mTBI and PTSD vs. PTSD only and (2) those with
co-occurring target, service-related, mTBI and PTSD vs. target, service-related, mTBI only.
Clinic by Nancy Cutter, M.D. and her team between January 1, 2009 and December 31, 2010.
Electronic Medical Record (EMR) progress note titles "OEF/OIF TBI 2nd Level Evaluation
Consult Report" and "TBI Consult Report" will be used to identify potential subjects.
Power is based on the primary hypothesis that those with PTSD only (Group 3) and those with
target, service-related mTBI only (Group 2) will have significantly more PC symptom
reporting than those with no history of target, service-related mTBI or PTSD (Group 4).
Belanger et al. (2010) reported a standard deviation of 15.3 on the NSI total score in a
sample of 134 mTBI subjects. Assuming variability similar to the Belanger study, a
significance level of 0.025 to correct for the two comparisons and 80% power, 180 subjects
per group will detect a clinically significant difference of 5 points. For simplicity, this
was calculated using a two-sided, two-sample t-test. Given that we are modeling all four
groups together, pooled standard error estimates will be used, which will result in slightly
higher power.
All analyses will assume a two-sided test of hypothesis with an overall significance level
of 0.05, unless otherwise noted, and will be performed in either Statistical Analysis
Software (SAS) v9.2 or above (SAS Institute, Inc., Cary, NC).
Demographic characteristics will be reported as means and standard deviations; medians and
ranges; and proportions, as appropriate. Likewise, characteristics will be compared between
the four aforementioned subject groups using Analysis of Variance (ANOVA), chi-square tests
and/or nonparametric tests as appropriate.
Hypothesis 1: An ANOVA with reference cell coding will be utilized to model NSI total score
as a function of the four groups (Group 1: Individuals with co-occurring target,
service-related, mTBI and PTSD; Group 2: those with target, service-related, mTBI only;
Group 3: those with PTSD only; and Group 4: those with no history of target,
service-related, mTBI or PTSD). Potential confounders will then be assessed individually by
adding them to the model with the groups. If any of the group parameter estimates changes by
more than 10% with the inclusion of the potential confounder, the variable will be utilized
in the final model. Once the final model is determined, a contrast will be set up within the
model to test (1) PTSD only vs. Neither and (2) target, service-related, mTBI only vs.
Neither, a Bonferroni correction will be employed such that the significance level will be
adjusted to 0.025 for these two primary tests. Estimated mean differences will be reported
with 95% CIs. Potential confounding variables to be considered are: age; gender; total
number of deployments; time since last deployment; time since earliest documented mTBI; time
since target, service-related, mTBI; and total number of mTBIs.
Hypothesis 2: Within the same final model above, a contrast will be used to test (1) those
with co-occurring target, service-related, mTBI and PTSD vs. PTSD only and (2) those with
co-occurring target, service-related, mTBI and PTSD vs. target, service-related, mTBI only.
Inclusion criteria for all groups includes:
- Veteran must be between the ages of 18 to 60
- Veteran must have at least one OEF/OIF deployment
- Veteran must have received an OEF/OIF TBI 2nd Level Evaluation though the VA ECHCS
TBI Clinic
Specific inclusion/exclusion criteria for each group are as follows:
Inclusion Criteria:
Group 1: (Both) Co-Occurring PTSD and target, service-related, mTBI
PTSD:
- Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related
to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI
Clinic, or
- Clinician confirmed PTSD diagnosis within 60 days after being seen in TBI Clinic
- Target, service-related, mTBI
- Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd
Level Evaluation Consult Report note in EMR
Group 2: (mTBI only) History of target, service-related, mTBI but with no diagnosis of
PTSD
- PTSD:
- Veterans with no history of clinician confirmed PTSD diagnosis, or
- Veterans with previous clinician confirmed PTSD diagnosis , but without continuous
documentation of PTSD symptoms within 1 year prior to being seen in the TBI clinic
- Target, service-related, mTBI
- Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd
Level Evaluation Consult Report note in EMR
Group 3: (PTSD only) No history of target, service-related, mTBI but with a diagnosis of
PTSD
- PTSD:
- Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related
to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
- Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI
Clinic, or
- Clinician confirmed PTSD diagnosis within 60 days of being seen in TBI Clinic
- TBI:
- Veterans with no history of clinician confirmed diagnosis of target, service-related,
mTBI
- Veterans with clinician confirmed mTBI prior to service and without continuous
documentation of related symptoms within 1 year of being seen in the TBI Clinic
Group 4: (Neither) No history of target, service-related, mTBI and no diagnosis of PTSD
- PTSD:
- Veterans with no history of clinician confirmed PTSD diagnosis, or
- Veterans with previous clinician confirmed PTSD diagnosis , but without continuous
documentation of PTSD symptoms within 1 year of being seen in the TBI clinic
- TBI:
- Veterans with no clinician confirmed diagnosis of target, service-related, mTBI
Exclusion Criteria:
- Those not meeting inclusion criteria as listed above, and
- Veterans with any history of clinician confirmed moderate or severe TBI, and
- Veterans with no NSI in TBI Consult Report note in EMR
- Veterans with documentation of any neurological event or disorder other than mTBI
- Veterans with positive brain imaging
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