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Association of Pseudobulbar Affect symptoms with quality of life and healthcare costs in Veterans with traumatic brain injury: STUDY


1. Introduction
Pseudobulbar Affect (PBA) is an affect disinhibition syndrome characterized by uncontrollable, exaggerated, and often inappropriate outbursts of crying or laughing (Schiffer and Pope, 2005). It has been associated with disruption or damage to neural systems that modulate voluntary and involuntary emotional expression (Wortzel et al., 2008; Parvizi et al., 2009; Lauterbach et al., 2013). PBA has been identified in patients with a multitude of neurological disorders, including traumatic brain injury (TBI), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, and Alzheimer's disease (Moore et al., 1997;Schiffer and Pope, 2005;Wortzel et al., 2008; Parvizi et al., 2009; Colamonico et al., 2012). TBI is common in military service members deployed in support of Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND), occurring in 10–23% of returning Veterans; the majority of TBI injuries are mild in severity (Hoge et al., 2008; Terrio et al., 2009; Cifu et al., 2013). In a survey that formed the basis for the present study, we identified PBA symptoms in ~70% (n=513) of OEF/OIF/OND Veteran respondents who screened positive for TBI ( Fonda et al., 2015).

TBI represents a well-recognized threat to mental well-being and health of Veterans. Veterans with TBI are more prone to pain syndromes, sleep disorders, and other mental health conditions, particularly posttraumatic stress disorder (PTSD) and depression (Lippa et al., 2015). PBA may further add to the mental health burden (Fonda et al., 2015). Additionally, Veterans with co-morbid TBI, PTSD, and depression reported substantially worse functioning compared to Veterans with single or pairwise combinations of these conditions (Lippa SM et al., 2015).

PTSD occurs in 12–30% of OEF/OIF/OND service members and Veterans (Seal et al., 2009; Thomas et al., 2010; Higgins et al., 2014). The co-occurrence of TBI and PTSD is much more common than TBI alone (Lippa SM et al., 2015), and PTSD is more prevalent and severe among Veterans who sustain a TBI (Hoge et al., 2008; Schneiderman et al., 2008). Because PTSD affects some of the same neural systems as traumatic brain injury (TBI) (Stein and McAllister, 2009), it is possible that the co-occurrence of TBI with PTSD may exacerbate PBA symptoms. As a result, when studying TBI within the Veteran population, the potential influence of comorbid PTSD must be considered.

The purpose of this study was to examine the relationship of PBA symptom frequency and severity to health-related quality of life and health system costs in Veterans with confirmed TBI, stratified by PTSD diagnosis. We hypothesized that increased PBA symptoms would be associated with reduced quality of life and increased medical costs in Veterans with TBI, and that these effects would be present irrespective of comorbid PTSD. We identified patients with TBI based on the Veterans Administration (VA) TBI electronic screening mechanism and surveyed patients with known TBI to assess quality of life and PBA symptoms. Clinical characteristics and healthcare utilization and cost were obtained from the Veterans Health Administration (VHA) electronic medical records.

2. Methods
2.1. Study population

Our study population consisted of OEF/OIF/OND Veterans in the New England region (VISN-1) who had a confirmed deployment-related TBI on the VHA comprehensive TBI evaluation between April 2007 and April 2013. Clinical and healthcare utilization records and VHA electronic medical records, including inpatient hospitalization admissions and clinic visits, were linked for qualifying Veterans for fiscal year 2012 (the study period). We excluded Veterans if they had a prior diagnosis of bipolar disorder, schizophrenia, or other major psychiatric disorder recorded in the VA medical record. Veterans with trauma-related hallucinations were retained in the study.

2.2. Procedure

Four thousand two hundred and eighty two (4282) Veterans in our study population who had a positive TBI screen were mailed a packet that included a cover letter, a survey, and a pre-addressed, postage-paid return envelope. Our methods have been previously described (Fonda et al., 2015). Briefly, the patient survey consisted of the Center for Neurologic Study-Lability Scale (CNS-LS), a seven-item instrument that assesses the frequency and severity of involuntary or excessive laughing and crying symptoms (Moore et al., 1997), and the EuroQol – Five Dimensions – Five Levels (EQ-5d-5L) (Rabin et al., 2011), a five-item survey questionnaire that assesses health-related quality of life. Among 3954 Veterans (92%) with accurate mailing addresses, 758 (19%) completed the survey. Among these, 210 with clinically confirmed TBI made up the study population. A previous report of this sample showed that, compared to survey non-respondents, respondents (n=758) were more likely to be older, white, married, and college graduates, and to have a higher prevalence of depression, prescriptions for depression, and arthropathy related pain ( Fonda et al., 2015). Respondents were similar to non-respondents for all other comorbid conditions and biomedical characteristics, including PTSD, anxiety disorders, substance abuse, and headaches/migraines. Baseline demographic and clinical characteristics and healthcare utilization and cost were obtained from the VHA electronic medical records. Outpatient visits and hospitalizations, including diagnosis codes, were extracted from the National Patient Care Database (NPCD). Pharmacy and cost data were extracted from the VA Decision Support System (DSS). The survey data were linked to the VA files using a unique identifier. The survey cover letter included all elements of informed consent, and completion and return of the questionnaire was considered implied consent. All procedures were approved by the VA Boston Institutional Review Board.

3. Measures
3.1. PBA symptom frequency/severity

We assessed the presence of PBA symptoms using the CNS-LS. The seven-item CNS-LS is a quantitative measure of the frequency and severity of PBA symptoms (range 7–35; higher is worse symptoms) (Moore et al., 1997; Smith et al., 2004). In validation studies, a score of ≥13 best predicted a physician diagnosis of PBA in patients with ALS (Moore et al., 1997) and a score ≥17 best predicted a physician diagnosis of PBA in patients with MS (Smith et al., 2004). For this analysis, PBA symptom frequency/severity was categorized as: low (CNS-LS <13), mild (CNS-LS 13–20), and moderate-severe (CNS-LS ≥21) (Moore et al., 1997; Colamonico et al., 2012; Brooks et al., 2013).

3.2. Prescription medications

We determined use of medication based on having at least one prescription filled during fiscal year 2012. Medication classes evaluated included antidepressants, opioids, sedative/hypnotics, antiepileptics, antilipemic agents, and antihypertensives.

3.3. Comorbid conditions

The presence of a current mental health disorder, including major depressive disorder, PTSD, anxiety disorders, and alcohol and substance abuse disorders, as well as pain conditions were determined using International Classification of Diseases, Ninth Revision (ICD-9) diagnostic codes. We considered a diagnosis to be current if the Veteran had one or more diagnosis codes or received a prescription for an agent to treat the conditions of interest during fiscal year 2012.

3.4. Health-Related Quality of Life

We measured health-related quality of life using the EQ-5D-5L questionnaire, which is an international, standardized, generic measure of health status developed by the EuroQol Group (Rabin et al., 2011). The EQ-5D-5L is a two-part instrument consisting of five health status dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale (VAS). Each health status dimension is rated using a five-level scale (range 1–5, with 1=no problems and 5=extreme problems/inability to perform activity). The information from the dimensions was also combined into an EQ-5D index score using weights from United States standard population values (Rabin et al., 2011) (range 0–1, lower is worse). The VAS represents the self-reported health status of the Veteran (range 0–100, lower scores indicate poorer health status). We calculated the mean and standard deviation (SD) for the VAS and index scores.

3.5. Healthcare utilization and cost

Healthcare utilization was captured by the unique number of claims, including inpatient hospitalization admissions and clinic visits, for each Veteran during fiscal year 2012. We calculated the median number of claims and the interquartile range (IQR). Variable direct costs, which include the cost of supplies and labor based on the volume of services, were chosen as opposed to total costs because the VA has significant fixed costs that are unrelated to the cost directly attributable to patient care (i.e., research service). Participants without a VHA claim during fiscal year 2012 were assigned a zero variable direct cost. We calculated descriptive statistics for the variable direct costs, including mean, SD, median, and IQR.

4. Statistical analyses
We summarized the demographic and clinical characteristics for the sample, both overall and stratified by PBA symptom frequency/severity. For categorical variables, statistical significance of differences between groups was determined using Fischer's exact test (α=0.05).

The remaining analyses were stratified by PTSD diagnosis to examine the effect(s) of TBI alone versus TBI with co-occurring PTSD. EQ-5D-5L health status was determined for the overall health scores and each of the five dimensions. For categorical variables, we tested statistical significance between strata using the Fisher's exact test. Analysis of variance (ANOVA) was used to determine if there was a significant interaction between the severities of PBA symptoms (low, mild, moderate- severe) and PTSD diagnosis (no, yes) for the overall health status measures, with a separate model for VAS and EQ-5D-5L index scores. For the health status dimensions, we calculated the mean and SD of the responses (1–5 for each dimension), as well as the frequency and percent of Veterans with moderate or worse impairment (moderate-severe problem or unable to perform; 3 or greater on 1–5 scale). Log-linear models were used to identify significant interactions between the severity of PBA symptoms (low, mild, moderate-severe) and PTSD diagnosis, and the EQ-5D-5L dimension responses (dichotomized to less than moderate and moderate or greater impairment) (Agresti, 2002).

Analyses were conducted using SAS (version 9.3) software and R (version 3.0.0).

5. Results
Our study population (n=210) was predominantly male (95%), with an average age of 37.8 years (SD=9.78). Based on reported CNS-LS scores, 27.1% (n=57) of respondents had no PBA symptoms, 44.3% (n=93) had mild PBA symptoms, and 27.6% (n=60) had moderate-severe PBA symptoms (Table 1). Age, sex, education level, and diagnosed physical comorbidities, including pain conditions, were not statistically different across the PBA symptom frequency/severity categories. The overall prevalence of a PTSD diagnosis was 53%, and significantly increased with PBA symptom frequency/severity: low (n=21, 36.8%), mild (n=49, 52.7%), and moderate-severe (n=42, 70%) (p=0.0015). Similarly, anxiety disorder (17% overall) increased significantly with PBA symptom frequency/severity: low (n=2, 3.5%), mild (n=20, 21.5%), and moderate-severe (n=14, 23%) (p=0.0021). Major depression increased similarly, but not significantly. The prevalence of prescription medications for mental health issues followed the same increasing trend, with all but opioids showing statistically significant differences across PBA symptom frequency/severity categories.

Story Source: The above story is based on materials provided by SCIENCEDIRECT
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