Two Decades of Department of Veterans Affairs Traumatic Brain Injury Care and Benefits for Veterans of Post-9/11 Conflicts.

OBJECTIVE: To describe the background, methodology, and results of the congressionally mandated Department of Veterans Affairs (VA) Traumatic Brain Injury (TBI) Veterans Health Registry. SETTING: Veterans Health Administration (VHA) and Veterans Benefit Administration (VBA). PARTICIPANTS: A total of 441 639 Veterans of post-9/11 conflicts who exhibited symptoms associated with TBI and sought care or benefits from the VA between September 2001 and September 2021. Design: Retrospective analysis of VHA and VBA administrative records. MAIN MEASURES: (1) VA/Department of Defense Identity Repository to identify Veterans with a deployment to the Southwest Asia theater of operations; (2) the VA TBI Screening and Evaluation Program data; (3) Inpatient and Outpatient Encounter data; and (4) an extract of the VBA Corporate Database to identify Veterans filing benefit claims based on TBI. RESULTS: An unduplicated total of 441 639 post-9/11 Veterans were identified in the Registry via three different pathways to entry: 369 909 Veterans through a positive TBI Screen, 253 177 Veterans receiving healthcare including a TBI diagnosis, and 108 541 Veterans filing TBI disability claims. Among Veterans reporting current TBI symptoms who completed a clinical evaluation, a diagnosis of TBI was confirmed by a TBI specialist in 68.7% of the cases. The TBI severity of confirmed cases was classified as mild in 86.6% of the cases, moderate in 8.3%, and severe in 4.1%. The TBI Registry Veterans were hospitalized 66 503 times and seen 1 521 898 times as outpatients in VHA facilities with diagnoses including TBI. Among Veterans filing TBI disability claims, 67.3% were adjudicated as service-connected. CONCLUSION: The VA TBI Health Registry has identified over 440 000 Veterans of post-9/11 conflicts who presented to the VA for care or benefits with TBI symptomatology. This large number and the volume of TBI health care and benefits provided over the two decades since 9/11 demonstrate the need for the VA's strong ongoing focus on screening, evaluation, and rehabilitation of TBI. Key words:Department of Veterans Affairs, post-9/11, Registry, TBI, traumatic brain injury, VA, VBA, Veterans, Veterans Benefit Administration, Veterans Health Administration, VHA.

Effect of Post-traumatic Amnesia Duration on Traumatic Brain Injury (TBI) First Year Hospital Costs: A Veterans Affairs Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To examine the association between severity of traumatic brain injury (TBI) as measured by duration of post-traumatic amnesia (PTA) and first year hospitalization costs for service members and veterans (SMVs) treated for TBI at Polytrauma Rehabilitation Centers (PRCs) within the Veterans Health Administration (VHA). DESIGN: Multivariable models of merged datasets from the VA TBI Model Systems (VA TBIMS) national database containing TBI clinical characterization including PTA with VHA hospital cost data. SETTING: Five VA PRCs. PARTICIPANTS: VA TBIMS participants with known PTA who received inpatient rehabilitation within 1 year of their TBI at any of 5 PRCs between 2010 and 2020 (N=717). INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: Total, acute care, rehabilitation, intensive care unit (ICU), and surgery costs across all VA hospitals. RESULTS: A total of 717 SMVs (mean age 36.9 years, 94.1% men, 76.8% non-Hispanic White, 7.8% active duty) met inclusion criteria for the unadjusted analyses. Unadjusted mean total hospital costs in the first-year post TBI were approximately $201,214 higher for those with PTA duration ≥24 hours ($351,157) than PTA <24 hours ($149,943). In adjusted models (n=583), each additional day of PTA duration incrementally increased total ($1453), rehabilitation ($1324), ICU ($78), and surgery ($39) costs. Other significant covariates included age, acute care length of stay, Disability Rating Scale on rehabilitation admission, penetrating violent cause of injury, and drug abuse. CONCLUSIONS: This study demonstrates that PTA as a quantitative measure of TBI severity significantly affects first-year hospitalization costs of SMVs treated at PRCs. Each additional day of PTA was associated with higher total, rehabilitation, ICU, and surgery costs. Mean first year hospital costs were also found to exceed the highest budget allocation to VHA facilities for a veteran treated at a PRC. These findings have possible implications for hospital care provision for those receiving inpatient rehabilitation in VHA settings.

The Impact of Opioid Medications on Sleep Architecture and Nocturnal Respiration During Acute Recovery From Moderate to Severe Traumatic Brain Injury: A TBI Model Systems Study.

OBJECTIVES: To describe patient and clinical characteristics associated with receipt of opioid medications and identify differences in sleep quality, architecture, and sleep-related respiration between those receiving and not receiving opioid medications. SETTING: Acute inpatient rehabilitation care for moderate to severe traumatic brain injury (TBI). PARTICIPANTS: A total of 248 consecutive admissions for inpatient rehabilitation care following moderate to severe TBI (average age of 43.6 years), who underwent level 1 polysomnography (PSG) (average time since injury: 120 days) across 6 sites. DESIGN: Cross-sectional, secondary analyses. MAIN MEASURES: The PSG sleep parameters included total sleep time (TST), sleep efficiency (SE), wake after sleep onset, rapid eye movement (REM) latency, sleep staging, and arousal and awakening indices. Respiratory measures included oxygen saturation, central apnea events per hour, obstructive apnea and hypopnea events per hour, and total apnea-hypopnea index. RESULTS: After adjustment for number of prescribed medication classes, those receiving opioid medications on the day of PSG experienced increased TST relative to those not receiving opioid medications (estimated mean difference [EMD] = 31.58; 95% confidence interval [CI], 1.9-61.3). Other indices of sleep did not differ significantly between groups. Among respiratory measures those receiving opioids on the day of PSG experienced increased frequency of central sleep apnea events during total (EMD = 2.92; 95% CI, 0.8-5.0) and non-REM sleep (EMD = 3.37; 95% CI, 1.0-5.7) and higher frequency of obstructive sleep apnea events during REM sleep (EMD = 6.97; 95% CI, 0.1-13.8). Compared with those who did not, receiving opioids was associated with lower oxygen saturation nadir during total sleep (EMD = -3.03; 95% CI, -5.6 to -0.4) and a greater number of oxygen desaturations across REM (EMD = 8.15; 95% CI, 0.2-16.1), non-REM (EMD = 7.30; 95% CI, 0.3-14.4), and total sleep (EMD = 8.01; 95% CI, 0.8-15.2) Greater total apnea-hypopnea index was observed during REM (EMD = 8.13; 95% CI, 0.8-15.5) and total sleep (EMD = 7.26; 95% CI, 0.08-14.4) for those receiving opioids. CONCLUSION: Opioid use following moderate to severe TBI is associated with an increase in indicators of sleep-related breathing disorders, a modifiable condition that is prevalent following TBI. As sleep-wake disorders are associated with poorer rehabilitation outcomes and opioid medications may frequently be administered following traumatic injury, additional longitudinal investigations are warranted in determining whether a causal relation between opioids and sleep-disordered breathing in those following moderate to severe TBI exists. Given current study limitations, future studies can improve upon methodology through the inclusion of indication for and dosage of opioid medications in this population when examining these associations.

Cost-Benefit Analysis From the Payor's Perspective for Screening and Diagnosing Obstructive Sleep Apnea During Inpatient Rehabilitation for Moderate to Severe TBI.

OBJECTIVE: To describe the cost benefit of 4 different approaches to screening for sleep apnea in a cohort of participants with moderate to severe traumatic brain injury (TBI) receiving inpatient rehabilitation from the payor's perspective. DESIGN: A cost-benefit analysis of phased approaches to sleep apnea diagnosis. SETTING: Six TBI Model System Inpatient Rehabilitation Centers. PARTICIPANTS: Trial data from participants (N=214) were used in analyses (mean age 44±18y, 82% male, 75% white, with primarily motor vehicle-related injury [44%] and falls [33%] with a sample mean emergency department Glasgow Coma Scale of 8±5). INTERVENTION: Not applicable. MAIN OUTCOME: Cost benefit. RESULTS: At apnea-hypopnea index (AHI) ≥15 (34%), phased modeling approaches using screening measures (Snoring, Tired, Observed, Blood Pressure, Body Mass Index, Age, Neck Circumference, and Gender [STOPBANG] [-$5291], Multivariable Apnea Prediction Index MAPI [-$5262]) resulted in greater cost savings and benefit relative to the portable diagnostic approach (-$5210) and initial use of laboratory-quality polysomnography (-$5,011). Analyses at AHI≥5 (70%) revealed the initial use of portable testing (-$6323) relative to the screening models (MAPI [-$6250], STOPBANG [-$6237) and initial assessment with polysomnography (-$5977) resulted in greater savings and cost-effectiveness. CONCLUSIONS: The high rates of sleep apnea after TBI highlight the importance of accurate diagnosis and treatment of this comorbid disorder. However, financial and practical barriers exist to obtaining an earlier diagnosis during inpatient rehabilitation hospitalization. Diagnostic cost savings are demonstrated across all phased approaches and OSA severity levels with the most cost-beneficial approach varying by incidence of OSA.

Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method.

Introduction: Obtaining body weights remotely could improve feasibility of pragmatic trials. This investigation examined whether weights collected via cellular scale or electronic health record (EHR) correspond to gold standard in-person study weights. Methods: The agreement of paired weight measurements from cellular scales were compared to study scales from a weight loss intervention and EHR-collected weights were compared to study scales from a weight loss maintenance intervention. Differential weight change estimates between intervention and control groups using both pragmatic methods were compared to study collected weight. In the Log2Lose feasibility weight loss trial, in-person weights were collected bi-weekly and compared to weights collected via cellular scales throughout the study period. In the MAINTAIN weight loss maintenance trial, in-person weights were collected at baseline, 14, 26, 42 and 56 weeks. All available weights from the EHR during the study period were obtained. Results: On average, in Log2Lose cellular scale weights were 0.6 kg (95% CI: -2.9, 2.2) lower than in-person weights; in MAINTAIN, EHR weights were 2.8 kg (SE: -0.5, 6.0) higher than in-person weights. Estimated weight change using pragmatic methods and study scales in both studies were in the same direction and of similar magnitude. Conclusion: Both methods can be used as cost-effective and real-world surrogates within a tolerable variability for the gold-standard. Trial registration: NCT02691260; NCT01357551.

Developing an Index of Medical Conditions Associated with Outcomes after Moderate-to-Severe Traumatic Brain Injury.

Medical conditions co-occurring with traumatic brain injury (TBI) are associated with outcomes, and comorbidity indices such as Charlson and Elixhauser are used in TBI research, but they are not TBI specific. The purpose of this research was to develop an index or indices of medical conditions, identified in acute care after moderate to severe TBI, that are associated with outcomes at rehabilitation discharge. Using the TBI Model Systems National Database, the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes of 8988 participants were converted to Healthcare Cost and Utilization Project (HCUP) diagnostic categories. Poisson regression models were built predicting Disability Rating Scale and Functional Independence Measure Cognitive and Motor subscale scores from HCUP categories after controlling for demographic and injury characteristics. Unweighted, weighted, and anchored indices based on the outcome models predicted 7.5-14.3% of the variance in the observed outcomes. When the indices were applied to a new validation sample of 1613 cases, however, only 2.6-6.6% of the observed outcomes were predicted. Therefore, no models or indices were recommended for future use, but several study findings are highlighted suggesting the importance and the potential for future research in this area.

Concordance between current American Academy of Sleep Medicine and Centers for Medicare and Medicare scoring criteria for obstructive sleep apnea in hospitalized persons with traumatic brain injury: a VA TBI Model System study.

STUDY OBJECTIVES: The objective of this study was to compare obstructive sleep apnea (OSA), demographic, and traumatic brain injury (TBI) characteristics across the American Academy of Sleep Medicine (AASM) and Centers for Medicare and Medicare (CMS) scoring rules in moderate to severe TBI undergoing inpatient neurorehabilitation. METHODS: This is a secondary analysis from a prospective clinical trial of sleep apnea at 6 TBI Model System study sites (n = 248). Scoring was completed by a centralized center using both the AASM and CMS criteria for OSA. Hospitalization and injury characteristics were abstracted from the medical record, and demographics were obtained by interview by trained research assistants using TBI Model System standard procedures. RESULTS: OSA was prevalent using the AASM (66%) and CMS (41.5%) criteria with moderate to strong agreement (weighted κ = 0.64; 95% confidence interval = 0.58-0.70). Significant differences were observed for participants meeting AASM and CMS criteria (concordant group) compared with those meeting criteria for AASM but not CMS (discordant group). At an apnea-hypopnea index ≥ 5 events/h, the discordant group (n = 61) had lower Emergency Department Glasgow Coma Scale Scores consistent with greater injury severity (median, 5 vs 13; P = .0050), younger age (median, 38 vs 58; P < .0001), and lower body mass index (median, 22.1 vs 24.8; P = .0007) compared with the concordant group (n = 103). At an apnea-hypopnea index ≥ 15 events/h, female sex but no other differences were noted, possibly because of the smaller sample size. CONCLUSIONS: The underestimation of sleep apnea using CMS criteria is consistent with prior literature; however, this is the first study to report the impact of the criteria in persons with moderate to severe TBI during a critical stage of neural recovery. Management of comorbidities in TBI has become an increasing focus for optimizing TBI outcomes. Given the chronic morbidity after moderate to severe TBI, the impact of CMS policy for OSA diagnosis for persons with chronic disability and young age are considerable. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome; Identifier: NCT03033901.

3D bioprinting of complex channels within cell-laden hydrogels.

3D bioprinting is an emerging manufacturing approach to fabricate (cell-laden) hydrogel constructs with embedded microchannels, which are potentially useful for fundamental studies to understand vascularization and angiogenesis, and for developing organ-on-a-chip devices for disease modeling. Although numerous printing approaches have been developed, novel approaches are still needed that enable printing of channels with user-defined and tunable size, morphology, and complexity. Here, we report a novel bioprinting approach enabling printing of a sacrificial ink within commonly used photocurable hydrogels using a sequential printing approach. To achieve this, photocurable hydrogel is printed layer-by-layer as usual, but each layer is exposed to light briefly (seconds) to create partially crosslinked, self-supporting layers. At a desired thickness, immediately after the layer is printed (prior to partial crosslinking step), sacrificial hydrogel is directly printed within this viscous uncrosslinked layer. The layer was then exposed to light to confine and support the sacrificial hydrogel. After fully crosslinking the system, the sacrificial hydrogel is washed away, forming a channel. This approach allows bioprinting of cells with the matrix material and seeding of cells into channels after the sacrificial ink is removed. This approach can potentially provide a robust platform for fabricating vascularized tissues and studying cell behaviors on diverse channel surfaces. STATEMENT OF SIGNIFICANCE: 3D bioprinting is an emerging platform for the fabrication of hydrogel-based constructs for in vitro tissue/disease modelling or tissue and organ printing. Although several approaches have been developed to print channels within these constructs, it is still challenging to incorporate microchannels (for vascularization) within 3D bioprinted constructs. This study presents a novel bioprinting approach to create user-defined and tunable channels embedded within cell-laden hydrogel constructs. We report an important advance as our approach does not require complex device modifications for bioprinters or complex synthesis and processing hurdles for the inks. Since our approach does not require special chemistries, there are potentially a greater number of commercially available options for ink materials.