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©2013 Samueli Institute

HBO REAL Screening Results ReportThe research question is: What is the state of the science and evidence for effectiveness of hyperbaric oxygen therapy on the consequences of traumatic brain injury?

The purpose of this REAL is to conduct a rigorous, transparent, high quality systematic review using Samueli Institute’s Rapid Evidence Assessment of the Literature (REAL©) process to determine the current state of the science on the efficacy of Hyperbaric Oxygen (HBO2) Therapy for patients suffering from the consequences of Traumatic Brain Injury (TBI); and to develop initial recommendations based on the current state of the evidence for its clinical use, implementation, as well as next steps for future research.

We will be looking specifically to:

Examine the quantity and quality of the research as a whole on HBO for TBI Provide a clear understanding as to the safety, dosing variations, cost and feasibility, and effect of this

intervention, as it is currently reported in the literature. Compare the differences noted across studies and gaps that exist in the research as it currently exists. Understand possible components of placebo that might explain the results to the extent that data is available in

all the studies included and analyzed.

ELIGIBILITY CRITERIA (PICO)Description

Population Patients suffering from the consequences of traumatic brain injury (TBI) in both military and civilian populations

Intervention Hyperbaric oxygen therapyControl/Comparison Not restrictedOutcome(s) TBD based on the data from screen activityStudy Design Peer-reviewed studies presented in the English language

SEARCH STRING(Brain injuries or Head Injuries or Craniocerebral Trauma) AND (Hyperbaric oxygenation or “Hyperbaric oxygen therapy“

or “Hyperbaric oxygen*“ or “Hyperbaric therap*“ or HBO or HBOT)Variations were applied across databases; MeSH Terms in red.

DATABASES SEARCHEDFrom database inception to present, not restricted to any study design or limiterPubMed (13AUG14)CINAHL (13AUG14)PsycInfo (15AUG14)Cochrane – ALL EMB (15AUG14)Cross-checked across other HBO like databases

©2013 Samueli Institute2

SCREENING QUESTIONS1. Is this a population with traumatic brain injury (TBI)?* 2. Is this a study on HBO? *3. What is the study design? 4. What is the comparator being studied? 5. What are the outcomes being evaluated?6. Is the study presented in the English language? * *Articles must answer YES to these questions to be included in this review

RESULTS OF SCREENINGArticles ID through Database Search (n= 396)Articles after Duplicates Removed (n=393)Title / Abstracts Screened at Screen Phase (n=393)

Articles Excluded (n=310) – see end of document for list of excluded citations Q#1. not TBI (Q#1) (n=238) Q#2. not HBO (Q#2) (n=14) Q#6. non-English (n=58)

o Non-English without abstract (n=31)

Articles Included (n=83) Randomized Control Trial (RCT) (n=15) Clinical Controlled Trial (CCT) (n=6) Systematic Review / Meta-Analysis (n=6) not directly related in some cases but can be used to support our

background Observational (n=13) Other (n=26) (includes 9 literature reviews, 11 case studies, 1 case series, 2 chart reviews, 1 thesis, 1 evaluation

study, 1 congress report Unsure (n=1) (research summary of clinical trial; looking at full text for any important information) No abstract (n=16) will have to pull full text to determine eligibility criteria

NOTE: Weaver and Miller’s RCT to be published in JAMA Internal Medicine will be added to the review once it is published. This article is not reflected in the numbers above.


Population Descriptions for CCT & RCT (n=21)Definition shared at Kick-off meeting Traumatic Brain Injury (TBI)

• A structural injury and/or physiological disruption in brain function as a result of an external force resulting in the onset or worsening of clinical signs immediately post-event. Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1–68. [PMID:20108447 ]

• We propose looking across the spectrum of TBI sequelae from acute to chronic effects and from mild to severe TBI, both in the military as well as civilian populations. (TBD and agreed upon at this meeting based on the initial screen activity)

Acute (n=1) Chronic (n=3) Mild (n=5) Severe (n=7) Subacute (n=1) Comatose (n=2) TBI (no further description) (n=1) Postbrain injury neural state (n=1)

Outcomes for CCTs and RCTsWhich outcomes are we interested in or any and all? Function, mortality, morbidity, disability…adverse events Glasgow Coma Scale scorearteriovenous differences in oxygen Glasgow Outcome Scale

blood glucose levelsImmediate Post-Concussion Assessment and Cognitive Testing (ImPACT(R))

blood velocity of MCA improvement in consciousnessbrain electric activity mapping (BEAM intracranial pressurebrain tissue PO2 levels mean duration of comabronchial alveolar lavage (BAL) fluid interleukin (IL)-8 and IL-6 assays Microdialysate lactate/pyruvate ratios Cerebral blood flow (CBF) mortality ratecerebral blood perfusion MRIs, or CTcerebral ischemia neurologic, neuropsychometriccerebral metabolic rate of oxygen (CMRO(2)) neuropsychological functioncerebral vascular resistance Plasma C-reactive proteincerebral vascular spasms Posttraumatic Disorder Checklist- Military Versioncognitive evaluations PVS scores (state and reaction subscores)composite scores on Post-traumatic Disorder Check List-Military Version (PCL-M) rate of recovered consciousness at 1 monthCSF lactate and F2-isoprostane concentrations Rivermead Postconcussion Symptom Questionnaireedema and ischemia in the zones of brain injuries Resolution of hydrocephalusendothelin (ET) SPECT brain scan / batteryEQ-5D subjective and objective measures

http://www.ncbi.nlm.nih.gov/pubmed/20108447

http://www.ncbi.nlm.nih.gov/pubmed/20108447


exercise testing Symptom resolutionfunctional, cognitive, or psychomotor outcome transcranial ultrasonic Doppler (TCD)


EXCLUSION REPORT 8SEP14

no TBI

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