Common Data Elements for Traumatic Brain Injury: Recommendations From the Interagency Working Group on Demographics and Clinical Assessment

Maas, Andrew I. R.; Harrison-Felix, Cynthia; Menon, David; Adelson, P. David; Balkin, Tom; Bullock, Ross; Engel, Doortje C.; Gordon, Wayne A.; Orman, Jean A.; Lew, Henry L.; Robertson, Claudia S.; Temkin, Nancy; Valadka, Alex B.; Verfaellie, Mieke; Wainwright, Mark S.; Wright, David W.; Schwab, Karen

doi:10.1016/j.apmr.2010.07.232

Cited by 162 publications

(108 citation statements)

References 28 publications

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“…The TRACK‐TBI Pilot study is a multicenter prospective observational study conducted at three Level I Trauma Centers in the U.S.—San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), and University Medical Center Brackenridge (UMCB) in Austin, Texas—using the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) TBI Common Data Elements (CDEs) (Yue et al., 2013; Maas et al., 2010; Duhaime et al., 2010; Manley et al., 2010; Wilde et al., 2010). Inclusion criteria for TRACK‐TBI Pilot were external force trauma to the head presenting to Level I trauma center, and clinically indicated head CT scan within 24 hr of injury.…”

Section: Methodsmentioning

confidence: 99%

Apolipoprotein E epsilon 4 (APOE‐ε4) genotype is associated with decreased 6‐month verbal memory performance after mild traumatic brain injury

et al. 2017

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IntroductionThe apolipoprotein E (APOE) ε4 allele associates with memory impairment in neurodegenerative diseases. Its association with memory after mild traumatic brain injury (mTBI) is unclear.Methods mTBI patients (Glasgow Coma Scale score 13–15, no neurosurgical intervention, extracranial Abbreviated Injury Scale score ≤1) aged ≥18 years with APOE genotyping results were extracted from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot (TRACK‐TBI Pilot) study. Cohorts determined by APOE‐ε4(+/−) were assessed for associations with 6‐month verbal memory, measured by California Verbal Learning Test, Second Edition (CVLT‐II) subscales: Immediate Recall Trials 1–5 (IRT), Short‐Delay Free Recall (SDFR), Short‐Delay Cued Recall (SDCR), Long‐Delay Free Recall (LDFR), and Long‐Delay Cued Recall (LDCR). Multivariable regression controlled for demographic factors, seizure history, loss of consciousness, posttraumatic amnesia, and acute intracranial pathology on computed tomography (CT).ResultsIn 114 mTBI patients (APOE‐ε4(−)=79; APOE‐ε4(+)=35), ApoE‐ε4(+) was associated with long‐delay verbal memory deficits (LDFR: B = −1.17 points, 95% CI [−2.33, −0.01], p = .049; LDCR: B = −1.58 [−2.63, −0.52], p = .004), and a marginal decrease on SDCR (B = −1.02 [−2.05, 0.00], p = .050). CT pathology was the strongest predictor of decreased verbal memory (IRT: B = −8.49, SDFR: B = −2.50, SDCR: B = −1.85, LDFR: B = −2.61, LDCR: B = −2.60; p < .001). Seizure history was associated with decreased short‐term memory (SDFR: B = −1.32, p = .037; SDCR: B = −1.44, p = .038).ConclusionThe APOE‐ε4 allele may confer an increased risk of impairment of 6‐month verbal memory for patients suffering mTBI, with implications for heightened surveillance and targeted therapies. Acute intracranial pathology remains the driver of decreased verbal memory performance at 6 months after mTBI.

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Section: Methodsmentioning

confidence: 99%

Apolipoprotein E epsilon 4 (APOE‐ε4) genotype is associated with decreased 6‐month verbal memory performance after mild traumatic brain injury

et al. 2017

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“…Within this initiative, four working groups on TBI addressed aspects of standardization concerning demographics and clinical assessment, biomarkers, neuroimaging, and outcome. The proceedings of the workshop have previously been published (Duhaime et al, 2010;Maas et al, 2010;Manley et al, 2010;Wilde et al, 2010). For detailed information on the recommendations for neuroimaging, biomarkers, and outcome, we refer the reader to these publications.…”

Section: Discussionmentioning

confidence: 99%

“…General recommendations for collecting data on demographics and clinical assessment, neuroimaging studies, biomarkers, and outcomes for TBI, have previously been published (Duhaime et al, 2010;Maas et al, 2010;Manley et al, 2010;Wilde et al, 2010). Here we present the full scope of the recommendations for assessment and collection of clinical data in TBI trials and observational studies during the acute, subacute, and chronic phases.…”

Section: Introductionmentioning

confidence: 99%

Standardizing Data Collection in Traumatic Brain Injury

Maas

Harrison-Felix

Menon

et al. 2011

Journal of Neurotrauma

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Collaboration among investigators, centers, countries, and disciplines is essential to advancing the care for traumatic brain injury (TBI). It is thus important that we ''speak the same language.'' Great variability, however, exists in data collection and coding of variables in TBI studies, confounding comparisons between and analysis across different studies. Randomized controlled trials can never address the many uncertainties concerning treatment approaches in TBI. Pooling data from different clinical studies and high-quality observational studies combined with comparative effectiveness research may provide excellent alternatives in a cost-efficient way. Standardization of data collection and coding is essential to this end. Common data elements (CDEs) are presented for demographics and clinical variables applicable across the broad spectrum of TBI. Most recommendations represent a consensus derived from clinical practice. Some recommendations concern novel approaches, for example assessment of the intensity of therapy in severely injured patients. Up to three levels of detail for coding data elements were developed: basic, intermediate, and advanced, with the greatest level of detail attained in the advanced version. More detailed codings can be collapsed into the basic version. Templates were produced to summarize coding formats, explanation of choices, and recommendations for procedures. Endorsement of the recommendations has been obtained from many authoritative organizations. The development of CDEs for TBI should be viewed as a continuing process; as more experience is gained, refinement and amendments will be required. This proposed process of standardization will facilitate comparative effectiveness research and encourage high-quality meta-analysis of individual patient data.

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“…The TRACK-TBI Pilot study outcome assessment battery listed below consisted of the core measures recommended by the NINDS consensus-based TBI-CDEs (Version 1). [23][24][25][26] Administered and self-reported neurocognitive and neuropsychological measures and global outcome ratings also were collected via in-person interview at 6 months post-injury.…”

Section: Methodsmentioning

confidence: 99%

“…In the current study, mTBI (Glasgow Coma Scale [GCS] score 13-15) patients were assessed with a broad range of outcome measures selected from the National Institute of Neurological Disorders and Stroke (NINDS) TBI Common Data Elements (TBI-CDE) Outcome Battery that included the PTSD Checklist-Civilian Version (PCL-C). [23][24][25][26] We report the incidence of PTSD symptoms at 6 months-a time when PTSD symptoms are reported to peak 3,27 -examine pre-and peri-injury risk factors, and describe associations with functional disability distinctive from other post-injury outcomes.…”

mentioning

confidence: 99%

Screening for Post-Traumatic Stress Disorder in a Civilian Emergency Department Population with Traumatic Brain Injury

Haarbauer‐Krupa

Taylor

Yue

et al. 2017

Journal of Neurotrauma

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Post-traumatic stress disorder (PTSD) is a condition associated with traumatic brain injury (TBI). While the importance of PTSD and TBI among military personnel is widely recognized, there is less awareness of PTSD associated with civilian TBI. We examined the incidence and factors associated with PTSD 6 months post-injury in a civilian emergency department population using measures from the National Institute of Neurological Disorders and Stroke TBI Common Data Elements Outcome Battery. Participants with mild TBI (mTBI) from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot study with complete 6-month outcome batteries (n = 280) were analyzed. Screening for PTSD symptoms was conducted using the PTSD Checklist-Civilian Version. Descriptive measures are summarized and predictors for PTSD were examined using logistic regression. Incidence of screening positive for PTSD was 26.8% at 6 months following mTBI. Screening positive for PTSD was significantly associated with concurrent functional disability, post-concussive and psychiatric symptomatology, decreased satisfaction with life, and decreased performance in visual processing and mental flexibility. Multi-variable regression showed injury mechanism of assault (odds ratio [OR] 3.59; 95% confidence interval [CI] 1.69-7.63; p = 0.001) and prior psychiatric history (OR 2.56; 95% CI 1.42-4.61; p = 0.002) remained significant predictors of screening positive for PTSD, while education (per year OR 0.88; 95% CI 0.79-0.98; p = 0.021) was associated with decreased odds of PTSD. Standardized data collection and review of pre-injury education, psychiatric history, and injury mechanism during initial hospital presentation can aid in identifying patients with mTBI at risk for developing PTSD symptoms who may benefit from closer follow-up after initial injury care.

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Common Data Elements for Traumatic Brain Injury: Recommendations From the Interagency Working Group on Demographics and Clinical Assessment

Cited by 162 publications

References 28 publications

Apolipoprotein E epsilon 4 (APOE‐ε4) genotype is associated with decreased 6‐month verbal memory performance after mild traumatic brain injury

Apolipoprotein E epsilon 4 (APOE‐ε4) genotype is associated with decreased 6‐month verbal memory performance after mild traumatic brain injury

Standardizing Data Collection in Traumatic Brain Injury

Screening for Post-Traumatic Stress Disorder in a Civilian Emergency Department Population with Traumatic Brain Injury

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