Randomized controlled trials in adult traumatic brain injury

Lü, Juan; Gary, Kelli W.; Neimeier, Janet P; Ward, John D.; Lapane, Kate L.

doi:10.3109/02699052.2012.722257

Cited by 75 publications

(63 citation statements)

References 111 publications

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“…This is reflected in previously published multi-topic TBI overviews, none of which have undertaken any risk of bias or quality evaluation. 7,[18][19][20][21][22][23][24][25] In this context, the decision to review two of the seven Cochrane risk of bias domains represents a substantial advance on comparable overviews.…”

Section: 105mentioning

confidence: 99%

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A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

Bragge

Synnot²,

Maas

et al. 2016

Journal of Neurotrauma

106

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Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative effectiveness research and precision medicine, are needed to fully realize the potential of acute TBI research to benefit patients.

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Section: 105mentioning

confidence: 99%

“…17 Existing TBI research overviews are limited in use of systematic search 18,19 and/or scope. [18][19][20][21][22][23] Therefore, this overview aimed to:…”

mentioning

confidence: 99%

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

Bragge

Synnot²,

Maas

et al. 2016

Journal of Neurotrauma

106

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“…Indeed, many preclinical, as well as some clinical, studies have evaluated various therapeutic interventions to target both the acute and more chronic consequences of TBI with some degree of success. [14][15][16][17][18][19][20][21][22] In this regard, neuroprotective, as well as treatment, strategies that target abnormally sustained elevations in intracranial pressure have been attempted. However, currently, there are limited therapeutic interventions that have been shown to improve the long-term consequences of TBI.…”

Section: Introductionmentioning

confidence: 99%

Long-Term Consequences of Traumatic Brain Injury: Current Status of Potential Mechanisms of Injury and Neurological Outcomes

Bramlett

Dietrich

2015

Journal of Neurotrauma

382

257

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Traumatic brain injury (TBI) is a significant clinical problem with few therapeutic interventions successfully translated to the clinic. Increased importance on the progressive, long-term consequences of TBI have been emphasized, both in the experimental and clinical literature. Thus, there is a need for a better understanding of the chronic consequences of TBI, with the ultimate goal of developing novel therapeutic interventions to treat the devastating consequences of brain injury. In models of mild, moderate, and severe TBI, histopathological and behavioral studies have emphasized the progressive nature of the initial traumatic insult and the involvement of multiple pathophysiological mechanisms, including sustained injury cascades leading to prolonged motor and cognitive deficits. Recently, the increased incidence in age-dependent neurodegenerative diseases in this patient population has also been emphasized. Pathomechanisms felt to be active in the acute and long-term consequences of TBI include excitotoxicity, apoptosis, inflammatory events, seizures, demyelination, white matter pathology, as well as decreased neurogenesis. The current article will review many of these pathophysiological mechanisms that may be important targets for limiting the chronic consequences of TBI.

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“…Because of the diversity of TBI-related challenges, treatment typically needs to be multimodal [32], and some medications or pharmacological combinations may exacerbate or create symptoms. Furthermore, the evidence base for pharmacological and behavioral treatment of chronic TBI is still quite limited [33]. For these reasons and because of initial indications of interest in CAM in TBI populations [23 • ] and the population at large [8 • ], better understanding of the evidence for CAM is warranted among rehabilitation professionals.…”

Section: Introductionmentioning

confidence: 99%

Use of Complementary and Alternative Medicine in Treating Individuals with Traumatic Brain Injury

Cantor

Gumber

2013

Curr Phys Med Rehabil Rep

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This article presents an overview of the clinical trials literature on complementary and alternative medicine for traumatic brain injury. In searches of PubMed and the Allied and Complementary Medicine Database, trials of acupuncture, acupressure, creatine, homeopathy, hyperbaric oxygen therapy, mindfulness-based practices, music therapy, neurotherapy, Tai Chi, and yoga were identified. Because of the high risk of bias in most of the studies reviewed, the evidence base is inadequate to recommend any specific complementary and alternative medicine treatments for traumatic brain injury, although promising findings were identified for a number of treatments. Safety data on many of the interventions were lacking.

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Randomized controlled trials in adult traumatic brain injury

Cited by 75 publications

References 111 publications

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

Long-Term Consequences of Traumatic Brain Injury: Current Status of Potential Mechanisms of Injury and Neurological Outcomes

Use of Complementary and Alternative Medicine in Treating Individuals with Traumatic Brain Injury

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