Articles: prospective-studies.
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Randomized Controlled Trial
An independent inter- and intra-observer agreement evaluation of the AOSpine subaxial cervical spine injury classification system.
An agreement study. ⋯ 3.
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Randomized Controlled Trial Comparative Study
Intrathecal Versus Intravenous Morphine in Minimally Invasive Posterior Lumbar Fusion: A Blinded Randomized Comparative Prospective Study.
A blinded, randomized, comparative prospective study. ⋯ 2.
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Journal of neurosurgery · Jan 2017
Randomized Controlled Trial Multicenter Study Comparative StudyCranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial.
OBJECTIVE Cranioplasty is routinely performed in neurosurgery. One of its underestimated problems is the high postoperative complication rate of up to 40%. Due to the lack of good prospective studies and the small number of patients (5-20 each year) who receive alloplastic materials, decisions in favor or against a certain material are based on subjective empirical or economic reasons. ⋯ In comparison with titanium, HA shows benefits in terms of the infection rate and the neurological outcome, but at the same time has a higher postoperative risk for epidural hematoma. Depending on the individual conditions, both materials have their place in future cranioplasty therapies. Clinical trial registration no.: NCT00923793 ( clinicaltrials.gov ).
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Journal of neurotrauma · Jan 2017
Randomized Controlled TrialVery Early Administration of Progesterone Does Not Improve Neuropsychological Outcomes in Subjects with Moderate to Severe TBI.
A Phase III, double-blind, placebo-controlled trial (ProTECT III) found that administration of progesterone did not reduce mortality or improve functional outcome as measured by the Glasgow Outcome Scale Extended (GOSE) in subjects with moderate to severe traumatic brain injury. We conducted a secondary analysis of neuropsychological outcomes to evaluate whether progesterone is associated with improved recovery of cognitive and motor functioning. ProTECT III was conducted at 49 level I trauma centers in the United States. ⋯ Analyses of covariance did not reveal significant treatment effects for memory (Buschke immediate recall, p = 0.53; delayed recall, p = 0.94), attention (Trails A speed, p = 0.81 and errors, p = 0.22; Digit Span Forward length, p = 0.66), executive functioning (Trails B speed, p = 0.97 and errors, p = 0.93; Digit Span Backward length, p = 0.60), language (timed phonemic fluency, p = 0.05), and fine motor coordination/dexterity (Grooved Pegboard dominant hand time, p = 0.75 and peg drops, p = 0.59; nondominant hand time, p = 0.74 and peg drops, p = 0.61). Pearson Product Moment Correlations demonstrated significant (p < 0.001) associations between better neuropsychological performance and higher GOSE scores. Similar to the ProTECT III trial's results of the primary outcome, the secondary outcomes do not provide evidence of a neuroprotective effect of progesterone.
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Randomized Controlled Trial
Making Sense of a Negative Clinical Trial Result: A Bayesian Analysis of a Clinical Trial of Lorazepam and Diazepam for Pediatric Status Epilepticus.
We demonstrate the application of a Bayesian approach to a recent negative clinical trial result. A Bayesian analysis of such a trial can provide a more useful interpretation of results and can incorporate previous evidence. ⋯ Because Bayesian analysis estimates the probability of one or more hypotheses, such an approach can provide more useful information about the meaning of the results of a negative trial outcome. In the case of pediatric status epilepticus, it is highly likely that lorazepam is noninferior and practically equivalent to diazepam.