Design and Implementation of a Single Source Multipurpose Hospital-Wide Clinical Trial Registry.

IT-supported patient recruitment, serious adverse event reporting as well as making information about clinical trials accessible to the public on websites, are still major challenges in clinical trials. Too often the distribution of information about trials being performed within a hospital across numerous institutions and IT systems is a barrier to provide efficient IT support for such scenarios. Thus, the essential prerequisite to mastering those challenges is to achieve one single point of truth with adequate, complete, accurate and up-to-date information about all clinical trials running at a hospital. We describe the design and implementation of such a single source clinical trial registry serving multiple purposes at a university hospital.

A comparison study of anxiety in children undergoing brain MRI vs adults undergoing brain MRI vs children undergoing an electroencephalogram.

BACKGROUND: Magnetic resonance imaging (MRI) of the brain in children and adolescents is a well-established method in both clinical practice and in neuroscientific research. This practice is sometimes viewed critically, as MRI scans might expose minors (e.g. through scan-associated fears) to more than the legally permissible "minimal burden". While there is evidence that a significant portion of adults undergoing brain MRI scans experience anxiety, data on anxiety in children and adolescents undergoing brain MRI scans is rare. This study therefore aimed to examine the prevalence and level of anxiety in children and adolescents who had MRI scans of the brain, and to compare the results to adults undergoing brain MRI scans, and to children and adolescents undergoing electroencephalography (EEG; which is usually regarded a "minimal burden"). METHOD: Participants were 57 children and adolescents who had a brain MRI scan (MRI-C; mean age 12.9 years), 28 adults who had a brain MRI scan (MRI-A; mean age 43.7 years), and 66 children and adolescents undergoing EEG (EEG-C; mean age 12.9 years). Anxiety was assessed on the subjective (situational anxiety) and on the physiological level (arousal), before and after the respective examination. RESULTS: More than 98% of children and adolescents reported no or only minimal fear during the MRI scan. Both pre- and post-examination, the MRI-C and the MRI-A groups did not differ significantly with respect to situational anxiety (p = 0.262 and p = 0.374, respectively), and to physiological arousal (p = 0.050, p = 0.472). Between the MRI-C and the EEG-C group, there were also no significant differences in terms of situational anxiety (p = 0.525, p = 0.875), or physiological arousal (p = 0.535, p = 0.189). Prior MRI experience did not significantly influence subjective or physiological anxiety parameters. CONCLUSIONS: In this study, children and adolescents undergoing a brain MRI scan did not experience significantly more anxiety than those undergoing an EEG, or adults undergoing MRI scanning. Therefore, a general exclusion of minors from MRI research studies does not appear reasonable.

Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept.

BACKGROUND: The authors compared the safety and efficacy of a newly developed fast-track concept at their center, including implementation of a direct admission postanesthetic care unit, to standard perioperative management. METHODS: All fast-track patients treated within the first 6 months of implementation of our direct admission postanesthetic care unit were matched via propensity scores and compared with a historical control group of patients who underwent cardiac surgery prior to fast-track implementation. RESULTS: A total of 421 fast-track patients were matched successfully to 421 control patients. The two groups of patients had a similar age (64 +/- 13 vs. 64 +/- 12 yr for fast-track vs. control, P = 0.45) and European System for Cardiac Operative Risk Evaluation-predicted risk of mortality (4.8 +/- 6.1% vs. 4.6 +/- 5.1%, P = 0.97). Fast-track patients had significantly shorter times to extubation (75 min [45-110] vs. 900 min [600-1140]), as well as shorter lengths of stay in the postanesthetic or intensive care unit (4 h [3.0-5] vs. 20 h [16-25]), intermediate care unit (21 h [17-39] vs. 26 h [19-49]), and hospital (10 days [8-12] vs. 11 days [9-14]) (expressed as median and interquartile range, all P < 0.01). Fast-track patients also had a lower risk of postoperative low cardiac output syndrome (0.5% vs. 2.9%, P < 0.05) and mortality (0.5% vs. 3.3%, P < 0.01). CONCLUSION: The Leipzig fast-track protocol is a safe and effective method to manage cardiac surgery patients after a variety of operations.