Coordinating Global Multi-Site Studies of Military-Relevant Traumatic Brain Injury: Opportunities, Challenges, and Harmonization Guidelines.

Traumatic brain injury (TBI) is common among military personnel and the civilian population and is often followed by a heterogeneous array of clinical, cognitive, behavioral, mood, and neuroimaging changes. Unlike many neurological disorders that have a characteristic abnormal central neurologic area(s) of abnormality pathognomonic to the disorder, a sufficient head impact may cause focal, multifocal, diffuse or combination of injury to the brain. This inconsistent presentation makes it difficult to establish or validate biological and imaging markers that could help improve diagnostic and prognostic accuracy in this patient population. The purpose of this manuscript is to describe both the challenges and opportunities when conducting military-relevant TBI research and introduce the Enhancing NeuroImaging Genetics through Meta-Analysis (ENIGMA) Military Brain Injury working group. ENIGMA is a worldwide consortium focused on improving replicability and analytical power through data sharing and collaboration. In this paper, we discuss challenges affecting efforts to aggregate data in this patient group. In addition, we highlight how "big data" approaches might be used to understand better the role that each of these variables might play in the imaging and functional phenotypes of TBI in Service member and Veteran populations, and how data may be used to examine important military specific issues such as return to duty, the late effects of combat-related injury, and alteration of the natural aging processes.

A Cognitive Aid for Neonatal Epinephrine Dosing.

OBJECTIVES: Errors are common when preparing epinephrine for neonatal resuscitation. Epinephrine is available in two concentrations (1 mg/mL and 1 mg/10 mL) and requires weight-based calculations, which increases the risk of dosing errors. We developed a printed cognitive aid to assist with dose preparation. We hypothesized that the cognitive aid would result in a 25% difference in errors in preparing the dose of epinephrine during simulated neonatal resuscitation. METHODS: Nurses (N = 100) in a large academic and community hospital were randomly assigned to calculate the intended dose and prepare epinephrine for neonatal resuscitation with or without the cognitive aid. Scenarios were video recorded and timed. Secondary outcomes included errors in the written intended dose, errors in choosing the correct epinephrine concentration, and time required to prepare the final dose. Proportions were compared by using Fisher's exact test. Variables influencing dosing errors were investigated by using logistic regression. RESULTS: Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%; P = .01). The aid also decreased errors in choosing the correct epinephrine concentration (12% vs 44%; P < .001), but there was no difference in the written intended dose or the time to prepare the dose. Years of experience, self-perceived math comfort, and anxiety were not predictive of dosing errors. CONCLUSIONS: A simple cognitive aid decreased epinephrine dosing errors during simulated neonatal resuscitation but did not improve efficiency. Despite the effectiveness of the cognitive aid, errors were not completely eliminated. This is a serious safety risk for newborns and requires additional interventions.

Providing researchers with online access to NHLBI biospecimen collections: The results of the first six years of the NHLBI BioLINCC program.

The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in 2008 to develop the infrastructure needed to link the contents of the NHLBI Biorepository and the NHLBI Data Repository, and to promote the utilization of these scientific resources by the broader research community. Program utilization metrics were developed to measure the impact of BioLINCC on Biorepository access by researchers, including visibility, program efficiency, user characteristics, scientific impact, and research types. Input data elements were defined and are continually populated as requests move through the process of initiation through fulfillment and publication. This paper reviews the elements of the tracking metrics which were developed for BioLINCC and reports the results for the first six on-line years of the program.

Providing Contemporary Access to Historical Biospecimen Collections: Development of the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).

The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established a Biorepository in 1976 that initially archived biospecimens from population-based blood product safety surveys. It was later expanded to biospecimens from clinical and epidemiological studies in heart, lung, and blood disorders. The NHLBI also established a Data Repository in 2000 to store and distribute study data from NHLBI-sponsored research. The NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) was established in 2008 to develop the infrastructure needed to link the contents of these two related NHLBI Repositories, facilitate access to repository resources, and streamline request processes. Three key program subcomponents were developed simultaneously: 1) the linkage of biospecimen electronic inventory records with their clinical or characterization data; 2) the development and implementation of a website with both public-facing information and private processing workspaces; and 3) the development of processes to maximize efficiency via a web-based system while maintaining workflow control, document tracking, and secure processes. The BioLINCC website was launched on October 1, 2009 with eight biospecimen collections and data from 72 research studies. By the end of the fourth online year, 38 biospecimen collections were linked and posted, and data from 108 research studies had been made available for request. The number of registered users by the end of the fourth online year approached 2600, and continues to show a trend towards an increasing rate of new users per year. BioLINCC has fulfilled 381 requests comprising 851 data collections, as well as 600 teaching dataset requests and 75 data renewal agreements. 154 biospecimen requests comprising 147,388 biospecimens were fulfilled or actively in process. We conclude that the BioLINCC program has been successful in its goal to increase the visibility and utilization of NHLBI biospecimen and data repository resources.