Earlier Assessment Studies Research Articles

AB0479 Patient outcomes following 10 years of treatment with adalimumab in the DE020 roll-over trial

BackgroundDE020 was a long-term, open-label (OL) roll-over study for 4 studies in the early development program of adalimumab (ADA). All 4 studies enrolled patients (pts) with active rheumatoid arthritis (RA)...

The effect of experience on system usability scale ratings

Longitudinal studies have to do with testing over time and thus take into consideration previous user experience with a product or product versions. However, it is difficult to conduct these types of studies. Therefore the literature is sparse on examples of the explicit effect of user experience on user satisfaction metrics in industry-standard survey instruments. During a development experience in 2009, we used a cross-sectional method to look at the effects of user profiles on ratings for commercial products that use one such instrument, the System Usability Scale or SUS. Recent research has reported finding that differences in user ratings could be based on the extent of a user's prior experience with the computer system, a Web site being visited or a desktop application like Microsoft's Office suite being used. Compared to off-the-shelf office products or personal Web applications, we were curious if we would find the same experience effect for domain specialists using geosciences products in the course of their daily professional job roles. In fact, from data collected with 262 end users across different geographic locations testing two related oilfield product releases, one Web-based and one desktop-based, we found results that were quite close to early assessment studies: Users having a more extensive experience with a product tended to provide higher, more favorable, SUS scores over users with either no or limited experience with a product---and by as much as 15-16%, regardless of the domain product type. This and other observations found during our product testing have led us to offer some practical how-to's to our internal product analysts responsible for managing product test cycles, administering instruments like the SUS to users, and reporting results to development teams.

An evaluation of a Shockroom located CT scanner: a randomized study of early assessment by CT scanning in trauma patients in the bi-located trauma center North-West Netherlands (REACT trial)

BackgroundTrauma is a major source of morbidity and mortality, especially in people below the age of 50 years. For the evaluation of trauma patients CT scanning has gained wide acceptance in and provides detailed information on location and severity of injuries. However, CT scanning is frequently time consuming due to logistical (location of CT scanner elsewhere in the hospital) and technical issues. An innovative and unique infrastructural change has been made in the AMC in which the CT scanner is transported to the patient instead of the patient to the CT scanner. As a consequence, early shockroom CT scanning provides an all-inclusive multifocal diagnostic modality that can detect (potentially life-threatening) injuries in an earlier stage, so that therapy can be directed based on these findings.Methods/designThe REACT-trial is a prospective, randomized trial, comparing two Dutch level-1 trauma centers, respectively the VUmc and AMC, with the only difference being the location of the CT scanner (respectively in the Radiology Department and in the shockroom). All trauma patients that are transported to the AMC or VUmc shockroom according to the current prehospital triage system are included. Patients younger than 16 years of age and patients who die during transport are excluded. Randomization will be performed prehospitally.Study parameters are the number of days outside the hospital during the first year following the trauma (primary outcome), general health at 6 and 12 months post trauma, mortality and morbidity, and various time intervals during initial evaluation. In addition a cost-effectiveness analysis of this shockroom concept will be performed.Regarding primary outcome it is estimated that the common standard deviation of days spent outside of the hospital during the first year following trauma is a total of 12 days. To detect an overall difference of 2 days within the first year between the two strategies, 562 patients per group are needed. (alpha 0.95 and beta 0.80).DiscussionThe REACT-trial will provide evidence on the effects of a strategy involving early shockroom CT scanning compared with a standard diagnostic imaging strategy in trauma patients on both patient outcome and operations research.Trial registrationISRCTN55332315

Biotic transport of radionuclides from a low-level radioactive waste site.

In the United States, concern for human exposures to radioactivity associated with the disposal of low-level radioactive waste has resulted in a series of regulatory guides, environmental assessments, management practices, and modeling tools. A large number of radionuclide transport processes and mechanisms that may contribute to human exposure have been modeled, using computer programs to make the required calculations. The objective of our work was to evaluate the relevance of potential biological transport processes in the assessment of potential impacts at low-level waste (LLW) disposal sites. As part of this effort, we developed an order-of-magnitude estimate for potential dose to man resulting from biological transport by burrowing animals and by plant translocation at a reference low-level waste site in the arid west. We also made comparative dose-to-man estimates for a more commonly considered human intrusion exposure scenario. Parameter values for defining a reference arid LLW disposal site and biotic transport processes are based on data reported in current literature. Estimates of waste volumes for the western United States are based on information described by the U.S. Nuclear Regulatory Commission in the Draft Environmental Impact Statement in support of 10 CFR Part 61. Our estimates of the dose-to-man resulting from biotic transport are of the same order of magnitude as those resulting from a more commonly evaluated human intrusion scenario. The previously assumed lack of potential importance of biotic transport at LLW sites in earlier assessment studies is not confirmed by our findings. Our results indicate that long-term biological transport processes have the potential to influence LLW site performance, and should be carefully evaluated as part of the impact assessment process.