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Purpose: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. Methods: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. Results: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46–91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20–70 cm) with a median diameter of 5.0 mm (range 3–6 mm) and 4.0 mm (range 2–6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). Conclusion: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD. [ABSTRACT FROM AUTHOR]

For studies relying on rater judgments of a vulnerable population, such as returning combat veterans, high consistency between primary and secondary raters is necessary. This study examined the inter-rater reliability of a primary and two secondary raters on scoring simulated driving assessments. Seven volunteer drivers were rated in two rounds (Round 1 n=4, Round 2 n=3). Driver performance was rated for two driving scenarios, a) ten-minute city/highway scenario, and b) six-minute suburban/residential scenario to measure driving errors. Based on a set 90% cut point for intra-class correlations (ICC), we examined each rated variable for each rater pairing. After round 1, secondary raters did not achieve the 90% cut point and participated in further training. Analysis of inter-rater reliability following round 2 showed improved inter-rater reliability, i.e., 99.3% for city/highway and 98% for the suburban/residential conditions. Our results suggest that by pinpointing incongruencies in raters' assessment of driving errors, strategies including problem identification, verifying driving errors via the simulator playback function, and establishing parameters for rating each error, can resolve such inconsistencies to significantly improve their inter-rater reliability. [ABSTRACT FROM AUTHOR]

This special issue reports on papers presented at a simulation user group meeting held in association with the University of Florida, Gainsville. This is the sixth in a series of special issues that have reported on driving simulator applications presented at simulation users conferences [1 - 5]. The meeting attracted 32 attendees from 5 different countries. This special issue includes 8 papers covering a wide range of research topics. The papers in this volume address in-vehicle systems, simulator sickness, simulator validation, driver behaviour and investigation of rider behaviour with a novel motorcycle simulator. [ABSTRACT FROM AUTHOR]

Combat veterans (CV) are experiencing mild traumatic brain injury and/or post traumatic stress disorder (mTBI/PTSD) which may hinder driving performance. Simulators provide a safe environment for testing individuals with impairments, but simulator sickness (SS) may occur and has not been studied in CV. In this retrospective study, we determined the occurrence of SS [total SS (TSS) score from the Simulator Sickness Questionnaire] at baseline, after an initial 5-minute acclimation drive, and after an entire 20-minute drive within and between 21 CV compared to 23 healthy controls (HC). Baseline differences in TSS were significant and were probably due to demographic differences (age and gender) and pre-experimental experience. Susceptibility to SS occurred in CV at two time periods and increased as driving exposure progressed. A significant increase in TSS existed between baseline and after the initial 5-minute acclimation drive in CV [t(-2.59), 8.10, p=0.02] and HC [t(-2.51), 6.41, p=0.02]; and between baseline and after the entire 20-minute drive in CV [t(-3.94), 8.07, p<.01] and HC [t(-4.05), 4.10, p<.01]. A main effect of TSS between groups approached significance (F=2.78, p=0.057) with CV having higher TSS scores than HC. Overall, these findings suggest that CV may have pre-existing conditions that make them more susceptible to SS; and that CV experienced SS more severely compared to HC, every time during the three time periods. Findings must be confirmed in an age and gender matched trial with a larger sample. [ABSTRACT FROM AUTHOR]

Purpose: To determine the correlations of the Useful Field of View (UFOV), compared to other clinical tests of Parkinson's disease (PD); vision; and cognition with measures of on-road driving assessments and to quantify the UFOV's ability to indicate passing/failing an on-road test in people with PD. Methods: Nineteen randomly selected people with idiopathic PD, mean age = 74.8 (6.1), 14 (73.7%) men, 18 (94.7%) Caucasians, were age-matched to 104 controls without PD. The controls had a mean age of 75.4 (6.4), 59 (56.7%) men, 96 (92.3%) Caucasians. Both groups were referred for a driving evaluation after institutional review board approval. Results: Compared to neuropsychological and clinical tests of vision and cognition, the UFOV showed the strongest correlations (r > .75, p < 0.05) with measures of failing a standardized road test and number of driving errors. Among PD patients, the UFOV Risk Index score of 3 (range 1-5) was established as the optimal cutoff value for passing the on-road test, with sensitivity 87 percent and specificity 82 percent, AUC = 92 percent (SE 0.61, p = .002). Similarly, the UFOV 2 (divided attention) optimum cutoff value is 223 ms (range 16-500 ms), sensitivity 87.5 percent, specificity 81.8 percent, AUC = 91 percent (SE 0.73, p = .003). The UFOV 3 (selected attention) optimal cutoff value is 273 ms (range 16-500 ms), sensitivity 75 percent, specificity 72.7 percent, AUC = 87 percent (SE 0.81, p = .007). Conclusion: In this pilot study among PD patients, the UFOV may be a superior screening measure (compared to other measures of disease, cognition, and vision) for predicting on-road driving performance but its rigor must be verified in a larger sample of people with PD. [ABSTRACT FROM AUTHOR]

Driving, an instrumental activity of daily living, requires safe person-environment interactions. The effectiveness (safety) of four United States Federal Highway Administration intersection design guidelines in the recovery phase of a turn was tested on older and younger adults. Using kinematics measures from an instrumented vehicle, drivers negotiating improved and unimproved intersections were examined in Gainesville, Florida. The findings from a 2 x 2 repeated measures ANOVA (within-subject variable = intersection condition: improved versus unimproved; between-subject variable = age: young versus old) yield support for three manoeuvres: extended receiving lane, right-turn channelisation with acceleration lane and left-turn offset, but not for no acute turn angle. One interaction effect (age x intersection) existed and age effects (favouring older drivers) appeared for three manoeuvres, yet showed little practical significance, suggesting that these design guidelines benefit older and younger drivers alike. This study informs occupational therapists that enhancements in the environment have an impact on safer driving, particularly at urban intersections. A replication of the concept of this study, that is, testing intersection design guidelines in the United Kingdom, may generate valuable information on the plausibility of environmental design guidelines and their effects on the driving performance of older and younger adults. [ABSTRACT FROM AUTHOR]

A meta-synthesis approach was used to identify, assess, and synthesize six qualitative studies on older driver safety and community mobility. Included studies had rich narrative results and thematic findings on older adults' and stakeholders' needs, factors influencing safety, and goals. The authors performed iterative data analysis, coded deductively and inductively, and developed themes from the constant comparison method. A core construct emerged: older adults' driving ability is innately connected to their identities and desire to maintain their independence. The five overarching themes--assessing risk, acceptance versus denial, cessation beliefs, communication, and involved others--Linform occupational therapy clinicians and researchers of opportunities for role expansion. The findings point to underlying beliefs that influence decision making and driving safety that can be explored using qualitative, survey, or experimental studies. Furthermore, these findings may facilitate changes in occupational therapy practice, such as enhancing driver evaluations. [ABSTRACT FROM AUTHOR]

The Rosenberg Self-Esteem Scale (RSES) demonstrates sound psychometric properties but has not been analyzed by item response theory (IRT). We used the Rasch model to determine the item-level psychometrics of the RSES in 986 noninstitutionalized elderly. The instrument showed appropriate item fit statistics and person separation index, but had limitations in the number and spread of items, unidimensionality, the logical progression of difficulty among the items, negative statements included in the rating scale, and the contextual relevance of items underlying the self-esteem construct. Based on clinical and cost implications, we offered suggestions to improve the RSES as a clinically meaningful measure of self-esteem in this population. [ABSTRACT FROM AUTHOR]

We compared classes of medication and inappropriately prescribed medications (IPDs) (potentially not indicated for seniors) to functional status and quality of life (QOL) in 1,099 seniors. We used data from the Physical Health Measure of the Older Americans Resources and Services (OARS) instrument, Functional Independence Measure (FIM), Instrumental Activities of Daily Living (IADL) of the OARS, two QOL questions, and Beer's criteria for IPDs. Multivariate analyses show cardiac medications positively, and analgesics inversely associated with FIM and IADLs, and endocrine medications inversely associated with FIM. Two high-risk groups emerged: older, not married (widowed, divorced and single) non-whites at risk for functional decline, and those with IPDs at risk for poorer QOL. These findings suggest research and prevention roles for rehabilitation professionals. [ABSTRACT FROM AUTHOR]

On December 1 and 2, 2003, 63 international experts on older driver issues met to examine three critical issues related to the safe mobility of older drivers. Conference participants addressed standards and protocols for screening and evaluating the skills of older drivers. For drivers judged to lack the necessary skills to drive safely, participants addressed methods of remediation that could enable older persons with limited cognitive or physical abilities, to continue to drive safely? For those persons whose skills are judged inadequate for safe driving, conference participants addressed the question as to how to best counsel individuals and their caregivers on practical alternatives to driving, Consensus was achieved as to the current methods for best assessing and screening drivers, remediation techniques, and providing advise and counsel for those persons and the caregivers as to appropriate actions for those no able to drive safely. [ABSTRACT FROM AUTHOR]

Concentrations of soluble c-erbB-2 were determined in the sera of 64 patients with distant metastasis from advanced breast cancer receiving second-line hormone or chemotherapy in comparison to 35 breast cancer patients without detectable recurrent disease and 17 healthy blood donors. The sera of non-metastatic breast cancer patients contained s-erbB-2 concentrations similar to those of healthy blood donors. Patients with distant metastasis from advanced breast cancer had significantly higher values of s-erbB-2 in comparison to patients with non-disseminated disease (mean: 59.6 vs. 11.6 U/ml; p = 0.022). A significant correlation was observed between s-erbB-2 serum levels and serum LDH concentrations (p < 0.001), levels of alkaline phosphatase (p < 0.001), and the presence of hepatic metastasis (p = 0.001). Time to tumor progression was significantly shorter in patients with s-erbB-2 levels above 40 U/ml (mean: 23.4 vs. 56.7 months; p = 0.002). Furthermore, breast cancer patients with hepatic metastasis and those with elevated s-erbB-2 serum levels above 40 U/ml had limited response to hormone or chemotherapy. Non-responders had significantly higher s-erbB-2 levels (mean: 270.3, range: 42-500 U/ml;) compared with the responder group (mean: 23.1, range: 0-149 U/ml; p < 0.001). Logistic regression analysis indicated that elevated s-erbB-2 serum levels above 40 U/ml independently predicted an unfavorable response to second-line hormone or chemotherapy in patients with advanced metastatic breast cancer. Copyright © 2002 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

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The original version of this Article omitted the following from the Acknowledgements: 'This project was supported by CRC128/Project A03 of the Deutsche Forschungsgemeinschaft (DFG).'This has not been corrected in either the PDF or HTML versions. [ABSTRACT FROM AUTHOR]

G-protein-coupled receptor (GPCR) expression is extensively studied in bulk cDNA, but heterogeneity and functional patterning of GPCR expression in individual vascular cells is poorly understood. Here, we perform a microfluidic-based single-cell GPCR expression analysis in primary smooth muscle cells (SMC) and endothelial cells (EC). GPCR expression is highly heterogeneous in all cell types, which is confirmed in reporter mice, on the protein level and in human cells. Inflammatory activation in murine models of sepsis or atherosclerosis results in characteristic changes in the GPCR repertoire, and we identify functionally relevant subgroups of cells that are characterized by specific GPCR patterns. We further show that dedifferentiating SMC upregulate GPCRs such as Gpr39, Gprc5b, Gprc5c or Gpr124, and that selective targeting of Gprc5b modulates their differentiation state. Taken together, single-cell profiling identifies receptors expressed on pathologically relevant subpopulations and provides a basis for the development of new therapeutic strategies in vascular diseases. [ABSTRACT FROM AUTHOR]