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BACKGROUND The prescription of prosthetic ankle-foot devices is often based on the professional judgment of the limb loss care team or limited evidentiary research. Current prosthetic research efforts have focused on the design and development of prosthetic devices rather than on understanding which devices are the most appropriate to prescribe. This investigation will evaluate biomechanical, functional, and subjective outcome measures to help determine the optimal prescription parameters of prosthetic ankle-foot devices. OBJECTIVE This study aims to develop evidence-based guidelines for limb loss care teams for the appropriate prescription of commercially available prosthetic ankle-foot devices to improve function and satisfaction. METHODS This investigation will be a multisite, randomized, crossover clinical trial targeting the enrollment of 100 participants. Participants will use 3 different types of prosthetic devices (energy storing and returning, articulating, and powered) in random order. Participants will be fitted and trained with each device and then separately use each device for a 1-week acclimation period. Following each 1-week acclimation period, participants will be evaluated using several functional measures and subjective surveys. A random subset of participants (30/100, 30%) will also undergo full-body gait analysis, following each 1-week acclimation period, to collect biomechanical data during level ground and incline and decline walking. After all individual device evaluations, participants will be given all 3 prostheses concurrently for 4 weeks of home and community use to capture user preference. Activity monitoring and a guided interview will be used to determine overall user preference. RESULTS The study was funded in August 2017, and data collection began in 2018. Data collection is expected to be completed before July 2023. Initial dissemination of results is expected to occur in the winter of 2023. CONCLUSIONS By identifying biomechanical, functional, and subjective outcomes that are sensitive to differences in prosthetic ankle-foot devices, a benchmark of evidence can be developed to guide effective prosthetic prescription. CLINICALTRIAL ClinicalTrials.gov NCT03505983; https://clinicaltrials.gov/ct2/show/NCT03505983 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/45612

Objectives To assess in Veterans with spinal cord injury (SCI) or amputated limb (AL) the following: (1) patient demographics, medical factors, cultural and psychosocial characteristic by race; (2) wheelchair quality by race; and (3) the independent associations of patient race and the other factors with wheelchair quality. Design Cross-sectional cohort study. Setting Three Department of Veterans Affairs (VA) medical centers affiliated with academic medical centers. Participants Eligible participants were Veterans with SCI or ALs (N=516); 482 of them completed the interview. Analyses were restricted to white and African American participants. Because there was no variation in wheelchair quality among AL patients (n=42), they were excluded from all but descriptive analyses, leading to a final sample size of 421. Interventions Not applicable. Main Outcome Measure Wheelchair quality as defined by the Medicare Healthcare Common Procedure Coding System. Results We found race differences in many of our variables, but not in quality for manual (odds ratio [OR]=.67; 95% confidence interval [CI], .33–1.36) or power (OR=.82; 95% CI, .51–1.34) wheelchairs. Several factors including age (OR=.96; 95% CI, .93–.99) and income (OR=3.78; 95% CI, 1.43–9.97) were associated with wheelchair quality. There were no significant associations of cultural or psychosocial factors with wheelchair quality. Conclusions Although there were no racial differences in wheelchair quality, we found a significant association of older age and lower income with poorer wheelchair quality among Veterans. Efforts are needed to raise awareness of such disparities among VA wheelchair providers and to take steps to eliminate these disparities in prescription practice across VA sites.

Approximately 80% to 95% of patients with Amyotrophic Lateral Sclerosis (ALS) eventually develop speech impairments, such as defective articulation, slow laborious speech and hypernasality. The relationship between impaired speech and asymptomatic speech may be seen as a divergence from a baseline. This relationship can be characterized in terms of measurable combinations of phonological characteristics that are indicative of the degree to which the two diverge. We demonstrate that divergence measurements based on phonological characteristics of speech correlate with physiological assessments of ALS. Speech-based assessments offer benefits over commonly-used physiological assessments in that they are inexpensive, non-intrusive, and do not require trained clinical personnel for administering and interpreting the results.

During the development of a genetically modified (GM) crop product, extensive phenotypic and agronomic data are collected to characterize the plant in comparison to a conventional control with a similar genetic background. The data are evaluated for potential differences resulting from the genetic modification process or the GM trait, and the differences--if any--are subsequently considered in the context of contributing to the pest potential of the GM crop. Ultimately, these study results and those of other studies are used in an ecological risk assessment of the GM crop. In the studies reported here, seed germination, vegetative and reproductive growth, and pollen morphology of Roundup Ready 2 Yield(®) soybean, MON 89788, were compared to those of A3244, a conventional control soybean variety with the same genetic background. Any statistically significant differences were considered in the context of the genetic variation known to occur in soybean and were evaluated as indicators of an effect of the genetic modification process and assessed for impact on plant pest (weed) characteristics and adverse ecological impact (ecological risk). The results of these studies revealed no effects attributable to the genetic modification process or to the GM trait in the plant that would result in increased pest potential or adverse ecological impact of MON 89788 compared with A3244. These results and the associated risk assessments obtained from diverse geographic and environmental conditions in the United States and Argentina can be used by regulators in other countries to inform various assessments of ecological risk.

Objective To understand the role of cultural and psychosocial factors in the outcomes of veteran wheelchair users with spinal cord injury (SCI) to help clinicians identify unique factors faced by their patients and help researchers identify target variables for interventions to reduce disparities in outcomes. Design Cross-sectional cohort study. Setting Three urban Veterans Affairs medical centers affiliated with academic medical centers. Participants Of the patients (N=516) who were eligible to participate, 482 completed the interview and 439 had SCI. Because of small numbers in other race groups, analyses were restricted to white and African American participants, resulting in a final sample of 422. Intervention Not applicable. Main Outcome Measures Quality of life (QOL, Veterans RAND 12-Item Health Survey); satisfaction (Client Satisfaction Questionnaire); and participation (Craig Handicap Assessment and Reporting Technique Short Form). Results African American Veterans reported poorer physical QOL but better mental QOL than did white Veterans. No other significant race differences were found in unadjusted analyses. Multivariable analyses showed that psychosocial factors were predominantly associated with patients' QOL outcomes and satisfaction with service, but demographic and medical factors were predominantly associated with participation outcomes. Interaction analyses showed that there was a stronger negative association between anxiety and mental QOL for African Americans than for whites, and a positive association between higher self-esteem and social integration for whites but not African Americans. Conclusions Findings suggest that attempts to improve the outcomes of Veterans with SCI should focus on a tailored approach that emphasizes patients' demographic, medical, and psychosocial assets (eg, building their sense of self-esteem or increasing their feelings of mastery), while providing services targeted to their specific limitations (eg, reducing depression and anxiety).

As part of an ecological risk assessment, Roundup Ready 2 Yield® soybean (MON 89788) was compared to a conventional control soybean variety, A3244, for disease and arthropod damage, plant response to abiotic stress and cold, effects on succeeding plant growth (allelopathic effects), plant response to a bacterial symbiont, and effects on the ability of seed to survive and volunteer in a subsequent growing season. Statistically significant differences between MON 89788 and A3244 were considered in the context of the genetic variation known to occur in soybean and were assessed for their potential impact on plant pest (weed) potential and adverse environmental impact. The results of these studies revealed no effects of the genetic modification that would result in increased pest potential or adverse environmental impact of MON 89788 compared with A3244. This paper illustrates how such characterization studies conducted in a range of environments where the crop is grown are used in an ecological risk assessment of the genetically modified (GM) crop. Furthermore, risk assessors and decision makers use this information when deciding whether to approve a GM crop for cultivation in-or grain import into-their country.