Patient Perspectives on Osseointegration: A National Survey of Veterans with Upper Limb Amputation

INTRODUCTION: Osseointegrated (OI) prostheses have a unique benefit-risk profile among prosthetic alternatives and have been marketed in the United States under a Humanitarian Device Exemption since 2015. Information about upper limb prosthesis user perspectives on benefits and risks, prosthesis-user subpopulations for whom OI is most acceptable, and outcomes that matter most to patients could help inform clinical and regulatory decision-making. Recent 21st Century Cures legislation expanded the role of patient experience data in the decision-making process of the U.S. Food and Drug Administration, recognizing that patient perspectives may be informative to regulators. OBJECTIVE: To better understand prosthesis user perspectives about the benefits and risks associated with upper limb OI prostheses. DESIGN: Patient perspective survey. SETTING: Telephone administration. PARTICIPANTS: National sample of veterans with upper limb loss. INTERVENTIONS: NA MAIN OUTCOME MEASURES: Benefit-risk survey developed for this study. RESULTS: Twenty-eight percent of unilateral and 13% of bilateral amputees were willing to consider osseointegration surgery. Multivariate logistic regression models [OR; 95% CI] showed that transhumeral amputation level [OR 1.40; 1.01-1.98] was associated with greater willingness to consider surgery, whereas older age [OR 0.17; 0.09-0.32] and higher VR-12 Mental Component Summary [OR 0.53; 0.35-0.81] were associated with less willingness. Having a durable/reliable device, the ability to do more activities, and having a comfortable device were rated as very important or somewhat important by 98% or more for every risk condition. CONCLUSIONS: Persons who were older, had transradial amputation (compared to transhumeral), and those who had better mental functioning were less willing to consider this surgery. Respondents who were willing to consider surgery indicated that the most important potential benefits were obtaining a durable/reliable device, the ability to do more activities, and having a comfortable device. Most were willing to accept one or more risks of surgery, with long-term risks including chronic pain, loss of nerve function, or device failure considered the most unacceptable. LEVEL OF EVIDENCE: III. has been contributed to by US Government employees and their work is in the public domain in the USA

Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users

Recent advances in upper limb prosthetics include sensory restoration techniques and osseointegration technology that introduce additional risks, higher costs, and longer periods of rehabilitation. To inform regulatory and clinical decision making, validated patient reported outcome measures are required to understand the relative benefits of these interventions. The Patient Experience Measure (PEM) was developed to quantify psychosocial outcomes for research studies on sensory-enabled upper limb prostheses. While the PEM was responsive to changes in prosthesis experience in prior studies, its psychometric properties had not been assessed. Here, the PEM was examined for structural validity and reliability across a large sample of people with upper limb loss (n = 677). The PEM was modified and tested in three phases: initial refinement and cognitive testing, pilot testing, and field testing. Exploratory factor analysis (EFA) was used to discover the underlying factor structure of the PEM items and confirmatory factor analysis (CFA) verified the structure. Rasch partial credit modeling evaluated monotonicity, fit, and magnitude of differential item functioning by age, sex, and prosthesis use for all scales. EFA resulted in a seven-factor solution that was reduced to the following six scales after CFA: social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness. After removal of two items during Rasch analyses, the overall model fit was acceptable (CFI = 0.973, TLI = 0.979, RMSEA = 0.038). The social interaction, self-efficacy and embodiment scales had strong person reliability (0.81, 0.80 and 0.77), Cronbach\u27s alpha (0.90, 0.80 and 0.71), and intraclass correlation coefficients (0.82, 0.85 and 0.74), respectively. The large sample size and use of contemporary measurement methods enabled identification of unidimensional constructs, differential item functioning by participant characteristics, and the rank ordering of the difficulty of each item in the scales. The PEM enables quantification of critical psychosocial impacts of advanced prosthetic technologies and provides a rigorous foundation for future studies of clinical and prosthetic interventions

Relationship between interRAI HC and the ICF: opportunity for operationalizing the ICF

Background: The International Classification of Functioning, Disability and Health (ICF) is embraced as a framework to conceptualize human functioning and disability. Health professionals choose measures to represent the domains of the framework. The ICF coding classification is an administrative system but multiple studies have linked diverse clinical assessments to ICF codes. InterRAI-HC (home care) is an assessment designed to assist planning of care for patients receiving home care. Examining the relationship between the ICF and the interRAI HC is of particular interest because the interRAI assessments are widely used in clinical practice and research, are computerized, and uploaded to databases that serve multiple purposes including public reporting of quality in Canada and internationally. The objective of this study was to examine the relationship between the interRAI HC (home care) assessment and the ICF. Specifically, the goal was to determine the proportion of interRAI HC items that can be linked to each of the major domains of the ICF (Body Function, Body Structure, Activities and Participation, and the Environmental Factors), the chapters and the specific ICF codes

Evaluation of EMG pattern recognition for upper limb prosthesis control: a case study in comparison with direct myoelectric control

Abstract Background Although electromyogram (EMG) pattern recognition (PR) for multifunctional upper limb prosthesis control has been reported for decades, the clinical benefits have rarely been examined. The study purposes were to: 1) compare self-report and performance outcomes of a transradial amputee immediately after training and one week after training of direct myoelectric control and EMG pattern recognition (PR) for a two-degree-of-freedom (DOF) prosthesis, and 2) examine the change in outcomes one week after pattern recognition training and the rate of skill acquisition in two subjects with transradial amputations. Methods In this cross-over study, participants were randomized to receive either PR control or direct control (DC) training of a 2 DOF myoelectric prosthesis first. Participants were 2 persons with traumatic transradial (TR) amputations who were 1 DOF myoelectric users. Outcomes, including measures of dexterity with and without cognitive load, activity performance, self-reported function, and prosthetic satisfaction were administered immediately and 1 week after training. Speed of skill acquisition was assessed hourly. One subject completed training under both PR control and DC conditions. Both subjects completed PR training and testing. Outcomes of test metrics were analyzed descriptively. Results Comparison of the two control strategies in one subject who completed training in both conditions showed better scores in 2 (18%) dexterity measures, 1 (50%) dexterity measure with cognitive load, and 1 (50%) self-report functional measure using DC, as compared to PR. Scores of all other metrics were comparable. Both subjects showed decline in dexterity after training. Findings related to rate of skill acquisition varied considerably by subject. Conclusions Outcomes of PR and DC for operating a 2-DOF prosthesis in a single subject cross-over study were similar for 74% of metrics, and favored DC in 26% of metrics. The two subjects who completed PR training showed decline in dexterity one week after training ended. Findings related to rate of skill acquisition varied considerably by subject. This study, despite its small sample size, highlights a need for additional research quantifying the functional and clinical benefits of PR control for upper limb prostheses

Telephone and face to face methods of assessment of veteran's community reintegration yield equivalent results

<p>Abstract</p> <p>Background</p> <p>The Community Reintegration of Service Members (CRIS) is a new measure of community reintegration developed to measure veteran's participation in life roles. It consists of three sub-scales: Extent of Participation (Extent), Perceived Limitations with Participation (Perceived), and Satisfaction with Participation (Satisfaction). Testing of the CRIS measure to date has utilized in-person administration. Administration of the CRIS measure by telephone, if equivalent to in-person administration, would be desirable to lower cost and decrease administrative burden. The purpose of this study was to test the equivalence of telephone and in-person mode of CRIS administration.</p> <p>Methods</p> <p>A convenience sample of 102 subjects (76% male, 24% female, age mean = 49 years, standard deviation = 8.3) were randomly assigned to received either telephone interview at Visit 1 and in-person interview at Visit 2, or in-person interview at Visit 1 and telephone interview a Visit 2. Both Visits were conducted within one week. Intraclass correlation coefficients, ICC (2,1), were used to evaluate correspondence between modes for both item scores and summary scores. ANOVAs with mode order as a covariate were used to test for presence of an ordering effect.</p> <p>Results</p> <p>ICCs (95%CI) for the subscales were 0.92 (0.88-0.94) for Extent, 0.85 (0.80-0.90) for Perceived, and 0.89 (0.84-0.93) for Satisfaction. No ordering effect was observed.</p> <p>Conclusion</p> <p>Telephone administration of the CRIS measure yielded equivalent results to in-person administration. Telephone administration of the CRIS may enable lower costs of administration and greater adoption.</p

Risk of infection and adverse outcomes among pregnant working women in selected occupational groups: A study in the Danish National Birth Cohort

<p>Abstract</p> <p>Background</p> <p>Exposure to infectious pathogens is a frequent occupational hazard for women who work with patients, children, animals or animal products. The purpose of the present study is to investigate if women working in occupations where exposure to infections agents is common have a high risk of infections and adverse pregnancy outcomes.</p> <p>Methods</p> <p>We used data from the Danish National Birth Cohort, a population-based cohort study and studied the risk of Infection and adverse outcomes in pregnant women working with patients, with children, with food products or with animals. The regression analysis were adjusted for the following covariates: maternal age, parity, history of miscarriage, socio-occupational status, pre-pregnancy body mass index, smoking habit, alcohol consumption.</p> <p>Results</p> <p>Pregnant women who worked with patients or children or food products had an excess risk of sick leave during pregnancy for more than three days. Most of negative reproductive outcomes were not increased in these occupations but the prevalence of congenital anomalies (CAs) was slightly higher in children of women who worked with patients. The prevalence of small for gestational age infants was higher among women who worked with food products. There was no association between occupation infections during pregnancy and the risk of reproductive failures in the exposed groups. However, the prevalence of CAs was slightly higher among children of women who suffered some infection during pregnancy but the numbers were small.</p> <p>Conclusion</p> <p>Despite preventive strategies, working in specific jobs during pregnancy may impose a higher risk of infections, and working in some of these occupations may impose a slightly higher risk of CAs in their offspring. Most other reproductive failures were not increased in these occupations.</p

Elevated protein concentrations in newborn blood and the risks of autism spectrum disorder, and of social impairment, at age 10 years among infants born before the 28th week of gestation

Among the 1 of 10 children who are born preterm annually in the United States, 6% are born before the third trimester. Among children who survive birth before the 28th week of gestation, the risks of autism spectrum disorder (ASD) and non-autistic social impairment are severalfold higher than in the general population. We examined the relationship between top quartile inflammation-related protein concentrations among children born extremely preterm and ASD or, separately, a high score on the Social Responsiveness Scale (SRS total score ≥65) among those who did not meet ASD criteria, using information only from the subset of children whose DAS-II verbal or non-verbal IQ was ≥70, who were assessed for ASD, and who had proteins measured in blood collected on ≥2 days (N = 763). ASD (N = 36) assessed at age 10 years is associated with recurrent top quartile concentrations of inflammation-related proteins during the first post-natal month (e.g., SAA odds ratio (OR); 95% confidence interval (CI): 2.5; 1.2–5.3) and IL-6 (OR; 95% CI: 2.6; 1.03–6.4)). Top quartile concentrations of neurotrophic proteins appear to moderate the increased risk of ASD associated with repeated top quartile concentrations of inflammation-related proteins. High (top quartile) concentrations of SAA are associated with elevated risk of ASD (2.8; 1.2–6.7) when Ang-1 concentrations are below the top quartile, but not when Ang-1 concentrations are high (1.3; 0.3–5.8). Similarly, high concentrations of TNF-α are associated with heightened risk of SRS-defined social impairment (N = 130) (2.0; 1.1–3.8) when ANG-1 concentrations are not high, but not when ANG-1 concentrations are elevated (0.5; 0.1–4.2)

An Analysis of the Relationship Between Television News Selection and Public Relations Techniques

The problem is to determine if identifiable factors influence selection of soft news for coverage on television newscasts. Data were obtained from news releases, newscast scripts, and interviews with participating practitioners and editors. Chapter I presents the problem; Chapter II contains an analysis of news releases submitted to editors; Chapter III presents analysis of techniques and attitudes of practitioners and editors; Chapter IV presents conclusions and guidelines. The study indicated practitioners could influence selection of their items through attention to certain factors and techniques: elements of newsworthiness, personal contact, method of item dissemination, quantity of items submitted, and professionalism and credibility. Specific guidelines were developed for practitioners to follow in dealing with television news editors