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

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)

The benefits of sensation on the experience of a hand: A qualitative case series.

BACKGROUND:The experience of upper limb loss involves loss of both functional capabilities and the sensory connection of a hand. Research studies to restore sensation to persons with upper limb loss with neural interfaces typically measure outcomes through standardized functional tests or quantitative surveys. However, these types of metrics cannot fully capture the personal experience of living with limb loss or the impact of sensory restoration on this experience. Qualitative studies can demonstrate the viewpoints and priorities of specific persons or groups and reveal the underlying conceptual structure of various aspects of their experiences. METHODS AND FINDINGS:Following a home use trial of a neural-connected, sensory-enabled prosthesis, two persons with upper limb loss were interviewed about their experiences using the sensory restoration system in unsupervised, unconstrained settings. We used grounded theory methodology to examine their experiences, perspectives, and opinions about the sensory restoration system. We then developed a model to describe the impact of sensation on the experience of a hand for persons with upper limb loss. CONCLUSIONS:The experience of sensation was complex and included concepts such as the naturalness of the experience, sensation modality, and the usefulness of the sensory information. Sensation was critical for outcome acceptance, and contributed to prosthesis embodiment, confidence, reduced focus and attention for using the prosthesis, and social interactions. Embodiment, confidence, and social interactions were also key determinants of outcome acceptance. This model provides a unified framework to study and understand the impact of sensation on the experience of limb loss and to understand outcome acceptance following upper limb loss more broadly

Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use

<div><p>Objectives</p><p>To: 1) describe perceptions of satisfaction with and usability of the DEKA Arm and preferences for the DEKA Arm or personal prosthesis; 2) compare perceptions of satisfaction and usability by DEKA Arm configuration level; and 3) evaluate satisfaction and usability for study completers and non-completers; and for those who did and did not want to receive a DEKA Arm.</p><p>Methods</p><p>The study had 2 phases: in-laboratory (Part A) and home trial (Part B). 32 participants with amputation, (50% transradial, 38% transhumeral and 13% shoulder) completed Part A and 18 completed Part B 16 (89%) of whom were prosthesis users at baseline. Measures of satisfaction, usability and user preferences were administered. Responses were compared for completers of Part A only and completers of Parts A and B. Preferences for the DEKA Arm over personal prosthesis and proportion of participants who wanted to receive a DEKA Arm were evaluated. Relationships between satisfaction, usability and desire to receive a DEKA Arm were examined.</p><p>Results</p><p>At end of Part A, 22 (69%) of the 32 participants who completed in-laboratory training wanted to receive a DEKA Arm and 5 (16%) might want one. At end of Part B, 14 (88%) of 16 prosthesis users who completed the home trial preferred the overall function of the DEKA Arm, 13 (81%) preferred DEKA hand function and 14 (88%) preferred DEKA wrist function to their own prosthesis. In contrast, 14 (88%) preferred the weight and 13 (81%) preferred the look of their own prosthesis. Most aspects of the DEKA Arm were rated “easy” to use. No items were rated as “difficult”. Users were satisfied with most aspects of the DEKA Arm, except for the weight, shoulder appearance and harnessing. There were few differences in perceived usability or satisfaction by configuration level. Findings about desire to receive a DEKA Arm pertain only to study completers. Non-completers viewed the DEKA Arm less favorably than completers. Satisfaction was strongly related to participants’ expressed desire to receive a DEKA Arm in the future.</p><p>Significance</p><p>To maximize likelihood of adoption of the DEKA Arm, findings suggest that both an in-laboratory and a home use trial may be useful prior to finalizing a recommendation for prescription.</p></div

Usability ratings by level of DEKA Arm configuration level.

<p>Usability ratings by level of DEKA Arm configuration level.</p

Desire to receive a DEKA Arm at End of A and End of B^* by configuration level (N = 18).

<p>Desire to receive a DEKA Arm at End of A and End of B^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0178640#t003fn001" target="_blank">*</a>} by configuration level (N = 18).</p

Study enrollment, attrition and completion.

<p>Study enrollment, attrition and completion.</p