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

ABSTRACT: 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's 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.

SUBMITTER: Resnik LJ

PROVIDER: S-EPMC8714100 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The Five-time Sit-to-Stand (5xSTS) Test is a performance-based measure used by clinicians and researchers to assess the body functions needed to accomplish sit-to-stand transitions (e.g., lower limb strength, balance, and trunk control). The current requirements for performance of the 5xSTS Test (i.e., crossing arms over the chest) may not be appropriate for many, if not most lower limb prosthesis (LLP) users. The study aims were to (1) develop a modified five-time sit-to-stand (m5xSTS) Test protocol; (2) to examine initial evidence of known-groups construct validity among LLP users by comparing differences in performance by amputation level, amputation etiology, and functional level; and (3) to assess initial evidence of convergent construct validity by examining the correlations between m5xSTS performance with self-reported mobility (Prosthetic Limb Users Survey of Mobility (PLUS-M)), self-reported balance confidence (Activities-balance Confidence Scale (ABC)) and functional capability (comfortable walking speed). Three-hundred sixty-one LLP users participated in this cross-sectional study. The investigators developed a m5xSTS Test protocol that allows tested individuals to use different assistance strategies (i.e., use of upper limbs to push off thighs, push up from the armrests, or use a walker) when needed to perform the test. The investigators recorded m5xSTS Test times and assistance strategies. Significant differences in m5xSTS Test times were found between those who did and did not use an assistance strategy, as well as between participants grouped by different amputation level, etiology, and functional level. Significant moderate negative correlations were found between m5xSTS Test times and PLUS-M T-score (ρ = -0.42, p<0.001), ABC score (ρ = -0.42, p<0.001), and comfortable walking speed (ρ = -0.64, p<0.001), respectively. The m5xSTS Test allows LLP users to perform sit-to-stand transitions in a manner that accounts for their functional impairments, is consistent with post-amputation training, and is safe for the tested individual. Results from this study provide preliminary evidence of known groups and convergent construct validity for the m5xSTS Test with a large national sample of LLP users.

Project description:Objective.Electrical stimulation can induce sensation in the phantom limb of individuals with amputation. It is difficult to generalize existing findings as there are many approaches to delivering stimulation and to assessing the characteristics and benefits of sensation. Therefore, the goal of this systematic review was to explore the stimulation parameters that effectively elicited referred sensation, the qualities of elicited sensation, and how the utility of referred sensation was assessed.Approach.We searched PubMed, Web of Science, and Engineering Village through January of 2022 to identify relevant papers. We included papers which electrically induced referred sensation in individuals with limb loss and excluded papers that did not contain stimulation parameters or outcome measures pertaining to stimulation. We extracted information on participant demographics, stimulation approaches, and participant outcomes.Main results.After applying exclusion criteria, 49 papers were included covering nine stimulation methods. Amplitude was the most commonly adjusted parameter (n= 25), followed by frequency (n= 22), and pulse width (n= 15). Of the 63 reports of sensation quality, most reported feelings of pressure (n= 52), paresthesia (n= 48), or vibration (n= 40) while less than half (n= 29) reported a sense of position or movement. Most papers evaluated the functional benefits of sensation (n= 33) using force matching or object identification tasks, while fewer papers quantified subjective measures (n= 16) such as pain or embodiment. Only 15 studies (36%) observed percept intensity, quality, or location over multiple sessions.Significance.Most studies that measured functional performance demonstrated some benefit to providing participants with sensory feedback. However, few studies could experimentally manipulate sensation location or quality. Direct comparisons between studies were limited by variability in methodologies and outcome measures. As such, we offer recommendations to aid in more standardized reporting for future research.

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

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