Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living With Multiple Sclerosis.

BACKGROUND: Sexual dysfunction is a common symptom of multiple sclerosis (MS). Clinically meaningful and psychometrically sound measures of sexual function validated in people with MS are necessary to identify people with MS who experience problems with sexual function. AIM: To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) v2.0 measure in people with MS and to extend the PROMIS SexFS Brief and Full Profiles to include additional aspects of sexual function relevant to people living with MS. METHODS: A convenience sample of MS clinicians and sexually active individuals with MS ranked relevance of 26 items that listed specific factors that interfere with sexual function. Rankings were used to select items to include in the modified SexFS for Multiple Sclerosis (SexFS-MS) profiles. Sex-FS Brief and Full profiles along with the top 22 ranked interfering factor items underwent cognitive interviews (CI) to assess whether the items were understandable and meaningful. OUTCOMES: The SexFS as originally published functioned well in people with MS after minor modifications. RESULTS: Twelve MS clinicians and 26 people with MS ranked items. The 10 highest ranked questions about factors that interfere with sexual function most relevant to people with MS were added to the SexFS-MS Brief profiles and 18 to the Full profiles. Ten men and 12 women with MS participated in CIs and found most items to be clear and meaningful. However, important changes were made to the profile instructions, some response sets, and to some items to improve clarity and function. New items to assess numbness and reasons why sexually active people choose at times not to engage in sexual activity were added. CLINICAL IMPLICATIONS: Brief and Full profiles are freely available and are recommended for research and clinical practice that include people with MS. STRENGTHS & LIMITATIONS: This study is the first to provide validity evidence for the PROMIS SexFS in people living with MS. Though the PROMIS SexFS was tested in people who identify as lesbian, gay, or bisexual, only individuals who identified as heterosexual participated in this study. Results may not represent views of people with MS who identify as other sexual orientations who may have different concerns and priorities related to sexual function. CONCLUSION: This study extended the PROMIS SexFS Brief and Full profiles to create the SexFS-MS by adding items that measure most relevant issues related to sexual function in individuals living with MS. Amtmann D, Bamer AM, Salem R, et al. Extension and Evaluation of the PROMIS Sexual Function and Satisfaction Measures for Use in Adults Living With Multiple Sclerosis. J Sex Med 2022;19:719-728.

Psychometric examination of short forms from the University of Washington pain-related self-efficacy and concerns about pain item banks in patients with low back pain.

PURPOSE: This study examined the psychometric properties of custom short forms assessing pain-related self-efficacy and catastrophizing, which are important psychosocial constructs for individuals with pain conditions. Short forms were derived from the University of Washington concerns about pain (UWCAP) and pain-related self-efficacy (UWPRSE) item banks. METHODS: Participants with low back pain (LBP) in a clinical trial (n = 241) examining nonpharmacologic treatments completed the 8-item UWCAP and 9-item UWPRSE and a numeric pain intensity rating, Oswestry Disability and Fear-Avoidance Beliefs questionnaires at baseline, 1-, 4- and 12-weeks after enrollment. Cronbach's alpha and intraclass correlation coefficients estimated internal consistency and test-retest reliability, respectively. Floor and ceiling effects for the UWCAP and UWPRSE were examined. Concurrent validity was evaluated with univariate correlation coefficients and predictive validity with multivariate regression models. Participants were divided into categories of treatment responsiveness based on a single-item global rating measure, and UWPRSE and UWCAP change scores and standardized effect sizes were calculated in each category. RESULTS: Both short forms had good internal consistency (α = 0.89-0.90) and test-retest reliability (ICC = 0.77-0.85), without substantial floor or ceiling effects. As expected, the UWCAP was positively correlated, and UWPRSE negatively correlated, with concurrent measures of pain intensity, disability and fear-avoidance beliefs. The UWCAP added to the prediction model for 4-week disability outcomes (ß = 0.25, p = 0.008). Responsiveness was supported by the mean change scores and effect sizes across treatment response categories. CONCLUSION: The UWCAP and UWPRSE short forms demonstrated acceptable psychometric properties, supporting future research on the role of these constructs in the management of persons with LBP. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02860834. Registered on August 16, 2016.

Use of Standardized Outcome Measures for People With Lower Limb Amputation: A Survey of Prosthetic Practitioners in the United States.

OBJECTIVE: To assess the clinical resources available for the assessment of health outcomes in people with lower limb amputation and to understand barriers and facilitators associated with use of standardized outcome measures in clinical practice. DESIGN: Cross-sectional survey. SETTING: General community (online). PARTICIPANTS: A volunteer sample of prosthetic practitioners was recruited through national professional organizations. Eligible participants were practitioners certified by a professional prosthetics organization and currently practicing as a prosthetist, prosthetist-orthotist, or prosthetic assistant. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A custom-designed online survey on clinical use of patient-reported and performance-based standardized outcome measures to assess patients with lower limb amputation. RESULTS: A total of 375 participants completed the survey. Most participants (79%) reported that they are encouraged or required to administer standardized outcome measures in their clinic or facility. Most participants reported that use of patient-reported and performance-based outcome measures are within their scope of practice (88%) and that they have the knowledge required for outcomes measurement (84%). Few participants agreed that outcomes measurement is standardized across the profession (30%). Most participants had access to small spaces and equipment for outcomes measurement, such as short hallways (65%-94%), stairs (69%), and tablets with wireless internet connection (83%). Most participants reported that they would be willing to spend between 5 (36% of participants) and 10 (43% of participants) minutes on self-reported surveys, and between 10 (41% of participants) and 20 (28% of participants) minutes on performance-based tests. CONCLUSIONS: Outcomes measurement is encouraged or expected in contemporary prosthetic practice. Strategies to improve standardization and efficiency of administration are needed to facilitate routine use of outcome measures in clinical care.

Agreement between proxy- and self-report scores on PROMIS health-related quality of life domains in pediatric burn survivors: a National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

PURPOSE: To examine agreement between pediatric burn survivor self- and caregiver proxy-report on multiple PROMIS domains and examine factors associated with differences between self- and proxy-reports. METHODS: Children 8-17 years of age and their caregivers completed PROMIS measures (physical function, depression, peer relationships, pain interference, and anger) between 6 months and 15 years after injury. Self- and proxy-report scores were compared using Wilcoxon sign rank test, Cohen's effect size, and intraclass correlation coefficients (ICC) and by agreement across severity of symptoms based on recommended cutoffs. Ordinary least squares regression analyses examined child- (self-report score, age, gender, and ethnicity) and proxy-related (relationship to child) factors associated with score differences. RESULTS: Two hundred and seventy four child-caregiver pairs completed the PROMIS measures. Mean child age was 13.0 (SD:3) years. Caregivers reported significantly worse scores than the child on physical function, pain, and anger (all p ≤ 0.01). The effect sizes were small across all domains except physical function. Similarly, ICCs were all of moderate agreement. The percentage of dyads in agreement by severity groups was high with only 5%-9% of pairs discordant. Only higher self-report score was associated (all p < 0.05) with greater differences across all domains in regression analyses. CONCLUSIONS: This study supports the use of pediatric proxy PROMIS depression, physical function, peer relationships, pain interference, and anger scales in pediatric burn patients. Although agreement was moderate to good, assessing proxy-report alone as a surrogate should only be considered when self-report is not possible or practical. Caregivers typically report slightly worse severity of symptoms than children across all domains.

Development and validation of the University of Washington caregiver stress and benefit scales for caregivers of children with or without serious health conditions.

PURPOSE: To develop item response theory (IRT)-based item banks and short forms to measure stress and benefit related to caregiving for children, including children with epilepsy or other serious health conditions. METHODS: Items developed with feedback from neurologists and caregivers of children with epilepsy were tested in cognitive interviews and administered to caregivers of children with severe epilepsy (N = 128), down syndrome (N = 143) and muscular dystrophy (N = 129), as well as a community sample of US caregivers (N = 322). IRT was used to analyze the data. Test-retest reliability was assessed using a two-way random effects (2,1) intraclass correlation coefficient (ICC). Validity was assessed by a pattern of correlations with relevant constructs (stress, depression, anxiety, and resilience) and by the pattern of scores by known groups. RESULTS: Caregivers of children with serious health conditions reported more stress and less benefit than the general sample. The final caregiver stress item bank (k = 19) and the caregiver benefit item bank (k = 13) were calibrated using IRT and centered on a sample of community caregivers representative of the US general caregiver population. Short form scores are highly correlated with full bank scores (r ≥ 0.98) and IRT reliability exceed 90% for most levels. Test-retest reliability was high (ICC > 0.92) for banks and short forms. CONCLUSIONS: Results provide strong support for reliability and validity of the caregiver stress and benefit scores. Instruments are publicly available, flexible, brief, and provide reliable and valid scores of caregiver stress and benefit of caregivers of children with and without serious health conditions.

Satisfaction With Life Over Time in People With Burn Injury: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

OBJECTIVE: To examine trajectories of satisfaction with life (SWL) of burn survivors over time and their clinical, demographic, and other predictors. DESIGN: Longitudinal survey. SETTING: Not applicable. PARTICIPANTS: Individuals ≥18 years of age who underwent burn-related surgery and met one of the following criteria: (1) >10% total body surface area (TBSA) burn and ≥65 years of age; (2) >20% TBSA burn and 18 to 64 years of age; (3) electrical high voltage/lightning injury; or (4) burn injury to the hands, face, or feet. The participants (N=378) had data on all variables of interest and were included in the analyses. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Satisfaction With Life Scale. RESULTS: Growth mixture modeling identified 2 classes with different trajectories of SWL. The mean SWL of the unchanged class (n=224, 60%) was flat over 2 years with high initial SWL scores. The SWL of the dissatisfied class (n=154, 40%) was at the low end of average and got progressively worse over time. CONCLUSIONS: SWL after burn injury can be described by 2 different trajectories with substantially different outcomes. Older age, worse mental health, and unemployment prior to injury predicted membership in the dissatisfied class. Additional services could be provided to those at high risk for low SWL to achieve better outcomes.

National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System: Review of Program and Database.

The Burn Model System (BMS) centers program was created in 1994 to evaluate the long-term outcomes of burn injuries. As part of this multicenter program, a comprehensive longitudinal database was developed to facilitate the study of a number of functional and psychosocial outcomes after burn injury. In this article, we provide an overview of the data collection procedures, measures selection process, and an overview of the participant data collected between 1994 and 2016. Surveys were administered during hospitalization and at 6, 12, and 24 months after discharge, and in the most recent funding cycle, data collection at every 5 years postinjury was added. More than 7200 people with burn injury were eligible to participate in the BMS National Longitudinal Database. Of these, >5900 (82%) were alive at discharge and consented to follow-up data collection. The BMS National Longitudinal Database represents a large sample of people with burn injury, including information on demographic characteristics, injury characteristics, and health outcomes. The database is publicly available and can be used to examine the effect of burn injury on long-term outcomes.

Factors Affecting Employment After Burn Injury in the United States: A Burn Model System National Database Investigation.

OBJECTIVE: To investigate the effect of patient and injury characteristics on employment for working-age, adult survivors of burn injury using the multicenter Burn Model System national database. DESIGN: Longitudinal survey. SETTING: Multicenter regional burn centers. PARTICIPANTS: Adult burn survivors (N=967) age≥18 years with known employment status prior to injury were included in the analysis at 12 months after injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Employment status at 12 months after injury. RESULTS: The analyses determined that those employed preinjury had higher odds of being employed (odds ratio [OR]=8.1; 95% confidence interval [CI], 4.9-13.1). White, non-Hispanic individuals were also more likely to be employed (OR=1.49; 95% CI, 1.0-2.1). Older individuals, females, those with longer hospitalizations, amputation during the acute hospitalization, and those with high pain interference at hospital discharge had lower odds of working after injury. Preinjury living situation, preinjury alcohol and drug misuse, number of acute operations and burn size (total body surface area, %) were not significant predictors of employment status at 12 months after burn injury. CONCLUSION: Preinjury employment remains the most significant predictor for postburn employment. Although past reports have focused on predictors for postburn employment, we believe that we need to seek greater understanding of modifiable risk factors for unemployment and examine issues related to work retention, performance, accommodations, and career trajectories for the working-age survivor of burn injury.

Factors associated with disease self-efficacy in individuals aging with a disability.

Self-management of a disability consists of treatment adherence, obtaining information about the disease and treatment options, caring for oneself, participating in decisions, and maintaining social relationships and emotional balance. Understanding and measuring an individual's beliefs about their ability to successfully self-manage and live well with a disability allows researchers and clinicians to better target interventions aimed at increasing disability management self-efficacy (DMSE). The purpose of this study was to examine the associations between demographic and clinical indicators, and self-efficacy for DMSE in individuals with chronic physical conditions. Adults (N = 815) with muscular dystrophy, multiple sclerosis, spinal cord injury, or post-polio syndrome completed a self-report mailed survey assessing DMSE, perceived social support, depression symptoms, resilience, fatigue, pain interference, satisfaction with participation in social roles, physical function, and demographics. A cross-sectional regression model was used to examine the associations between the clinical and demographic factors, and DMSE. The model explained 67% of the variance in DMSE. Satisfaction with participation in social roles, resilience, pain interference, social support, and fatigue were statistically significant. Better social functioning, more resilience, and less pain and fatigue were most strongly associated with DMSE. Interventions aimed at increasing DMSE should include strategies for improving social participation.

Do measures of depressive symptoms function differently in people with spinal cord injury versus primary care patients: the CES-D, PHQ-9, and PROMIS®-D.

PURPOSE: To evaluate whether items of three measures of depressive symptoms function differently in persons with spinal cord injury (SCI) than in persons from a primary care sample. METHODS: This study was a retrospective analysis of responses to the Patient Health Questionnaire depression scale, the Center for Epidemiological Studies Depression scale, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) version 1.0 eight-item depression short form 8b (PROMIS-D). The presence of differential item function (DIF) was evaluated using ordinal logistic regression. RESULTS: No items of any of the three target measures were flagged for DIF based on standard criteria. In a follow-up sensitivity analyses, the criterion was changed to make the analysis more sensitive to potential DIF. Scores were corrected for DIF flagged under this criterion. Minimal differences were found between the original scores and those corrected for DIF under the sensitivity criterion. CONCLUSIONS: The three depression screening measures evaluated in this study did not perform differently in samples of individuals with SCI compared to general and community samples. Transdiagnostic symptoms did not appear to spuriously inflate depression severity estimates when administered to people with SCI.

Testing the measurement invariance of the University of Washington Self-Efficacy Scale short form across four diagnostic subgroups.

PURPOSE: The University of Washington Self-Efficacy Scale (UW-SES) was originally developed for people with multiple sclerosis (MS) and spinal cord injury (SCI). This study evaluates the measurement invariance of the 6-item short form of the UW-SES across four disability subgroups. Evidence of measurement invariance would extend the UW-SES for use in two additional diagnostic groups: muscular dystrophy (MD) and post-polio syndrome (PPS). METHODS: Multi-group confirmatory factor analysis was used to evaluate successive levels of measurement invariance of the 6-item short form, the UW-SES: (a) configural invariance, i.e., equivalent item-factor structures between groups; (b) metric invariance, i.e., equivalent unstandardized factor loadings between groups; and (c) scalar invariance, i.e., equivalent item intercepts between groups. Responses from the four groups with different diagnostic disorders were compared: MD (n = 172), MS (n = 868), PPS (n = 225), and SCI (n = 242). RESULTS: The results of this study support that the most rigorous form of invariance (i.e., scalar) holds for the 6-item short form of the UW-SES across the four diagnostic subgroups. CONCLUSIONS: The current study suggests that the 6-item short form of the UW-SES has the same meaning across the four diagnostic subgroups. Thus, the 6-item short form is validated for people with MD, MS, PPS, and SCI.

Comparison of self-report sleep measures for individuals with multiple sclerosis and spinal cord injury.

OBJECTIVE: To investigate self-report measures of sleep disturbances and sleep-related impairments in samples of individuals with multiple sclerosis (MS) or spinal cord injury (SCI). DESIGN: Cross-sectional survey. SETTING: Community based. PARTICIPANTS: Adults (age ≥18y) (N=700) with either MS (n=461) or SCI (n=239) who were enrolled in a longitudinal survey of self-reported health outcomes and who completed self-report sleep measures at 1 time point. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Medical Outcomes Study Sleep Scale (MOS-S), Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short form, and PROMIS sleep-related impairments short form. RESULTS: Mean scores on the MOS-S sleep index II were significantly worse for both the MS and SCI samples than those of previously reported samples representative of the U.S. general population (P<.0001 for each group). The PROMIS sleep disturbance short form and PROMIS sleep-related impairments short form scores of the MS sample were also significantly different from those reported for the calibration cohort (P<.0001 on each scale). However, although the scores of the SCI sample were significantly different from those of the comparison cohort for the PROMIS sleep-related impairments short form (P=.045), the differences on the PROMIS sleep disturbance short form were not significant (P=.069). CONCLUSIONS: Although the MOS-S scores for the MS and SCI cohorts clearly indicated significantly high levels of sleep-related problems and were consistent with existing literature, the more ambiguous findings from the PROMIS sleep disturbance short form and PROMIS sleep-related impairments short form suggest that not enough is currently known about how these instruments function when applied to those with chronic neurologic dysfunction.

The Communicative Participation Item Bank-Gender-Diverse Version: Item Bank Calibration and Short Form.

PURPOSE: The purpose of this study was to calibrate an item set for a new version of the Communicative Participation Item Bank (CPIB) specifically for use with gender-diverse clients. This new version contains a new item stem as well as other minor wording changes from the original CPIB in order to be acceptable to gender-diverse respondents. METHOD: Survey data on 47 candidate items were collected from 434 transgender individuals: 219 assigned female at birth (AFAB) and 215 assigned male at birth (AMAB). Item response theory analyses included evaluation of unidimensionality, local dependence, fit to a graded response model, and differential item functioning (DIF) between AFAB and AMAB respondents. RESULTS: The original set of 47 items was unidimensional, but 16 items were removed due to local dependence, resulting in a final item bank of 31 items. There was no evidence of DIF between AFAB and AMAB participants. Reliability of the full item bank is good (i.e., > 0.8) between T scores of 20 and 76 and high (i.e., > 0.9) between T scores of 20 and 68. The short form had good reliability (i.e., > 0.8) between T scores of 24 and 64. CONCLUSIONS: The Communicative Participation Item Bank-Gender-Diverse (CPIB-GD) version provides a new option for person-reported outcome measurement with gender-diverse clients. Clinicians are cautioned to use only the new CPIB-GD with gender-diverse clients, and not the original CPIB due to unacceptable wording in the original version for this population. The original CPIB remains valid and appropriate for the populations for which it was developed. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24993309.

Utilization of orthoses and assistive devices among a national sample of lower limb orthosis users.

Introduction: Lower limb orthoses (LLOs) and assistive devices (ADs) can be used together or separately to improve mobility when performing daily activities. The goal of this study was to examine utilization of LLOs and ADs in a national sample of adult LLO users. Methods: A survey was designed to ask participants whether they typically use their LLOs and/or ADs to perform 20 daily activities. LLO users from orthotic clinics across the United States were invited to complete the survey. Descriptive statistics were used to examine utilization trends. Results: Survey responses from 1036 LLO users were analyzed. Community-based activities were performed with LLOs by at least 80% of participants. Activities that involved walking short distances in the home were more often performed without LLOs or ADs. Among participants with the four most prevalent health conditions, LLO use in the community was greatest among participants with Charcot-Marie-Tooth disease. Conclusions: LLOs were frequently used for a wide range of community-based activities. Simultaneous use of ADs and LLOs may be most beneficial for LLO users when performing activities outside of the home. Clinicians can discuss LLO and AD use with patients to optimize their functional outcomes at home and in the community.

Correction: Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses.

[This corrects the article DOI: 10.1371/journal.pone.0293848.].

Chronic Use of Prescription Pain Medication and Outcomes in Patients With Burn Injury: A Burn Model System National Database Study.

OBJECTIVE: This study attempts to examine long-term pain medication usage after burn injury and its association with functional and psychosocial outcomes. DESIGN: This is a multicenter retrospective cohort study utilizing the Burn Model System National Longitudinal Database. Participants injured from 2015 to 2021 were divided into two groups, those taking and not taking prescription pain medication at 12 mos after injury. Regression analyses examined associations between pain medication use and outcomes at 12 mos, adjusting for demographics, burn size, length of hospital stay, and preinjury pain medication use and employment status. Outcomes included VR-12 Physical and Mental Component Summary scores Patient-Reported Outcomes Measurement Information System Anxiety and Depression scores, Satisfaction with Life Scale, and employment status. RESULTS: Of 358 participants analyzed, prescription pain medication use was associated with worse outcomes at 12 mos: Physical Component Summary (ß = -7.11, P < 0.001), Mental Component Summary (ß = -6.01, P < 0.001), and Patient-Reported Outcomes Measurement Information System Depression (ß = 4.88, P < 0.001) and Anxiety (ß = 6.16, P < 0.001). Satisfaction with Life Scale was not significantly associated with pain medication use ( P = 0.069) and those taking pain medication were 52% less likely to be employed at 12 mos ( P = 0.035). CONCLUSIONS: There is a significant association between prescription pain medication use and worse physical, mental, and employment outcomes at 12 mos after burn injury.

Defining numerical cut points for mild, moderate, and severe pain in adult burn survivors: A northwest regional burn model system investigation.

INTRODUCTION: Pain is a common and often debilitating sequela of burn injury. Burn pain develops following damage to peripheral sensory nerves and the release of inflammatory mediators from injury. Burn pain is complex and can include background and procedural pain that result from the injury itself, wound care, stretching, and surgery. Clinicians and researchers need valid and reliable pain measures to guide screening, treatment, and research protocols. Unlike other conditions, visual analog, or numeric pain rating scale (VAS/NRS) scores that represent mild, moderate, and severe pain among people with burn injury have not been established. The aim of this study was to identify the most suitable average pain intensity rating scores for mild, moderate, and severe pain in adult burn survivors using a PROMIS Pain Interference (PROMIS-PI) short form. METHODS: An average pain intensity VAS/NRS score (0-10) and customized PROMIS-PI short form were administered to adults with burn injury treated at a regional burn center at hospital discharge (baseline) and at 6, 12, and 24-months after injury. To identify pain intensity scores that represent mild, moderate, and severe pain, we computed F values and Bayesian Information Criterion (BIC) statistics associated with multiple ANOVA comparisons for mean pain interference scores by various pain intensity cut points. Six possible cut points (CP) were compared: CP 3,6; 3,7; 4,6; 4,7; 2,5; and 3,5. Optimal cut points were considered those with the highest ANOVA F statistics. Models with similar F statistics were also compared with BIC. RESULTS: Data from a sample of 253 participants (83% white, 66% male, mean age 47 years) with VAS/NRS pain intensity and PROMIS-PI scores at one or more timepoints were analyzed. The optimal classification for mild, moderate, and severe pain was CP 2,5 at baseline and 12-months. Although CP 3,6 had the highest F value at 6-months, there was not strong evidence to support CP 3,6 over CP 2,5 (BIC difference: 2.9); similarly, CP 3,7 had the highest value at 24-months, but the BIC difference over CP 2,5 was only 2.2. CONCLUSIONS: VAS/NRS scores for pain among adults with burn injury can be categorized as mild (0-2), moderate (3-5), and severe (6-10). These findings advance our understanding regarding the meaning of pain intensity ratings after burn injury, and provide an objective definition for clinical management, quality improvement, and pain research.

Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses.

Lower limb orthoses (LLOs) are externally-applied leg braces that are designed to improve or maintain mobility in people with a variety of health conditions that affect lower limb function. Clinicians and researchers are therefore often motivated to measure LLO users' mobility to select or assess the effectiveness of these devices. Patient-reported outcome measures (PROMs) can provide insights into important aspects of a LLO user's mobility for these purposes. However, few PROMs are available to measure mobility of LLO users. Those few that exist have issues that may limit their clinical or scientific utility. The objective of this study was to create a population-specific item bank for measuring mobility of LLO users. Previously-developed candidate items were administered in a cross-sectional study to a large national sample of LLO users. Responses from study participants (n = 1036) were calibrated to a graded response statistical model using Item Response Theory methods. A set of 39 items was found to be unidimensional, locally independent, and function without bias due to characteristics unrelated to mobility. The set of final calibrated items, termed the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M) item bank, was evaluated for initial evidence of convergent, divergent, and known groups construct validity. OPRO-M was strongly correlated with existing PROMs designed to measure aspects of physical function. Conversely, OPRO-M was weakly correlated with PROMs that measured unrelated constructs, like sleep disturbance and depression. OPRO-M also showed an ability to differentiate groups with expected mobility differences. Two fixed-length short forms were created from the OPRO-M item bank. Items on the short forms were selected based on statistical and clinical criteria. Collectively, results from this study indicate that OPRO-M can effectively measure mobility of LLO users, and OPRO-M short forms can now be recommended for use in routine clinical practice and research studies.

PROMIS-25 Reliability and Validity Among Children Living with Burn Injury: A Burn Model System National Database Study.

This study examined the reliability and validity of the Patient Reported Outcomes Measurement System (PROMIS)-25, a profile instrument consisting of four-item fixed short forms for six health domains, in children living with burn injury. Data were provided by children participating in a multi-center longitudinal study of outcomes after burn injury. Floor and ceiling effects, unidimensionality, internal consistency, reliability, and differential item functioning (DIF) of the PROMIS-25 Profile v.2.0 were examined. Correlations with other established measures were calculated to assess concurrent validity. Children (n = 256) between the ages of 8-18 years with moderate to severe injury provided responses on PROMIS-25 domains. All PROMIS-25 domains showed high internal consistency. Substantial portions of the sample reported no symptoms (anxiety [58.2%], depressive symptoms [54.6%], fatigue [50.8%], pain [60.1%]). There was a large ceiling effect on peer relationships (46.8%) and physical function mobility (57.5%). One-factor confirmatory factor analyses supported unidimensionality for all domains. Reliability was sufficient for group mean comparisons (>0.8) across at least some trait levels for most domains except fatigue and anxiety. No DIF with respect to burn status was detected when comparing the burn sample to the PROMIS pediatric general U.S. population testing sample. These results provide evidence of reliability and validity of PROMIS-25 scores among children living with burn injury. Reliability of domains was low to moderate and would likely be improved, and ceiling effects reduced for some domains, by administering the PROMIS-37, which includes six items per domain.

The Effect of Distance to Treatment Center on Long-Term Outcomes of Burn Patients.

Geospatial proximity to American Burn Association (ABA)-verified burn centers or self-designated burn care facilities varies across the country. This study evaluates the effect of distance to treatment center on long-term, patient-reported outcomes. Data from the Burn Model System (BMS) National Longitudinal Database were analyzed. Demographic and clinical data were compared between three cohorts stratified by distance to BMS center (<20, 20-49.9, ≥50 miles). Distance to BMS center was calculated as driving distance between discharge and BMS center ZIP code centroids. The following patient-reported outcomes, collected at 12-months follow-up, were examined: Veterans RAND 12-Item Health Survey (VR-12), Satisfaction with Life (SWL) scale, employment status, and days to return to work. Mixed model regression analyses were used to examine the associations between distance to BMS center and each outcome, controlling for demographic and clinical variables. Of 726 patients included in this study, 26.3% and 28.1% were <20 and between 20 and 49.9 miles to a BMS center, respectively; 46.6% were ≥50 miles to a BMS center. Greater distance was associated with white/non-Hispanic race/ethnicity, preinjury employment, flame injury, and larger burn size (P < .001). Regression analyses did not identify significant associations between distance to BMS center and any patient-reported outcomes. This study suggests that patients treated at BMS centers have similar long-term, patient-reported outcomes of physical and psychosocial function, as well as employment, despite centralization of burn care and rehabilitation services. Given a steady decline in the incidence of burn injury, continued concentration of key resources is logical and safe.