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.

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.

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.

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.].

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.

Posttraumatic Stress Disorder Symptom Clusters as Predictors of Pain Interference in Burn Survivors: A Burn Model System National Database Study.

Individuals who experience burns are at higher risk of developing posttraumatic stress disorder and chronic pain. A synergistic relationship exists between posttraumatic stress disorder and chronic pain. We sought to evaluate the role of individual posttraumatic stress disorder symptom clusters as predictors of pain interference. We hypothesized that the hyperarousal and emotional numbing symptom clusters would be predictive of pain interference, even when accounting for the other two posttraumatic stress disorder symptom clusters, pain intensity, and other covariates. Multivariate linear regression analyses were completed using data from the Burn Model System National Database. A total of 439 adult participants had complete responses on self-report measures assessing posttraumatic stress disorder symptoms, pain intensity, and pain interference at 6-month after discharge and were included in analyses. Results indicate hyperarousal (B = .10, p = .03) and emotional numbing (B = .13, p = .01) posttraumatic stress disorder symptom clusters were each significantly associated with pain interference, even when accounting for pain intensity (B = .64, p < .001). Results highlight the importance of the emotional numbing and hyperarousal posttraumatic stress disorder symptom clusters in explaining pain interference. Findings suggest that when posttraumatic stress disorder symptoms or chronic pain are present, screening for and treating either condition may be warranted to reduce pain interference. Further, psychological interventions that target emotional numbing and hyperarousal posttraumatic stress disorder symptoms may be fruitful for promoting better coping with chronic pain and reducing pain interference.

Development of an item bank for measuring prosthetic mobility in people with lower limb amputation: The Prosthetic Limb Users Survey of Mobility (PLUS-M).

BACKGROUND: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research. OBJECTIVE: To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility. DESIGN: A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity. SETTING: Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings. PARTICIPANTS: Adult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Candidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents. RESULTS: A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility. CONCLUSION: The PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

A PROMIS fatigue short form for use by individuals who have multiple sclerosis.

PURPOSE: To derive from the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue item bank, a short form for individuals with multiple sclerosis (MS), the PROMIS-Fatigue(MS). METHODS: A panel of 37 clinicians and 46 individuals with MS ranked the relevance of PROMIS fatigue items to persons with MS. Eight items were selected for the PROMIS-Fatigue(MS) that maximized relevance rankings, content coverage, and item discrimination. The PROMIS-Fatigue(MS) and an existing, 7-item PROMIS fatigue short form (PROMIS-Fatigue(SFv1.0)) were administered to a new sample of 231 individuals with MS. Known groups and content validity were assessed. RESULTS: Scores from the short forms were highly correlated (r = 0.92). Discriminant validity of the PROMIS-Fatigue(MS) scores was supported in known groups comparisons. Scores of neither short form exhibited an advantage in quantitative analyses. The PROMIS-Fatigue(MS) targeted more of the content included in participants' responses to open-ended questions than did the PROMIS-Fatigue(SFv1.0). CONCLUSIONS: The PROMIS-Fatigue(MS) was derived to have content validity in MS samples. The validity of the measure was further supported by the ability of PROMIS-Fatigue(MS) items to discriminate among groups expected to differ in levels of fatigue. We recommend its use in measuring the fatigue of individuals with MS.

Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form.

PURPOSE: To create cross-walk tables to associate scores for the Modified Fatigue Impact Scale (MFIS) with scores for the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) in persons with Multiple Sclerosis (MS). METHODS: Cross-walk tables were created using equipercentile linking and based on data collected at one time point in a longitudinal study of persons with MS (N = 458). Validation of the tables was conducted using data collected at a subsequent time point (N = 444). Deviations between estimates and actual scores were compared across levels of fatigue. The impact of sample size on the precision of sample mean estimates was evaluated using bootstrapping. RESULTS: Correlations between deviations and fatigue level for the PROMIS Fatigue SF and MFIS were (-0.31) and (-0.30), respectively, indicating moderately greater deviations with lower fatigue scores. Estimated sample means were impacted by sample size. CONCLUSIONS: Cross-walk tables allow data from studies using different measures of fatigue to be combined to achieve larger sample sizes and to compare results. These tables are valid for group-level analyses with sample sizes of 150 or greater.

Six patient-reported outcome measurement information system short form measures have negligible age- or diagnosis-related differential item functioning in individuals with disabilities.

OBJECTIVE: To evaluate the measurement invariance of 6 self-report measures selected for an ongoing longitudinal study of individuals with spinal cord injury, muscular dystrophy, postpolio syndrome, and multiple sclerosis. DESIGN: Participants completed and returned by mail surveys that included the targeted self-report measures. Ordinal logistic regressions methods were applied to evaluate items for differential item functioning (DIF) by diagnosis and age range. SETTING: Community. PARTICIPANTS: Participants (N=2479) who had 1 of the 4 target diagnoses. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Six short-form measures from the Patient-Reported Outcome Measurement Information System (PROMIS) were administered to participants to measure fatigue, pain interference, satisfaction with social roles, sleep disturbance, sleep-related impairment, and depression. RESULTS: One item of 1 measure (fatigue) exhibited DIF by diagnosis based on a published standard for meaningful DIF. However, scores corrected for this DIF were highly correlated with uncorrected scores (r>.999). No DIF by age range was found for any of the measures. CONCLUSIONS: Study findings support the use of the selected PROMIS short forms for comparing symptoms and quality of life indicators across different diagnoses and age ranges.