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 multi-center 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 months after injury. Regression analyses examined associations between pain medication use and outcomes at 12 months, adjusting for demographics, burn size, length of hospital stay, and pre-injury pain medication use and employment status. Outcomes included VR-12 Physical and Mental Component Summary scores (PCS and MCS), Patient-Reported Outcomes Measurement Information System (PROMIS-29) Anxiety and Depression scores, Satisfaction with Life Scale (SWLS), and employment status. RESULTS: Of 358 participants analyzed, prescription pain medication use was associated with worse outcomes at 12 months: PCS (ß = -7.11, p < 0.001), MCS (ß = -6.01, p < 0.001), and PROMIS-29 Depression (ß = 4.88, p < 0.001) and Anxiety (ß = 6.16, p < 0.001). SWLS 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 months (p = 0.035). CONCLUSION: There is a significant association between prescription pain medication use and worse physical, mental, and employment outcomes at 12 months after burn injury.

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.

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.

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.

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.

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.

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.

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.

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.

Validation of PROMIS-29 domain scores among adult burn survivors: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

BACKGROUND: Patient-reported outcomes are important for understanding recovery after burn injury, benchmarking service delivery and measuring the impact of interventions. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 domains have been validated for use among diverse populations though not among burn survivors. The purpose of this study was to examine validity and reliability of PROMIS-29 scores in this population. METHODS: The PROMIS-29 scores of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference were evaluated for validity and reliability in adult burn survivors. Unidimensionality, floor and ceiling effects, internal consistency, and reliability were examined. Differential item functioning was used to examine bias with respect to demographic and injury characteristics. Correlations with measures of related constructs (Community Integration Questionnaire, Satisfaction with Life Scale, Post-Traumatic Stress Checklist-Civilian, and Veteran's Rand-12) and known-group differences were examined. RESULTS: Eight hundred and seventy-six burn survivors with moderate to severe injury from 6 months to 20 years postburn provided responses on PROMIS-29 domains. Participants' ages ranged from 18 years to 93 years at time of assessment; mean years since injury was 3.4. All PROMIS domain scores showed high internal consistency (Cronbach's α = 0.87-0.97). There was a large ceiling effect on ability to participate in social roles (39.7%) and physical function (43.3%). One-factor confirmatory factor analyses supported unidimensionality (all comparative fit indices >0.95). We found no statistically significant bias (differential item functioning). Reliability was high (>0.9) across trait levels for all domains except sleep, which reached moderate reliability (>0.85). All known-group differences by demographic and clinical characteristics were in the hypothesized direction and magnitude except burn size categories. CONCLUSION: The results provide strong evidence for reliability and validity of PROMIS-29 domain scores among adult burn survivors. Reliability of the extreme scores could be increased and the ceiling effects reduced by administering PROMIS-43, which includes six items per domain, or by administering by computerized adaptive testing. LEVEL OF EVIDENCE: Diagnostic Test or Criteria, level III.

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.

Evaluation of the Psychometric Properties of the Burn Specific Health Scale-Brief: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

The Burn Specific Health Scale-Brief (BSHS-B) is a commonly used burn-specific health outcome measure that includes 40 items across nine subscales. The objective of this study was to use both classical and modern psychometric methods to evaluate psychometric properties of the BSHS-B. Data were collected postburn injury by a multisite federally funded project tracking long-term outcomes. We examined dimensionality, local dependence, item fit, and functioning of response categories, homogeneity, and floor and ceiling effects. Items were fit to Item Response Theory models for evaluation. A total of 653 adults with burn injury completed the BSHS-B. Factor analyses supported unidimensionality for all subscales, but not for a total score based on all 40 items. All nine of the subscales had significant ceiling effects. Six item pairs displayed local dependence suggesting redundance and 11 items did not fit the Item Response Theory models. At least 15 items have too many response options. Results identified numerous psychometric issues with the BSHS-B. A single summary score should never be used for any purpose. Psychometric properties of the scale need to be improved by removing redundant items, reducing response categories, and modifying or deleting problematic items. Additional conceptual work is needed to, at a minimum, revise the work subscale and optimally to revisit and clearly define the constructs measured by all the subscales. Additional items are needed to address ceiling effects.

Translation and cultural validation of the University of Washington Caregiver Stress and Benefit Scales.

BACKGROUND: English versions of the University of Washington Caregiver Stress (UW-CSS) and Benefit (UW-CBS) Scales were developed in the United States (US) to measure impact on caregivers of caring for a child/children. Caregiving stress and benefit are important constructs to study worldwide. The purpose of this study was to translate and validate the UW-CSS and UW-CBS into French, German, Italian, and Spanish languages. METHOD: UW-CSS and UW-CBS were translated using forward and backward translation with reconciliation. Cognitive interviews (CIs) were completed with caregivers of children < 18 years with severe epilepsy. Translated versions were also administered to at least 100 caregivers in each of the four countries: France, Germany, Italy, and Spain. Differential item functioning (DIF) analyses were used to assess linguistic and cultural bias by country. The US development sample of 722 caregivers was used as a comparison sample for DIF analyses. DIF adjusted scores were calculated to determine impact of DIF on the item response theory (IRT)-based T-score. Benefit and stress scores were also calculated and compared across countries and health condition subgroups. Finally, short forms were modified to minimize the impact of DIF on the UW-CSS and UW-CBS T-scores and to reflect feedback from CIs. RESULTS: Interviews were completed with 47 caregivers (German n = 14; Spanish n = 10; French n = 13; Italian n = 10). UW-CSS and UW-CBS were administered to 456 (German n = 117, Spanish n = 114, French n = 115, Italian n = 110) caregivers of children with and without health conditions. All stress items functioned well in CIs, though results indicated statistically significant DIF for three items in multiple countries and in the overall sample. Four of the 13 benefit items were problematic based on CI feedback, and six items showed DIF in one or more countries or in the combined sample. However, average differences between DIF adjusted and non-adjusted scores were minimal for both scales and all comparisons, indicating the impact of DIF on the total score was negligible. CONCLUSION: Modified short forms functioned well in all four of the translated versions. All language versions are freely publicly available.

Linking scores on the 4- and 5-item versions of the Satisfaction with Life Scale in people with traumatic brain, spinal cord, or burn injury: a National Institute on Disability, Independent Living, and Rehabilitation Research Model System study.

BACKGROUND: The Satisfaction with Life Scale (SWLS) is a widely used measure of subjective well-being. Recent evidence indicates the fifth item of the scale reduces the reliability of the scale and is inappropriate for use in traumatic injury populations. The purpose of this study was to develop a linking procedure between the five-item version of the SWLS and a modified four-item version, which removes the problematic item, for use in Spinal Cord (SCI), Traumatic Brain (TBI), and Burn Injury populations. METHODS: Proration (i.e. adding the mean of the four items to their total) was identified as a potential linking solution that could be easily implemented in clinical or research settings. The validity of the proration approach was evaluated by examining mean differences, cross group classification by SWLS category, score correlations, the intraclass correlation coefficient, and visual inspection of Bland-Altman plots in a large sample of SCI, TBI, and Burn Injury survivors who were participants in the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) Model Systems' National Databases. RESULTS: A total of 17,897 (SCI n = 8566, TBI n = 7941, and Burn n = 1390) participants were included in this study. SWLS scores ranged from 5 to 35, and the average score difference between directly derived and prorated scores was 0.39 points. A large majority of the sample (93%) had score differences of < 4 points (i.e. approximately 0.5 SD). The correlation between the prorated and directly derived scores was very high (r = 0.97) and the ICC value indicated excellent reliability (ICC = 0.97). CONCLUSIONS: This study provides a valid scoring approach for researchers or clinicians who don't want to lose continuity with previously collected data but prefer to switch to the modified four-item version of the SWLS. Clear guidance is provided for traumatic injury researchers or clinicians on how to implement the proration scoring approach.

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.

Validation of the Communicative Participation Item Bank as an Outcome Measure for Spasmodic Dysphonia.

OBJECTIVES: Current patient-reported outcome measures do not adequately capture the impact of spasmodic dysphonia (SD) on communication in daily life situations. The aim of this study was to validate the Communicative Participation Item Bank (CPIB), which specifically measures a disease's impact on daily conversational situations, as an outcome measure for SD. STUDY DESIGN: Multi-institutional prospective cohort study. METHODS: A prospective study was conducted with administration of the 46-question CPIB and the Voice Handicap Index-10 (VHI-10) to 190 participants with SD before (time 1) and 6 weeks after (time 2) botulinum toxin injection. Differential item function (DIF) analyses were performed to examine potential item bias. Paired t-tests were used to assess change in each of the CPIB and VHI-10 scores after treatment. Pearson correlations were calculated between the CPIB and VHI-10. RESULTS: DIF analyses revealed no clinically meaningful difference between the item parameters generated for this SD sample and the original CPIB calibration sample. There were statistically significant changes between the pre-treatment and post-treatment time points for both the CPIB and VHI-10. Correlations between the CPIB and VHI were moderate-high. CONCLUSIONS: The CPIB item bank, General Short Form, and scoring parameters can be used with people with SD for valid and reliable measurement of the impact of communication disorders on communication in everyday life. The CPIB is sensitive to changes with intervention, proving useful for clinical and research purposes to assess the efficacy and effectiveness of interventions. LEVEL OF EVIDENCE: Level 2, prospective observational research with an experimental design (ie, cohort study). Laryngoscope, 131:859-864, 2021.

Development of Proxy and Self-report Burn Model System Pediatric Itch Interference Scales: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

Pruritus is a commonly reported symptom after burn injury. Valid and reliable scales to measure itch in pediatric burn survivors are important for treatment and epidemiological studies. This study sought to develop psychometrically sound, publicly available self- and proxy-report measures of itch for use in pediatric burn survivors suitable for use in research and clinical practice. A panel of burn experts developed a definition of itch interference and a set of parallel self- and proxy-report candidate items that covered important activities affected by itch. Candidate items were evaluated in cognitive interviews with pediatric burn survivors (n = 4) and proxies (n = 2). Items were translated to Spanish and administered in both English and Spanish to a sample (N = 264) of pediatric burn survivors and/or their proxy enrolled in the Burn Model System (BMS) longitudinal database. The mean age of the pediatric sample was 13 years and average time since burn 5 years. The final itch interference measures each included 5 parallel items calibrated using a one-parameter graded response item response theory model, with a mean of 50 representing the average itch interference of the sample. Reliability of the scores is excellent between the mean and two standard deviations above. Initial analyses provide support for validity of the score. Concordance between the self- and proxy-report scores was moderate (ICC = 0.68). The results support the reliability and validity of the itch scale in children and youth with burn injury. The new BMS Pediatric Itch Interference scales are freely and publicly available at https://burndata.washington.edu/itch.

Inhalation injury is associated with long-term employment outcomes in the burn population: Findings from a cross-sectional examination of the Burn Model System National Database.

INTRODUCTION: Inhalation injuries carry significant acute care burden including prolonged ventilator days and length of stay. However, few studies have examined post-acute outcomes of inhalation injury survivors. This study compares the long-term outcomes of burn survivors with and without inhalation injury. METHODS: Data collected by the Burn Model System National Database from 1993 to 2019 were analyzed. Demographic and clinical characteristics for adult burn survivors with and without inhalation injury were examined. Outcomes included employment status, Short Form-12/Veterans Rand-12 Physical Composite Score (SF-12/VR-12 PCS), Short Form-12/Veterans Rand-12 Mental Composite Score (SF-12/VR-12 MCS), and Satisfaction With Life Scale (SWLS) at 24 months post-injury. Regression models were used to assess the impacts of sociodemographic and clinical covariates on long-term outcome measures. All models controlled for demographic and clinical characteristics. RESULTS: Data from 1,871 individuals were analyzed (208 with inhalation injury; 1,663 without inhalation injury). The inhalation injury population had a median age of 40.1 years, 68.8% were male, and 69% were White, non-Hispanic. Individuals that sustained an inhalation injury had larger burn size, more operations, and longer lengths of hospital stay (p<0.001). Individuals with inhalation injury were less likely to be employed at 24 months post-injury compared to survivors without inhalation injury (OR = 0.63, p = 0.028). There were no significant differences in PCS, MCS, or SWLS scores between groups in adjusted regression analyses. CONCLUSIONS: Burn survivors with inhalation injury were significantly less likely to be employed at 24 months post-injury compared to survivors without inhalation injury. However, other health-related quality of life outcomes were similar between groups. This study suggests distinct long-term outcomes in adult burn survivors with inhalation injury which may inform future resource allocation and treatment paradigms.

The Concerns About Pain (CAP) Scale: A Patient-Reported Outcome Measure of Pain Catastrophizing.

Pain catastrophizing has been recognized as an important and consistent psychosocial predictor of nearly every key pain-related outcome. The purpose of this study was to develop a new measure of pain catastrophizing using modern psychometric methodology. People with chronic pain (N = 795) responded to thirty items. Data were analyzed using item response theory, including assessment of differential item functioning and reliability. Sensitivity to change and validity were examined using data collected from patients undergoing spinal fusion surgery (n = 184) and participating in an ongoing longitudinal aging with a disability survey study (n = 1,388). The final 24-item bank had no items with significant local dependence, misfit, or differential item functioning. Results provided strong evidence of reliability and validity. Six- and 2-item short forms were developed for use when computer adaptive testing is not feasible or desirable. The item bank was named the University of Washington Concerns About Pain scale because the term "catastrophizing" was considered stigmatizing by people with chronic pain. Guidance for score interpretation was developed with extensive feedback from individuals with chronic pain. The Concerns About Pain item bank, short forms, and user manuals are free and publicly available to all users and can be accessed online at https://uwcorr.washington.edu/measures/. PERSPECTIVE: This article presents the development of the University of Washington Concerns About Pain scale, the first item response theory-based item bank of pain catastrophizing. The measure is intended for clinicians interested in improving outcomes of patients with chronic pain and for researchers who study impact of and treatment interventions aimed at reducing pain catastrophizing.