Abstract Introduction While burn injuries impact physical and mental health as measured by self-reported health outcomes, no known work has identified outcome profiles across multiple physical and mental health domains. This work aims to identify unique classes of outcome profiles in people with burn injuries, compare these classes to those previously identified in adults with chronic conditions, and compare demographic and injury characteristics between classes. Methods Utilizing data from a large, national burn outcome database, a latent profile analysis was conducted to identify unique class profiles at 6 months following discharge across all PROMIS 29 domains, which consists of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. A variety of fit metrics (Bayesian information criterion, entropy, and class size) were used to determine the optimal number of classes. Summary statistics were used to compare patient reported outcomes, demographic, and injury characteristics across classes from the optimum model. Results A total of 894 participants had complete PROMIS-29 data available at 6-months following discharge and were included in the analysis. Although no single model was uniformly superior, a 5-class model was determined most appropriate. The 5 classes correspond to those with very severe outcomes (n = 72), severe outcomes (n = 235), moderate outcomes with worse mental health outcomes(n = 112), moderate outcomes with worse pain (n = 188), and minimally impacted outcomes (n = 287). Conclusions Participants’ scores were generally consistent across PROMIS-29 domains, with severe scores in one domain indicating severe scores across all domains. These classes approximately corresponded to previously identified classes in a general population of adults with chronic conditions. While differences in demographic and injury characteristics between classes were apparent, no uniform trend was present across the severity classes this work identified. Applicability of Research to Practice These findings indicate those with poor outcomes in any one domain likely need support across a wide range of physical and mental health domains. Funding for the study The contents of this manuscript were developed under grants from the National Institute on Disability, Independent Living, and Rehabilitation Research.

The Posttraumatic Growth Inventory (PTGI) was developed to measure positive psychological changes individuals can experience after trauma. While the 10-item form (PTGI-10) is relatively brief, an even shorter version would be valuable in situations where participant response burden is of particular concern. The PTGI-10 was administered to 1076 adults recovering from moderate to severe burn injury between 6 months and 20 years after injury as part of an ongoing longitudinal study. Analyses completed to inform item selection included classical test theory analyses of reliability (ie, Cronbach's alpha) and item performance, item response theory analyses, and qualitative item review. A focus group selected items for a new short form while considering results of the analyses as well as item content and acceptability. Score agreement between the PTGI-10 and the newly created short form was examined. A confirmatory factor analysis supported unidimensionality; however, reliability (α = 0.94) and results of local dependency indicated items were highly redundant. A new 3-item short form (PTGI-3) was created and includes 1 item from each of the 3 categories of perceived benefits identified in posttraumatic growth theory. Reliability of the new short form is moderate (>0.8) for scores ±1 SD around the mean. Scores on the PTGI-3 correlate highly (r = 0.94) with scores on the PTGI-10. The PTGI-3 has sufficient reliability for group comparisons, balances item content, and includes items that are acceptable to people with burn injury.

Introduction The National Trauma Research Repository (NTRR) serves as the central warehouse for trauma clinical research data that result from military and civilian trauma research. An effort to enhance the NTRR was undertaken through the identification and integration of common data elements (CDEs). CDEs will improve usability for primary investigators and allow for enhanced secondary analysis and combing of NTRR archived studies. A consensus-driven approach was used to review established data elements and recommend trauma basic CDEs for the outcomes and rehabilitation environments of care for inclusion in the NTRR data dictionary.Methods A multidisciplinary workgroup located and reviewed data dictionaries, codebooks, data collection forms, and published articles for outcome measurement instruments and individual outcome and rehabilitation data elements. Three rounds of a Delphi Survey were completed, and monthly meetings with the workgroup were conducted. Consensus during the Delphi Survey was identified with an 80% agreement threshold.Results Fifteen sources were reviewed for outcome measurement instruments, 39 measurement instruments were presented for consideration in the Delphi Survey, and 12 instruments (28%) reached consensus for inclusion in the NTRR data dictionary. Seventeen sources were reviewed for individual outcome data elements, 55 data elements were included in the Delphi Survey, and 45 data elements reached consensus for inclusion. Eleven sources were reviewed for rehabilitation data elements. Of the 41 rehabilitation data elements identified and included in the Delphi, 17 data elements reached consensus for inclusion.Discussion This workgroup selected outcome measurement instruments, outcome CDEs, and rehabilitation CDEs for inclusion in the NTRR data dictionary as basic CDEs. Next steps include disseminating these elements, integrating their use in trauma studies, and tracking the use and usability of these instruments and CDEs.Level of evidence VII.

The Posttraumatic Growth Inventory (PTGI) was developed to measure the positive psychological changes that individuals can experience after trauma. The original scale contained 21 items measuring three categories of perceived benefits based on posttraumatic growth theory: changes in self-perception, interpersonal relationships, and philosophy of life. Prior research identified five data derived subfactors, which were used to create a 10-item short form (two items each). While the 10-item form is relatively brief, an even shorter version was desired to reduce participant response burden. Thus, the aim of this study was to create a briefer version of the PTGI using item response theory (IRT) that can detect group differences (i.e. reliability >0.8) and is suitable for use in individuals with burn injury. The 10-item PTGI was administered to 1,076 adults recovering from moderate to severe burn injury between 6-months and 20-years after injury as part of an ongoing longitudinal study. Items were fit to Samejima’s graded response model if unidimensionality was supported by a 1-factor confirmatory factor analysis (CFA). Local dependance (LD) was examined using the X2 statistic in IRTPRO software. A focus group of burn clinicians, data collectors, and psychometricians selected items for a new short form while considering item content, acceptability, and reliability. CFA confirmed unidimensionality, but LD results indicated that items were highly redundant. A new three item short form was created and includes one item from each of the three categories of perceived benefits identified in posttraumatic growth theory. Reliability of the new short form is moderate (>0.8) for scores ±1 SD around the mean (figure 1). Raw summary scores on the new 3-item short form correlate highly (r=0.94) with summary scores on the 10-item short form. The new 3-item short form (figure 2) of the PTGI has reliability sufficient for group comparisons and summary scores correlate highly with the 10-item version. The new short form balances item content and items are acceptable to people with burn injury. This short form represents less burden to patients and can be used to assess posttraumatic growth in a clinic or research setting. N/A

Depression and anxiety are common after burn injury. Psychological interventions are a key component in managing these mental health challenges. However, utilization of such interventions in the burn population is underexplored. Thus, this study aims to examine the association between psychological symptom severity and treatment utilization. The data of adult burn survivors from a multicenter longitudinal database from 2006 to 2024 were analyzed. The study sample was divided into two groups: minimal or no anxiety or depression symptoms (PROMIS Anxiety and Depression T < 60) and moderate to severe depression or anxiety symptoms (T ≥60) at 12 months. For between group comparisons, Wilcoxon-Mann-Whitney tests were applied for continuous variables, while Chi-square and Fisher’s exact tests were used for categorical variables. Logistic regression models assessed if psychological symptom severity was associated with receiving psychological interventions (psychological services at home or outpatient; psychological therapy or counseling; medication for pain, anxiety, or depression) at 12 months, controlling for demographic and clinical variables. Out of 669 burn survivors assessed for symptoms of anxiety or depression at 12-months after injury, those in the moderate-to-severe symptom group (n=154), compared to the minimal symptom group (n=515), were younger (mean age 43 vs 49), female (72% vs 56%), unemployed at time of injury (30% vs 13%), single (70% vs 45%), have Medicaid insurance (28% vs 13%) and have a pre-injury psychiatric diagnosis (41% vs. 21%). The moderate-to-severe symptom group reported higher use of medication for pain, anxiety, or depression (89% vs. 63%), psychological therapy/counseling (34% vs. 12%) and home/outpatient psychological services (21% vs. 6%) at 12 months (p≤0.001 for all comparisons). Logistic regression analysis revealed that individuals with more severe symptoms were 171% more likely to receive psychological interventions at 12 months (p< 0.001). Additionally, those with larger burns had a 274% higher likelihood, and individuals treated at ‘Site 6’ were 321% more likely to receive these interventions (p< 0.001). Compared to those with no or mild symptoms, individuals with moderate or severe anxiety or depression symptoms were more likely to receive psychological interventions. Future work may examine the impact of treatment on those at high risk. This research emphasizes the importance of screening for anxiety and depression to ensure appropriate interventions are offered to individuals based on symptoms severity. NIDILRR #90DPBU0008, 90DPGE0004

The value of engaging people with lived experience into chronic pain research is becoming increasingly recognized, yet the perspectives of individuals with chronic pain who have not previously participated in research are underexplored. This study aims to fill this gap by assessing the attitudes, preferences, and barriers related to patient engagement among adults living with chronic pain in the United States (US). An online survey was developed in collaboration with an advisory board and community engagement studio and distributed through Qualtrics panels from December 2023-January 2024. Quotas for age, gender, and race were employed to reach a representative sample for each of these variables based on the 2020 US census.1,2 Of the 505 participants, 267 reported chronic low back pain (53%) and 144 had headaches or migraines (22%). A majority (65%-79%) were familiar with medical research, and 64% (n = 327) expressed interest in engaging as patient partners. Key facilitators for engagement included the desire to help others and learn about their condition, while compensation was also an important motivator. Barriers were time constraints, lack of payment, and worry about privacy. Younger participants (Chi-square p = 0.04) and those with higher education (Chi-square p = 0.01) were more likely to express interest in research partnerships. Strategies to enhance patient engagement should focus on reducing barriers and providing clear, meaningful opportunities for engagement, potentially increasing both recruitment and retention in chronic pain research. Future research should explore these dynamics further and consider international perspectives to develop comprehensive patient engagement strategies. PERSPECTIVE: This study surveys over 500 individuals with chronic pain to understand their attitudes towards engagement in clinical pain research. It identifies key facilitators and barriers, such as time constraints and low compensation, and aims to refine strategies to enhance patient partner engagement and representation in clinical pain research.

Abstract Introduction Health disparities associated with racial and ethnic minoritized status as well as sex are well documented in burn survivors. Specifically, previous work has found that people from racial and ethnic minority backgrounds as well as females tend to have lower satisfaction with appearance after injury1,2. However, the impact of the intersection between race/ethnicity and sex outside their individual effects has not been well studied. This study aims to assess: 1) the independent association between race/ethnicity and sex with body image, as measured using the Burn Specific Health Scale body image subscale (BSHS-BI), with higher scores corresponding to a better outcome; and 2) test if the association between sex and BSHS-BI differs by survivors’ race/ethnicity. Methods Adult participants enrolled in a large longitudinal study who had at least one BSHS-BI score and complete race/ethnicity, sex, age, and total burn surface area (TBSA) data were included. Race/ethnicity and sex were obtained through a combination of self-report and electronic health records. Due to sample size restrictions, race/ethnicity was categorized as White, non-Hispanic; Hispanic; or other, non-Hispanic. A linear mixed effects model was used to analyze the effects of race/ethnicity and sex after adjusting for age, TBSA, and follow-up time. A second linear mixed effects model was used to analyze the interaction between race/ethnicity and sex to determine if race modifies the association between sex and BSHS-BI. Results Data from 1,191 participants with injuries from 1996 to 2021 were included in the final analysis. The study sample was796 (66.8%) male, 398 (33.2%) female, 869 (73.0%) White, non-Hispanic, 145 (12.2%) Hispanic, and 177 (14.9%) other, non-Hispanic. The mean age was 43 (standard deviation (SD) = 17) and mean TBSA was 21 (SD = 44). After adjusting for age, TBSA, and follow-up time, mean BSHS-BI score for females was significantly lower than males (0.62 points lower; p < 0.001) and those identifying as Hispanic had mean scores 0.32 (p=.002) higher than White, non-Hispanic and 0.41 (p=0.02) higher than other, non-Hispanic. No significant differences in BSHS-BI were found between White, non-Hispanic and other, non-Hispanic groups. There was no evidence that the association between sex and BSHS-BI differed by race/ethnicity. Conclusions Those who self-identified as male and Hispanic had significantly better BSHS-BI scores; however, there was no evidence that the intersection between sex and race/ethnicity was associated with BSHS-BI after accounting for individual sex and race/ethnicity effects. Applicability of Research to Practice Consistent with previous research, the results suggest that sex and race/ethnicity are important characteristics to consider when addressing body image changes after burn injury.

WHAT IS THIS SUMMARY ABOUT?:This summary describes how researchers worked with people with multiple sclerosis (MS), neurologists and measurement experts to create an easy-to-use questionnaire to measure the physical function of people with MS. This questionnaire covers topics that are relevant and important to people with MS and their doctors.The ability to do what you want to do, when you want to do it, is one of the most important concerns for people with MS. This questionnaire could help doctors to record and manage how much MS affects people's lives.MS can bring a range of challenging symptoms such as 'brain fog', tiredness, and problems with movement and balance. Many of these symptoms can make day-to-day activities, like working, very difficult for people with MS. Doctors currently use examinations like the Expanded Disability Status Scale (EDSS) and the MS Functional Composite (MSFC), but these do not fully consider what is important to people living with MS. A questionnaire that specifically measures physical functioning of people with MS could help doctors and people with MS to better understand, communicate and manage the physical effects of MS. In this study, people with MS were asked to help create a questionnaire about physical function that reflects topics that are important to them. WHAT WERE THE RESULTS?:The PROMIS®nq physical function - Multiple Sclerosis 15a (the PROMIS® PF MS questionnaire) was successfully created with the help of people with MS. People with MS thought that the PROMIS® PF MS questionnaire covered issues important to their physical function. Scores were in line with results of other physical symptom measurement scales like the EDSS. WHAT DO THE RESULTS MEAN?:The PROMIS® PF MS questionnaire could be used to meaningfully record physical function among people with MS.

What is this summary about? This summary explains the findings of a recent study that compared different questionnaires used by doctors to measure levels of fatigue in people with multiple sclerosis (MS). The aim of the study was to find out which questionnaire doctors should use to measure fatigue in people with MS in the future. Fatigue, which can be described as the overwhelming feeling of tiredness or exhaustion, is a very common symptom of MS. For the majority of people with MS, fatigue is one of the worst symptoms of MS, so it is essential that doctors can measure it accurately. Currently, people with MS are asked to complete questionnaires so that their care team can see the effect of fatigue on their day-to-day lives. There are many questionnaires that are used to measure fatigue in people with MS. It would be valuable to come to an agreement, based on evidence from research like this study, on which questionnaire is the most appropriate for measuring fatigue in both research and healthcare settings. This study compared a questionnaire called the PROMIS® Fatigue (MS) 8a, referred to throughout this summary as the PROMIS® MS Fatigue Short Form, with two of the most commonly used questionnaires: the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). The questionnaires were compared to see which one should be recommended to doctors for measuring fatigue in people with MS. What are the key takeaways? It was found that while all three questionnaires were good, the PROMIS® MS Fatigue Short Form questionnaire was better than the other two questionnaires at showing differences in levels of fatigue between people with MS. The PROMIS® MS Fatigue Short Form was also found to be better than the Fatigue Severity Scale (FSS) at showing changes in the person with MS's level of fatigue. The PROMIS® MS Fatigue Short Form questionnaire may help people with MS to better communicate challenges with their fatigue to their doctors. What was the main conclusion reported by the researchers? The study suggests that the PROMIS® MS Fatigue Short Form questionnaire is a helpful tool for doctors and people with MS to measure fatigue.

Abstract Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.

Research ObjectivesTo describe the Burn Model System (BMS) National Longitudinal Database.DesignThe BMS is a long-term multi-center project that has been collecting data on the long-term outcomes of burn survivors for almost thirty years.SettingFour comprehensive, multidisciplinary burn injury centers contribute data at any one time to the database; current centers are located in Boston, Massachusetts, Dallas, Texas, Los Angeles, California, and Seattle, Washington.ParticipantsAdults and children with serious burn injury alive at hospital discharge.InterventionsN/A.Main Outcome MeasuresSurveys are filled out to collect self-report information about mental and physical health, rehabilitation services, depression, sleep, distress, and community participation. Data has been collected at six months, twelve months, and twenty-four months post-injury since 1994. In 2015, data collection expanded to include surveys every five years for the lifespan of the participant. Health measures included have varied over time but data collection has always included the domains of burn injury details, demographics, overall health related quality of life, employment, social integration, drug and alcohol abuse, and pain.ResultsA total of 7,049 people have consented to provide data. Mean age of participants in the database is 31.4 years, and 70.8% are male. 71.9% of the participants were White and 27.2% were Hispanic. For all participants, mean total body surface area burned was 23%.ConclusionsA rich database describing recovery and functioning after burn injury is available to any researchers to investigate questions related to long-term outcomes of burn survivors. The process of accessing data is easy and brief and technical support is available to guide interested investigators in accessing and interpreting the data. The BMS represents an extensive effort to understand the needs of burn survivors and their long-term rehabilitation outcomes in the areas of health and function, community living, participation and employment.Author(s) DisclosuresThis project was supported in part by grant number 90DPGE0004 from the U.S. Administration for Community Living. Authors have nothing else to disclose.

ImportanceTest accuracy studies often use small datasets to simultaneously select an optimal cutoff score that maximizes test accuracy and generate accuracy estimates.ObjectiveTo evaluate the degree to which using data-driven methods to simultaneously select an optimal Patient Health Questionnaire-9 (PHQ-9) cutoff score and estimate accuracy yields (1) optimal cutoff scores that differ from the population-level optimal cutoff score and (2) biased accuracy estimates.Design, Setting, and ParticipantsThis study used cross-sectional data from an existing individual participant data meta-analysis (IPDMA) database on PHQ-9 screening accuracy to represent a hypothetical population. Studies in the IPDMA database compared participant PHQ-9 scores with a major depression classification. From the IPDMA population, 1000 studies of 100, 200, 500, and 1000 participants each were resampled.Main Outcomes and MeasuresFor the full IPDMA population and each simulated study, an optimal cutoff score was selected by maximizing the Youden index. Accuracy estimates for optimal cutoff scores in simulated studies were compared with accuracy in the full population.ResultsThe IPDMA database included 100 primary studies with 44 503 participants (4541 [10%] cases of major depression). The population-level optimal cutoff score was 8 or higher. Optimal cutoff scores in simulated studies ranged from 2 or higher to 21 or higher in samples of 100 participants and 5 or higher to 11 or higher in samples of 1000 participants. The percentage of simulated studies that identified the true optimal cutoff score of 8 or higher was 17% for samples of 100 participants and 33% for samples of 1000 participants. Compared with estimates for a cutoff score of 8 or higher in the population, sensitivity was overestimated by 6.4 (95% CI, 5.7-7.1) percentage points in samples of 100 participants, 4.9 (95% CI, 4.3-5.5) percentage points in samples of 200 participants, 2.2 (95% CI, 1.8-2.6) percentage points in samples of 500 participants, and 1.8 (95% CI, 1.5-2.1) percentage points in samples of 1000 participants. Specificity was within 1 percentage point across sample sizes.Conclusions and RelevanceThis study of cross-sectional data found that optimal cutoff scores and accuracy estimates differed substantially from population values when data-driven methods were used to simultaneously identify an optimal cutoff score and estimate accuracy. Users of diagnostic accuracy evidence should evaluate studies of accuracy with caution and ensure that cutoff score recommendations are based on adequately powered research or well-conducted meta-analyses.

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.

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.

BACKGROUND:Orthoses are often prescribed to improve mobility of people with chronic health conditions that affect lower limb function. Patient-reported survey instruments can be used to measure aspects of mobility that cannot be easily assessed in clinical or research settings. A population-specific item bank could be designed to measure aspects of mobility that are most important to lower limb orthosis users and used to evaluate the effects of orthoses.OBJECTIVE:To develop items for a new survey instrument to measure mobility of lower limb orthosis users.DESIGN:Survey items were developed using a qualitative item review process.SETTING:Focus groups were held by video conferencing. Cognitive interviews were conducted by telephone.PARTICIPANTS:Focus group and cognitive interview participants were adults with at least 6 months of experience using a lower limb orthosis that extended from the foot to a level above the ankle.METHODS:Research methods included focus groups with lower limb orthosis users, an item generation and reduction process that involved a stakeholder advisory panel, and cognitive interviews with target respondents.RESULTS:A total of 1180 extant items were identified in a literature review. Focus group participants (n = 29) provided feedback that informed the suitability of a construct definition and conceptual model. An advisory panel contributed to the selection of 118 candidate items for measuring orthotic mobility. Feedback from cognitive interview participants (n = 30) informed removal or revision of problematic items, resulting in a candidate bank of 100 mobility items.CONCLUSIONS:The rigorous qualitative methods applied here resulted in a large set of candidate items that spanned a range of situations relevant to moving with a lower limb orthosis. Next steps include administration of the candidate items to a large sample of lower limb orthosis users and calibration of the item bank.

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.