Data-driven characterization of traumatic brain injury severity from clinical, neuroimaging, and blood-based indicators.

The conventional clinical approach to characterizing traumatic brain injuries (TBIs) as mild, moderate, or severe using the Glasgow Coma Scale (GCS) total score has well-known limitations, prompting calls for more sophisticated strategies to characterize TBI. Here, we use item response theory (IRT) to develop a novel method for quantifying TBI severity that incorporates neuroimaging and blood-based biomarkers along with clinical measures. Within the multicenter Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study sample (N = 2545), we show that a set of 23 clinical, head computed tomography (CT), and blood-based biomarker variables familiar to clinicians and researchers index a common latent continuum of TBI severity. We illustrate how IRT can be used to identify the relative value of these features to estimate an individual's position along the TBI severity continuum. Finally, we show that TBI severity scores generated using this novel IRT-based method incrementally predict functional outcome over classic clinical (mild, moderate, severe) or International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) classification methods. Our findings directly inform ongoing international efforts to refine and deploy new pragmatic, empirically-supported strategies for characterizing TBI, while illustrating a strategy that may be useful to evolve staging systems for other diseases.

Linking Rivermead Post Concussion Symptoms Questionnaire (RPQ) and Sport Concussion Assessment Tool (SCAT) scores with item response theory.

OBJECTIVE: Despite the public health burden of traumatic brain injury (TBI) across broader society, most TBI studies have been isolated to a distinct subpopulation. The TBI research literature is fragmented further because often studies of distinct populations have used different assessment procedures and instruments. Addressing calls to harmonize the literature will require tools to link data collected from different instruments that measure the same construct, such as civilian mild traumatic brain injury (mTBI) and sports concussion symptom inventories. METHOD: We used item response theory (IRT) to link scores from the Rivermead Post Concussion Symptoms Questionnaire (RPQ) and the Sport Concussion Assessment Tool (SCAT) symptom checklist, widely used instruments for assessing civilian and sport-related mTBI symptoms, respectively. The sample included data from n = 397 patients who suffered a sports-related concussion, civilian mTBI, orthopedic injury control, or non-athlete control and completed the SCAT and/or RPQ. RESULTS: The results of several analyses supported sufficient unidimensionality to treat the RPQ + SCAT combined item set as measuring a single construct. Fixed-parameter IRT was used to create a cross-walk table that maps RPQ total scores to SCAT symptom severity scores. Linked and observed scores were highly correlated (r = .92). Standard errors of the IRT scores were slightly higher for civilian mTBI patients and orthopedic controls, particularly for RPQ scores linked from the SCAT. CONCLUSION: By linking the RPQ to the SCAT we facilitated efforts to effectively combine samples and harmonize data relating to mTBI.

Does Response Format Matter? The Psychometric Effects of Filter Questions on Self-Reported Symptom Frequencies.

The presence-severity response format uses a filter question to ask about the presence of a symptom, followed by a question about the severity of that symptom. Only an affirmative response to the filter question triggers the follow-up question. Despite its widespread use, little research has compared the psychometric properties of the presence-severity response format to those of the traditional single-item response format. The purpose of this research was to understand how filter questions influence item responses and characteristics on several short health-related questionnaires. Using two different experimental designs, we find that depending on the construct being measured, the inclusion of a filter question can have a substantial effect on people's responses, and in turn, the psychometric properties of the items. Overall, the presence-severity response format results in a reduction in symptom reporting and loss of information about individual differences, particularly for people experiencing mild symptoms. Measurement recommendations are provided.

Symptom Presence and Symptom Severity as Unique Indicators of Psychopathology: An Application of Multidimensional Zero-Inflated and Hurdle Graded Response Models.

Questionnaires inquiring about psychopathology symptoms often produce data with excess zeros or the equivalent (e.g., none, never, and not at all). This type of zero inflation is especially common in nonclinical samples in which many people do not exhibit psychopathology, and if unaccounted for, can result in biased parameter estimates when fitting latent variable models. In the present research, we adopt a maximum likelihood approach in fitting multidimensional zero-inflated and hurdle graded response models to data from a psychological distress measure. These models include two latent variables: susceptibility, which relates to the probability of endorsing the symptom at all, and severity, which relates to the frequency of the symptom, given its presence. After estimating model parameters, we compute susceptibility and severity scale scores and include them as explanatory variables in modeling health-related criterion measures (e.g., suicide attempts, diagnosis of major depressive disorder). Results indicate that susceptibility and severity uniquely and differentially predict other health outcomes, which suggests that symptom presence and symptom severity are unique indicators of psychopathology and both may be clinically useful. Psychometric and clinical implications are discussed, including scale score reliability.

How Do Scores on the Functional Status Examination (FSE) Correspond to Scores on the Glasgow Outcome Scale-Extended (GOSE)?

This study was designed to determine how raw scores correspond between two alternative measures of functional recovery from traumatic brain injury (TBI), the Functional Status Examination (FSE) and the Glasgow Outcome Scale-Extended (GOSE). Using data from 357 persons with moderate-severe TBI who participated in a large clinical trial, we performed item response theory analysis to characterize the relationship between functional ability measured by the FSE and GOSE at 6 months post-injury. Results revealed that raw scores for the FSE and GOSE can be linked, and a table is provided to translate scores from one instrument to the other. For example, a FSE score of 7 (on its 0-21 scale, where higher scores reflect more impairment) is equivalent to a GOSE score of 6 (where GOSE is scaled on an 8-point scale, with higher scores reflecting less impairment). These results allow clinicians or researchers who have a score for a person on one instrument to cross-reference it to a score on the other instrument. Importantly, this enables researchers to combine data sets where some persons only completed the GOSE and some only the FSE. In addition, an investigator could save participant time by eliminating one instrument from a battery of tests, yet still retain a score on that instrument for each participant. More broadly, the findings help anchor scores from these two instruments to the broader continuum of injury-related functional limitations.

Improving the Precision of the Glasgow Outcome Scale-Extended Using Item Response Theory: A TRACK-TBI Study.

The Glasgow Outcome Scale-Extended (GOSE) is a functional outcome measure intended to place individuals with traumatic brain injury (TBI) into one of eight broad levels of injury-related disability. This simplicity is not always optimal, particularly when more granular assessment of individuals' injury recovery is desired. The GOSE, however, is customarily assessed using a multi-question interview that contains richer information than is reflected in the GOSE score. Using data from the multi-center Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study (N = 1544), we used item response theory (IRT) to evaluate whether rescoring the GOSE using IRT, which posits that a continuous latent variable (disability) underlies responses, can yield a more precise index of injury-related functional limitations. We fit IRT models to GOSE interview responses collected at three months post-injury. Each participant's level of functional limitation was estimated from the model (GOSE-IRT) and comparisons were made between IRT-based and standard (GOSE-Ordinal) scores. The IRT scoring resulted in 141 possible scores (vs. 7 GOSE-Ordinal scores in this sample of individuals with GOSE scores ranging between 2 and 8). Moreover, GOSE-IRT scores were significantly more strongly associated with measures of TBI-related symptoms, psychological symptoms, and quality of life. Our findings demonstrate that rescoring the GOSE interview using IRT yields more granular, meaningful measurement of injury-related functional limitations, while adding no additional respondent or examiner burden. This technique may have utility for many applications, such as clinical trials aiming to detect small treatment effects, and small-scale studies that need to maximize statistical efficiency.

A multidimensional zero-inflated graded response model for ordinal symptom data.

Zero responses and their equivalents-for example, never, none, not at all-are commonly observed on measures of psychopathology inquiring about symptom frequencies, particularly when these measures are administered to community samples. Measurement researchers typically accommodate multivariate zero inflation by including a nonpathological class of respondents who endorse zero for all symptoms. While this latent class approach accounts for test-level zero inflation (i.e., a proportion of individuals who do not experience any of the symptoms), it may be overly restrictive on questionnaires comprising items of differing severity. For example, an item about suicidal ideation is likely to exhibit a much higher degree of zero inflation than an item about low energy. Existing models do not account for this variability. We propose a multidimensional zero-inflated graded response model (MZI-GRM) as a more flexible approach for modeling zero inflation on questionnaires. According to the model, two distinct but correlated latent variables underlie ordinal item responses; one represents susceptibility to the construct, whereas the other represents severity. As a motivating example, we show how the MZI-GRM can be fit to data from the PHQ-9, a common depression screener. Results suggest that the MZI-GRM is better able to capture zero inflation across items than existing alternative models. Further, we find support for a multidimensional model that allows distinct but correlated latent variables to underlie each response process. Some items better measure susceptibility to depression (symptom presence), whereas others better capture severity of depression (symptom frequency). Implications for scale development and scoring are discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A Preliminary Psychometric Analysis of the Difficulties with Emotion Regulation Scale (DERS) Among Autistic Adolescents and Adults: Factor Structure, Reliability, and Validity.

Emotion dysregulation is common among autistic people, yet few measures have received psychometric evaluation in this population. We examined the factor structure, reliability, and validity of a commonly-used measure of emotion dysregulation, the Difficulties with Emotion Regulation Scale (DERS), in a sample of 156 autistic adolescents and adults. Data were drawn from the NIH National Database for Autism Research (NDAR) and an author's existing dataset. Results demonstrated that the factor structure generally conformed to the original 6-factor model, with modifications. Reliability analyses revealed good-to-excellent internal consistencies. Validity analyses indicated that the DERS was positively associated with measures of anxiety, depression, and alexithymia. Our findings provide preliminary evidence for the utility of the DERS in a small autistic sample, with minor modifications.

Parental Enrollment Decision-Making for a Neonatal Clinical Trial.

OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.

Functional Status Examination Yields Higher Measurement Precision than the Glasgow Outcome Scale-Extended after Moderate-to-Severe Traumatic Brain Injury.

A limited evidence base supports the Functional Status Examination (FSE) as superior to the more commonly used Glasgow Outcome Scale-Extended (GOSE) for precisely characterizing injury-related functional limitations. The aim of this study was to use modern psychometric tools to test the hypothesis that the FSE is more precise than the GOSE in characterizing individual differences in functional limitations after moderate-to-severe traumatic brain injury (TBI). Secondarily, we sought to confirm that the type of interviewee (patient, significant other) does not affect the test performance of the FSE. Using data from 357 individuals with TBI who participated in the Magnesium Sulfate clinical trial and had six-month outcome data, we performed item response theory (IRT) analyses comparing the FSE and GOSE at six months post-injury. Results showed that the FSE yielded higher measurement precision (IRT test information) than the GOSE across most of the disability severity spectrum. The GOSE yielded more information than the FSE at a very high level of disability, because of the GOSE's assignment of a unique score for individuals who are in a vegetative state. Finally, the FSE showed no evidence of differential item functioning by interviewee, indicating it is appropriate to interview either persons with TBI or significant others and combine data across respondents as is typically done. The findings support the FSE as a viable and oftentimes advantageous substitute for the GOSE in clinical trials and translational studies of TBI.

Differential Item Functioning Based on Autism Features, IQ, and Age on the Screen for Child Anxiety Related Disorders (SCARED) Among Youth on the Autism Spectrum.

Anxiety commonly occurs among youth on the autism spectrum, yet measurement of anxiety in this population is complicated by a number of factors, including potentially overlapping symptomatology, the child's intellectual functioning, and changes in anxiety across development. Moreover, few studies have examined the psychometric properties of anxiety measures in this population, and no study to date has tested whether there are systematic differences in the measurement of anxiety, or differential item functioning (DIF), across the high degree of heterogeneity and the developmental course of autism. To test this possibility, data were combined across multiple studies using the National Database for Autism Research, an NIH-funded data repository. Parent-report on the Screen for Child Anxiety Related Disorders (SCARED) and Social Communication Questionnaire (SCQ) were used as measures of anxiety and autism features, respectively. A confirmatory factor analysis indicated good fit of the literature standard five-factor structure. Moderated nonlinear factor analysis (MNLFA) revealed multiple items with intercept and loading DIF based on level of autism features, IQ, and age, especially for items related to social behavior. Therefore, although the measure's factor structure is consistent with that found in the general population, the SCARED may not capture differences in anxiety equivalently for all children on the spectrum and across their development. Clinicians and researchers need to be especially vigilant in measuring anxiety symptoms in children with autism by removing items flagged for DIF from the SCARED and/or by using multiple measures and informants. LAY ABSTRACT: Autistic youth often experience clinical levels of anxiety. Many tools used to measure anxiety were developed for the general population, but not for use with autistic youth. This study found that the Screen for Child Anxiety Related Disorders (SCARED) measures the same five dimensions of anxiety as in the general population. Parents, however, may respond differently to questions on the SCARED based on their child's autism features, intellectual functioning, and age, which impacts our ability to accurately measure anxiety among autistic youth.

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.

Importance: It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. Objective: To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. Design, Setting, and Participants: This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. Exposure: Parental choice of enrollment in neonatal clinical trial. Main Outcomes and Measures: Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. Results: Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. Conclusions and Relevance: In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.

Changes in Electroencephalogram Coherence in Adolescents With Autism Spectrum Disorder After a Social Skills Intervention.

Autism spectrum disorder (ASD) is a developmental condition that affects social communication and behavior. There is consensus that neurological differences are present in ASD. Further, theories emphasize the mixture of hypo- and hyper-connectivity as a neuropathologies in ASD [O'Reilly, Lewis, & Elsabbagh, 2017]; however, there is a paucity of studies specifically testing neurological underpinnings as predictors of success on social skills interventions. This study examined functional neural connectivity (electroencephalogram [EEG], coherence) of adolescents with ASD before and after the Program for the Education and Enrichment of Relational Skills (PEERS®) intervention, using a randomized controlled trial of two groups: an Experimental ASD (EXP) Group and a Waitlist Control ASD (WL) Group. The study had two purposes. First, the study aimed to determine whether changes in EEG coherence differed for adolescents that received PEERS® versus those that did not receive PEERS®. Results revealed a significant increase in connectivity in the occipital left to temporal left pair for the EXP group after intervention. Second, the study aimed to determine if changes in EEG coherence related to changes in behavior, friendships, and social skills measured by questionnaires. At post-intervention, results indicated: (a) positive change in frontal right to parietal right coherence was linked to an increase in social skills scores; and (b) positive changes in occipital right to temporal right coherence and occipital left to parietal left coherence were linked to an increase in the total number of get-togethers. Results of this study support utilizing neurobehavioral domains as indicators of treatment outcome. Lay Summary: This study examined how well various areas of the brain communicate in adolescents with ASD before and after a social skills intervention. Results revealed increased connectivity in the adolescents that received the intervention. Secondly, the study aimed to determine if changes in connectivity of brain areas related to changes in behavior, friendships, and social skills. Results indicated that changes in connectivity were also linked to increased social skills. Autism Res 2021, 14: 787-803. © 2021 International Society for Autism Research and Wiley Periodicals LLC.

A Psychometric Analysis of the Social Anxiety Scale for Adolescents Among Youth With Autism Spectrum Disorder: Caregiver-Adolescent Agreement, Factor Structure, and Validity.

Social anxiety is common among adolescents with autism spectrum disorder (ASD). An ongoing challenge for both research and clinical practice in ASD is the assessment of anxious symptomatology. Despite its widespread use in samples of youth with ASD, the Social Anxiety Scale for Adolescents (SAS-A) has not received psychometric evaluation within this population; thus, the validity of its use in research and clinical practice for ASD remains unclear. The present study conducted a psychometric analysis of caregiver and adolescent SAS-A forms in a sample of adolescents with ASD (N = 197). Results revealed (1) poor caregiver-adolescent item-level agreement, (2) a two-factor structure, (3) lack of measurement invariance between reporters, and (4) modest evidence for convergent and discriminant validity. Overall, findings suggest that this measure demonstrates reasonable psychometric properties in an ASD sample. Lack of measurement invariance, however, calls for careful interpretation of research involving the SAS-A in ASD samples, particularly when the primary goal is to compare adolescent and caregiver reports. The implications of these findings for future research and clinical practice are discussed.

Assessing the Psychometric Proprieties of the Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF) Among Latino Adults.

The Latino population continues to underutilize mental health services at an alarming rate. The Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF) is one of the most commonly used instruments to assess help-seeking attitudes. The current study sought to evaluate the factor structure and test for the presence of differential item functioning on the ATSPPH-SF with a sample of Latino adult individuals across nativity status (U.S.- vs. foreign-born), language format (English vs. Spanish), and gender. The analyses revealed two relatively independent factors named Openness to Seeking Treatment and Value and Need in Seeking Treatment. Measurement equivalence and practical implications are discussed in the context of use with Latino individuals.

Preliminary Validation of an Abbreviated Acute Concussion Symptom Checklist Using Item Response Theory.

BACKGROUND: Symptom assessment is a critical component of concussion diagnosis and management, with item selection primarily driven by clinical judgment or expert consensus. We recently demonstrated that concussion symptoms assessed by the Sport Concussion Assessment Tool (SCAT) are essentially unidimensional, implying that overall symptom severity may be accurately estimated with relatively few questions. Briefer, evidence-based forms for symptom assessment would provide clinicians flexibility. PURPOSE: To develop and validate an abbreviated assessment of general concussion symptom severity using item response theory analyses. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: Broad clinical assessments (SCAT3, Immediate Post-concussion and Cognitive Testing, Balance Error Scoring System, and Brief Symptom Inventory-18 Global Severity Index) were completed by 265 injured athletes and 235 matched teammate controls at 24 to 48 hours and 8, 15, and 45 days after concussion. Symptom checklist short forms (3-14 items from the original 22) were selected using item response theory item information curves. Internal consistency reliability (Cronbach alpha), correlation with criterion measures assessed concurrently (ie, acute neurocognitive performance, balance, and emotional symptoms), predictive validity (correlations with symptom duration), and differences between concussed and control groups (Cohen d) were examined across forms. Sensitivity and false-positive rates of the forms were estimated and compared using reliable change indices derived from controls. RESULTS: Across the 3- to 22-item forms, internal consistency was excellent (Cronbach alphas, 0.90-0.94). Clinical correlations were significant (P≤ .017) and to similar degrees for all short forms. Group difference confidence intervals overlapped across forms at 24- to 48-hour (Cohen d, 1.27-1.51) and 8-day follow-up (Cohen d, 0.31-0.44). Sensitivity remained similar across short forms, with a low false-positive rate in controls. CONCLUSION: Our findings suggest that even an ultrashort (3-item) inventory provides sufficiently reliable and valid estimates of overall concussion symptom severity 24 to 48 hours after injury. Future revisions of the SCAT could eliminate inefficient items, although replication in larger samples and extension to other postinjury time points are warranted.

Leveraging item accuracy and reaction time to improve measurement of child executive function ability.

Traditionally, executive function (EF) tasks have been scored using either accuracy or reaction time (RT) metrics. The current study, which includes 1,015 first-grade children from the Family Life Project, demonstrates a new scoring approach for the Hearts and Flowers (HF) task that uses both item-level accuracy and RT data to estimate latent EF ability. Our primary aim was to compare scores derived from this approach to standard scores often reported in the HF literature. A second aim was to test whether item-level accuracy and RT data were differentially related to latent EF ability, depending on children's overall level of task performance. Our results indicated that item-level accuracy and RT data both convey unique information related to latent EF ability but that the relative contributions of each source of data vary across children. Accuracy was comparatively more informative of latent ability in children with lower HF task performance, while RT was comparatively more informative of latent ability in children with higher overall performance. Moreover, item-level RT was differentially related to latent EF ability for children in lower versus higher performing groups. Whereas faster responding was associated with higher ability in the higher performing group, slower responding was associated with higher ability for the lower performing group. Latent EF ability was related to criterion measures in ways comparable to traditional scores. Results are discussed in relation to the broader EF assessment literature. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

The use of PROMIS patient-reported outcomes (PROs) to inform light chain (AL) amyloid disease severity at diagnosis.

We sought to evaluate how PROMIS patient-reported outcome (PRO) measures correlated with disease characteristics in systemic light chain (AL) amyloidosis patients at diagnosis. Newly diagnosed AL patients were recruited at two centres (N = 61). Patients completed the PROMIS Global Health v1.2, PROMIS-29 Profile v2.0 and Fatigue 8a v1.0. We assigned disease severity based on stage, presence of cardiac AL, and number of organs involved. We evaluated a) known groups validity by comparing PROMIS T-scores by disease severity, b) internal consistency using Cronbach's alpha and c) convergent/discriminant validity based on correlations across the domains and summary scores. Using receiver operating characteristic (ROC) curve analysis, NT-proBNP cut-off level corresponding to normal/mild vs moderate/severe PRO scores was determined. The median age was 68 (48-83) years with 58% males. Sixty-six percent had cardiac involvement and 25% had 3 or more organs involved with AL amyloidosis; 14% had stage 1, 28% stage 2, 36% stage 3 and 16% stage 4 disease. PROMIS measures had acceptable to excellent internal consistency and expected patterns of correlations. PROMIS Global Physical Health score was worse than the Global Mental Health Score at diagnosis; Physical function, fatigue and anxiety were the most impaired domains. PROMIS Global Health summary scores discriminated across AL amyloidosis stage and number of organs involved. Physical Function showed the strongest effects across known groups by stage, cardiac involvement and number of organs involved followed by Ability to Participate in Social Roles and Activities. A diagnostic NT-proBNP cut-off of 4200 pg/ml identified patients with moderate/severe PRO scores for these domains. Our results provide evidence for reliability and validity of select PROMIS short form measures in AL amyloidosis at diagnosis.

Functional Status Examination Yields Higher Measurement Precision of Functional Limitations after Traumatic Injury than the Glasgow Outcome Scale-Extended: A Preliminary Study.

The Glasgow Outcome Scale-Extended (GOSE) is one of the most widely used measures of functional limitations after traumatic brain injury (TBI), and is the primary outcome measure used in clinical trials of acute TBI treatment. However, the GOSE appears insensitive to the full spectrum of TBI-related functional limitations, which may limit its potential to capture treatment effects or correlate with other variables that impact outcome. The Functional Status Examination (FSE) was designed to improve on the assessment of injury-related functional limitations using a standardized assessment and wider possible score range. The aim of this pilot study was to employ item response theory (IRT) to test the hypothesis that the FSE yields more precise estimation of functional outcome than the GOSE. Traumatically injured patients (n = 100, 77 TBI, 23 orthopedic injuries) were interviewed at 3 months post-injury using both the GOSE and FSE structured interviews. IRT was used to quantify and compare the tests' information functions, which reflect the degree to which each instrument precisely measures functional limitations across the severity spectrum. Findings were consistent with predictions: the FSE yielded stronger measurement of functional limitations (i.e., higher test information) across a wider range of severity than the GOSE, whether scoring the GOSE from all interview items or using the traditional GOSE overall score. Although the FSE appears to be a promising alternative measure to the GOSE, further research is needed to cross-validate these findings in a larger sample and understand how to best deploy it in clinical and translational research.