Distinct trajectories of neuropsychiatric symptoms in the 12 months following traumatic brain injury (TBI): a TRACK-TBI study.

BACKGROUND: Neuropsychiatric symptoms are common after traumatic brain injury (TBI) and often resolve within 3 months post-injury. However, the degree to which individual patients follow this course is unknown. We characterized trajectories of neuropsychiatric symptoms over 12 months post-TBI. We hypothesized that a substantial proportion of individuals would display trajectories distinct from the group-average course, with some exhibiting less favorable courses. METHODS: Participants were level 1 trauma center patients with TBI (n = 1943), orthopedic trauma controls (n = 257), and non-injured friend controls (n = 300). Trajectories of six symptom dimensions (Depression, Anxiety, Fear, Sleep, Physical, and Pain) were identified using growth mixture modeling from 2 weeks to 12 months post-injury. RESULTS: Depression, Anxiety, Fear, and Physical symptoms displayed three trajectories: Stable-Low (86.2-88.6%), Worsening (5.6-10.9%), and Improving (2.6-6.4%). Among symptomatic trajectories (Worsening, Improving), lower-severity TBI was associated with higher prevalence of elevated symptoms at 2 weeks that steadily resolved over 12 months compared to all other groups, whereas higher-severity TBI was associated with higher prevalence of symptoms that gradually worsened from 3-12 months. Sleep and Pain displayed more variable recovery courses, and the most common trajectory entailed an average level of problems that remained stable over time (Stable-Average; 46.7-82.6%). Symptomatic Sleep and Pain trajectories (Stable-Average, Improving) were more common in traumatically injured groups. CONCLUSIONS: Findings illustrate the nature and rates of distinct neuropsychiatric symptom trajectories and their relationship to traumatic injuries. Providers may use these results as a referent for gauging typical v. atypical recovery in the first 12 months post-injury.

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.

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.

To bin or not to bin? A comparison of symptom frequency response formats in the assessment of health-related quality of life.

PURPOSE: The goal of this study is to compare three different types of retrospective frequency response formats on the Healthy Days Symptoms Module (HDSM). Responses are compared in terms of intra-individual consistency, psychometric value, and participant feedback about each type of response format. METHODS: Respondents each completed three versions of the HDSM, where items were framed to elicit an open-ended frequency, a fixed choice frequency, or a vague quantifier response. Traditional reliability statistics were used to evaluate intra-individual consistency. Differential item functioning (DIF) was used to test for response format effects, and item response theory (IRT) scale scores and standard errors were computed across the three forms to compare psychometric value. Linear mixed modeling was used to examine the associations of IRT scale scores across response formats with respondent characteristics. RESULTS: People are largely consistent in how they respond to items about their health, regardless of the response format, and no DIF was detected between response formats. The IRT scores computed from the "# of days" frequency response formats tend to have better measurement precision than those from vague quantifiers. Open-ended frequencies capture a greater span of individual differences for people reporting fewer symptoms; however, little measurement precision is lost in collapsing the frequencies into categories. CONCLUSIONS: Both the open-ended and fixed choice frequency response formats offer more measurement precision than vague quantifiers. While the open-ended frequency response format may capture more individual differences, respondents tend to report more difficulty with exact frequency recall, and thus, prefer the fixed choice frequency format.

Determining a transitional scoring link between PROMIS® pediatric and adult physical health measures.

PURPOSE: Having independent versions of the PROMIS® scales (for Pediatric and Adults) is problematic as scores cannot be evaluated longitudinally as individuals move from childhood into adulthood. The primary aim of this research project is to use item response theory (IRT) to develop a transitional scoring link (or "crosswalk") between the PROMIS adult and pediatric physical health measures. SETTING: Sample 1 was collected at 6 rehabilitation hospitals in the U.S., and participants in Sample 2 were recruited from public health insurance programs and an online research panel. METHODS: PROMIS pediatric and adult physical function, mobility, upper extremity, fatigue, and pain measures were administered to a sample of 874 individuals aged 14-20 years old with special health needs and a sample of 641 individuals aged 14-25 years with a disability. IRT-based scores were linked using a linear approximation to calibrated projection. RESULTS: Estimated latent variable correlations ranged between 0.84 and 0.95 for the PROMIS pediatric and adult scores. Root Expected Mean Square Difference values were below the 0.08 threshold in all cases except when comparing genders on the Mobility (0.097) and Pain (0.10) scales in the special health care needs sample. Sum score conversion tables for the pediatric and adult PROMIS measures are presented. CONCLUSIONS: The linking coefficients can be used to calculate scale scores on PROMIS adult measures from pediatric measure scores and vice versa. This may lead to more accurate measurement in cross-sectional studies spanning multiple age groups or longitudinal studies that require comparable measurement across distinct developmental stages.

Estimating HIV Medication Adherence and Persistence: Two Instruments for Clinical and Research Use.

Antiretroviral therapy (ART) requires lifelong daily oral therapy. While patient characteristics associated with suboptimal ART adherence and persistence have been described in cohorts of HIV-infected persons, these factors are poor predictors of individual medication taking behaviors. We aimed to create and test instruments for the estimation of future ART adherence and persistence for clinical and research applications. Following formative work, a battery of 148 items broadly related to HIV infection and treatment was developed and administered to 181 HIV-infected patients. ART adherence and persistence were assessed using electronic monitoring for 3 months. Perceived confidence in medication taking and self-reported barriers to adherence were strongest in predicting non-adherence over time. Barriers to adherence (e.g., affordability, scheduling) were the strongest predictors of non-adherence, as well as 3- and 7-day non-persistence. A ten-item battery for prediction of these outcomes ( www.med.unc.edu/ncaidstraining/adherence/for-providers ) and a 30-item battery reflective of underlying psychological constructs can help identify and study individuals at risk for suboptimal ART adherence and persistence.

The benefits of adding a brief measure of simple reaction time to the assessment of executive function skills in early childhood.

Early childhood represents a period of rapid cognitive developmental change in executive function (EF) skills along with a variety of related cognitive processes, including processing speed. This leads to interpretational challenges in that children's performance on EF tasks reflects more than EF skills per se. We tested whether the inclusion of a brief measure of simple reaction time (SRT) during EF assessments could help to partially address this challenge. Data were drawn from a cross-sectional convenience sample of 830 preschool-aged children. Individual differences in SRT were significantly associated with performance on all tasks (R2s = .09-.26); slower performance on the SRT task was associated with poorer performance on each EF task. Age-related differences in individual EF tasks were reduced by approximately one half after accounting for age-related differences in SRT, and EF task scores were less coherent (i.e., less strongly intercorrelated with each other) after the removal of SRT. Age-related differences in EF were smaller (Cohen ds = 1.36 vs. 0.78), and poverty-related differences in EF were larger (Cohen ds = 0.30 vs. 0.46) after accounting for SRT-related variation. Finally, consistent with previous studies, SRT-related differences in fluid reasoning were mediated by EF skills. Results are discussed with respect to using a brief measure of SRT to partially address the problem of measurement impurity at the level of individual EF tasks.

Mode effects between computer self-administration and telephone interviewer-administration of the PROMIS(®) pediatric measures, self- and proxy report.

OBJECTIVE: To test equivalence of scores obtained with the PROMIS(®) pediatric Depressive Symptoms, Fatigue, and Mobility measures across two modes of administration: computer self-administration and telephone interviewer-administration. If mode effects are found, to estimate the magnitude and direction of the mode effects. METHODS: Respondents from an internet survey panel completed the child self-report and parent proxy-report versions of the PROMIS(®) pediatric Depressive Symptoms, Fatigue, and Mobility measures using both computer self-administration and telephone interviewer-administration in a crossed counterbalanced design. Pearson correlations and multivariate analysis of variance were used to examine the effects of mode of administration as well as order and form effects. RESULTS: Correlations between scores obtained with the two modes of administration were high. Scores were generally comparable across modes of administration, but there were some small significant effects involving mode of administration; significant differences in scores between the two modes ranged from 1.24 to 4.36 points. CONCLUSIONS: Scores for these pediatric PROMIS measures are generally comparable across modes of administration. Studies planning to use multiple modes (e.g., self-administration and interviewer-administration) should exercise good study design principles to minimize possible confounding effects from mixed modes.

Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method.

OBJECTIVE: To assess minimally important differences (MIDs) for several pediatric self-report item banks from the National Institutes of Health Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)). METHODS: We presented vignettes comprising sets of two completed PROMIS questionnaires and asked judges to declare whether the individual completing those questionnaires had an important change or not. We enrolled judges (including adolescents, parents, and clinicians) who responded to 24 vignettes (six for each domain of depression, pain interference, fatigue, and mobility). We used item response theory to model responses to the vignettes across different judges and estimated MID as the point at which 50 % of the judges would declare an important change. RESULTS: We enrolled 246 judges (78 adolescents, 85 parents, and 83 clinicians). The MID estimated with clinician data was about 2 points on the PROMIS T-score scale, and the MID estimated with adolescent and parent data was about 3 points on that same scale. CONCLUSIONS: The MIDs enhance the value of PROMIS pediatric measures in clinical research studies to identify meaningful changes in health status over time.

Linkage between the PROMIS® pediatric and adult emotional distress measures.

PURPOSE: Research studies that measure health-related quality of life (HRQOL) in both children and adults and longitudinal studies that follow children into adulthood need measures that can be compared across these age groups. This study links the PROMIS pediatric and adult emotional distress measures using data from participants with diverse health conditions and disabilities. METHODS: Analyses were conducted and compared in two separate samples to confirm the stability of results. One sample (n = 874) included individuals aged 14-20 years with special health care needs and who require health services. The other sample (n = 641) included individuals aged 14-25 years who have a physical or cognitive disability. Participants completed both PROMIS pediatric and adult measures. Item response theory-based scores were linked using the linear approximation to calibrated projection. RESULTS: The estimated latent-variable correlation between pediatric and adult PROMIS measures ranged from 0.87 to 0.94. Regression coefficients ß 0 (intercept) and ß 1 (slope), and mean squared error are provided to transform scores from the pediatric to the adult measures, and vice versa. CONCLUSIONS: This study used a relatively new linking method, calibrated projection, to link PROMIS pediatric and adult measure scores, thus expanding the use of PROMIS measures to research that includes both populations.

Item-level informant discrepancies between children and their parents on the PROMIS(®) pediatric scales.

OBJECTIVE: The study objective was to describe the individual item-level discrepancies between children ages 8-17 years and their parents for the PROMIS(®) pediatric scales. Contextual effects on item-level informant discrepancies for the pediatric pain interference items were further analyzed conditional on whether the child, the parent, or anyone else in the household experienced chronic pain. METHODS: Parallel pediatric self-report and parent proxy-report items were completed by approximately 300 parent-child dyads depending on form assignment and individual nonresponse. Agreement between parent and child responses to individual items was measured using the polychoric correlation coefficient and weighted κ. The Chi-square test of symmetry was utilized for a comparison of the pattern of parent-child item discrepancies on the response scales, and the differences between the child and parent responses on the 1-5 item response scale are summarized . RESULTS: A continuum of higher item-level parent-child discrepancies was demonstrated starting with peer relationships, anger, anxiety, and depressive symptoms, followed by progressively lower parent-child discrepancies for energy, fatigue, asthma impact, pain interference, upper extremity, and mobility items. Parent-child discrepancies for pain interference items were lower in the context of chronic pain either in the child or in the parent. CONCLUSIONS: Parent-child item-level discrepancies were lower for more objective or visible items than for items measuring internal states or less observable items measuring latent variables such as peer relationships and fatigue. Future research should focus on the child and parent characteristics that influence domain-specific item-level discrepancies, and under what conditions item-level parent-child discrepancies predict child health outcomes.

Development and validation of the Proxy-Reported Pulmonary Outcomes Scale for premature infants.

OBJECTIVE: Test the feasibility of using a bedside nurse-reported tool (Proxy-Reported Pulmonary Outcome Scale, PRPOS) for evaluating the severity of bronchopulmonary dysplasia (BPD) by assessing functional, disease-related measures. STUDY DESIGN: Bedside nurses tested the 26-item instrument by observing preterm infants (23-30 weeks at birth) at 36 to 37(4/7) weeks postmenstrual age before, during, and after a care time. We analyzed item reliability, validity, and model fit to determine the six items to include in the final measurement tool. RESULT: We completed assessments on 188 preterm infants. The frequency of an abnormal PRPOS item score increased with increasing National Institute of Child Health and Development (NICHD) BPD category. The six-candidate items produced an internally consistent scale. Addition of the NICHD BPD classification increased reliability moderately; addition of feeding items decreased reliability. The PRPOS score correlated with postmenstrual age at discharge. Infants discharged on oxygen or diuretics had higher median PRPOS scores than did infants who were not prescribed those therapies. CONCLUSION: The PRPOS is an internally consistent, proxy-reported measure of respiratory function in premature infants, based on observable, functional performance measures. Initial testing demonstrates known-groups validity and ongoing testing can assess predictive validity.

Using item response theory to enrich and expand the PROMIS® pediatric self report banks.

BACKGROUND: The primary objective was to enhance the content coverage of some of the pediatric self-report item banks for ages 8-17 years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®), and extend the range of precise measurement to higher levels of physical functioning. METHODS: Data from 1,419 pediatric patients with cancer, chronic kidney disease, obesity, rehabilitation needs, rheumatic disease, and sickle cell disease were combined with item responses from the original standardization sample of 3,048 children to calibrate new items for the pediatric PROMIS Anger, Anxiety, Depressive Symptoms, Pain Interference, Fatigue, and physical functioning Upper Extremity and Mobility scales. Simultaneous or concurrent calibration using the graded item response theory model placed all of the items on the same scale. RESULTS: Twenty-two of 28 potential new items were added across the seven scales. A recommended short form was proposed for the Anger scale, and the recommended short forms for the Anxiety and Depressive Symptoms scales were revised. Unfortunately, we were not particularly successful at extending the range of measurement for the physical functioning banks. CONCLUSIONS: The present study expanded PROMIS pediatric item banks to add new content and to increase the range of measurement. Using item response theory, the banks were revised and expanded without changing the underlying scale of measurement. For Anger, Anxiety, and Depressive Symptoms, we successfully added new content that may render those banks more robust and flexible.

Psychometric properties of the PROMIS ® pediatric scales: precision, stability, and comparison of different scoring and administration options.

OBJECTIVES: The objectives of the present study are to investigate the precision of static (fixed-length) short forms versus computerized adaptive testing (CAT) administration, response pattern scoring versus summed score conversion, and test-retest reliability (stability) of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) pediatric self-report scales measuring the latent constructs of depressive symptoms, anxiety, anger, pain interference, peer relationships, fatigue, mobility, upper extremity functioning, and asthma impact with polytomous items. METHODS: Participants (N = 331) between the ages of 8 and 17 were recruited from outpatient general pediatrics and subspecialty clinics. Of the 331 participants, 137 were diagnosed with asthma. Three scores based on item response theory (IRT) were computed for each respondent: CAT response pattern expected a posteriori estimates, short-form response pattern expected a posteriori estimates, and short-form summed score expected a posteriori estimates. Scores were also compared between participants with and without asthma. To examine test-retest reliability, 54 children were selected for retesting approximately 2 weeks after the first assessment. RESULTS: A short CAT (maximum 12 items with a standard error of 0.4) was found, on average, to be less precise than the static short forms. The CAT appears to have limited usefulness over and above what can be accomplished with the existing static short forms (8-10 items). Stability of the scale scores over a 2-week period was generally supported. CONCLUSION: The study provides further information on the psychometric properties of the PROMIS pediatric scales and extends the previous IRT analyses to include precision estimates of dynamic versus static administration, test-retest reliability, and validity of administration across groups. Both the positive and negative aspects of using CAT versus short forms are highlighted.

PROMIS® Parent Proxy Report Scales for children ages 5-7 years: an item response theory analysis of differential item functioning across age groups.

OBJECTIVE: The objective of the present study is to describe the extension of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS(®)) pediatric parent proxy-report item banks for parents of children ages 5-7 years, and to investigate differential item functioning (DIF) between the data obtained from parents of 5-7-year-old children with the data obtained from parents of 8-17 year-old children in the original construction of the scales. METHODS: Item response theory (IRT) analyses of DIF were conducted comparing data from the 5-7 age group with data from the established scales for ages 8-17 across 5 generic health domains (physical functioning, pain, fatigue, emotional health, and social health) and asthma. RESULTS: IRT DIF analyses revealed that the majority of the items functioned similarly with responses from parents of younger and older children. A small number of items were removed from the item bank for younger children, and a few items that exhibited statistical DIF were retained in the pools with the caveat that they should not be used in studies that involve comparisons of younger children with older children. CONCLUSIONS: The study confirms that most of the items in the PROMIS parent proxy-report item banks can be used with parents of children ages 5-7. It is anticipated that these new scales will have application for younger pediatric populations when pediatric self-report is not feasible.

Item Response Modeling of Clinical Instruments With Filter Questions: Disentangling Symptom Presence and Severity.

Clinical instruments that use a filter/follow-up response format often produce data with excess zeros, especially when administered to nonclinical samples. When the unidimensional graded response model (GRM) is then fit to these data, parameter estimates and scale scores tend to suggest that the instrument measures individual differences only among individuals with severe levels of the psychopathology. In such scenarios, alternative item response models that explicitly account for excess zeros may be more appropriate. The multivariate hurdle graded response model (MH-GRM), which has been previously proposed for handling zero-inflated questionnaire data, includes two latent variables: susceptibility, which underlies responses to the filter question, and severity, which underlies responses to the follow-up question. Using both simulated and empirical data, the current research shows that compared to unidimensional GRMs, the MH-GRM is better able to capture individual differences across a wider range of psychopathology, and that when unidimensional GRMs are fit to data from questionnaires that include filter questions, individual differences at the lower end of the severity continuum largely go unmeasured. Practical implications are discussed.

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.

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.