Psychometric Properties of the Spinal Cord Injury-Quality of Life (SCI-QOL) Resilience Short Form in a Sample With Spinal Cord Injury.

OBJECTIVE: To explore the psychometric properties (eg, data distribution characteristics, convergent or discriminant validity, internal consistency reliability) of the Spinal Cord Injury-Quality of Life measurement system (SCI-QOL) Resilience 8-item short form (SF) in comparison to the criterion standard resilience measure, Connor Davidson Resilience Scale (CD-RISC) in a sample of individuals with spinal cord injury (SCI). DESIGN: Descriptive statistics were calculated to examine variable data distribution characteristics. Correlation analyses were conducted for convergent and discriminant validity. Reliability statistics were calculated for resilience and other validity measures. SETTING: General community. PARTICIPANTS: Individuals with SCI (N=202; 51.5% male, 48% female). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient-Reported Outcomes Measurement Information System measures (depression, anxiety, ability to participate in social roles and activities, pain intensity, fatigue, sleep disturbance), SCI-QOL short forms (SF) (resilience, positive affect and well-being, mobility), CD-RISC, National Institutes of Health Toolbox for Assessment of Neurological and Behavioral Function - perceived stress (NIH Toolbox-perceived stress), and the Satisfaction with Life Scale were administered. RESULTS: The mean and SD for the SCI-QOL Resilience SF (mean=48.60; SD=8.20) approximated the normative mean (mean=50, SD=10). The SCI-QOL Resilience SF scores were essentially normally distributed though somewhat kurtotic, with skew=-0.17 and excess kurtosis=1.4; internal consistency reliability was good (Cronbach's alpha=0.89). Convergent validity was supported by significant moderate correlations in expected directions between the SCI-QOL Resilience SF and measures of CD-RISC resilience, depressive symptoms, anxiety, social participation, positive affect and well-being, stress, and satisfaction with life. Discriminant validity was supported by small non-significant correlations between the SCI-QOL Resilience SF and age, sex, injury level, time since injury, pain intensity, mobility, sleep disturbance, and fatigue. CONCLUSION: The SCI-QOL Resilience SF demonstrated good convergent and discriminant validity. Our study showed that the SCI-QOL Resilience SF is a psychometrically valid tool that can reliably estimate levels of resilience in the SCI population.

Development of a New Measure of Housing Security: The REDD-CAT Housing Security Measure.

BACKGROUND: Housing security is a key social determinant of behavior related to health outcomes. OBJECTIVE: The purpose of this study was to develop a new patient-reported outcome measure that evaluates aspects of housing security for use in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system. DESIGN: Qualitative data, literature reviews, and cross-sectional survey study. PARTICIPANTS: A total of 225 people with T2DM provided responses to the items in this item pool. MAIN MEASURES: A new item pool that evaluates important aspects of housing security was developed using stakeholder data from focus groups of persons with T2DM. KEY RESULTS: For the Housing Affordability scale, factor analysis (both exploratory and confirmatory) supported the retention of six items. Of these items, none exhibited sparse cells or problems with monotonicity; no items were deleted due to low item-adjusted total score correlations. For the six affordability items, a constrained graded response model indicated no items exhibited misfit; thus, all were retained. No items indicated differential item functioning (examined for age, sex, education, race, and socioeconomic status). Thus, the final Affordability item bank comprised six items. A Housing Safety index (three items) and a Home Features index (eight items) were also developed. Reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measures were also supported. CONCLUSIONS: The REDD-CAT Housing Security Measure provides a reliable and valid assessment of housing affordability, safety, and home features in people with type 2 diabetes mellitus. Future work is needed to establish the clinical utility of this measure in other clinical populations.

Development and calibration data for the Illness Burden item bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships. METHODS: Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients' beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus. RESULTS: No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test-retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank. CONCLUSION: The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients' perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus.

Development and calibration data for the Medication Adherence Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus. METHODS: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence. RESULTS: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats. CONCLUSIONS: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net.

Development and calibration data for the Healthcare Access Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure to evaluate the ability to receive medical services when needed among persons with type 2 diabetes mellitus. METHODS: The Healthcare Access measure was developed using data from 225 persons with type 2 diabetes mellitus who completed an item pool comprised of 54 questions pertaining to their experience accessing healthcare services. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 45 items. In addition, a constrained graded response model (GRM), as well as analyses that examined item misfit and differential item functioning (investigated for age, sex, education, race, and socioeconomic status), supported the retention of 44 items in the final item bank. Expert review and GRM item calibration products were used to inform the selection of a 6-item static short form and to program the Healthcare Access computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measure. CONCLUSIONS: The new Healthcare Access item bank can be used to examine the experiences that persons with type 2 diabetes mellitus have with healthcare access, to better target treatment improvements and mitigate disparities; it will be available as a part of the Neuro-Qol measurement system through healthmeasures.net and the PROMIS Application Programmable Interface (API) in early 2023.

Item Banks for Measuring the Effect of Blood Pressure Dysregulation on Health-Related Quality of Life in Persons With Spinal Cord Injury.

OBJECTIVE: To report on the development and calibration of the new Blood Pressure Dysregulation Measurement System (BPD-MS) item banks that assess the effect of BPD on health-related quality of life (HRQOL) and the daily activities of Veterans and non-Veterans with spinal cord injury (SCI). DESIGN: Cross-sectional survey study. SETTING: Two Veteran Affairs medical centers and a SCI model system site. PARTICIPANTS: 454 respondents with SCI (n=262 American Veterans and n=192 non-Veterans; N=454). INTERVENTIONS: Not applicable MAIN OUTCOME MEASURES: The BPD-MS item banks. RESULTS: BPD item pools were developed and refined using literature reviews, qualitative data from focus groups, and cognitive debriefing of persons with SCI and professional caregivers. The item banks then underwent expert review, reading level assessment, and translatability review prior to field testing. The items pools consisted of 180 unique questions (items). Exploratory and confirmatory factor analyses, item response theory modeling, and differential item function investigations resulted in item banks that included a total of 150 items: 75 describing the effect of autonomic dysreflexia on HRQOL, 55 describing the effect of low blood pressure (LBP) on HRQOL, and 20 describing the effect of LBP on daily activities. In addition, 10-item short forms were constructed based on item response theory-derived item information values and the clinical relevance of item content. CONCLUSIONS: The new BPD-MS item banks and corresponding 10-item short forms were developed using established rigorous measurement development standards, which represents the first BPD-specific patient-reported outcomes measurement system unique for use in the SCI population.

Initial Evidence for Reliable and Valid Use of Scores on the 8-Item Econ-QOL Short Form to Measure Economic Quality of Life in Caregivers of Persons With Traumatic Brain Injury.

OBJECTIVE: To provide reliability and validity data to support the clinical utility of Economic Quality of Life Measure (Econ-QOL) scores in caregivers of civilians and service members/veterans with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Three academic medical centers and a Veterans Affairs treatment facility. PARTICIPANTS: 376 caregivers of civilians (n=213) and service members/veterans (n=163) with TBI (N=376). INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: Econ-QOL and several patient-reported outcome measures (Traumatic Brain Injury Caregiver Quality of Life Caregiver-Specific Anxiety and Caregiver Strain, Patient-Reported Outcomes Measurement Information System sleep-related impairment, Neurological Quality of Life Measurement System positive affect and well-being) and measures of financial status (self-reported income). RESULTS: Internal consistency reliability of the Econ-QOL Short Form scores were excellent (all Cronbach's alphas ≥.92). There were no floor or ceiling effects for scores. There was evidence of convergent and discriminant validity, with the Econ-QOL scores having the strongest relationships with self-reported income (convergent validity evidence) and weak relationships with the other measures (discriminant validity evidence). Individuals with scores that were "below or possibly below" the poverty line (according to 2016 federal government poverty level thresholds) reported worse economic quality of life relative to those individuals who were definitely above the poverty line, supporting known-groups validity. CONCLUSIONS: This article establishes the clinical utility of scores on the Econ-QOL Short Form in caregivers of persons with TBI and provides evidence that it is valid and appropriate to use such scores not only in a variety of different disability populations (eg, spinal cord injury, stroke) but also in caregivers.

Do You Recall?: Results From a Within-Person Recall Study of the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 8c.

OBJECTIVES: This study aimed to determine whether responses to Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF8c) items differed when the use of a 7-day recall period was compared with no specified recall period. METHODS: Using a within-subject design, we surveyed 1810 individuals from the US general population, administering PROMIS PF8c at survey beginning and end. The order of measure presentation was randomly assigned. We calculated recall difference scores (RDSs) as no recall score minus 7-day recall score using both item response theory-based T scores and raw summed scores. We examined the distribution and created Bland-Altman plots for both RDSTscore and RDSRaw. We also calculated correlations between no recall versus 7-day recall T score and raw scores. Finally, we determined whether differences in no recall versus 7-day recall scores were associated with patient-reported PF. RESULTS: RDSTscore and RDSRaw had means (root mean square differences) of 0.00 (5.43) and -0.04 (3.79), respectively. The vast majority (%) of RDSTscore and RDSRaw values fell between the Bland-Altman limits of agreement (-10.65 to 10.66 and -7.46 to 7.38, respectively). Pearson's correlations between no recall and 7-day recall for T scores and raw scores were 0.88 and 0.87, respectively. Effect sizes for mean RDSTscore and RDSRaw compared across level of Eastern Oncology Cooperative Group performance status, patient global impression of PF severity, and single PF items were near 0. CONCLUSIONS: We did not find any significant recall period effect on PF8c responses. Therefore, we recommend the use of the PROMIS physical function standard, with no specified recall time period.

Psychometric Considerations in Developing PROMIS® Measures for Early Childhood.

OBJECTIVE: The early expression of lifespan health and disease states can often be detected in early childhood. Currently, the Patient-Reported Outcome Measurement Information System (PROMIS®) includes over 300 measures of health for individuals ages 5 years and older. We extended PROMIS to early childhood by creating developmentally appropriate, lifespan coherent parent-report measures for 1-5-year-olds. This paper describes the psychometric approaches used for these efforts. METHODS: 2 waves of data from parents of children ages 1-5 were collected via 2 internet panel companies. Wave 1 data (n = 1,400) were used to evaluate item pool unidimensionality, model fit, and initial item parameters. Combined data from wave 1 and wave 2 (reference sample; n = 1,057) were used to estimate final item parameters. Using item response theory methods, we developed and tested 12 item pools: Global Health, Physical Activity, Sleep Disturbance, Sleep-related Impairment, Anger/Irritability, Anxiety, Depressive Symptoms, Positive Affect, Self-Regulation, Engagement, Family Relationships, and Peer Relationships. RESULTS: Wave 1 analyses supported the unidimensionality of Physical Activity, Positive Affect, Anger/Irritability, Anxiety, Depressive Symptoms, and Global Health. Family Relationships and Peer Relationships were combined to form "Social Relationships"; Sleep Disturbance and Sleep-related Impairment were combined to form "Sleep Problems." Self-Regulation was divided into "Flexibility" and "Frustration Tolerance"; Engagement was divided into "Curiosity" and "Persistence." Short forms were developed for item banks with more than 10 items; and. CONCLUSIONS: Using rigorous mixed-methods, we successfully extended PROMIS to early childhood (1-5-year-olds). Measures are now publicly available in English and Spanish (www.healthmeasures.net).

Measuring PROMIS® Well-Being in Early Childhood.

OBJECTIVE: Expand the current Patient-Reported Outcome Measurement Information System (PROMIS®) well-being measures to early childhood (1-5 years) using best practices from PROMIS and developmental science. METHODS: Qualitative methods included expert input, literature and measure review, and parent interviews to confirm measure frameworks, item understandability, and developmental appropriateness. Quantitative methods included two waves of field testing and item response theory (IRT)-based psychometric evaluation of reliability and validity, as well as IRT centering and item calibration. Correlational analyses with other PROMIS Early Childhood (EC) Parent Report measures and known-group differences analyses by health status were conducted to evaluate construct validity. All measures were normed to the general U.S. population. RESULTS: Qualitative results suggested three primary early childhood well-being domains: Positive Affect, Engagement, and Self-Regulation. Quantitative results revealed a unidimensional factor structure for Positive Affect and multidimensional factor structures for Engagement and Self-Regulation, both of which had two factors accounting for >10% of modeled variance reflecting unique unidimensional domains. This resulted in five final PROMIS EC well-being measures: Positive Affect, Engagement-Curiosity, Engagement-Persistence, Self-Regulation-Flexibility, and Self-Regulation-Frustration Tolerance. Correlations and known-groups differences analyses showed robust construct validity across a range of chronic health conditions. CONCLUSIONS: The new PROMIS EC Parent Report well-being measures offer clinicians and researchers a brief, efficient, and precise way to evaluate young children's well-being. All five measures include only positively valanced item content, which pushes the field to evaluate the presence of children's positive assets rather than the absence of problems.

Measuring PROMIS® Global Health in Early Childhood.

OBJECTIVE: Assessing general ("global") health is important to clinicians caring for patients, researchers studying patient subgroups, and epidemiologists tracking population trends. The Patient-Reported Outcomes Measurement Information System® (PROMIS®) introduced an adult self-report Global Health measure (ages 18+) in 2009 and pediatric versions (ages 5-17 years) in 2014. Our aim was to extend global health assessment to 1-5-year olds. METHODS: We used the PROMIS mixed-methods approach to develop PROMIS Early Childhood (EC) Global Health, emphasizing qualitative measure development guidance utilizing input from experts and parents. Quantitatively, we conducted two data collection waves with parents of 1-5-year olds and applied state-of-the-science measure development methods, including exploratory, confirmatory, and bi-factor analytics, particularly regarding potentially multi-dimensional Global Health item content. We conducted a series of hypothesis-based across-domain association analyses, which were more exploratory in nature, and known-groups validity analyses. RESULTS: Experts emphasized the physical, mental, and social facets of global health, and parents described the broader, overarching construct. Using Waves 1 (N = 1,400) and 2 (N = 1,057) data, we retained six items directly sourced from the age 5-17 version and two new items. The resulting 8-item PROMIS EC Global Health was sufficiently unidimensional, so we fit item responses to the graded response model for parameter estimation. This produced an 8-item scale with one total score. Across-domain associations and known-groups validity analyses largely supported our hypotheses. CONCLUSIONS: We achieved our aim to extend global health assessment to 1-5-year olds and to thereby expand the range of PROMIS life course global health assessment from children aged 1-17 years, to adults of all ages.

Measuring PROMIS® Emotional Distress in Early Childhood.

OBJECTIVE: Create and validate developmentally sensitive parent-report measures of emotional distress for children ages 1-5 years that conceptually align with the Patient-Reported Outcome Measurement Information System (PROMIS®) pediatric measures. METHODS: Initial items were generated based on expert and parent input regarding core components of emotional distress in early childhood and review of theoretical and empirical work in this domain. Items were psychometrically tested using data from two waves of panel surveys. Item response theory (IRT) was applied to develop item calibration parameters (Wave 1), and scores were centered on a general U.S. population sample (Wave 2). Final PROMIS early childhood (EC) instruments were compared with existing measures of related constructs to establish construct validity. RESULTS: Experts and parents confirmed the content validity of the existing PROMIS Pediatric emotional distress domains (i.e., anger, anxiety, and depressive symptoms) as developmentally salient for young children. Existing items were adapted and expanded for early childhood by employing best practices from developmental measurement science. Item banks as well as 4- and 8-item short forms, free from differential item functioning across sex and age, were constructed for the three domains based on rigorous IRT analyses. Correlations with subscales from previously validated measures provided further evidence of construct validity. CONCLUSIONS: The PROMIS EC Anger/Irritability, Anxiety, and Depressive Symptoms measures demonstrated good reliability and initial evidence of validity for use in early childhood. This is an important contribution to advancing brief, efficient measurement of emotional distress in young children, closing a developmental gap in PROMIS pediatric emotional distress assessment.

Psychometric properties of the spinal cord injury-quality of life (SCI-QOL) Resilience item bank in a sample with spinal cord injury and chronic pain.

PURPOSE: To describe the psychometric properties (e.g., data distribution characteristics, convergent/discriminant validity, internal consistency reliability, and test administration characteristics) of the spinal cord injury quality of life measurement system (SCI-QOL) Resilience item bank delivered as a computer adaptive test (CAT) in a sample of individuals with chronic pain and spinal cord injury (SCI). METHODS: Descriptive statistics were calculated to investigate variable data distribution characteristics. Correlation analyses were conducted for convergent and discriminant validity. Item response theory-derived reliability was calculated for the SCI-QOL Resilience CAT. RESULT: One hundred thirty-three adults with SCI (N = 133; 73.5% male, 26.5% female) were enrolled. Sample mean T score on the SCI-QOL Resilience measure was 48.40, SD = 8.60 (min = 29.4; max = 70.0). The CAT administered between 4 (most common, 41.4% of cases) and 12 (9% of cases) items with the Mean#items = 5.73, SD = 2.45. The SCI-QOL Resilience CAT scores were normally distributed, with very low ceiling (0%) and floor (3%) effects. The SCI-QOL Resilience CAT had a reliability of 0.89, and the mean length of time for respondents to complete the SCI-QOL Resilience CAT was 44.34 s. SCI-QOL Resilience CAT validity was supported by significant moderate correlations with pain acceptance, depressive symptoms, pain catastrophizing, positive affect and well-being, and pain interference (convergent validity) and small non-significant correlations with age, sex, injury level, pain intensity, mobility level, and years since injury (discriminant validity). CONCLUSION: The SCI-QOL Resilience CAT demonstrated good convergent and discriminant validity. The CAT administration characteristics were impressive: With few items (low response burden), the scale achieved good reliability.

New complementary perspectives for inpatient physical function assessment: matched clinician-report and patient-report short form measures from the PROMIS adult physical function item bank.

PURPOSE: To develop two item content-matched, precise, score-level targeted inpatient physical function (PF) short form (SF) measures: one clinician-reported, one patient-reported. Items were derived from PROMIS PF bank content; scores are reported on the PROMIS PF T-score metric. METHODS: The PROMIS PF item bank was reviewed for content measuring lower-level PF status (T-scores 10-50) with high item set score-level reliability (≥ 0.90). Selected patient-reported (PR) items were also edited to function as clinician-reported (CR) items. Items were reviewed by clinicians and field tested; responses were assessed for meeting PROMIS measure development standards. New CR and PR items were calibrated using patient responses to the original PROMIS PF items as anchoring data. SFs were constructed, based on content and precision. RESULTS: Nine PROMIS PF items were candidates for CR and PR inpatient PF assessment; three new items were written to extend content coverage. An inpatient sample (N = 515; 55.1% female; mean age = 66.2 years) completed 12 PR items and was assessed by physical therapists (using 12 CR items). Analyses indicated item sets met expected measure development standards. Twelve new CR and three new PR items were linked to the PROMIS PF metric (raw score r = 0.73 and 0.90, respectively). A 5-item CR SF measure was constructed; score-level reliabilities were ≥ 0.90 for T-scores 13-45. A 5-item PR SF measure was assembled, mirroring CR SF content. CONCLUSIONS: Two item content-matched SFs have been developed for clinician and patient reporting and are an effective, efficient means of assessing inpatient PF and offer complementary perspectives.

Development of Reliable and Valid Negative Mood Screening Tools for Orthopaedic Patients with Musculoskeletal Pain.

BACKGROUND: Negative mood is an important risk factor for poor clinical outcomes among individuals with musculoskeletal pain. Screening for negative mood can aid in identifying those who may need additional psychological interventions. Limitations of current negative mood screening tools include (1) high response burden, (2) a focus on single dimensions of negative mood, (3) poor precision for identifying individuals with low or high negative mood levels, and/or (4) design not specific for use in populations with orthopaedic conditions and musculoskeletal pain. QUESTIONS/PURPOSES: (1) Can item response theory methods be used to construct screening tools for negative mood (such as depression, anxiety, and anger) in patients undergoing physical therapy for orthopaedic conditions? (2) Do these tools demonstrate reliability and construct validity when used in a clinical setting? METHODS: This was a cross-sectional study involving outpatients having physical therapy in tertiary-care settings. A total of 431 outpatients with neck (n = 93), shoulder (n = 108), low back (n = 119), or knee (n = 111) conditions were enrolled between December 2014 and December 2015, with 24% (103 of 431) seeking care after orthopaedic surgery. Participants completed three validated psychological questionnaires measuring negative mood, resulting in 39 candidate items for item response theory analysis. Factor analysis was used to identify the dimensions (factors) assessed by the candidate items and select items that loaded on the main factor of interest (negative mood), establishing a unidimensional item set. Unidimensionality of an item set suggests they are assessing one main factor or trait, allowing unbiased score estimates. The identified items were assessed for their fit to the graded item response theory model. This model allows for items to vary by the level of difficulty they represent and by their ability to discriminate between patients at different levels of the trait being assessed, in this case, negative mood. Finally, a hierarchical bifactor model where multiple subfactors are allowed to load on an overall factor was used to confirm that the items identified as representing a unidimensional item set explained the large majority of variance of the overall factor, providing additional support for essential unidimensionality. Using the final item bank, we constructed a computer adaptive test administration mode, and reduced item sets were selected to create short forms including items with the highest information (reliability) at targeted score levels of the trait being measured, while also considering clinical content. RESULTS: We identified a 12-item bank for assessment of negative mood; eight-item and four-item short-form versions were developed to reduce administrative burden. Computer adaptive test administration used a mean ± SD of 8 ± 1 items. The item bank's reliability (0 = no reliability; 1 = perfect reliability) was 0.89 for the computer adaptive test administration, 0.86 for the eight-item short form, and 0.71 for the four-item short form. Reliability values equal to or greater than 0.7 are considered acceptable for group level measures. Construct validity sufficient for clinical practice was supported by more severe negative mood scores among individuals with a previous episode of pain in the involved anatomical region, pain and activity limitations during the past 3 months, a work-related injury, education less than a college degree, and income less than or equal to USD 50,000. CONCLUSION: These newly derived tools include short-form and computer adaptive test options for reliable and valid negative mood assessment in outpatient orthopaedic populations. Future research should determine the responsiveness of these measures to change and establish score thresholds for clinical decision-making. CLINICAL RELEVANCE: Orthopaedic providers can use these tools to inform prognosis, establish clinical benchmarks, and identify patients who may benefit from psychological and/or behavioral treatments.

The Lower Extremity Physical Function Patient-Reported Outcome Measure Was Reliable, Valid, and Efficient for Patients With Musculoskeletal Impairments.

OBJECTIVE: To calibrate the Lower Extremity Functional Scale (LEFS) items into a regional lower extremity physical function (LEPF) item bank and assess reliability, validity, and efficiency of computerized adaptive test (CAT) and short form (SF) administration modes. DESIGN: Retrospective cohort. SETTING: Data were collected from patients treated in outpatient rehabilitation clinics for musculoskeletal impairments of the hip, knee, foot, and ankle that responded to all 20 LEFS items at intake. PARTICIPANTS: Patients aged 14 years or older who started an episode of care during January 2016-October 2019 and identified the lower extremity region as the source of a primary musculoskeletal complaint. Total cohort included 78,186 patients (mean age, 53±19y, range, 14-89y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Item response theory (IRT) model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were studied. LEPF-CAT- and LEPF-SF-generated scores were evaluated. RESULTS: An 18-item solution was supported for its unidimensionality and fit to the IRT model, with reliability estimates >0.9 for all administration modes. No DIF impact on LEPF scores was identified. Scores discriminated between multiple patient groups in clinically logical ways and were highly responsive to change, with negligible floor or ceiling effects. CAT scores were generated using an average of 4.9 items (median, 4). CONCLUSIONS: The LEPF scores were reliable, valid, and efficient for assessing perceived physical function of patients with musculoskeletal impairments of the hip, knee, foot, and ankle; thus, it was found suitable for research and routine clinical administration. These findings are limited to the type of patients included in this study, with further validation needed to assess their generalizability.

PROMIS® Pediatric Depressive Symptoms as a Harmonized Score Metric.

OBJECTIVE: To conduct an evidence-based review of adolescent self-report depression measures and to demonstrate how various measures can be rescored onto a harmonized metric. METHOD: Six widely used person-reported outcome measures (PROMs) were reviewed. Psychometric properties were evaluated using previously published guidance for PROMs. Next, two secondary data sources (from an outpatient behavioral health clinic and from the general population) were evaluated to harmonize scores across three of the measures. Both item response theory and equipercentile linking methods were used and compared. RESULTS: All six PROMs demonstrated a high evidence base for widespread use depending on the purpose of the assessments. Adolescent involvement when developing the PROM for content validity and floor or ceiling effects were the least frequent available evidence. Three of the PROMs were linked to the PROMIS® Pediatric Depressive Symptoms v2.0 (PROMIS-PedDepSx) metric. The scales were highly correlated and essentially unidimensional when aggregated. All linking methods were broadly comparable. Group-level score conversions are recommended to minimize linking bias. CONCLUSIONS: There are a number of strong, widely used PROMs for the evidence-based assessment (EBD) of adolescent depression. However, score comparability is a concern whenever there is a proliferation of measures. Harmonized score metrics support data aggregation and re-analysis. Using four PROMs, one of which served as the scoring metric, we demonstrated the possibility of harmonized depression scores. Future directions for EBD should evaluate whether harmonized PROMs for other pediatric health domains would be useful.

Associations between interim patient-reported outcome measures and functional status at discharge from rehabilitation for non-specific lumbar impairments.

PURPOSE: Identify impact of frequency and timing of interim Patient-Reported Outcome Measures (PROMs) assessments during episodes of care for rehabilitation services in outpatient clinical settings on functional status (FS) outcomes at discharge for patients with low back pain. METHODS: FS outcomes of patients who had no interim PROMs were compared to outcomes of six patient groups defined by interim timing (early, mid, late) and frequency (1, 2 or more). For each comparison, patients were matched using propensity score matching for variables known to be associated with FS outcomes and for episode duration (days) and number of visits. FS was assessed using the lumbar computerized adaptive test (LCAT) where scores range from 0 to 100 with higher scores representing better physical function. RESULTS: A sample of 140,336 patients was considered for matching (mean age = 58 [SD = 17] range 18-89; 60% females) with 83,101 patients (59%) having no interim PROMs. Patients who had only one interim PROM, administered during early (first 2 weeks), mid (weeks 3-4), or late (week 5 or later) timing, had 4.6, 2.7, and 1.0 additional FS score points at discharge compared to those without an interim PROM, respectively (p < 0.001). Having two or more interim PROMs was associated with an additional 1.2 FS points compared to having only one interim assessment, but only if the first interim was administered early. CONCLUSIONS: Optimal utilization of interim PROM assessment during clinical practice to enhance treatment outcomes was related to administering the first interim PROM within the first 2 weeks after the initial evaluation.

Does recall period matter? Comparing PROMIS® physical function with no recall, 24-hr recall, and 7-day recall.

PURPOSE: To evaluate the influence of recall periods on the assessment of physical function, we compared, in cancer and general population samples, the standard administration of PROMIS Physical Function items without a recall period to administrations with 24-hour and 7-day recall periods. METHODS: We administered 31 items from the PROMIS Physical Function v2.0 item bank to 2400 respondents (n = 1001 with cancer; n = 1399 from the general population). Respondents were randomly assigned to one of three recall conditions (no recall, 24-hours, or 7-days) and one of two "reminder" conditions (with recall periods presented only at the start of the survey or with every item). We assessed items for potential differential item functioning (DIF) by recall time period. We then tested recall and reminder effects with analysis of variance controlling for demographics, English fluency, and co-morbidities. RESULTS: Based on conservative pre-set criteria, no items were flagged for recall time period-related DIF. Using analysis of variance, each condition was compared to the standard PROMIS administration for Physical Function (no recall period). There was no evidence of significant differences among groups in the cancer sample. In the general population sample, only the 24-hour recall condition with reminders was significantly different from the "no recall" PROMIS standard. At the item level, for both samples, the number of items with non-trivial effect size differences across conditions was minimal. CONCLUSIONS: Compared to no recall, the use of a recall period has little to no effect upon PROMIS physical function responses or scores. We recommend that PROMIS Physical Function be administered with the standard PROMIS "no recall" period.

Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Fatigue and Sleep Disturbance Item Banks.

OBJECTIVE: To examine the reliability and validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures of sleep disturbance and fatigue in traumatic brain injury (TBI) caregivers and to determine the severity of fatigue and sleep disturbance in these caregivers. DESIGN: Cross-sectional survey data collected through an online data capture platform. SETTING: A total of 4 rehabilitation hospitals and Walter Reed National Military Medical Center. PARTICIPANTS: Caregivers (N=560) of civilians (n=344) and service member/veterans (SMVs) (n=216) with TBI. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: PROMIS sleep and fatigue measures administered as both computerized adaptive tests (CATs) and 4-item short forms (SFs). RESULTS: For both samples, floor and ceiling effects for the PROMIS measures were low (<11%), internal consistency was very good (all α≥0.80), and test-retest reliability was acceptable (all r≥0.70 except for the fatigue CAT in the SMV sample r=0.63). Convergent validity was supported by moderate correlations between the PROMIS and related measures. Discriminant validity was supported by low correlations between PROMIS measures and measures of dissimilar constructs. PROMIS scores indicated significantly worse sleep and fatigue for those caring for someone with high levels versus low levels of impairment. CONCLUSIONS: Findings support the reliability and validity of the PROMIS CAT and SF measures of sleep disturbance and fatigue in caregivers of civilians and SMVs with TBI.