Pain Interference Item Bank Research Articles

Using bookmarking methods with orthopedic clinicians and patients with fractures produces score interpretation labels for patient-reported outcome measures

ObjectiveThe objective of this study was to determine the patient-reported outcome measure (PROM) score ranges associated with descriptive labels (i.e., within normal limits, mild, moderate, severe) by using bookmarking methods with orthopedic clinicians and patients who have experienced a bone fracture.Study design and settingWe created vignettes comprised of six items and responses from the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function, Physical Function, and Pain Interference item banks reflecting different levels of severity. Two groups of patients with fractures (n = 11) and two groups of orthopedic clinicians (n = 16) reviewed the vignettes and assigned descriptive labels independently and then discussed as a group until reaching consensus via a videoconference platform.ResultsPROMIS Physical Function and Pain Interference thresholds (T = 50, 40, 25/30 and T = 50/55, 60, 65/70, respectively) for patients with bone fractures were consistent with the results from other patient populations. Upper Extremity thresholds were about 10 points (1 SD) more severe (T = 40, 30, 25/20) compared to the other measures. Patient and clinician perspectives were similar.ConclusionBookmarking methods generated meaningful score thresholds for PROMIS measures. These thresholds between severity categories varied by domain. Threshold values for severity represent important supplemental information to interpret PROMIS scores clinically.

German translation of the PROMIS® pediatric anxiety, anger, depressive symptoms, fatigue, pain interference and peer relationships item banks

BackgroundThe present study aimed at the translation and cross-cultural adaptation of six PROMIS® pediatric self- and proxy- item banks and short forms to universal German: anxiety (ANX), anger (ANG), depressive symptoms (DEP), Fatigue (FAT), pain interference (P) and peer relationships (PR).MethodsUsing standardized methodology approved by the PROMIS Statistical Center and in line with recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Translation Task Force, two translators for each German-speaking country (Germany, Austria, and Switzerland) commented on and rated the translation difficulty and provided forward translations, followed by a review and reconciliation phase. An independent translator performed back translations, which were reviewed and harmonized. The items were tested in cognitive interviews with 58 children and adolescents from Germany (16), Austria (22), and Switzerland (20) for the self-report and 42 parents and other caregivers (Germany (12), Austria (17), and Switzerland (13)) for the proxy-report.ResultsTranslators rated the translation difficulty of most items (95%) as easy or feasible. Pretesting showed that items of the universal German version were understood as they were intended, as only 14 out of 82 items of the self-report and 15 out of 82 items of the proxy-report versions required minor rewording. However, on average German translators rated the items more difficult to translate (M = 1.5, SD = 0.20) than the Austrian (M = 1.3, SD = 0.16) and the Swiss translators (M = 1.2, SD = 0.14) on a three-point Likert scale.ConclusionsThe translated German short forms are ready for use by researchers and clinicians (https://www.healthmeasures.net/search-view-measures).

The relationship between pain and sleep in pediatric sickle cell disease.

Pain and sleep disturbances are prevalent complications experienced by pediatric patients with sickle cell disease (SCD). This study aims to identify associations between pain and sleep, and to characterize sleep chronotype and social jetlag in children and adolescent patients with SCD. We performed a cross-sectional survey of 105 pediatric patients with SCD aged 8-17years using PROMIS (Patient Reported Outcomes Measurement System) pain interference, sleep disturbance, and sleep-related impairment item banks. The μMCTQ (Ultra-short Munich Chronotype Questionnaire) assessed chronotype and social jetlag. Analyses were performed to assess associations between PROMIS measures, sleep patterns, and clinical variables. Female participants reported higher T-scores for sleep-related impairment than males (females: 56.7±10 vs. males 50.2±9.4, p=.0009). Patients with one or more emergency department (ED) visits for pain in the last 12months reported greater sleep disturbance (55.0±8.5 vs. 50.7±10, p=.046) and sleep-related impairment (57.1±9.3 vs. 52.1±10.2, p=.03) than patients without any ED visits for pain in the last 12months. Pain interference was significantly associated with both sleep disturbance (r=.49, p<.0001) and sleep-related impairment (r=.46, p<.0001). The average mid-sleep time was 4:14±1:44 a.m. and the average social jetlag (hh:mm) was 2:32±1:35. Our study demonstrates that pain interference is associated with both sleep disturbance and sleep-related impairment. PROMIS measures can identify patients that suffer from pain and sleep disturbances and highlights the need to conduct longitudinal prospective studies to define the directionality of pain and sleep in SCD.

The Relationship of Sleep and Pain in Pediatric Sickle Cell Disease

Background: Pain interference and sleep problems (sleep disturbance and sleep-related impairment) are prevalent complications experienced by pediatric patients living with sickle cell disease (SCD). If sleep problems contribute to increased pain interference, sleep-directed behavioral interventions could be an additional non-opioid approach to minimizing pain in SCD patients. We hypothesized that sleep disturbance and sleep-related impairment are associated with an increase in pain interference. Second, we studied the prevalence of a later chronotype (preferred timing of sleep) and social jetlag (difference in sleep patterns during the week and weekend), which are measures of circadian sleep patterns, in pediatric patients with SCD. Methods: We performed a IRB approved cross-sectional survey of pediatric patients with SCD aged 8-17 years at a single clinic visit using PROMIS (Patient Reported Outcomes Measurement System) pain interference, sleep disturbance and sleep-related impairment item banks, which utilize T-scores to measure the severity of these parameters; greater scores in each domain signify greater severity. The µMCTQ (ultra-short Munich Chronotype Questionnaire) assessed mid-sleep time (a proxy for chronotype) and social jetlag. Analyses were performed to assess associations between PROMIS measures, sleep patterns and clinical variables using JMP Pro16 (Cary, NC). Results: One hundred and five patients (mean age: 13.1±2.6 years; 53 male, 52 female) completed the PROMIS sleep and pain measures. All participants approached completed the PROMIS evaluation for pain and sleep. The majority of patients (81.9%) were diagnosed with either HbSS or HbSβ0 -thalassemia and 61% were on hydroxyurea (alone or with an additional sickle cell modifying therapy). Pain interference was significantly associated with both sleep disturbance (r=0.49, p<0.0001) and sleep-related impairment (r=0.46, p<0.0001). In multivariate analysis for pain interference, both sleep disturbance (p=0.0007) and sleep-related impairment (p=0.006) remained in the model. Females participants reported higher T-scores for sleep-related impairment than males (females: 56.7± 10 vs males 50.2± 9.4, p=0.0009). Patients with one or more ED visits for pain in the last year reported greater sleep disturbance (55.0±8.5 vs 50.7± 10, p=0.046) and sleep-related impairment (57.1± 9.3 vs 52.1± 10.2, p=0.026) (Figure). The average mid-sleep time (clock time) was 4:14 ± 1:44 AM and the average social jetlag (hh:mm) was 2:32 ± 1:35. Conclusion: Pain interference is associated with both sleep disturbance and sleep-related impairment and our 100% acceptance rate for completing PROs highlights the clinical importance of performing formal sleep and pain assessments. A longitudinal examination of sleep and pain in pediatric SCD patients is needed to determine if sleep problems and pain have a bi-directional relationship. Furthermore, the high prevalence of later mid-sleep times and social jetlag in this sample suggests that longitudinal studies should incorporate measures of sleep timing and social jetlag impact on pain. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Responsiveness and Minimal Important Change of the PROMIS Pain Interference Item Bank in Patients Presented in Musculoskeletal Practice

We evaluated the responsiveness of the Patient Reported Outcome Information System Pain Interference item bank in patients with musculoskeletal pain by testing predefined hypotheses about the relationship between the change scores on the item bank, change scores on legacy instruments and Global Ratings of Change (GRoC), and we estimated Minimal Important Change (MIC). Patients answered the full Dutch-Flemish V1.1 item bank. From the responses we derived scores for the standard 8-item short form (SF8a) and a CAT-score was simulated. Correlations between the change scores on the item bank, GRoC and legacy instruments were calculated, together with Effect Sizes, Standardized Response Means, and Area Under the Curve. GRoC were used as an anchor for estimating the MIC with (adjusted) predictive modeling. Of 1,677 patients answering baseline questionnaires 960 completed follow-up questionnaires at 3 months. The item bank correlated moderately high with the GRoC (Spearman's rho 0.63) and with the legacy instruments (Pearson's R ranging from .45 to .68). It showed a high ES (.97) and Standardized Response Means (.71), and could distinguish well between improved and not improved patients based on the GRoC (Area Under the Curve .77). Comparable results were found for the derived SF8a and CAT-scores. The MIC was estimated to be 3.2 (CI 2.6-3.7) T-score points. PerspectiveOur study supports the responsiveness of the PROMIS-PI item bank in patients with musculoskeletal complaints. Almost all predefined hypotheses were met (94%). The PROMIS-PI item bank correlated well with several legacy instruments which supports generic use of the item bank. MIC for PROMIS-PI was estimated to be 3.2 T-score points.

Tailoring Pain Interference Measurement in People with Cancer: A Feasibility Study.

Most patient-reported outcomes (PRO) are not directly tailored to an individual patient's values, partially because tailored PROs require clinical interviews or are difficult to use in statistical analyses. This study tested a method for tailoring pain PROs, Precision PROs, that can be implemented, and analyzed using standard statistical tests. People with cancer and pain (n=231) completed an online survey and then a second survey (n=161) one to two weeks later. Participants reviewed the PROMIS pain interference item bank, chose the four items most important to their quality of life, and then completed those items. Kappas compared choices between the two surveys. Participants completed measures of pain intensity, physical function, and a standard pain interference measure. All participants were able to select four items that were personally meaningful. Only one item (enjoyment of life) was chosen by more than half the sample (50.6%). Kappas for item choice were in the moderate to nearly perfect range for 32 of 35 items. The majority of the sample (59%) preferred tailoring their own PRO questions to completing a previously determined, non-patient-specific PRO. The Precision PRO scores had similar associations with pain intensity and physical function as the standard pain interference measure. The Precision PRO approach was feasible, more preferred by patients, and showed consistency over a short timeframe. This approach could be used to make PRO assessment in clinical care and clinical trials more patient-centered. Additional research is needed to determine the generalizability of this approach to other outcomes and populations.

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis

BackgroundPatients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health.MethodsA qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance).ResultsThirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation.ConclusionPain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Defining Pain That Does Not Interfere With Activities Among Rheumatoid Arthritis Patients

The objectives of this study were to: 1) characterize the distribution of noninterfering pain (defined as the pain intensity level at which individuals can function without interference) across different aspects of life among patients with rheumatoid arthritis (RA), and 2) identify clinical characteristics associated with differing levels of noninterfering pain. Patients with RA in FORWARD, The National Databank for Rheumatic Diseases completed 8 items from the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference item bank that asked about interference with activities. If subjects reported pain interference, they were asked, "At what level would pain no longer interfere with this activity?" on a scale of 0 to 10. Subjects were also asked, "At what level of pain would you be able to do everything you want to do?" Multiple linear regression analyses examined associations between clinical characteristics and noninterfering pain. A total of 3,949 patients with RA completed the questionnaires. Pain interference was most common for daily activities and least common for ability to concentrate. The mean ± SD level at which pain no longer interfered with activities ranged from 2.7 ± 2.1 for ability to fall/stay asleep to 3.1 ± 2.0 for social activities. Overall, the mean ± SD threshold for noninterfering pain was 2.8 ± 1.9. The mean ± SD level of pain at which patients could do everything they wanted to do was 2.3 ± 1.9. More severe pain intensity was associated with higher noninterfering pain. The mean pain level that did not interfere with activities was 3. High pain intensity was associated with high self-reported noninterfering pain.

Psychometric Properties of the Pediatric Patient-Reported Outcomes Measurement Information System Item Banks in a Dutch Clinical Sample of Children With Juvenile Idiopathic Arthritis.

ObjectiveTo assess the psychometric properties of 8 pediatric Patient‐Reported Outcomes Measurement Information System (PROMIS) item banks in a clinical sample of children with juvenile idiopathic arthritis (JIA).MethodsA total of 154 Dutch children (mean ± SD age 14.4 ± 3.0 years; range 8–18 years) with JIA completed 8 pediatric version 1.0 PROMIS item banks (anger, anxiety, depressive symptoms, fatigue, pain interference, peer relationships, physical function mobility, physical function upper extremity) twice and the Pediatric Quality of Life Inventory (PedsQL) and the Childhood Health Assessment Questionnaire (C‐HAQ) once. Structural validity of the item banks was assessed by fitting a graded response model (GRM) and inspecting GRM fit (comparative fit index [CFI], Tucker‐Lewis index [TLI], and root mean square error of approximation [RMSEA]) and item fit (S‐X2 statistic). Convergent validity (with PedsQL/C‐HAQ subdomains) and discriminative validity (active/inactive disease) were assessed. Reliability of the item banks, short forms, and computerized adaptive testing (CAT) was expressed as the SE of theta (SE[θ]). Test–retest reliability was assessed using intraclass correlation coefficients (ICCs) and smallest detectable change.ResultsAll item banks had sufficient overall GRM fit (CFI >0.95, TLI >0.95, RMSEA <0.08) and no item misfit (all S‐X2 P > 0.001). High correlations (>0.70) were found between most PROMIS T scores and hypothesized PedsQL/C‐HAQ (sub)domains. Mobility, pain interference, and upper extremity item banks were able to discriminate between patients with active and inactive disease. Regarding reliability, PROMIS item banks outperformed legacy instruments. Post hoc CAT simulations outperformed short forms. Test–retest reliability was strong (ICC >0.70) for all full‐length item banks and short forms, except for the peer relationships item bank.ConclusionThe pediatric PROMIS item banks displayed sufficient psychometric properties for Dutch children with JIA. PROMIS item banks are ready for use in clinical research and practice for children with JIA.

First Validation of the Full PROMIS Pain Interference and Pain Behavior Item Banks in Patients With Rheumatoid Arthritis.

Pain interference and pain behavior are highly relevant outcomes in patients with rheumatoid arthritis (RA). The Patient-Reported Outcomes Measurement Information System (PROMIS) is a universally applicable set of item banks measuring patient-reported health, and if applied as computerized adaptive tests (CATs), more efficiently and precisely than current instruments. The objective was to study the psychometric properties of the Dutch-Flemish PROMIS pain interference (PROMIS-PI) and the PROMIS pain behavior (PROMIS-PB) item banks in patients with RA. A total of 2,029 patients with RA completed the full PROMIS-PI (version 1.1, 40 items), and 1,554 patients completed the full PROMIS-PB (version 1.1, 39 items). The following psychometric properties were studied: unidimensionality, local dependence, monotonicity and graded response model (GRM) fit, cross-cultural validity (differential item functioning [DIF] for language [Dutch versus Flemish]), other forms of measurement invariance, construct validity, reliability, and floor and ceiling effects. The PROMIS-PI and PROMIS-PB banks were sufficiently unidimensional (Omega-hierarchical [Omega-H] 0.99, 0.95, and explained common variance 0.95, 0.78, respectively), had negligible local dependence (0.3-1.4% of item pairs), good monotonicity (H 0.75, 0.46), and a good GRM model fit (no misfitting items). Furthermore, both item banks showed good cross-cultural validity (no DIF for language), measurement invariance (no DIF for age, sex, administration mode, and disease activity), good construct validity (all hypotheses met), high reliability (>0.90 in the range of patients with RA), and an absence of floor and ceiling effects (0% minimum or maximum score, respectively). Both PROMIS-PI and PROMIS-PB banks showed good psychometric properties in patients with RA and can be used as CATs in research and clinical practice.

Evaluation of preoperative pain in patients undergoing shoulder surgery using the PROMIS pain interference computer-adaptive test

ObjectiveThe purpose of this study was to evaluate the Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive testing Pain Interference (PROMIS PI) item bank in patients undergoing shoulder surgery. We hypothesized that PROMIS PI would exhibit a strong positive correlation with the numerical pain scale for the operative shoulder (shoulder NPS) with less floor and ceiling effects. Secondary study aims included assessing the relationships between patient characteristics and PROMIS PI. DesignAnalytical cross-sectional study. SettingUrban academic medical center. PatientsOne-hundred and ninety-five patients undergoing shoulder surgery between June 2015 to June 2017. Main outcome measuresAll patients completed a series of patient-reported outcomes measures, including PROMIS PI and NPS. Non-parametric tests were used for bivariate analysis. Multivariable regression models were used to determine independent associations. ResultsThere was a moderate correlation between the PROMIS PI and shoulder NPS scores (rs = 0.53; p < 0.001). PROMIS PI had no ceiling or floor effects while shoulder NPS had 26 patients (13.3%) at either the floor or the ceiling. PROMIS PI demonstrated a strong correlation with PROMIS Physical Function (rs = -0.65; p < 0.001), ASES total score (rs = -0.67; p < 0.001), and PROMIS Fatigue (rs = 0.64; p < 0.001). ConclusionsThe strong association noted between PROMIS PI and psychosocial and behavioral factors, versus that of NPS, demonstrates that PROMIS Pain Interference may be a more appropriate choice as an outcome measure where the surgeon is concerned about a patient’s improvement of functioning and decrease in the impact of pain in other aspects of wellbeing following shoulder surgery. Level of evidenceIV.

Measuring Pain in TBI: Development of the TBI-QOL Pain Interference Item Bank and Short Form

ObjectiveTo develop a pain interference item bank, computer adaptive test (CAT), and short form for use by individuals with traumatic brain injury (TBI). DesignCross-sectional survey study. SettingFive TBI Model Systems rehabilitation hospitals. ParticipantsIndividuals with TBI (N=590). InterventionsNot applicable. Outcome MeasuresTraumatic Brain Injury–Quality of Life (TBI-QOL) Pain Interference item bank. ResultsConfirmatory factor analysis provided evidence of a single underlying trait (χ2 [740]=3254.030; P<.001; Comparative Fix Index=0.988; Tucker-Lewis Index=0.980; Root Mean Square Error of Approximation=0.076) and a graded response model (GRM) supported item fit of 40 Pain Interference items. Items did not exhibit differential item functioning or local item dependence. GRM calibration data were used to inform the selection of a 10-item static short form and to program a TBI-QOL Pain Interference CAT. Comparative analyses indicated excellent comparability and reliability across test administration formats. ConclusionThe 40-item TBI-QOL Pain Interference item bank demonstrated strong psychometric properties. End users can administer this measure as either a 10-item short form or CAT.

Validation of the Dutch-Flemish PROMIS Pain Interference Item Bank in Patients With Musculoskeletal Complaints.

A cross-sectional study. The aim of this study was to validate the Dutch-Flemish PROMIS Pain Interference item bank in patients with musculoskeletal complaints. PROMIS item banks have been developed and validated in the US. They need to be further validated in various patient populations and in different languages. One thousand six hundred seventy-seven patients answered the full item bank. A Graded Response Model (GRM) was used to study dimensionality with confirmatory factor analyses and by assessing local independency. Monotonicity was evaluated with Mokken scaling. An Item Response Theory (IRT) model was used to study item fit and to estimate slope and threshold parameters. Differential item functioning (DIF) for language, age, and gender was assessed using ordinal logistic regression analyses. DIF for language was evaluated by comparing our data with a similar US sample. Hypotheses concerning construct validity were tested by correlating item bank-scores with scores on several legacy instruments. The GRM showed suboptimal evidence of unidimensionality in confirmatory factor analysis [Comparative Fit Index (CFI): 0.903, Tucker-Lewis Index (TLI): 0.897, Root Mean Square Error of Approximation (RMSEA): 0.144], and 99 item pairs with local dependence. A bifactor model showed good fit (CFI: 0.964, TLI: 0.961, RMSEA: 0.089), with a high Omega-H (0.97), a high explained common variance (ECV: 0.81), and no local dependence. Sufficient monotonicity was shown for all items (Mokken H(i): 0.367-0.686). The unidimensional IRT model showed good fit (only two items with S-X < 0.001), with slope parameters ranging from 1.00 to 4.27, and threshold parameters ranging from -1.77 to 3.66. None of the items showed DIF for age or gender. One item showed DIF for language. Correlations with legacy instruments were high (Pearson R: 0.53-0.75), supporting construct validity. The high omega-H and the high ECV indicate that the item bank could be considered essentially unidimensional. The item bank showed good item fit, good coverage of the pain interference trait, and good construct validity. N/A.

Differential item functioning of the PROMIS physical function, pain interference, and pain behavior item banks across patients with different musculoskeletal disorders and persons from the general population.

To investigate the validity of comparisons across patients with different musculoskeletal disorders and persons from the general population by evaluating differential item functioning (DIF) for the PROMIS physical function (PROMIS-PF), pain interference (PROMIS-PI), and pain behavior (PROMIS-PB) item banks. Patients with chronic pain, rheumatoid arthritis (RA), or osteoarthritis (OA); patients receiving physiotherapy (PT); and persons from the Dutch general population completed the full Dutch-Flemish PROMIS-PF (121-items), PROMIS-PI (40-items), or PROMIS-PB (39-items) banks. DIF was assessed with ordinal logistic regression models and McFadden's pseudo R2-change of ≥ 2% as critical value. The impact of DIF on item scores and the T-scores per bank was examined by inspecting item characteristic curves (ICCs) and test characteristic curves (TCCs). 2762 patients with chronic pain, 2029 with RA, 1247 with OA, 805 receiving PT, and 1310 healthy persons participated. For the PROMIS-PF, 25 out of 121 items were flagged for DIF, of which 10 items were flagged in multiple comparisons. For the PROMIS-PI, only 2 out of 40 items were flagged for DIF and for the PROMIS-PB, only 3 out of 39 items. Most DIF items had R2 values just above the critical value of 2% and all showed uniform DIF. The ICCs and TCCs showed that the magnitude and impact of DIF on the item and T-scores were negligible. This study supports the universal applicability of PROMIS across (patient) populations. Comparisons across patients with different musculoskeletal disorders and persons from the general population are valid, when applying the PROMIS-PF, PROMIS-PI, and PROMIS-PB banks.

Psychometric evaluation of the pediatric and parent-proxy Patient-Reported Outcomes Measurement Information System and the Neurology and Traumatic Brain Injury Quality of Life measurement item banks in pediatric traumatic brain injury.

The primary objective is to provide evidence of convergent and discriminant validity for the pediatric and parent-proxy versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, Depression, Anger, Peer Relations, Mobility, Pain Interference, and Fatigue item banks, the Neurology Quality of Life measurement system (Neuro-QOL) Cognition-General Concerns and Stigma item banks, and the Traumatic Brain Injury Quality of Life (TBI-QOL) Executive Function and Headache item banks in a pediatric traumatic brain injury (TBI) sample. Participants were 134 parent-child (ages 8-18 years) days. Children all sustained TBI and the dyads completed outcome ratings 6 months after injury at one of six medical centers across the United States. Ratings included PROMIS, Neuro-QOL, and TBI-QOL item banks, as well as the Pediatric Quality of Life inventory (PedsQL), the Health Behavior Inventory (HBI), and the Strengths and Difficulties Questionnaire (SDQ) as legacy criterion measures against which these item banks were validated. The PROMIS, Neuro-QOL, and TBI-QOL item banks demonstrated good convergent validity, as evidenced by moderate to strong correlations with comparable scales on the legacy measures. PROMIS, Neuro-QOL, and TBI-QOL item banks showed weaker correlations with ratings of unrelated constructs on legacy measures, providing evidence of discriminant validity. Our results indicate that the constructs measured by the PROMIS, Neuro-QOL, and TBI-QOL item banks are valid in our pediatric TBI sample and that it is appropriate to use these standardized scores for our primary study analyses.

Differential item functioning of the patient-reported outcomes information system (PROMIS®) pain interference item bank by language (Spanish versus English).

About 70% of Latinos, 5years old or older, in the United States speak Spanish at home. Measurement equivalence of the PROMIS® pain interference (PI) item bank by language of administration (English versus Spanish) has not been evaluated. A sample of 527 adult Spanish-speaking Latinos completed the Spanish version of the 41-item PROMIS® pain interference item bank. We evaluate dimensionality, monotonicity and local independence of the Spanish-language items. Then we evaluate differential item functioning (DIF) using ordinal logistic regression with item response theory scores estimated from DIF-free "anchor" items. One of the 41 items in the Spanish version of the PROMIS® PI item bank was identified as having significant uniform DIF. English- and Spanish-speaking subjects with the same level of pain interference responded differently to 1 of the 41 items in the PROMIS® PI item bank. This item was not retained due to proprietary issues. The original English language item parameters can be used when estimating PROMIS® PI scores.

Measuring pain phenomena after spinal cord injury: Development and psychometric properties of the SCI-QOL Pain Interference and Pain Behavior assessment tools

Objective: To develop modern patient-reported outcome measures that assess pain interference and pain behavior after spinal cord injury (SCI). Design: Grounded-theory based qualitative item development; large-scale item calibration field-testing; confirmatory factor analyses; graded response model item response theory analyses; statistical linking techniques to transform scores to the Patient Reported Outcome Measurement Information System (PROMIS) metric. Setting: Five SCI Model Systems centers and one Department of Veterans Affairs medical center in the United States. Participants: Adults with traumatic SCI. Interventions: N/A. Outcome Measures: Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference item bank, SCI-QOL Pain Interference short form, and SCI-QOL Pain Behavior scale. Results: Seven hundred fifty-seven individuals with traumatic SCI completed 58 items addressing various aspects of pain. Items were then separated by whether they assessed pain interference or pain behavior, and poorly functioning items were removed. Confirmatory factor analyses confirmed that each set of items was unidimensional, and item response theory analyses were used to estimate slopes and thresholds for the items. Ultimately, 7 items (4 from PROMIS) comprised the Pain Behavior scale and 25 items (18 from PROMIS) comprised the Pain Interference item bank. Ten of these 25 items were selected to form the Pain Interference short form. Conclusions: The SCI-QOL Pain Interference item bank and the SCI-QOL Pain Behavior scale demonstrated robust psychometric properties. The Pain Interference item bank is available as a computer adaptive test or short form for research and clinical applications, and scores are transformed to the PROMIS metric.

Impact of IRT item misfit on score estimates and severity classifications: an examination of PROMIS depression and pain interference item banks.

In patient-reported outcome research that utilizes item response theory (IRT), using statistical significance tests to detect misfit is usually the focus of IRT model-data fit evaluations. However, such evaluations rarely address the impact/consequence of using misfitting items on the intended clinical applications. This study was designed to evaluate the impact of IRT item misfit on score estimates and severity classifications and to demonstrate a recommended process of model-fit evaluation. Using secondary data sources collected from the Patient-Reported Outcome Measurement Information System (PROMIS) wave 1 testing phase, analyses were conducted based on PROMIS depression (28 items; 782 cases) and pain interference (41 items; 845 cases) item banks. The identification of misfitting items was assessed using Orlando and Thissen's summed-score item-fit statistics and graphical displays. The impact of misfit was evaluated according to the agreement of both IRT-derived T-scores and severity classifications between inclusion and exclusion of misfitting items. The examination of the presence and impact of misfit suggested that item misfit had a negligible impact on the T-score estimates and severity classifications with the general population sample in the PROMIS depression and pain interference item banks, implying that the impact of item misfit was insignificant. Findings support the T-score estimates in the two item banks as robust against item misfit at both the group and individual levels and add confidence to the use of T-scores for severity diagnosis in the studied sample. Recommendations on approaches for identifying item misfit (statistical significance) and assessing the misfit impact (practical significance) are given.

Individuals with knee impairments identify items in need of clarification in the Patient Reported Outcomes Measurement Information System (PROMIS®) pain interference and physical function item banks - a qualitative study.

BackgroundThe content and wording of the Patient Reported Outcome Measurement Information System (PROMIS) Physical Function and Pain Interference item banks have not been qualitatively assessed by individuals with knee joint impairments. The purpose of this investigation was to identify items in the PROMIS Physical Function and Pain Interference Item Banks that are irrelevant, unclear, or otherwise difficult to respond to for individuals with impairment of the knee and to suggest modifications based on cognitive interviews.MethodsTwenty-nine individuals with knee joint impairments qualitatively assessed items in the Pain Interference and Physical Function Item Banks in a mixed-methods cognitive interview. Field notes were analyzed to identify themes and frequency counts were calculated to identify items not relevant to individuals with knee joint impairments.ResultsIssues with clarity were identified in 23 items in the Physical Function Item Bank, resulting in the creation of 43 new or modified items, typically changing words within the item to be clearer. Interpretation issues included whether or not the knee joint played a significant role in overall health and age/gender differences in items. One quarter of the original items (31 of 124) in the Physical Function Item Bank were identified as irrelevant to the knee joint. All 41 items in the Pain Interference Item Bank were identified as clear, although individuals without significant pain substituted other symptoms which interfered with their life.ConclusionsThe Physical Function Item Bank would benefit from additional items that are relevant to individuals with knee joint impairments and, by extension, to other lower extremity impairments. Several issues in clarity were identified that are likely to be present in other patient cohorts as well.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-016-0478-7) contains supplementary material, which is available to authorized users.

THU0563 Validation of the Dutch-Flemish PROMIS Pain Behavior and Pain Interference Item Banks in Patients with Chronic Pain

BackgroundIn the assessment of chronic pain patients it is important to measure pain behavior and pain interference. The National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed...