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• The newly developed regional lower extremity physical function (LEPF) patient-reported outcome measure (PROM) is reliable, valid, and efficient. • The LEPF computerized adaptive test and LEPF short form can be used for research and clinical care. • Clinicians may simplify PROM administration by using a single regional measure. 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. Retrospective cohort. 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. 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). Not applicable. 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. 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). 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. [ABSTRACT FROM AUTHOR]

To compare, by collection time and patient characteristics, inpatient rehabilitation quality measure scores calculated using patient-reported data. Cohort study of rehabilitation inpatients with neurologic conditions who reported their experience of care and pain status at discharge and 1month after discharge. Two inpatient rehabilitation facilities (IRFs). Patients with neurologic conditions (N=391). Not applicable. We calculated 18 quality measure scores using participants' responses to 55 experience of care and health status questions addressing communication, support and encouragement, care coordination, discharge information, goals, new medications, responsiveness of staff, cleanliness, quietness, pain management, care transitions, overall hospital rating, willingness to recommend, and pain. Of the 391 participants reporting at discharge, 277 (71%) also reported postdischarge after multiple attempts by e-mail, mail, and telephone. Discharge experience of care quality scores ranged from 25% (responsiveness of hospital staff) to 75% (willingness to recommend hospital); corresponding postdischarge scores were 32% to 87%, respectively. Five of the 16 experience of care quality scores increased significantly between discharge and postdischarge. The percentage of participants reporting high pain levels at discharge did not change across time periods. Patients with less education, older age, higher motor and cognitive function, and those who were not Hispanic or black had more favorable quality measure scores. Patients' experience of care responses tended to be more favorable after discharge compared to discharge, suggesting that survey timing is important. Responses were more favorable for patients with selected characteristics, suggesting the possible need for risk adjustment if patient-reported quality measure scores are compared across IRFs. [ABSTRACT FROM AUTHOR]

To date, there is no validated measure for pain catastrophizing at the daily level. The Pain Catastrophizing Scale (PCS) is widely used to measure trait pain catastrophizing. We sought to develop and validate a brief, daily version of the PCS for use in daily diary studies to facilitate research on mechanisms of catastrophizing treatment, individual differences in self-regulation, and to reveal the nuanced relationships between catastrophizing, correlates, and pain outcomes. After adapting the PCS for daily use, we evaluated the resulting 14 items using 3 rounds of cognitive interviews with 30 adults with chronic pain. We refined and tested the final daily PCS in 3 independent, prospective, cross-sectional, observational validation studies conducted in a combined total of 519 adults with chronic pain who completed online measures daily for 14 consecutive days. For study 1 (N = 131), exploratory factor analysis revealed adequate fit and-unexpectedly-unidimensionality for item responses to the daily PCS. Study 2 (N = 177) correlations indicated adequate association with related constructs (anger, anxiety, pain intensity, depression). Similarly, results for study 3 (N = 211) revealed expected correlations for daily PCS and measures of daily constructs including physical activity, sleep, energy level, and positive affect. Results from complex/multilevel confirmatory factor analysis confirmed good fit to a unidimensional model. Scores on the daily PCS were statistically comparable with and more parsimonious than the full 14-item version. Next steps include evaluation of score validity in populations with medical diagnoses, greater demographic diversity, and in patients with acute pain.Perspective: This article describes the development and validation of a daily PCS. This daily measure may facilitate research that aims to characterize pain mechanisms, individual differences in self-regulation, adaptation, and nuanced relationships between catastrophizing, correlates, and pain outcomes. [ABSTRACT FROM AUTHOR]

Objectives: Neuropathic pain (NP) is a consequence of many chronic conditions. This study aimed to develop an unidimensional NP scale with scores that represent levels of NP and distinguish between individuals with NP and non-NP conditions.Methods: A candidate item pool of 42 pain quality descriptors was administered to participants with osteoarthritis, rheumatoid arthritis, diabetic neuropathy, and cancer chemotherapy-induced peripheral neuropathy. A subset of pain quality descriptors (items) that best distinguished between participants with and those without NP conditions were identified. Dimensionality of pain descriptors was evaluated in a development sample and cross-validated in a holdout sample. Item responses were calibrated using an item response theory model, and scores were generated on a T-score metric. NP scale scores were evaluated in terms of the reliability, validity, and ability to distinguish between participants with and without conditions typically associated with NP.Results: Of the 42 initial items, 5 were identified for the Patient-Reported Outcome Measurement Information System (PROMIS) Neuropathic Pain Quality Scale. T scores exhibited good discriminatory ability on the basis of receiver-operator characteristic analysis. Score thresholds that optimize sensitivity and specificity were identified. Construct, criterion, and discriminant validity, and reliability of scale scores were supported.Conclusions: The five-item Patient-Reported Outcome Measurement Information System (PROMIS PQ-Neuro) Neuropathic Pain Quality Scale is a short and practical measure that can be used to identify patients more likely to have NP and to distinguish levels of NP. The data collected will support future research that targets other unidimensional pain quality domains (e.g., nociceptive pain). [ABSTRACT FROM AUTHOR]

• An improved and comprehensive technique for measuring/assessing self-reported physical function is needed in MS. • We have developed a new PROMIS short form for assessing physical function in MS. • The new short form demonstrated validity and reliability across US and UK MS populations. • A preliminary minimal important difference estimate and score interpretation guidance are provided. A valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed. A mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening. Factor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (≥ 0.97) and intraclass correlation coefficient (≥ 0.97) of test-retest scores (5–27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3–2.7 points are proposed as MID criteria for minimal worsening in PF. PROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. Input from patients and clinicians ensured the content is comprehensive and relevant for people with MS. [ABSTRACT FROM AUTHOR]

Objectives: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed nonspecific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. The purpose of this article is to disseminate the report of the National Institutes of Health (NIH) task force on research standards for cLBP. Methods: The NIH Pain Consortium charged a research task force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel developed a 3-stage process, each with a 2-day meeting. Results: The panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research subjects (drawing heavily on the Patient Reported Outcomes Measurement Information System methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved these recommendations, which investigators should incorporate into NIH grant proposals. Conclusions: The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of cLBP. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. We expect the RTF recommendations will become a dynamic document and undergo continual improvement. [ABSTRACT FROM AUTHOR]

Abstract: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement. Perspective: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. [Copyright &y& Elsevier]

Highlights: [•] We produced cross-walk tables linking three popular instruments to PROMIS Anxiety. [•] The scores of our common measure (PROMIS Anxiety) are centered on the 2000 US census. [•] Users can directly compare clinical scores obtained on multiple measures of anxiety. [•] Clinical means or cut-off scores were close to one SD above the population mean. [Copyright &y& Elsevier]

Context: Pain is a common and complex experience for individuals who live with multiple sclerosis (MS) and it interferes with physical, psychological, and social function. A valid and reliable tool for quantifying observed pain behaviors in MS is critical to understand how pain behaviors contribute to pain-related disability in this clinical population. Objectives: To evaluate the reliability and validity of a pain behavioral observation protocol in individuals who have MS. Methods: Community-dwelling volunteers with MS (N =30), back pain (N =5), or arthritis (N =8) were recruited based on clinician referrals, advertisements, fliers, web postings, and participation in previous research. Participants completed the measures of pain severity, pain interference, and self-reported pain behaviors and were videotaped doing typical activities (e.g., walking and sitting). Two coders independently recorded frequencies of pain behaviors by category (e.g., guarding and bracing) and interrater reliability statistics were calculated. Naïve observers reviewed videotapes of individuals with MS and rated their pain. The Spearman's correlations were calculated between pain behavior frequencies and self-reported pain and pain ratings by naïve observers. Results: Interrater reliability estimates indicated the reliability of pain codes in the MS sample. Kappa coefficients ranged from moderate (sighing=0.40) to substantial agreements (guarding=0.83). These values were comparable with those obtained in the combined back pain and arthritis sample. Concurrent validity was supported by correlations with self-reported pain (0.46–0.53) and with self-reports of pain behaviors (0.58). Construct validity was supported by a finding of 0.87 correlation between total pain behaviors observed by coders and mean pain ratings by naïve observers. Conclusion: Results support the use of the pain behavior observation protocol for assessing pain behaviors of individuals with MS. Valid assessments of pain behaviors of individuals with MS could lead to creative interventions in the management of chronic pain in this population. [ABSTRACT FROM AUTHOR]

Abstract: Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington Self-Efficacy Scale: a new self-efficacy scale for people with disabilities. Objective: To develop a self-efficacy scale for people living with multiple sclerosis (MS) and spinal cord injury (SCI) that can be used across diagnostic conditions. Design: The scale was developed using modern psychometric methods including item response theory. Items were administered at 3 time-points of a longitudinal survey of individuals with MS and SCI. Setting: Survey participants with MS were recruited from the National MS Society, and participants with SCI were recruited from the Northwest Regional Spinal Cord Injury Model System and the Shepherd Center at the Virginia Crawford Research Institute in Atlanta, GA. Participants: Adults aged 18 years and older reporting a definitive diagnosis of MS (N=473) or SCI (N=253). Interventions: None. Main Outcome Measures: Evaluation of the new self-efficacy measure called the University of Washington Self-Efficacy Scale (UW-SES) included comparisons with the Chronic Disease Self-Efficacy Scale and other patient-reported outcome measures. Results: UW-SES has excellent psychometric properties including well-functioning response categories, no floor effects, and low ceiling effects. A long form (17 items) and a short form (6 items) are available. The correlation between the score on the newly developed scale and the Chronic Disease Self-Efficacy Scale was high (.83), providing support for convergent validity. Higher self-efficacy scores were statistically significantly associated with better mental health, better physical health, less fatigue, less stress, less pain interference, less pain, fewer sleep problems, and lower depressive symptoms. Conclusions: The UW-SES is a psychometrically sound instrument for measuring self-efficacy, validated in MS and SCI, and can be used across both conditions. Both the long form and the short form are available free of charge. [Copyright &y& Elsevier]

The aim of the study was to evaluate children''s and adolescents'' understanding of items from self-report measures. Cognitive interviews were conducted as part of a larger study on pain and fatigue in children with disabilities. A list of guiding questions was used to encourage participants to talk about words or concepts in the scale that they found difficult. The sample included 32 children and adolescents with physical disabilities. Participants had difficulty with words such as intense, severe, and anxiety. They had more difficulty with abstract ideas, such as average, than they did with more concrete ideas, such as naming a recreational or social activity. Because poor outcome measurement hinders symptom evaluation, findings support the need to put greater emphasis on the child perspective when developing and using self-report measures. Suggestions for increasing accuracy of these measures are offered for clinicians and researchers. [Copyright &y& Elsevier]

Abstract: Cook KF, Molton IR, Jensen MP. Fatigue and aging with a disability. Objective: To compare self-reported fatigue in 4 disability populations with age-matched, U.S. population norms. We assessed fatigue and age in a sample of individuals with spinal cord injury (SCI), postpolio syndrome (PPS), multiple sclerosis (MS), and muscular dystrophy (MD). Design: This study used survey responses and published age cohort means for fatigue to test the hypothesis that fatigue would be higher in each of 4 clinical samples than the U.S. population norm. We also hypothesized that, for clinical samples, the mean fatigue reported within age cohorts would be higher than the general U.S. population norms for those age ranges derived in the Patient-Reported Outcomes Measurement Information System (PROMIS). Setting: Survey responses were collected from participants in the Washington state area. Participants: Participants (N=1836) were persons with MD (n=337), MS (n=580), Post-polio (n=441), and SCI (n=478). Interventions: Not applicable. Main Outcome Measure: PROMIS Depression Short Form. Results: Individuals with disabilities reported higher levels of fatigue than the normative PROMIS population. In the normative population, self-reported fatigue was substantially lower in age cohorts from middle age to retirement age. However, individuals with disabilities did not demonstrate this age cohort effect. Conclusions: Individuals with disabilities are not only at greater risk to experience fatigue, but this risk, relative to normative values, increases with age. More research is needed to determine the specific negative impact of fatigue symptoms on functioning in individuals with disabilities as they age. [Copyright &y& Elsevier]

Abstract: Cook KF, Bombardier CH, Bamer AM, Choi SW, Kroenke K, Fann JR. Do somatic and cognitive symptoms of traumatic brain injury confound depression screening? Objective: To evaluate whether items of the Patient Health Questionnaire 9 (PHQ-9) function differently in persons with traumatic brain injury (TBI) than in persons from a primary care sample. Design: This study was a retrospective analysis of responses to the PHQ-9 collected in 2 previous studies. Responses to the PHQ-9 were modeled using item response theory, and the presence of DIF was evaluated using ordinal logistic regression. Setting: Eight primary care sites and a single trauma center in Washington state. Participants: Participants (N=3365) were persons from 8 primary care sites (n=3000) and a consecutive sample of persons with complicated mild to severe TBI from a trauma center who were 1 year postinjury (n=365). Interventions: Not applicable. Main Outcome Measure: PHQ-9. Results: No PHQ-9 item demonstrated statistically significant or meaningful DIF attributable to TBI. A sensitivity analysis failed to show that the cumulative effects of nonsignificant DIF resulted in a systematic inflation of PHQ-9 total scores. Therefore, the results also do not support the hypothesis that cumulative DIF for PHQ-9 items spuriously inflates the numbers of persons with TBI screened as potentially having major depressive disorder. Conclusions: The PHQ-9 is a valid screener of major depressive disorder in people with complicated mild to severe TBI, and all symptoms can be counted toward the diagnosis of major depressive disorder without special concern about overdiagnosis or unnecessary treatment. [Copyright &y& Elsevier]

Objective: This study compared self-reported fatigue between 7-day and 4-week time frames and explored factors that affect patients' responses.Study Design and Setting: Two hundred and sixteen cancer patients completed either 7-day or 4-week version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Cochran-Mantel-Haenszel statistics and Cochran-Armitage trend tests were used to assess the association between time frame and item scores. Information function curves at both item and scale levels were depicted to evaluate the precision along the fatigue continuum. Differential item functioning (DIF) was used to examine the stability of the psychometric properties between time frames.Results: Time frame did not influence patients' item responses. Examination of information function curves at item level did not clearly favor either time frame. At the scale level, the 7-day time frame was slightly more precise overall than the 4-week time frame. No item demonstrated DIF between time frames. Neither gender nor fatigue severity had an impact on above results.Conclusion: This study suggests 7-day and 4-week time frame are equally appropriate in measuring fatigue, preference might be given to the more informative 7-day time frame. However, substantive considerations regarding the appropriate time frame should outweigh statistical ones. [ABSTRACT FROM AUTHOR]

Abstract: Mahoney JS, Engebretson JC, Cook KF, Hart KA, Robinson-Whelen S, Sherwood AM. Spasticity experience domains in persons with spinal cord injury. Objective: To understand the everyday life experiences of persons who have spasticity associated with spinal cord injury (SCI). Design: Applied ethnographic design. Setting: Patients’ homes and rehabilitation clinics. Participants: Twenty-four people with SCI who experience spasticity. Interventions: Not applicable. Main Outcome Measures: Domains identified through qualitative analysis of in-depth open-ended interviews. Results: Domain analysis revealed 7 domains: physical, activity, emotional, economic, interpersonal, management, and cognitive. Descriptive subcategories within each domain were identified. Patients personalized the meaning of spasticity and expressed their understandings of the condition in ways that may not be consistent with clinical definitions. Some patients suggested that being able to control spasticity was preferable to total suppression. Conclusions: Spasticity-related interventions need to be aimed at what matters most to the patient. It is critical for clinicians to understand patients’ experiences to make accurate assessments, effectively evaluate treatment interventions, and select appropriate management strategies. When providers reconfigure patients’ descriptions to fit neatly with a biomedical understanding of spasticity without carefully assessing the descriptions in terms of what matters most to patients, a potential risk for misappropriating interventions may arise. [Copyright &y& Elsevier]

Abstract: Background and Objective: To test unidimensionality and local independence of a set of shoulder functional status (SFS) items, develop a computerized adaptive test (CAT) of the items using a rating scale item response theory model (RSM), and compare discriminant validity of measures generated using all items (θIRT) and measures generated using the simulated CAT (θCAT). Study Design and Setting: We performed a secondary analysis of data collected prospectively during rehabilitation of 400 patients with shoulder impairments who completed 60 SFS items. Results: Factor analytic techniques supported that the 42 SFS items formed a unidimensional scale and were locally independent. Except for five items, which were deleted, the RSM fit the data well. The remaining 37 SFS items were used to generate the CAT. On average, 6 items were needed to estimate precise measures of function using the SFS CAT, compared with all 37 SFS items. The θIRT and θCAT measures were highly correlated (r = .96) and resulted in similar classifications of patients. Conclusion: The simulated SFS CAT was efficient and produced precise, clinically relevant measures of functional status with good discriminating ability. [Copyright &y& Elsevier]

Evaluates the psychometrics of the health utilities in the United States. Analysis of utility cost; Examination of the health states; Efficacy of the medical strategies.

• Current questionnaires used to measure fatigue in patients with MS exhibit varied robustness in psychometric properties. • We evaluated the PROMIS Fatigue (MS) 8a as a measure of fatigue severity in MS. • The instrument demonstrated strong validity, test-retest reliability and responsiveness. • The psychometric properties of the PROMIS Fatigue (MS) 8a as reported in the current study are generalizable to patients with MS not requiring a scooter or wheelchair for mobility. • Our data extend evidence supporting this fatigue measure across MS populations. Fatigue is one of the most common and the single most disabling symptom of multiple sclerosis (MS). However, there is a lack of consensus on the most appropriate fatigue measures in clinical practice and research, based upon rigorously validated, generalizable, and publicly available instruments. The objective of this research was to generate additional evidence regarding the validity and applicability of the PROMIS SF v1.0 – Fatigue (MS) 8a, including content validity, reliability, construct validity and responsiveness, as well as to assess minimal important difference (MID) estimates and a score interpretation tool to aide meaningful individual level score interpretation. A mixed-methods, sequential design was followed. Cognitive debriefing (CD) interviews (n=29) were performed with MS patients, to assess the relevance and comprehensiveness of the PROMIS Fatigue (MS) 8a scores. To evaluate the psychometric properties of the PROMIS Fatigue (MS) 8a, two observational studies were conducted: a cross-sectional study at two US MS centers (n=296), and a 96-week longitudinal study in a UK MS Register cohort (n=384). Main outcomes and measures were estimates of known-groups validity, convergence validity, reliability, and responsiveness, a guide for interpreting PROMIS Fatigue (MS) 8a T-scores, and anchor-based MID estimates. The CD interviews confirmed the comprehensiveness and relevance of the PROMIS Fatigue (MS) 8a in assessing MS fatigue. Cronbach's alpha (>0.9) and intra-class correlation coefficient (≥0.9) for test-retest scores at 5–7 days follow-up, supported strong internal consistency and test-retest reliability. Hypothesized differences were found across patient groups in patient reported fatigue and related concepts (analysis of variance [ANOVA], P <0.001). PROMIS Fatigue (MS) 8a scores were sensitive to bi-directional changes in fatigue (GHS fatigue global question) and physical health (PROMIS GHS GPH), over a 52-week follow-up. Score changes of 3.4–4 points are proposed as MID criteria for minimal improvement or worsening in fatigue. This research extends the evidence supporting the content validity and the robust psychometric performance of the PROMIS Fatigue (MS) 8a across US and UK MS populations. Importantly, data supporting the measure's integration in clinical practice and research, including meaningful score interpretation, are now available. [ABSTRACT FROM AUTHOR]

Abstract: Cook KF, Bamer AM, Amtmann D, Molton IR, Jensen MP. Six Patient-Reported Outcome Measurement Information System short form measures have negligible age- or diagnosis-related differential item functioning in individuals with disabilities. Objective: To evaluate the measurement invariance of 6 self-report measures selected for an ongoing longitudinal study of individuals with spinal cord injury, muscular dystrophy, postpolio syndrome, and multiple sclerosis. Design: Participants completed and returned by mail surveys that included the targeted self-report measures. Ordinal logistic regressions methods were applied to evaluate items for differential item functioning (DIF) by diagnosis and age range. Setting: Community. Participants: Participants (N=2479) who had 1 of the 4 target diagnoses. Interventions: None. Main Outcome Measures: Six short-form measures from the Patient-Reported Outcome Measurement Information System (PROMIS) were administered to participants to measure fatigue, pain interference, satisfaction with social roles, sleep disturbance, sleep-related impairment, and depression. Results: One item of 1 measure (fatigue) exhibited DIF by diagnosis based on a published standard for meaningful DIF. However, scores corrected for this DIF were highly correlated with uncorrected scores (r>.999). No DIF by age range was found for any of the measures. Conclusions: Study findings support the use of the selected PROMIS short forms for comparing symptoms and quality of life indicators across different diagnoses and age ranges. [Copyright &y& Elsevier]

Abstract: Amtmann D, Cook KF, Johnson KL, Cella D. The PROMIS initiative: involvement of rehabilitation stakeholders in development and examples of applications in rehabilitation research. To fully capture the impact of a disease or condition on the lives of individuals, patient-reported outcomes are considered a necessary component of health measurement in rehabilitation. This article provides an overview of the involvement of rehabilitation stakeholders in the development of sound measurement tools for the Patient-Reported Outcomes Measurement Information System (PROMIS), a National Institutes of Health–funded initiative. PROMIS is a multisite study that included many different populations. We focus on the involvement of people with several chronic conditions, including multiple sclerosis, spinal cord injury, and arthritis, in the development of PROMIS measures. We describe both qualitative and quantitative methods used, including expert panels, focus groups, cognitive interviews, and item response theory modeling, which resulted in enhanced utility of PROMIS measures in rehabilitation. Measures include a set of global health items and 12 item banks representing 6 domains. Scores are reported in the T score metric (mean ± SD, 50±10) and centered on mean values from the U.S. general population. The PROMIS item banks measure quality of life and symptoms of people with chronic conditions and have the potential to enhance research and clinical practice by facilitating comparisons of scores across domains and populations. [Copyright &y& Elsevier]

Objectives: Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items.Study Design and Setting: Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census.Results: Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures.Conclusion: PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations. [ABSTRACT FROM AUTHOR]

Abstract: This study examined two approaches to linking items from two pain surveys to form a single item bank with a common measurement scale. Secondary analysis of two independent surveys: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Survey with Main Survey (959 chronic pain patients; 42 pain items) and Pain Module (n =148; 36 pain items), and Center on Outcomes, Research and Education Survey (400 cancer patients; 43 pain items). There were common items included among the three data sets. In the first approach, all items were calibrated to an item response theory (IRT) model simultaneously, and in the second approach, items were calibrated separately and then the scales were transformed to a common metric. The two approaches produced similar linking results across the two sets of pain interference items because there was sufficient number of common items and large enough sample size. For pain intensity, simultaneous calibration yielded more stable results. Separated calibration yielded an unsatisfactory linking result for pain intensity because of a single common item with small sample size. The results suggested that a simultaneous IRT calibration method produces the more stable item parameters across independent samples, and hence, should be recommended for developing comprehensive item banks. Patient-reported health outcome surveys are often limited in sample sizes and the number of items owing to the difficulty of recruitment and the burden to the patients. As a result, the surveys either lack statistical power or are limited in scope. Using IRT methodology, survey data can be pooled to lend strength to each other to expand the scope and to increase the sample sizes. [Copyright &y& Elsevier]

Abstract: Objective: Measures of shoulder function may differ by dominance of affected shoulder, surgical history, gender, or race. We present a technique for determining whether observed differences in function between groups are due to biased test items or real differences in function. Study Design and Setting: Four hundred patients who were receiving rehabilitation for a variety of shoulder impairments completed a survey of shoulder function. Thirty-seven items measuring shoulder function were analyzed for differential item functioning (DIF) related to demographic characteristics using an ordinal logistic regression (OLR) and item response theory (IRT) approach. When DIF was identified in an item, we modified the IRT analysis to calibrate item parameters separately in appropriate demographic groups. We compared adjusted and unadjusted patient ability measures in each demographic group. Results: Several items were found to have a modest amount of DIF related to the different demographic characteristics, especially gender; however, adjusting measures for DIF had little impact on overall measures of shoulder function and made almost no difference in average shoulder function across demographic groups. Conclusion: In this pool of shoulder function items, adjustment for DIF made almost no difference in measures of function across demographic groups. [Copyright &y& Elsevier]

Abstract Objective To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference items for use in a quality measure and to compare the resulting quality score, along with internal reliability and validity, to a similar item set in the Minimum Data Set Version 3.0 (MDS). Design Cross-sectional, observational study. Setting One freestanding inpatient rehabilitation facility (IRF) and one large hospital-based IRF. Participants Patients with neurologic disorders. Of 1055 consecutive admissions, 26% were excluded based on clinician-determined cognitive impairment or emotional distress. Of the remainder, 50% consented and completed the survey near the end of their IRF stay (N = 391). Of these, more than half (57%) reported pain over the last day (n = 224). Measurements Psychometric statistics and quality scores were computed from a 55-question survey, including the MDS and PROMIS pain interference items. Results Estimates for internal reliability were higher for the PROMIS 2-item scale compared to the MDS: Cronbach α (0.86 vs 0.48) and interitem correlations (0.75 vs 0.31). The PROMIS-2 items were better able to detect differences in patients with mild and severe pain intensity (Cohen d = 1.57) relative to the corresponding MDS items (Cohen d = 0.81). Two quality scores based on the PROMIS-2 items, reflecting low and high levels of pain interference, showed 46% or 12% of patients meeting these thresholds. This compared to a 30% rate when patients were classified by the MDS as experiencing pain interference. Conclusions PROMIS pain interference items appear to be more internally consistent than similar MDS items. The graded PROMIS items permit the creation of multiple quality scores, showing predictable overlap with corresponding MDS quality scores. Because PROMIS items provide finer distinctions, they allow greater latitude in reporting quality scores. We recommend further study of pain interference scores across IRFs to improve their reliability and validity. [ABSTRACT FROM AUTHOR]