Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking.

OBJECTIVES: Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System® (PROMIS®) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. METHODS: We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face 'bookmarking' sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. RESULTS: In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5-10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. CONCLUSION: Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.

Customizing CAT Administration of the PROMIS Misuse of Prescription Pain Medication Item Bank for Patients with Chronic Pain.

OBJECTIVE: The 22-item PROMIS®-Rx Pain Medication Misuse item bank (Bank-22) imposes a high response burden. This study aimed to characterize the performance of the Bank-22 in a computer adaptive testing (CAT) setting based on varied stopping rules. METHODS: The 22 items were administered to 288 patients. We performed a CAT simulation using default stopping rules (CATPROMIS). In 5 other simulations, a "best health" response rule was added to decrease response burden. This rule stopped CAT administration when a participant selected "never" to a specified number of initial Bank-22 items (2-6 in this study, designated CATAlt2-Alt6). The Bank-22 and 7-item short form (SF-7) scores were compared to scores based on CATPROMIS, and the 5 CAT variations. RESULTS: Bank-22 scores correlated highly with the SF-7 and CATPROMIS, Alt5, Alt6 scores (r=0.87-0.95) and moderately with CATAlt2- Alt4 scores (r=0.63-0.74). In all CAT conditions, the greatest differences with Bank-22 scores were at the lower end of misuse T-scores. The smallest differences with Bank-22 and CATPROMIS scores were observed with CATAlt5 and CATAlt6. Compared to the SF-7, CATAlt5 and CATAlt6 reduced overall response burden by about 42%. Finally, the correlations between PROMIS-Rx Misuse and Anxiety T-scores remained relatively unchanged across the conditions (r=0.31-0.43, Ps < .001). CONCLUSIONS: Applying a stopping rule based on number of initial "best health" responses reduced response burden for respondents with lower levels of misuse. The tradeoff was less measurement precision for those individuals, which could be an acceptable tradeoff when the chief concern is in discriminating higher levels of misuse.

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.

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.

PRO-Bookmarking to Estimate Clinical Thresholds for Patient-reported Symptoms and Function.

INTRODUCTION: PRO-Bookmarking is an alternative to traditional methods for deriving cut scores and applying qualitative modifiers to score ranges. METHODS: In PRO-Bookmarking, a working group of stakeholders identifies ranges of scores they judge to credibly define different levels of a patient-reported outcome (PRO). Subsets of items and responses, called "clinical vignettes," are woven into a narrative to represent different levels of the PRO. Working individually, stakeholders bookmark thresholds between clinical vignettes, ordered by PRO level, to define thresholds (eg, no problems, mild problems). Discussion of individual bookmark placements is led by a moderator with the goal of consensus with regard to bookmark locations. DISCUSSION: The value of PRO measures depends on the extent to which different stakeholders are able to interpret scores. The PRO-Bookmarking method provides credible evidence on the common-language meaning of different ranges of scores. This evidence supplements other interpretative methods such as normative comparisons and comparisons with an external standard. PRO-Bookmarking is particularly valuable when, as is often the case with PRO measures, there is no clear external standard or even a useful external reference with which to compare PRO scores. KEY POINTS: The PRO-Bookmarking procedure is a qualitative method that engages key stakeholders in in-depth consideration of the semantic meaning of ranges of PRO scores. Measures based on item banks calibrated using item response theory are ideal for PRO-Bookmarking. Response probabilities conditioned on different levels of the PRO are derived directly from the item response theory model, and item banks contain more items than traditional measures. Having a large number of items provides flexibility in the choice and variety of items that can be used to comprise the clinical vignettes. There is much to learn about Bookmarking in the PRO context and, more generally, about all methods for establishing PRO score thresholds. Issues for further study include the role of context of use for classifications, selection of semantic labels for levels of a PRO, and the extent to which findings generalize to clinical utility.

PROMIS® Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains.

BACKGROUND: There is a need for valid self-report measures of core health-related quality of life (HRQoL) domains. OBJECTIVE: To derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System® (PROMIS®) item banks. METHODS: Literature review, investigator consensus process, item response theory (IRT) analysis, and expert review of scaling results from multiple PROMIS data sets. We developed 3 profile measures ranging in length from 29 to 57 questions. These profiles assess important HRQoL domains with highly informative subsets of items from respective item banks and yield reliable information across mild-to-severe levels of HRQoL experiences. Each instrument assesses the domains of pain interference, fatigue, depression, anxiety, sleep disturbance, physical function, and social function using 4-, 6-, and 8-item short forms for each domain, and an average pain intensity domain score, using a 0-10 numeric rating scale. RESULTS: With few exceptions, all domain short forms within the profile measures were highly reliable across at least 3 standard deviation (30 T-score) units and were strongly correlated with the full bank scores. Construct validity with ratings of general health and quality of life was demonstrated. Information to inform statistical power for clinical and general population samples is also provided. CONCLUSIONS: Although these profile measures have been used widely, with summary scoring routines published, description of their development, reliability, and initial validity has not been published until this article. Further evaluation of these measures and clinical applications are encouraged.

Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting.

PURPOSE: Patient-Reported Outcomes Measurement Information System® (PROMIS®) physical function, cognitive function, and sleep disturbance measures are increasingly used in cancer care. However, there is limited guidance for interpreting the clinical meaning of scores. This study aimed to apply bookmarking, a standard setting methodology, to identify PROMIS score thresholds in the context of cancer care. METHODS: Using item parameters, we constructed vignettes of five items covering the range of possible scores. Focus groups were held with cancer care providers and people with cancer. Terminology for categorizing levels of severity was explored. Participants rank ordered vignettes by severity and then placed bookmarks between vignettes representing different levels of severity. Group discussion was held until consensus on bookmark placement was reached. RESULTS: Clinicians selected "within normal limits," "mild," "moderate," and "severe" to describe levels of severity. Both patients and clinicians were able to apply these labels, but there was not unanimous support for any set of descriptors. Clinicians and patients agreed on all severity thresholds for sleep disturbance. For cognitive and physical function, clinicians and patients agreed on the threshold between "within normal limits" and "mild." However, patients required greater dysfunction than clinicians before applying "moderate" and "severe" labels. CONCLUSIONS: Bookmarking can be applied to develop provisional score interpretation for PROMIS measures. Patients and clinicians were frequently consistent in their bookmark placement. When there was variance, patients required more dysfunction before assigning more severity. Additional research with other cancer samples is needed to evaluate the replicability and generalizability of our findings.

Evaluation of the Preliminary Validity of Misuse of Prescription Pain Medication Items from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

OBJECTIVE: The National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS)® includes an item bank for measuring misuse of prescription pain medication (PROMIS-Rx Misuse). The bank was developed and its validity evaluated in samples of community-dwelling adults and patients in addiction treatment programs. The goal of the current study was to investigate the validity of the item bank among patients with mixed-etiology chronic pain conditions. METHOD: A consecutive sample of 288 patients who presented for initial medical evaluations at a tertiary pain clinic completed questionnaires using the open-source Collaborative Health Outcomes Information Registry. Participants were predominantly middle-aged (M [SD] = 51.6 [15.5] years), female (62.2%), and white/non-Hispanic (51.7%). Validity was evaluated by estimating the association between PROMIS-Rx Misuse scores and scores on other measures and testing the ability of scores to distinguish among risk factor subgroups expected to have different levels of prescription pain medicine misuse (known groups analyses). RESULTS: Overall, score associations with other measures were as expected and scores effectively distinguished among patients with and without relevant risk factors. CONCLUSION: The study results supported the preliminary validity of PROMIS-Rx Misuse item bank scores for the assessment of prescription opioid misuse in patients visiting an outpatient pain clinic.

Developing a Pain Intensity Measure for Persons with Dementia: Initial Construction and Testing.

OBJECTIVE: The goal of this study was to identify a limited set of pain indicators that were most predicive of physical pain. We began with 140 items culled from existing pain observation tools and used a modified Delphi approach followed by statistical analyses to reduce the item pool. METHODS: Through the Delphi Method, we created a candidate item set of behavioral indicators. Next, trained staff observed nursing home residents and rated the items on scales of behavior intensity and frequency. We evaluated associations among the items and expert clinicians' assessment of pain intensity. SETTING: Four government-owned nursing homes and 12 community nursing homes in Alabama and Southeastern Pennsylvania. PARTICIPANTS: Ninety-five residents (mean age = 84.9 years) with moderate to severe cognitive impairment. RESULTS: Using the least absolute shrinkage and selection operator model, we identified seven items that best predicted clinicians' evaluations of pain intensity. These items were rigid/stiff body or body parts, bracing, complaining, expressive eyes, grimacing, frowning, and sighing. We also found that a model based on ratings of frequency of behaviors did not have better predictive ability than a model based on ratings of intensity of behaviors. CONCLUSIONS: We used two complementary approaches-expert opinion and statistical analysis-to reduce a large pool of behavioral indicators to a parsimonious set of items to predict pain intensity in persons with dementia. Future studies are needed to examine the psychometric properties of this scale, which is called the Pain Intensity Measure for Persons with Dementia.

Inpatient Rehabilitation Quality of Care From the Patient's Perspective: Effect of Data Collection Timing and Patient Characteristics.

OBJECTIVE: To compare, by collection time and patient characteristics, inpatient rehabilitation quality measure scores calculated using patient-reported data. DESIGN: Cohort study of rehabilitation inpatients with neurologic conditions who reported their experience of care and pain status at discharge and 1month after discharge. SETTING: Two inpatient rehabilitation facilities (IRFs). PARTICIPANTS: Patients with neurologic conditions (N=391). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: 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.

Moving from significance to real-world meaning: methods for interpreting change in clinical outcome assessment scores.

PURPOSE: Clinical outcome assessments (COAs) require evidence not only of reliability, validity, and ability to detect change, but also a definition of what constitutes a meaningful change on the instrument. The responder definition specifies the amount of change on the COA that may be interpreted as a treatment benefit and is critical for interpreting what constitutes a meaningful change on the COA scores. However, the literature that describes methods for developing and applying responder definitions can be difficult to navigate. Clear and concise guidelines regarding which methods to apply under what circumstances and how to interpret the results are lacking. This article provides a guide to the variety of available methods and issues that should be considered when establishing responder definitions for interpreting meaningful changes in COA scores. METHODS: An overview is provided for selecting anchors, developing study designs, planning psychometric analyses, using psychometric results to set responder thresholds, and applying responder thresholds in demonstrating treatment efficacy. RESULTS: There are a variety of anchor-based methods for consideration, but they all rely on a preference for strongly related and easily interpretable anchors. The benefits of applying multiple anchors and multiple analytic methods are discussed. The process of triangulation can synthesize results across multiple sources to gain confidence in a proposed responder definition. Though a link to meaningfulness from the patient's perspective is absent, distribution-based methods provide lower bound estimates of score precision and have a role in triangulation. Responder definitions are typically required within regulatory review, but their application may differ across clinical trial programs. CONCLUSIONS: By careful planning of anchor selection, study design, and psychometric methods, COA researchers can establish defensible responder thresholds that ultimately aid patients and clinicians in making informed treatment decisions.

Grooming a CAT: customizing CAT administration rules to increase response efficiency in specific research and clinical settings.

PURPOSE: To evaluate the degree to which applying alternative stopping rules would reduce response burden while maintaining score precision in the context of computer adaptive testing (CAT). DATA: Analyses were conducted on secondary data comprised of CATs administered in a clinical setting at multiple time points (baseline and up to two follow ups) to 417 study participants who had back pain (51.3%) and/or depression (47.0%). Participant mean age was 51.3 years (SD = 17.2) and ranged from 18 to 86. Participants tended to be white (84.7%), relatively well educated (77% with at least some college), female (63.9%), and married or living in a committed relationship (57.4%). The unit of analysis was individual assessment histories (i.e., CAT item response histories) from the parent study. Data were first aggregated across all individuals, domains, and time points in an omnibus dataset of assessment histories and then were disaggregated by measure for domain-specific analyses. Finally, assessment histories within a "clinically relevant range" (score ≥ 1 SD from the mean in direction of poorer health) were analyzed separately to explore score level-specific findings. METHOD: Two different sets of CAT administration rules were compared. The original CAT (CATORIG) rules required at least four and no more than 12 items be administered. If the score standard error (SE) reached a value < 3 points (T score metric) before 12 items were administered, the CAT was stopped. We simulated applying alternative stopping rules (CATALT), removing the requirement that a minimum four items be administered, and stopped a CAT if responses to the first two items were both associated with best health, if the SE was < 3, if SE change < 0.1 (T score metric), or if 12 items were administered. We then compared score fidelity and response burden, defined as number of items administered, between CATORIG and CATALT. RESULTS: CATORIG and CATALT scores varied little, especially within the clinically relevant range, and response burden was substantially lower under CATALT (e.g., 41.2% savings in omnibus dataset). CONCLUSIONS: Alternate stopping rules result in substantial reductions in response burden with minimal sacrifice in score precision.

Idio Scale Judgment: evaluation of a new method for estimating responder thresholds.

PURPOSE: To pilot the newly developed Idio Scale Judgment method for estimating the amount of score change that matters to patients (i.e., change thresholds). METHODS: An online panel of 500 participants diagnosed with multiple sclerosis (MS) responded to the Neuro-QoL fatigue scale and to demographic and clinical questions. Participants compared their own fatigue to that represented by seven short form summaries (SFSs) that were located relatively close to their own fatigue levels. They judged these as representing the same, greater, or less fatigue than their own. We calculated the distances between patients' own levels of fatigue and the location of SFSs they endorsed as a change that would make a difference in daily life. These distances were used as estimates of change thresholds. Logically inconsistent judgments were tabulated and associations with clinical and demographic variables were estimated. RESULTS: Change thresholds based on mean individual thresholds for consequential change were calculated for improvement (-3.5) and worsening (3.2). The majority of participants had no logically inconsistent judgments (69%). Having one or more reversals in judgment was not significantly associated with education or fatigue score, but was weakly associated with age, gender, and MS type and moderately associated with ratings of confidence in SFS comparisons. CONCLUSIONS: As piloted, Idio Scale Judgment had a number of design strengths. Participants made comparisons to levels of fatigue that were within range of their own, and their judgments were contextualized in personally relevant consequences. The design lends itself to collection of data in large samples allowing evaluation of the range of judgments. Some study limitations could be mitigated with modifications. We concluded that the Idio Scale Judgment has substantial promise as a new tool for estimating change thresholds.

Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers.

BACKGROUND: Patient-Reported Outcomes Measurement Information System (PROMIS) measures are used increasingly in clinical care. However, for juvenile idiopathic arthritis (JIA), scores lack a framework for interpretation of clinical severity, and minimally important differences (MID) have not been established, which are necessary to evaluate the importance of change. METHODS: We identified clinical severity thresholds for pediatric PROMIS measures of mobility, upper extremity function (UE), fatigue, and pain interference working with adolescents with JIA, parents of JIA patients, and clinicians, using a standard setting methodology modified from educational testing. Item parameters were used to develop clinical vignettes across a range of symptom severity. Vignettes were ordered by severity, and panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut-points (i.e., from none/mild problems to moderate/severe). To define MIDs, panelists reviewed a full score report for the vignettes and indicated which items would need to change and by how much to represent "just enough improvement to make a difference." RESULTS: For fatigue and UE, cut-points among panels were within 0.5 SD of each other. For mobility and pain interference, cut-scores among panels were more divergent, with parents setting the lowest cut-scores for increasing severity. The size of MIDs varied by stakeholders (parents estimated largest, followed by patients, then clinicians). MIDs also varied by severity classification of the symptom. CONCLUSIONS: We estimated clinically relevant severity cut-points and MIDs for PROMIS measures for JIA from the perspectives of multiple stakeholders and found notable differences in perspectives.

Do measures of depressive symptoms function differently in people with spinal cord injury versus primary care patients: the CES-D, PHQ-9, and PROMIS®-D.

PURPOSE: To evaluate whether items of three measures of depressive symptoms function differently in persons with spinal cord injury (SCI) than in persons from a primary care sample. METHODS: This study was a retrospective analysis of responses to the Patient Health Questionnaire depression scale, the Center for Epidemiological Studies Depression scale, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) version 1.0 eight-item depression short form 8b (PROMIS-D). The presence of differential item function (DIF) was evaluated using ordinal logistic regression. RESULTS: No items of any of the three target measures were flagged for DIF based on standard criteria. In a follow-up sensitivity analyses, the criterion was changed to make the analysis more sensitive to potential DIF. Scores were corrected for DIF flagged under this criterion. Minimal differences were found between the original scores and those corrected for DIF under the sensitivity criterion. CONCLUSIONS: The three depression screening measures evaluated in this study did not perform differently in samples of individuals with SCI compared to general and community samples. Transdiagnostic symptoms did not appear to spuriously inflate depression severity estimates when administered to people with SCI.

A PROMIS Measure of Neuropathic Pain Quality.

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).

Development and Initial Validation of Military Deployment-Related TBI Quality-of-Life Item Banks.

OBJECTIVE: To investigate unique factors that affect health-related quality of life (QOL) in individuals with military deployment-related traumatic brain injury (MDR-TBI) and to develop appropriate assessment tools, consistent with the TBI-QOL/PROMIS/Neuro-QOL systems. PARTICIPANTS: Three focus groups from each of the 4 Veterans Administration (VA) Polytrauma Rehabilitation Centers, consisting of 20 veterans with mild to severe MDR-TBI, and 36 VA providers were involved in early stage of new item banks development. The item banks were field tested in a sample (N = 485) of veterans enrolled in VA and diagnosed with an MDR-TBI. DESIGN: Focus groups and survey. OUTCOME MEASURES: Developed item banks and short forms for Guilt, Posttraumatic Stress Disorder/Trauma, and Military-Related Loss. RESULTS: Three new item banks representing unique domains of MDR-TBI health outcomes were created: 15 new Posttraumatic Stress Disorder items plus 16 SCI-QOL legacy Trauma items, 37 new Military-Related Loss items plus 18 TBI-QOL legacy Grief/Loss items, and 33 new Guilt items. Exploratory and confirmatory factor analyses plus bifactor analysis of the items supported sufficient unidimensionality of the new item pools. Convergent and discriminant analyses results, as well as known group comparisons, provided initial support for the validity and clinical utility of the new item response theory-calibrated item banks and their short forms. CONCLUSION: This work provides a unique opportunity to identify issues specific to individuals with MDR-TBI and ensure that they are captured in QOL assessment, thus extending the existing TBI-QOL measurement system.

Establishing a Common Metric for Physical Function: Linking the HAQ-DI and SF-36 PF Subscale to PROMIS(®) Physical Function.

BACKGROUND: Physical function (PF) is a common health concept measured in clinical trials and clinical care. It is measured with different instruments that are not directly comparable, making comparative effectiveness research (CER) challenging when PF is the outcome of interest. OBJECTIVE: Our goal was to establish a common reporting metric, so that scores on commonly used physical function measures can be converted into PROMIS scores. DESIGN: Following a single-sample linking design, all participants completed items from the NIH Patient Reported Outcomes Measurement Information System (PROMIS®) Physical Function (PROMIS PF) item bank and at least one other commonly used "legacy" measure: the Health Assessment Questionnaire (HAQ) or the Short Form-36 physical function ten-item PF scale (SF-36 PF). A common metric was created using analyses based on item response theory (IRT), producing score cross-walk tables. PARTICIPANTS: Participants (N = 733) were part of an internet panel, many of whom reported one or more chronic health conditions. MAIN MEASURES: PROMIS PF, SF-36 PF, and the HAQ-Disability Index (HAQ-DI). RESULTS: Our results supported the hypothesis that all three scales measure essentially the same concept. Cross-walk tables for use in CER are therefore justified. CONCLUSIONS: HAQ-DI and SF-36 PF results can be expressed on the PROMIS PF metric for the purposes of CER and other efforts to compare PF results across studies that utilize any one of these three measures. Clinicians seeking to incorporate PROs into their clinics can collect patient data on any one of these three instruments and estimate the equivalent on the other two.

Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale.

BACKGROUND: Global health measures represent an attractive option for researchers and clinicians seeking a brief snapshot of a patient's overall perspective on his or her health. Because scores on different global health measures are not comparable, comparative effectiveness research (CER) is challenging. OBJECTIVE: To establish a common reporting metric so that the physical and mental health scores on the Veterans RAND 12-Item Health Survey (VR-12 (©) ) can be converted into scores on the corresponding Patient Reported Outcomes Measurement Information System (PROMIS(®)) Global Health scores. DESIGN: Following a single-sample linking design, participants from an Internet panel completed items from the PROMIS Global Health and VR-12 Health Survey. A common metric was created using analyses based on item response theory (IRT), producing score cross-walk tables for the mental and physical health components of each measure. The linking relationships were evaluated by calculating the standard deviation of differences between the observed and linked PROMIS scores and estimating confidence intervals by sample size. PARTICIPANTS: Participants (N = 2025) were 49 % male and 73 % white; mean age was 46 years. MAIN MEASURES: Mental and physical health subscales of the PROMIS Global Health and the VR-12. The mean VR-12 physical component and mental component scores were 45.2 and 46.6, respectively; the mean PROMIS physical and mental health scores were 48.3 and 48.5, respectively. KEY RESULTS: We found evidence that the combined set of VR-12 and PROMIS items were relatively unidimensional and that we could proceed with linking. Linking worked better between the physical health than mental health scores using VR-12 item responses (vs. linking based on algorithmic scores). For each of the cross-walks, users can minimize the impact of linking error with modest increases in sample sizes. CONCLUSIONS: VR-12 scores can be expressed on the PROMIS Global Health metric to facilitate the evaluation of treatment, including CER. Extending these results to other common measures of global health is encouraged.

Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning, and sleep disturbance using standard setting with patients and providers.

PURPOSE: To establish clinically relevant classifications of health outcome scores for four Neuro-QOL measures (lower extremity function, upper extremity function, fatigue, and sleep disturbance). METHODS: We employed a modified educational standard-setting methodology to identify cut-scores for symptom severity. Clinical vignettes were developed to represent graduated levels of symptom severity. A clinician panel and a panel of persons with multiple sclerosis (PwMS) were recruited, and, in separate, 1-day meetings, the panelists identified adjacent vignettes they judged to represent the threshold between two levels of severity for a given domain (e.g., threshold between a vignette that indicated "no problems" with sleep and the adjacent one that represented "mild problems" with sleep). Working independently, each panel (PwMS and clinicians) reached consensus on its recommended thresholds for each of the four targeted measures. Cut-scores were defined as the mean location for each pair of threshold vignettes. RESULTS: PwMS and clinician panels derived identical thresholds for severity levels of lower extremity function and sleep disturbance, but slightly different ones for upper extremity function and fatigue. In every case of divergence, PwMS set higher thresholds for more severe classifications of symptoms (by 0.5 SDs) than did clinicians. CONCLUSIONS: The modified bookmarking method is effective for defining thresholds for symptom severity based on self-reported outcome scores and consensus judgments. Derived cut-scores and severity levels provide an interpretative context for Neuro-QOL scores. Future studies should explore whether these findings can be replicated and evaluate the validity of the classifications compared to external criteria.