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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.

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.

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., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

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 (CAT ORIG ) 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 (CAT ALT ), 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 CAT ORIG and CAT ALT ., Results: CAT ORIG and CAT ALT scores varied little, especially within the clinically relevant range, and response burden was substantially lower under CAT ALT (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.

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.

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.

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.

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.

Purpose: The assessment of pain sensation and quality is a key component in understanding the experience of individuals with chronic pain. This study evaluated the factor structure of the patient-reported outcome measurement information system (PROMIS) pain quality item bank., Methods: As part of the PROMIS project, we developed a pool of 37 pain quality items, based on a review of existing pain questionnaires and development of new items. A web-based survey was designed and completed by 845 members of the general population and 967 individuals with different types of chronic pain. Exploratory factor analysis (EFA) was conducted on a random split-half sample of the data to examine the factor structure of the 37 PROMIS pain quality items in the general population and in a chronic pain sample. A confirmatory factor analysis was conducted in the holdout sample., Results: The EFA of the pain quality items resulted in comparable six-factor solutions for the general and chronic pain samples: (1) pulling/tugging pain; (2) tingling/numbness pain; (3) sharp/stabbing pain; (4) dull/aching pain; (5) pounding/pulsing pain; and (6) affective pain. The confirmatory factor analysis in the holdout sample supported this factor structure., Conclusions: Further research is needed to evaluate the psychometric characteristics of the derived scales based on their factor scores.

Purpose: This study examined the measurement invariance of responses to the patient-reported outcomes measurement information system (PROMIS) pain interference (PI) item bank. The original PROMIS calibration sample (Wave I) was augmented with a sample of persons recruited from the American Chronic Pain Association (ACPA) to increase the number of participants reporting higher levels of pain. Establishing measurement invariance of an item bank is essential for the valid interpretation of group differences in the latent concept being measured., Methods: Multi-group confirmatory factor analysis (MG-CFA) was used to evaluate successive levels of measurement invariance: configural, metric, and scalar invariance., Results: Support was found for configural and metric invariance of the PROMIS-PI, but not for scalar invariance., Conclusions and Recommendations: Based on our results of MG-CFA, we recommend retaining the original parameter estimates obtained by combining the community sample of Wave I and ACPA participants. Future studies should extend this study by examining measurement equivalence in an item response theory framework such as differential item functioning analysis.

Purpose: To derive from the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue item bank, a short form for individuals with multiple sclerosis (MS), the PROMIS-Fatigue(MS)., Methods: A panel of 37 clinicians and 46 individuals with MS ranked the relevance of PROMIS fatigue items to persons with MS. Eight items were selected for the PROMIS-Fatigue(MS) that maximized relevance rankings, content coverage, and item discrimination. The PROMIS-Fatigue(MS) and an existing, 7-item PROMIS fatigue short form (PROMIS-Fatigue(SFv1.0)) were administered to a new sample of 231 individuals with MS. Known groups and content validity were assessed., Results: Scores from the short forms were highly correlated (r = 0.92). Discriminant validity of the PROMIS-Fatigue(MS) scores was supported in known groups comparisons. Scores of neither short form exhibited an advantage in quantitative analyses. The PROMIS-Fatigue(MS) targeted more of the content included in participants' responses to open-ended questions than did the PROMIS-Fatigue(SFv1.0)., Conclusions: The PROMIS-Fatigue(MS) was derived to have content validity in MS samples. The validity of the measure was further supported by the ability of PROMIS-Fatigue(MS) items to discriminate among groups expected to differ in levels of fatigue. We recommend its use in measuring the fatigue of individuals with MS.

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 © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

This paper describes the psychometric properties of the PROMIS-pain interference (PROMIS-PI) bank. An initial candidate item pool (n=644) was developed and evaluated based on the review of existing instruments, interviews with patients, and consultation with pain experts. From this pool, a candidate item bank of 56 items was selected and responses to the items were collected from large community and clinical samples. A total of 14,848 participants responded to all or a subset of candidate items. The responses were calibrated using an item response theory (IRT) model. A final 41-item bank was evaluated with respect to IRT assumptions, model fit, differential item function (DIF), precision, and construct and concurrent validity. Items of the revised bank had good fit to the IRT model (CFI and NNFI/TLI ranged from 0.974 to 0.997), and the data were strongly unidimensional (e.g., ratio of first and second eigenvalue=35). Nine items exhibited statistically significant DIF. However, adjusting for DIF had little practical impact on score estimates and the items were retained without modifying scoring. Scores provided substantial information across levels of pain; for scores in the T-score range 50-80, the reliability was equivalent to 0.96-0.99. Patterns of correlations with other health outcomes supported the construct validity of the item bank. The scores discriminated among persons with different numbers of chronic conditions, disabling conditions, levels of self-reported health, and pain intensity (p<0.0001). The results indicated that the PROMIS-PI items constitute a psychometrically sound bank. Computerized adaptive testing and short forms are available., (Copyright 2010 International Association for the Study of Pain. All rights reserved.)

Purpose: Confirmatory factor analysis fit criteria typically are used to evaluate the unidimensionality of item banks. This study explored the degree to which the values of these statistics are affected by two characteristics of item banks developed to measure health outcomes: large numbers of items and nonnormal data., Methods: Analyses were conducted on simulated and observed data. Observed data were responses to the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Impact Item Bank. Simulated data fit the graded response model and conformed to a normal distribution or mirrored the distribution of the observed data. Confirmatory factor analyses (CFA), parallel analysis, and bifactor analysis were conducted., Results: CFA fit values were found to be sensitive to data distribution and number of items. In some instances impact of distribution and item number was quite large., Conclusions: We concluded that using traditional cutoffs and standards for CFA fit statistics is not recommended for establishing unidimensionality of item banks. An investigative approach is favored over reliance on published criteria. We found bifactor analysis to be appealing in this regard because it allows evaluation of the relative impact of secondary dimensions. In addition to these methodological conclusions, we judged the items of the PROMIS Pain Impact bank to be sufficiently unidimensional for item response theory (IRT) modeling.

As interest grows in creating computerized versions of established paper-and-pencil (P&P) questionnaires, it becomes increasingly important to explore whether changing the administration modes of questionnaires affects participants' responses. This study investigated whether mode effects exist when administering the Center for Epidemiologic Studies Depression (CES-D) scale by a personal digital assistant (PDA) versus the classic P&P mode. The Differential Functioning of Items and Tests (DFIT) procedure identified mode effects on the overall test and individual items. A mixed-effects regression model summarized the mode effects in terms of CES-D scores, and identified interactions with covariates. When the P&P questionnaire was administered first, scores were higher on average (2.4-2.8 points) than those of the other administrations (PDA second, PDA first, and P&P second), and all 20 questionnaire items exhibited a statistically significant mode effect. Highly educated people and younger people demonstrated a smaller difference in scores between the two modes. The mode-by-order effect influenced the interpretation of CES-D scores, especially when screening for depression using the established cut-off scores. These results underscore the importance of evaluating the cross-mode equivalence of psychosocial instruments before administering them in non-established modes.

Background: The construction and evaluation of item banks to measure unidimensional constructs of health-related quality of life (HRQOL) is a fundamental objective of the Patient-Reported Outcomes Measurement Information System (PROMIS) project., Objectives: Item banks will be used as the foundation for developing short-form instruments and enabling computerized adaptive testing. The PROMIS Steering Committee selected 5 HRQOL domains for initial focus: physical functioning, fatigue, pain, emotional distress, and social role participation. This report provides an overview of the methods used in the PROMIS item analyses and proposed calibration of item banks., Analyses: Analyses include evaluation of data quality (eg, logic and range checking, spread of response distribution within an item), descriptive statistics (eg, frequencies, means), item response theory model assumptions (unidimensionality, local independence, monotonicity), model fit, differential item functioning, and item calibration for banking., Recommendations: Summarized are key analytic issues; recommendations are provided for future evaluations of item banks in HRQOL assessment.

Background: Several techniques have been developed to detect differential item functioning (DIF), including ordinal logistic regression (OLR). This study compared different criteria for determining whether items have DIF using OLR., Objectives: To compare and contrast findings from three different sets of criteria for detecting DIF using OLR. General distress and physical functioning items were evaluated for DIF related to five covariates: age, marital status, gender, race, and Hispanic origin., Research Design: Cross-sectional study., Subjects: 1,714 patients with cancer or HIV/AIDS., Measures: A total of 23 items addressing physical functioning and 15 items addressing general distress were selected from a pool of 154 items from four different health-related quality of life questionnaires., Results: The three sets of criteria produced qualitatively and quantitatively different results. Criteria based on statistical significance alone detected DIF in almost all the items, while alternative criteria based on magnitude detected DIF in far fewer items. Accounting for DIF by using demographic-group specific item parameters had negligible effects on individual scores, except for race., Conclusions: Specific criteria chosen to determine whether items have DIF have an impact on the findings. Criteria based entirely on statistical significance may detect small differences that are clinically negligible.

Background: In June 2004, the National Cancer Institute and the Drug Information Association co-sponsored the conference, "Improving the Measurement of Health Outcomes through the Applications of Item Response Theory (IRT) Modeling: Exploration of Item Banks and Computer-Adaptive Assessment." A component of the conference was presentation of a psychometric and content analysis of a secondary dataset., Objectives: A thorough psychometric and content analysis was conducted of two primary domains within a cancer health-related quality of life (HRQOL) dataset., Research Design: HRQOL scales were evaluated using factor analysis for categorical data, IRT modeling, and differential item functioning analyses. In addition, computerized adaptive administration of HRQOL item banks was simulated, and various IRT models were applied and compared., Subjects: The original data were collected as part of the NCI-funded Quality of Life Evaluation in Oncology (Q-Score) Project. A total of 1,714 patients with cancer or HIV/AIDS were recruited from 5 clinical sites., Measures: Items from 4 HRQOL instruments were evaluated: Cancer Rehabilitation Evaluation System-Short Form, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Functional Assessment of Cancer Therapy and Medical Outcomes Study Short-Form Health Survey., Results and Conclusions: Four lessons learned from the project are discussed: the importance of good developmental item banks, the ambiguity of model fit results, the limits of our knowledge regarding the practical implications of model misfit, and the importance in the measurement of HRQOL of construct definition. With respect to these lessons, areas for future research are suggested. The feasibility of developing item banks for broad definitions of health is discussed.

Background: Methods based on item response theory (IRT) that can be used to examine differential item functioning (DIF) are illustrated. An IRT-based approach to the detection of DIF was applied to physical function and general distress item sets. DIF was examined with respect to gender, age and race. The method used for DIF detection was the item response theory log-likelihood ratio (IRTLR) approach. DIF magnitude was measured using the differences in the expected item scores, expressed as the unsigned probability differences, and calculated using the non-compensatory DIF index (NCDIF). Finally, impact was assessed using expected scale scores, expressed as group differences in the total test (measure) response functions., Methods: The example for the illustration of the methods came from a study of 1,714 patients with cancer or HIV/AIDS. The measure contained 23 items measuring physical functioning ability and 15 items addressing general distress, scored in the positive direction., Results: The substantive findings were of relatively small magnitude DIF. In total, six items showed relatively larger magnitude (expected item score differences greater than the cutoff) of DIF with respect to physical function across the three comparisons: "trouble with a long walk" (race), "vigorous activities" (race, age), "bending, kneeling stooping" (age), "lifting or carrying groceries" (race), "limited in hobbies, leisure" (age), "lack of energy" (race). None of the general distress items evidenced high magnitude DIF; although "worrying about dying" showed some DIF with respect to both age and race, after adjustment., Conclusions: The fact that many physical function items showed DIF with respect to age, even after adjustment for multiple comparisons, indicates that the instrument may be performing differently for these groups. While the magnitude and impact of DIF at the item and scale level was minimal, caution should be exercised in the use of subsets of these items, as might occur with selection for clinical decisions or computerized adaptive testing. The issues of selection of anchor items, and of criteria for DIF detection, including the integration of significance and magnitude measures remain as issues requiring investigation. Further research is needed regarding the criteria and guidelines appropriate for DIF detection in the context of health-related items.

We evaluated patient-proxy agreement in a population of veterans with Parkinson's disease and compared levels of agreement by patient subgroups. Patient and caregiver pairs completed questionnaires composed of standard measures and additional demographic and activity questions. Participants completed the Center for Epidemiologic Studies Depression Scale (CES-D), the PD Questionnaire 39 (PDQ-39), and three questions regarding physical activity. Caregivers completed proxy forms of the PDQ-39 and the physical activity questionnaire. The proxy forms asked caregivers to choose the answers that best described their "friend's/patient's situation." The results of our comparison of patient and proxy reports of quality of life were consistent with findings in other diseases. On average, proxies rated patient disability higher and quality of life lower than did patients. However, our comparison of patient and proxy reports of frequency of exercise diverged from previously published work. Less agreement was observed between patient and proxy reports of physical activity, even though this is a more objective variable than are the domains measured by the PDQ-39. Proxy reports may diverge appreciably from patient self-reports. These differences should be considered in research design and clinical decision making. Alternative approaches to the measurement of patient relevant outcomes could supplement traditional, retrospective self-reports.

BackgroundThere is a need for valid self-report measures of core health-related quality of life (HRQoL) domains.ObjectiveTo derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System® (PROMIS®) item banks.MethodsLiterature 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.ResultsWith 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.ConclusionsAlthough 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.

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]

• Evidence is lacking supporting the use of any single PRO fatigue measure across all settings in persons with MS. • Observational studies were performed across US and UK MS populations. • Relative validity of PROMIS Fatigue (MS) 8a score in comparison to the MFIS and FSS scores was evaluated. • Stronger psychometric performance was observed for the PROMIS Fatigue (MS) 8a scores compared to scores from legacy fatigue measures. Amidst the growing number of patient-reported outcome (PRO) measures of fatigue being used in multiple sclerosis (MS) clinical trials and clinics, evidence-based consensus on the most appropriate and generalizable measures across different settings would be beneficial for clinical research and patient care. The objective of this research was to compare the validity and responsiveness of scores from the PROMIS Fatigue (MS) 8a with those of the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS), across US and UK MS populations. Two observational studies were performed in MS populations as part of a PRO measure development project, including a cross-sectional study in two tertiary US MS centers (n = 340) and a 96-week longitudinal study in the UK MS Register cohort (n = 352). In post-hoc analyses, we examined relative validity, based on ability to discriminate across patient groups with different fatigue levels or functional status at baseline (i.e., ANOVA-F PRO X ÷ ANOVA-F PROMIS (MS) 8a), and relative responsiveness, based on baseline-to-Week-52 score change (effect sizes) across fatigue or functional status response groups. Mean ± standard deviation (SD) age was 44.6 ± 11.3/50.0 ± 9.7; and 72.9%/77.3% were female (US/UK samples). The mean PROMIS Fatigue (MS) 8a T-score ± SD at baseline was 57.7 ± 10.5/58.9 ± 9.3 (US/UK samples). Compared with the PROMIS Fatigue (MS) 8a, relative validity (anchor: Global Health Score [GHS] fatigue global question) was 85% for MFIS symptom score, 48% for MFIS total score, and 44% for the FSS. Relative to the FSS, PROMIS Fatigue (MS) 8a scores were more sensitive to worsening (effect size = -0.43 versus -0.18) as well as improvement (effect size = 0.5 versus 0.2) in fatigue (≥1-point increase/decrease in GHS fatigue global question) over 52 weeks of follow-up. A similar pattern of score changes was observed based on a second anchor. The PROMIS Fatigue (MS) 8a scores showed higher responsiveness to fatigue changes than those of the FSS. The PROMIS measure also had higher precision in differentiating levels of fatigue compared to the FSS, the MFIS physical, and MFIS total scores. These differences have practical implications for the application of these questionnaires in both clinical practice and research settings (e.g., sample size estimation in clinical trials). [ABSTRACT FROM AUTHOR]

The article reports on a post hoc simulation of a computer adaptive administration of the items of a modified version of the Roland-Morris Disability Questionnaire. The objective of the study is to evaluate the effectiveness of adaptive administration of back pain-related disability items compared with a fixed 11-item short form. Computer adaptive test-based back pain related disability measure may be a valuable tool in clinical and research contexts.

Persons with spinal cord injury (SCI) may experience a range of symptoms typically labeled "spasticity." Previous efforts to develop assessment tools that measure spasticity have failed to represent the experiences of persons who live with the condition. The purpose of this multicenter study was to develop an instrument that measures the impact of spasticity on quality of life. Based on 24 semistructured interviews, a developmental form of the Patient Reported Impact of Spasticity Measure (PRISM) was constructed. The developmental PRISM was administered to 180 persons at five sites. Subscales were developed based on factor analytic results. Evidence for the reliability and validity of the scores was evaluated. Seven subscales were developed, including one that measures the positive effects of spasticity. Results of reliability and validity assessments indicate that the PRISM subscale scores effectively measure the impact of spasticity in the population of veterans with SCI. [ABSTRACT FROM AUTHOR]

Background. The use of item response theory (IRT) to measure self-reported outcomes has burgeoned in recent years. Perhaps the most important application of IRT is computer-adaptive testing (CAT), a measurement approach in which the selection of items is tailored for each respondent. Objective. To provide an introduction to the use of CAT in the measurement of health outcomes, describe several IRT models that can be used as the basis of CAT, and discuss practical issues associated with the use of adaptive scaling in research settings. Principal Points. The development of a CAT requires several steps that are not required in the development of a traditional measure including identification of “starting” and “stopping” rules. CAT's most attractive advantage is its efficiency. Greater measurement precision can be achieved with fewer items. Disadvantages of CAT include the high cost and level of technical expertise required to develop a CAT. Conclusions. Researchers, clinicians, and patients benefit from the availability of psychometrically rigorous measures that are not burdensome. CAT outcome measures hold substantial promise in this regard, but their development is not without challenges. [ABSTRACT FROM AUTHOR]

• 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]

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]