%0 Journal Article %J Sleep %D 2010 %T Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments %A Buysse, D. J. %A Yu, L. %A Moul, D. E. %A Germain, A. %A Stover, A. %A Dodds, N. E. %A Johnston, K. L. %A Shablesky-Cade, M. A. %A Pilkonis, P. A. %K *Outcome Assessment (Health Care) %K *Self Disclosure %K Adult %K Aged %K Aged, 80 and over %K Cross-Sectional Studies %K Factor Analysis, Statistical %K Female %K Humans %K Male %K Middle Aged %K Psychometrics %K Questionnaires %K Reproducibility of Results %K Sleep Disorders/*diagnosis %K Young Adult %X STUDY OBJECTIVES: To develop an archive of self-report questions assessing sleep disturbance and sleep-related impairments (SRI), to develop item banks from this archive, and to validate and calibrate the item banks using classic validation techniques and item response theory analyses in a sample of clinical and community participants. DESIGN: Cross-sectional self-report study. SETTING: Academic medical center and participant homes. PARTICIPANTS: One thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics. INTERVENTIONS: None. MEASUREMENTS AND RESULTS: This study was part of PROMIS (Patient-Reported Outcomes Information System), a National Institutes of Health Roadmap initiative. Self-report item banks were developed through an iterative process of literature searches, collecting and sorting items, expert content review, qualitative patient research, and pilot testing. Internal consistency, convergent validity, and exploratory and confirmatory factor analysis were examined in the resulting item banks. Factor analyses identified 2 preliminary item banks, sleep disturbance and SRI. Item response theory analyses and expert content review narrowed the item banks to 27 and 16 items, respectively. Validity of the item banks was supported by moderate to high correlations with existing scales and by significant differences in sleep disturbance and SRI scores between participants with and without sleep disorders. CONCLUSIONS: The PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions. %B Sleep %7 2010/06/17 %V 33 %P 781-92 %8 Jun 1 %@ 0161-8105 (Print)0161-8105 (Linking) %G eng %M 20550019 %2 2880437 %0 Journal Article %J Rehabilitation Psychology %D 2009 %T Development of an item bank for the assessment of depression in persons with mental illnesses and physical diseases using Rasch analysis %A Forkmann, T. %A Boecker, M. %A Norra, C. %A Eberle, N. %A Kircher, T. %A Schauerte, P. %A Mischke, K. %A Westhofen, M. %A Gauggel, S. %A Wirtz, M. %K Adaptation, Psychological %K Adult %K Aged %K Depressive Disorder/*diagnosis/psychology %K Diagnosis, Computer-Assisted %K Female %K Heart Diseases/*psychology %K Humans %K Male %K Mental Disorders/*psychology %K Middle Aged %K Models, Statistical %K Otorhinolaryngologic Diseases/*psychology %K Personality Assessment/statistics & numerical data %K Personality Inventory/*statistics & numerical data %K Psychometrics/statistics & numerical data %K Questionnaires %K Reproducibility of Results %K Sick Role %X OBJECTIVE: The calibration of item banks provides the basis for computerized adaptive testing that ensures high diagnostic precision and minimizes participants' test burden. The present study aimed at developing a new item bank that allows for assessing depression in persons with mental and persons with somatic diseases. METHOD: The sample consisted of 161 participants treated for a depressive syndrome, and 206 participants with somatic illnesses (103 cardiologic, 103 otorhinolaryngologic; overall mean age = 44.1 years, SD =14.0; 44.7% women) to allow for validation of the item bank in both groups. Persons answered a pool of 182 depression items on a 5-point Likert scale. RESULTS: Evaluation of Rasch model fit (infit < 1.3), differential item functioning, dimensionality, local independence, item spread, item and person separation (>2.0), and reliability (>.80) resulted in a bank of 79 items with good psychometric properties. CONCLUSIONS: The bank provides items with a wide range of content coverage and may serve as a sound basis for computerized adaptive testing applications. It might also be useful for researchers who wish to develop new fixed-length scales for the assessment of depression in specific rehabilitation settings. %B Rehabilitation Psychology %7 2009/05/28 %V 54 %P 186-97 %8 May %@ 0090-5550 (Print)0090-5550 (Linking) %G eng %M 19469609 %0 Journal Article %J Journal of Clinical Epidemiology %D 2009 %T An evaluation of patient-reported outcomes found computerized adaptive testing was efficient in assessing stress perception %A Kocalevent, R. D. %A Rose, M. %A Becker, J. %A Walter, O. B. %A Fliege, H. %A Bjorner, J. B. %A Kleiber, D. %A Klapp, B. F. %K *Diagnosis, Computer-Assisted %K Adolescent %K Adult %K Aged %K Aged, 80 and over %K Confidence Intervals %K Female %K Humans %K Male %K Middle Aged %K Perception %K Quality of Health Care/*standards %K Questionnaires %K Reproducibility of Results %K Sickness Impact Profile %K Stress, Psychological/*diagnosis/psychology %K Treatment Outcome %X OBJECTIVES: This study aimed to develop and evaluate a first computerized adaptive test (CAT) for the measurement of stress perception (Stress-CAT), in terms of the two dimensions: exposure to stress and stress reaction. STUDY DESIGN AND SETTING: Item response theory modeling was performed using a two-parameter model (Generalized Partial Credit Model). The evaluation of the Stress-CAT comprised a simulation study and real clinical application. A total of 1,092 psychosomatic patients (N1) were studied. Two hundred simulees (N2) were generated for a simulated response data set. Then the Stress-CAT was given to n=116 inpatients, (N3) together with established stress questionnaires as validity criteria. RESULTS: The final banks included n=38 stress exposure items and n=31 stress reaction items. In the first simulation study, CAT scores could be estimated with a high measurement precision (SE<0.32; rho>0.90) using 7.0+/-2.3 (M+/-SD) stress reaction items and 11.6+/-1.7 stress exposure items. The second simulation study reanalyzed real patients data (N1) and showed an average use of items of 5.6+/-2.1 for the dimension stress reaction and 10.0+/-4.9 for the dimension stress exposure. Convergent validity showed significantly high correlations. CONCLUSIONS: The Stress-CAT is short and precise, potentially lowering the response burden of patients in clinical decision making. %B Journal of Clinical Epidemiology %7 2008/07/22 %V 62 %P 278-287 %@ 1878-5921 (Electronic)0895-4356 (Linking) %G eng %M 18639439 %0 Journal Article %J Annual Review of Clinical Psychology %D 2009 %T Item response theory and clinical measurement %A Reise, S. P. %A Waller, N. G. %K *Psychological Theory %K Humans %K Mental Disorders/diagnosis/psychology %K Psychological Tests %K Psychometrics %K Quality of Life %K Questionnaires %X In this review, we examine studies that use item response theory (IRT) to explore the psychometric properties of clinical measures. Next, we consider how IRT has been used in clinical research for: scale linking, computerized adaptive testing, and differential item functioning analysis. Finally, we consider the scale properties of IRT trait scores. We conclude that there are notable differences between cognitive and clinical measures that have relevance for IRT modeling. Future research should be directed toward a better understanding of the metric of the latent trait and the psychological processes that lead to individual differences in item response behaviors. %B Annual Review of Clinical Psychology %7 2008/11/04 %V 5 %P 27-48 %@ 1548-5951 (Electronic) %G eng %M 18976138 %0 Journal Article %J Quality of Life Research %D 2009 %T Measuring global physical health in children with cerebral palsy: Illustration of a multidimensional bi-factor model and computerized adaptive testing %A Haley, S. M. %A Ni, P. %A Dumas, H. M. %A Fragala-Pinkham, M. A. %A Hambleton, R. K. %A Montpetit, K. %A Bilodeau, N. %A Gorton, G. E. %A Watson, K. %A Tucker, C. A. %K *Computer Simulation %K *Health Status %K *Models, Statistical %K Adaptation, Psychological %K Adolescent %K Cerebral Palsy/*physiopathology %K Child %K Child, Preschool %K Factor Analysis, Statistical %K Female %K Humans %K Male %K Massachusetts %K Pennsylvania %K Questionnaires %K Young Adult %X PURPOSE: The purposes of this study were to apply a bi-factor model for the determination of test dimensionality and a multidimensional CAT using computer simulations of real data for the assessment of a new global physical health measure for children with cerebral palsy (CP). METHODS: Parent respondents of 306 children with cerebral palsy were recruited from four pediatric rehabilitation hospitals and outpatient clinics. We compared confirmatory factor analysis results across four models: (1) one-factor unidimensional; (2) two-factor multidimensional (MIRT); (3) bi-factor MIRT with fixed slopes; and (4) bi-factor MIRT with varied slopes. We tested whether the general and content (fatigue and pain) person score estimates could discriminate across severity and types of CP, and whether score estimates from a simulated CAT were similar to estimates based on the total item bank, and whether they correlated as expected with external measures. RESULTS: Confirmatory factor analysis suggested separate pain and fatigue sub-factors; all 37 items were retained in the analyses. From the bi-factor MIRT model with fixed slopes, the full item bank scores discriminated across levels of severity and types of CP, and compared favorably to external instruments. CAT scores based on 10- and 15-item versions accurately captured the global physical health scores. CONCLUSIONS: The bi-factor MIRT CAT application, especially the 10- and 15-item versions, yielded accurate global physical health scores that discriminated across known severity groups and types of CP, and correlated as expected with concurrent measures. The CATs have potential for collecting complex data on the physical health of children with CP in an efficient manner. %B Quality of Life Research %7 2009/02/18 %V 18 %P 359-370 %8 Apr %@ 0962-9343 (Print)0962-9343 (Linking) %G eng %M 19221892 %2 2692519 %0 Journal Article %J American Journal of Physical Medicine and Rehabilitation %D 2008 %T Adaptive short forms for outpatient rehabilitation outcome assessment %A Jette, A. M. %A Haley, S. M. %A Ni, P. %A Moed, R. %K *Activities of Daily Living %K *Ambulatory Care Facilities %K *Mobility Limitation %K *Treatment Outcome %K Disabled Persons/psychology/*rehabilitation %K Female %K Humans %K Male %K Middle Aged %K Questionnaires %K Rehabilitation Centers %X OBJECTIVE: To develop outpatient Adaptive Short Forms for the Activity Measure for Post-Acute Care item bank for use in outpatient therapy settings. DESIGN: A convenience sample of 11,809 adults with spine, lower limb, upper limb, and miscellaneous orthopedic impairments who received outpatient rehabilitation in 1 of 127 outpatient rehabilitation clinics in the United States. We identified optimal items for use in developing outpatient Adaptive Short Forms based on the Basic Mobility and Daily Activities domains of the Activity Measure for Post-Acute Care item bank. Patient scores were derived from the Activity Measure for Post-Acute Care computerized adaptive testing program. Items were selected for inclusion on the Adaptive Short Forms based on functional content, range of item coverage, measurement precision, item exposure rate, and data collection burden. RESULTS: Two outpatient Adaptive Short Forms were developed: (1) an 18-item Basic Mobility Adaptive Short Form and (2) a 15-item Daily Activities Adaptive Short Form, derived from the same item bank used to develop the Activity Measure for Post-Acute Care computerized adaptive testing program. Both Adaptive Short Forms achieved acceptable psychometric properties. CONCLUSIONS: In outpatient postacute care settings where computerized adaptive testing outcome applications are currently not feasible, item response theory-derived Adaptive Short Forms provide the efficient capability to monitor patients' functional outcomes. The development of Adaptive Short Form functional outcome instruments linked by a common, calibrated item bank has the potential to create a bridge to outcome monitoring across postacute care settings and can facilitate the eventual transformation from Adaptive Short Forms to computerized adaptive testing applications easier and more acceptable to the rehabilitation community. %B American Journal of Physical Medicine and Rehabilitation %7 2008/09/23 %V 87 %P 842-52 %8 Oct %@ 1537-7385 (Electronic) %G eng %M 18806511 %0 Journal Article %J Quality of Life Research %D 2007 %T Patient-reported outcomes measurement and management with innovative methodologies and technologies %A Chang, C-H. %K *Health Status %K *Outcome Assessment (Health Care) %K *Quality of Life %K *Software %K Computer Systems/*trends %K Health Insurance Portability and Accountability Act %K Humans %K Patient Satisfaction %K Questionnaires %K United States %X Successful integration of modern psychometrics and advanced informatics in patient-reported outcomes (PRO) measurement and management can potentially maximize the value of health outcomes research and optimize the delivery of quality patient care. Unlike the traditional labor-intensive paper-and-pencil data collection method, item response theory-based computerized adaptive testing methodologies coupled with novel technologies provide an integrated environment to collect, analyze and present ready-to-use PRO data for informed and shared decision-making. This article describes the needs, challenges and solutions for accurate, efficient and cost-effective PRO data acquisition and dissemination means in order to provide critical and timely PRO information necessary to actively support and enhance routine patient care in busy clinical settings. %B Quality of Life Research %7 2007/05/29 %V 16 Suppl 1 %P 157-66 %@ 0962-9343 (Print)0962-9343 (Linking) %G eng %M 17530448 %0 Journal Article %J Quality of Life Research %D 2006 %T Factor analysis techniques for assessing sufficient unidimensionality of cancer related fatigue %A Lai, J-S. %A Crane, P. K. %A Cella, D. %K *Factor Analysis, Statistical %K *Quality of Life %K Aged %K Chicago %K Fatigue/*etiology %K Female %K Humans %K Male %K Middle Aged %K Neoplasms/*complications %K Questionnaires %X BACKGROUND: Fatigue is the most common unrelieved symptom experienced by people with cancer. The purpose of this study was to examine whether cancer-related fatigue (CRF) can be summarized using a single score, that is, whether CRF is sufficiently unidimensional for measurement approaches that require or assume unidimensionality. We evaluated this question using factor analysis techniques including the theory-driven bi-factor model. METHODS: Five hundred and fifty five cancer patients from the Chicago metropolitan area completed a 72-item fatigue item bank, covering a range of fatigue-related concerns including intensity, frequency and interference with physical, mental, and social activities. Dimensionality was assessed using exploratory and confirmatory factor analysis (CFA) techniques. RESULTS: Exploratory factor analysis (EFA) techniques identified from 1 to 17 factors. The bi-factor model suggested that CRF was sufficiently unidimensional. CONCLUSIONS: CRF can be considered sufficiently unidimensional for applications that require unidimensionality. One such application, item response theory (IRT), will facilitate the development of short-form and computer-adaptive testing. This may further enable practical and accurate clinical assessment of CRF. %B Quality of Life Research %V 15 %P 1179-90 %8 Sep %G eng %M 17001438 %0 Journal Article %J Journal of Clinical Epidemiology %D 2005 %T An item bank was created to improve the measurement of cancer-related fatigue %A Lai, J-S. %A Cella, D. %A Dineen, K. %A Bode, R. %A Von Roenn, J. %A Gershon, R. C. %A Shevrin, D. %K Adult %K Aged %K Aged, 80 and over %K Factor Analysis, Statistical %K Fatigue/*etiology/psychology %K Female %K Humans %K Male %K Middle Aged %K Neoplasms/*complications/psychology %K Psychometrics %K Questionnaires %X OBJECTIVE: Cancer-related fatigue (CRF) is one of the most common unrelieved symptoms experienced by patients. CRF is underrecognized and undertreated due to a lack of clinically sensitive instruments that integrate easily into clinics. Modern computerized adaptive testing (CAT) can overcome these obstacles by enabling precise assessment of fatigue without requiring the administration of a large number of questions. A working item bank is essential for development of a CAT platform. The present report describes the building of an operational item bank for use in clinical settings with the ultimate goal of improving CRF identification and treatment. STUDY DESIGN AND SETTING: The sample included 301 cancer patients. Psychometric properties of items were examined by using Rasch analysis, an Item Response Theory (IRT) model. RESULTS AND CONCLUSION: The final bank includes 72 items. These 72 unidimensional items explained 57.5% of the variance, based on factor analysis results. Excellent internal consistency (alpha=0.99) and acceptable item-total correlation were found (range: 0.51-0.85). The 72 items covered a reasonable range of the fatigue continuum. No significant ceiling effects, floor effects, or gaps were found. A sample short form was created for demonstration purposes. The resulting bank is amenable to the development of a CAT platform. %B Journal of Clinical Epidemiology %7 2005/02/01 %V 58 %P 190-7 %8 Feb %@ 0895-4356 (Print)0895-4356 (Linking) %G eng %9 Multicenter Study %M 15680754 %0 Journal Article %J Quality of Life Research %D 2003 %T The feasibility of applying item response theory to measures of migraine impact: a re-analysis of three clinical studies %A Bjorner, J. B. %A Kosinski, M. %A Ware, J. E., Jr. %K *Sickness Impact Profile %K Adolescent %K Adult %K Aged %K Comparative Study %K Cost of Illness %K Factor Analysis, Statistical %K Feasibility Studies %K Female %K Human %K Male %K Middle Aged %K Migraine/*psychology %K Models, Psychological %K Psychometrics/instrumentation/*methods %K Quality of Life/*psychology %K Questionnaires %K Support, Non-U.S. Gov't %X BACKGROUND: Item response theory (IRT) is a powerful framework for analyzing multiitem scales and is central to the implementation of computerized adaptive testing. OBJECTIVES: To explain the use of IRT to examine measurement properties and to apply IRT to a questionnaire for measuring migraine impact--the Migraine Specific Questionnaire (MSQ). METHODS: Data from three clinical studies that employed the MSQ-version 1 were analyzed by confirmatory factor analysis for categorical data and by IRT modeling. RESULTS: Confirmatory factor analyses showed very high correlations between the factors hypothesized by the original test constructions. Further, high item loadings on one common factor suggest that migraine impact may be adequately assessed by only one score. IRT analyses of the MSQ were feasible and provided several suggestions as to how to improve the items and in particular the response choices. Out of 15 items, 13 showed adequate fit to the IRT model. In general, IRT scores were strongly associated with the scores proposed by the original test developers and with the total item sum score. Analysis of response consistency showed that more than 90% of the patients answered consistently according to a unidimensional IRT model. For the remaining patients, scores on the dimension of emotional function were less strongly related to the overall IRT scores that mainly reflected role limitations. Such response patterns can be detected easily using response consistency indices. Analysis of test precision across score levels revealed that the MSQ was most precise at one standard deviation worse than the mean impact level for migraine patients that are not in treatment. Thus, gains in test precision can be achieved by developing items aimed at less severe levels of migraine impact. CONCLUSIONS: IRT proved useful for analyzing the MSQ. The approach warrants further testing in a more comprehensive item pool for headache impact that would enable computerized adaptive testing. %B Quality of Life Research %V 12 %P 887-902 %G eng %M 14661765 %0 Journal Article %J Seminars in Oncology %D 2002 %T Advances in quality of life measurements in oncology patients %A Cella, D. %A Chang, C-H. %A Lai, J. S. %A Webster, K. %K *Quality of Life %K *Sickness Impact Profile %K Cross-Cultural Comparison %K Culture %K Humans %K Language %K Neoplasms/*physiopathology %K Questionnaires %X Accurate assessment of the quality of life (QOL) of patients can provide important clinical information to physicians, especially in the area of oncology. Changes in QOL are important indicators of the impact of a new cytotoxic therapy, can affect a patient's willingness to continue treatment, and may aid in defining response in the absence of quantifiable endpoints such as tumor regression. Because QOL is becoming an increasingly important aspect in the management of patients with malignant disease, it is vital that the instruments used to measure QOL are reliable and accurate. Assessment of QOL involves a multidimensional approach that includes physical, functional, social, and emotional well-being, and the most comprehensive instruments measure at least three of these domains. Instruments to measure QOL can be generic (eg, the Nottingham Health Profile), targeted toward specific illnesses (eg, Functional Assessment of Cancer Therapy - Lung), or be a combination of generic and targeted. Two of the most widely used examples of the combination, or hybrid, instruments are the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items and the Functional Assessment of Chronic Illness Therapy. A consequence of the increasing international collaboration in clinical trials has been the growing necessity for instruments that are valid across languages and cultures. To assure the continuing reliability and validity of QOL instruments in this regard, item response theory can be applied. Techniques such as item response theory may be used in the future to construct QOL item banks containing large sets of validated questions that represent various levels of QOL domains. As QOL becomes increasingly important in understanding and approaching the overall management of cancer patients, the tools available to clinicians and researchers to assess QOL will continue to evolve. While the instruments currently available provide reliable and valid measurement, further improvements in precision and application are anticipated. %B Seminars in Oncology %V 29 %P 60-8 %8 Jun %G eng %M 12082656 %0 Journal Article %J Archives of Physical Medicine and Rehabilitation %D 2002 %T Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system %A Cella, D. %A Nowinski, C. J. %K *Chronic Disease %K *Quality of Life %K *Rehabilitation %K Adult %K Comparative Study %K Health Status Indicators %K Humans %K Psychometrics %K Questionnaires %K Research Support, U.S. Gov't, P.H.S. %K Sensitivity and Specificity %X We focus on quality of life (QOL) measurement as applied to chronic illness. There are 2 major types of health-related quality of life (HRQOL) instruments-generic health status and targeted. Generic instruments offer the opportunity to compare results across patient and population cohorts, and some can provide normative or benchmark data from which to interpret results. Targeted instruments ask questions that focus more on the specific condition or treatment under study and, as a result, tend to be more responsive to clinically important changes than generic instruments. Each type of instrument has a place in the assessment of HRQOL in chronic illness, and consideration of the relative advantages and disadvantages of the 2 options best drives choice of instrument. The Functional Assessment of Chronic Illness Therapy (FACIT) system of HRQOL measurement is a hybrid of the 2 approaches. The FACIT system combines a core general measure with supplemental measures targeted toward specific diseases, conditions, or treatments. Thus, it capitalizes on the strengths of each type of measure. Recently, FACIT questionnaires were administered to a representative sample of the general population with results used to derive FACIT norms. These normative data can be used for benchmarking and to better understand changes in HRQOL that are often seen in clinical trials. Future directions in HRQOL assessment include test equating, item banking, and computerized adaptive testing. %B Archives of Physical Medicine and Rehabilitation %V 83 %P S10-7 %8 Dec %G eng %M 12474167