TY - JOUR T1 - Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS) JF - Medical Care Y1 - 2007 A1 - Reeve, B. B. A1 - Hays, R. D. A1 - Bjorner, J. B. A1 - Cook, K. F. A1 - Crane, P. K. A1 - Teresi, J. A. A1 - Thissen, D. A1 - Revicki, D. A. A1 - Weiss, D. J. A1 - Hambleton, R. K. A1 - Liu, H. A1 - Gershon, R. C. A1 - Reise, S. P. A1 - Lai, J. S. A1 - Cella, D. KW - *Health Status KW - *Information Systems KW - *Quality of Life KW - *Self Disclosure KW - Adolescent KW - Adult KW - Aged KW - Calibration KW - Databases as Topic KW - Evaluation Studies as Topic KW - Female KW - Humans KW - Male KW - Middle Aged KW - Outcome Assessment (Health Care)/*methods KW - Psychometrics KW - Questionnaires/standards KW - United States AB - 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. VL - 45 SN - 0025-7079 (Print) N1 - Reeve, Bryce BHays, Ron DBjorner, Jakob BCook, Karon FCrane, Paul KTeresi, Jeanne AThissen, DavidRevicki, Dennis AWeiss, David JHambleton, Ronald KLiu, HonghuGershon, RichardReise, Steven PLai, Jin-sheiCella, DavidPROMIS Cooperative GroupAG015815/AG/United States NIAResearch Support, N.I.H., ExtramuralUnited StatesMedical careMed Care. 2007 May;45(5 Suppl 1):S22-31. ER - TY - JOUR T1 - Expansion of a physical function item bank and development of an abbreviated form for clinical research JF - Journal of Applied Measurement Y1 - 2006 A1 - Bode, R. K. A1 - Lai, J-S. A1 - Dineen, K. A1 - Heinemann, A. W. A1 - Shevrin, D. A1 - Von Roenn, J. A1 - Cella, D. KW - clinical research KW - computerized adaptive testing KW - performance levels KW - physical function item bank KW - Psychometrics KW - test reliability KW - Test Validity AB - We expanded an existing 33-item physical function (PF) item bank with a sufficient number of items to enable computerized adaptive testing (CAT). Ten items were written to expand the bank and the new item pool was administered to 295 people with cancer. For this analysis of the new pool, seven poorly performing items were identified for further examination. This resulted in a bank with items that define an essentially unidimensional PF construct, cover a wide range of that construct, reliably measure the PF of persons with cancer, and distinguish differences in self-reported functional performance levels. We also developed a 5-item (static) assessment form ("BriefPF") that can be used in clinical research to express scores on the same metric as the overall bank. The BriefPF was compared to the PF-10 from the Medical Outcomes Study SF-36. Both short forms significantly differentiated persons across functional performance levels. While the entire bank was more precise across the PF continuum than either short form, there were differences in the area of the continuum in which each short form was more precise: the BriefPF was more precise than the PF-10 at the lower functional levels and the PF-10 was more precise than the BriefPF at the higher levels. Future research on this bank will include the development of a CAT version, the PF-CAT. (PsycINFO Database Record (c) 2007 APA, all rights reserved) PB - Richard M Smith: US VL - 7 SN - 1529-7713 (Print) ER - TY - JOUR T1 - Factor analysis techniques for assessing sufficient unidimensionality of cancer related fatigue JF - Quality of Life Research Y1 - 2006 A1 - Lai, J-S. A1 - Crane, P. K. A1 - Cella, D. KW - *Factor Analysis, Statistical KW - *Quality of Life KW - Aged KW - Chicago KW - Fatigue/*etiology KW - Female KW - Humans KW - Male KW - Middle Aged KW - Neoplasms/*complications KW - Questionnaires AB - 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. VL - 15 N1 - 0962-9343 (Print)Journal ArticleResearch Support, N.I.H., Extramural ER - TY - JOUR T1 - An item response theory-based pain item bank can enhance measurement precision JF - Journal of Pain and Symptom Management Y1 - 2005 A1 - Lai, J-S. A1 - Dineen, K. A1 - Reeve, B. B. A1 - Von Roenn, J. A1 - Shervin, D. A1 - McGuire, M. A1 - Bode, R. K. A1 - Paice, J. A1 - Cella, D. KW - computerized adaptive testing AB - Cancer-related pain is often under-recognized and undertreated. This is partly due to the lack of appropriate assessments, which need to be comprehensive and precise yet easily integrated into clinics. Computerized adaptive testing (CAT) can enable precise-yet-brief assessments by only selecting the most informative items from a calibrated item bank. The purpose of this study was to create such a bank. The sample included 400 cancer patients who were asked to complete 61 pain-related items. Data were analyzed using factor analysis and the Rasch model. The final bank consisted of 43 items which satisfied the measurement requirement of factor analysis and the Rasch model, demonstrated high internal consistency and reasonable item-total correlations, and discriminated patients with differing degrees of pain. We conclude that this bank demonstrates good psychometric properties, is sensitive to pain reported by patients, and can be used as the foundation for a CAT pain-testing platform for use in clinical practice. VL - 30 N1 - 0885-3924Journal Article ER - TY - JOUR T1 - The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes JF - Clinical and Experimental Rheumatology Y1 - 2005 A1 - Fries, J.F. A1 - Bruce, B. A1 - Cella, D. KW - computerized adaptive testing AB - PROMIS (Patient-Reported-Outcomes Measurement Information System) is an NIH Roadmap network project intended to improve the reliability, validity, and precision of PROs and to provide definitive new instruments that will exceed the capabilities of classic instruments and enable improved outcome measurement for clinical research across all NIH institutes. Item response theory (IRT) measurement models now permit us to transition conventional health status assessment into an era of item banking and computerized adaptive testing (CAT). Item banking uses IRT measurement models and methods to develop item banks from large pools of items from many available questionnaires. IRT allows the reduction and improvement of items and assembles domains of items which are unidimensional and not excessively redundant. CAT provides a model-driven algorithm and software to iteratively select the most informative remaining item in a domain until a desired degree of precision is obtained. Through these approaches the number of patients required for a clinical trial may be reduced while holding statistical power constant. PROMIS tools, expected to improve precision and enable assessment at the individual patient level which should broaden the appeal of PROs, will begin to be available to the general medical community in 2008. VL - 23 ER - TY - JOUR T1 - Advances in quality of life measurements in oncology patients JF - Seminars in Oncology Y1 - 2002 A1 - Cella, D. A1 - Chang, C-H. A1 - Lai, J. S. A1 - Webster, K. KW - *Quality of Life KW - *Sickness Impact Profile KW - Cross-Cultural Comparison KW - Culture KW - Humans KW - Language KW - Neoplasms/*physiopathology KW - Questionnaires AB - 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. VL - 29 N1 - 0093-7754 (Print)Journal ArticleReview ER - TY - JOUR T1 - Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system JF - Archives of Physical Medicine and Rehabilitation Y1 - 2002 A1 - Cella, D. A1 - Nowinski, C. J. KW - *Chronic Disease KW - *Quality of Life KW - *Rehabilitation KW - Adult KW - Comparative Study KW - Health Status Indicators KW - Humans KW - Psychometrics KW - Questionnaires KW - Research Support, U.S. Gov't, P.H.S. KW - Sensitivity and Specificity AB - 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. VL - 83 N1 - 0003-9993Journal Article ER -