Psychometric properties of an index of three patient reported outcome (PRO) measures, termed the CLinical ARthritis Activity (PRO-CLARA) in patients with rheumatoid arthritis. The NEW INDICES study.

OBJECTIVES To evaluate the psychometric properties of an index based on 3 patient reported outcomes measures, termed PRO-CLinical ARthritis Activity (PRO-CLARA), in order to facilitate rapid and easy rheumatoid arthritis (RA) activity assessment in daily routine. METHODS 196 patients partially or not responding to disease modifying anti-rheumatic drugs (DMARDs), consented to participate in a multicentre cross-sectional study. For the evaluation of the psychometric properties of the PRO-CLARA, this population has been compared to another cohort of 247 outpatients with RA who were participating in a long-term observational study and who satisfying minimal disease activity and remission definitions. All patients completed the PRO-CLARA, combining patient's physical function, self-administered tender joint count and perception of global health status into a single measure of disease activity. Additional comparator composite indices were analysed. Internal consistency was assessed with Cronbach's alpha coefficient. A confirmatory factor analysis was carried out to test factor structure. Concurrent validity was analyzed using Spearman's correlations and cross-tabulations. Discriminant validity to distinguish patients with active and non-active disease was assessed with receiver operating characteristic (ROC) curve analysis. For agreement analysis, kappa statistics were calculated. RESULTS In testing for internal consistency, we found that Cronbach's alpha for the PRO-CLARA was 0.893, indicating high reliability. PRO-CLARA proved to be significantly correlated to established RA activity assessment tools. The area under ROC curve of the PRO-CLARA gives identical results to those provided by other comparator indices. CONCLUSIONS The study showed satisfactory psychometric properties of the PRO-CLARA.

[1]  F. Salaffi,et al.  Disease activity assessment of rheumatoid arthritis in daily practice: validity, internal consistency, reliability and congruency of the Disease Activity Score including 28 joints (DAS28) compared with the Clinical Disease Activity Index (CDAI). , 2009, Clinical and experimental rheumatology.

[2]  F. Salaffi,et al.  The use of computer touch-screen technology for the collection of patient-reported outcome data in rheumatoid arthritis: comparison with standardized paper questionnaires. , 2009, Clinical and experimental rheumatology.

[3]  M. Dougados,et al.  Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative , 2008, Annals of the rheumatic diseases.

[4]  T. Pincus,et al.  RAPID3 (Routine Assessment of Patient Index Data 3), a Rheumatoid Arthritis Index Without Formal Joint Counts for Routine Care: Proposed Severity Categories Compared to Disease Activity Score and Clinical Disease Activity Index Categories , 2008, The Journal of Rheumatology.

[5]  P Tugwell,et al.  Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. , 2008, Arthritis and rheumatism.

[6]  H. Mäkinen,et al.  A new disease activity index for rheumatoid arthritis: Mean Overall Index for Rheumatoid Arthritis (MOI-RA). , 2008, The Journal of rheumatology.

[7]  B. Leeb,et al.  Patient-centered rheumatoid arthritis disease activity assessment by a modified RADAI. , 2008, The Journal of rheumatology.

[8]  Jeffrey R Curtis,et al.  American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. , 2008, Arthritis and rheumatism.

[9]  C. Sofka.  Inter-Observer Agreement of Standard Joint Counts in Early Rheumatoid Arthritis: A Comparison With Grey Scale Ultrasonography-A Preliminary Study , 2008 .

[10]  T. Pincus,et al.  Time to score quantitative rheumatoid arthritis measures: 28-Joint Count, Disease Activity Score, Health Assessment Questionnaire (HAQ), Multidimensional HAQ (MDHAQ), and Routine Assessment of Patient Index Data (RAPID) scores. , 2008, The Journal of rheumatology.

[11]  G. Reed,et al.  Simplified composite disease activity measures in rheumatoid arthritis: should they be used in standard care? , 2008, Clinical and experimental rheumatology.

[12]  B. Leeb,et al.  Disease activity score-28 values differ considerably depending on patient's pain perception and sex. , 2007, The Journal of rheumatology.

[13]  T. Pincus,et al.  An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. , 2007, Rheumatology.

[14]  E. Taal,et al.  Psychometric properties of the Rheumatoid Arthritis Disease Activity Index (RADAI) in a cohort of consecutive Dutch patients with RA starting anti-tumour necrosis factor treatment , 2007, Annals of the rheumatic diseases.

[15]  T. Pincus,et al.  Quantitative measurement of patient status in the regular care of patients with rheumatic diseases over 25 years as a continuous quality improvement activity, rather than traditional research. , 2007, Clinical and experimental rheumatology.

[16]  T. Pincus,et al.  Assessment of quality of rheumatoid arthritis care requires joint count and/or patient questionnaire data not found in a usual medical record: examples from studies of premature mortality, changes in clinical status between 1985 and 2000, and a QUEST-RA global perspective. , 2007, Clinical and experimental rheumatology.

[17]  J. Smolen,et al.  Identification of disease activity and health status cut-off points for the symptom state acceptable to patients with rheumatoid arthritis , 2007, Annals of the rheumatic diseases.

[18]  J. Jacobs,et al.  Tight control in the treatment of rheumatoid arthritis: efficacy and feasibility , 2007, Annals of the rheumatic diseases.

[19]  T. Pincus,et al.  Quantitative measures of rheumatic diseases for clinical research versus standard clinical care: differences, advantages and limitations. , 2007, Best practice & research. Clinical rheumatology.

[20]  T. Pincus,et al.  A proposed continuous quality improvement approach to assessment and management of patients with rheumatoid arthritis without formal joint counts, based on quantitative routine assessment of patient index data (RAPID) scores on a multidimensional health assessment questionnaire (MDHAQ). , 2007, Best practice & research. Clinical rheumatology.

[21]  Gerald. D. Levy,et al.  Validation of patient-reported joint counts in rheumatoid arthritis and the role of training. , 2007, The Journal of rheumatology.

[22]  J. Jacobs,et al.  Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial) , 2007, Annals of the rheumatic diseases.

[23]  H. Paulus,et al.  Comparison of composite measures of disease activity in an early seropositive rheumatoid arthritis cohort , 2007, Annals of the rheumatic diseases.

[24]  Désirée van der Heijde,et al.  A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. , 2007, Arthritis and rheumatism.

[25]  T. Pincus,et al.  A proposed approach to recognise "near-remission" quantitatively without formal joint counts or laboratory tests: a patient self-report questionnaire routine assessment of patient index data (RAPID) score as a guide to a "continuous quality improvement" s. , 2006, Clinical and experimental rheumatology.

[26]  J. Smolen,et al.  The definition and measurement of disease modification in inflammatory rheumatic diseases. , 2006, Rheumatic diseases clinics of North America.

[27]  F. Wolfe,et al.  A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II). , 2005, The Journal of rheumatology.

[28]  T. Pincus,et al.  Most visits of most patients with rheumatoid arthritis to most rheumatologists do not include a formal quantitative joint count , 2005, Annals of the rheumatic diseases.

[29]  B. Dijkmans,et al.  Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. , 2005, Arthritis and rheumatism.

[30]  F. Salaffi,et al.  Prevalence of musculoskeletal conditions in an Italian population sample : results of a regional community-based study , 2005 .

[31]  J. Cush.  Biological drug use: US perspectives on indications and monitoring , 2005, Annals of the rheumatic diseases.

[32]  David T Felson,et al.  Minimal disease activity for rheumatoid arthritis: a preliminary definition. , 2005, The Journal of rheumatology.

[33]  F. Salaffi,et al.  Measuring functional disability in early rheumatoid arthritis: the validity, reliability and responsiveness of the Recent-Onset Arthritis Disability (ROAD) index. , 2005, Clinical and experimental rheumatology.

[34]  Tanja Stamm,et al.  Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. , 2005, Arthritis and rheumatism.

[35]  J. Smolen,et al.  The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis. , 2005, Clinical and experimental rheumatology.

[36]  F. Salaffi,et al.  Development of a functional disability measurement tool to assess early arthritis: the Recent-Onset Arthritis Disability (ROAD) questionnaire. , 2005, Clinical and experimental rheumatology.

[37]  P. V. van Riel,et al.  Effectiveness of systematic monitoring of rheumatoid arthritis disease activity in daily practice: a multicentre, cluster randomised controlled trial , 2005, Annals of the rheumatic diseases.

[38]  M. Uffmann,et al.  Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score , 2005, Arthritis research & therapy.

[39]  Gary G Koch,et al.  Continuous indices of core data set measures in rheumatoid arthritis clinical trials: lower responses to placebo than seen with categorical responses with the American College of Rheumatology 20% criteria. , 2005, Arthritis and rheumatism.

[40]  P. V. van Riel,et al.  Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. , 2004, Rheumatology.

[41]  A. McMahon,et al.  Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial , 2004, The Lancet.

[42]  N. Bellamy,et al.  Validation and patient acceptance of a computer touch screen version of the WOMAC 3.1 osteoarthritis index , 2004, Annals of the rheumatic diseases.

[43]  P. Hannonen,et al.  Retardation of joint damage in patients with early rheumatoid arthritis by initial aggressive treatment with disease-modifying antirheumatic drugs: five-year experience from the FIN-RACo study. , 2004, Arthritis and rheumatism.

[44]  Maarten Boers,et al.  The relationship between disease activity and radiologic progression in patients with rheumatoid arthritis: a longitudinal analysis. , 2004, Arthritis and rheumatism.

[45]  L. Klareskog,et al.  Relationship between inflammation and joint destruction in early rheumatoid arthritis: a mathematical description , 2004, Annals of the rheumatic diseases.

[46]  P. Hannonen,et al.  Similar prediction of mortality by the health assessment questionnaire in patients with rheumatoid arthritis and the general population , 2004, Annals of the rheumatic diseases.

[47]  T. Pincus,et al.  A proposed treatment algorithm for rheumatoid arthritis: aggressive therapy, methotrexate, and quantitative measures. , 2003, Clinical and experimental rheumatology.

[48]  P. Tugwell,et al.  The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: lessons learned. , 2003, Arthritis and rheumatism.

[49]  Frederick Wolfe,et al.  The assessment of rheumatoid arthritis and the acceptability of self-report questionnaires in clinical practice. , 2003, Arthritis and rheumatism.

[50]  P. Tugwell,et al.  A simplified disease activity index for rheumatoid arthritis for use in clinical practice. , 2003, Rheumatology.

[51]  F. Salaffi,et al.  A multicenter cost-of-illness study on rheumatoid arthritis in Italy. , 2002, Clinical and experimental rheumatology.

[52]  H. Paulus,et al.  Patient self-report tender and swollen joint counts in early rheumatoid arthritis. Western Consortium of Practicing Rheumatologists. , 1999, The Journal of rheumatology.

[53]  P. Hannonen,et al.  Work disability in rheumatoid arthritis 10 years after the diagnosis. , 1999, The Journal of rheumatology.

[54]  P. Hannonen,et al.  Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial , 1999, The Lancet.

[55]  D. Forman,et al.  Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[56]  F. Romero,et al.  Self-administered joint counts in rheumatoid arthritis: comparison with standard joint counts. , 1999, The Journal of rheumatology.

[57]  F. Wolfe,et al.  The long-term outcomes of rheumatoid arthritis: a 23-year prospective, longitudinal study of total joint replacement and its predictors in 1,600 patients with rheumatoid arthritis. , 1998, Arthritis and rheumatism.

[58]  M. Prevoo,et al.  Remission in a prospective study of patients with rheumatoid arthritis. American Rheumatism Association preliminary remission criteria in relation to the disease activity score. , 1996, British journal of rheumatology.

[59]  Marsha P. Johnson.  Statistical Methods for Health Care Research , 1996 .

[60]  J J Anderson,et al.  American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. , 1995, Arthritis and rheumatism.

[61]  M. Liang,et al.  A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiologic research. Psychometric properties and correlation with parameters of disease activity. , 1995, Arthritis and rheumatism.

[62]  P. Tugwell,et al.  World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. , 1994, The Journal of rheumatology. Supplement.

[63]  J J Anderson,et al.  The American college of rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials , 1993 .

[64]  D. Felson.  Choosing a core set of disease activity measures for rheumatoid arthritis clinical trials. , 1993, The Journal of rheumatology.

[65]  G. Calori,et al.  The Italian version of the Functional Disability Index of the Health Assessment Questionnaire. A reliable instrument for multicenter studies on rheumatoid arthritis. , 1993, Clinical and experimental rheumatology.

[66]  P. Tugwell,et al.  OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. , 1993, The Journal of rheumatology.

[67]  van der Heijde Dm,et al.  Development of a disease activity score based on judgment in clinical practice by rheumatologists. , 1993 .

[68]  J. Anderson,et al.  The rapid assessment of disease activity in rheumatology (radar) questionnaire. Validity and sensitivity to change of a patient self-report measure of joint count and clinical status. , 1992, Arthritis and rheumatism.

[69]  F. Wolfe,et al.  The assessment and prediction of functional disability in rheumatoid arthritis. , 1991, The Journal of rheumatology.

[70]  M. A. van 't Hof,et al.  Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. , 1990, Annals of the rheumatic diseases.

[71]  J A Swets,et al.  Measuring the accuracy of diagnostic systems. , 1988, Science.

[72]  M. Liang,et al.  The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. , 1988, Arthritis and rheumatism.

[73]  E. Coles,et al.  Significant changes in Ritchie scores. , 1988, British journal of rheumatology.

[74]  J. Hanley,et al.  A method of comparing the areas under receiver operating characteristic curves derived from the same cases. , 1983, Radiology.

[75]  H. Skinner.  Factor analysis and studies on alcohol. A methodological review. , 1980, Journal of studies on alcohol.

[76]  W. Buchanan,et al.  Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. , 1968, The Quarterly journal of medicine.

[77]  S. Berney.  Comparison of Treatment Strategies in Early Rheumatoid Arthritis: A Randomized Trial , 2008 .

[78]  D V Doyle,et al.  Touch-screen computer systems in the rheumatology clinic offer a reliable and user-friendly means of collecting quality-of-life and outcome data from patients with rheumatoid arthritis. , 2006, Rheumatology.

[79]  A. Gibofsky.  American College of Rheumatology. , 2002, Journal of the Medical Association of Georgia.

[80]  G. Stucki,et al.  Responsiveness of the self-assessed rheumatoid arthritis disease activity index to a flare of disease activity. , 2001, Arthritis and rheumatism.

[81]  G. Stucki,et al.  A patient-derived disease activity score can substitute for a physician-derived disease activity score in clinical research. , 1999, Rheumatology.

[82]  M. Prevoo,et al.  Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. , 1996, Arthritis and rheumatism.

[83]  M. Prevoo,et al.  Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. , 1995, Arthritis and rheumatism.

[84]  M. A. van 't Hof,et al.  Development of a disease activity score based on judgment in clinical practice by rheumatologists. , 1993, The Journal of rheumatology.

[85]  G. Guyatt,et al.  Validation of an index of the quality of review articles. , 1991, Journal of clinical epidemiology.

[86]  B Kirshner,et al.  A methodological framework for assessing health indices. , 1985, Journal of chronic diseases.

[87]  A. Masi,et al.  Preliminary criteria for clinical remission in rheumatoid arthritis. , 1981, Arthritis and rheumatism.

[88]  H. Holman,et al.  Measurement of patient outcome in arthritis. , 1980, Arthritis and rheumatism.

[89]  J. Nunnally.  Psychometric Theory (2nd ed), New York: McGraw-Hill. , 1978 .