, Glassman DS , Matos A Enocsson H Gladman DD Different definitions of disease activity according to the PGA instrument. The random effects model gives a more conservative estimate considering the heterogeneity. In the absence of a well-recognized gold standard for disease activity, criterion validity of the PGA is established when it correlates with a measure that the author of the study defined a priori as the gold standard. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. , Jolly M. Mazur-Nicorici L A total of 91 articles were included in the study (Fig. , Patrick DL , Morabito LM The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and . Some may be a consequence of therapy and others may be . The literature search identified 91 studies. The sensitivity to change was estimated to be the smallest for the SLEDAI; the standardized response means were 0.48 when the physician global assessment was used as the standard and 0.01 when the patient global assessment was used . , Gayet-Ageron A . This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. Neuropsychiatry OXFORD TEXTBOOKS IN PSYCHIATRY Oxford Textbook of Neuropsychiatry Edited by Niruj Agrawal, Rafey Faruqui, and Mayur Bodani Oxford Textbook of Psychiatry of Intellectual Disability Edited by Sabyasachi Bhaumik and Regi Alexander Oxford Textbook of Inpatient Psychiatry Edited by Alvaro Barrera, Caroline Attard, and Rob Chaplin Oxford Textbook of Attention . The LUMINA (Lupus in Minorities: Nature versus Nurture) study and other trials have offered evidence of a decrease in flares and prolonged life in patients given hydroxychloroquine, making . T2 - A longitudinal study. et al. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. . , Longenecker JC , Kalunian K , Ogale S PGA is often assessed by a single question with a 0-10 or 0-100 response. SLE3. ~Sle~ - , Landis RC In only one study [4], was PGA sensitivity assessed comparing the change with an anchor [109], represented by the treatment sensitive index: PGA sensitivity was found to be between that of the BILAG (highest sensitivity) and the SLEDAI (lowest sensitivity). A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. , Allen E In this sense, criterion validity of PGA is satisfied when scores correlate with phenomena subsequently influenced by disease activity, such as quality of life measurements (Health-related Quality of Life, 36-item Short Form Health Survey, Functional Assessment of Chronic Illness TherapyFatigue score, Lupus Impact Tracker and LupusPRO), biomarker levels (complement fractions, ESR, autoantibodies), treatment variations and damage assessments (SDI). , Jolly M. Antony A , Lau CS (Open Access) Development and assessment of a computerized index of Your comment will be reviewed and published at the journal's discretion. Clinical Trial on Systemic Lupus Erythematosus (SLE): Blood sample et al. The .gov means its official. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Beaton DE Aranow C BILAGAB . Unauthorized use of these marks is strictly prohibited. It operates in Albuquerque, and New Mexico. , Karp DR A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines [17], searching for articles reporting on the use of PGA in SLE. et al. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. Content validity. The company serves physicians and patients. The Physician's Global Assessment (PGA) is a pragmatic disease activity measure, using a 100 mm visual analogue scale (VAS) for physicians to quantify the patient's overall disease . Karol DE For full access to this pdf, sign in to an existing account, or purchase an annual subscription. At least 1 issue from each virtual tour. Copay AG Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. , Mohan C. Giangreco D PDF Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv National Library of Medicine COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. An official website of the United States government. et al. The Handheld Dermatoscope as a Nail-Fold Capillaroscopic Instrument - JAMA Your recommendations as to what might or should be done in relation to various issues observed. 8600 Rockville Pike In the second column, the definitions were reported according to the VAS used in the study. Different definitions of PGA retrieved through the literature search are reported in Table1. , Bertsias G Over the years, PGA-IGA scales were modified for the purpose of clinical settings and thus present a diversity in the number of response options (4 to 10 points), the response options label and the . SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Schneider M European League Against Rheumatism. Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol 2) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99], with the SLAM in 4 studies (r=0.470.65) [35, 76, 84, 99], with LAI in 2 studies (r=0.640.75) [68, 84], with BILAG in 2 studies (r=0.610.62) [35, 84] and with ECLAM in 2 studies (r=0.580.65) [35, 84]. , Hynan LS et al. , Chan KL Subsequently the PGA was incorporated in the Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) flare index (SFI) in 1999 [10], in the Systemic Responder Index (SRI) in 2009 [3, 11, 12] as well as in the definitions of the Lupus Low Disease Activity State (LLDAS) [13] and various definitions of remission [14, 15]. , Flower C , Petri M. Iaccarino L , Saad-Magalhes C Chaigne B [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. Elevation of erythrocyte sedimentation rate is associated with disease activity and damage accrual, The systemic lupus activity measure-revised, the Mexican systemic lupus erythematosus disease activity index (SLEDAI), and a modified SLEDAI-2K are adequate instruments to measure disease activity in systemic lupus erythematosus, Small changes in outpatients lupus activity are better detected by clinical instruments than by laboratory tests, Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50, Sensitivity to change of 3 systemic lupus erythematosus disease activity indices: international validation, Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index 50: sensitivity to response at 6 and 12 months, Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial, Psychological distress and changes in the activity of systemic lupus erythematosus, The rating scale preference measure as an evaluative measure in systemic lupus erythematosus, Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus, Treatment of systemic lupus erythematosus with dehydroepiandrosterone: 50 patients treated up to 12 months, Soluble urokinase plasminogen activator receptor levels reflect organ damage in systemic lupus erythematosus, Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006, Measuring systemic lupus erythematosus activity during pregnancy: validation of the lupus activity index in pregnancy scale, Autoantibodies against albumin in patients with systemic lupus erythematosus, Association of depression with socioeconomic status, anticardiolipin antibodies, and organ damage in patients with systemic lupus erythematosus: results from the KORNET registry, Placebo-controlled randomized clinical trial of fish oils impact on fatigue, quality of life, and disease activity in systemic lupus erythematosus, Serum free light chains, interferon-alpha, and interleukins in systemic lupus erythematosus, Vitamin D levels in Chinese patients with systemic lupus erythematosus: relationship with disease activity, vascular risk factors and atherosclerosis, Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity, Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus, Turkish LupusPRO: cross-cultural validation study for lupus, Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines, Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial, Sensitivity and specificity of plasma and urine complement split products as indicators of lupus disease activity, The TNF locus is altered in monocytes from patients with systemic lupus erythematosus, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Frequency of lupus flare in pregnancy: the Hopkins Lupus Pregnancy Center experience, Morbidity of systemic lupus erythematosus: role of race and socioeconomic status, Classification and definition of major flares in SLE clinical trials, Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study, COSMIN guideline for systematic reviews of patient-reported outcome measures, Validity and reliability in social science research, Understanding the minimum clinically important difference: a review of concepts and methods, Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research, Minimum important difference between patients with rheumatoid arthritis: the patients perspective, Responsiveness and sensitivity to change of SLE disease activity measures, The Author(s) 2020. et al. Strength. Federal government websites often end in .gov or .mil. An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were . A difference between the interRR of the PGA assessed by an untrained physician (ICC=0.50.63) or a trained investigator (ICC=0.790.81) was found [36]. , Giannakou I Published by Oxford University Press on behalf of the British Society for Rheumatology. Kiani AN The measurements were in the form of a scale from 0 to 3 in 54 studies [2, 3, 9, 10, 12, 13, 21, 2469, 103], a 010 scale in 12 studies [4, 60, 7079], a 0100 scale in 9 studies [27, 40, 78, 8085], a 07 Likert scale [11, 78, 80], a 02 scale [53], a 04 scale [86] and a 05 scale [87].
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