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However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Jolly M. Mazur-Nicorici L SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. A validation study of the SRI for juvenile SLE [60] showed that exclusion of the BILAG or PGA from the SRI did not change the accuracy of the SRI in detecting improvement. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. Background Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Navarra SV A prospective cohort study, Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients, A novel lupus activity index accounting for glucocorticoids: SLEDAI-2K glucocorticoid index, Low disease activityirrespective of serologic status at baselineassociated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: a real-life observational study, Definition and initial validation of a lupus low disease activity state (LLDAS), A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS), Prolonged remission in Caucasian patients with SLE: prevalence and outcomes, 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus, PRISMA Group. et al. , Socher SA , Shinada S This button displays the currently selected search type. 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). Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . , Wallace DJ Reliability. Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. et al. , Beaumont JL watch for seizures after the procedure. ~SLE~. , Allen E The patients were diagnosed as having the following disorders: scleroderma (n = 27), dermatomyositis (n = 11), systemic lupus erythematosus (SLE) (n = 22), MCTD (n = 8), and RP without evidence of underlying CTD (n = 38). Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. 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. , Magder L et al. Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. , Lerman RH Background: Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Altman DG 2022 May;9(1):e000700. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. The content can vary and relates either to global health (e . , Jolly M. Mok CC allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). The .gov means its official. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. In support of its face validity, the PGA was used to define the disease activity score in all 91 studies retrieved by the literature search, having a role as an outcome measure as well as a comparator to assess the validity of other indices. Different definitions of disease activity according to the PGA instrument. Importance: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. Barr et al. 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]. , Block JA This scoring modality was used for the SRI [3]. The https:// ensures that you are connecting to the et al. , Farewell V Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. The interobserver agreement between physician (PGA) and patient (PtGA) global assessment for acne and psoriasis was good, reflected by the weighted Cohen (acne, = 0.68; psoriasis, = 0.70) (eTable in the Supplement). 2. , Hochberg M. Wallace DJ , Perneger T 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Touma Z Content validity was reported in 89 studies. , Block JA Methods In one open-label study [43], the decrease in PGA score was considered the primary endpoint. , Fang H , Friebus-Kardash J , Chatzidionysiou K In 16 studies the PGA was used as a mean to assess changes in disease activity after treatment [3, 12, 22, 29, 40, 42, 43, 52, 54, 56, 57, 80, 85, 87, 95, 98, 101]. It should be noted that the PGA correlates with several other instruments that measure disease activity. The quantification of reliability is expressed by a correlation coefficient. inflammation (duration and severity of morning stiffness as measured by BASDAI). Methods: Supervise the development of junior medical affairs staff . BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. , Bentow C Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. It does not provide a predefined or limited list of disease manifestations or organ systems, thus allowing one to capture all the heterogeneous aspects of SLE disease activity. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures . More frequently, responsiveness was assessed by correlating changes in the PGA with changes in other scores [23, 50, 58, 77, 78, 81, 83], finding a significant correlation with variations in the SLEDAI (r=0.390.66) [23, 77, 78], SLAM (0.61) [77], LAI (0.56) [77], patient global assessment (0.37) [77], SRI-50 (0.48) [78] and ESR (P<0.0001) [58], but not with C3, C4, circulating immunocomplexes and prednisone dose [77]. X 20 sentence examples within Physician Global Assessment. , Gladman DD. Would you like email updates of new search results? Face validity. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. PGA is a valid, responsive and feasible instrument, while its reliability was impacted by the scale adopted, suggesting the major need for a standardization of its scoring. et al. The literature search identified 91 studies. Annapureddy N SLE is an immune-mediated multisystemic disease characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares [1, 2]. Observed and articulated management issues and responses. The aim of this systematic literature review is to describe and analyse the . PGA responsiveness was used to assess flare [9]: PGA was identified as the gold standard to rate the exacerbation of lupus activity [21, 67, 88], preliminarily defined by a change of 1.0 on a 03 VAS since the last visit. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Once two investigators (E.C., M.P.) SLE3. Reviews and case series with fewer than five patients were excluded. The company serves physicians and patients. Brunner HI , Giangreco D 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 . PGA is a valid, responsive and feasible instrument, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . et al. To increase its reliability, the PGA should be scored by a physician with significant expertise in SLE, with prior knowledge of laboratory results [112], considering the overall disease activity at the time of the visit and comparing it to the last visit in order to assess flares [9]. In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. et al. Touma Z All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. , Wetter J , Petri M. Thanou A Content validity. , Jolly M. Antony A et al. Piga M Ward et al. Background: Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Forbess LJ 8600 Rockville Pike . , Askanase A et al. , Costenbader K Learn more. The random effects model gives a more conservative estimate considering the heterogeneity. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of multifactorial origin that can affect any organ or organ system, resulting in a broad spectrum of clinical manifestations ranging from dermatological involvement to multi-organ failure with episodes of relapses and remissions. Fanouriakis A Liang MH Glossary: PGA. The site is secure. , Arbab-Zadeh A [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. , Saad-Magalhes C The judgment of whether a patient with SLE has active disease is a central question both in routine patient management and in clinical research [4]. Mokkink LB , Klein-Gitelman MS , Guzmn RM The index assesses separately eight organ-based systems. , Raeisi A Thanou A This is a top barrier, both for treat-to-target management of SLE patients in clinical practice, as well as in clinical trials for new SLE treatments. PGA is an important tool for assessing disease activity, response to treatment (it is a component . Mok CC Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Adamichou C independently selected the articles, initially on the basis of titles and abstracts, then, if necessary, on the full texts, an eligibility assessment was performed independently in a blinded standardized manner. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. , Schur PH. Enocsson H et al. The correlation with the SLEDAI was determined in 12 studies (Fig. , Cella D. van Vollenhoven RF A 21-numbered circle visual analog scale (VAS) may be a desirable alternative to the traditional 10-cm horizontal line for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ). In 1988, Liang et al. et al. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. A good responsiveness for PGA was shown in eight studies. Franklyn K Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. TOTAL DOCUMENTS. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. et al. . , Schirmbeck LA The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Flow chart illustrating the literature search and study selection. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. , Chang AY Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. Conclusion: The geographical analysis of the Global Global Respiratory Devices market provided in the report is just the right tool that competitors can use to discover untapped sales and business expansion . et al. , Petri MA Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). Petri M Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. The OMERACT defines an instrument as an outcome measure if it passes the three pillars of evidence: truth (that refers to validity), discrimination (that includes reliability and responsiveness) and feasibility. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Of note, it is not trivial that we found a good convergent validity with other instruments (SLEDAI, BILAG, LAI, SLAM and ECLAM) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. , Pilkington C PGA is a simple instrument and the result is easily understood. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Thousand Oaks. , Liberati A , Tugwell P Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). , Rairie JE , Vogel-Claussen J Federal government websites often end in .gov or .mil. . In the last 30years, more than a dozen scores have been derived to assess disease activity in SLE, but not all of these have proven to be valid and reliable tools. government site. Changes in the PGA correlated with changes of other disease activity indices (SLEDAI, SLAM, LAI, patient global assessment), laboratory exams (ESR), patient-reported outcomes (Lupus Impact Tracker) [23, 50, 58, 77, 78, 81, 83] and response to treatment [4]. Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . An official website of the United States government. For permissions, please email: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Gladman DD If you have a published paper from this period that does not appear on this list, please contact Sue Marone, who will add it to next week's collection. The official NJDOE Incident Reporting Form, as well as a guide to completing , Pego-Reigosa J-M Kiani AN , Ding HH et al. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Sullivan KE 2022 Sep;8(2):e002395. Nehring J The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Chan KL , Alunno A et al. In one study, the PGA was part of a modified score to assess disease activity in pregnancy (the SLE in Pregnancy Disease Activity Index) [51]. Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). The following search strategy was used through MEDLINE via PubMed: (((lupus erythematosus, systemic[MeSH Terms] OR (lupus[TIAB] AND erythematosus[TIAB] AND systemic[TIAB]) OR systemic lupus erythematosus[TIAB] OR (systemic[TIAB] AND lupus[TIAB] AND erythematosus[TIAB]))) OR SLE[TIAB]) AND (physician global assessment[TIAB] OR PGA[TIAB]). Construct validity. , Engleman EG , Buyon J Nevertheless, despite the fact that the PGA was considered the reference in 39 studies involving other indices, it was used as the sole instrument in only 2 of them. Careers. The responsiveness of the PGA is the ability to detect worthwhile variations in disease activity over time, measuring worsening or improvements in SLE disease status. physician's global assessment (PGA) of disease activity in SLE. Int J Environ Res Public Health.
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