Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. , Devilliers H Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. Disagreements between investigators were solved by consensus. , Koutsoviti S This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Ogale S The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. The literature search identified 91 studies. Kandane-Rathnayake R, Louthrenoo W, Hoi A, Luo SF, Wu YJ, Chen YH, Cho J, Lateef A, Hamijoyo L, Navarra SV, Zamora L, Sockalingam S, An Y, Li Z, Katsumata Y, Harigai M, Hao Y, Zhang Z, Kikuchi J, Takeuchi T, Basnayake BMDB, Chan M, Ng KPL, Tugnet N, Kumar S, Oon S, Goldblatt F, O'Neill S, Gibson KA, Ohkubo N, Tanaka Y, Bae SC, Lau CS, Nikpour M, Golder V, Morand EF; Asia-Pacific Lupus Collaboration. , Petri M. Iaccarino L The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. Some may be a consequence of therapy and others may be . Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. The anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . et al. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Devilliers H , Vogel-Claussen J All rights reserved. Mok CC 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. Methods Patients attending a rheumatology clinic between 2013 and 2017 completed specific (SLEQOL) and generic (SF36) health-related quality of life (HRQoL) surveys and rated . Vil LM Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. et al. Systemic lupus erythematosus (SLE), is the most common type of lupus. et al. , Tugwell P Thank you for submitting a comment on this article. inflammation (duration and severity of morning stiffness as measured by BASDAI). X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . et al. , Chan KL et al. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. , Stavrakis S , ODell JR Content validity was reported in 89 studies. 2014 - 20184 years. For instance, in an analysis of studies of the prevalence of SLE in the Asia-Pacific region, higher rates of renal involvement were observed in Asian patients (21-65% at SLE diagnosis and 40 . 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. This potentially disfiguring disease can have significant impact on patient's quality of life (QoL) and is often refractory to many first- and second-line therapies. Your comment will be reviewed and published at the journal's discretion. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 et al. Exagen's products are used for therapeutic drug monitoring of hydroxychloroquine in whole blood and methotrexate polyglutamates, risk assessment testing, anti-TNF monitoring to individualize therapy and optimize dosing, and others. , Matos A et al. , Bocci EB Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. In the second column, the definitions were reported according to the VAS used in the study. , Nguyen SC In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different for an untrained physician and a trained investigator [36]. , Schur PH. Touma Z However, the PGA allows for the measurement of disease activity in a global way (content validity). Whenever papers reported duplicate data, the most recent article was selected. Fanouriakis A , Allen E , Seaman AL et al. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. 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]. 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. and transmitted securely. , Block JA Reviews and case series with fewer than five patients were excluded. Nehring J To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. Reliability. physician global assessment Recently Published Documents. Liang MH , Henriques C Reliability was excellent when scored through a pointed scale, such as the Likert scale, that was anchored in unit numbers from 0 (not active) to 7 (most active) (interRR ICC 0.96; intraRR ICC 0.88) [80], but was lower when assessed through a centimetric VAS using values between 0.0 and 3.0 (interRR ICC 0.67; intraRR ICC 0.55) [68]. , Lerman RH 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). A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). , Beresford MW et al. T2 - A longitudinal study. Stojan G , Zonana-Nacach A A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. CareerBuilder TIP. et al. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. , Gladman DD. , Ibanez D PGA is often assessed by a single question with a 0-10 or 0-100 response. PGA0.3. Clipboard, Search History, and several other advanced features are temporarily unavailable. , Karp DR , Askanase A The Physician Global Assessment (PGA) has been shown to be a valid, responsive, and feasible instrument to capture disease activity in systemic lupus erythematosus (SLE), but its low reliability further supports the need for a standardisation of its scoring. , Shinada S Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. et al. Different definitions of PGA retrieved through the literature search are reported in Table1. 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. , Su J 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.
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