, Holland M SLE2ACR1997SLICC2012. The last MEDLINE search was performed on 1 July 2019. , Mohan C. Giangreco D , Lau CS , Kosinski M Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, Instrument selection using the OMERACT filter 2.1: the OMERACT methodology, The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes, Health measurement scales: a practical guide to their development and use, A decrease in complement is associated with increased renal and hematologic activity in patients with systemic lupus erythematosus, Efficacy and safety of methotrexate in articular and cutaneous manifestations of systemic lupus erythematosus, Performance of SLEDAI-2K to detect a clinically meaningful change in SLE disease activity: a 36-month prospective cohort study of 334 patients, Disease activity patterns over time in patients with SLE: analysis of the Hopkins Lupus Cohort, Comparison of the systemic lupus erythematosus activity questionnaire and the systemic lupus erythematosus disease activity index in a black Barbadian population, A pilot study to determine the optimal timing of the Physician Global Assessment (PGA) in patients with systemic lupus erythematosus, Preliminary test of the LFA rapid evaluation of activity in lupus (LFA-REAL): an efficient outcome measure correlates with validated instruments, Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity, Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies, Erythrocyte-bound C4d in combination with complement and autoantibody status for the monitoring of SLE, Validation of SIMPLE index for lupus disease activity, Performance characteristics of different anti-double-stranded DNA antibody assays in the monitoring of systemic lupus erythematosus, Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus, Therapeutic adherence in patients with systemic lupus erythematosus: a cross-sectional study, Sensitivity analyses of four systemic lupus erythematosus disease activity indices in predicting the treatment changes in consecutive visits: a longitudinal study, Comparison of the lupus foundation of America-rapid evaluation of activity in lupus to more complex disease activity instruments as evaluated by clinical investigators or real-world clinicians, Lupus low disease activity state is associated with a decrease in damage progression in Caucasian patients with SLE, but overlaps with remission, Impact of disease activity on health-related quality of life in systemic lupus erythematosusa cross-sectional analysis of the Swiss Systemic Lupus Erythematosus Cohort Study (SSCS), Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study, Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus, Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings, Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned, Belimumab for the treatment of recalcitrant cutaneous lupus, Progression of noncalcified and calcified coronary plaque by CT angiography in SLE, Impact of heart rate variability, a marker for cardiac health, on lupus disease activity, The lupus impact tracker is responsive to changes in clinical activity measured by the systemic lupus erythematosus responder index, Validation of the Lupus Impact Tracker in an Australian patient cohort, Axl, ferritin, IGFBP2 and TNFR2 as biomarkers in systemic lupus erythematosus, Lupus anticoagulant, disease activity and low complement in the first trimester are predictive of pregnancy loss, Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus, Predictors of pregnancy outcomes in patients with lupus: a cohort study, Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials, Validation of the LupusPRO in Chinese patients from Hong Kong with systemic lupus erythematosus, The Swiss Systemic lupus erythematosus Cohort Study (SSCS)cross-sectional analysis of clinical characteristics and treatments across different medical disciplines in Switzerland, How should lupus flares be measured? An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. A good correlation was considered for a value >0.60. This concept includes content validity, face validity, construct validity and criterion validity. , Genovese M , Pego-Reigosa J-M 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. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. AU - Louthrenoo, Worawit. , Zonana-Nacach A (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Block JA , Karp DR AU - Kandane-Rathnayake, Rangi. 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]. , Petri MA 1 2. 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 . Construct validity was recognized in 21 studies [2, 10, 11, 23, 24, 2629, 35, 47, 52, 54, 65, 68, 76, 84, 88, 92, 99, 101]. X 20 sentence examples within Physician Global Assessment. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). et al. All rights reserved. Petri M et al. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. , Clowse M. Moorthy LN Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. JSS Medical Research. Methods The search strategy for SSc-related publications identified 75 citations . A good responsiveness for PGA was shown in eight studies. et al. et al. et al. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . Schneider M Manzi S et al. , Siega-Riz AM , Skogh T Additional papers were obtained by checking the references from the selected studies. A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. 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. official website and that any information you provide is encrypted Before , Gomez A et al. , Jolly M. Mazur-Nicorici L How should lupus flares be measured? CareerBuilder TIP. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . No data were found regarding the feasibility of the PGA. The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Magder LS Pincus and colleagues conducted a study of . , Devilliers H Copay AG HHS Vulnerability Disclosure, Help 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. The company serves physicians and patients. European League Against Rheumatism. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Bocci EB 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. 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]. Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. J Clin Med. Touma Z , Chang AY Because of its dynamic nature, this disease has an unpredictable natural course leading to high . Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. In a post-hoc analysis of phase 3 belimumab trials, improvements and no worsening in the PGA were greater among SRI responders vs SRI non-responders (P<0.001) [52]. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . The other authors have declared no conflicts of interest. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. A good responsiveness for PGA was shown in eight studies. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . A total of 91 articles were included in the study (Fig. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. , Shea BJ 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 . The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. , Oon S . doi: 10.1136/rmdopen-2022-002395. Wells GA , Carpenter AB In 32 studies, disease activity measured by PGA was compared with changes in laboratory markers, with the aim of correlating clinical and serological features [9, 21, 30, 32, 34, 3739, 44, 45, 48, 49, 55, 5861, 63, 64, 66, 67, 69, 71, 74, 75, 82, 86, 89, 9194]. , Ding HH , Mokkink LB , Vogel-Claussen J Disclosure statement: L.A. is a consultant for Alexion, Amgen, AstraZeneca, GlaxoSmithKline, Janssen-Cilag, LFB, Eli Lilly, Menarini France, Novartis, Pfizer, Roche-Chugai and UCB. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. Akhter E Oxford University Press is a department of the University of Oxford. BATCH RUBY INTENSIVE REVIEWRTRMF 3. 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]. 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. MeSH , Kalunian K , Annapureddy N The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. Gandhi N Your recommendations as to what might or should be done in relation to various issues observed. et al. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. , Gayet-Ageron A , Tetzlaff J PGA is a simple instrument and the result is easily understood. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Careers. Parodis I PGA is an important tool for assessing disease activity, response to treatment (it is a component . , Brunetta P Medical-Surgical Nursing Clinical Lab (NUR1211L) U.S. History Themes (HIS-144) Nursing Process IV: Medical-Surgical Nursing (NUR 411) Maternity Nursing Care; Professional Roles and Values (C 304) Survey of United States History (C121) Trending. Whenever papers reported duplicate data, the most recent article was selected. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. 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. LECTURE 10: MEDICAL SURGICAL NURSING. MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). Federal government websites often end in .gov or .mil. , Mikolaitis-Preuss RA 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. , Ibaez D et al. Rheumatology (Oxford). et al. 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. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. , Aggarwal R Cloud, mobility, security, and more. Elisabetta Chessa, Matteo Piga, Alberto Floris, Herv Devilliers, Alberto Cauli, Laurent Arnaud, Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties, Rheumatology, Volume 59, Issue 12, December 2020, Pages 36223632, https://doi.org/10.1093/rheumatology/keaa383. Parodis I , OMalley T Stojan G Once two investigators (E.C., M.P.) Fanouriakis A 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. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. 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. Mok CC et al. BILAGAB . , Klein-Gitelman MS , Mohan C. Jolly M et al. When expanded it provides a list of search options that will switch the search inputs to match the current selection. 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. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. 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, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring. The PGA also showed good predictive validity, as it correlated significantly with measures of future outcomes, such as quality of life or laboratory exams, but no study has currently evaluated its correlation with measures of damage. 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. Gladman DD Chaigne B et al. Piga M Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. 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. Petri M , Lin M , Tanangunan R It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . PGA is often assessed by a single question with a 0-10 or 0 . , Nguyen SC Thanou A , Dietzmann K Please enable it to take advantage of the complete set of features! 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]. , Kostopoulou M Tel: 03 88 12 84 74; Fax: 03 88 12 82 90; E-mail: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research, Patterns of disease activity in systemic lupus erythematosus, Novel evidence-based systemic lupus erythematosus responder index, Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus, Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus, Treatment target in newly diagnosed systemic lupus erythematosus, 10 most important contemporary challenges in the management of SLE, Measurement of systemic lupus erythematosus activity in clinical research, Definition, incidence, and clinical description of flare in systemic lupus erythematosus.
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