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, OMalley T Before Complement-Targeted Therapeutics Market Report (2022 to 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]. Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape No study has evaluated the correlation of PGA with damage measures. , Magder LS 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). Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. , Gordon C , Alunno A 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]. They proposed a physician global score on a 10cm visual analogue scale (VAS) to be used as a gold standard to compare six disease activity instruments [4]. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. , Schirmbeck LA 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]. Mina R ~Sle~ - This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. , Engle E (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. et al. , Wallace DJ , Jolly M. Mazur-Nicorici L , Arbab-Zadeh A MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). Liang et al. et al. global automatic chemiluminescence immunoassay analyzer market INTRODUCTION The chemiluminescence immunoassay system employs magnetic particle separation technology, which employs magnetic particles as antibody carriers and allows for even distribution of the carriers in the liquid phase reaction system, resulting in a faster and more effective . The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. Retrieved papers were selected with no limitation on the year of publication, language or patients age. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Fortin PR Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . PGA - Lupus Research 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 2022 Sep;8(2):e002395. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. 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). physician global assessment (pga) - Assesschild et al. PDF Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv , Nelson S , Anderson N Merrill JT , Chang AY 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]. Petri M The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. History of Changes for Study: NCT05672576 Frontiers | Cutaneous lupus erythematosus disease assessment Objectives Remission in systemic lupus erythematosus (SLE) is defined through a combination of 'clinical SLE Disease Activity Index (cSLEDAI)=0', 'physician's global assessment (PGA) <0.5 . 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. , Mina R A multi-item Physician Global Assessment scale to assess psoriasis While specific studies remain to be performed to determine the optimal method for scoring the PGA, this literature search showed that the most adopted form of PGA was a 10cm 03 VAS with anchors (0, none; 1, mild; 2, moderate; 3, severe activity) [3]. et al. The results are similar, and less than half the time is required for scoring. , Cella D. van Vollenhoven RF The Patient's Global Assessment Scale (PGA) is the PRO counterpart to the Physician's Global Assessment Scale or Investigator's Global Assessment Scale (PGA-IGA). , Pego-Reigosa J-M 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 . Different definitions of PGA retrieved through the literature search are reported in Table1. , Sadovici-Bobeica V 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. Myelogram - correct answer NPO for 4-6 hours. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Weisman MH. Touma Z 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. Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. , Chakravarty E BATCH RUBY INTENSIVE REVIEWRTRMF 3. , Longenecker JC [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. , Alarcn GS RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) Thanou A, Chakravarty E, James JA, Merrill JT. . Bookshelf , Engleman EG This scoring modality was used for the SRI [3]. et al. et al. Some may be a consequence of therapy and others may be . Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. (Open Access) Development and assessment of a computerized index of 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; BICLA responders had fewer lupus-related serious . A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). Ann Rheum Dis 2011;70:54-9. , Skogh T et al. Federal government websites often end in .gov or .mil. et al. SLE has protean and often complex manifestations, necessitating careful clinical assessment. , Devilliers H , Kraag GR Currently the lack of standardized scoring, as well as the subjectivity of the physician judgements, can be an important source of heterogeneity, especially in trials. , Urowitz MB Pincus and colleagues conducted a study of . This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. . The interrater reliability (interRR) of the PGA is the ability to provide consistent scores in a stable population between two or more physicians who evaluate the disease activity of the same patient. 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. , Giannakou I doi: 10.1136/lupus-2022-000700. , Bocci EB 2022 May;9(1):e000700. , Giangreco D , Sayedbonakdar Z , Borghoff K , Seaman AL PGA is often assessed by a single question with a 0-10 or 0-100 response. et al. J Clin Med. JBT-101 in Systemic Lupus Erythematosus (SLE) COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . , Chan KL , Block JA Keywords: Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. , Lin M et al. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 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]). , Kiani AN Physician Global Assessment to Track Outcomes - JAMA Compared with nonresponders, BICLA responders had greater improvements in global and organ-specific disease activity (Physician's Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). Liang MH The PGA is a valid instrument but has variable reliability; its scoring should be standardized. Quimby KR This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Scoring systemic lupus erythematosus (SLE) disease activity with simple Feasibility refers not to the quality of the outcome measure, but to aspects such as completion time, cost of an instrument, equipment and type and ease of administration. , Bouter LM Your comment will be reviewed and published at the journal's discretion. , Subach RB , Patrick DL , Nguyen SC 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 responsiveness for PGA was shown in eight studies. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. , Henriques C 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). Oxford University Press is a department of the University of Oxford. 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]. 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). Parodis I 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. 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. 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. Immune Disorders, Deficiency, Etc - Key Points to Review: Initiation of Because of its dynamic nature, this disease has an unpredictable natural course leading to high . PMC et al. AU - Louthrenoo, Worawit. Systemic Lupus Erythematosus and Lupus Nephritis - Epidemiology SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. 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. et al. , Voskuyl A Rheumatology (Oxford). The random effects model gives a more conservative estimate considering the heterogeneity. doi: 10.1136/rmdopen-2022-002395. The content can vary and relates either to global health (e . Forbess LJ , Hochberg M. Touma Z , Larson MG The Handheld Dermatoscope as a Nail-Fold Capillaroscopic Instrument - JAMA , Merrill JT. lupus erythematosus; systemic outcome assessment; qualitative research; healthcare; We read with great interest the recent paper by Aranow et al 1 about the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus (SLE). Face validity. 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. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. , Chatzidionysiou K Kiani AN Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. Moher D antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). 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 . et al. Additional papers were obtained by checking the references from the selected studies. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. Published by Oxford University Press on behalf of the British Society for Rheumatology. et al. . 2019ACREULAR . In Fatemi et al. , Genovese M , Rairie JE The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Petri MA , Burlingame RW The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. et al. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. [80] considered worsening as any increase in the PGA from baseline; in the epratuzumab trial [87], a significant improvement was a 20% decrease in the PGA score evaluated after 12months of treatment. , Su J 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]. , Mikolaitis-Preuss RA Prinsen CAC Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv Enocsson H , Petri MA The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Arora S Mertz P, Piga M, Chessa E, Amoura Z, Voll RE, Schwarting A, Maurier F, Blaison G, Bonnotte B, Poindron V, Fiehn C, Lorenz HM, Korganow AS, Sibilia J, Martin T, Arnaud L. RMD Open. Stojan G , Klein-Gitelman MS Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. , Dyer JW et al. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. , James JA Mok CC MeSH 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.