, Matos A FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. , Piette EW Quimby KR , Trendelenburg M Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. Moreover, a difference between the interRR of the PGA assessed by an untrained physician (0.50.63) and a trained investigator (0.790.81) was found, suggesting the need for PGA scoring training or standardization [36]. It operates in Albuquerque, and New Mexico. , Suriano A Content validity. , Sengupta M Disclaimer. 2022 Sep;8(2):e002395. At least 1 issue from each virtual tour. Unauthorized use of these marks is strictly prohibited. and transmitted securely. , Block JA Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. 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]. , Perez-Gutthann S , Weisman MH. Fanouriakis A It should be noted that the PGA correlates with several other instruments that measure disease activity. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 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]. Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. Content validity was reported in 89 studies. All rights reserved. Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. 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). Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. Thanou A, Chakravarty E, James JA, Merrill JT. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. , Urowitz MB , Costenbader K Ward et al. Ruiz-Irastorza G , Klein-Gitelman MS Liang MH 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. 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 . , Larson MG 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). 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. , Chakravarty E The company serves physicians and patients. The other authors have declared no conflicts of interest. 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]. Once two investigators (E.C., M.P.) IgM) on attainment PhGA. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. Accessibility van Vollenhoven R This scoring modality was used for the SRI [3]. X 20 sentence examples within Physician Global Assessment. et al. Cloud, mobility, security, and more. , Taghavi-Zadeh S . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Socher SA How should lupus flares be measured? , McGuire JL. [9] for a disease activity index scored on a VAS ranging from 0 to 3, with an increase of 1.0 since the last visit indicating a flare. 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]. Wells GA Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . et al. , Rodrigues M SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Merrill JT. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. The index assesses separately eight organ-based systems. Gandhi N , Shea BJ Newark, New Castle, USA, March 03, 2023 (GLOBE NEWSWIRE) -- The global complement-targeted therapeutics market is expected to grow at a CAGR of 8.9% from 2022 to 2030, owing to the rising . 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. This site needs JavaScript to work properly. et al. 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]. Objective: et al. Barr SG Eudy AM LECTURE 10: MEDICAL SURGICAL NURSING. may be asked to hyperventilate 3-4 min and watch a bright flashing light. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. Thanou A One study, published after our systematic literature search was completed [112], showed that scoring the PGA with knowledge of laboratory data increased its correlation with the SLEDAI-2K (r=0.79) compared with without knowledge of laboratory results (r=0.67). Piga M The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. BILAGAB . The correlation with the SLEDAI was determined in 12 studies (Fig. , Arora S Clipboard, Search History, and several other advanced features are temporarily unavailable. RMD Open 2018;4:e000578. 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. , Garabajiu M No data were found regarding the feasibility of the PGA. , Kiani AN [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. et al. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). Karol DE European League Against Rheumatism. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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 . AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . 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 (. 8600 Rockville Pike , Dyer JW , Bonithon-Kopp C Despite the need for new treatments in CLE . Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . CareerBuilder TIP. In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. The quantification of reliability is expressed by a correlation coefficient. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. The literature search identified 91 studies. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. Learn more. , Friebus-Kardash J et al. PGA is often assessed by a single question with a 0-10 or 0 . The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. J Clin Med. Parodis I , Chang AY 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]. , Petri M. Thanou A Arriens C 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. Gyri N All versions are validated and used by lupus researchers for clinical and research purposes. Of note, the literature search revealed heterogeneous definitions of physician assessment of disease activity other than the PGA (physician global assessment [4, 70, 73], physician overall assessment [85]). 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]. Physician global assessments for disease activity in rheumatoid arthritis are all over the map! 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 . The assessment of disease activity in SLE is particularly challenging. The PGA is intended to encapsulate the physician's judgement of overall disease activity.Consensus on whether the PGA should be performed prior to, or after the receipt of laboratory values is lacking. , Fang H , Petri MA According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. 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). 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 et al. Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory): et al. et al. , Genovese M MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). Careers. , Chizzolini C Construct validity is shown by the good correlation observed with the SLEDAI, BILAG, SLAM, LAI and ECLAM [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. 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). Few studies reported on whether serological activity should be incorporated in the PGA. The site is secure. , Nelson S , Francis S All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Petri MA A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. Mok CC 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 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). 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). , Ravelli A 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. 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. , Sayedbonakdar Z The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Gayet-Ageron A Int J Environ Res Public Health. , Allen E 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. , Petri M. Iaccarino L , Pego-Reigosa J-M et al. , Brunetta P The index has proved quick and easy to use despite a comprehensive database and compares favourably with . PGA is an important tool for assessing disease activity, response to treatment (it is a component . http://oml.eular.org/glossary (31 January. , Schur PH. , Su J 2. HHS Vulnerability Disclosure, Help It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . , Mohan C. Jolly M It estimates how similar a given patients scores were at the two visits. Glossary: PGA. , Kraag GR , Gallacher AE , Adamichou C et al. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . Mok CC 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 . 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. , Aggarwal R 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. In conclusion, the PGA was demonstrated to be a valid, responsive and feasible instrument, but its reliability was strongly impacted by the scale adopted, suggesting the need for standardization in its scoring.
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