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]. 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. et al. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Jolly M. Mok CC , Kalunian K The company serves physicians and patients. Keywords: Sullivan KE Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . , Hochberg M. Wallace DJ Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . , Chizzolini C HHS Vulnerability Disclosure, Help These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. et al. et al. , Devilliers H , Rodrigues M It operates in Albuquerque, and New Mexico. The last MEDLINE search was performed on 1 July 2019. , Kraag GR , Navarra SV , Adamichou C et al. , Oon S PGA0.3. Moher D Patient-Reported Outcomes in Systemic Lupus Erythematosus. The https:// ensures that you are connecting to the et al. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . 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]. Five centres in Great Britain and the Republic of Ireland have collaborated to produce a computerized index of clinical disease activity in systemic lupus erythematosus, based on the principle of the physician's intention to treat. 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). Mahler M 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. , Annapureddy N , Chang AY , Bentow C 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]. Oxford Textbook of. Learn more. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. 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]. 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]. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. et al. Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. [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. However, the PGA allows for the measurement of disease activity in a global way (content validity). PGA is often assessed by a single question with a 0-10 or 0 . The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. 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]. BICLA responders had fewer lupus-related serious . 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 . , Bertsias G Face validity. et al. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. , Mosca M 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. , Giannakou I 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 . . ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. T2 - A longitudinal study. Vil LM Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. , Giangreco D MeSH The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. Bookshelf This may be explored through convergent and divergent validity. , Gladman DD In this sense, criterion validity of PGA is satisfied when scores correlate with phenomena subsequently influenced by disease activity, such as quality of life measurements (Health-related Quality of Life, 36-item Short Form Health Survey, Functional Assessment of Chronic Illness TherapyFatigue score, Lupus Impact Tracker and LupusPRO), biomarker levels (complement fractions, ESR, autoantibodies), treatment variations and damage assessments (SDI). Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. Search for other works by this author on: Rheumatology Unit, AOU University Clinic and University of Cagliari, Department of Medical Sciences and Public Health, Cagliari, Italy, Centre Hospitalier Universitaire de Dijon, Hpital Franois-Mitterrand, service de mdecine interne et maladies systmiques (mdecine interne, 2) et Centre dInvestigation Clinique, Service de rhumatologie, Hpitaux Universitaires de Strasbourg, Universit de Strasbourg, Centre National de Rfrence des Maladies Systmiques et Autoimmunes Rares Est Sud-Ouest (RESO). It estimates how similar a given patients scores were at the two visits. , Ho LY , Chatzidionysiou K The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). In Fatemi et al. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. 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. , Ibaez D FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). , Urowitz MB The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. , Landis RC Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . 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 . 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]. All rights reserved. Manzi S It is therefore desirable to use the PGA along with other tools (typically the SLEDAI) or to include the PGA in a composite index (e.g. et al. 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. 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 content can vary and relates either to global health (e . Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. Akhter E Physician training is very important. Parodis I et al. , Buyon J et al. et al. , Smiley A. Askanase AD Neuropsychiatry OXFORD TEXTBOOKS IN PSYCHIATRY Oxford Textbook of Neuropsychiatry Edited by Niruj Agrawal, Rafey Faruqui, and Mayur Bodani Oxford Textbook of Psychiatry of Intellectual Disability Edited by Sabyasachi Bhaumik and Regi Alexander Oxford Textbook of Inpatient Psychiatry Edited by Alvaro Barrera, Caroline Attard, and Rob Chaplin Oxford Textbook of Attention . Prinsen CAC We have systematically reviewed all studies about validation of the PGA in SLE. 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]. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. [8] and adopted in childhood SLE; the most common tool (the 03 VAS) was developed [68] to capture the concept of flare and is measured on a 3cm VAS in the SRI [3] and a 10cm VAS in the SFI [10, 104], but other scores (02, 04, 05, 07) [11, 53, 78, 80, 86, 87] and lengths (8cm, 15cm) [10, 8284] have also been used. 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? Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Brunetta P Bethesda, MD 20894, Web Policies The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. , Raeisi A Content validity was reported in 89 studies. 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. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. TOTAL DOCUMENTS. Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials. 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 (. , Matos A Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. 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). 2022 Sep;8(2):e002395. , Leung HW Before 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Methods , Voskuyl A , Magder L Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. Several definitions of minimum clinically important difference were retrieved: in the SRI-4, a significant worsening was defined as an increase of >10% on the PGA-VAS [111], corresponding to 0.3 points from baseline; Touma et al. , Urowitz MB Brunner HI Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Beaton DE This button displays the currently selected search type. et al. The PGA was introduced in 1998 by a US Food and Drug Administration panel as the preferred tool to assess and record the severity of disease in clinical studies, and typically rates a patient's disease from 'clear' to 'severe' or 'very severe' [1, 2]. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. , Schur PH. , Kharboutli M . A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. 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]. 2019ACREULAR . SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Flow chart illustrating the literature search and study selection. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Gordon C , Su J Careers. In an epratuzumab trial, the absence of deterioration of the PGA (not >10% worsening) was one of the items to achieve a BILAG-based Composite Lupus Assessment (BICLA) response [105]. , James JA T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Responsiveness. , Socher SA Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , Clowse M. Moorthy LN et al. , Terwee CB Strength. 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 SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. 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. , Engel SM , Floris A et al. A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. Criterion validity is defined as the degree to which the scores of an instrument adequately reflect the truth in the form of a gold standard [107]. The results are similar, and less than half the time is required for scoring. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. , Jolly M. Ribi C 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. Construct validity. In the absence of a consensus, Aranow [26] found a better correlation between the SLEDAI and the PGA when the latter was assessed taking into account laboratory test results. doi: 10.1136/rmdopen-2022-002395. et al. The PGA was integrated in composite indices, including the definition of the LLDAS [12, 13, 29, 34, 37, 39, 40] and remission [29, 37] (Table1). , Holland M , Farewell V , Klein-Gitelman MS The literature search identified 91 studies. Epub 2014 Jul 10. X 20 sentence examples within Physician Global Assessment. , Magder LS , Jolly M. Mazur-Nicorici L . , Schirmbeck LA , Birmingham DJ [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. Construct validity was demonstrated by a good correlation (r0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). Unable to load your collection due to an error, Unable to load your delegates due to an error. , Wallace DJ , Bouter LM Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Dyer JW Definition: At least a 20%, 40%, 50%, or 70% improvement and an absolute improvement of at least 1 unit on a scale of 1-10 in at least three of the following criteria: patient global assessment; pain; function (BASFI); and. It was published in 1977 and was initially designed for the measurement of self-assessed pain in rheumatoid arthritis although it has since been used to evaluate RA more globally. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. , Kiani AN Thank you for submitting a comment on this article. 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. BILAGAB . Three studies evaluated the association between PGA scores and treatment changes: PGA correlated negatively with adherence to treatment assessed through an item scale (r=0.31, P=0.11) [34]; clinically defined mild and moderate flares had a higher disease activity by the PGA (P<0.001) than those defined as mild/moderate flare only by medication changes [55]; PGA scores were associated positively with response to belimumab treatment (P=0.039) [43]. 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]. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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 index assesses separately eight organ-based systems. No data were found regarding the feasibility of the PGA. 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). Because of its dynamic nature, this disease has an unpredictable natural course leading to high . In the second column, the definitions were reported according to the VAS used in the study. , Skogh T Kiani AN The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Gomez A 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.