et al. Management of systemic lupus erythematosus (SLE) often depends on disease severity and disease manifestations, [] although hydroxychloroquine has a central role for long-term treatment in all SLE patients. , Maxwell LJ Arriens C et al. , Giangreco D The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Petri MA [PDF] Use of Physician Global Assessment in systemic lupus Patient-Reported Outcomes in Systemic Lupus Erythematosus. Use of Physician Global Assessment (PGA) in Systemic lupus Treatment of lupus nephritis: consensus, evidence and perspectives et al. Liang MH Kiani AN , Nelson S However, the PGA allows for the measurement of disease activity in a global way (content validity). , Kandane-Rathnayake RK The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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]. Annapureddy N (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Terwee CB 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. 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. The index assesses separately eight organ-based systems. It operates in Albuquerque, and New Mexico. Ward et al. Physician's Global Assessment in Psoriatic Arthritis: A Multicenter , Floris A On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . 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 . TOTAL DOCUMENTS. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Beaton DE disease activity). The Handheld Dermatoscope as a Nail-Fold Capillaroscopic Instrument - JAMA FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). 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). In the second column, the definitions were reported according to the VAS used in the study. et al. Direkt zum Inhalt springen . The interRR was assessed in seven studies [4, 10, 11, 36, 65, 68, 94], showing values ranging from 0.67 [68] to 0.96 [94]. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). One study showed a significant ability of the PGA in distinguishing between patients (P<0.0001) and observers (P<0.0001), but not between visits [79]. Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) - Full Different definitions of PGA retrieved through the literature search are reported in Table1. , Anderson N In 1988, Liang et al. BATCH RUBY INTENSIVE REVIEWRTRMF 3. AU - Kandane-Rathnayake, Rangi. Cloud, mobility, security, and more. 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]. disease activity in SLE, with the Physician Global Assessment (PGA) being the only one included in the updated EULAR recommendations for the management of SLE.11. et al. 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. 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. 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. PGA0.3. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. Nehring J et al. The last MEDLINE search was performed on 1 July 2019. National Library of Medicine Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. , Hynan LS No study has evaluated the feasibility of the PGA in SLE to date. et al. Unable to load your collection due to an error, Unable to load your delegates due to an error. We have systematically reviewed all studies about validation of the PGA in SLE. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. , Landis RC , Magder LS AU - Louthrenoo, Worawit. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. Manzi S et al. AU - Kasitanon, Nuntana. 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. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Mosca M , Petri MA et al. , Gordon C , Alarcn GS 2014 - 20184 years. et al. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. , Guzmn RM The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Borghoff K Navarra SV 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). Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases 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. The company serves physicians and patients. Conclusion: Learn more. This site needs JavaScript to work properly. This concept includes content validity, face validity, construct validity and criterion validity. Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. physician's global assessment (PGA) of disease activity in SLE. Piga M , Beresford MW 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]. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. Thanou A , Gladman DD Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Taghavi-Zadeh S van Vollenhoven R In our centre, new tools for the assessment of SLE activity: the Lupus Activity Scoring Tool (LAST) and Clinical Lupus Activity Scoring Tool (C-LAST) were developed and validated. 215 (FIVE YEARS 146) H-INDEX. , Shea BJ , Seaman AL 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. , Gladman DD. , ODell JR 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. , Kostopoulou M A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). In one open-label study [43], the decrease in PGA score was considered the primary endpoint. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. , Devilliers H Schlencker A, Messer L, Ardizzone M, Blaison G, Hinschberger O, Dahan E, Sordet C, Walther J, Dory A, Gonzalez M, Kleinlogel S, Bramont-Nachman A, Barrand L, Payen-Revol I, Sibilia J, Martin T, Arnaud L. Lupus Sci Med. The site is secure. , Gallacher AE Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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 Validity of Patient and Physician Global Disease Activity Oxford Textbook of. Systemic lupus erythematosus (SLE), is the most common type of lupus. 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. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . 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. , Matos A COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Urowitz MB Pain assessment: An alternative measure - hcplive.com , Fang H 04 Measuring SLE disease activity in 2020: perspectives from clinical Disclaimer. Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. JSS Medical Research. 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. , Burlingame RW , Magder LS The Physician's Global Assessment (PhGA) is a number without unit. , Chatzidionysiou K The official NJDOE Incident Reporting Form, as well as a guide to completing Enocsson H , Zonana-Nacach A , Wallace DJ In support of its face validity, the PGA was used to define the disease activity score in all 91 studies retrieved by the literature search, having a role as an outcome measure as well as a comparator to assess the validity of other indices. Mahler M PDF Physician global assessments for disease activity in rheumatoid Ahmed S. - Managing Director/ Medical Lead - Global Bio-pharma Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , Gomez A Face validity. , Hochberg M. Wallace DJ 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). , Bresee C Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. , Dietzmann K 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. J Clin Med. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Mok CC , Su J Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape (SLE) GSKpro 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). 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]. Touma Z , Ho LY , Skogh T The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. Touma Z 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. In the last 30years, more than a dozen scores have been derived to assess disease activity in SLE, but not all of these have proven to be valid and reliable tools. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. Barr et al. 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. In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. et al. 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 . [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. , Emamikia S . 2. Liang 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. Parodis I A good responsiveness for PGA was shown in eight studies. Petri M The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. Your comment will be reviewed and published at the journal's discretion. No study has evaluated the correlation of PGA with damage measures. , Brunetta P A prospective cohort study, Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients, A novel lupus activity index accounting for glucocorticoids: SLEDAI-2K glucocorticoid index, Low disease activityirrespective of serologic status at baselineassociated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: a real-life observational study, Definition and initial validation of a lupus low disease activity state (LLDAS), A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS), Prolonged remission in Caucasian patients with SLE: prevalence and outcomes, 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus, PRISMA Group. Physician's global assessment is often useful in SLE - ResearchGate , Farewell V 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. Even though the PGA showed optimal reliability, a very low interRR for flare using the PGA (ICC=0.18) was found in a single study [65] compared with that of the BILAG (ICC=0.54) or SFI (ICC=0.21). 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. , Altman DG [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. This may be explored through convergent and divergent validity. A good correlation was considered for a value >0.60. , Longenecker JC All rights reserved. . doi: 10.1136/rmdopen-2022-002395. Would you like email updates of new search results? , Chizzolini C Copay AG In 11 retrieved studies [10, 13, 33, 36, 45, 48, 50, 55, 56, 65, 96] the PGA was part of the SFI [104] and in 10 studies [3, 29, 40, 46, 52, 60, 69, 80, 94, 98] it was part of the SRI [3] (both discussed in the Responsiveness section). Exagen Diagnostics Inc (XGN) - Product Pipeline Analysis, 2022 Update 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]. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Wells GA Gordon C , Sjwall C Moher D Criterion validity was assessed exploring the PGA correlation with quality of life measurements, biomarker levels and treatment changes in 28 studies, while no study has evaluated correlation with damage. Epub 2014 Apr 11. Physician global assessment in systemic lupus erythematosus: can we 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. , Goldsmith CH This study assesses the reliability of the PGA, measured by means of 0-100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA). Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . Arthritis Res Ther. , Koutsoviti S et al. BILAGAB . Results: Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. PGA is often assessed by a single question with a 0-10 or 0-100 response. Gladman DD , Petri M. Iaccarino L , Saad-Magalhes C . Feb 2016 - Jan 20182 years. In Fatemi et al. A good responsiveness for PGA was shown in eight studies. No data were found regarding the feasibility of the PGA. X 20 sentence examples within Physician Global Assessment. Karol DE 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. , Vogel-Claussen J et al. 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. physician global assessment Latest Research Papers | ScienceGate Physician global assessments for disease activity in rheumatoid 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 . , Friebus-Kardash J Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. 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). 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. Epub 2014 Jul 10. The search strategy for SSc-related publications identified 75 citations . Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. Laboratory Investigation Results Influence Physician's Global 1 2. Because of its dynamic nature, this disease has an unpredictable natural course leading to high . , Engel SM 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. et al. , Lau CS MeSH , Voskuyl A Liang MH Faculty Publications: Feb. 23-March 2 , Gladman DD , Birmingham DJ , Magder LS , Socher SA 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. , Cella D. van Vollenhoven RF 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. , Holland M Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol A difference between the interRR of the PGA assessed by an untrained physician (ICC=0.50.63) or a trained investigator (ICC=0.790.81) was found [36]. government site. The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. For permissions, please email: journals.permissions@oup.com. The results are similar, and less than half the time is required for scoring. Complement-Targeted Therapeutics Market Report (2022 to The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. sharing sensitive information, make sure youre on a federal 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. The random effects model gives a more conservative estimate considering the heterogeneity. The literature search identified 91 studies. Once two investigators (E.C., M.P.) , Mikolaitis-Preuss RA , Wetter J Systemic Lupus Erythematosus and Lupus Nephritis - Epidemiology A total of 91 articles were included in the study (Fig. An official website of the United States government. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. , Hearth-Holmes M. Khan A The quantification of reliability is expressed by a correlation coefficient. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. A multi-item Physician Global Assessment scale to assess psoriasis The https:// ensures that you are connecting to the Correspondence to: Laurent Arnaud, Service de Rhumatologie, Centre National de Rfrence des Maladies Autoimmunes et Systmiques Rares, Hpital de Hautepierre, 1 Avenue Molire BP 83049, 67098 Strasbourg Cedex, France. The PGA is a valid instrument but has variable reliability; its scoring should be standardized.