, Navarra SV Observed and articulated management issues and responses. , Bresee C In one study, the PGA was part of a modified score to assess disease activity in pregnancy (the SLE in Pregnancy Disease Activity Index) [51]. 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. Accessibility 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. , Stavrakis S To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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 . et al. Please check for further notifications by email. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Sayedbonakdar Z , Alunno A Ann Rheum Dis 2011;70:54-9. Methods , Jolly M. Antony A 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]. , Ding HH , Magder L 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. Nehring J Discrimination refers to whether the score (PGA-VAS) differentiates between situations of interest [18]: discrimination of the PGA measures the ability of the PGA-VAS to report a consistent score where no change in disease activity has occurred (reliability) and to detect a change when a change in disease activity has occurred (sensitivity to change or responsiveness). Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. Ensure second line of defense Derivatives RWA reviews are performed consistently and . , Beaumont JL , ODell JR The official NJDOE Incident Reporting Form, as well as a guide to completing , Rairie JE Face validity. A total of 91 articles were included in the study (Fig. et al. 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. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . 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 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. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. et al. Arriens C Patient-Reported Outcomes in Systemic Lupus Erythematosus. They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician's Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures . Physician global assessments for disease activity in rheumatoid arthritis are all over the map! 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. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. The Physician's Global Assessment (PhGA) is a number without unit. 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). In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different for an untrained physician and a trained investigator [36]. FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Published by Oxford University Press on behalf of the British Society for Rheumatology. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Lerman RH IgM) on attainment PhGA. X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . , Adamichou C Flow chart illustrating the literature search and study selection. 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 (. 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). , Jolly M. Mok CC et al. Supervise the development of junior medical affairs staff . The assessment of disease activity in SLE is particularly challenging. When expanded it provides a list of search options that will switch the search inputs to match the current selection. 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 Apr 11. physician's global assessment (PGA) of disease activity in SLE. No study has evaluated the correlation of PGA with damage measures. 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. 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]. Mahler M The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). This may be explored through convergent and divergent validity. , Urowitz MB PGA responsiveness was used to assess flare [9]: PGA was identified as the gold standard to rate the exacerbation of lupus activity [21, 67, 88], preliminarily defined by a change of 1.0 on a 03 VAS since the last visit. MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). Genetic linkage has related dysfunction of . Criterion validity. BICLA responders had fewer lupus-related serious . , Chakravarty E Wells GA Results. 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). et al. 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 . , Esdaile JM. ~SLE~. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Patrick DL 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]. Keywords: 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]. , Francis S Bethesda, MD 20894, Web Policies Epub 2014 Jul 10. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. Chaigne B 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): 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]. 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. 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). It operates in Albuquerque, and New Mexico. Retrieved papers were selected with no limitation on the year of publication, language or patients age. 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. , Jnsen A The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Petri MA Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. , Schirmbeck LA , Perneger T , Holland M Franklyn K PGA is a valid, responsive and feasible instrument, while its reliability was impacted by the scale adopted, suggesting the major need for a standardization of its scoring. , Landis RC Barr SG AU - Louthrenoo, Worawit. et al. 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]. The .gov means its official. Thank you for submitting a comment on this article. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. 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]. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. , Wallace DJ Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. et al. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. , Genovese M Strength. Copay AG , Askanase A , Hearth-Holmes M. Khan A Akhter E Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , Saad-Magalhes C 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 . Once two investigators (E.C., M.P.) , Bentow C , Lin M Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. , Kalunian K 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). et al. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). et al. Jesus D 2. , Terwee CB , Brunetta P [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. , Pego-Reigosa J-M 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. , Goldsmith CH 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]. There is no cure for lupus, but medical . Physician training is very important. Eudy AM Parodis I , Shinada S et al. , Giannakou I 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 . , Skogh T , Taghavi-Zadeh S For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. , Smiley A. Askanase AD Mok CC Gandhi N , Weisman MH. 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]. , Guzmn RM , Mikolaitis-Preuss RA Whenever papers reported duplicate data, the most recent article was selected. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Touma Z The quantification of reliability is expressed by a correlation coefficient. . et al. All versions are validated and used by lupus researchers for clinical and research purposes. 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]. Conclusion: CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. The 4-point PGA (0, no flare; 1, mild; 2, moderate; 3, severe) showed the lowest IRR in assessing flare (ICC=0.18) compared with the BILAG-2004 (ICC=0.54) and SFI (ICC=0.21) [65]. This property is reported across all articles selected through this systematic review [24, 913, 21103]. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Dietzmann K Liang et al. , Sadovici-Bobeica V Parodis I It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . , Khamashta MA , McGwin G et al. Moher D , Ibanez D The index assesses separately eight organ-based systems. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. , Beresford MW , Farewell V et al. 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. , Kosinski M Gordon C et al. , Gladman DD. , Kostopoulou M [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. 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. Navarra SV et al. Disagreements between investigators were solved by consensus. FOIA Glossary: PGA. 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. , Klein-Gitelman MS 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]. , Tetzlaff J Annapureddy N J Clin Med. , Mazur M. Fatemi A T2 - A longitudinal study. et al. Fanouriakis A , Hochberg M. Touma Z Some may be a consequence of therapy and others may be . Schneider M , Voskuyl A , Subach RB SLE has protean and often complex manifestations, necessitating careful clinical assessment. Stojan G 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. Merrill JT Clipboard, Search History, and several other advanced features are temporarily unavailable. physician global assessment Recently Published Documents. 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). , Urowitz MB 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 . 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). Mokkink LB , Kalunian K A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. , Lau CS T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Data regarding divergent validity are lacking for the PGA. , Gladman DD 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]. 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. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. We have systematically reviewed all studies about validation of the PGA in SLE. Petri M The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. . Thanou A, Chakravarty E, James JA, Merrill JT. Published by Oxford University Press on behalf of the British Society for Rheumatology. , Nelson S Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. Learn more. , Matos A However, the PGA allows for the measurement of disease activity in a global way (content validity). 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 .