Results: 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). et al. Lai J-S 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 . 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. 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. , Urowitz MB. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Smiley A. Askanase AD et al. , Petri M. Isenberg DA , Petri MA , Wallace DJ Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. The Physician Global Assessment (PGA) has been shown to be a valid, responsive, and feasible instrument to capture disease activity in systemic lupus erythematosus (SLE), but its low reliability further supports the need for a standardisation of its scoring. , Chatzidionysiou K SLE has protean and often complex manifestations, necessitating careful clinical assessment. 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]. However, no precise guidelines exist regarding the optimal use of the PGA in SLE, such as the adequate length of the VAS, the presence of anchored values, the incorporation of laboratory data and the time frame of assessment. Some may be a consequence of therapy and others may be . The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence-based and expert-based consensus standardisation of the Physician Global Assessment (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). AU - Kasitanon, Nuntana. , Cella D. van Vollenhoven RF , Sayedbonakdar Z It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Prinsen CAC , Sadovici-Bobeica V , Ravelli A , Jolly M. Mok CC 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. , OMalley T Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , Urowitz MB. watch for seizures after the procedure. , Tanangunan R 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]. , Dietzmann K Responsiveness. , Urowitz MB , Bocci EB Content validity was reported in 89 studies. 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. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; et al. , Voskuyl A 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]. Disclaimer. It operates in Albuquerque, and New Mexico. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. MeSH On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . Navarra SV Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. , Wetter J , Landis RC Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. , Klein-Gitelman MS Published by Oxford University Press on behalf of the British Society for Rheumatology. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. , Petri M. Thanou A , Bouter LM COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. Tel: 03 88 12 84 74; Fax: 03 88 12 82 90; E-mail: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research, Patterns of disease activity in systemic lupus erythematosus, Novel evidence-based systemic lupus erythematosus responder index, Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus, Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus, Treatment target in newly diagnosed systemic lupus erythematosus, 10 most important contemporary challenges in the management of SLE, Measurement of systemic lupus erythematosus activity in clinical research, Definition, incidence, and clinical description of flare in systemic lupus erythematosus. , Devilliers H Few studies reported on whether serological activity should be incorporated in the PGA. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 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]. , Petri MA et al. X 20 sentence examples within Physician Global Assessment. Navarra SV A good responsiveness for PGA was shown in eight studies. Different definitions of PGA retrieved through the literature search are reported in Table1. , Genovese M BILAGAB . The assessment of disease activity in SLE is particularly challenging. 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). Annapureddy N , Birmingham DJ 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. , Wallace DJ The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. 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]. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. , Stavrakis S European League Against Rheumatism. Subsequently the PGA was incorporated in the Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) flare index (SFI) in 1999 [10], in the Systemic Responder Index (SRI) in 2009 [3, 11, 12] as well as in the definitions of the Lupus Low Disease Activity State (LLDAS) [13] and various definitions of remission [14, 15]. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). , Engle E 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]. National Library of Medicine Bookshelf , Terwee CB SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. AU - Louthrenoo, Worawit. The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. Fanouriakis A This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. , Matos A 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]. 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]. , ODell JR , Bentow C Mok CC Gordon C Mina R 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 . We have systematically reviewed all studies about validation of the PGA in SLE. , Gallacher AE , Mokkink LB , McGuire JL. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. , Clowse M. Moorthy LN 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]. BATCH RUBY INTENSIVE REVIEWRTRMF 3. , Rodrigues M , Aggarwal R Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. Thanou A An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. 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. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Cloud, mobility, security, and more. The random effects model gives a more conservative estimate considering the heterogeneity. All versions are validated and used by lupus researchers for clinical and research purposes. All rights reserved. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. Rheumatology (Oxford). However, the PGA allows for the measurement of disease activity in a global way (content validity). 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. , Andreoli L 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]. In a post-hoc analysis of phase 3 belimumab trials, improvements and no worsening in the PGA were greater among SRI responders vs SRI non-responders (P<0.001) [52]. The interrater reliability (interRR) of the PGA is the ability to provide consistent scores in a stable population between two or more physicians who evaluate the disease activity of the same patient. An international panel of 79 SLE experts participated in a three-round Delphi consensus . Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . Over the years, PGA-IGA scales were modified for the purpose of clinical settings and thus present a diversity in the number of response options (4 to 10 points), the response options label and the . , Francis S 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Longenecker JC , Brunetta P et al. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. 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. 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). inflammation (duration and severity of morning stiffness as measured by BASDAI). Pincus and colleagues conducted a study of . et al. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. 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. How should lupus flares be measured? , Shinada S Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Physician training is very important. 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). , Hynan LS 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 . Stojan G , Larson MG The literature search identified 91 studies. Disagreements between investigators were solved by consensus. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. In the second column, the definitions were reported according to the VAS used in the study. 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). Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. van Vollenhoven R Supervise the development of junior medical affairs staff . [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. , Petri MA et al. 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.
