van Vollenhoven R Barr SG , Engleman EG Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. Careers. 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. Construct validity was demonstrated by a good correlation (r 0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). 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. , Tanangunan R et al. , Kandane-Rathnayake RK Annapureddy N PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Chizzolini C , Mosca M 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). The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. Your comment will be reviewed and published at the journal's discretion. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. SLE has protean and often complex manifestations, necessitating careful clinical assessment. Supervise the development of junior medical affairs staff . , Rodrigues M (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. , Petri M Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. 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]. Data regarding divergent validity are lacking for the PGA. AU - Louthrenoo, Worawit. [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. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. 2014 - 20184 years. 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). , Emamikia S Mahler M Touma Z PMC , Engle E Systemic lupus erythematosus (SLE), is the most common type of lupus. Copay AG [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. et al. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . , Ding HH European League Against Rheumatism. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. No study has evaluated the feasibility of the PGA in SLE to date. AU - Morand, Eric. , Gladman DD et al. , Matos A , Perez-Gutthann S J Clin Med. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. et al. , Lerman RH Brunner HI , Weisman MH. ~SLE~. , Francis S doi: 10.1136/rmdopen-2022-002395. 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): 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). The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. HHS Vulnerability Disclosure, Help There is no cure for lupus, but medical . Devilliers H All rights reserved. PGA is an important tool for assessing disease activity, response to treatment (it is a component . X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. , Koutsoviti S Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. , Birmingham DJ , Sjwall C The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and . 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. et al. Unable to load your collection due to an error, Unable to load your delegates due to an error. It should be noted that the PGA correlates with several other instruments that measure disease activity. , Jolly M. Antony A , Beaumont JL Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). , Gayet-Ageron A , Magder L The company serves physicians and patients. , Esdaile JM. BILAGAB . Schneider M et al. , Glassman DS 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. 8600 Rockville Pike et al. Keywords: FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Oxford Textbook of. , Chan KL , Carpenter AB This concept includes content validity, face validity, construct validity and criterion validity. Barr et al. Epub 2014 Apr 11. , Farewell V Higher disease activity is an important predictor of both organ damage and mortality [2] and the attainment of low disease activity is associated with a reduction in early damage [5, 6]. , Oon S 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). , Friebus-Kardash J , Ibaez D Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. Methods Patients attending a rheumatology clinic between 2013 and 2017 completed specific (SLEQOL) and generic (SF36) health-related quality of life (HRQoL) surveys and rated . , Petri M. Furie RA 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. , Tugwell P , Nelson S Thanou A Int J Environ Res Public Health. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Arora S , Devilliers H 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]. Sullivan KE , Kharboutli M , Chakravarty E et al. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. , Suriano A Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. The index assesses separately eight organ-based systems. Touma Z In the second column, the definitions were reported according to the VAS used in the study. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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 . 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. , Kiani AN 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. , Flower C , Petri M. Foering K et al. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Criterion validity. Piga M [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. et al. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Gordon C Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. 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 . Fanouriakis A 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. 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. , Fang H Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. et al. 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. 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. , Block JA , Pego-Reigosa J-M , Matos A et al. Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. The last MEDLINE search was performed on 1 July 2019. , Terwee CB 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). Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. 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 . et al. PGA is often assessed by a single question with a 0-10 or 0 . Please enable it to take advantage of the complete set of features! . , Gomez A Once two investigators (E.C., M.P.) , Bertsias G , Wallace DJ , Dietzmann K Akhter E , Larson MG Results. JSS Medical Research. Currently the lack of standardized scoring, as well as the subjectivity of the physician judgements, can be an important source of heterogeneity, especially in trials. , ODell JR In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. , Shinada S 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. , Maxwell LJ 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. Face validity. , Kostopoulou M , Devilliers H All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. Some may be a consequence of therapy and others may be . Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. Your recommendations as to what might or should be done in relation to various issues observed. , Bocci EB Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. Glossary: PGA. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. , McGuire JL. , Anderson N All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. , Andreoli L BATCH RUBY INTENSIVE REVIEWRTRMF 3. doi: 10.1136/lupus-2022-000700. AU - Kandane-Rathnayake, Rangi. Rheumatology (Oxford). 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. , Siega-Riz AM , Sjwall C. Strand V 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]. , Schirmbeck LA , Wallace DJ , Adamichou C 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. , Genovese 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. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. , Perneger T This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. physician's global assessment (PGA) of disease activity in SLE. 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]. Content validity pertains to the degree to which the instrument measures all facets of a construct of interest [20]: this property is satisfied if the PGA is considered able to measure all aspects of disease activity in SLE in a comprehensive way. , Ho LY , Seaman 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]. 2019ACREULAR . How should lupus flares be measured? , Wallace DJ , Kosinski M 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). Lai J-S , Urowitz MB. , Hochberg M. Touma Z The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Saad-Magalhes C 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). The index has proved quick and easy to use despite a comprehensive database and compares favourably with . , Jolly M. Mazur-Nicorici L , Lin M It operates in Albuquerque, and New Mexico. , Floris A Published by Oxford University Press on behalf of the British Society for Rheumatology. 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]. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. 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]. 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 interRR was assessed in seven studies [4, 10, 11, 36, 65, 68, 94], showing values ranging from 0.67 [68] to 0.96 [94]. , Merrill JT. 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. , Trendelenburg M et al. , Jnsen A , Socher SA The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. 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. 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 . , Cappellazzo G , Shea BJ 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]. RMD Open 2018;4:e000578. 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]. Ruiz-Irastorza G , Nguyen SC A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). However, the PGA allows for the measurement of disease activity in a global way (content validity). 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. et al. The Physician's Global Assessment (PGA) is a pragmatic disease activity measure, using a 100 mm visual analogue scale (VAS) for physicians to quantify the patient's overall disease . may be asked to hyperventilate 3-4 min and watch a bright flashing light. Ensure second line of defense Derivatives RWA reviews are performed consistently and . 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]. , Petri M. Iaccarino L Epub 2014 Jul 10. 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 . and transmitted securely. , OMalley T SELENA SLEDAI4. 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Jolly M. Ribi C 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). , Arbab-Zadeh A 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]. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Hennis A. Jesus D , Block JA T2 - A longitudinal study. 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 aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Smiley A. Askanase AD , Bresee C Liang MH , Petri MA Feasibility is the ease of application of the instrument of measure in its intended setting [106]. Quimby KR Because of its dynamic nature, this disease has an unpredictable natural course leading to high . 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 Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Jolly M. Mok CC physician global assessment Recently Published Documents. Before , James JA The content can vary and relates either to global health (e . et al. Unauthorized use of these marks is strictly prohibited. , Ravelli A . It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Touma Z , Alarcn GS et al. Ward et al. In 1988, Liang et al. , Hambleton IR 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). The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model.
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