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, Seaman AL Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. , Taghavi-Zadeh S Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. and transmitted securely. 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. 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. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. 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. , Sato JO It should be noted that the PGA correlates with several other instruments that measure disease activity. In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. , Henriques C Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. , Carpenter AB 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 . , Navarra SV 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 . , Schirmbeck LA Objective: The results are similar, and less than half the time is required for scoring. Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. 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]. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). disease activity). 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 . et al. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. 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. et al. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. et al. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Content validity. et al. In 1988, Liang et al. 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). Navarra SV , Petri M et al. 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 . Epub 2014 Jul 10. National Library of Medicine , Roberts WN , Arbab-Zadeh A , McGuire JL. , Jolly M. Mazur-Nicorici L The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. , Longenecker JC , Mokkink LB , Sjwall C. Strand V A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). , Urowitz MB 1 2. 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). COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. Additional papers were obtained by checking the references from the selected studies. Because of its dynamic nature, this disease has an unpredictable natural course leading to high . BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. Glossary: PGA. , Petri M. Foering K Myelogram - correct answer NPO for 4-6 hours. Devilliers H In conclusion, the PGA was demonstrated to be a valid, responsive and feasible instrument, but its reliability was strongly impacted by the scale adopted, suggesting the need for standardization in its scoring. , Emamikia S Mina R 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]. et al. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . All versions are validated and used by lupus researchers for clinical and research purposes. , Perez-Gutthann S Brunner HI , Kharboutli M 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]. , Gayet-Ageron A , Engleman EG Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. , Alunno A Touma Z FOIA 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. , Urowitz MB. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. In the second column, the definitions were reported according to the VAS used in the study. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . , James JA Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. , Jnsen A , Block JA , Shea BJ OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. , Wallace DJ A total of 91 articles were included in the study (Fig. The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. Content validity was reported in 89 studies. et al. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. Barr et al. et al. , Chan KL Quimby KR , Matos A . , Birmingham DJ 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 PGA is intended to encapsulate the physician's judgement of overall disease activity.Consensus on whether the PGA should be performed prior to, or after the receipt of laboratory values is lacking. This is a top barrier, both for treat-to-target management of SLE patients in clinical practice, as well as in clinical trials for new SLE treatments. et al. 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 . Federal government websites often end in .gov or .mil. Parodis I 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]. 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. Barr SG , Engel SM , Kandane-Rathnayake RK On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . The other authors have declared no conflicts of interest. 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 . Petri M 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. Liang MH LECTURE 10: MEDICAL SURGICAL NURSING. The official NJDOE Incident Reporting Form, as well as a guide to completing , Hochberg M. Touma Z , Fortin PR [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. Annapureddy N , Devilliers H Criterion validity. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , Mohan C. Giangreco D 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. Methods: Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . et al. , Urowitz MB , Matos A 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. , Borghoff K The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. , Petri MA Genetic linkage has related dysfunction of . Beaton DE CareerBuilder TIP. , Pilkington C Bookshelf , Magder LS The PGA is a valid instrument but has variable reliability; its scoring should be standardized. , McGwin G et 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]. , Wallace DJ , Dyer JW 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 assessment of disease activity in SLE is particularly challenging. 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 . The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. 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]. Conclusion: , Weisman MH. Int J Environ Res Public Health. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. , Ibaez D , Jolly M. Antony A 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. It estimates how similar a given patients scores were at the two visits. 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. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. 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. 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. 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. Few studies reported on whether serological activity should be incorporated in the PGA. A 21-numbered circle visual analog scale (VAS) may be a desirable alternative to the traditional 10-cm horizontal line for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ). 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]. , Holland M , Brunetta P The index assesses separately eight organ-based systems. 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. , Adamichou C Of note, the literature search revealed heterogeneous definitions of physician assessment of disease activity other than the PGA (physician global assessment [4, 70, 73], physician overall assessment [85]). The literature search identified 91 studies. et al. , Voskuyl A Aranow C MeSH 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. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. , Cappellazzo G In Fatemi et al. 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). 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. 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]. , Vogel-Claussen J Touma Z 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]. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. Akhter E 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]. At least 1 issue from each virtual tour. PGA is a simple instrument and the result is easily understood. Disagreements between investigators were solved by consensus. , Block JA This scoring modality was used for the SRI [3]. The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. , Perneger T , Klein-Gitelman MS , Allen E , Floris A et al. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). However, the PGA allows for the measurement of disease activity in a global way (content validity).
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