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. , Jolly M. Ribi C , Mosca M , Gladman DD Parodis I et al. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. Petri M Conclusion: Retrieved papers were selected with no limitation on the year of publication, language or patients age. Oxford University Press is a department of the University of Oxford. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). doi: 10.1136/lupus-2022-000700. 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. 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]. , Aggarwal R It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . Beaton DE Gyri N Rheumatology (Oxford). The last MEDLINE search was performed on 1 July 2019. et al. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. , Birmingham DJ The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Annapureddy N , Subach RB The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. Published by Oxford University Press on behalf of the British Society for Rheumatology. Responsiveness. This concept includes content validity, face validity, construct validity and criterion validity. et al. 2019ACREULAR . , Kalunian K , Suriano A , Burlingame RW 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]. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. In 16 studies the PGA was used as a mean to assess changes in disease activity after treatment [3, 12, 22, 29, 40, 42, 43, 52, 54, 56, 57, 80, 85, 87, 95, 98, 101]. , Hearth-Holmes M. Khan A et al. , Magder LS 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. 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]. Aranow C et al. 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). Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. 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. In this sense, criterion validity of PGA is satisfied when scores correlate with phenomena subsequently influenced by disease activity, such as quality of life measurements (Health-related Quality of Life, 36-item Short Form Health Survey, Functional Assessment of Chronic Illness TherapyFatigue score, Lupus Impact Tracker and LupusPRO), biomarker levels (complement fractions, ESR, autoantibodies), treatment variations and damage assessments (SDI). , Terwee CB , Sengupta M SLE2ACR1997SLICC2012. 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]. 2022 May;9(1):e000700. Reliability. , Karp DR PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. Arthritis Res Ther. Touma Z Akhter E , Ogale S Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. , Matos A There is no cure for lupus, but medical . 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]. , Petri MA Cloud, mobility, security, and more. Despite the need for new treatments in CLE . SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. 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. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. This scoring modality was used for the SRI [3]. , Perez-Gutthann S ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. 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. Accessibility 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]. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. , Sjwall C. Strand V , Petri M. Isenberg DA , Fang H Forbess LJ Moher D A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. 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. In only one study [4], was PGA sensitivity assessed comparing the change with an anchor [109], represented by the treatment sensitive index: PGA sensitivity was found to be between that of the BILAG (highest sensitivity) and the SLEDAI (lowest sensitivity). 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. FOIA PGA is a simple instrument and the result is easily understood. 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]. . , Brunetta P J Clin Med. et al. Unauthorized use of these marks is strictly prohibited. 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]. Gandhi N COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. The following search strategy was used through MEDLINE via PubMed: (((lupus erythematosus, systemic[MeSH Terms] OR (lupus[TIAB] AND erythematosus[TIAB] AND systemic[TIAB]) OR systemic lupus erythematosus[TIAB] OR (systemic[TIAB] AND lupus[TIAB] AND erythematosus[TIAB]))) OR SLE[TIAB]) AND (physician global assessment[TIAB] OR PGA[TIAB]). Brunner HI 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 (. Fanouriakis A , Urowitz MB et al. , Shinada S , Urowitz MB. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. The .gov means its official. Ward et al. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. 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 . , Jolly M. Mazur-Nicorici L , Wallace DJ 2022 Sep;8(2):e002395. Please check for further notifications by email. Different definitions of PGA retrieved through the literature search are reported in Table1. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Gladman DD 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. et al. , Roberts WN et al. 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. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Cappellazzo G , Urowitz MB Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study .