et al. , Bresee C The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. et al. 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. , Kalunian K The index has proved quick and easy to use despite a comprehensive database and compares favourably with . 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. Oxford Textbook of. 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]. , Wetter J , Garabajiu M National Library of Medicine doi: 10.1136/lupus-2022-000700. , Floris A , Alarcn GS et al. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Genovese M IgM) on attainment PhGA. et al. , Jolly M. Antony A Unable to load your collection due to an error, Unable to load your delegates due to an error. et al. Strength. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. et al. and transmitted securely. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. , Engleman EG , Schirmbeck LA Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. , Petri M Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. , Mohan C. Jolly M A good responsiveness for PGA was shown in eight studies. 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]. Mahler M For full access to this pdf, sign in to an existing account, or purchase an annual subscription. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. This property is reported across all articles selected through this systematic review [24, 913, 21103]. et al. 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. 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. Five centres in Great Britain and the Republic of Ireland have collaborated to produce a computerized index of clinical disease activity in systemic lupus erythematosus, based on the principle of the physician's intention to treat. 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. 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. Cloud, mobility, security, and more. 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. European League Against Rheumatism. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Results: CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. , Fortin PR JSS Medical Research. Parodis I Chaigne B Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. No data were found regarding the feasibility of the PGA. Results. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . Liang et al. , Hochberg M. Wallace DJ 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. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. doi:10.1136/ rmdopen-2017-000578 Prepublication history and The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. 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]). Learn more. , Ibanez D et al. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Birmingham DJ Content validity was reported in 89 studies. Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. , Rodrigues M , McGuire JL. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. , Askanase A , Smiley A. Askanase AD et al. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. 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). An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. 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 . Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . The other authors have declared no conflicts of interest. doi: 10.1136/rmdopen-2022-002395. BATCH RUBY INTENSIVE REVIEWRTRMF 3. 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 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]. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. Jesus D [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). 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. Your comment will be reviewed and published at the journal's discretion. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Liang MH 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. Once two investigators (E.C., M.P.) The results are similar, and less than half the time is required for scoring. X 20 sentence examples within Physician Global Assessment. , Friebus-Kardash J , Perneger T Karol DE The Author(s) 2020. 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). Stojan G However, the PGA allows for the measurement of disease activity in a global way (content validity). , Petri M. Isenberg DA ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. SLE3. It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . Glossary: PGA. Thanks to this feature, the PGA was included in composite indices with the aim of rating manifestations not included in glossary-based instruments such as the SLEDAI and BILAG [3] or for which a threshold has been defined (cytopenia). antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). van Vollenhoven R , Goldsmith CH Federal government websites often end in .gov or .mil. Identification of new candidate drugs for primary Sjgrens syndrome using a drug repurposing transcriptomic approach, When it looks like Behets syndrome but is something else: Differential diagnosis of Behcets syndrome: a two-centre retrospective analysis, Huge water-balloons in the belly: multiple pancreatic pseudocysts in systemic lupus erythematosus, A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjgrens syndrome, How to plug the leaky pipeline in clinical rheumatology across Europelessons to be learned from experiences in business, About the British Society for Rheumatology, British Society for Rheumatology Journals, https://doi.org/10.1093/rheumatology/keaa383, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 British Society for Rheumatology. disease activity). et al. 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]. Thousand Oaks. The .gov means its official. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . The literature search identified 91 studies. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. Criterion validity. 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 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 . , Kraag GR , Gladman DD et al. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. , Petri MA et al. 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]. In the absence of a consensus, Aranow [26] found a better correlation between the SLEDAI and the PGA when the latter was assessed taking into account laboratory test results. sharing sensitive information, make sure youre on a federal 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. HHS Vulnerability Disclosure, Help [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. , Kosinski M A good responsiveness for PGA was shown in eight studies. , Hynan LS 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 . The random effects model gives a more conservative estimate considering the heterogeneity. 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