Bookshelf et al. , Shinada S Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. , Petri M. Furie RA [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. , Arora S , Annapureddy N The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Bethesda, MD 20894, Web Policies The results are similar, and less than half the time is required for scoring. MeSH Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. All rights reserved. , Kraag GR , Chang AY 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): 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. , Chan KL Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . 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. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. , Leung HW , Hochberg M. Touma Z Your comment will be reviewed and published at the journal's discretion. Responsiveness. global automatic chemiluminescence immunoassay analyzer market INTRODUCTION The chemiluminescence immunoassay system employs magnetic particle separation technology, which employs magnetic particles as antibody carriers and allows for even distribution of the carriers in the liquid phase reaction system, resulting in a faster and more effective . , Dietzmann K , Trendelenburg M An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. 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]. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 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]). PMC 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). et al. , Glassman DS Before et al. 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]. , Gladman DD Gordon C et al. et al. CareerBuilder TIP. , Pego-Reigosa J-M Flow chart illustrating the literature search and study selection. , Buyon J Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. Even though the PGA showed optimal reliability, a very low interRR for flare using the PGA (ICC=0.18) was found in a single study [65] compared with that of the BILAG (ICC=0.54) or SFI (ICC=0.21). 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. 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. , Morabito LM , Chizzolini C 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]. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. . , Longenecker JC et al. , Alarcn GS Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. , Alunno A et al. , Tugwell P Disagreements between investigators were solved by consensus. lupus erythematosus; systemic outcome assessment; qualitative research; healthcare; We read with great interest the recent paper by Aranow et al 1 about the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus (SLE). 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). The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Holland M 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]. Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. doi: 10.1136/rmdopen-2022-002395. 2022 Sep;8(2):e002395. SELENA SLEDAI4. 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. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Neuropsychiatry OXFORD TEXTBOOKS IN PSYCHIATRY Oxford Textbook of Neuropsychiatry Edited by Niruj Agrawal, Rafey Faruqui, and Mayur Bodani Oxford Textbook of Psychiatry of Intellectual Disability Edited by Sabyasachi Bhaumik and Regi Alexander Oxford Textbook of Inpatient Psychiatry Edited by Alvaro Barrera, Caroline Attard, and Rob Chaplin Oxford Textbook of Attention . 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]. , Navarra SV Quimby KR Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Engle E For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. , Friebus-Kardash J 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). , Klein-Gitelman MS et al. The site is secure. , Kandane-Rathnayake RK disease activity). Unable to load your collection due to an error, Unable to load your delegates due to an error. The literature search identified 91 studies. et al. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. The content can vary and relates either to global health (e . 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 . 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). Brunner HI , Wallace DJ , Hochberg M. Wallace DJ In one open-label study [43], the decrease in PGA score was considered the primary endpoint. . , Smiley A. Askanase AD Elevation of erythrocyte sedimentation rate is associated with disease activity and damage accrual, 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, Small changes in outpatients lupus activity are better detected by clinical instruments than by laboratory tests, Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50, Sensitivity to change of 3 systemic lupus erythematosus disease activity indices: international validation, Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index 50: sensitivity to response at 6 and 12 months, Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial, Psychological distress and changes in the activity of systemic lupus erythematosus, The rating scale preference measure as an evaluative measure in systemic lupus erythematosus, Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus, Treatment of systemic lupus erythematosus with dehydroepiandrosterone: 50 patients treated up to 12 months, Soluble urokinase plasminogen activator receptor levels reflect organ damage in systemic lupus erythematosus, Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006, Measuring systemic lupus erythematosus activity during pregnancy: validation of the lupus activity index in pregnancy scale, Autoantibodies against albumin in patients with systemic lupus erythematosus, Association of depression with socioeconomic status, anticardiolipin antibodies, and organ damage in patients with systemic lupus erythematosus: results from the KORNET registry, Placebo-controlled randomized clinical trial of fish oils impact on fatigue, quality of life, and disease activity in systemic lupus erythematosus, Serum free light chains, interferon-alpha, and interleukins in systemic lupus erythematosus, Vitamin D levels in Chinese patients with systemic lupus erythematosus: relationship with disease activity, vascular risk factors and atherosclerosis, Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity, Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus, Turkish LupusPRO: cross-cultural validation study for lupus, Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines, Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial, Sensitivity and specificity of plasma and urine complement split products as indicators of lupus disease activity, The TNF locus is altered in monocytes from patients with systemic lupus erythematosus, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Frequency of lupus flare in pregnancy: the Hopkins Lupus Pregnancy Center experience, Morbidity of systemic lupus erythematosus: role of race and socioeconomic status, Classification and definition of major flares in SLE clinical trials, Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study, COSMIN guideline for systematic reviews of patient-reported outcome measures, Validity and reliability in social science research, Understanding the minimum clinically important difference: a review of concepts and methods, Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research, Minimum important difference between patients with rheumatoid arthritis: the patients perspective, Responsiveness and sensitivity to change of SLE disease activity measures, The Author(s) 2020. , ODell JR The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Petri M. Foering K 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 . 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. The other authors have declared no conflicts of interest. 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. , Criscione-Schreiber LG 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. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. et al. No study has evaluated the correlation of PGA with damage measures. , Su J , Gordon C Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. sharing sensitive information, make sure youre on a federal Content validity was reported in 89 studies. This scoring modality was used for the SRI [3]. Objective: , Kosinski M Arriens C et al. The .gov means its official. MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). The company serves physicians and patients. Criterion validity. , Petri M. Thanou A , Kostopoulou M Direkt zum Inhalt springen . . , Nelson S Feasibility is the ease of application of the instrument of measure in its intended setting [106]. All versions are validated and used by lupus researchers for clinical and research purposes. , Ho LY , Urowitz MB It does not provide a predefined or limited list of disease manifestations or organ systems, thus allowing one to capture all the heterogeneous aspects of SLE disease activity. SLE2ACR1997SLICC2012. et al. Liang MH Arthritis Res Ther. The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Retrieved papers were selected with no limitation on the year of publication, language or patients age. BILAGAB . National Library of Medicine Mok CC Observed and articulated management issues and responses. , Siega-Riz AM In 32 studies, disease activity measured by PGA was compared with changes in laboratory markers, with the aim of correlating clinical and serological features [9, 21, 30, 32, 34, 3739, 44, 45, 48, 49, 55, 5861, 63, 64, 66, 67, 69, 71, 74, 75, 82, 86, 89, 9194]. TOTAL DOCUMENTS. Fanouriakis A 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. , Birmingham DJ [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Urowitz MB . 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]. http://oml.eular.org/glossary (31 January. Feb 2016 - Jan 20182 years. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Petri M , Landis RC , Magder L Aranow C This button displays the currently selected search type. 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. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. 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 . Stojan G Parodis I , Lerman RH Mina R Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). An official website of the United States government. , Clowse M. Moorthy LN 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). This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. Results: The random effects model gives a more conservative estimate considering the heterogeneity. , Raeisi A Annapureddy N Thanou A, Chakravarty E, James JA, Merrill JT. Gyri N doi: 10.1136/lupus-2022-000700. , Kiani AN , Beaumont JL , Henriques C T2 - A longitudinal study. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. , Block JA Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. , Urowitz MB , Jolly M. Mazur-Nicorici L , Giangreco D , Suriano A , Jolly M. Antony A 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]. Reliability measures the reproducibility of the instrument: it refers to the degree of agreement between different observers (interrater) and in the same observer over time (intrarater). 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Mokkink LB Fanouriakis A Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. et al. , McGuire JL. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Devilliers H 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13

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