physician global assessment sle

The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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 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 . Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Mikolaitis-Preuss RA , Weisman MH. 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. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . 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. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. et al. This scoring modality was used for the SRI [3]. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. doi: 10.1136/lupus-2022-000700. 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. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). 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. Jesus D Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Annapureddy N , Petri MA Gladman DD , Petri M. Iaccarino L Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. 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 . Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. 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). watch for seizures after the procedure. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . et al. , Flower C et al. Physician global assessments for disease activity in rheumatoid arthritis are all over the map! , Jolly M. Mazur-Nicorici L , Bonithon-Kopp C The assessment of disease activity in SLE is particularly challenging. Content validity was reported in 89 studies. 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 . , Matos A 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]. 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]. Petri M Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. et al. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. doi: 10.1136/rmdopen-2022-002395. 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). , Oon S Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. et al. Supervise the development of junior medical affairs staff . 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. 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. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. 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 . Touma Z Ward et al. , Farewell V The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. 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]. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. may be asked to hyperventilate 3-4 min and watch a bright flashing light. , Navarra SV The index assesses separately eight organ-based systems. 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 . Wells GA They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). , Landis RC , McGuire JL. Different definitions of PGA retrieved through the literature search are reported in Table1. , Schirmbeck LA According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Engel SM , Bocci EB Published by Oxford University Press on behalf of the British Society for Rheumatology. [8] and adopted in childhood SLE; the most common tool (the 03 VAS) was developed [68] to capture the concept of flare and is measured on a 3cm VAS in the SRI [3] and a 10cm VAS in the SFI [10, 104], but other scores (02, 04, 05, 07) [11, 53, 78, 80, 86, 87] and lengths (8cm, 15cm) [10, 8284] have also been used. , Urowitz MB et al. 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. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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. et al. et al. , Block JA OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Seaman AL The results are similar, and less than half the time is required for scoring. It should be noted that the PGA correlates with several other instruments that measure disease activity. Sullivan KE 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). Liang MH Unable to load your collection due to an error, Unable to load your delegates due to an error. Prinsen CAC 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . , Wallace DJ Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. Medical-Surgical Nursing Clinical Lab (NUR1211L) U.S. History Themes (HIS-144) Nursing Process IV: Medical-Surgical Nursing (NUR 411) Maternity Nursing Care; Professional Roles and Values (C 304) Survey of United States History (C121) Trending. 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). Vashisht P Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. , Alarcn GS Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. 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]. , Rodrigues M 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 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]). 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 Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Kalunian K , Arora S , Sadovici-Bobeica V Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Glossary: PGA. 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. Responsiveness. et al. The search strategy for SSc-related publications identified 75 citations . et al. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. 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]. et al. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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 last MEDLINE search was performed on 1 July 2019. 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. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Arriens C , Khamashta MA Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. et al. et al. Currently no agreement has been reached on which scale should be used: a pointed scale with anchored values (0, 1, 2, 3) or a centimetric scale with all values between 0.0 and 3.0. Ann Rheum Dis 2011;70:54-9. , Vogel-Claussen J 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. Epub 2014 Jul 10. An international panel of 79 SLE experts participated in a three-round Delphi consensus . , Magder L Notorious to increase IOP and cause severe PAIN and headache; Diagnostics: - History - Tonometry examinations - measures IOP QUESTION A client states that the physician has told her that her intraocular was 14. 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. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). Disclaimer. Parodis I Navarra SV , Lerman RH , Alunno A 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. 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). Genetic linkage has related dysfunction of . , Bouter LM Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. , Sayedbonakdar Z 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). The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. , Petri M. Isenberg DA SLE2ACR1997SLICC2012. HHS Vulnerability Disclosure, Help Conclusion: 2022 Sep;8(2):e002395. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. SELENA SLEDAI4. Face validity. , Subach RB et al. 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]. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. , Smiley A. Askanase AD This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. , Karp DR , Kraag GR , Taghavi-Zadeh S Whenever papers reported duplicate data, the most recent article was selected. sharing sensitive information, make sure youre on a federal , Devilliers H Mina R 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). , Bresee C However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. TOTAL DOCUMENTS. , Gomez A et al. et al. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. , Jolly M. Antony A In the second column, the definitions were reported according to the VAS used in the study. , Borghoff K Flow chart illustrating the literature search and study selection. Importance: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value. Keywords: The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. 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. , Wetter J Manzi S The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. , Larson MG Petri M inflammation (duration and severity of morning stiffness as measured by BASDAI). Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. , Francis S Reliability was excellent when scored through a pointed scale, such as the Likert scale, that was anchored in unit numbers from 0 (not active) to 7 (most active) (interRR ICC 0.96; intraRR ICC 0.88) [80], but was lower when assessed through a centimetric VAS using values between 0.0 and 3.0 (interRR ICC 0.67; intraRR ICC 0.55) [68]. 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. . 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). The Physician's Global Assessment (PhGA) is a number without unit. et al. T2 - A longitudinal study. , Gordon C The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. The quantification of reliability is expressed by a correlation coefficient. Chaigne B Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . , Costenbader K , Engle E Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Leung HW , Andreoli L A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). et al. AU - Kandane-Rathnayake, Rangi. Fanouriakis A Your recommendations as to what might or should be done in relation to various issues observed. 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. Enocsson H Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. , Su J 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]. , Kalunian K , ODell JR , Beaumont JL PGA0.3. , Ravelli A 1 2. 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). Stojan G 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 . All versions are validated and used by lupus researchers for clinical and research purposes. 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 . , Hennis A. Jesus D , Hynan LS Criterion validity. Accessibility The judgment of whether a patient with SLE has active disease is a central question both in routine patient management and in clinical research [4]. J Clin Med.

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