Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. 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. , Kharboutli M 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. A total of 91 articles were included in the study (Fig. , Sjwall C. Strand V The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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 . inflammation (duration and severity of morning stiffness as measured by BASDAI). It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. 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 . 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). Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. , Tetzlaff J Touma Z Few studies reported on whether serological activity should be incorporated in the PGA. Would you like email updates of new search results? 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. , Chizzolini C HRQoL: Health-related Quality of Life; ICAM: intercellular adhesion molecule; VCAM: vascular cell adhesion molecule; MCP-1: monocyte chemoattractant protein-1; NC: non-calcified; suPAR: soluble urokinase plasminogen activator receptor; LFA-REAL: Lupus Foundation of America Rapid Evaluation of Activity in Lupus; CES-D: Centers for Epidemiological StudiesDepression scale; SLAQ: Systemic Lupus Erythematosus Activity Questionnaire; NA: not acquired; NS: not significant. No data were found regarding the feasibility of the PGA. , Nelson S AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , Mikolaitis-Preuss RA , Raeisi A Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 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 (. 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. , Voskuyl A The correlation with the SLEDAI was determined in 12 studies (Fig. . , Holland M Prinsen CAC Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. Face validity. Montreal, Canada Area. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. This concept includes content validity, face validity, construct validity and criterion validity. Barr SG Schneider M , Taghavi-Zadeh S et al. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. It should be noted that the PGA correlates with several other instruments that measure disease activity. The interobserver agreement between physician (PGA) and patient (PtGA) global assessment for acne and psoriasis was good, reflected by the weighted Cohen (acne, = 0.68; psoriasis, = 0.70) (eTable in the Supplement). Lai J-S Merrill JT , Rodrigues M 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. , Goldsmith CH , McGwin G , Perez-Gutthann S , Lerman RH , Gomez A Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. The company serves physicians and patients. , Socher SA This scoring modality was used for the SRI [3]. 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. ~SLE~. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. , Suriano A 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. 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. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. , Gladman DD 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. 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]. , Urowitz MB. No study has evaluated the feasibility of the PGA in SLE to date. , Urowitz MB 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]. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. It is therefore desirable to use the PGA along with other tools (typically the SLEDAI) or to include the PGA in a composite index (e.g. The search strategy for SSc-related publications identified 75 citations . Physician global assessments for disease activity in rheumatoid arthritis are all over the map! , Hochberg M. Touma Z 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]. 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. et al. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. 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 . Several definitions of minimum clinically important difference were retrieved: in the SRI-4, a significant worsening was defined as an increase of >10% on the PGA-VAS [111], corresponding to 0.3 points from baseline; Touma et al. [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. official website and that any information you provide is encrypted Rheumatology (Oxford). ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). All rights reserved. , Flower C 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]. Please enable it to take advantage of the complete set of features! Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . et al. Despite the need for new treatments in CLE . Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . Construct validity. Mina R 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. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. 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. Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . 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 . Chaigne B , McGuire JL. , Stavrakis S , Kostopoulou M SELENA SLEDAI4. However, the PGA allows for the measurement of disease activity in a global way (content validity). This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. Liang MH , Su J , Hynan LS et al. Mina R Thank you for submitting a comment on this article. et al. SLE2ACR1997SLICC2012. It operates in Albuquerque, and New Mexico. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. , Ko T LECTURE 10: MEDICAL SURGICAL NURSING. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. , Annapureddy N Karol DE Disclosure statement: L.A. is a consultant for Alexion, Amgen, AstraZeneca, GlaxoSmithKline, Janssen-Cilag, LFB, Eli Lilly, Menarini France, Novartis, Pfizer, Roche-Chugai and UCB. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. Feb 2016 - Jan 20182 years. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. et al. Objective: Results: The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. et al. Mahler M Published by Oxford University Press on behalf of the British Society for Rheumatology. , Aggarwal R et al. et al. , Kosinski M (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. , James JA Federal government websites often end in .gov or .mil. , Farewell V The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. Learn more. , Mokkink LB , Anderson N Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. Gladman DD X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . SLE has protean and often complex manifestations, necessitating careful clinical assessment. , Skogh T The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Altman DG Vashisht P Piga M Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. , Gallacher AE This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Merrill JT. Direkt zum Inhalt springen . 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.