scholarly journals FRI0307 DETERMINANTS OF PATIENT-PHYSICIAN DISCORDANCE IN GLOBAL ASSESSMENT IN SPONDYLOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 743.1-744
Author(s):  
S. Azevedo ◽  
F. Guimarães ◽  
D. Almeida ◽  
D. Faria ◽  
J. Silva ◽  
...  

Background:Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) are important measures in the evaluation of patients with Spondyloarthritis (SpA), but often provide discordant results.1Both PtGA and PhGA are assessed as part of ankylosing spondylitis disease activity score (ASDAS), that is a measure of axial SpA disease activity endorsed by the Assessment of SpA International Society (ASAS) and Outcome Measures in Rheumatology.2,3In peripheral SpA, although there are no formally validated indexes, the American College of Rheumatology (ACR) and Disease Activity Score 28 (DAS 28) response criteria have shown reliable discriminant characteristics and both include PtGA and PhGA.3The lack of concordance between PtGA and PhGA may mislead treatment decisions, namely switches.Objectives:To assess the determinants of patient-physician discordance in SpA patients under biologic treatment.Methods:Cross-sectional study, including 72 with SpA according ASAS criteria. Physicians’ evaluation included comorbidities, parameters of inflammatory activity (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP], PhGA, ASDAS PCR and, DAS 28, and Participants completed patient-reported outcomes (PROs) and sociodemographic characteristics. For statistical analysis, SPSS was used and significance level was 2-sided p<0.05.Results:Clinical and laboratory characteristics of patients are shown in table 1. PtGA and PhGA were significantly different (34.8±21.2vs7.8±12.5 mm, respectively, p< .001) and patient-physician discordance (ΔPtGA - PhGA) was 27.5±14.3 mm.In peripheral SpA, patient-physician discordance had a correlation with patient age, Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy (FACIT), EuroQol-5 dimension (EQ5D), Short Form (36) Health Survey (SF-36), Hospital Anxiety and Depression scales (HADS), CRP, ESR, number of comorbidities and daily medication, and an association with employment status (employees had lesser discordance), anxiety/depression, fibromyalgia and osteoarthritis (OA). In multivariable analysis including employment status, SF-36, OA, number of comorbidities, and ESR (R2adjusted= .505), the main predictors of patient-physician discordance were lower SF36, higher number of comorbidities and employment status.In axial SpA, patient-physician discordance had a correlation with nocturnal back pain and total back pain VAS, FACIT, EQ5D, SF-36, HADS, Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Activity Index (BASDAI) scales, age, number of comorbidities and daily medication and an association with employment status (employees had lesser discordance), anxiety/depression and fibromyalgia. In multivariable analysis including employment status, SF-36, fibromyalgia, and number of comorbidities (R2adjusted= .738), the main predictors of patient-physician discordance were lower SF36, higher number of comorbidities and concomitant diagnosis of fibromyalgia.Neither for peripheral SpA nor for axial SpA an association with SpA subtype, HLA-B27 positivity, patient or physician gender, or patient education level was found.Conclusion:This study shows the variability implied in patient-physician discordance. We have demonstrated that comorbidities, employment status, and other factors not directly related to the disease are determinants for the patient-physician discordance.References:[1]Desthieux C, et al. 2016[2]Machado P et al. 2013[3]Mease PJ. 2011Disclosure of Interests:None declared

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV


Rheumatology ◽  
2020 ◽  
Author(s):  
Augusta Ortolan ◽  
Sofia Ramiro ◽  
Floris van Gaalen ◽  
Tore K Kvien ◽  
Robert B M Landewe ◽  
...  

Abstract Objective To develop an alternative Ankylosing Spondylitis Disease Activity Score (ASDAS) to be used in research settings in axial SpA (axSpA) when Patient Global Assessment (PGA) is unavailable in databases. Methods Longitudinal data from four axSpA cohorts and two randomized controlled trials were combined. Observations were randomly split in a development (N = 1026) and a validation cohort (N = 1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were established in the development cohort. Conversion factors for each substitute were defined by Generalized Estimating Equations, obtaining seven ‘alternative’ formulae. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: (i) truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient and in disease activity states, by weighted kappa); (ii) discrimination [standardized mean difference of ASDAS scores between high/low disease activity states defined by external anchors, e.g. Patient Acceptable Symptom State; agreement (kappa) in the percentage of patients reaching ASDAS improvement criteria according to alternative vs original formulae]; and (iii) feasibility. Results Comparing various options, alternative-ASDAS using BASDAI total as PGA replacement proved to be: truthful (intraclass correlation coefficient = 0.98, kappa = 0.90), discriminative [ASDAS scores between Patient Acceptable Symptom State no/yes: standardized mean difference = 1.37 (original-ASDAS standardized mean difference = 1.43); agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa = 0.93/0.88] and feasible (BASDAI total often available, as questions required for the ASDAS; conversion coefficient ≈ 1). Conclusion Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument.


2011 ◽  
Vol 38 (11) ◽  
pp. 2326-2328 ◽  
Author(s):  
MAXIME DOUGADOS ◽  
MAHAUT RIPERT ◽  
PASCAL HILLIQUIN ◽  
PATRICE FARDELLONE ◽  
OLIVIER BROCQ ◽  
...  

Objective.Patient global assessment (PGA) is one of the 4 items included in the Disease Activity Score (DAS28) for evaluation of activity of rheumatoid arthritis (RA). We studied the influence of the use of 3 different techniques of PGA on the assessment of disease activity.Methods.We evaluated 3 different DAS28 according to the technique of PGA in 108 patients with active RA before and after 12 weeks of etanercept therapy.Results.The reliability (intraclass coefficient of correlation) between screening and baseline was very high and similar for the 3 DAS28. The percentage of patients in the different states of disease (from remission to higher disease activity) and the sensitivity to change across the 3 DAS28 scales were very similar.Conclusion.The different techniques of collection of PGA to be included in the DAS calculation yield similar results. However, an accepted, unequivocal technique should be encouraged in order to reduce heterogeneity in scoring DAS among patients with RA.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1418.1-1418
Author(s):  
S. Azevedo ◽  
F. Guimarães ◽  
D. Almeida ◽  
D. Faria ◽  
J. Silva ◽  
...  

Background:Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) are assessed as part of commonly used measures of disease activity in RA.1Both are important measures in treat-to-target strategies in Rheumatoid Arthritis (RA), but often provide discordant results.2,3This can provide an erroneous assessment of disease activity in patients under Biologic treatment and mislead treatment decisions, namely switches.Objectives:To assess differences and determinants of PtGA and PhGA in RA patients under biologic treatment.Methods:Cross-sectional study, including 46 patients with RA diagnosed according to the ACR/EULAR criteria, under biologic treatment, consecutively evaluated in day-care unit. Participants completed patient-reported outcomes (PROs), including PtGA, and sociodemographic characteristics. Physicians collected comorbidities and parameters of inflammatory activity (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]) and completed PhGA and disease activity score 28 with ESR (DAS28). SPSS was used for statistical analysis and significance level was defined as 2-sided p<0.05.Results:Clinical and laboratory characteristics of patients are shown in table 1. PtGA and PhGA were significantly different (36.1±27.6 mmvs8.7±14.2 mm, p< 0.001) and a positive discordance (PtGA>PhGA, more than 25mm in visual analogue scale [VAS]) was found in 54.3% of cases.PtGA had a correlation with PROs (Pain VAS, 36-Item Short Form Health Survey [SF-36], Health Assessment Questionnaire [HAQ], Functional Assessment of Chronic Illness Therapy [FACIT], EuroQol [EQ5D] and Hospital Anxiety and Depression Scale [HADS]), CRP, tender and swollen joint counts and an association with comorbidities like fibromyalgia or osteoarthritis (OA). No association was found between PtGA and age, sex, education level, profession, employment status, extra-articular manifestations, positivity of rheumatoid factor, ESR, years of disease evolution or number of biologic treatments. In multivariable analyse including SF-36, CRP, tender joints count and OA (R2adjusted= 0.672), the main predictors of PtGA were lower SF36, concomitant OA and higher CRP level.PhGA had a correlation with PtGA, pain VAS, CRP, tender and swollen joints. No association was found between PhGA and patient or physician age, patient or physician sex, extra-articular manifestations, positivity of rheumatoid factor, ESR level, years of disease evolution or number of biologic treatments. In multivariable analysis including ESR, tender and swollen joints count and CRP (R2adjusted= .800), the main predictors of PhGA were swollen joint count and higher CRP level.Conclusion:This study showed the variability implied on global assessment of RA activity. Overall PtGA is based on function and also in subjective and emotional experience of pain, whereas the PhGA is based on more objective measures, more related to disease activity.References:[1]Kanekoa Y. et al, Determinants of Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity in patients with rheumatoid arthritis: A post hoc analysis of overall and Japanese results from phase 3 clinical trials.Modern Rheumatology2018; 28(6):960–967[2]Furu M. et al. Discordance and accordance between patient’s and physician’s assessments in rheumatoid arthritis.Scand J Rheumatol.2014; 43(4):291-5.Ann Rheum Dis. 2016 Sep;75(9):1661-6. doi: 10.1136/annrheumdis-2015-208251. Epub 2015 Oct 22.[3]Portier A. et al, Patient-perceived flares in rheumatoid arthritis: A sub-analysis of the STRASS treatment tapering strategy trial.Joint Bone Spine. 2017; 84(5):577-581Disclosure of Interests:None declared


2008 ◽  
Vol 68 (1) ◽  
pp. 18-24 ◽  
Author(s):  
C Lukas ◽  
R Landewé ◽  
J Sieper ◽  
M Dougados ◽  
J Davis ◽  
...  

Objectives:To develop a new index for disease activity in ankylosing spondylitis (ASDAS) that is truthful, discriminative and feasible, and includes domains/items that are considered relevant by patients and doctors.Methods:Eleven candidate variables covering six domains of disease activity, selected by ASAS experts in a Delphi exercise, were tested in a three-step approach, similar to the methodology used for the disease activity score in rheumatoid arthritis. Data on 708 patients included in ISSAS (International Study on Starting tumour necrosis factor blocking agents in Ankylosing Spondylitis) were used. Cross validation was carried out in the OASIS cohort (Outcome in Ankylosing Spondylitis International Study).Results:Principal component analysis disclosed three factors with eigenvalues >0.75: patient assessments, peripheral joint assessments and acute phase reactants. Discriminant function analysis resulted in a correct classification in ∼72% of the cases (prior probability ∼50%). Regression analysis resulted in an index with five variables (total back pain, patient global assessment, duration of morning stiffness, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)). Three additional candidate indices were designed using similar methodology while omitting either ESR or CRP or patient global assessment. All four scores correlated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; r = 0.67–0.80), patient (0.58–0.75) and physician’s global assessment (0.41–0.48) of disease activity. All four candidate ASDAS indices performed better than BASDAI or single-item variables in discriminating between high and low disease activity state, according to doctors as well as patients in the OASIS cohort.Conclusion:The first steps in the development of a new assessment tool of disease activity in AS derived four candidate indices with good face and construct validity, and high discriminant capacity.


2020 ◽  
Vol 14 (2) ◽  
pp. 62-66
Author(s):  
Abhijit Datta ◽  
Minhaj Rahim Choudhury ◽  
Md Abu Shahin ◽  
Md Nazrul Islam ◽  
Shamim Ahmed ◽  
...  

Ankylosing Spondylitis Disease Activity Score (ASDAS) is a very important tool for measuring disease activity in patients with axial spondyloarthritis (axSpA). This study was aimed to develop a culturally adapted, valid and reliable Bengali version of questionnaire for the ASDAS. The original English ASDAS was translated into Bangla and adapted in the local socio-cultural context, following standard international recommendations. Content validity of the adapted Bangla version was assessed by the item-level & scale level content validity indices (I-CVI & S-CVI). A total 120 patients with axSpA were assessed in the study. For construct validity, correlation between ASDAS with BASDAI, ESR, CRP, Maastricht enthesitis score, physician's global assessment and BASMI was assessed by Spearman's rank correlation coefficient. Internal consistency and test-retest reliability were assessed using Cronbach's alpha coefficient and intraclass correlation coefficient respectively. I-CVI for each item was 1 and S-CVI was 1. ASDAS-ESR and ASDAS-CRP showed strong correlation (Spearman's correlation coefficient >0.5) with BASDAI, ESR, MASES and physician global assessment of disease activity. The scale demonstrated excellent internal consistency (Crohnbach's alpha=0.703) and test-retest reliability (ICC=0.98). The adapted Bangla version of the ASDAS demonstrated acceptable psychometric properties (validity & reliability) in Bangladeshi patients with axSpA. Faridpur Med. Coll. J. Jul 2019;14(2): 62-66


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 721-721
Author(s):  
A. Deodhar ◽  
P. J. Mease ◽  
D. Poddubnyy ◽  
R. Calheiros ◽  
X. Meng ◽  
...  

Background:Ankylosing spondylitis (AS) is strongly associated with the genetic marker HLA-B27. Approximately 80%-90% of white patients with AS express HLA-B27 compared with < 8% of the general population. In patients with AS, negative HLA-B27 status is a predictor of worse response to TNFis.1The impact of HLA-B27 status on clinical efficacy of secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A, has not been studied.Objectives:To analyze the impact of HLA-B27 status on clinical outcomes at Week 16 in patients with AS treated with secukinumab vs placebo.Methods:Patients with AS were pooled from the MEASURE 1-4 studies (NCT01358175,NCT01649375,NCT02008916, andNCT02159053) and stratified by HLA-B27 status. All trials included patients who received secukinumab 150 mg every 4 weeks with or without an initial loading dose (10 mg/kg IV at Weeks 0, 2, 4 or 150 mg SC at Weeks 0, 1, 2, and 3) or placebo control. MEASURE 3 included patients receiving secukinumab 300 mg every 4 weeks following the initial IV loading dose. Efficacy at Week 16 was determined by the proportion of patients achieving ASAS20/40, ASAS5/6, ASAS partial remission, BASDAI50, ASDAS-CRP < 2.1, ASDAS-CRP < 1.3, and improvement in Patient Global Assessment (VAS) and total spinal/back pain (VAS) scores. In MEASURE 1, 2, and 4, quality of life (QOL) was assessed at Week 16 by the SF-36 PCS, SF-36 MCS, and ASQOL. ASAS, BASDAI, and ASDAS-CRP responses were analyzed by nonresponder imputation, and all other outcomes by mixed models for repeated measures. For hypothesis generation, outcomes at Week 16 with secukinumab vs placebo within HLA-B27 strata were compared by logistic regression analysis without adjustment for multiple comparisons.Results:Baseline characteristics were balanced across treatment groups, although more HLA-B27+ patients than HLA-B27− patients were male (71%-73% vs 43%-50%). HLA-B27+ patients receiving any dose of secukinumab were significantly more likely to achieve ASAS, BASDAI50, and ASDAS-CRP responses vs those receiving placebo (P< .05; Figure 1). HLA-B27− patients receiving secukinumab 300 mg were significantly more likely to achieve ASAS40, ASAS partial remission (Figure 1A), and BASDAI50 (Figure 1B) responses than those receiving placebo (P< .05). Patients receiving any dose of secukinumab were more likely to achieve ASAS5/6 and ASDAS-CRP < 2.1 than those receiving placebo, regardless of HLA-B27 status (P< .05; Figure 1B). All secukinumab-treated patients experienced significant improvement in Patient Global Assessment at Week 16 vs placebo, regardless of HLA-B27 status, while only HLA-B27+ patients experienced significant reduction in total spinal/back pain vs placebo (P< .05; Figure 2A). Numerical improvements in QOL were observed in all patients receiving secukinumab 150 mg vs placebo; these reached significance for HLA-B27+ patients (Figure 2B).Conclusion:Secukinumab is effective in patients with AS regardless of HLA-B27 status; HLA-B27+ patients may derive increased therapeutic benefit compared with HLA-B27− patients.Reference:[1]Alazmi M, et al.Arthritis Care Res (Hoboken). 2018;70:1393-9.Acknowledgments:This study was funded by Novartis Pharmaceuticals Corporation. The authors thank Rich Karpowicz, PhD, of Health Interactions, Inc, for providing medical writing support/editorial support, which was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).Disclosure of Interests:Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Renato Calheiros Shareholder of: Novartis, Employee of: Novartis, Xiangyi Meng Shareholder of: Novartis, Employee of: Novartis, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Marina Magrey Grant/research support from: AbbVie, Amgen, and UCB, Consultant of: Eli Lilly and Novartis


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