scholarly journals AB0749 COMPARING PATIENT-PHYSICIAN DISCORDANCE IN RA AND PsA PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1671.1-1671
Author(s):  
L. Brites ◽  
L. Saraiva ◽  
F. Costa ◽  
J. Dinis de Freitas ◽  
M. Luis ◽  
...  

Background:Patient global Assessment (PGA) of disease activity is considered a key patient reported outcome in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA), both being included in combined indices of disease activity. However, patients and physicians frequently disagree in their assessment.Objectives:This study aimed at comparing the degree of this discrepancy and its determinants in RA and PsA.Methods:Cross sectional study including 100 patients with RA (ACR/EULAR 2010 criteria) and 100 patients with PsA with predominant peripheral joint involvement (CASPAR criteria), aged ≥18 years, randomly selected from the electronic registry Reuma.pt. Data were collected from the most recent rheumatology visit during the last year: sociodemographic data, disease duration (years), tender and swollen joint counts 0-28 (TJC and SJC), disease activity (DAS28 3V-PCR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), patient’s pain assessment, PGA and physician global assessment (PhGA). The discrepancy between patients and physicians (ΔPPhGA) was defined as PGA minus PhGA, and a difference > |20mm| was taken as “discordance”. Categorical variables are presented as proportions and continuous variables as mean (±SD). Patient and clinical characteristics were compared between patients with RA and PsA using t- test and χ2 test, as adequate. Variables with p<0.05 or clinically relevant were included in multivariable logistic regression analysis to identify correlates for ΔPPhGA in the whole sample. A p≤0.05 was considered statistically significant.Results:Compared to PsA, patients with RA were more often female (90% Vs 49%,p< 0.05), older (66.7 ± 10.7 Vs 58.3 ± 12.2 years,p< 0.05) and had a shorter disease duration (18.2 ± 9.8 Vs 19.9 ± 9.7 years,p= 0.202). Regarding disease activity, the RA and PsA groups were comparable: DAS28 3V-PCR (2.3 ± 0.9 Vs 2.4 ± 1.0,p= 0.34). Patients with RA had a higher mean ΔPPhGA (30.4 ± 30.6 Vs 25.4 ± 27.5,p< 0.05), and were more frequently discordant to the physician (69% Vs 51%,p< 0.05). In univariable analysis, having RA, higher patient’s pain assessment and higher ESR were associated to patient-physician discordance. In multivariable analysis, only patient’s pain assessment (OR 1.04 [95% CI 1.03-1.06], p = 0.00) and TJC (OR 0.82 [95% CI 0.68-0.97], p = 0.02) remained as predictors of discordance.Conclusion:Despite comparable disease activity scores in RA and PsA patients, RA patients tend to have a worst self-perception of their disease activity compared to their physician´s. Patient’s pain assessment and TJC were the only predictors of patient-physician discordance, irrespective of the disease.Disclosure of Interests:Luisa Brites: None declared, LILIANA SARAIVA: None declared, Flavio Costa: None declared, João Dinis de Freitas: None declared, Mariana Luis: None declared, Ana Rita Prata: None declared, Helena Assunção: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis, João Rovisco: None declared, Catia Duarte: None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 668.2-669
Author(s):  
S. Monti ◽  
P. Delvino ◽  
C. Klersy ◽  
G. Coppa ◽  
A. Milanesi ◽  
...  

Background:Patient-reported outcomes (PROs) are currently poorly integrated in the clinical evaluation of disease activity in patients with ANCA-associated vasculitis (AAV).Objectives:To assess the distribution of the Patient Global Assessment (PtGA) in patients with AAV in stable remission, and to identify correlates of PtGA; to assess the discordance between PtGA score and PhGA.Methods:Patients with a diagnosis of AAV [eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis] in stable, complete remission (defined by a BVAS=0) and with a Physician Global Assessment (PhGA)=0 were included. A questionnaire including several aspects of disease captured by PROs was collected. PtGA on a 0-100 mm visual analogue scale (VAS) was assessed, with higher scores representing higher/worse levels of disease activity. Similarly, VAS for pain, chronic damage according to the patient’s opinion, general health (GH), fatigue, and sleep quality were collected. The worst symptom in the patient’s opinion affecting the overall assessment of disease activity was recorded. The Cragg Hurdle model was used to assess the predictors of PtGA.Results:65 patients were included, female 57%, mean age 61±12 years. Mean disease duration at enrollment was 8±6 years. Mean vasculitis damage index (VDI) was 4.4 ±2.3, with 45% of patients having a VDI ≥ 5. Despite having been classified as being in remission, PtGA was elevated in 37% of patients. We explored several correlates of PtGA. Higher degree of damage accrual (VDI) did not influence the patient’s evaluation of current disease activity. Similarly, we did not identify a correlation between older age, educational level, number of organ-systems involved, number of comorbidities, the number of previous major or minor relapses, higher disease duration, nor the type of AAV diagnosis (figure 1, panel A). Only sex significantly correlated with PtGA scores: 19 (51%) of female patients reported an elevated PtGA compared to only 5 (18%) of male (p=0.009). PtGA resulted to be significantly correlated with other (mostly modifiable) PROs including VAS pain, perception of the level of chronic damage accrual, GH, and fatigue (figure 1, panel B). The agreement between patients’ and physicians’ assessments of disease activity was 63%. Patients reported pain, followed by chronic respiratory symptoms to be the worst-experienced ongoing manifestations affecting their evaluation of disease activity.Conclusion:A significant proportion of patients with AAV considered to be in remission by the physician still declares to have persistent aspects of uncontrolled disease. PtGA is significantly influenced by persistent pain and fatigue, which warrant better assessment in the future.Disclosure of Interests:None declared


2012 ◽  
Vol 39 (11) ◽  
pp. 2081-2087 ◽  
Author(s):  
LONNIE PYNE ◽  
VIVIAN P. BYKERK ◽  
GILLES BOIRE ◽  
BOULOS HARAOUI ◽  
CAROL HITCHON ◽  
...  

Objective.To determine the factors most strongly associated with an increase in therapy of early rheumatoid arthritis (ERA).Methods.Data from the Canadian Early Arthritis Cohort (CATCH) were included if the patient had ≥ 2 visits and baseline and 6 months data. A regression analysis was done to determine factors associated with treatment intensification.Results.Of 1145 patients with ERA, 790 met inclusion criteria; mean age was 53.4 years (SD 14.7), mean disease duration 6.1 months (SD 2.8), 75% were female, baseline Disease Activity Score-28 (DAS28) was 4.7 (SD 1.8) and 2.9 (SD 1.8) at 6 months for included patients. Univariate factors for intensifying treatment were physician global assessment (MDGA; OR 7.8 and OR 7.4 at 3 and 6 months, respectively, p < 0.0005), swollen joint count (SJC; OR 4.7 and OR 7.3 at 3 and 6 months, p < 0.0005), and DAS28 (OR 3.0 and OR 4.6 at 3 and 6 months, p < 0.0005). In the regression model only MDGA was strongly associated with treatment intensification (OR 1.5 and OR 1.2 at 3 and 6 months, p < 0.0005); DAS28 was not consistently predictive (OR 1.0, p = 0.987, and OR 1.2, p = 0.023, at 3 and 6 months). DAS28 was the reason for treatment intensification 2.3% of the time, compared to 51.7% for SJC, 49.9% for tender joint count, and 23.8% for MDGA. For the same SJC, larger joint involvement was more likely to influence treatment than small joints at 3 months (OR 1.4, p = 0.027).Conclusion.MDGA was strongly associated with an increase in treatment at 3 and 6 months in ERA, whereas DAS28 was not. Physicians rarely stated that DAS28 was the reason for increasing treatment.


2015 ◽  
Vol 75 (4) ◽  
pp. 715-720 ◽  
Author(s):  
Polina Putrik ◽  
Sofia Ramiro ◽  
Monika Hifinger ◽  
Andras P Keszei ◽  
Ihsane Hmamouchi ◽  
...  

ObjectivesTo investigate patterns in patient-reported and physician-reported disease outcomes in patients with rheumatoid arthritis (RA) from countries with different level of socioeconomic development.MethodsData from a cross-sectional multinational study (COMOrbidities in RA) were used. Contribution of socioeconomic welfare (gross domestic product (GDP); low vs high) of country of residence to physician-reported (tender joint count, swollen joint count (SJC), erythrocyte sedimentation rate, disease activity score based on 28 joints assessment (DAS28)-3v based on these three components and physician global assessment) and patient-reported (modified Health Assessment Questionnaire (mHAQ), patient global assessment and fatigue) disease outcomes was explored in linear regressions, adjusting for relevant confounders.ResultsIn total, 3920 patients with RA from 17 countries (30 to 411 patients per country) were included, with mean age of 56 years (SD13) and 82% women. Mean SJC varied between 6.7 (Morocco) and 0.9 (The Netherlands), mean mHAQ ranged between 0.7 (Taiwan) and 1.5 (The Netherlands). Venezuela had the lowest (1.7) and the Netherlands the highest score on fatigue (5.0). In fully adjusted models, lower GDP was associated with worse physician-reported outcomes (1.85 and 2.84 more swollen and tender joints, respectively, and 1.0 point higher DAS28-3v), but only slightly worse performance-based patient-reported outcome (0.15 higher mHAQ), and with better evaluation-based patient-reported outcomes (0.43 and 0.97 points lower on patient global assessment and fatigue, respectively).ConclusionsIn patients with RA, important differences in physician-reported and patient-reported outcomes across countries were seen, with overall a paradox of worse physician-reported outcomes but better patient-reported outcomes in low-income countries, while results indicate that these outcomes in multinational studies should be interpreted with caution. Research on explanatory factors of this paradox should include non-disease driven cultural factors influencing health.


Lupus ◽  
2021 ◽  
pp. 096120332110279
Author(s):  
Worawit Louthrenoo ◽  
Nuntana Kasitanon ◽  
Eric Morand ◽  
Rangi Kandane-Rathnayake

Objective To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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 their global rating of change (GRC) at each visit. PGA, SLEDAI-2K and SLE Flare Index (SFI) were also captured on all visits. Generalised estimating equations (GEE) methods were used to examine longitudinal associations of PGA with PROs and clinical indicators. Results 337 patients were followed for a median [IQR] of 3.2 [1.6, 3.4] years (2,059 visits). High PGA (>1) was strongly associated with high SLEDAI-2K scores, the presence of flares and poor PROs. Odd ratios (OR) [95% CI] of PGA > 1 in patients with SLEDAI-2K >4 & <10 and SLEDAI-2K ≥10, compared to SLEDAI-2K ≤ 4, were 3.46 [2.36, 5.08], p < 0.001 and 6.39 [4.30, 9.49], p < 0.001, respectively. OR [95% CI] of PGA > 1 in patients with mild-to-moderate or severe flares were 2.09 [1.62, 2.71], p < 0.001 and 4.42 [3.21, 6.07], p < 0.001, respectively. Mental components of both SLEQOL (mood, self-image) and SF36 (MCS) surveys demonstrated significant associations with high PGA. After adjusting for SLEDAI-2K, one-point increase in PGA was associated with reductions in SLEQOL total score and SF36-MCS by 2.33 (regression coefficient (RC) [95% CI] = −2.33 [−3.77, −0.88], p = 0.002), and 4.16 (RC [95% CI] = −4.16 [−5.19, −3.13], p < 0.001) points, respectively. Associations of some physical components (SLEQOL-symptoms, and SF36-PCS) with PGA attenuated when adjusted for SLEDAI-2K. Patients who rated low scores of GRC, which indicate health deterioration, were twice as likely to have PGA > 1 (OR [95%CI] 1.99 [1.25, 3.16], p = 0.004). Conclusion High PGA was strongly associated with poor mental health, high disease activity and flares. This study confirms the value of PGA as an efficient assessment tool for SLE.


2012 ◽  
Vol 39 (9) ◽  
pp. 1850-1853 ◽  
Author(s):  
DAFNA D. GLADMAN ◽  
VINOD CHANDRAN ◽  
ARANE THAVANESWARAN ◽  
MICHEL ZUMMER

Objective.We aimed to determine disease severity and treatment of patients with psoriatic arthritis (PsA) in rheumatology practices in Canada through the PsA Assessment in Rheumatology (PAIR) study.Methods.Rheumatologists who were members of the Canadian Rheumatology Association were asked to complete a form for each patient addressing demographic questions, history, clinical examination, and patient-reported outcomes. Results were compared with a cohort seen in a PsA clinic during the same period.Results.From across Canada, 22 rheumatologists from 5 provinces submitted information about 233 consecutive patients with PsA [145 men (62.2%), 88 women (37.8%), mean age 53.2 yrs (± 12.7), 88.4% disease duration > 2 yrs]. A majority (80.7%) fulfilled ClASsification for Psoriatic ARthritis (CASPAR) criteria, and 30% had taken no disease-modifying antirheumatic drugs. Clinical joint damage was documented in 60% of the patients, active skin disease in 70%, and nail lesions in 32%. Only 22% were rated as having moderate to high disease activity, while 52% were rated as low disease activity and 26% were deemed in remission. The decision was based on joint counts, patient global assessment, physician global assessment, and acute-phase reactants. Twenty-seven percent of the patients were to have their medications changed based on the current visit, the majority for inadequate response to medications. Patients in the PAIR cohort had more inflamed joints but similar damage to those in the PsA clinic.Conclusion.Patients with PsA seen in regular rheumatology practice fulfill CASPAR criteria, have active disease, and more than half have joint damage. The majority have low activity or are in remission.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 98.1-98
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
T. Hospach ◽  
S. Mrusek ◽  
M. Rühlmann ◽  
...  

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 767.1-767
Author(s):  
P. Fischer ◽  
A. Zbinden ◽  
F. Foerger

Background:Disease activity in patients with axial spondyloarthritis (axSpA) can be measured by BASDAI and ASDAS. Both instruments were validated in non-pregnant patients with cutoff values for active diseases. In pregnant women with axSpA, however, BASDAI and ASDAS scores might be biased by signs and symptoms of pregnancy itself.Objectives:To compare the performance of ASDAS and BASDAI during pregnancyMethods:Patients with axSpA were prospectively followed before pregnancy, at each trimester and 6 to 12 weeks postpartum. Disease activity was assessed by BASDAI, ASDAS, patient global assessment (PGA) and physician global assessment (PhGA). We analysed the disease course throughout pregnancy and postpartum, the correlation between BASDAI and ASDAS and the agreement in the classification of active disease. We applied receiver operating curves (ROC) to evaluate the cut-off points in pregnant patients.Results:The study involved 40 women with axSpA. Disease activity scores were higher during pregnancy (median ASDAS score: 2.5, median BASDAI score 3.1) than during a non-pregnant state (median ASDAS score 2.3, median BASDAI score 2.1). Median BASDAI scores were highest at the first trimester, median ASDAS scores were highest at the second trimester. ASDAS strongly correlated with BASDAI, both in the pregnant and in the non-pregnant state (r=0.796, r=0.727). However, there was a discordance when analysing the proportion of patients with high disease activity using the common cut-off values (ASDAS >2.1, BASDAS >4). More patients had high disease activity when measured by ASDAS (1st trimester (T): 63%, 2nd T: 76%, 3rd T: 61%) compared to those measured by BASDAI (1st T 43%, 2nd T: 39%, 3rd T: 34%). The κ coefficient showed only fair agreement (κ=0.39). ROC analysis among pregnant patients showed that the cut-off point estimation for high disease activity using ASDAS >2.75 corresponded to a BASDAI >4. The ASDAS >2.75 cut-off for high disease activity had a good agreement with BASDAI >4 (κ=0.657). When ASDAS >2.75 was applied in pregnant women with axSpA, about 40% experienced high disease activity.Conclusion:During pregnancy, the majority of women with axSpA experience ongoing disease activity. However, the cut-off values defining low and high disease activity might differ between pregnant and non-pregnant individuals since BASDAI and ASDAS are biased by pregnancy related symptoms like fatigue and mechanical back pain.Disclosure of Interests:None declared.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 734.1-734
Author(s):  
S. Maguire ◽  
F. B. O’shea

Background:Previous research in axial spondyloarthropathy(axSpA) has shown this population to have a high prevalence of depression. This co-morbidity has been previously shown to impact disease activity in patients with rheumatic disease.Objectives:The purpose of this study was to screen for early signs of depression using two validated tools, the Patient Health Questionaire-9 (PHQ-9) and the Hospital Anxiety and Depression Scale for depression (HADs-D) in patients with known axSpA.Methods:AxSpA patients attending the Rheumatology department in St James’ Hospital between February and October 2020 were invited to take a self-administered survey which included the PHQ-9 and the HADs-D. Scores from the HADs-D yielded a numerical result which was then categorised as normal, borderline or abnormal. PHQ-9 numerical results were categorised as normal, mild, moderate, moderate/severe or severe. Patients with a known diagnosis of depression were excluded. In addition to baseline demographics, patient reported outcomes from the clinic visit were also recorded.Data analysis was performed using IBM SPSS version 26. Continuous variables were recorded as means, categorical variables as frequencies with percentages. A one-way analysis of variance analysis (ANOVA) was used to determine significance of variation in outcomes between patient outcomes as determined by the HADs-D and PHQ-9. A p-value of <0.05 was deemed significant. Consent was obtained prior to participation. Approval was received from the St James’/Tallaght Hospital Joint Ethics Committee.Results:In total 71 axSpA patients took part in the survey. The population was 70.4%(50) males and 29.5%(21) female, with an average age 47.9 years and mean disease duration 19.7 years (mean outcomes: BASDAI 4.08, BASFI 3.62, BASMI 3.54, ASQoL 6.79). Overall, 7 (9.9%) participants recorded abnormal HADs-D scores, while 17 (23.9%) recorded moderate to severe PHQ-9 scores indicative of underlying depression. AxSpA females had higher mean HADs-D scores (7.5 vs 4.8, p=0.01) than males, with abnormal scores in 19%(4) of females and 6% (3) of males. No significant differences were found in PHQ-9 scores between genders.Analysis revealed significantly worse BASDAI (6.27 vs 3.42, p<0.01) and AQoL scores (12.57 vs 5.26, p<0.01) in axSpA patients with abnormal compared to normal HADs-D scores. No significant differences were noted in BASFI, BASMI or baseline demographics. A similar pattern was noted on analysis of PHQ-9 scores, with significantly worse BASDAI (7.9 vs 2.55, p<0.01), BASFI (8.05 vs 2.33, p<0.01) and ASQoL (19.5 vs 2.62, p<0.01) noted in those scoring as severe compared to normal. No significant differences were detected in BASMI scores or baseline demographics.Conclusion:A high percentage of axSpA patients recorded high HADs-D and PHQ-9 scores concerning for undiagnosed depression. These patients were noted to have significantly worse disease activity and quality of life as compared to patients with normal scores. Clinicians treating axSpA should consider screening for depression in this population.Disclosure of Interests:Sinead Maguire Speakers bureau: Speaker fee from Jassen, Grant/research support from: Recipient of the Gilead Inflammation Fellowship Grant, Finbar Barry O’Shea: None declared


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Alberto Floris ◽  
◽  
Gerard Espinosa ◽  
Luisa Serpa Pinto ◽  
Nikolaos Kougkas ◽  
...  

Abstract Background To compare the patients’ and physician’s global assessment of disease activity in Behçet’s syndrome (BS) and investigate the frequency, magnitude, and determinants of potential discordance. Methods A total of 226 adult BS patients with a median (IQR) age of 46.9 (35.6–55.2) years were enrolled across Italy, Greece, Portugal, and Spain. Demographic, clinical, and therapeutic variables, as well as the patient reported outcomes, were collected at the recruitment visit. The physical (PCS) and mental (MCS) component summary scores of the Short Form Questionnaire 36 (SF-36) and the Behçet’s syndrome Overall Damage Index (BODI) were calculated. Disease activity was assessed by the patients’ (PtGA) and physician’s global assessment (PGA) in a 10-cm visual analog scale, as well as the Behçet Disease Current Activity Form (BDCAF). Discordance (∆) was calculated by subtracting the PGA from the PtGA and defined as positive (PtGA>PGA) and negative (PtGA<PGA) discordance using both a more stringent (∆ = ±2) and a less stringent (∆ = ±1) cutoff. Univariate and multivariate logistic regressions were performed. Results Median PtGA and PGA scores were 2.0 (0.3–5.0) and 1.0 (0.0–3.0) cm, respectively. The discordance prevalence varied (from 29.6 to 55.3%) according to the cutoff applied, and the majority (> 80%) of disagreements were due to patients rating higher their disease activity. Higher values of BDCAF were associated to increased rate of positive discordance. When BDCAF = 0, the median (IQR) values of PtGA and PGA were 0.2 (0–2) and 0 (0–1), respectively. PCS (adjusted odds ratio (adjOR) 0.96 per unit, 95% CI 0.93–0.98, p = 0.006) and MCS (adjOR 0.96 per unit, 95% CI 0.93–0.99, p = 0.003) were independently associated with positive discordance using both cutoffs. Active ocular involvement emerged as a potential determinant of negative discordance (adjOR 5.88, 95% CI 1.48–23.30, p = 0.012). Conclusions PtGA and PGA should be considered as complementary measures in BS, as patients and physicians may be influenced by different factors when assessing active disease manifestations. Particularly, PtGA may be a useful tool in the assessment of BS disease activity, as it carries a low risk to misclassify an inactive disease, and may allow to capture aspects of the patient’s health that negatively affect his well-being and the treatment.


2015 ◽  
Vol 33 (10) ◽  
pp. 1171-1179 ◽  
Author(s):  
Lari Wenzel ◽  
Kathryn Osann ◽  
Susie Hsieh ◽  
Jo A. Tucker ◽  
Bradley J. Monk ◽  
...  

Purpose Survivors of cervical cancer experience quality-of-life (QOL) disruptions that persist years after treatment. This study examines the effect of a psychosocial telephone counseling (PTC) intervention on QOL domains and associations with biomarkers. Patients and Methods We conducted a randomized clinical trial in survivors of cervical cancer, who were ≥ 9 and less than 30 months from diagnosis (n = 204), to compare PTC to usual care (UC). PTC included five weekly sessions and a 1-month booster. Patient-reported outcomes (PROs) and biospecimens were collected at baseline and 4 and 9 months after enrollment. Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures. Results Participant mean age was 43 years; 40% of women were Hispanic, and 51% were non-Hispanic white. Adjusting for age and baseline scores, participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants (all P < .05); significant differences in gynecologic and cancer-specific concerns (P < .05) were sustained at 9 months. Longitudinal change in overall QOL and anxiety did not reach statistical significance. Participants with decreasing interleukin (IL) -4, IL-5, IL-10, and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels. Conclusion This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer. The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship.


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