Effectiveness of biosimilar infliximab CT-P13 compared to originator infliximab in biological-naïve patients with rheumatoid arthritis and axial spondyloarthritis: data from the Portuguese Register.

OBJECTIVES: To compare the effectiveness of the infliximab biosimilar CT-P13 with originator infliximab over 24 months of follow-up in biological-naïve patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). METHODS: Biological-naïve patients from the Rheumatic Diseases Portuguese Register (Reuma.pt), with a clinical diagnosis of RA or axSpA, who were starting either the infliximab biosimilar CT-P13 or the originator infliximab after 2014 (date of market entry of CT-P13 in Portugal), were included. Patients on biosimilar and originator were compared regarding different response outcomes at 3 and 6 months, adjusting for age, sex and baseline C-reactive protein (CRP). The main outcome was the change in DAS28-erytrocyte sedimentation rate (ESR) for RA and the ASDAS-CRP for axSpA. Additionally, the effect of infliximab biosimilar vs originator on different response outcomes over 24 months of follow-up was tested with longitudinal generalized estimating equations (GEE) models. RESULTS: In total, 140 patients were included, 66 (47%) of which with RA. The distribution of patients starting the infliximab biosimilar and the originator was the same between the two diseases (approximately 60% and 40%, respectively). From the 66 patients with RA, 82% were females, mean age was 56 years (SD 11) and mean DAS28-ESR 4.9 (1.3) at baseline. As for the patients with axSpA, 53% were males, mean age was 46 years (13) and mean ASDAS-CRP 3.7 (0.9) at baseline. There were no differences in efficacy between RA patients treated with the infliximab biosimilar and the originator, either at 3 months (∆DAS28-ESR: -0.6 (95% CI -1.3; 0.1) vs -1.2 (-2.0; -0.4)), or at 6 months (∆DAS28-ESR: -0.7 (-1.5; 0.0) vs -1.5 (-2.4; -0.7)). This was also true for patients with axSpA (∆ASDAS-CRP at 3 months: -1.6 (-2.0; -1.1) vs -1.4 (-1.8; -0.9) and at 6 months: -1.5 (-2.0; -1.1) vs -1.1 (-1.5; -0.7)). Results were similar with the longitudinal models over 24 months. CONCLUSION: There are no differences in effectiveness between the infliximab biosimilar CT-P13 and the infliximab originator in the treatment of biological-naïve patients with active RA and axSpA in clinical practice.

Test-retest reliability, agreement and construct validity of the International Physical Activity Questionnaire short-form (IPAQ-sf) in people with COPD.

INTRODUCTION: This study assessed the test-retest reliability/agreement and construct validity of the International Physical Activity Questionnaire short-form (IPAQ-sf) in patients with chronic obstructive pulmonary disease (COPD). It also explored differences in its validity according to age, sex and GOLD airflow obstruction levels. METHODS: 62 participants (68 ± 8 years, 53 males, FEV1 51 ± 23%pred) completed the Portuguese IPAQ-sf, wore an accelerometer for 7 days and completed a second IPAQ-sf. Test-retest reliability/agreement was assessed with Intraclass Correlation Coefficient (ICC2,1), 95% Limits of Agreement (LoA), standard error of measurement (SEM) and minimal detectable change (MDC95) for continuous variables, and percentage of agreement (%agreement) for categories ("active"/"inactive"). Validity was assessed with 95% LoA and Spearman's correlations (ρ) between IPAQ-sf 2 (METs-min/week, time in vigorous [VPA], moderate PA [MPA] and walking) and accelerometry (time in MVPA, VPA, MPA and step counts) for continuous variables; %agreement, Cohen's kappa, and sensitivity specificity and±predictive values for categories. Correlations were also performed for age, sex and GOLD airflow obstruction grades. RESULTS: Reliability was good (ICC2,1 = 0.707) with wide LoA (-6446-6409 METs-min/week). SEM and MDC95 were 1840 and 4971 METs-min/week, respectively. %agreement between the two IPAQ-sf was 84% (kappa = 0.660). Positive, moderate and significant correlations were found between IPAQ-sf and accelerometry (0.396 ≤ ρ ≤ 0.527, p < 0.001), except for VPA (p > 0.05). The strongest correlations were found in age (<65 years) and male (0.466 ≤ ρ ≤ 0.653, p < 0.05). %agreement between tools was 65% (kappa = 0.313), with high sensitivity (0.830) but low specificity (0.500). CONCLUSIONS: The IPAQ-sf seems valid to be used in COPD but caution on its widespread use is recommended as its accuracy may be limited.

Construct validity and reliability of the Informal Caregiver Burden Assessment Questionnaire (QASCI) in caregivers of patients with COPD.

INTRODUCTION: COPD often leads to loss of independence in daily activities which may increase the dependency on the informal caregiver, resulting in caregiving burden. Several instruments have been used to assess caregiving burden in COPD; however, their measurement properties have been poorly investigated in this population. This study assessed the construct validity and reliability of the Informal Caregiver Burden Assessment Questionnaire (QASCI) in informal caregivers of patients with COPD. METHODS: Participants completed the QASCI (higher scores indicate higher burden) and the following questionnaires to assess construct validity: Zarit Burden Interview (ZBI), Hospital Anxiety and Depression Scale (HADS) and World Health Organization Quality of Life Instrument - Short Form (WHOQOL-Bref). QASCI was completed again one week later to assess test-retest reliability. Statistical analyses included: Pearson's (r) or Spearman's (ρ) correlations (construct validity); Cronbach's α (internal consistency); Intraclass Correlation Coefficient (ICC2,1, test-retest reliability) and Standard Error of Measurement (SEM), Minimal Detectable Change (MDC95) and Bland and Altman 95% Limits of Agreement (LoA). RESULTS: Fifty caregivers (62.7 ± 9.8 years, 88% female; patients' FEV1 = 45.2 ± 21.3%predicted) participated. QASCI mean score was 28.5 ± 19.8 (moderate burden). QASCI was positively correlated with ZBI (r = 0.908; p < 0.01), HADS anxiety (r = 0.613; p < 0.01) and depression (ρ = 0.634; <0.01) and negatively correlated with WHOQOL-Bref (-0.476 to -0.739) (all p < 0.01). Cronbach's α was 0.793 for the QASCI total score (subscales: 0.747-0.932). The ICC2,1 was 0.924, SEM 2.8 and MDC95 7.8, and the LoA were -18.3 to 11.1. CONCLUSIONS: The QASCI seems to be a promising measure to assess burden levels associated with informal caregiving in COPD.

Usefulness of serum C-reactive protein and calprotectin for the early detection of colorectal anastomotic leakage: A prospective observational study.

BACKGROUND: Colorectal anastomotic leakage (CAL) is one of the most dreaded complications after colorectal surgery, with an incidence that can be as high as 27%. This event is associated with increased morbidity and mortality; therefore, its early diagnosis is crucial to reduce clinical consequences and costs. Some biomarkers have been suggested as laboratory tools for the diagnosis of CAL. AIM: To assess the usefulness of plasma C-reactive protein (CRP) and calprotectin (CLP) as early predictors of CAL. METHODS: A prospective monocentric observational study was conducted including patients who underwent colorectal resection with anastomosis, from March 2017 to August 2019. Patients were divided into three groups: G1 - no complications; G2 - complications not related to CAL; and G3 - CAL. Five biomarkers were measured and analyzed in the first 5 postoperative days (PODs), namely white blood cell (WBC) count, eosinophil cell count (ECC), CRP, CLP, and procalcitonin (PCT). Clinical criteria, such as abdominal pain and clinical condition, were also assessed. The correlation between biomarkers and CAL was evaluated. Receiver operating characteristic (ROC) curve analysis was used to compare the accuracy of these biomarkers as predictors of CAL, and the area under the ROC curve (AUROC), specificity, sensitivity, positive predictive value, and negative predictive value (NPV) during this period were estimated. RESULTS: In total, 25 of 396 patients developed CAL (6.3%), and the mean time for this diagnosis was 9.0 ± 6.8 d. Some operative characteristics, such as surgical approach, blood loss, intraoperative complications, and duration of the procedure, were notably related to the development of CAL. The length of hospital stay was markedly higher in the group that developed CAL compared with the group with complications other than CAL and the group with no complications (median of 21 d vs 13 d and 7 d respectively; P < 0.001). For abdominal pain, the best predictive performance was on POD4 and POD5, with the largest AUROC of 0.84 on POD4. Worsening of the clinical condition was associated with the diagnosis of CAL, presenting a higher predictive effect on POD5, with an AUROC of 0.9. WBC and ECC showed better predictive effects on POD5 (AUROC = 0.62 and 0.7, respectively). Those markers also presented a high NPV (94%-98%). PCT had the best predictive effect on POD5 (AUROC = 0.61), although it presented low accuracy. However, this biomarker revealed a high NPV on POD3, POD4, and POD5 (96%, 95%, and 96%, respectively). The mean CRP value on POD5 was significantly higher in the group that developed CAL compared with the group without complications (195.5 ± 139.9 mg/L vs 59.5 ± 43.4 mg/L; P < 0.00001). On POD5, CRP had a NPV of 98%. The mean CLP value on POD3 was significantly higher in G3 compared with G1 (5.26 ± 3.58 µg/mL vs 11.52 ± 6.81 µg/mL; P < 0.00005). On POD3, the combination of CLP and CRP values showed a high diagnostic accuracy (AUROC = 0.82), providing a 5.2 d reduction in the time to CAL diagnosis. CONCLUSION: CRP and CLP are moderate predictors of CAL. However, the combination of these biomarkers presents an increased diagnostic accuracy, potentially decreasing the time to CAL diagnosis.

Effectiveness of exercise training on cancer-related fatigue in colorectal cancer survivors: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: To investigate the effects of exercise training on cancer-related fatigue (CRF) in colorectal cancer survivors. METHODS: Randomized controlled trials published between 1 January 2010 and 19 October 2020, selected through online search conducted in PubMed, Scopus, Web of Science, SPORTDiscus and PEDro databases, were included. Eligible trials compared the effect of exercise training interventions, versus non-exercise controls on CRF, in colorectal cancer survivors, during or after treatment. The methodological quality of individual studies was analysed using the Physiotherapy Evidence Database (PEDro) scale. Standardized mean differences (SMD) that were pooled using random-effects models were included as the effect size. In addition, 95% prediction intervals (PI) were calculated. RESULTS: Six trials involving 330 colorectal cancer patients met the inclusion criteria and presented reasonable to good methodological quality. An overall small-to-moderate effect of exercise training on CRF was found (SMD = - 0.29: 95% CI: [- 0.53; - 0.06]; p = 0.01; PI: [- 0.63; 0.04]; low-quality evidence). Subgroup analysis revealed moderate effects of exercise interventions performed during chemotherapy (SMD = - 0.63; 95% CI: [- 1.06; - 0.21]; p = 0.003) and small, non-significant effects, when exercise training was performed after cancer treatment (SMD = - 0.14; 95% CI: [- 0.43; 0.14]; p = 0.32). Steady improvements were achieved when a combination of aerobic plus resistance exercise was used, in interventions lasting 12 to 24 weeks. CONCLUSION: Exercise training could be regarded as a supportive therapy for the clinical management of CRF in colorectal cancer patients undergoing chemotherapy, but further studies are necessary to clarify the effects of exercise interventions on CRF after cancer treatment.

Diagnosis and phylogenetic analysis of bovine leukemia virus in dairy cattle in northeastern Brazil.

Enzootic bovine leukosis (EBL) is a chronic viral disease of wide distribution in cattle herds and may take several years for the first manifestation of clinical signs. Most animals do not present clinical signs. However, the economic losses are underestimated due to this disease. Thus, this work aimed to detect and characterize BLV in dairy cattle in the Maranhão state, northeastern Brazil. Blood samples were collected from 176 animals from 8 municipalities in the southeastern state of Maranhão. Bovine blood samples were subjected to DNA extraction and molecular diagnosis using nested PCR assays for BLV, targeting gp51 gene. Positive samples were then sequenced and then subjected to phylogenetic inferences. BLV DNA was detected in 16 cattle (16/176, 9.09%) in 4 municipalities. Phylogenetic analyzes showed that the sequence obtained clustered in a clade containing BLV sequences classified as genotype 6, with a high degree of support. Our data shows BLV occurrence in the Northeast of Brazil and the identification of genotype 6 in this region. These findings contribute to the molecular epidemiology of this agent in Brazil.

Percepciones, conocimiento y rutina de los padres acerca de los métodos de introducción de alimentos y su relación con el habla / Perceptions, knowledge, and routines of parents regarding food introduction methods and their relationship with speech

Este estudio analizó las rutinas y los hábitos de alimentación de niños portugueses de entre 4 y 18 meses, los métodos de introducción de alimentos más utilizados y las percepciones de los padres acerca de la importancia de la introducción de alimentos en el desarrollo del habla, Se aplicó un cuestionario online a una muestra de 297 padres. El cuestionario mostró una alta fiabilidad (α = 0.86). La mayoría de las madres portuguesas respondió que amamantan a sus hijos o que lo hacen en combinación con mamadera. Además, que les presentan nuevos alimentos a sus hijos en forma de sopas o purés y que varían los sabores, texturas y consistencias con frecuencia. Aunque hubo resultados razonables con respecto al conocimiento sobre los métodos tradicionales y Baby Led Weaning (BLW), en esta muestra se observó una mayor frecuencia de uso del método tradicional en comparación con BLW. Por otro lado, no hubo una correlación significativa entre la edad de los padres y su percepción sobre la importancia de la alimentación para el habla. Sin embargo, los padres con estudios superiores mostraron una mayor percepción sobre la importancia de la alimentación en el habla. Los padres con un mayor número de hijos mostraron una menor consciencia sobre la importancia de la relación entre la alimentación y el habla.

This study analyzedthe eating routines and habits of Portuguese children aged 4 to 18 months, the methods of food introduction most frequently used, and the parents' perceptions regarding the importance of food introduction for speech development. A sample of 297 parents filled out an online self-report questionnaire about their perceptions, knowledge, and routines regarding food introduction methods, and their relationship with speech development. This questionnaire showed high reliability (α=0.86). The majority of the Portuguese mothers that filled out the survey answered either that they breastfed their children or breastfed them in combination with bottle feeding. They also stated that they introduce new food to their children in the form of soups or purees and that they vary the flavors, textures, and consistencies frequently. Although the results showed a reasonable level of knowledge regarding the traditional and Baby Led Weaning (BLW) methods, there was a higher frequency of use of the traditional method in this samplewhen compared to BLW. There was not a significant correlation between the age of the parents and their perception of the importance of feeding for speech. In turn, parents with a higher level of education showed a greater awareness of the relevance of feeding in the development of speech. Parents with a higher number of children showed less awareness of the relationship between feeding and speech development.

What Motivates Patients with COPD to Be Physically Active? A Cross-Sectional Study.

Motivation can be broadly defined as what moves people to act. Low motivation is a frequently reported factor for the reduced physical activity (PA) levels observed in patients with chronic obstructive pulmonary disease (COPD). This study assessed patients' motives to be physically active, according to three pulmonary rehabilitation (PR) participation groups (Never PR, Previous PR and Current PR) and explored whether these motives were related to the PA levels and clinical characteristics. The motives to be physically active were assessed with the Exercise Motivation Inventory-2 (EMI-2, 14 motivational factors, five dimensions) and PA with accelerometry (PA groups: <5000 steps/day vs. ≥5000 steps/day). The clinical variables included symptoms, impact of the disease, exercise capacity and comorbidities. Ninety-two patients (67.4 ± 8.1 years, 82.6% male, forced expiratory volume in 1s (FEV1) 48.3 ± 18.9% predicted; 30.4% Never PR, 51% Previous PR and 18.5% Current PR) participated. The motivational dimensions related to health/fitness presented the highest scores (3.8 ± 1.1; 3.4 ± 1.3). The motives to be active were not significantly different between PA groups (p > 0.05) but having less symptoms and ≥two comorbidities were associated with higher scores in psychological/health and body-related motives, respectively (p < 0.05). The findings may encourage health professionals to actively explore with patients their motives to be physically active to individualise PA promotion.

Phenotyping Adopters of Mobile Applications Among Patients With COPD: A Cross-Sectional Study.

Effectiveness of technology-based interventions to improve physical activity (PA) in people with COPD is controversial. Mixed results may be due to participants' characteristics influencing their use of and engagement with mobile health apps. This study compared demographic, clinical, physical and PA characteristics of patients with COPD using and not using mobile apps in daily life. Patients with COPD who used smartphones were asked about their sociodemographic and clinic characteristics, PA habits and use of mobile apps (general and PA-related). Participants performed a six-minute walk test (6MWT), gait speed test and wore an accelerometer for 7 days. Data were compared between participants using (App Users) and not using (Non-App Users) mobile apps. A sub-analysis was conducted comparing characteristics of PA-App Users and Non-Users. 59 participants were enrolled (73% Male; 66.3 ± 8.3 yrs; FEV1 48.7 ± 18.4% predicted): 59% were App Users and 25% were PA-App Users. Significant differences between App Users and Non-App Users were found for age (64.2 ± 8.9 vs. 69.2 ± 6.3yrs), 6MWT (462.9 ± 91.7 vs. 414.9 ± 82.3 m), Gait Speed (Median 1.5 [Q1-Q3: 1.4-1.8] vs. 2.0 [1.0-1.5]m/s), Time in Vigorous PA (0.6 [0.2-2.8] vs. 0.14 [0.1-0.7]min) and Self-Reported PA (4.0 [1.0-4.0] vs. 1.0 [0.0-4.0] Points). Differences between PA-App Users and Non-Users were found in time in sedentary behavior (764.1 [641.8-819.8] vs. 672.2 [581.2-749.4] min) and self-reported PA (4.0 [2.0-6.0] vs. 2.0 [0.0-4.0] points). People with COPD using mobile apps were younger and had higher physical capacity than their peers not using mobile apps. PA-App Users spent more time in sedentary behaviors than Non-Users although self-reporting more time in PA.

Ultrasonography Reliability in the Detection of Inflammatory and Structural Abnormalities: An Exercise in Multiple Joints.

BACKGROUND: Ultrasonography is an image technique that allows rheumatologists to visualize structural and inflammatory changes within a joint. The objective of this study was to assess the interobserver and intraobserver reliability of musculoskeletal ultrasound (US) in the detection of inflammatory and destructive joint changes in patients with polyarthritis. METHODS: A Delphi exercise was undertaken to standardize and adapt the EULAR-OMERACT elementary US definitions of inflammatory lesions (effusion, synovial hypertrophy, power Doppler, bone erosions, and synovitis) for each joint. Fifteen patients were analyzed, and video clips of 600 joints were collected. Each joint was scored for the presence of each elementary component, on 2 separate occasions, by 6 examiners. Interobserver and intraobserver agreement analysis was assessed through Fleiss κ coefficient (κ). RESULTS: Considering all patients and all joints, the interobserver values were highest for erosions and lowest for effusion (κ = 0.7314 and κ = 0.6044, respectively). When analyzing different regions, the highest interobserver agreement was for tibiotalar joint (κ = 0.8043) and the lowest for wrist (κ = 0.6767). Intraobserver reliability was excellent for each and all elementary components and anatomical region. CONCLUSIONS: The present study showed either a good or excellent US interobserver and intraobserver reliability in elementary elements and anatomical region. This kind of US reliability exercises are important for standardization of exploration in everyday practice by reducing the variability associated with this imaging technique, and ensuring a greater degree of homogeneity and future comparability in the assessment of disease activity in polyarthritis patients.

Avaliação do impacto das abordagens bottomup e top-down nas atividades da vida diária em pessoas com neglect ­ revisão sistemática / Evaluation of the impact of bottom-up and topdown approaches on daily activities in people with neglet ­ a systematic review

Atualmente não existe um consenso entre quais as caraterísticas das abordagens (bottom-up ou top-down) mais eficazes na reabilitação das Atividades da Vida Diária (AVDs) em pessoas com Síndrome de Neglect (SN). OBJETIVO: Caracterizar as abordagens (bottom-up ou top-down) e o seu impacto nas AVDs em adultos e idosos com SN. MÉTODOS: Esta revisão sistemática foi realizada de acordo com a recomendação PRISMA - Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A pesquisa bibliográfica foi realizada nas bases de dados PubMed, Web of Science, PEDro e Cochrane. Foram considerados estudos experimentais em que pelo menos uma técnica das abordagens bottom-up e top-down fosse utilizada. A ferramenta Joanna Briggs Institute Critical Appraisal Checklist for RCTs foi utilizada para avaliar a qualidade metodológica dos estudos. Foi usada a seguinte combinação de palavras chave: Neglect Syndrome OR Unilateral Syndrome OR Neglect (…) AND Activities of Daily Living OR Daily (…) AND Treatment OR Intervention OR Technique (…). RESULTADOS: Foram incluídos 16 estudos, dos quais 9 incluem técnicas de abordagem bottom-up, 6 incluem técnicas de abordagem top-down e 1 artigo inclui técnicas das duas abordagens. As técnicas da abordagem bottom-up que aumentaram a independência nas AVDs foram Visuomotor Feedback Training, Smooth Pursuit Eye Movement Training e a combinação de Eye Patching com Constraint-induced Therapy. Na abordagem top-down as técnicas com os mesmos resultados foram Visual Scanning, Mental Practice, Continuous Theta Burst Stimulation e Transcranial Direct Current Stimulation. CONCLUSÃO: As abordagens bottom-up e top-down aumentam a independência nas AVDs e cada uma contém técnicas com significativo impacto positivo, como Visuomotor Feedback Training e Continuous Theta Burst Stimulation. O presente trabalho permitiu uma análise crítica à classificação das abordagens em bottom-up e top-down, uma vez que não são sensíveis à distinção dos mecanismos de reabilitação envolvidos.

Currently there is no consensus on which are the characteristics of rehabilitation approaches (bottom-up or top-down) most effective in the rehabilitation of ADLs in people with Neglet Syndrome (NS). AIM: To characterize the approaches (bottomup or top-down) with more impact on ADLs in adults and elderly with NS. METHODS: This systematic review was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Metaanalyses (PRISMA) recommendation. A bibliographic search was carried out in PubMed, Web of Science, PEDro and Cochrane databases. Experimental studies were considered in which at least one technique of the bottom-up and top-down approaches was used. The Joanna Briggs Institute Critical Appraisal Checklist for RCTs tool was used to assess the methodological quality of the studies. The following combination of keywords was used: Negligence Syndrome OR Unilateral Syndrome OR Negligence (...) AND Activities OF Daily OR Daily Life (...) AND Treatment OR Intervention OR Technique (...). RESULTS: 16 studies were included, which 9 include techniques from the bottom-up approach, 6 include techniques from the top-down approach and 1 article includes two techniques, each belonging to each approach. The techniques of the bottom-up approach that increased independence in the ADLs were Visuomotor Feedback Training, Smooth Pursuit Eye Movement Training and the combination of Eye Patching with Constraint-induced Therapy. In the top-down approach, the techniques with the same results were Visual Scanning, Mental Practice, Continuous Theta Burst Stimulation and Transcranial Direct Current Stimulation. CONCLUSION: Both bottom-up and top-down approaches increase independence in ADLs. Each approach contains techniques with a significant positive impact on ADLs such as Visuomotor Feedback Training and Continuous Theta Burst Stimulation. The present work also allowed a critical analysis to the classification of the approaches in bottom-up and top-down, since they are not different to the category of rehabilitation mechanisms.

Relationship between Distress Related to Caregiver Burden and Physical Activity in Informal Caregivers of Patients with COPD.

Chronic obstructive pulmonary disease (COPD) can lead to increased dependence on the informal caregiver and, consequently, to distress associated with caregiving burden. In the general population, higher levels of physical activity (PA) are related to lower distress levels; however, this relationship has been scarcely studied in COPD. This study aimed to explore the relationship between distress and PA in informal caregivers of patients with COPD, and the influence of caregivers' (age, sex) and patients' (age, sex, lung function) characteristics and caregiving duration on this relationship.A cross-sectional study was conducted with 50 caregivers (62.7 ± 9.8 years, 88% female; 78% caring for a spouse/partner; 38% caring >40 h/week; patients' FEV1=45.2 ± 21.3% predicted). Data collection comprised questions related to the caregiving context, distress related to caregiving burden assessed with the Informal Caregiver Burden Assessment Questionnaire (QASCI; total score, 7 subscales), and self-reported PA with the Habitual Physical Activity Questionnaire (HPAQ). Spearman's correlation coefficient and linear regressions were used.Significant, negative and moderate correlations were found between the QASCI (28.5 ± 19.8) and the HPAQ (5.2 ± 1.3) (ρ=-0.46; p = 0.01); and between the HPAQ and some QASCI subscales (emotional burden ρ=-0.47; implications for personal life ρ=-0.52; financial burden ρ=-0.44; perception of efficacy and control mechanisms ρ=-0.42; p < 0.01). Two linear regression models were tested to predict QASCI total score including as predictors: 1) HPAQ alone (p = 0.001; r2=0.23); 2) HPAQ and caregiving h/week (p < 0.001; r2=0.34).Higher self-reported PA levels are related to decreased levels of distress associated with caregiver burden in COPD caregivers. Duration of caregiving may negatively influence this relationship.

Remission and low disease activity matrix tools: results in real-world rheumatoid arthritis patients under anti-TNF therapy.

BACKGROUND: Remission/ low disease activity (LDA) are the main treatment goals in rheumatoid arthritis (RA) patients. Two tools showing the ability to predict golimumab treatment outcomes in patients with RA were published. OBJECTIVES: To estimate the real-world accuracy of two quantitative tools created to predict RA remission and low disease activity. METHODS: Multicenter, observational study, using data from the Rheumatic Diseases Portuguese Register (Reuma.pt), including biologic naïve RA patients who started an anti-TNF as first-line biologic and with at least 6 months of follow-up. The accuracy of two matrices tools was assessed by likelihood-ratios (LR), sensitivity (SN), specificity (SP), positive predictive value (PPV), negative predictive value (NPV) and area under the ROC curve (AUC). RESULTS: 674 RA patients under first-line anti-TNF (266 etanercept, 186 infliximab, 131 adalimumab, 85 golimumab, 6 certolizumab pegol) were included. The median (IQR) age was 53.4 (44.7-61.1) years and the median disease duration was 7.7 (3.7-14.6) years. The majority were female (72%). Most patients were RF and/or ACPA positive (75.5%) and had erosive disease (54.9%); 58.6% had comorbidities. At 6-months, 157 (23.3%) patients achieved remission (DAS28 ESR < 2.6) and 269 (39.9%) LDA (DAS28 ESR ≤ 3.2). Area under the curve for remission in this real-world sample was 0.756 [IC 95% (0.713-0.799)] and for LDA was 0.724 [IC 95% (0.686 -0.763)]. The highest LR (8.23) for remission state was obtained at a cut-off ≥ 67%, with high specificity (SP) (99.6%) but low sensitivity (SN) (3.2%). A better balance of SN and SP (65.6% and 73.9%, respectively) was observed for a cut-off >30%, with a LR of 2.51, PPV of 43.3% and NPV of 87.6%. CONCLUSION: In this population, the accuracy of the prediction tool was good for remission and LDA. Our results corroborate the idea that these matrix tools could be helpful to select patients for anti-TNF therapy.

Subacute cutaneous lupus erythematosus in a patient with Sjögren's syndrome taking terbinafine for onychomycosis.

We report the case of a 40-year old woman followed at our Rheumatology department for a 14-year history of a relatively well controlled Sjögren's syndrome who developed, for the first time in life, lesions suggestive of subacute cutaneous lupus erythematosus, nine weeks after taking oral terbinafine prescribed for onychomycosis. She denied additional symptoms, namely systemics, and no other clinical finding besides cutaneous lesions were detected. No laboratory findings were in favour of a flare of her connective tissue disease. Here we explore the possibility of terbinafine-induced subacute cutaneous lupus erythematosus in the context of previous autoimmunity. This clinical case highlights the importance of avoiding the prescription of terbinafine in this kind of patients.

Predictors and causes of first-line biologic agent discontinuation in rheumatoid arthritis: data from Reuma.pt.

OBJECTIVES: To assess the discontinuation of first-line biological treatment and to evaluate the reasons and predictors thereof in patients with rheumatoid arthritis (RA) from daily clinical practice. METHODS: RA patients registered in the Rheumatic Diseases Portuguese Register (Reuma.pt) starting treatment with biologic DMARDs (bDMARDs) were included in this prospective observational study. The main outcome was the time to discontinuation (in years) due to any cause. Discontinuation was defined as a 90-day discontinuation of treatment or the occurrence of any switch to another bDMARD during follow-up. Baseline and time-varying sociodemographic and clinical characteristics were tested as possible predictors of discontinuation using multivariable Cox models. RESULTS: Of the 1,851 RA patients included in the study, 871 (47%) discontinued their first bDMARD. The median overall persistence of the first bDMARD was 5.5 years and the leading cause of discontinuation was inefficacy [N=476 (55%)], followed by adverse events [N=262 (30%)], other causes [N=69, (8%)] and unknown causes [N=64 (7%)]. Patients with a higher HAQ score (more disability) at baseline were more likely to discontinue their first bDMARD [hazard ratio (HR):1.39 (95% CI: 1.17-1.64)], as were patients with a higher number of comorbidities [HR: 1.17 (1.05-1.29)] and patients starting treatment from 2007 onwards [HR:1.89 (1.5-2.38)]. On the contrary, receiving TNFi bDMARD [HR:0.74 (0.57-0.94)] as opposed to non-TNFi was associated with less discontinuation. Expectedly, the higher the DAS28 during follow-up the higher the likelihood to discontinue bDMARD [HR:1.08 (1.06-1.1)]. No other time-varying predictor was found. CONCLUSION: In the Portuguese RA population, maintenance of first-line bDMARD was shown to be relatively high. Inefficacy was the leading cause of discontinuation. Features found to predict drug discontinuation (e.g. baseline disability) may contribute to inform clinician's decisions in clinical practice.

Relationship between the perceived social support and catastrophization in individuals with chronic knee pain / Relação entre suporte social percebido e catastrofização em indivíduos com dor crônica do joelho

ABSTRACT BACKGROUND AND OBJECTIVES: Catastrophization and social support influence health outcomes in people with chronic pain. However, there is still no consensus regarding the relationship between these factors, and the information available in what relates to chronic pain in the knee joint is even scarcer. The objective of this study was to describe and understand the relationship between the perceived social support and pain catastrophization in adults with chronic knee pain. METHODS: Sociodemographic data were collected, and the West Haven-Yale Multidimensional Pain Inventory and Pain Catastrophizing Scale were completed by the participants. The sample included 28 participants attending daycare institutions in Aveiro, Braga and Leiria districts (Portugal). RESULTS: Seventy-five percent of the participants presented clinically significant catastrophization, and 64.3% reported high perceived social support. There is a direct relationship between high catastrophization and frequent solicitations and distraction responses. Conversely, an inverse association between high catastrophization levels and infrequent negative responses was observed in the collected sample. CONCLUSION: Useful social support contributes to a maladaptive response to pain by increasing catastrophization levels, and the catastrophic response may be a way to ask for support. There is a direct association between the perceived social support and the catastrophization of chronic knee pain in the participants. However, the association between these variables was poor/low evidencing the need to consider other factors in the catastrophization study.

RESUMO JUSTIFICATIVA E OBJETIVOS: Tanto a catastrofização como o suporte social influenciam os resultados na saúde de indivíduos com dor crônica. Porém, não há consenso sobre a relação entre esses fatores, sendo escassa a informação direcionada à articulação do joelho. O objetivo deste estudo foi descrever e compreender a relação entre o suporte social percebido e a catastrofização da dor em idosos com dor crônica do joelho. MÉTODOS: Foi feita a coleta de dados sociodemográficos, em conjunto com o preenchimento dos instrumentos West Haven-Yale Multidimensional Pain Inventory e Pain Catastrophizing Scale pelos participantes. A amostra foi constituída por 28 participantes, institucionalizados em regime de centro de dia dos distritos de Aveiro, Braga e Leiria (Portugal). RESULTADOS: Setenta e cinco por cento dos participantes apresentaram catastrofização clinicamente significativa e 64,3% referiram alto suporte social percebido. Verificou-se uma relação diretamente proporcional entre a elevada catastrofização e as respostas solícitas e de distração frequentes. Contrariamente, existe uma associação inversamente proporcional entre o elevado nível de catastrofização e as respostas negativas pouco frequentes na amostra recolhida. CONCLUSÃO: O suporte social útil contribui para uma resposta desadaptativa à dor, pelo aumento dos níveis de catastrofização, podendo a resposta catastrófica constituir um meio para solicitar apoio. Denota-se uma associação diretamente proporcional entre o suporte social percebido e a catastrofização da dor crônica do joelho nos participantes. Contudo, a relação demonstrou ser pobre/baixa, evidenciando a necessidade de considerar outros fatores no estudo da catastrofização.

Adolescentes na Rede: Riscos ou Ritos de Passagem? / Teens in the Network: Risks or Rites of Passage? / Adolescentes en la Red: ¿Riesgos o Ritos de Paso?

Os adolescentes estão cada vez mais conectados às redes sociais, especialmente com o surgimento dos dispositivos digitais móveis. O uso intenso desses aparelhos pelos jovens tem gerado preocupação nos pais, familiares e educadores. Orientadas pela psicanálise, compreendemos a adolescência como um tempo lógico de elaboração simbólica do real da puberdade, trabalho psíquico que requer o desligamento da autoridade dos pais e a inserção no laço social. Nas sociedades tradicionais, a passagem da vida infantil para a vida adulta conta com marcadores sociais estabelecidos, como os ritos de passagem, que auxiliam a inclusão do jovem na comunidade. Nas sociedades ocidentais contemporâneas, a rarefação dos referentes simbólicos dificulta essa transição do espaço familiar para o grupo social mais amplo. Assim, buscamos, neste artigo, empreender uma discussão teórica relacionando os riscos na internet com os ritos de passagem no tempo lógico da adolescência. Como apoio para esta reflexão, utilizamos fragmentos de conversação realizada com adolescentes. Consideramos que, na atualidade, os impasses dessa operação de passagem se exprimem pela profusão de atos de caráter sacrificial que a juventude apresenta, contando com o papel decisivo da visibilidade proporcionada pelas tecnologias digitais....(AU)

Adolescents are increasingly connected to social networks, especially with the appearance of mobile devices. The intense use of such devices has generated worry for parents, family and educators. Guided by psychoanalysis, we understand that adolescence is a logical time of subjective elaboration of "the real" of puberty, psychic work that requires the detachment of parental authority and insertion into the social environment. In traditional societies, the passage from childhood to adult life has established social markers, such as rites of passage, which help to include the young person in the community. In contemporary western societies, the rarefaction of symbolic references creates difficulties for that transition from the family space towards the general social group. Therefore, we intend in this article to undertake a theoretical discussion that relates the risks on the internet with the rites of passage in the logical time of adolescence. In support of this reflection, we used fragments of the Methodology of the Conversation with adolescents. We consider that, at present, the impasses of this operation of passage are expressed by the profusion of sacrificial acts that the youth presents, counting on the decisive role of the visibility provided by digital technologies....(AU)

Los adolescentes están cada vez más conectados a las redes sociales, especialmente con el surgimiento de los dispositivos digitales móviles. El uso intenso de estos aparatos por los jóvenes ha generado preocupación en los padres, familiares y educadores. Orientadas por el psicoanálisis, comprendemos la adolescencia como un tiempo lógico de elaboración simbólica de lo real de la pubertad, trabajo psíquico que requiere el desligamiento de la autoridad de los padres y la inserción en el lazo social. En las sociedades tradicionales, el paso de la vida infantil a la vida adulta cuenta con marcadores sociales establecidos, como los ritos de paso, que auxilian la inclusión del joven en la comunidad. En las sociedades occidentales contemporáneas, la rarefación de los referentes simbólicos dificulta esa transición del espacio familiar al grupo social más amplio. Así, buscamos, en este artículo, emprender una discusión teórica relacionando los riesgos en Internet con los ritos de paso en el tiempo lógico de la adolescencia. Como apoyo para esta reflexión, utilizamos fragmentos de conversación realizada con adolescentes. Consideramos que en la actualidad los impases de esa operación de paso se expresan por la profusión de actos de carácter sacrificial que la juventud presenta, contando con el papel decisivo de la visibilidad proporcionada por las tecnologías digitales....(AU)

Sex-associated Treatment Differences and Their Outcomes in Rheumatoid Arthritis: Results from the METEOR Register.

OBJECTIVE: To assess differences in initial treatment and treatment response in male and female patients with rheumatoid arthritis (RA) in daily clinical practice. METHODS: The proportion of patients with RA starting different antirheumatic treatments (disease-modifying antirheumatic drugs; DMARD) and the response to treatment were compared in the international, observational METEOR register. All visits from start of the first DMARD until the first DMARD switch or the end of followup were selected. The effect of sex on time to switch from first to second treatment was calculated using Cox regression. Linear mixed model analyses were performed to assess whether men and women responded differently to treatments, as measured by Disease Activity Score (DAS) or Health Assessment Questionnaire. RESULTS: Women (n = 4393) more often started treatment with hydroxychloroquine, as monotherapy or in combination with methotrexate (MTX) or a glucocorticoid, and men (n = 1142) more often started treatment with MTX and/or sulfasalazine. Time to switch DMARD was shorter for women than for men. Women had a statistically significantly higher DAS over time than men (DAS improvement per year ß -0.69, 95% CI -0.75 to -0.62 for men and -0.58, 95% CI -0.62 to -0.55 for women). Subanalyses per DMARD group showed for the conventional synthetic DMARD combination therapy a slightly greater decrease in DAS over time in men (-0.89, 95% CI -1.07 to -0.71) compared to women (-0.59, 95% CI -0.67 to -0.51), but these difference between the sexes were clinically negligible. CONCLUSION: This worldwide observational study suggests that in daily practice, men and women with RA are prescribed different initial treatments, but there were no differences in response to treatment between the sexes.

The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update.

Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements. Literature searches on these issues were performed and the search results were presented and discussed in a national meeting. Portuguese rheumatologists considered that affordability should be taken into consideration when initiating a biological drug, but other factors were equally important. In patients already on reference biological treatment, switch to a more affordable biosimilar is desirable, provided a set of conditions is rigorously met. Automatic substitution is not acceptable and current evidence is insufficient to support interchangeability. Extrapolation of clinical indications is endorsed by Portuguese rheumatologists, and the statements on safety, pharmacovigilance and traceability are in accordance with the previous position paper.