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- Portuguese Recommendations for the Use of Biological and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis - 2020 UpdatePublication . Fernandes, BM; Guimarães, F; Almeida, DE; Neto, A; Tavares-Costa, J; Roxo Ribeiro, A; Quintal, A; Pereira, JP; Silva, L; Nóvoa, TS; Faustino, A; Vaz, C; Khmelinskii, N; Samões, B; Dourado, E; Silva, JL; Barcelos, A; Mariz, E; Guerra, M; Santos, MJ; Silvério-António, M; Teixeira, RL; Romão, VC; Santos, H; Santos-Faria, D; Azevedo, S; Rodrigues, A; Dias, JM; Lopes, C; Pinto, P; Couto, M; Miranda, LC; Bernardo, A; Cruz, M; Teixeira, F; Mourão, AF; Neto, A; Teixeira, V; Cordeiro, A; Barreira, S; Inês, LS; Capela, S; Sepriano, A; Canhão, H; Fonseca, JE; Duarte, C; Bernardes, MObjective: To update the recommendations for the treatment of rheumatoid arthritis (RA) with biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs), endorsed by the Portuguese Society of Rheumatology (SPR). Methods: These treatment recommendations were formulated by Portuguese rheumatologists taking into account previous recommendations, new literature evidence and consensus opinion. At a national meeting, in a virtual format, three of the ten previous recommendations were re-addressed and discussed after a more focused literature review. A first draft of the updated recommendations was elaborated by a team of SPR rheumatologists from the SPR rheumatoid arthritis study group, GEAR. The resulting document circulated among all SPR rheumatologists for discussion and input. The level of agreement with each of all the recommendations was anonymously voted online by all SPR rheumatologists. Results: These recommendations cover general aspects such as shared decision, treatment objectives, systematic assessment of disease activity and burden and its registry in Reuma.pt. Consensus was also achieved regarding specific aspects such as initiation of bDMARDs and tsDMARDs, assessment of treatment response, switching and definition of persistent remission. Conclusion: These recommendations may be used for guidance of treatment with bDMARDs and tsDMARDs in patients with RA. As more evidence becomes available and more therapies are licensed, these recommendations will be updated.
- Investigação Clínica da Iniciativa do Investigador em Portugal: Identificação de Problemas e Propostas para MelhoriaPublication . Ferreira, JP; Leite-Moreira, A; Costa-Pereira, A; Soares, AJ; Robalo-Cordeiro, C; Jerónimo, C; Gavina, C; J. Pinto, F; Schmitt, F; Saraiva, F; Vasques-Nóvoa, F; Canhão, H; Cyrne-Carvalho, H; Palmeirim, I; Pimenta, J; Cabral da Fonseca, JE; Firmino-Machado, J; Correia Pinto, J; Gonçalves, L; Castelo Branco, M; Sousa, N; Fontes de Carvalho, R; Machado Luciano, T; Gil Oliveira, T; Resende Oliveira, C
- Clinical Courses, Impact and Prognostic Indicators for a Persistent Course of Low Back Pain: Results from a Population-Based Cohort StudyPublication . Antunes Gomes, L; Rodrigues, AM; Branco, J; Canhão, H; Brazete Cruz, EBackground: Low back pain (LBP) is a long-term health condition with distinct clinical courses. Its characterization together with the identification of prognostic factors for a persistent LBP course may trigger the development of personalized interventions. This study aimed to investigate the courses of chronic LBP (CLBP), its cumulative impact, and the indicators for the persistence of pain. Material and methods: Patients with active CLBP from the EpiDoC, a population-based cohort study of a randomly recruited sample of 10.661 adults with prolonged follow-up, were considered. Pain, disability, and health-related quality of life (HRQoL) were assessed at three time-points over five years. According to their pain symptoms over time, participants were classified as having a persistent (pain at the baseline and at all the subsequent time-points) or a relapsing pain course (pain at the baseline and no pain at least in one of the subsequent time-points). A mixed ANOVA was used to compare mean differences within and between patients of distinct courses. Prognostic indicators for the persistent LBP course were modulated through logistic regression. Results: Among the 1.201 adults with active CLBP at baseline, 634 (52.8%) completed the three time-points of data collection: 400 (63.1%) had a persistent and 234 (36.9%) a relapsing course. Statistically significant interactions were found between the group and time on disability (F (2,1258) = 23.779, p<0.001) and HRQoL (F (2,1252) = 82.779, p<0.001). In the adjusted model, the persistent course was associated with the disability level (OR 1.86, CI95% 1.40-2.40, p<0.001), depressive symptoms (OR 1.96, CI95% 1.21-3.18, p = 0.007), female gender (OR 1.90, CI95% 1.26-2.87, p = 0.002) and having a manual job (OR 1.46, CI95% 1.02-2.10, p = 0.040). Conclusion: In the long-term, patients with CLBP may follow a persistent or relapsing course of pain. Being female, presenting depressive symptoms, having a manual job and higher disability at baseline predicts a persistent course of LBP.
- Challenges and Knowledge Gaps with Immune Checkpoint Inhibitors Monotherapy in the Management of Patients with Non-Small-Cell Lung Cancer: a Survey of Oncologist PerceptionsPublication . Castelo-Branco, L; Morgan, G; Prelaj, A; Scheffler, M; Canhão, H; Van Meerbeeck, JP; Awada, ABackground: Immune checkpoint-inhibitors (ICIs) are changing outcomes in different cancer settings, notably for patients with non-small-cell lung cancer (NSCLC). There are, however, still important gaps of evidence for clinical practice when using these novel treatments. In this study, we assessed physicians' opinion and experience on challenges for clinical practice with ICIs monotherapy in NSCLC. Methods: A survey was conducted on experienced physicians treating patients with NSCLC with ICIs. Two rounds of pilot tests were carried out for validation among a group of experts. Topics under analysis were in relation to treatment of elderly populations, performance status, brain metastases, use of steroids or antibiotics, the effects of gut microbiome, autoimmune diseases, human immunodeficiency virus infection, solid organ transplants, use of anti-programmed cell death protein 1 versus anti-programmed death-ligand 1 drugs, atypical tumour responses, predictors of response, duration of treatment and a final open question on additional relevant challenges. Results: Two hundred and twenty-one answers were collected, including 106 (48%) valid answers from experts for final analysis (physicians who have treated at least 20 patients with NSCLC with ICIs). The vast majority agreed that the selected topics in this study are important challenges ahead and more evidence is needed. Moreover, predictors of response, treating brain metastasis, shorter duration of treatment, the effects of gut microbiome and concomitant use of steroids were voted the most important topics to be further addressed in prospective clinical research. Conclusions: This survey contributed to understanding which are the main challenges for clinical practice with ICIs monotherapy in NSCLC. It can also contribute to guide further clinical research, considering the opinions and experience of those who regularly treat NSCLC patients with ICIs.
- Using Patient-Reported Outcome Measures to Evaluate Care for Patients With Inflammatory Chronic Rheumatic DiseasePublication . Rodrigues, D; Street, A; Santos, MJ; Rodrigues, AM; Marques-Gomes, J; Canhão, HObjectives: Few countries integrate patient-reported outcome measures (PROMs) in routine performance assessment and those that do focus on elective surgery. This study addresses the challenges of using PROMs to evaluate care in chronic conditions. We set out a modeling strategy to assess the extent to which changes over time in self-reported health status by patients with inflammatory chronic rheumatic disease are related to their biological drug therapy and rheumatology center primarily responsible for their care. Methods: Using data from the Portuguese Register of Rheumatic Diseases, we assess health status using the Health Assessment Questionnaire-Disability Index for rheumatic patients receiving biological drugs between 2000 and 2017. We specify a fixed-effects model using the least squares dummy variables estimator. Results: Patients receiving infliximab or rituximab report lower health status than those on etanercept (the most common therapy) and patients in 4 of the 26 rheumatology centers report higher health status than those at other centers. Conclusions: PROMs can be used for those with chronic conditions to provide the patient's perspective about the impact on their health status of the choice of drug therapy and care provider. Care for chronic patients might be improved if healthcare organizations monitor PROMs and engage in performance assessment initiatives on a routine basis.
- Prevalence of Vitamin D Deficiency and its Predictors in the Portuguese Population: a Nationwide Population-Based StudyPublication . Duarte, C; Carvalheiro, H; Rodrigues, A; Dias, S; Marques, A; Santiago, T; Canhão, H; Branco, J; Pereira da Silva, JAVitamin D deficiency is prevalent worldwide, but its prevalence is unknown in adult Portuguese population. In Portugal, 66% of adults present Vitamin D insufficiency/deficiency. Winter, living in Azores, older age, and obesity were the most important risk factors. It highlights the need of strategies to prevent vitamin D deficiency in Portugal. Objective: To estimate the prevalence and risk factors of vitamin D deficiency in the adult Portuguese population. Methods: Adults (≥ 18 years old) from the EpiReumaPt Study (2011-2013) were included. Standardized questionnaires on socio-demographic and lifestyle features were obtained. Serum 25-hydroxyvitamin D [25(OH)D] concentrations were evaluated using ADVIA Centaur VitD competitive immunoassay (Siemens Healthineers) in 2015-2017 as 25 (OH)D Level 0: ≤ 10 ng/mL; Level 1: 11-19 ng/mL; Level 2: 20-29 ng/mL, and Level 3: ≥ 30 ng/mL. Weighted multinomial regression analysis was conducted to evaluate the association between socio-demographic and lifestyle variables and vitamin D status. Results: Based on weighted analysis, the estimated prevalence of levels of 25(OH)D ≤ 10, < 20, and < 30 ng/mL was 21.2, 66.6, and 96.4%, respectively. The strongest independent predictors of serum 25 (OH)D ≤ 10 ng/mL were living in the Azores archipelagos (OR 9.39; 95%CI 1.27-69.6) and having the blood sample collection in winter (OR 18.53; 95%CI 7.83-43.87) or spring (11.55; 95%CI 5.18-25.74). Other significant predictors included older age (OR 5.65, 95%CI 2.08-15.35), obesity (OR 2.61; 95%CI 1.35-5.08), current smoking (OR 2.33; 95%CI 1.23-4.43), and female gender (OR 1.9, 95%CI 1.1-3.28). Conversely, physical exercise (OR 0.48, 95%CI 0.28-0.81) and occasional alcohol intake (OR 0.48, 95%CI 0.29-0.81) were associated with a lower risk of 25(OH)D ≤ 10 ng/mL. Conclusion: Vitamin D deficiency/insufficiency [25(OH)D < 20 ng/ml] is highly prevalent in Portugal, affecting > 60% of all Portuguese adults, with strong geographical and seasonal variation. This study highlights the need to critically assess the relevance of vitamin D deficiency as a public health problem and the urgent need for a wide and scientifically robust debate about the most appropriate interventions at the individual and societal levels.
- Obesity and Diabetes Are Associated with Disability in Women with Hand Osteoarthritis. Results from the EpiReumaPt Nationwide StudyPublication . Cruz, M; Rodrigues, AM; Dias, S; Sepriano, A; Canhão, H; Gouveia, N; Ramiro, S; Branco, JCBackground: Hand osteoarthritis (HOA) is a highly prevalent rheumatic disease that predominates in females and causes pain and loss of functional capacity. Obesity and metabolic syndrome have been previously suggested to associate with the severity of HOA, but clarity on these associations is yet to be achieved. Objective: Test the association between obesity and other components of the metabolic syndrome and disability in women with hand osteoarthritis (HOA). Design: Individuals from EpiReumaPt epidemiological community-based study (2011-2013) are representative of the Portuguese population. Women with diagnosis of primary HOA were included. Primary outcome: hand functional status, assessed by Cochin questionnaire. Secondary outcomes: hand pain, assessed by visual analogue scale and tender hand joint count (THJ). Explanatory variables: obesity, diabetes mellitus, arterial hypertension and hypercholesterolemia. Possible associations between obesity and the other components of metabolic syndrome with Cochin score, hand pain and THJ were tested in a multivariable linear regression model. Potential confounders considered: age, education level and countrywide distribution. Results: 473 women with primary HOA were included. Forty percent were overweight and 29% obese. Ninety-three (19.8%) participants had diabetes, 261 (55.8%) reported hypertension and 261 (55.9%) hypercholesterolemia. Mean Cochin score was 15.5±14.8, mean pain VAS was 4.7±2.6 and mean THJ 1.4±3. In the multivariable analysis, obesity (β 4.6 CI 0.7;8.5) and diabetes (β 4.0 CI 0.4;7.6) were found to significantly associate with HOA functional disability. In addition, diabetes, but not obesity, associated with hand pain. There was no association between obesity or diabetes with THJ. Conclusion: In a Portuguese female population with primary HOA, obesity and diabetes mellitus independently associated with a worse hand functional status. These data add to evidence suggesting a role of metabolic factors in the severity of HOA.
- Systematic Literature Review Informing the 2018 Update of the EULAR Recommendation for the Management of Large Vessel Vasculitis: Focus on Giant Cell ArteritisPublication . Monti, S; Águeda, A; Luqmani, R; Buttgereit, F; Cid, M; Dejaco, C; Mahr, A; Ponte, C; Salvarani, C; Schmidt, W; Hellmich, BObjectives: To analyse the current evidence for the management of large vessel vasculitis (LVV) to inform the 2018 update of the EULAR recommendations. Methods: Two systematic literature reviews (SLRs) dealing with diagnosis/monitoring and treatment strategies for LVV, respectively, were performed. Medline, Embase and Cochrane databases were searched from inception to 31 December 2017. Evidence on imaging was excluded as recently published in dedicated EULAR recommendations. This paper focuses on the data relevant to giant cell arteritis (GCA). Results: We identified 287 eligible articles (122 studies focused on diagnosis/monitoring, 165 on treatment). The implementation of a fast-track approach to diagnosis significantly lowers the risk of permanent visual loss compared with historical cohorts (level of evidence, LoE 2b). Reliable diagnostic or prognostic biomarkers for GCA are still not available (LoE 3b).The SLR confirms the efficacy of prompt initiation of glucocorticoids (GC). There is no high-quality evidence on the most appropriate starting dose, route of administration, tapering and duration of GC (LoE 4). Patients with GCA are at increased risk of dose-dependent GC-related adverse events (LoE 3b). The addition of methotrexate or tocilizumab reduces relapse rates and GC requirements (LoE 1b). There is no consistent evidence that initiating antiplatelet agents at diagnosis would prevent future ischaemic events (LoE 2a). There is little evidence to guide monitoring of patients with GCA. Conclusions: Results from two SLRs identified novel evidence on the management of GCA to guide the 2018 update of the EULAR recommendations on the management of LVV.
- Validation of the Telephone-Administered Version of the Mediterranean Diet Adherence Screener (MEDAS) QuestionnairePublication . Gregório, MJ; Rodrigues, AM; Salvador, C; Dias, S; Sousa, R; Mendes, J; Coelho, P; Branco, J; Lopes, C; Martínez-González, M; Graça, P; Canhão, HA 14-Item Mediterranean Diet Adherence Screener (MEDAS) questionnaire was developed and validated in face-to-face interviews, but not via telephone. The aims of this study were to evaluate the validity and reliability of a telephone-administered version of the MEDAS as well as to validate the Portuguese version of the MEDAS questionnaire. A convenience community-based sample of adults (n = 224) participated in a three-stage survey. First, trained researchers administered MEDAS via a telephone. Second, the Portuguese version of Food Frequency Questionnaire (FFQ), and MEDAS were administered in a semi-structured face-to-face interview. Finally, MEDAS was again administered via telephone. The telephone-administered MEDAS questionnaire was compared with the face-to-face-version using several metrics. The telephone-administered MEDAS was significantly correlated with the face-to-face-administered MEDAS [r = 0.805, p < 0.001; interclass correlation coefficient (ICC) = 0.803, p < 0.001] and showed strong agreement (k = 0.60). The MEDAS scores that were obtained in the first and second telephone interviews were significantly correlated (r = 0.661, p < 0.001; ICC = 0.639, p < 0.001). The overall agreement between the Portuguese version of MEDAS and the FFQ-derived Mediterranean diet adherence score had a Cohen's k = 0.39. The telephone-administered version of MEDAS is a valid tool for assessing the adherence to the Mediterranean diet and acquiring data for large population-based studies.
- The Role of Pain and Disability Changes After Physiotherapy Treatment on Global Perception of Improvement in Patients with Chronic Low Back PainPublication . Fonseca Pires, DA; Brazete Cruz, EJ; Canhão, H; Delgado Nunes, CBackground: The effectiveness of physiotherapy in patients with chronic low back pain is usually measured through changes in pain and disability domains. However, recent research has suggested that these two domains are not sufficient to capture all the physiotherapy benefits when patients' perspective is considered. Objective: The aim of this study was to investigate the role of pain and disability changes in explaining the global perception of improvement in patients with chronic low back pain undergoing physiotherapy. Design: Prospective cohort study. Methods: The study was conducted on183 patients who were referred to physiotherapy treatment due to low back pain lasting more than 12 weeks. Sociodemographic and clinical characteristics were measured at baseline, together with pain intensity and disability. Eight (post-intervention) and twelve weeks later, global perception of improvement was measured together with pain and disability. The Pearson correlation coefficient and linear regression models were used for analyses. Results: Of the 183 participants included, 144 completed the 12-weeks follow-up. Significant and moderate correlation was found between pain and disability changes and the global perception of improvement after intervention and at the 12-weeks follow-up. Pain and disability changes explained 20.7%-36.3% of the variance in the global perception of improvement. Conclusions: Pain and disability changes are related and contributed to explaining a partial proportion of variance in the global perception of improvement. The findings suggest that these domains are not sufficient to explain and measure all of the benefits of physiotherapy when patients' global perception of improvement is considered.