[Digital health in Latin America: current legislation and ethical aspectsSaúde digital na América Latina: legislação atual e aspectos éticos]. / Salud digital en América Latina: legislación actual y aspectos éticos.

Objectives: Describe the current legislation on electronic medical records (EMR) and telehealth in Latin American countries and analyze the treatment of confidentiality and professional secrecy. Methods: Between March and September 2022, a survey of the regulations in force in 21 Latin American countries was conducted at two levels: the existence of legislation on EMR and telehealth, and the treatment of confidentiality and professional secrecy in EMR and telehealth. A data extraction form was prepared for each country. Data were collected from official on-line sources. The information was analyzed qualitatively and synthesized in tables when possible. Results: The use of EMR is legally regulated in 16 countries. Nineteen countries have legislation on telehealth. All the countries analyzed safeguard confidentiality and professional secrecy through regulations. However, confidentiality and professional secrecy are mentioned in 11 countries in the context of telehealth, and in only nine countries in the context of EMR. Conclusions: Since the start of this century, Latin America has made progress in the legislation of digital tools for health care, such as EMR and telehealth. There is also interest in ethical issues related to the use of EMR and telehealth, particularly confidentiality and professional secrecy, aspects that should be strengthened in digital health.

Objetivo: Descrever a legislação vigente sobre prontuários eletrônicos e telessaúde nos países da América Latina e analisar o tratamento da confidencialidade e do sigilo profissional. Métodos: Entre março e setembro de 2022, realizou-se um levantamento sobre a regulamentação vigente nos 21 países latino-americanos incluídos no estudo, em dois níveis: i) existência de legislação sobre prontuários eletrônicos e telessaúde; e ii) tratamento da confidencialidade e do sigilo profissional em prontuários eletrônicos e telessaúde. Uma planilha para extração de dados foi elaborada para cada país. Os dados foram coletados de fontes oficiais disponíveis on-line. Foi realizada uma análise qualitativa das informações, que foram resumidas em tabelas, quando possível. Resultados: O uso dos prontuários eletrônicos é legalmente regulamentado em 16 países. Quanto à telessaúde, 19 países têm legislação sobre essa ferramenta. Todos os países analisados protegem a confidencialidade e o sigilo profissional por meio de regulamentação. No entanto, no contexto da telessaúde, eles são mencionados em 11 países; já no contexto dos prontuários eletrônicos, em apenas 9 países. Conclusões: Desde o início dos anos 2000, a América Latina vem avançando em relação à legislação sobre ferramentas digitais na atenção à saúde, como prontuários eletrônicos e telessaúde. Há também interesse nas questões éticas relacionadas ao uso de prontuários eletrônicos e telessaúde, especialmente em relação à confidencialidade e ao sigilo profissional, embora esses aspectos precisem ser reforçados na saúde digital.

Increased eryptosis in patients with primary antiphospholipid syndrome (APS): a new actor in the pathogenesis of APS.

OBJECTIVES: Antiphospholipid syndrome (APS) is an autoimmune disease characterised by a hypercoagulable state and the presence of antiphospholipid antibodies (aPL). During the mechanism of red blood cells (RBCs) death, called eryptosis, RBCs can adhere to vascular wall participating in the development of a pro-thrombotic state. It is known that enhanced eryptosis contributes to several pathological conditions but the role of this process in APS has not been investigated yet. We analysed spontaneous eryptosis in a cohort of APS patients and aPL carriers (asymptomatic subjects with positive aPL tests). The effect on eryptosis of antibodies (Abs) purified from serum of APS patients and aPL carriers was also investigated. METHODS: In this study, 30 patients with primary APS (PAPS) and 17 aPL carriers were recruited. Twenty healthy donors (HD) and 13 patients affected by autoimmune haemolytic anaemia (AHIA) were also recruited. RBCs were incubated with PAPS and aPL carriers Abs, purified by ammonium sulfate precipitation. Levels of eryptosis were analysed by flow cytometry. RESULTS: In vitro Abs from APS patients induced eryptosis in RBCs isolated from HD after 4 h of culture. On the contrary, Abs from aPL carriers had no effect on the percentage of phosphatidylserine-exposing RBCs. Ex vivo, APS patients showed higher levels of spontaneous eryptosis compared to HD and aPL carriers. CONCLUSIONS: In this study, we demonstrated a potential new aspect of APS pathogenesis based on the ability of Abs isolated from APS patients, not identified in aPL carriers, to stimulate eryptosis suggesting a possible contribution of this process in the clinical manifestations of APS.

The influence of comorbidities on the efficacy of tumour necrosis factor inhibitors, and the effect of tumour necrosis factor inhibitors on comorbidities in rheumatoid arthritis: report from a National Consensus Conference.

Objective: To define the safety and efficacy of TNF inhibitors (TNFi) in RA patients with comorbidities. Methods: A National Consensus Conference adopted a five-step process to better address the place of TNFi in the treatment of RA. Here we report the work focused on the influence of comorbidities on TNFi efficacy and the effect of TNFi on comorbidities using a Population Intervention Comparison Outcome-based strategy from 8 April 2013 to 15 January 2016. Results: A total of 4453 hits were analysed, of which 10 were eligible for full review. Data show that the presence of comorbidities influences the treatment strategy and several clinical outcomes. The risk of solid cancer is similar in RA patients treated with TNFi or with conventional synthetic DMARDs, and the risk of recurrent breast cancer is not higher in RA patients treated with TNFi. The risk of developing serious infections is higher in RA patients receiving TNFi than conventional synthetic DMARDs. Patients with previous serious infections before starting TNFi are not at increased risk of subsequent serious infection. The hazard rate of hospitalization due to infections is not different among patients remaining on the same TNFi, or switching to a different TNFi or to an agent with another mechanism of action. Longer exposure to TNFi is associated with a reduction in the risk of cardiovascular events. Conclusion: Comorbidities affect RA treatment strategies and the efficacy of TNFi. TNFi treatment may decrease the risk of cardiovascular diseases and their use in patients with previous infection is not associated with a higher risk of recurrences.

Jaccoud's arthropathy in systemic lupus erythematosus: clinical, laboratory and ultrasonographic features.

OBJECTIVES: Jaccoud's arthropathy (JA) is a deforming, non-erosive arthritis, occurring in 2-35% of systemic lupus erythematosus (SLE) patients. We aimed to evaluate JA patients in a wide monocentric SLE cohort in terms of clinical, serological and ultrasonographic features. METHODS: Consecutive SLE patients (ACR criteria 1997) were evaluated. The JA index was applied for patients with reducible deformities. Patients with a JA index ≥5 underwent physical examination, blood testing and ultrasound (US) assessment. Detection of anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF) was performed. A single rheumatologist performed the US assessment of bilateral wrist and hands. RESULTS: Four hundred and eighty SLE patients were evaluated: 17 (3.5%) showed a JA index ≥5 (M:F 1:16; mean age±SD 50.7±11.1 years; mean disease duration±SD 247.8±116.2 months). Four patients (23.5%) showed ACPA positivity. Fifteen patients (88.2%) showed at least one US abnormality. Bone erosions were found in 10 patients (58.8%). ACPA+ve patients showed erosive damage more frequently in at least one joint compared with ACPA-ve (75% vs. 53.8%, p=0.002). CONCLUSIONS: JA should no longer be considered a non-erosive condition since bone damage can occur in more than half of patients. Moreover, the erosive damage seems to be associated with the presence of ACPA.

Systemic Lupus Erythematosus with and without Anti-dsDNA Antibodies: Analysis from a Large Monocentric Cohort.

OBJECTIVES: The anti-dsDNA antibodies are a marker for Systemic Lupus Erythematosus (SLE) and 70-98% of patients test positive. We evaluated the demographic, clinical, laboratory, and therapeutical features of a monocentric SLE cohort according to the anti-dsDNA status. METHODS: We identified three groups: anti-dsDNA + (persistent positivity); anti-dsDNA ± (initial positivity and subsequent negativity during disease course); anti-dsDNA - (persistent negativity). Disease activity was assessed by the European Consensus Lupus Activity Measurement (ECLAM). RESULTS: We evaluated 393 patients (anti-dsDNA +: 62.3%; anti-dsDNA ±: 13.3%; anti-dsDNA -: 24.4%). The renal involvement was significantly more frequent in anti-dsDNA + (30.2%), compared with anti-dsDNA ± and anti-dsDNA - (21.1% and 18.7%, resp.; P = 0.001). Serositis resulted significantly more frequent in anti-dsDNA - (82.3%) compared to anti-dsDNA + and anti-dsDNA ± (20.8% and 13.4%, resp.; P < 0.0001). The reduction of C4 serum levels was identified significantly more frequently in anti-dsDNA + and anti-dsDNA ± (40.0% and 44.2%, resp.) compared with anti-dsDNA - (21.8%, P = 0.005). We did not identify significant differences in the mean ECLAM values before and after modification of anti-dsDNA status (P = 0.7). CONCLUSION: Anti-dsDNA status influences the clinical and immunological features of SLE patients. Nonetheless, it does not appear to affect disease activity.

Ultrasound evaluation of hand, wrist and foot joint synovitis in systemic lupus erythematosus.

OBJECTIVES: To assess the prevalence and severity of inflammatory abnormalities of the hand, wrist and foot joints in SLE patients by US and to correlate them with clinical, laboratory and disease activity score parameters. METHODS: Sixty-two consecutive SLE patients were enrolled in the present study and underwent clinical evaluation, laboratory tests and bilateral high-resolution US of the hand, wrist and foot joints. Joint effusion (JE), synovial hypertrophy (SH) and local pathological vascularization [power Doppler (PD)] were evaluated according to both a dichotomous score and a semi-quantitative (0-3) grading system. In addition, a global US score was calculated by summing the values given to each elementary lesion for every single joint and every joint group. US findings were correlated with physical examination, serological parameters (CRP, ANA, anti-dsDNA, ENA, aPL, C3 and C4 serum levels) and disease activity indexes (SLEDAI-2K, ECLAM). RESULTS: US detected inflammatory joint abnormalities in 54/62 patients (87.1%); 72.6% presented involvement of the MTP joints, 46.7% the MCP joints, 19.3% the PIP joints and 53% the wrists. A total of 1984 joints were examined highlighting JE in 19.1% of cases, SH in 6.9% and positive PD in 1.1%. The global US inflammatory score had a mean value of 10.9 (s.d. 15.2). No correlations were found between US findings and SLE disease activity parameters. CONCLUSION: US demonstrated a high prevalence of inflammatory joint abnormalities in SLE that were also present in asymptomatic patients. Interestingly, the foot joints were the most frequently involved. US is a valuable tool for detecting subclinical synovitis in SLE.

The Italian MSUS Study Group recommendations for the format and content of the report and documentation in musculoskeletal ultrasonography in rheumatology.

OBJECTIVE: The objective of this study was to draw up a set of recommendations for the format and content of the musculoskeletal ultrasonography (MSUS) report in rheumatology. METHODS: A panel of rheumatologists, members of the MSUS Study Group of the Italian Society of Rheumatology, met in order to identify the main discrepancies in the MSUS report. A set of 15 recommendations was then defined, aimed at resolving the main discrepancies. They consisted of information about the motivations for the MSUS examination, the equipment, the US modalities and scanning technique, a list of the examined structures and findings, the scoring/grading systems, the number of images and main findings to include and conclusions. Subsequently a Delphi-based procedure was started in order to obtain agreement on a core set of recommendations. Consensus for each recommendation was considered achieved when the percentage of agreement was >75%. RESULTS: Three complete rounds were performed. The response rate was 85.2% for the first round, 78.3% for the second and 88.9% for the third. Finally, consensus was obtained for 14 of 15 statements. These 14 statements represent the recommendations of the group for the format and content of the report and documentation in MSUS in rheumatology. CONCLUSION: To the best of our knowledge, our group has produced the first recommendations for the format and content of the report and documentation in MSUS in rheumatology. The report is an integral part of the MSUS examination and its use in a homogeneous form can help in the correct interpretation of the findings.

The role of disease activity score 28 in the evaluation of articular involvement in systemic lupus erythematosus.

OBJECTIVES: To evaluate the application of Disease Activity Score 28 (DAS28) to assess joint involvement in Systemic Lupus Erythematosus (SLE). METHODS: Sixty-nine SLE patients, complaining of joint symptoms, and 44 rheumatoid arthritis (RA) patients were enrolled. In SLE patients disease activity was assessed with SLEDAI-2K. DAS28 was calculated in all the patients. RESULTS: Thirty SLE patients (43.5%) showed clinical signs of arthritis. Mean DAS28 was 4.0±1.4, 22 patients (31.9%) had low disease activity, 29 (42.0%) moderate, and 18 (26.1%) high. We dichotomized SLE patients according to the presence (Group 1) or absence (Group 2) of articular involvement according to SLEDAI-2K: 56.3% of the patients of the second group had a moderate/high activity according to DAS28. We compared SLE patients with 44 RA patients (M/F 9/35, mean age 55.6±14.5 years; mean disease duration 140.4±105.6 months). No significant differences were found regarding the values of DAS28 between SLE and RA patients. On the contrary, the values of tender and swollen joint count were significantly higher in RA compared to SLE patients (P=0.0002 and P=0.0001, resp.). CONCLUSIONS: We suggest the use of the DAS28 in the assessment of joint involvement in SLE patients.

Inflammatory rheumatic diseases with onset after SARS-CoV-2 infection or COVID-19 vaccination: a report of 267 cases from the COVID-19 and ASD group.

OBJECTIVES: To better define the spectrum of new-onset post-COVID-19 and post-COVID-19 vaccine inflammatory rheumatic diseases (IRD) from a large multicentric observational study. METHODS: Consecutive cases of IRD encountered during a 12-month period and satisfying one of the following inclusion criteria: (a) onset of the rheumatic manifestations within 4 weeks from SARS-CoV-2 infection or (b) onset of the rheumatic manifestations within 4 weeks from the administration of one of the COVID-19 vaccines ws recruited. RESULTS: The final analysis cohort comprised 267 patients, of which 122 (45.2%) in the post-COVID-19 and 145 (54.8%) in the postvaccine cohort. Distribution of IRD categories differed between the two cohorts: the post-COVID-19 cohort had a higher percentage of patients classified as having inflammatory joint diseases (IJD, 52.5% vs 37.2%, p=0.013) while the post-vaccine cohort had a higher prevalence of patients classified as polymyalgia rheumatica (PMR, 33.1% vs 21.3%, p=0.032). No differences were detected in the percentage of patients diagnosed with connective tissue diseases (CTD 19.7% vs 20.7%, p=0.837) or vasculitis (6.6% vs 9.0%, p=0.467). Despite the short follow-up period, IJD and PMR patients' response to first-line therapy was favourable, with both groups achieving a drop in baseline disease activity scores of ~30% and ~70% respectively. CONCLUSION: Our article reports the largest cohort published to date of new-onset IRD following SARS-CoV-2 infection or COVID-19 vaccines. Although causality cannot be ascertained, the spectrum of possible clinical manifestations is broad and includes IJD, PMR, CTD and vasculitis.

Rituximab infusion-related adverse event rates are lower in patients with systemic lupus erythematosus than in those with rheumatoid arthritis.

OBJECTIVES: Rituximab (RTX) is a therapeutic option for patients with SLE or RA. We conducted a prospective, longitudinal, observational study to compare rates of RTX-related adverse events (AEs) in these two patient groups. METHODS: RTX was used in 23 patients with SLE that was refractory to conventional therapy and in 31 patients with RA that had been unsuccessfully treated with TNF-α inhibitors. Infusion-related and infectious AE rates were calculated for each group. RESULTS: Seven (22.5%) RA patients experienced an infusion-related reaction. These AEs involved 7/91 (7.7%) infusions administered in the RA group. None of the 102 infusions administered to SLE patients was associated with infusion-related AEs (P = 0.038 vs RA group). The mean daily glucocorticoid dose administered during the week preceding RTX treatment in the SLE group was higher than that for the RA group [0.25 (0.2) vs 0.18 (0.14) mg/kg, P = not significant] and significantly higher than that received by the subgroup of the seven RA patients who experienced infusion-related AEs [0.10 (0.02) mg/kg; P = 0.0017]. Infectious AE rates were also lower (but not significantly so) in the SLE group (8.7 vs 12.9% in RA). CONCLUSIONS: Repeated cycles of RTX in combination with different immunosuppressants is a safe therapeutic option for SLE and RA patients. The lower incidence of infusion-related AEs in the SLE patients might reflect the higher dosage glucocorticoid therapy they received during the week before RTX infusion.

Pragmatic language dysfunction in systemic lupus erythematosus patients: Results from a single center Italian study.

BACKGROUND: Cognitive impairment (CI) in systemic lupus erythematosus (SLE) is a frequent neuropsychiatric manifestation affecting several domains, even in apparently asymptomatic patients. Current research revealed that the typical CI pattern affects frontal-subcortical circuit and thus executive functions. The impairment of non-literal language or pragmatic language (PL), including metaphors, idioms, inferences or irony has been well described in several conditions such as autism disorders, Parkinson's disease, brain injury and even in earlier phases of neurodegenerative processes. Even if PL neuro-anatomy remains controversial, correlation between executive dysfunctions and non-literal language involvement has been reported both in traumatic injury and mild cognitive impairment patients. Nonetheless, no specific study has been performed to evaluate PL impairment in SLE patients so far. OBJECTIVES: We aimed at assessing the PL domain in a Italian monocentric SLE cohort in comparison to healthy controls, matched to age and education, through a specific battery, the batteria sul linguaggio dell'emisfero destro (BLED). Secondly, we focused attention on possible correlations between CI and clinical and laboratory SLE-related features. METHODS: Forty adult patients affected by SLE, according to the American College of Rheumatology (ACR) criteria, and thirty healthy subjects were enrolled consecutively in this cross-sectional study. The protocol included complete physical examination, extensive clinical and laboratory data collection (comprehensive of demographics, past medical history, co-morbidities, disease activity, chronic damage evaluation, previous and concomitant treatments) and cognitive assessment for five different domains: memory, attention, pragmatic language, executive and visuospatial functions. Self-reported scale for anxiety and depression were performed to exclude the influence of mood disorders on cognitive dysfunction. RESULTS: We studied 40 Caucasian SLE patients [male (M)/ female (F) 3/37; mean±standard deviation (SD) age 45.9±10.1 years, mean±SD disease duration 120.8±81.2 months] and 30 healthy subjects (M/F 9/21; mean±SD age 41.3±13 years). According to the low level of disease activity and damage (mean±SD Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) of 1.3±2.3, mean±SD Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) of 0.2±0.5), only 30% of patients was on glucocorticoid treatment at the study entry. PL was the most compromised domain in terms of Mean Domain Z scores. As for the Domain Cognitive Dysfunction score, a deficit of PL was observed in 45% of patients and was significantly more prevalent than memory, executive and visuospatial functions impairment (P = 0.0002, P = 0.0002 and P<0.000001, respectively). According to Global Cognitive Dysfunction score, 25% of patients experienced a mild impairment and 7.5% a moderate one. Anti-phospholipid antibodies positivity was significantly associated with memory impairment (P<0.0005), whereas the presence of other neuropsychiatric events was associated with executive dysfunctions (P<0.05); no further significant association nor correlation were identified. CONCLUSION: In this study we evaluated for the first time PL in SLE patients finding a dysfunction in almost half of patients. The dysfunction of PL was significantly more frequent than the other domains assessed.

B lymphocyte stimulator modulates number and function of endothelial progenitor cells in systemic lupus erythematosus.

BACKGROUND: Circulating endothelial progenitor cells (EPCs) are biologic markers of endothelial function. In patients with systemic lupus erythematosus (SLE), the numerical reduction and functional impairment of EPCs contribute to the endothelial dysfunction. Through ex vivo and in vitro studies, we aimed at evaluating the effects of B lymphocyte stimulator (BLyS) on EPC colonies and endothelial cells and also investigating BLyS receptor expression on these cells. METHODS: EPCs were isolated from peripheral blood mononuclear cells (PBMC). In order to evaluate their ability to form colonies, EPCs were cultured on fibronectin-coated dishes and incubated with BlyS alone or BlyS and belimumab. Apoptosis of EPCs and endothelial cell line EA.hy926 was evaluated after 6, 12, and 24 h of incubation with BLyS and after 6 h with BLyS and belimumab. The expression of B cell activating factor-receptor (BAFF-R), B cell maturation antigen (BCMA), and transmembrane activator and calcium modulator and cyclophilin ligand (CAML) interactor (TACI) on EPCs and EA.hy926 was analyzed by cytofluorimetry. RESULTS: The number of EPC colonies was lower in patients than in controls. Moreover, the colonies from SLE patients were poorly organized compared to controls; the addition of belimumab restored the colony structure. Incubation with BLyS induced apoptosis of EPCs and EA.hy926 that was inhibited by the co-incubation with belimumab. BAFF-R and BCMA were expressed on both EPCs and EA.hy926, while TACI was expressed only on EPCs. CONCLUSIONS: EPCs and endothelial cells preferentially express BAFF-R which could be involved in the pro-apoptotic effect of BlyS. Belimumab administration seems to restore the quantitative and qualitative changes of EPC colonies both ex vivo and in vitro.

Correction: Biomarkers of erosive arthritis in systemic lupus erythematosus: Application of machine learning models.

[This corrects the article DOI: 10.1371/journal.pone.0207926.].

Salud digital en América Latina: legislación actual y aspectos éticos / Digital health in Latin America: current legislation and ethical aspects / Saúde digital na América Latina: legislação atual e aspectos éticos

RESUMEN Objetivo. Describir la legislación vigente respecto a historia clínica electrónica (HCE) y telesalud de los países latinoamericanos y analizar el tratamiento de la confidencialidad y el secreto profesional. Métodos. Entre marzo y septiembre de 2022, se realizó un relevamiento de la reglamentación vigente en los 21 países latinoamericanos en estudio, en dos niveles: i) la existencia de legislación respecto a la HCE y la telesalud, y ii) el tratamiento de la confidencialidad y el secreto profesional en la HCE y la telesalud. Se confeccionó una ficha de extracción de datos por país. Se recolectaron datos a partir de fuentes on-line oficiales. Se analizó cualitativamente la información y se sintetizó en forma de tablas cuando fue posible. Resultados. El uso de la HCE está reglamentado legalmente en 16 países. Para el caso de telesalud, son 19 países los que cuentan con legislación en referencia a esta herramienta. Todos los países analizados resguardan la confidencialidad y el secreto profesional a través de reglamentaciones. Sin embargo, en el contexto de telesalud se mencionan en 11 países, en tanto en el contexto de la HCE, solo en 9 países. Conclusiones. Desde el inicio del segundo milenio América Latina ha avanzado respecto a la legislación de herramientas digitales en la atención en salud como la HCE y la telesalud. Se observa a su vez un interés por las cuestiones éticas relacionadas con el uso de la HCE y la telesalud, en particular de la confidencialidad y secreto profesional, aunque dichos aspectos deben ser fortalecidos en la salud digital.

ABSTRACT Objectives. Describe the current legislation on electronic medical records (EMR) and telehealth in Latin American countries and analyze the treatment of confidentiality and professional secrecy. Methods. Between March and September 2022, a survey of the regulations in force in 21 Latin American countries was conducted at two levels: the existence of legislation on EMR and telehealth, and the treatment of confidentiality and professional secrecy in EMR and telehealth. A data extraction form was prepared for each country. Data were collected from official on-line sources. The information was analyzed qualitatively and synthesized in tables when possible. Results. The use of EMR is legally regulated in 16 countries. Nineteen countries have legislation on telehealth. All the countries analyzed safeguard confidentiality and professional secrecy through regulations. However, confidentiality and professional secrecy are mentioned in 11 countries in the context of telehealth, and in only nine countries in the context of EMR. Conclusions. Since the start of this century, Latin America has made progress in the legislation of digital tools for health care, such as EMR and telehealth. There is also interest in ethical issues related to the use of EMR and telehealth, particularly confidentiality and professional secrecy, aspects that should be strengthened in digital health.

RESUMO Objetivo. Descrever a legislação vigente sobre prontuários eletrônicos e telessaúde nos países da América Latina e analisar o tratamento da confidencialidade e do sigilo profissional. Métodos. Entre março e setembro de 2022, realizou-se um levantamento sobre a regulamentação vigente nos 21 países latino-americanos incluídos no estudo, em dois níveis: i) existência de legislação sobre prontuários eletrônicos e telessaúde; e ii) tratamento da confidencialidade e do sigilo profissional em prontuários eletrônicos e telessaúde. Uma planilha para extração de dados foi elaborada para cada país. Os dados foram coletados de fontes oficiais disponíveis on-line. Foi realizada uma análise qualitativa das informações, que foram resumidas em tabelas, quando possível. Resultados. O uso dos prontuários eletrônicos é legalmente regulamentado em 16 países. Quanto à telessaúde, 19 países têm legislação sobre essa ferramenta. Todos os países analisados protegem a confidencialidade e o sigilo profissional por meio de regulamentação. No entanto, no contexto da telessaúde, eles são mencionados em 11 países; já no contexto dos prontuários eletrônicos, em apenas 9 países. Conclusões. Desde o início dos anos 2000, a América Latina vem avançando em relação à legislação sobre ferramentas digitais na atenção à saúde, como prontuários eletrônicos e telessaúde. Há também interesse nas questões éticas relacionadas ao uso de prontuários eletrônicos e telessaúde, especialmente em relação à confidencialidade e ao sigilo profissional, embora esses aspectos precisem ser reforçados na saúde digital.

Biomarkers of erosive arthritis in systemic lupus erythematosus: Application of machine learning models.

OBJECTIVE: Limited evidences are available on biomarkers to recognize Systemic Lupus erythematosus (SLE) patients at risk to develop erosive arthritis. Anti-citrullinated peptide antibodies (ACPA) have been widely investigated and identified in up to 50% of X-ray detected erosive arthritis; conversely, few studies evaluated anti-carbamylated proteins antibodies (anti-CarP). Here, we considered the application of machine learning models to identify relevant factors in the development of ultrasonography (US)-detected erosive damage in a large cohort of SLE patients with joint involvement. METHODS: We enrolled consecutive SLE patients with arthritis/arthralgia. All patients underwent joint (DAS28, STR) and laboratory assessment (detection of ACPA, anti-CarP, Rheumatoid Factor, SLE-related antibodies). The bone surfaces of metacarpophalangeal and proximal interphalangeal joints were assessed by US: the presence of erosions was registered with a dichotomous value (0/1), obtaining a total score (0-20). Concerning machine learning techniques, we applied and compared Logistic Regression and Decision Trees in conjunction with the feature selection Forward Wrapper method. RESULTS: We enrolled 120 SLE patients [M/F 8/112, median age 47.0 years (IQR 15.0); median disease duration 120.0 months (IQR 156.0)], 73.3% of them referring at least one episode of arthritis. Erosive damage was identified in 25.8% of patients (mean±SD 0.7±1.6), all of them with clinically evident arthritis. We applied Logistic Regression in conjunction with the Forward Wrapper method, obtaining an AUC value of 0.806±0.02. As a result of the learning procedure, we evaluated the relevance of the different factors: this value was higher than 35% for ACPA and anti-CarP. CONCLUSION: The application of Machine Learning Models allowed to identify factors associated with US-detected erosive bone damage in a large SLE cohort and their relevance in determining this phenotype. Although the scope of this study is limited by the small sample size and its cross-sectional nature, the results suggest the relevance of ACPA and anti-CarP antibodies in the development of erosive damage as also pointed out in other studies.

Anti-carbamylated protein antibodies as a new biomarker of erosive joint damage in systemic lupus erythematosus.

BACKGROUND: The application of more sensitive imaging techniques, such as ultrasonography (US), changed the concept of non-erosive arthritis in systemic lupus erythematosus (SLE), underlining the need for biomarkers to identify patients developing the erosive phenotype. Anti-citrullinated peptide antibodies (ACPA), associated with erosions in inflammatory arthritis, have been identified in about 50% of patients with SLE with erosive arthritis. More recently, anti-carbamylated proteins antibodies (anti-CarP) have been associated with erosive damage in rheumatoid arthritis. We aimed to assess the association between anti-CarP and erosive damage in a large SLE cohort with joint involvement. METHODS: We evaluated 152 patients (male/female patients 11/141; median age 46 years, IQR 16; median disease duration 108 months, IQR 168). All patients underwent blood draw to detect rheumatoid factor (RF) and ACPA (commercial enzyme-linked immunosorbent assay (ELISA) kit), and anti-CarP ("home-made" ELISA, cutoff 340 aU/mL). The bone surfaces of the metacarpophalangeal and proximal interphalangeal joints were assessed by US: the presence of erosions was registered as a dichotomous value (0/1), obtaining a total score (0-20). RESULTS: The prevalence of anti-CarP was 28.3%, similar to RF (27.6%) and significantly higher than ACPA (11.2%, p = 0.003). Erosive arthritis was identified in 25.6% of patients: this phenotype was significantly associated with anti-CarP (p = 0.004). Significant correlation between anti-CarP titer and US erosive score was observed (r = 0.2, p = 0.01). CONCLUSIONS: Significant association was identified between anti-CarP and erosive damage in SLE-related arthritis, in terms of frequency and severity, suggesting that these antibodies can represent a biomarker of severity in patients with SLE with joint involvement.

Cognitive dysfunction improves in systemic lupus erythematosus: Results of a 10 years prospective study.

OBJECTIVE: Cognitive impairment (CI) has been described in 3-80% of Systemic lupus erythematosus (SLE) patients but only short-term studies evaluated its over-time changes, suggesting that CI is usually a stable finding. We aimed at evaluating the changes of SLE-related CI in a 10-years prospective single center cohort study. METHODS: We evaluated 43 patients (M/F 5/38; mean age = 45.7±10.1 years; mean disease duration = 230.8±74.3 months) at baseline (T0) and after 10 years (T1). A test battery designed to detect fronto-subcortical dysfunction across five domains (memory, attention, abstract reasoning, executive and visuospatial function) was administered. A global cognitive dysfunction score (GCD) was obtained and associated with clinical and laboratory features. RESULTS: Prevalence of CI was 20.9% at T0 and 13.9% at T1 (P = NS). This impairment was prevalently mild at T0 (55.5%) and mild or moderate at T1 (36.3% for both degrees). After 10 years, CI improved in 50% of patients, while 10% worsened. Impaired memory (P = 0.02), executive functions (P = 0.02) and abstract reasoning (P = 0.03) were associated with dyslipidemia at T0. Worsening of visuospatial functions was significantly associated with dyslipidemia and Lupus Anticoagulant (P = 0.04 for both parameters). Finally, GCD significantly correlated with chronic damage measured by SLICC/damage index at T0 (r = 0.3; P = 0.04) and T1 (r = 0.3; P = 0.03). CONCLUSIONS: For the first time, we assessed CI changes over 10-years in SLE. CI improved in the majority of the patients. Furthermore, we observed an improvement of the overall cognitive functions. These results could suggest that an appropriate management of the disease during the follow-up could be able to control SLE-related CI.

Systemic lupus erythematosus: state of the art on clinical practice guidelines.

Systemic lupus erythematosus (SLE) is the paradigm of systemic autoimmune diseases characterised by a wide spectrum of clinical manifestations with an unpredictable relapsing-remitting course. The aim of the present work was to identify current available clinical practice guidelines (CPGs) for SLE, to provide their review and to identify physicians' and patients' unmet needs. Twenty-three original guidelines published between 2004 and 2017 were identified. Many aspects of disease management are covered, including global disease management, lupus nephritis and neuropsychiatric involvement, management of pregnancies, vaccinations and comorbidities monitoring. Unmet needs relate with disease management of some clinical manifestations and adherence to treatment. Many patient's unmet needs have been identified starting with faster diagnosis, need for more therapeutic options, guidelines on lifestyle issues, attention to quality of life and adequate education.

Primary thromboprophylaxis with low-dose aspirin and antiphospholipid antibodies: Pro's and Con's.

Whether primary prophylaxis should be prescribed in individuals with antiphospholipid antibodies (aPL) remains controversial due to the lack of relevant evidence-based data. Indeed, it is unclear whether the benefit of LDA outweighs the risk of major bleeding associated with LDA in a low-risk population. On the contrary, stratification of aPL-positive subjects according to their aPL profile (combination, isotype and titer), presence of other concomitant risk factors for thrombosis and coexistence of an underling autoimmune disease is essential to decide whether primary prophylactic therapy should be prescribed. Additionally, the management of modifiable thrombotic risk factors is a necessary strategy, and the use of transient prophylaxis is crucial during high-risk periods. Specifically designed prospective trials are urgently needed to determine the real prophylactic impact of aspirin, as well as of alternative or concomitant therapeutic strategies such as hydroxychloroquine, statins or DOACS in aPL positive patients.

The role of dietary sodium intake on the modulation of T helper 17 cells and regulatory T cells in patients with rheumatoid arthritis and systemic lupus erythematosus.

We aimed at investigating whether the frequency and function of T helper 17 (Th17) and regulatory T cells (Treg) are affected by a restriction of dietary sodium intake in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). We enrolled RA and SLE patients not receiving drugs known to increase urinary sodium excretion. Patients underwent a dietary regimen starting with a restricted daily sodium intake followed by a normal-sodium daily intake. The timepoints were identified at baseline (T0), after 3 weeks of low-sodium dietary regimen (T3), after 2 weeks of normal-sodium dietary regimen (T5). On these visits, we measured the 24-hour urinary sodium excretion, the frequency and function of Th17 and Treg cells in the peripheral blood, the serum levels of cytokines. Analysis of urinary sodium excretion confirmed adherence to the dietary regimen. In RA patients, a trend toward a reduction in the frequencies of Th17 cells over the low-sodium dietary regimen followed by an increase at T5 was observed, while Treg cells exhibited the opposite trend. SLE patients showed a progressive reduction in the percentage of Th17 cells that reached a significance at T5 compared to T0 (p = 0.01) and an increase in the percentage of Treg cells following the low-sodium dietary regimen at both T1 and T3 compared to T0 (p = 0.04 and p = 0.02, respectively). No significant apoptosis or proliferation modulation was found. In RA patients, we found a reduction at T5 compared to T0 in serum levels of both TGFß (p = 0.0016) and IL-9 (p = 0.0007); serum IL-9 levels were also reduced in SLE patients at T5 with respect to T0 (p = 0.03). This is the first study investigating the effects of dietary sodium intake on adaptive immunity. Based on the results, we hypothesize that a restricted sodium dietary intake may dampen the inflammatory response in RA and SLE patients.