Reflecting on a decade of the international consensus on ANA patterns (ICAP): Accomplishments and challenges from the perspective of the 7th ICAP workshop.

The International Consensus on ANA Patterns (ICAP) is an ongoing international initiative dedicated to harmonizing technical and interpretation aspects of the HEp-2 IFA test. Comprised of internationally recognized experts in autoimmunity and HEp-2 IFA testing, ICAP has operated for the last 10 years by promoting accurate reading, interpretation, and reporting of HEp-2 IFA images by professionals involved in various areas related to autoimmune diseases, such as clinical diagnostic laboratories, academic research, IVD industry, and patient care. ICAP operates through continuous information exchange with the international community and encourages the participation of younger experts from all over the world. The 7th ICAP workshop has addressed several aspects that originated from this interaction with the international community and has effectively established objective goals and tasks to be delivered over the next two years. Some of these are outlined in this article, including the planning of three audio-visual educational modules to be posted at the www.anapattern.org website, the classification of two novel HEp-2 IFA patterns, the implementation of a project dedicated to continuously updating the information on the clinical and immunologic relevance of the HEp-2 IFA patterns, and the launch of two additional branches of the HEp-2 Clinical and Immunological (HEp-2 CIC) project.

Assessment of combined α-GAL enzyme activity and lyso-GL3 for Fabry disease screening in women with chronic kidney disease.

INTRODUCTION: The spectrum of clinical presentation of Fabry disease (FD) in women is broad and challenging. The aim is to evaluate the effectiveness of an alternative screening method for FD in women. METHODS: A collaborative multicenter cross-sectional study to evaluate the sensitivity and specificity of the combination of two tests (α-GAL enzyme activity assay and lyso-GL3 assay) for the diagnosis of FD in women. We included women with chronic kidney disease (CKD) stages 3 to 5, receiving conservative treatment or on dialysis programs, from different nephrology services in Brazil. RESULTS: We evaluated 1874 patients that underwent blood collection for α-GAL and lyso-GL3 assays. Isolated decreased α-GAL enzyme activity was found in 64 patients (3.5%), while isolated increased lyso-GL3 levels were found in 67 patients (3.6%), with one patient presenting alterations in both tests. All cases with low α-GAL enzyme activity and/or increased lyso-GL3 levels underwent genetic analysis for FD variants (132 performed GLA genetic test). Low α-GAL enzyme activity had higher sensitivity and specificity to detect FD compared to the other measures (elevated lyso-GL3 alone or both altered). The negative predictive value (NPV) of α-GAL activity was 99%, and the positive predictive value (PPV) was 9.2%. For lyso-GL3 assay, the specificity was 99.7% and the PPV was 2.9%, therefore considered inferior to α-GAL assay. Both assays altered, had higher PPV (100%) and higher NPV (99.7%) considered the best method. We found 7 cases of GLA gene variants found, resulting in an initial prevalence of 0.37% for FD in this sample female population. CONCLUSION: This study contributes to the diagnostic value of the biomarkers α-GAL and lyso-GL3 in the context of FD in women with CKD. The combination of these biomarkers was an effective approach for the diagnosis of the disease, with high PPV and NPV.

Kidney Replacement Therapy in Brazil: A Retrospective Cohort Study Based on Analysis of the Brazilian Public Health System.

BACKGROUND: Brazil has the largest Public Health System providing universal coverage for chronic dialysis. The objective was to describe the number, sociodemographic, and clinical characteristics of patients undergoing kidney replacement therapy (KRT) by dialysis within the Public Health System in Brazil. METHODS: We carried out a retrospective cohort study analyzing the database from the Brazilian Public Health System, focusing on procedures related to KRT. The study encompassed both prevalent and incident patients who underwent KRT in Brazil between 2015 and 2023. RESULTS: We observed an increase in the number and prevalence rate of dialysis patients from 2015 to 2023. We also noticed an increase in the age at dialysis initiation and in the prevalence of mixed-race patients and a reduction in the proportion of those undergoing peritoneal dialysis and with arteriovenous fistula. We identified an upward trajectory in the values of single-pool Kt/V over the years, contrasting with a decline in hemoglobin levels. The overall estimated prevalence rate of dialysis patients increased from 654 per million population (pmp) to 792 pmp over the years. The survival rates of incident KRT patients at 12 and 96 months were 81% and 60%, respectively. CONCLUSION: We reported an increase in the age at which dialysis began and a decline in the adoption of peritoneal dialysis over the years. While there have been some improvements over the years resulting in better adequacy of hemodialysis as measured by Kt/V, controlling certain parameters such as hemoglobin levels has remained challenging.

Use of Machine Perfusion to Increase the Number of Expanded Criteria Deceased Donor Kidney Transplants: A Pharmacoeconomic Analysis.

Background: The discard of expanded criteria donor (ECD) kidneys is unacceptably high, considering the growing demand for transplantation. Using machine perfusion may reduce the discard rate, increase the number of transplants, and reduce mortality on the waiting list. Methods: We developed a 5-y Markov model to simulate incorporating the pulsatile perfusion machine into the current government-funded healthcare system. The model compared the universal use of static cold storage for all kidneys with the selective use of machine perfusion for ECD kidneys. Real-life data were used to compose the cohort characteristics in this model. This pharmacoeconomic analysis aimed to determine the cost-effectiveness and budgetary impact of using machine perfusion to preserve ECD kidneys. Results: Compared with the universal use of static cold storage, the use of machine perfusion for ECD kidneys was associated with an increase in the number of kidney transplants (n = 1123), a decrease in the number of patients on the waiting list (n = 815), and decrease in mortality (n = 120), with a cost difference of US dollar 4 486 009 in the period. The budget impact analysis revealed an additional cost of US dollar 4 453 749 >5 y. The budget impact analysis demonstrated a progressive reduction in costs, becoming cost-saving during the last year of the analysis. Conclusions: This stochastic model showed that incorporating machine perfusion for ECD kidneys is most often a dominant or cost-effective technology associated with an increase in the number of transplants and a reduction in the number of patients on the waiting list, reducing mortality on the waiting list.

Evaluation of an RBD-nucleocapsid fusion protein as a booster candidate for COVID-19 vaccine.

Despite successful vaccines and updates, constant mutations of SARS-CoV-2 makes necessary the search for new vaccines. We generated a chimeric protein that comprises the receptor-binding domain from spike and the nucleocapsid antigens (SpiN) from SARS-CoV-2. Once SpiN elicits a protective immune response in rodents, here we show that convalescent and previously vaccinated individuals respond to SpiN. CD4+ and CD8+ T cells from these individuals produced greater amounts of IFN-γ when stimulated with SpiN, compared to SARS-CoV-2 antigens. Also, B cells from these individuals were able to secrete antibodies that recognize SpiN. When administered as a boost dose in mice previously immunized with CoronaVac, ChAdOx1-S or BNT162b2, SpiN was able to induce a greater or equivalent immune response to homologous prime/boost. Our data reveal the ability of SpiN to induce cellular and humoral responses in vaccinated human donors, rendering it a promising candidate.

Radiological presentation of active pulmonary tuberculosis in kidney transplant recipients: a retrospective study of four cases and a review of the literature.

Although kidney transplantation is the best therapeutic option for patients with chronic kidney disease, the immunosuppression required greatly increases susceptibility to infections that are responsible for high post-transplant mortality. Pulmonary tuberculosis (TB) represents a major cause of such infections, and its early diagnosis is therefore quite important. In view of that, we researched the manifestations of active pulmonary TB in kidney transplant recipients, through chest X-ray and computed tomography (CT), as well as determining the number of cases of active pulmonary TB occurring over a 3.5-year period at our institution. We identified four cases of active pulmonary TB in kidney transplant recipients. The CT scans provided information complementary to the chest X-ray findings in all four of those cases. We compared our CT findings with those reported in the literature. We analyzed our experience in conjunction with an extensive review of the literature that was nevertheless limited because few studies have been carried out in lowand middle-income countries, where the incidence of TB is higher.

Apesar de o transplante renal ser a melhor opção terapêutica para pacientes com doença renal crônica, a imunodepressão decorrente desse tratamento eleva muito a suscetibilidade desses pacientes a infecções, responsáveis por altas taxas de mortalidade pós-operatórias. A tuberculose (TB) pulmonar é uma significativa causa dessas infecções, sendo muito importante o seu diagnóstico precoce. Assim, nós pesquisamos as manifestações da TB pulmonar ativa nessa população de transplantados renais por meio de radiografias simples e tomografia computadorizada (TC) do tórax, também para estabelecer o número de casos de TB pulmonar ativa em nossa instituição após levantamento de 3,5 anos. Encontramos quatro casos de TB pulmonar ativa em pacientes transplantados renais. A TC forneceu informações adicionais em relação às radiografias de tórax em 100% dos casos analisados. Comparamos os nossos achados de TC com os relatados na literatura. Somamos a experiência obtida com extensa revisão da literatura, ainda limitada nessa questão, com poucos estudos realizados em países em desenvolvimento onde a incidência de TB é maior.

Clinical, epidemiological characteristics and mortality of pregnant and postpartum women associated with COVID-19 in Brazil: cohort study.

Objective: To analyze the death of Brazilian pregnant and postpartum women due to COVID-19 or unspecific cause. Methods: This is retrospective, descriptive-exploratory, population-based study carried out with the Sistema de Informação de Vigilância Epidemiológica da Gripe (SIVEP-Gripe) database, with pregnant and postpartum women of reproductive age who died from confirmed COVID-19 between 2020 and 2021. The chosen variables were: age, gestational period, type and number of comorbidities, skin color, using the statistical software R Foundation for Statistical Computing Platform, version 4.0.3 and Statistical Package for Social Science, version 29.0 for analysis. Results: A total of 19,333 cases of pregnant and postpartum women aged between 10 and 55 years diagnosed with SARS were identified, whether due to confirmed COVID-19 or unspecific causes. Of these, 1,279 died, these cases were classified into two groups according to the cause of death: deaths from COVID-19 (n= 1,026) and deaths from SARS of unspecific cause (n= 253). Conclusion: The risk of death increased among black and brown women, in the postpartum period and with the presence of comorbidities, mainly diabetes, cardiovascular diseases and obesity. The data presented here draw attention to the number of deaths from SARS, especially among sociodemographic profiles, precarious access to health, such as the black population. In addition, limitations in adequate access to health care are reinforced by even lower rates of ICU admissions among women who died from SARS of an unspecified cause.

The impact of preservation solutions for static cold storage on kidney transplantation outcomes: Results of a Brazilian nationwide multicenter study.

This study evaluated the current practices of selecting cold storage preservation solutions in Brazil and their impact on delayed graft function (DGF) incidence and 1-year outcomes in kidney transplant recipients. A retrospective cohort study was conducted, including 3,134 brain-dead deceased donor kidney transplants performed between 2014 and 2015 in 18 Brazilian centers. The most commonly used preservation solution was Euro-collins (EC, 55.4%), followed by Histidine-tryptophan-ketoglutarate (HTK, 30%) and Institut Georges Lopez (IGL-1, 14.6%). The incidence of DGF was 54.4%, with 11.7% of patients requiring dialysis for more than 14 days, indicating prolonged DGF. Upon adjusting for confounding variables, HTK demonstrated a significantly lower risk of DGF than EC (OR 0.7350.82500.926), as did IGL-1 (OR 0.6050.7120.837). Similar protective effects were observed for prolonged DGF when comparing HTK (OR 0.4780.5990.749) and IGL-1 (OR 0.4780.6810.749) against EC. No significant association was found between preservation solutions and 1-year death-censored graft survival. In conclusion, EC was the most frequently used cold storage perfusion solution, demonstrating a higher incidence and duration of DGF compared with HTK and IGL-1, but with no impact on 1-year graft survival.

Treatment of Brachioradial Pruritus: A Tertiary Center Retrospective Analysis.

This retrospective study investigates the efficacy of 2 treatment regimens, pregabalin alone versus pregabalin combined with ketamine, amitriptyline, and lidocaine cream, in reducing itch in patients with brachioradial pruritus at a tertiary care center. Electronic medical records of 64 brachioradial pruritus patients seen at the University of Miami Itch Center were analyzed. A significant reduction in itch scores was seen with both treatments, with no significant difference between the groups. A small number of patients experienced adverse effects, including drowsiness and weight gain with pregabalin and skin irritation with ketamine, amitriptyline, and lidocaine cream. Ultimately, our findings underscore the potential of utilizing combined therapy for difficult-to-treat brachioradial pruritus cases and implementing individualized approaches for managing neuropathic pruritus. Further controlled clinical trials are needed to establish optimal treatment protocols.

Clinical profiles and treatment outcomes of outpatients with interstitial lung disease and mechanic's hands: A retrospective and observational cohort.

Idiopathic inflammatory myopathies, especially antisynthetase syndrome, often appear outside of the muscles as interstitial lung disease (ILD). Another typical finding is the presence of mechanic's hands. The aim of the present study was to describe the clinical, functional, tomographic, and serological data of patients with ILD and mechanic's hands and their response to treatment and survival rates. This is a retrospective study of ILD with concurrent myopathy. Among the 119 patients initially selected, 51 had mechanic's hands. All the patients were screened for anti-Jo-1 antibodies. An expanded panel of myopathy autoantibodies was also performed in 27 individuals. Of the 51 patients, 35 had 1 or more antibodies. The most common were anti-Jo-1, anti-PL-7, and anti-PL-12, while of the associated antibodies, anti-Ro52 was present in 70% of the 27 tested individuals. A significant response to treatment was characterized by an increase in predicted forced vital capacity (FVC) of at least 5% in the last evaluation done after 6 to 24 months of treatment. A decrease in predicted FVC of at least 5%, the need for oxygen therapy, or death were all considered treatment failures. All patients were treated with corticosteroids, and 71% with mycophenolate. After 24 months, 18 patients had an increase in FVC, 11 had a decrease, and 22 remained stable. After a median follow-up of 58 months, 48 patients remained alive and three died. Patients with honeycombing on high-resolution chest tomography (log-rank = 34.65; P < .001) and a decrease in FVC ≥5% (log-rank = 18.28, P < .001) had a poorer survival rate. Patients with ILD and mechanic's hands respond well to immunosuppressive treatment.

Trends in inpatient burden from pressure injuries in the United States: Cross-sectional study National Inpatient Sample 2009-2019.

Pressure injuries are a significant comorbidity and lead to increased overall healthcare costs. Several European and global studies have assessed the burden of pressure injuries; however, no comprehensive analysis has been completed in the United States. In this study, we investigated the trends in the burden of pressure injuries among hospitalised adults in the United States from 2009 to 2019, stratified by sociodemographic subgroups. The length of admission, total cost of hospitalisation, and sociodemographic data was extracted from the National Inpatient Sample provided by the Healthcare Cost and Utilisation Project, Agency for Healthcare Research and Quality. Overall, the annual prevalence of pressure injuries and annual mean hospitalisation cost increased ($69,499.29 to $102,939.14), while annual mean length of stay decreased (11.14-9.90 days). Among all races, minority groups had higher average cost and length of hospitalisation. Our findings suggest that while the length of hospitalisation is decreasing, hospital costs and prevalence are rising. In addition, differing trends among racial groups exist with decreasing prevalence in White patients. Further studies and targeted interventions are needed to address these differences, as well as discrepancies in racial groups.

Knowledge, Attitudes, and Perceptions of Skin Cancer Clinical Trials in the Hispanic Population.

OBJECTIVE: To determine the factors that might limit Hispanic patients from participating in dermatological clinical trials. METHODS: From January 2022 to July 2022, we administered a 31-item, in-person questionnaire to patients recruited in the waiting area of the Caridad Center, one of the largest free clinics in the United States with a predominately Hispanic population, and a nearby private primary care clinic. RESULTS: Overall, Hispanic patients agreed significantly more with statements in the domain of attitude and behavioral beliefs compared to non-Hispanic survey respondents. The Hispanic ethnicity was associated with increased odds of agreeing with the following statements: "My community would really benefit from skin cancer clinical trials" (OR=0.52; 95% CI 0.30, 0.92), "My participation in a skin cancer study would be very good" (OR=0.59; 95% CI 0.35, 0.99), and "I like to do good for others" (OR=0.41; 95% CI 0.22, 0.77). CONCLUSION: While the United States population is composed of 18.5% Hispanics, they only account for 1% of patients enrolled in clinical trials. This study helps identify potential motivational factors for Hispanic patients to participate in skin cancer clinical trials.

Effectiveness of atopic dermatitis patient education programs - a systematic review and meta-analysis.

Patient education in atopic dermatitis (AD) has worked in parallel to the gold standard of pharmacological treatment as a foundational component of therapeutic regimens. In addition to improving patient education, past investigations of educational interventions have demonstrated profound reductions in disease severity for patients living with AD. However, prior meta-analytical work has focused mostly on comparing in-person interventions, and thus the need to determine the effectiveness of virtual methodologies in the current post-COVID era remains. In this study, we conducted a systematic review of the literature to determine the effectiveness of online programming in AD education compared to in-person interventions. A comprehensive search was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions 2019. Studies were retrieved based on articles published up to 04 April 2023. Adherence to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement guided the reportage process for this systematic review and meta-analysis. The primary outcome of our meta-analysis was the effect of various educational modalities on atopic dermatitis severity as measured by multiple scales across the studies, the most common including SCORAD, Dermatology Life Quality Index (DLQI), Patient Oriented Eczema Measure (POEM), and Eczema Area and Severity Index (EASI). Most studies were randomized controlled trials, primarily from North America and Western Europe and focused on patient and/or caregiver education about disease management, self-care techniques, avoidance of triggers, and comprehensive understanding of the disease process. Our pooled analyses showed that targeted educational programs in understudied adult populations can be as impactful as those in pediatric groups. Moreover, virtual interventions can be employed as constructive tools for reducing barriers of access to patient education. Future research on educational interventions should utilize various methodologies to encourage individual learning preferences with a focus on adult cohorts.

Application of natural language processing to predict final recommendation of Brazilian health technology assessment reports.

INTRODUCTION: Health technology assessment (HTA) plays a vital role in healthcare decision-making globally, necessitating the identification of key factors impacting evaluation outcomes due to the significant workload faced by HTA agencies. OBJECTIVES: The aim of this study was to predict the approval status of evaluations conducted by the Brazilian Committee for Health Technology Incorporation (CONITEC) using natural language processing (NLP). METHODS: Data encompassing CONITEC's official report summaries from 2012 to 2022. Textual data was tokenized for NLP analysis. Least Absolute Shrinkage and Selection Operator, logistic regression, support vector machine, random forest, neural network, and extreme gradient boosting (XGBoost), were evaluated for accuracy, area under the receiver operating characteristic curve (ROC AUC) score, precision, and recall. Cluster analysis using the k-modes algorithm categorized entries into two clusters (approved, rejected). RESULTS: The neural network model exhibited the highest accuracy metrics (precision at 0.815, accuracy at 0.769, ROC AUC at 0.871, and recall at 0.746), followed by XGBoost model. The lexical analysis uncovered linguistic markers, like references to international HTA agencies' experiences and government as demandant, potentially influencing CONITEC's decisions. Cluster and XGBoost analyses emphasized that approved evaluations mainly concerned drug assessments, often government-initiated, while non-approved ones frequently evaluated drugs, with the industry as the requester. CONCLUSIONS: NLP model can predict health technology incorporation outcomes, opening avenues for future research using HTA reports from other agencies. This model has the potential to enhance HTA system efficiency by offering initial insights and decision-making criteria, thereby benefiting healthcare experts.

Body fat predicts urinary tract infection in kidney transplant recipients: a prospective cohort study.

BACKGROUND: The association between obesity and infectious diseases is increasingly reported in the literature. There are scarce studies on the association between obesity and urinary tract infection after kidney transplantation (KTx). These studies defined obesity based on body mass index, and their results were conflicting. The present study aimed to evaluate this association using bioelectrical impedance analysis for body composition evaluation, and obesity definition. METHODS: A single-center cohort study was conducted. Demographic, clinical, anthropometric, and laboratory data were collected at KTx admission, and bioelectrical impedance analysis was performed to measure the visceral fat area, waist circumference, and total fat mass. The occurrence of urinary tract infection (symptomatic bacteriuria and/or histological evidence of pyelonephritis) was evaluated within three months after KTx. RESULTS: Seventy-seven patients were included in the cohort, and 67 were included in the final analysis. Urinary tract infection was diagnosed in 23.9% of the transplanted patients. Waist circumference (HR: 1.053; 95% CI 1.005-1.104; p = 0.032), visceral fat area (HR: 1.015; 95% CI 1.003-1.027; p = 0.014), and total fat mass (HR: 1.075; 95% CI 1.008-1.146; p = 0.028) were associated with urinary tract infection occurrence after KTx, using Cox regression models. Patients with high waist circumference (above 102 cm for men and above 88 cm for women) had a 4.7 times higher risk of a urinary tract infection than those with normal waist circumference (HR: 4.726; 95% CI 1.267-17.630; p = 0.021). Kaplan-Meier curves showed that patients with high waist circumference, high visceral fat area, and high total fat mass had more urinary tract infections (Log-rank test p = 0.014, p = 0.020, and p = 0.018, respectively). Body mass index was not able to predict urinary tract infection in the study sample. CONCLUSIONS: Waist circumference, visceral fat area, and total fat mass, assessed by bioelectrical impedance analysis, were predictors of urinary tract infection risk within the first three months after KTx.