EUS- versus ERCP-guided biliary drainage for malignant biliary obstruction: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Increasing evidence supports EUS-guided biliary drainage (EUS-BD) as a potential alternative to ERCP-guided biliary drainage (ERCP-BD) in the primary treatment of malignant biliary obstruction (MBO). This systematic review and meta-analysis aimed to compare the efficacy and safety of both techniques as the initial approach for MBO. METHODS: We systematically searched in MEDLINE, Embase, and Cochrane databases for randomized controlled trials comparing both techniques and reporting at least one of the outcomes of interest. The pooled estimates were calculated using the random-effects model, and I2 statistics were used to evaluate heterogeneity. RESULTS: We included 6 randomized controlled trials (577 patients). There were no significant differences between both groups in terms of stent patency (mean difference [MD], 8.18 days; 95% confidence interval [CI], -22.55 to 38.91), procedure time (MD, -6.31 minutes; 95% CI, -12.68 to 0.06), and survival (MD, 4.59 days; 95% CI, -34.23 to 43.40). Technical success (risk ratio [RR], 1.04; 95% CI, 0.96-1.13), clinical success (RR, 1.02; 95% CI, 0.96-1.08), overall adverse events (RR, 0.58; 95% CI, 0.24-1.43), and cholangitis (RR, 1.19; 95% CI, 0.39-3.61) were also similar between groups. However, the hospital stay was significantly shorter (MD, -1.03 days; 95% CI, -1.53 to -0.53), and the risk of reintervention (RR, 0.57; 95% CI, 0.37-0.88), postprocedure pancreatitis (RR, 0.15; 95% CI, 0.03-0.66), and tumor ingrowth/overgrowth (RR, 0.28; 95% CI, 0.11-0.70) were significantly lower with EUS-BD. CONCLUSIONS: EUS-BD and ERCP-BD had similar efficacy and safety as the initial approach for MBO. However, EUS-BD had a significantly lower risk of reintervention, postprocedure pancreatitis, tumor ingrowth/overgrowth, and reduced hospital stay.

Cold endoscopic mucosal resection versus cold snare polypectomy for colorectal lesions: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cold resection of colorectal lesions is widely performed because of its safety and effectiveness; however, it remains uncertain whether adding submucosal injection could improve the efficacy and safety. We aimed to compare cold endoscopic mucosal resection (C-EMR) versus cold snare polypectomy (CSP) for colorectal lesions. METHODS: We performed a systematic review of randomized controlled trials (RCTs) identified from PubMed, Cochrane Library, and Embase. The primary outcome was complete resection. Secondary outcomes were procedure time, en bloc resection, and adverse events (AEs). Prespecified subgroup analyses based on the size and morphology of the polyps were performed. The random-effects model was used to calculate the pooled risk ratio (RR) and mean difference, with corresponding 95%CIs, for dichotomous and continuous variables, respectively. Heterogeneity was assessed using the Cochran Q test and I 2 statistics. RESULTS: 7 RCTs were included, comprising 1556 patients, with 2287 polyps analyzed. C-EMR and CSP had similar risk ratios for complete resection (RR 1.02, 95%CI 0.98-1.07), en bloc resection (RR 1.08, 95%CI 0.82-1.41), and AEs (RR 0.74, 95%CI 0.41-1.32). C-EMR had a longer procedure time (mean difference 42.1 seconds, 95%CI 14.5-69.7 seconds). In stratified subgroup analyses, the risk was not statistically different between C-EMR and CSP for complete resection in polyps<10 mm or ≥10 mm, or for complete resection, en bloc resection, and AEs in the two groups among nonpedunculated polyps. CONCLUSIONS: The findings of this meta-analysis suggest that C-EMR has similar efficacy and safety to CSP, but significantly increases the procedure time. PROSPERO: CRD42023439605.

Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis.

BACKGROUND: Propofol has a favourable efficacy profile in gastrointestinal endoscopic procedures, however adverse events remain frequent. Emerging evidence supports remimazolam use in gastrointestinal endoscopy. This systematic review and meta-analysis compares remimazolam and propofol, both combined with a short-acting opioid, for sedation of adults in gastrointestinal endoscopy. METHODS: We searched MEDLINE, Embase, and Cochrane databases for randomised controlled trials comparing efficacy-, safety-, and satisfaction-related outcomes between remimazolam and propofol, both combined with short-acting opioids, for sedation of adults undergoing gastrointestinal endoscopy. We performed sensitivity analyses, subgroup assessments by type of short-acting opioid used and age range, and meta-regression analysis using mean patient age as a covariate. We used R statistical software for statistical analyses. RESULTS: We included 15 trials (4516 subjects). Remimazolam was associated with a significantly lower sedation success rate (risk ratio [RR] 0.991; 95% confidence interval [CI] 0.984-0.998; high-quality evidence) and a slightly longer induction time (mean difference [MD] 9 s; 95% CI 4-13; moderate-quality evidence), whereas there was no significant difference between the sedatives in other time-related outcomes. Remimazolam was associated with significantly lower rates of respiratory depression (RR 0.41; 95% CI 0.30-0.56; high-quality evidence), hypotension (RR 0.43; 95% CI 0.35-0.51; moderate-quality evidence), hypotension requiring treatment (RR 0.25; 95% CI 0.12-0.52; high-quality evidence), and bradycardia (RR 0.42; 95% CI 0.30-0.58; high-quality evidence). There was no difference in patient (MD 0.41; 95% CI -0.07 to 0.89; moderate-quality evidence) and endoscopist satisfaction (MD -0.31; 95% CI -0.65 to 0.04; high-quality evidence) between both drugs. CONCLUSIONS: Remimazolam has clinically similar efficacy and greater safety when compared with propofol for sedation in gastrointestinal endoscopies.

Socio-Economic Factors and Clinical Context Can Predict Adherence to Incidental Pulmonary Nodule Follow-up via Machine Learning Models.

OBJECTIVE: To quantify the relative importance of demographic, contextual, socio-economic, and nodule-related factors that influence patient adherence to incidental pulmonary nodule (IPN) follow-up visits and evaluate the predictive performance of machine learning models utilizing these features. METHODS: We curated a 1,610-subject patient data set from electronic medical records consisting of 13 clinical and socio-economic predictors and IPN follow-up adherence status (timely, delayed, or never) as the outcome. Univariate analysis and multivariate logistic regression were performed to quantify the predictors' contributions to follow-up adherence. Three additional machine learning models (random forests, neural network, and support vector machine) were fitted and cross-validated to examine prediction performance across different model architectures and evaluate intermodel concordance. RESULTS: On univariate basis, all 13 predictors except comorbidity were found to have a significant association with follow-up. In multiple logistic regression, inpatient or emergency clinical context (odds ratio favoring never following up: 7.28 and 8.56 versus outpatient, respectively) and high nodule risk (odds ratio: 0.25 versus low risk) are the most significant predictors of follow-up, and sex, race, and marital status become additionally significant if clinical context is removed from the model. Clinical context itself is associated with sex, race, insurance, employment, marriage, income, nodule risk, and smoking status, suggesting its role in mediating socio-economic inequities. On cross-validation, all four machine learning models demonstrated comparable and good predictive performances, with mean area under the curve ranging from 0.759 to 0.802, with sensitivity 0.641 to 0.660 and specificity 0.768 to 0.840. CONCLUSION: Socio-economic factors and clinical context are predictive of IPN follow-up adherence, with clinical context being the most significant contributor and likely representing uncaptured socio-economic determinants.

Demographics and socioeconomic determinants of health predict continued participation in a CT lung cancer screening program.

PURPOSE: We developed machine learning (ML) models to assess demographic and socioeconomic status (SES) variables' value in predicting continued participation in a low-dose CT lung cancer screening (LCS) program. MATERIALS AND METHODS: 480 LCS subjects were retrospectively examined for the following outcomes: (#1) no follow-up (single LCS scan) vs. multiple follow-ups (220 and 260 subjects respectively) and (#2) absent or delayed (>1 month past the due date) follow-up vs timely follow-up (356 and 124 subjects respectively). We quantified the contributions of 14 socioeconomic, demographic, and clinical predictors to LCS adherence, and validated and compared prediction performances of multivariate logistic regression (MLR), support vector machine (SVM) and shallow neural network (NN) models. RESULTS: For outcome #1, age, sex, race, insurance status, personal cancer history, and median household income were found to be associated with returning for follow-ups. For outcome #2, age, sex, race, and insurance status were significant predictor of absent/delayed LCS follow-up. Across 5-fold cross-validation, the MLR model achieved an average AUC of 0.732 (95% CI, 0.661-0.803) for outcome #1 and 0.633 (95% CI, 0.602-0.664) for outcome #2 and is the model with best predictive performance overall, whereas NN and SVM tended to overfit training data and fell short on testing data performance for either outcome. CONCLUSIONS: We identified significant predictors of LCS adherence, and our ML models can predict which subjects are at higher risk of receiving no or delayed LCS follow-ups. Our results could inform data-driven interventions to engage vulnerable populations and extend the benefits of LCS.

The usefulness of SAGE score in predicting high pulse wave velocity in hypertensive patients: a retrospective cohort study.

Introduction: Aortic stiffness assessed by pulse wave velocity (PWV) is an important predictor to evaluate the risk of hypertensive patients. However, it is underutilized in clinical practice. We aimed to identify the optimal cutoff SAGE score that would indicate a risk PWV ≥ 10 m/s in Brazilian ambulatory hypertensive patients. Materials and methods: A retrospective cohort study. Patients underwent central blood pressure measurement using a validated oscillometric device from August 2020 to December 2021. A ROC curve was constructed using the Youden statistic to define the best score to identify those at high risk for PWV ≥ 10 m/s. Results: A total of 212 hypertensive individuals were selected. The mean age was 64.0 ± 12.4 years and 57.5% were female. The following comorbidities were present: overweight (47.6%), obesity (34.3%), and diabetes (25.0%). Most of the sample (68.9%) had PWV < 10 m/s. According to Youden's statistic, a cutoff point of 6 provided the optimal combination of sensitivity and specificity for identifying patients with a PWV ≥ 10 m/s. This cutoff achieved sensitivity of 97.0%, and specificity of 82.9%. In clinical practice, however, a cutoff point of 7 (where score values of at least 7 were considered to indicate high risk) had a positive likelihood ratio of 8.2 and a negative likelihood ration of 0.346, making this the ideal choice by accurately excluding patients who are less likely to have PWV ≥ 10 m/s. Conclusion: A SAGE score ≥7 identified Brazilian hypertensive patients with a high risk of PWV ≥ 10 m/s.

Evaluation of Salivary Glucose and Salivary Cortisol in Association with Periodontitis in People with Type II Diabetes: A Case-control Study.

BACKGROUND: The relationship between type II diabetes mellitus (DM) and periodontal disease (PD) has been discussed in recent years and may vary according to the patient's location, sex, age and family history. OBJECTIVE: In view of this possible association between periodontitis and DM, this study aimed to evaluate salivary glucose and salivary cortisol levels with periodontitis (staging and degree) in people with type II diabetes compared to non-diabetic individuals. METHODS: This was a case-control study, with 60 participants divided into two groups: DM2- people with type II diabetes (n=30) and NDM- non-diabetic individuals (n=30). For both, a clinical form and periogram were filled out, and blood samples (glycemia, glycated hemoglobin, and cortisol) and saliva (glucose and cortisol) were collected. RESULTS: The diagnosis of periodontitis was 100% in the DM2 group and 80% in the NDM group. As for staging and degree, in the DM2 group, 70% of the participants were in stage IV and 86.67% were in grade C, while in the NDM group, 58.3% of the participants were in stage I and 70.8% were in grade A. Significant differences were observed for the following variables: bleeding to probing and clinical attachment level. The laboratory data presented significant results regarding serum glucose, salivary glucose, and glycated hemoglobin. CONCLUSION: Regarding the influence of salivary glucose and cortisol on periodontal status (staging and degree), these had higher means in the DM2 group when compared to the NDM group. An association of salivary glucose and cortisol levels with the periodontal condition presented by type II diabetic individuals compared to non-diabetic individuals is suggested.

Lithium inelastic cross-sections and their impact on micro and nano dosimetry of boron neutron capture.

Objective.To present a new set of lithium-ion cross-sections for (i) ionization and excitation processes down to 700 eV, and (ii) charge-exchange processes down to 1 keV u-1. To evaluate the impact of the use of these cross-sections on micro a nano dosimetric quantities in the context of boron neutron capture (BNC) applications/techniques.Approach.The Classical Trajectory Monte Carlo method was used to calculate Li ion charge-exchange cross sections in the energy range of 1 keV u-1to 10 MeV u-1. Partial Li ion charge states ionization and excitation cross-sections were calculated using a detailed charge screening factor. The cross-sections were implemented in Geant4-DNA v10.07 and simulations and verified using TOPAS-nBio by calculating stopping power and continuous slowing down approximation (CSDA) range against data from ICRU and SRIM. Further microdosimetric and nanodosimetric calculations were performed to quantify differences against other simulation approaches for low energy Li ions. These calculations were: lineal energy spectra (yf(y) andyd(y)), frequency mean lineal energyyF-, dose mean lineal energyyD-and ionization cluster size distribution analysis. Microdosimetric calculations were compared against a previous MC study that neglected charge-exchange and excitation processes. Nanodosimetric results were compared against pure ionization scaled cross-sections calculations.Main results.Calculated stopping power differences between ICRU and Geant4-DNA decreased from 33.78% to 6.9%. The CSDA range difference decreased from 621% to 34% when compared against SRIM calculations. Geant4-DNA/TOPAS calculated dose mean lineal energy differed by 128% from the previous Monte Carlo. Ionization cluster size frequency distributions for Li ions differed by 76%-344.11% for 21 keV and 2 MeV respectively. With a decrease in theN1within 9% at 10 keV and agreeing after the 100 keV. With the new set of cross-sections being able to better simulate low energy behaviors of Li ions.Significance.This work shows an increase in detail gained from the use of a more complete set of low energy cross-sections which include charge exchange processes. Significant differences to previous simulation results were found at the microdosimetric and nanodosimetric scales that suggest that Li ions cause less ionizations per path length traveled but with more energy deposits. Microdosimetry results suggest that the BNC's contribution to cellular death may be mainly due to alpha particle production when boron-based drugs are distributed in the cellular membrane and beyond and by Li when it is at the cell cytoplasm regions.

Effects of Intravenous Lidocaine on Quality of Recovery After Laparoscopic Bariatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

This systematic review and meta-analysis aimed to assess the effects of pre and intraoperative lidocaine infusion on short-term recovery quality after laparoscopic bariatric surgeries. In the search across MEDLINE, Embase, and Cochrane databases, we considered randomized controlled trials comparing intravenous lidocaine vs placebo (saline) for patients with obesity undergoing laparoscopic bariatric surgery. Seven studies (640 patients) were included. The lidocaine group had a significantly higher recovery quality score, a lower morphine consumption, and a notably reduced rate of nausea and vomiting compared with the placebo group. Additionally, Lidocaine infusion was associated with a shorter hospital stay, while no significant difference was observed in the time to bowel function recovery between both groups. In conclusion, lidocaine infusion before and during laparoscopic bariatric surgery contributes to an enhanced quality of recovery.

Chest CT Imaging Provides More Information Than Chest Radiography Alone in Determining Extent of Physiologic Impairment in Pulmonary Sarcoidosis.

BACKGROUND: Sarcoidosis staging primarily has relied on the Scadding chest radiographic system, although chest CT imaging is finding increased clinical use. RESEARCH QUESTION: Whether standardized chest CT scan assessment provides additional understanding of lung function beyond Scadding stage and demographics is unknown and the focus of this study. STUDY DESIGN AND METHODS: We used the National Heart, Lung, and Blood Institute study Genomics Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis cases of sarcoidosis (n = 351) with Scadding stage and chest CT scans obtained in a standardized manner. One chest radiologist scored all CT scans with a visual scoring system, with a subset read by another chest radiologist. We compared demographic features, Scadding stage, and CT scan findings and the correlation between these measures. Associations between spirometry results and Dlco, CT scan findings, and Scadding stage were determined using regression analysis (n = 318). Agreement between readers was evaluated using Cohen's κ value. RESULTS: CT scan features were inconsistent with Scadding stage in approximately 40% of cases. Most CT scan features assessed on visual scoring were associated negatively with lung function. Associations persisted for FEV1 and Dlco when adjusting for Scadding stage, although some CT scan feature associations with FVC became insignificant. Scadding stage was associated primarily with FEV1, and inclusion of CT scan features reduced significance in association between Scadding stage and lung function. Multivariable regression modeling to identify radiologic measures explaining lung function included Scadding stage for FEV1 and FEV1 to FVC ratio (P < .05) and marginally for Dlco (P < .15). Combinations of CT scan measures accounted for Scadding stage for FVC. Correlations among Scadding stage and CT scan features were noted. Agreement between readers was poor to moderate for presence or absence of CT scan features and poor for degree and location of abnormality. INTERPRETATION: CT scan features explained additional variability in lung function beyond Scadding stage, with some CT scan features obviating the associations between lung function and Scadding stage. Whether CT scan features, phenotypes, or endotypes could be useful for managing patients with sarcoidosis needs more study.

Cutoffs for white-coat and masked blood pressure effects: an ambulatory blood pressure monitoring study.

The values used to define white-coat and masked blood pressure (BP) effects are usually arbitrary. This study aimed at investigating the accuracy of various cutoffs based on the differences (ΔBP) between office BP (OBP) and 24h-ambulatory BP monitoring (ABPM) to identify white-coat (WCH) and masked (MH) hypertension, which are phenotypes coupled with adverse prognosis. This cross-sectional study included 11,350 [Derivation cohort; 45% men, mean age = 55.1 ± 14.1 years, OBP = 132.1 ± 17.6/83.9 ± 12.5 mmHg, 24 h-ABPM = 121.6 ± 11.4/76.1 ± 9.6 mmHg, 25% using antihypertensive medications (AH)] and 7220 (Validation cohort; 46% men, mean age = 58.6 ± 15.1 years, OBP = 136.8 ± 18.7/87.6 ± 13.0 mmHg, 24 h-ABPM = 125.5 ± 12.6/77.7 ± 10.3 mmHg; 32% using AH) unique individuals who underwent 24 h-ABPM. We compared the sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) of diverse ΔBP cutoffs to detect WCH (ΔsystolicBP/ΔdiastolicBP = 28/17, 20/15, 20/10, 16/11, 15/9, 14/9 mmHg and ΔsystolicBP = 13 and 10 mmHg) and MH (ΔsystolicBP/ΔdiastolicBP = -14/-9, -5/-2, -3/-1, -1/-1, 0/0, 2/2 mmHg and ΔsystolicBP = -5 and -3mmHg). The 20/15 mmHg cutoff showed the best AUC (0.804, 95%CI = 0.794-0.814) to detect WCH, while the 2/2 mmHg cutoff showed the highest AUC (0.741, 95%CI = 0.728-0.754) to detect MH in the Derivation cohort. Both cutoffs also had the best accuracy to detect WCH (0.767, 95%CI = 0.754-0.780) and MH (0.767, 95%CI = 0.750-0.784) in the Validation cohort. In secondary analyses, these cutoffs had the best accuracy to detect individuals with higher and lower office-than-ABPM grades in both cohorts. In conclusion, the 20/15 and 2/2 mmHg ΔBP cutoffs had the best accuracy to detect hypertensive patients with WCH and MH, respectively, and can serve as indicators of marked white-coat and masked BP effects derived from 24 h-ABPM.

Physiological and psychoaffective responses of adults trained in acute hiit protocols / Respuestas fisiológicas y psicoafectivas de adultos entrenados en protocolos agudos de hiit / Respostas fisiológicas e psicoafetivas de adultos treinados em protocolos agudos de hiit

ABSTRACT High Intensity Interval Training (HIIT) promotes similar adaptations and in some cases, superior to continuous aerobic training of moderate intensity, even when performed at all-out intensities. In this condition, it tends to have the greatest physiological disturbance and accumulation of metabolites compared to submaximal intensities, being one of the main factors associated with the negative response of pleasure in training. Objective: To verify the relationship between physiological and psychophysiological responses in order to repeat the training of two HIIT protocols of mesm volume load and different periods of work in trained adults of both sexes. Methods: In a randomized experiment, the sample consisted of 9 individuals aged 28±5 years, body mass 69.6±14.2 kg, height 169±0.1cm, BMI 24.1±2.3 kg/m2 and body fat percentage 20.2±7.9% practitioners of structured aerobic physical exercises for at least six months. Two different HIIT protocols were performed on an exercise bike, being (I) protocol 1:0.5, with prescribed intensity (80-90% of MAX HR), (II) protocol 1:2 with prescribed intensity (all-out) with total duration of effort of 20 minutes and interval of at least 48 hours between each session. Heart rate (HR), systemic blood pressure (SBP), subjective perception of exertion (SPE), visual analog scale (VAS), affective response (AR), fun (PACES) and intention to repeat the session were analyzed. The statistical analysis used was ANOVA with Tukey's post-hoc (p<0.05). Results: The analyses of HR, SBP, VAS, PACES and SPE showed no significant difference between the training protocols. The affective response (AR and intention to repeat) showed a decline in the protocol 1:0.5, but without significance (p>0.05). Conclusion: The data allow us to conclude that the 1:2 protocol caused greater physiological disturbances during exertion and presented greater positive affective response and intention to repeat the exercise session, variables that may contribute to adherence to regular physical exercise. Level of Evidence I; Therapeutic studies - Investigation of treatment results.

RESUMEN El entrenamiento de intervalos de alta intensidad (HIIT) promueve adaptaciones similares y, en algunos casos, superiores al entrenamiento aeróbico continuo de intensidad moderada. En esta condición, tiende a tener una mayor alteración fisiológica y acumulación de metabolitos en comparación con las intensidades submáximas, siendo uno de los principales factores asociados con la respuesta negativa del placer en el entrenamiento. Objetivo: Verificar la relación entre las respuestas fisiológicas y psicofisiológicas para repetir el entrenamiento de dos protocolos HIIT de carga del mismo volumen y diferentes períodos de trabajo en adultos entrenados de ambos sexos. Métodos: En un experimento aleatorizado, la muestra estuvo constituida por 9 individuos de 28±5 años, masa corporal 69,6±14,2 kg, altura 169±0,1cm, IMC 24,1±2,3 kg/m2 y porcentaje de grasa corporal 20,2±7,9% practicantes de ejercicios físicos aeróbicos estructurados durante al menos seis meses. Se realizaron dos protocolos HIIT diferentes en bicicleta estática, siendo protocolo 1: 0,5, con intensidad prescrita (80-90% de la FC MÁXIMA), protocolo 1: 2 con intensidad prescrita (total) con duración total del esfuerzo de 20 minutos e intervalo de al menos 48 horas entre cada sesión. Se analizaron la frecuencia cardíaca (FC), presión arterial sistémica (PAS), percepción subjetiva de esfuerzo (PSE), escala analógica visual (EVA), respuesta afectiva (FS), diversión (PACES) e intención de repetir la sesión. El análisis estadístico utilizado fue ANOVA con post-hoc de Tukey (p<0,05). Resultados: Los análisis de HR, PAS, EVA, PACES y PSE no mostraron diferencias significativas entre los protocolos de entrenamiento. La respuesta afectiva (FS e intención de repetir) mostró una disminución en el protocolo 1:0,5, pero sin significancia (p>0,05). Conclusión: Los datos permiten concluir que el protocolo 1:2 causó mayores alteraciones fisiológicas durante el esfuerzo y presentó mayor respuesta afectiva positiva e intención de repetir la sesión de ejercicio, variables que pueden contribuir para la adhesión al ejercicio físico. Nivel de Evidencia I; Estudios Terapéuticos - Investigación de los Resultados del Tratamiento.

RESUMO O Treinamento Intervalado de Alta Intensidade (HIIT) promove adaptações semelhantes e em alguns casos, superiores ao treinamento aeróbico contínuo de intensidade moderada, mesmo quando executado em intensidades all out. Nesta condição, tende a maior perturbação fisiológica e acúmulo de metabólitos comparado a intensidades submáximas, sendo um dos principais fatores associados a resposta negativa de prazer no treinamento. Objetivo: Verificar qual relação entre respostas fisiológicas e psicofisiológicas na intenção de repetir o treinamento de dois protocolos HIIT de mesmo volume load e distintos períodos de trabalho, em adultos treinados de ambos os sexos. Métodos: Em experimento randomizado, a amostra foi composta por 9 indivíduos com idade entre 28±5 anos, massa corporal 69,6±14,2 kg, estatura 169±0,1cm, IMC 24,1±2,3 kg/m2 e percentual de gordura corporal 20,2±7,9% praticantes de exercícios físicos aeróbicos estruturados por pelo menos seis meses. Realizaram dois diferentes protocolos de HIIT em bicicleta ergométrica, sendo (I) protocolo 1:0,5, com intensidade prescrita (80-90% da FCmáx), (II) protocolo 1:2 com intensidade prescrita (all-out) com duração total de esforço de 20 minutos e intervalo de pelo menos 48 horas entre cada sessão. Foram analisados frequência cardíaca (FC), pressão arterial sistêmica (PAS), percepção subjetiva de esforço (PSE), escala visual analógica (EVA), resposta afetiva (FS), divertimento (PACES) e intenção de repetir a sessão. A análise estatística usada foi ANOVA com post-hoc de Tukey (p<0,05). Resultados: As análises da FC, PAS, EVA, PACES e PSE não apresentaram diferença significativa entre os protocolos de treinamento. As respostas afetivas (FS e intenção de repetir) apresentaram maior declínio no protocolo 1:0,5, porém sem significância (p>0,05). Conclusão: Os dados permitem concluir que o protocolo 1:2 provocou maiores perturbações fisiológicas durante esforço e apresentou maior resposta afetiva positiva e intenção de repetir a sessão de exercício, variáveis que podem vir a contribuir na aderência à prática regular de exercícios físicos. Nível de Evidência I; Estudos terapêuticos - Investigação dos resultados do tratamento.

Therapeutic Adherence According to the Morisky Scale in Patients with Hypertension

Abstract Background In view of the high prevalence of hypertension and the importance of adequate drug therapy in the prevention of complications, it is necessary to know the adherence to drug treatment in this population. Objective To verify adherence to antihypertensive drug treatment in Brazilian patients with hypertension using the Morisky-Green Test (MGT), relating it with demographic data. Methods Prospective, observational, multicenter, national registry study, with 2,578 hypertensive patients participating in study I, the Brazilian Cardiovascular Registry of Arterial Hypertension (I-RBH), recruited in the five regions of Brazil. The analyses carried out on the data were descriptive statistics, qui-square tests, ANOVA, and logistic regression, adopting 5% as the significance level for the tests. Results The research shows that 56.13% of patients in the sample were female; 56.71% were elderly (≥ 65 years); 55.86% were White; 52.37% were from the Southeast Region; and 59.74% were non-adherent. Logistic regression showed an independent relationship between patients' age, ethnicity, and region with medication adherence. Conclusion Adherence to treatment is the key to reducing high rates of cardiovascular complications. The study brings a successful outcome in the relationship between the factors ethnicity, age, and region of patients with hypertension and medication adherence. To this end, it is necessary to understand these factors, considering systematic evaluation in the care of patients with hypertension and other chronic non-communicable diseases. This study is a significant contribution to multidisciplinary teams, as it highlights which risk factors interfere with medication adherence, incorporating better strategies in health education.

Physiological and morphological responses of two beans common genotype to water stress at different phenological stages

Comprehension of the bean responses of beans common under to water deficit is an important tool in agricultural planning, like sowing time, and deficit irrigation management strategies. The study aimed to understand the morpho-physiological responses and yield attributes of two common bean genotypes submitted to water stress at different phenological stages. The study was carried out in a greenhouse, in randomized block scheme with five repetitions. To achieve the objectives deficit irrigation of 25% of crop evapotranspiration was practiced during vegetative (DI-V), flowering (DI-F), and pod filling (DI-PF) stages. A non-deficit irrigated (NDI) and deficit irrigated through vegetative to pod filling stages (DI-VP) treatments were added for comparison. The following morphophysiological responses and yield attributes were evaluated: net assimilation of CO2, stomatal conductance, and leaf transpiration, chlorophyll index, number of trifoliate leaves, chlorophyll index, leaf area, number of grains per plant, number of grains per pod, number of pods per plant, the mass of thousand grains, harvest index, and water use efficiency. The beans genotype under DI-V exhibited acclimation, observed by the relative increment with NDI of 195%, 759%, and 231% of net assimilation of CO2, stomatal conductance, and leaf transpiration, respectively. Plants under treatment DI-PF experienced dis-stress and plastic responses as leaf losses and exhaustion of gas exchanges. Treatment DI-V received 11% less water than NDI and exhibited equal yield, resulting in higher water use efficiency. Yield attributes correlations indicated that yield penalty might be related to pods abortion, which not occurred to plants under DI-V.

Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Characterization of meibomian gland dysfunction in patients with rosacea / Caracterização da disfunção das glândulas de Meibomio em pacientes com rosácea

ABSTRACT Purpose: To compare ocular surface parameters in rosacea patients with those of controls. Methods: Ninety-three participants took part in this cross-sectional, observational, non-interventional study. These consisted of a rosacea group (n=40) and a control group (n=53). We compared objective parameters of the ocular surface, including conjunctival hyperemia, tear film stability and volume, meibomian gland dysfunction, dry eye disease, and ocular surface staining, between the two groups. Results: In the rosacea group, 69.23% were female. The mean age was 47.34 ± 12.62 years old. No statistically significant differences between groups were found in visual acuity (p=0.987), tear film parameters (tear meniscus height (p=0.338), noninvasive tear film rupture time (p=0.228), invasive rupture time (p=0.471), Schirmer's test scores (p=0.244), conjunctival hyperemia (p=0.106), and fluorescein staining (p=0.489). Significant differences were found in meibography evaluations (p=0.026), mucous layer integrity (p=0.015), and ocular surface symptoms (p<0.0001). Rosacea patients also showed important eyelid differences in glandular expressibility (p<0.001), glandular secretion pattern (p<0.001), and telangiectasia (p<0.001) compared to controls. Conclusion: Meibomian gland dysfunction is frequently associated with dermatological conditions. It can be observed in morphological findings from meibography as well as lipid secretion impairment, leading to evaporative dry eye, ocular surface dysfunction, and inflammation.

RESUMO Objetivo: Avaliar as alterações da superfície ocular em pacientes com Rosácea, e comparar com grupo controle. Métodos: Noventa e três indivíduos foram selecionados para este estudo transversal, observacional e não intervencionista, dividido em dois grupos: rosácea (n=40) e controles (n=53). Foram avaliados parâmetros objetivos da superfície ocular (hiperemia conjuntival, estabilidade e volume do filme lacrimal, disfunção da glândula meibomiana, doença do olho seco, coloração da superfície ocular) e comparado indivíduos saudáveis com pacientes com rosácea. Resultados: 69,23% dos indivíduos com rosácea eram mulheres, com média de idade de 47,34 ± 12,62 anos. Em comparação com controles pareados, não foram evidenciadas diferenças estatisticamente significativas em relação à acuidade visual (p=0,987) e parâmetros do filme lacrimal (altura do menisco lacrimal (p=0,338), tempo de ruptura do filme lacrimal não invasivo (p=0,228), tempo invasivo de ruptura (p=0,471) e teste de Schirmer (p=0,244), bem como hiperemia conjuntival (p=0,106) e coloração com fluoresceína (p=0,489). Associação significativa foi encontrada na avaliação da meibografia (p=0,026), integridade da camada mucosa (p=0,015) e sintomas de superfície ocular (p<0,0001). Pacientes com rosácea também apresentaram alterações importantes na borda palpebral: expressibilidade glandular (p<0,001), padrão de secreção glandular (p<0,001) e telangiectasia (p<0,001). Conclusão: A disfunção da glândula de Meibômio está frequentemente associada a condições dermatológicas e é caracterizada por achados morfológicos na meibografia, bem como comprometimento da secreção lipídica que leva ao olho seco evaporativo e alterações da superfície ocular e inflamação.

Escore SAGE em Normotensos e Pré-Hipertensos: Uma Prova de Conceito / SAGE Score in Normotensive and Pre-Hypertensive Patients: A Proof of Concept

Resumo Fundamento O SAGE foi desenvolvido para identificar hipertensos com chance de velocidade de onda de pulso (VOP) aumentada. Até o momento, as publicações do escore foram em hipertensos. Objetivo Verificar a capacidade do SAGE de identificar os normotensos ou pré-hipertensos com chance de aumento da VOP. Métodos Transversal retrospectivo, incluiu exames de normotensos e pré-hipertensos que realizaram a medida central da pressão arterial e apresentavam os parâmetros para o cálculo do escore. Para cada pontuação do escore, foi analisada a sensibilidade, especificidade, valor preditivo positivo e negativo utilizando como ponto de corte para o diagnóstico positivo VOP ≥ 10m/s, ≥9,08 m/s (percentil 75) e ≥7,30 m/s (percentil 50). Um valor de p<0,05 foi adotado como estatisticamente significante. Resultados A amostra foi de 100 participantes normotensos ou pré-hipertensos, com média (DP) de 52,64 (14,94) anos e VOP mediana de 7,30 m/s (6,03 - 9,08). O SAGE apresentou correlação com idade (r=0,938, p<0,001), glicemia (r=0,366, p<0,001) e taxa de filtração de glomerular (r=-0,658, p<0,001). A área sob a curva ROC foi de 0,968 (p<0,001) para VOP≥10 m/s, 0,977 (p<0,001) para VOP≥9,08 m/s e 0,967 (p<0,001) para VOP≥7,30 m/s. O escore 7 apresentou especificidade de 95,40% e sensibilidade de 100% para VOP≥10 m/s. O ponto de corte seria cinco para VOP≥9,08 m/s (s=96,00%, e= 94,70%), e dois para VOP≥7,30 m/s. Conclusão O SAGE foi capaz de identificar indivíduos com maior chance de apresentar rigidez arterial, utilizando diferentes pontos de corte de VOP. Entretanto, o desenvolvimento de um escore específico para normontensos e pré-hipertensos faz-se necessário.

Abstract Background The SAGE score was developed to detect individuals at risk for increased pulse wave velocity (PWV). So far, studies have been focused on hypertensive patients. Objective To assess the ability of the score to detect non-hypertensive and pre-hypertensive patients at risk for increased PWV. Methods Retrospective cross-sectional study of analysis of central blood pressure data and calculation of the SAGE score of non-hypertensive and pre-hypertensive patients. Each score point was analyzed for sensitivity, specificity, positive and negative predictive values, using the cut-off point for positive diagnosis a PVW ≥ 10m/s, ≥9.08 m/s (75thpercentile) and ≥7.30 m/s (50thpercentile). A p<0.05 was considered statistically significant. Results The sample was composed of 100 normotensive and pre-hypertensive individuals, with mean age of 52.64 ± 14.94 years and median PWV of 7.30 m/s (6.03 - 9.08). The SAGE score was correlated with age (r=0.938, p<0.001), glycemia (r=0.366, p<0.001) and glomerular filtration rate (r=-0.658, p<0.001). The area under the ROC curve was 0.968 (p<0.001) for PWV ≥ 10 m/s, 0.977 (p<0.001) for PWV ≥ 9.08 m/s and 0.967 (p<0.001) for PWV ≥ 7.30 m/s. The score 7 showed a specificity of 95.40% and sensitivity of 100% for PWV≥10 m/s. The cut-off point would be of five for a PWV≥9.08 m/s (sensitivity =96.00%, specificity = 94.70%), and two for a PWV ≥ 7.30 m/s. Conclusion The SAGE score could identify individuals at higher risk of arterial stiffness, using different PWV cutoff points. However, the development of a specific score for normotensive and pre-hypertensive subjects is needed.

Fecal microbiota transplantation and its repercussions in patients with melanoma refractory to anti-PD-1 therapy: scope review / Transplante de microbiota fecal e suas repercussões em pacientes com melanoma refratário à terapia anti-PD-1: revisão de escopo

ABSTRACT Introduction: despite being extremely effective in some cases, up to 70% of patients with melanoma do not respond to anti-PD-1/PD-L1 (primary resistance) and many of the responders eventually progress (secondary resistance). Extensive efforts are being made to overcome this resistance through new strategies, especially aimed at modulating the intestinal microbiota. Objective: to assess whether fecal microbiota transplantation (FMT), associated with immunotherapy, is beneficial in the clinical course of patients with refractory melanoma. Methods: this is a scope review, based on studies collected on the MEDLINE, ScienceDirect, The Cochrane Library, Embase and BMJ Journals; using the terms: "Antibodies, Monoclonal"; "Drug Resistance, Neoplasm"; "Fecal Microbiota Transplantation"; "Host Microbial Interactions"; "Immunotherapy"; "Melanoma"; and "Microbiota". Clinical trials, in English, with relevant data on the subject and fully available were included. A cut-off period was not determined, due to the limited amount of evidence on the topic. Results: crossing the descriptors allowed the identification of 342 publications and, after applying the eligibility criteria, allowed the selection of 4 studies. From the analyses, it was observed that a considerable part of those studied overcame resistance to immune checkpoint inhibitors after FMT, with better response to treatment, less tumor growth and increased beneficial immune response. Conclusion: it is noted that FMT favors the response of melanoma to immunotherapy, translated into significant clinical benefit. However, further studies are necessary for the complete elucidation of the bacteria and the mechanisms involved, as well as for the translation of new evidence to oncological care practice.

RESUMO Introdução: apesar de extremamente eficaz em alguns casos, até 70% dos pacientes com melanoma não respondem aos anti-PD-1/PD-L1 (resistência primária) e muitos dos respondedores, eventualmente, acabam progredindo (resistência secundária). Extensos esforços estão sendo realizados para superar esta resistência através de novas estratégias, sobretudo, visando a modulação da microbiota intestinal. Objetivo: avaliar se o transplante de microbiota fecal (TMF), associado à imunoterapia, é benéfico no curso clínico do paciente com melanoma refratário. Métodos: trata-se de uma revisão de escopo, baseada em estudos coletados nas plataformas MEDLINE, ScienceDirect, The Cochrane Library, Embase e BMJ Journals; utilizando os descritores: "Antibodies, Monoclonal"; "Drug Resistance, Neoplasm"; "Fecal Microbiota Transplantation"; "Host Microbial Interactions"; "Immunotherapy"; "Melanoma"; e "Microbiota". Foram incluídos ensaios clínicos, na língua inglesa, com dados relevantes sobre a temática e disponíveis integralmente. Não foi determinado um período de corte temporal, devido à quantidade limitada de evidências sobre o tema. Resultados: o cruzamento dos descritores permitiu a identificação de 342 publicações e, após a aplicação dos critérios de elegibilidade, permitiu a seleção de 4 estudos. A partir das análises, observou-se que grande parte dos estudados superaram a resistência aos inibidores do checkpoint imunológico pós-TMF, com melhor resposta ao tratamento, menor crescimento tumoral e aumento da resposta imunológica benéfica. Conclusão: nota-se que o TMF favorece a resposta do melanoma à imunoterapia, traduzido por benefício clínico significativo. Entretanto, novos estudos são necessários para a completa elucidação das bactérias e mecanismos envolvidos, bem como para que haja a translação das novas evidências para a prática assistencial oncológica.