Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial.

BACKGROUND: With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes. METHODS: This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes. We plan to enroll a total of 112 individuals who will be randomized 1:1 to receive the Smart Speaker EchoDot 3rd Gen device (Amazon Echo®) for home use (intervention arm) or to maintain usual care (control arm). The primary outcome is mental distress, assessed using the 20-item Self Reporting Questionnaire (SRQ-20) after a 12-week intervention period. Secondary outcomes include quality of life, adherence to diabetes self-care behaviors, perception of stress, glycemic control, blood pressure, and lipid profile. Analysis of covariance (ANCOVA) will be used to evaluate the effects of the intervention on the outcomes. DISCUSSION: This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.

1ª Mostra brasileira de literacia em saúde: Pistas para o SUS e as políticas públicas / 1st Brazilian Health Literacy Exhibition: Clues for the SUS and public policies

A Promoção da Saúde defende que para produzirmos saúde é necessário termos capacidade de reconhecer e realizar desejos e projetos, satisfazer nossas necessidades, transformar e/ou criar mecanismos de convivência com a realidade social e ambiental. Nessa direção, saúde e qualidade de vida implicam em estarmos informados para decidir sobre os rumos singulares de nossas vidas e sobre os processos de determinação social que operam no cotidiano, associando-se à ideia de autonomia. O exercício da autonomia, que se distancia muito de uma liberdade individualista e ilimitada, vincula-se à ampliação da nossa capacidade reflexiva frente ao bombardeio de informações que nos cercam e nos chegam, notadamente com a presença e expansão das tecnologias digitais. Daí a importância, em especial no campo da Promoção da Saúde, da literacia em saúde. A literacia em saúde pode ser definida como a capacidade dos sujeitos em obter, compreender, avaliar criticamente e utilizar informações sobre saúde para seu próprio cuidado ou de terceiros. Ela envolve uma ampla gama de habilidades e competências, que são desenvolvidas ao longo da vida e que possuem influência de fatores demográficos, culturais, sociopolíticos e ambientais. Com as novas e crescentes exigências de compreensão e uso de informações sobre saúde na vida cotidiana, especialmente para enfrentarmos os riscos da desinformação, é fundamental ampliar o debate acerca da literacia em saúde. Esse foi o principal objetivo da I Mostra Brasileira de Literacia em Saúde, cujas conferências e trabalhos encontram-se sistematizados neste e-book.

Survival and Response Outcomes for Gastrointestinal Neuroendocrine Tumor (GEP-NETs) Patients Treated with Lutetium-177-DOTATATE in a Brazilian Reference Center: A Six-Year Follow-Up Experience.

BACKGROUND: PRRT can be an option for all-grade GEP-NETs, but selecting patients is challenging. In this scenario, clinical-pathological and radiological characteristics, such as pre-treatment Ga-68 DOTA PET/CT, might have the potential to help. METHODS: A retrospective chart review was conducted on advanced GEP-NETs treated with at least one PRRT dose. Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. Krenning Score (KS), and the maximum standardized uptake value (SUVmax) were derived from the pre-treatment scans. A maximally selected rank statistics test was used for SUVmax simple cut point estimate. RESULTS: Among 36 patients, 19 had primary pancreatic tumors. The numbers of G1, G2, and G3 tumors were 10, 18, and 7, respectively. During a median follow-up of 90.5 months, 4 patients died. Median OS was not reached for G1 and G2 tumors, and it was 30 months for G3 (p = 0.001). Median PFS was 23 months, with G3 showing lower PFS compared to G1 [7 versus 30 months; HR 8.41 (95%CI 2.2-31.0; p = 0.001)]. CONCLUSIONS: PRRT provides long-term PFS in patients with G1/G2 GEP-NETs independent of clinical characteristics and primary site. G3 has worse survival, but selected patients may experience long OS after PRRT treatment.

Systemic treatment in patients with Child-Pugh B liver dysfunction and advanced hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a major cause of death among patients with liver cirrhosis. The rise of immuno-oncology has revolutionized treatment for advanced HCC. However, most pivotal randomized controlled trials have excluded patients with moderate liver dysfunction (Child-Pugh-Turcotte B), despite the high incidence of liver disease in patients with HCC at the time of diagnosis. Overall survival in patients with HCC and moderate liver dysfunction treated with sorafenib has been found to be only approximately 3-5 months, underlining the need for improved treatment algorithms for this increasingly important subgroup of patients. In this review, we summarize available data on the treatment of patients with HCC and moderate liver dysfunction. Opportunities, as well as clinical challenges, are discussed in detail, highlighting potential changes to the therapeutic landscape.

Low-energy amplitude-modulated electromagnetic field exposure: Feasibility study in patients with hepatocellular carcinoma.

BACKGROUND: Patients with advanced hepatocellular carcinoma (HCC) and poor liver function lack effective systemic therapies. Low-energy electromagnetic fields (EMFs) can influence cell biological processes via non-thermal effects and may represent a new treatment option. METHODS: This single-site feasibility trial enrolled patients with advanced HCC, Child-Pugh A and B, Eastern Cooperative Oncology Group 0-2. Patients underwent 90-min amplitude-modulated EMF exposure procedures every 2-4 weeks, using the AutEMdev (Autem Therapeutics). Patients could also receive standard care. The primary endpoints were safety and the identification of hemodynamic variability patterns. Exploratory endpoints included health-related quality of life (HRQoL), overall survival (OS). and objective response rate (ORR) using RECIST v1.1. RESULTS: Sixty-six patients with advanced HCC received 539 AutEMdev procedures (median follow-up, 30 months). No serious adverse events occurred during procedures. Self-limiting grade 1 somnolence occurred in 78.7% of patients. Hemodynamic variability during EMF exposure was associated with specific amplitude-modulation frequencies. HRQoL was maintained or improved among patients remaining on treatment. Median OS was 11.3 months (95% confidence interval [CI]: 6.0, 16.6) overall (16.0 months [95% CI: 4.4, 27.6] and 12.0 months [6.4, 17.6] for combination therapy and monotherapy, respectively). ORR was 24.3% (32% and 17% for combination therapy and monotherapy, respectively). CONCLUSION: AutEMdev EMF exposure has an excellent safety profile in patients with advanced HCC. Hemodynamic alterations at personalized frequencies may represent a surrogate of anti-tumor efficacy. NCT01686412.

Association Between Knee Extension Strength and Functional Capacity After Intensive Care Unit Discharge: A 6-Mo Prospective Cohort Study.

INTRODUCTION: Assessing functional improvement after intensive care unit discharge is particularly challenging. The aim of this study was to measure the association between (1) changes in knee extension muscle strength or quadriceps femoris and rectus femoris muscle thickness and (2) changes in functionality/function-related measurements in post-intensive care unit patients. METHODS: This prospective cohort study included adult patients without previous disability, consecutively selected after intensive care unit discharge. Some parameters, such as Short-Form 36, 6-min walking test, 1-min sit-to-stand, and Short Physical Performance Battery, were measured at baseline and 3 and 6 mos after discharge. Correlations were assessed and regression models were built to assess the association between evolution in knee extension strength or muscle thickness and evolution in functional tests. RESULTS: Thirty patients completed the follow-up. Moderate correlation was found between knee extension strength change and Short-Form 36 physical functioning (correlation coefficient [ ρ ] = 0.53), 6-min walking test ( ρ = 0.38), 1-min sit-to-stand ( ρ = 0.52), and Short Physical Performance Battery ( ρ = 0.38). Baseline values and changes in knee extension strength moderately predicted evolution in Short-Form 36 physical functioning ( r2 = 0.32, P = 0.006). Changes in muscle thickness were overall not associated with changes in functional variables. CONCLUSION: Changes in knee extension muscle strength may inform on functional progression over time after intensive care unit discharge, although confirmatory studies are needed.

The Effect of Physical Activity on Motor Skills of Children with Autism Spectrum Disorder: A Meta-Analysis.

OBJECTIVE: The present study was aimed at analyzing the effect of physical activity on motor coordination in children with ASD. METHODS: On 28 June 2021, a systematic review with meta-analysis was performed using the following databases: MEDLINE, SciELO, LILACS, PEDro, SPORTDiscus, CINAHL, SCOPUS, Web of Science, Cochrane, and Science Direct. We analyzed the methodological quality and risk of bias using the Jadad scale and Cochrane tool, respectively. Motor coordination results were meta-analyzed using the RevMan program. Two independent researchers used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool to assess the level of evidence from the meta-analysis. RESULTS: We found four studies in the listed databases and five randomized clinical trials were included in the meta-analysis that included 109 children with ASD. Children with ASD who performed physical activity did not present significantly better motor coordination than control children (p = 0.12). CONCLUSIONS: Considering the clinical importance of physical activity for children with ASD, this systematic review with meta-analysis showed that physical activity had no statistically significant effects on coordination in individuals with ASD.

Low-energy amplitude-modulated radiofrequency electromagnetic fields as a systemic treatment for cancer: Review and proposed mechanisms of action.

Exposure to Low-Energy Amplitude-Modulated Radiofrequency Electromagnetic Fields (LEAMRFEMF) represents a new treatment option for patients with advanced hepatocellular carcinoma (AHCC). We focus on two medical devices that modulate the amplitude of a 27.12 MHz carrier wave to generate envelope waves in the low Hz to kHz range. Each provides systemic exposure to LEAMRFEMF via an intrabuccal antenna. This technology differs from so-called Tumour Treating Fields because it uses different frequency ranges, uses electromagnetic rather than electric fields, and delivers energy systemically rather than locally. The AutemDev also deploys patient-specific frequencies. LEAMRFEMF devices use 100-fold less power than mobile phones and have no thermal effects on tissue. Tumour type-specific or patient-specific treatment frequencies can be derived by measuring haemodynamic changes induced by exposure to LEAMRFEMF. These specific frequencies inhibited growth of human cancer cell lines in vitro and in mouse xenograft models. In uncontrolled prospective clinical trials in patients with AHCC, minorities of patients experienced complete or partial tumour responses. Pooled comparisons showed enhanced overall survival in treated patients compared to historical controls. Mild transient somnolence was the only notable treatment-related adverse event. We hypothesize that intracellular oscillations of charged macromolecules and ion flows couple resonantly with LEAMRFEMF. This resonant coupling appears to disrupt cell division and subcellular trafficking of mitochondria. We provide an estimate of the contribution of the electromagnetic effects to the overall energy balance of an exposed cell by calculating the power delivered to the cell, and the energy dissipated through the cell due to EMF induction of ionic flows along microtubules. We then compare this with total cellular metabolic energy production and conclude that energy delivered by LEAMRFEMF may provide a beneficial shift in cancer cell metabolism away from aberrant glycolysis. Further clinical research may confirm that LEAMRFEMF has therapeutic value in AHCC.

Reliability of point-of-care ultrasound for measuring quadriceps femoris muscle thickness.

BACKGROUND: Point-of-care ultrasound can be used to assess muscle thickness. However, its reliability has not been fully evaluated. AIM: This study aimed to assess the intrarater and inter-rater reliability of point-of-care ultrasound for the estimation of quadriceps and rectus femoris thickness in patients from a rehabilitation setting. DESIGN: This is a cross-sectional study. SETTING: This study was conducted at the Department of Physical Medicine and Rehabilitation of a tertiary care hospital. POPULATION: Twenty-nine inpatients consecutively selected after admission. METHODS: Four observers, two trained and two untrained, used point-of-care ultrasound to measure quadriceps femoris and rectus femoris thickness. Each observer performed two measurements followed by a second set of two measurements three hours later. Intraclass correlation coefficients (ICC) were then calculated. RESULTS: Both intrarater and inter-rater ICC were higher than 0.888 for both quadriceps and rectus femoris measurements. Reliability was highest when ICC were calculated based on the average of two measurements, with the intrarater ICC being of 0.956 (95% CI: 0.937-0.970) for rectus femoris and of 0.966 (95% CI: 0.951-0.976) for quadriceps femoris; and with the inter-rater ICC being of 0.919 (95% CI: 0.863-0.957) for rectus femoris and 0.945 (95% CI: 0.907- 0.971) for quadriceps femoris. Trained and untrained observers did not have significantly different ICC values. CONCLUSIONS: These results suggest that point-of-care ultrasound is a reliable option to measure muscle thickness of knee extensors by the same or different observers. CLINICAL REHABILITATION IMPACT: Measuring knee extensors thickness may aid to adequately modulate treatment choices in patients with disability. This study suggests that quadriceps and rectus femoris muscle thickness measured after a short training course, by either an experienced or inexperienced clinician, presents high reliability. Reliability can be increased if the average of two measurements is used. Besides being inexpensive and portable, point-of-care ultrasound is a reliable tool for measuring knee extensors' thickness, rendering it potentially adequate to be used in clinical practice.

Handheld dynamometer reliability to measure knee extension strength in rehabilitation patients-A cross-sectional study.

INTRODUCTION: The Handheld Dynamometer (HHD) has the potential to overcome some of the logistic and economic limitations of isokinetic dynamometers for measuring knee extension muscle strength. However, its reliability has not been fully assessed. The purpose of this study is to measure intra and inter-rater reliability of HHD for knee extension strength in patients receiving rehabilitation treatment, as well as to understand in which conditions is the reliability higher. METHODS: Twenty-nine patients admitted in an inpatient Physical Medicine and Rehabilitation unit were consecutively included in this cross-sectional study. Two experienced and two inexperienced physicians made two assessments of knee extension strength with HHD, separated by three hours. Intraclass Correlation Coefficients (ICC), absolute differences between assessments, and correlations between strength and functional variables were calculated. RESULTS: Intra and inter-rater ICC were overall high (≥ 0.950 and 0.927, respectively). Higher values were found when average of two measurements were made for estimating intra-rater ICC (ICC = 0.978; 95%CI = 0.969-0.985) but not for inter-rater ICC. ICC were not statistically significantly different when calculated based on measurements performed by inexperienced physicians and experienced ones. There was a moderate correlation between strength and functional variables. CONCLUSION: Handheld Dynamometer seems to be a reliable option to measure knee extension muscle strength, particularly when two measurements are performed and their average is reported.

ENETS standardized (synoptic) reporting for molecular imaging studies in neuroendocrine tumours.

The European Neuroendocrine Tumor Society (ENETS) promotes practices and procedures that aim to improve the standard of care delivered to patients diagnosed with or suspected of having neuroendocrine neoplasia (NEN). At its annual Scientific Advisory Board Meeting in 2018, experts in imaging, pathology and clinical care of patients with NEN drafted guidance for the standardised reporting of diagnostic studies critical to the diagnosis, grading, staging and treatment of NEN. These included pathology, radiology, endoscopy and molecular imaging procedures. In an iterative process, a synoptic reporting template for molecular imaging procedures was developed to guide personalised therapies. Following pilot implementation and refinement within the ENETS Center of Excellence network, harmonisation with specialist imaging societies including the Society of Nuclear Medicine, European Association of Nuclear Medicine and the International Cancer Imaging Society will be pursued.

Programa Bolsa Família: Narrativas de Beneficiárias(os) Abordadas em Produções Científicas / Bolsa Família Program: Beneficiaries Narratives Presented in Scientific Productions / Programa Bolsa Família: Narrativas de Beneficiarias(os) en Producciones Científicas

O presente artigo trata de uma revisão de literatura que objetiva compreender os significados atribuídos ao Programa Bolsa Família (PBF) por beneficiárias(os) a partir de narrativas presentes em produções científicas. Para tanto, realizamos um levantamento bibliográfico no Portal de Periódicos CAPES, no período de junho e agosto de 2018. Selecionamos 35 artigos que apresentavam discussões sobre narrativas de sujeitos vinculados ao PBF. Observamos nessas narrativas uma pluralidade discursiva quanto às potencialidades e aos limites do Programa em torno de cinco pontos: a) Usos do benefício; b) Titularidade feminina e relações familiares; c) Condicionalidades e acesso a serviços públicos; d) Dinâmica trabalho/emprego; e) Portas de saída. Acreditamos que esta pesquisa auxilia na construção de reflexões que visam a ampliação e/ou aperfeiçoamento do Programa, um debate que se enquadra no campo da psicologia social e política interessada em pensar o papel das políticas públicas no enfretamento às desigualdades sociais brasileiras. (AU)

The article deals with a literature review that aims to understand the meanings attributed to the Bolsa Família Program (PBF) by beneficiaries, based on narratives present in scientific productions. To this end, we carried out a bibliographic survey on the "Portal de Periódicos CAPES" between june and august 2018. We selected 35 articles that presented discussions about the narratives of beneficiaries. We observed in these narratives a discursive plurality regarding the potential and limits of the Program around five points: a) Uses of the PBF benefit; b) Female ownership and family relationships; c) Conditionalities and access to public services; d) Work/employment dynamics; e) "Exit doors". We believe that this research helps to build reflections aimed at expanding and/or improving the Program. This debate is localized in the field of social and political psychology interested in thinking about the role of public policies in addressing Brazilian social inequalities. (AU)

El presente artículo se trata de una revisión de literatura que tiene como objetivo comprender los significados atribuidos al Programa Bolsa Familia (PBF) por beneficiarios(as) desde las narrativas presentes en producciones científicas. Para eso, realizamos un levantamiento bibliográfico en la Entrada de Periódicos CAPES, en el periodo de junio a agosto de 2018. Elegimos 35 artículos que presentaban discusiones acerca de las narrativas de sujetos registrados en el PBF. Observamos en ellas una pluralidad discursiva cuánto a las potencialidades y a los límites del Programa alrededor de cinco puntos: a) Usos del beneficio; b) Titularidad femenina y las relaciones familiares; c) Condiciones y el acceso a los servicios públicos; d) Dinámica trabajo/empleo; e) Portales de salida. Creemos que esta investigación auxilia en la construcción de reflexiones que visan la ampliación y/o la optimización del Programa, un debate que se encuadra en el campo de la psicología social y política interesada en pensar el papel de las políticas públicas en la confrontación a las desigualdades sociales brasileñas. (AU)

NLRP1 acts as a negative regulator of Th17 cell programming in mice and humans with autoimmune diabetes.

Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of pancreatic ß cells. We show here that the protein NOD-like receptor family pyrin domain containing 1 (NLRP1) has a key role in the pathogenesis of mouse and human T1D. More specifically, downregulation of NLRP1 expression occurs during T helper 17 (Th17) differentiation, alongside greater expression of several molecules related to Th17 cell differentiation in a signal transducers and activators of transcription 3 (STAT3)-dependent pathway. These changes lead to a consequent increase in interleukin 17 (IL-17) production within the pancreas and higher incidence of diabetes in streptozotocin (STZ)-injected mice. Finally, in patients with T1D and a SNP (rs12150220) in NLRP1, there is a robust decrease in IL-17 levels in serum and in memory Th17 cells from peripheral blood mononuclear cells. Our results demonstrate that NLRP1 acts as a negative regulator of the Th17 cell polarization program, making it an interesting target for intervention during the early stages of T1D.

Tumor Growth Rate to Predict the Outcome of Patients with Neuroendocrine Tumors: Performance and Sources of Variability.

INTRODUCTION: Tumor growth rate (TGR), percentage of change in tumor volume/month, has been previously identified as an early radiological biomarker for treatment monitoring in neuroendocrine tumor (NET) patients. We assessed the performance and reproducibility of TGR at 3 months (TGR3m) as a predictor factor of progression-free survival (PFS), including the impact of imaging method and reader variability. METHODS: Baseline and 3-month (±1 month) CT/MRI images from patients with advanced, grade 1-2 NETs were retrospectively reviewed by 2 readers. Influence of number of targets, tumor burden, and location of lesion on the performance of TGR3m to predict PFS was assessed by uni/multivariable Cox regression analysis. Agreement between readers was assessed by Lin's concordance coefficient (LCC) and kappa coefficient (KC). RESULTS: A total of 790 lesions were measured in 222 patients. Median PFS was 22.9 months. On univariable analysis, number of lesions (

Opportunistic and Serious Infections in Patients with Neuroendocrine Tumors Treated with Everolimus: A Multicenter Study of Real-World Patients.

INTRODUCTION: The incidence of infections is poorly studied in patients with neuroendocrine tumors (NET) treated with everolimus outside of clinical trials. We aimed to evaluate the frequency of and risk factors for opportunistic infections (Opl) or any serious infection in eligible patients. METHODS: This was a retrospective multicenter study of a Latin American cohort of consecutive patients with advanced NET treated with everolimus. Duration of everolimus, comorbidities, Charlson comorbidity score, type of prior treatment, institution, and concurrent immunosuppressive conditions were tested for possible associations with serious (grade 3-5) infections in univariate and multivariable logistic regression models. RESULTS: One hundred eleven patients from 5 centers were included. The median duration of everolimus was 8.9 months. After a median follow-up of 32.9 months, 34 patients (30.6%; 95% CI 22.2-40.1) experienced infections of any grade, with 24 (21.6%; 95% CI 14.8-30.4) having a serious infection and 7 (6.3%; 95% CI 2.6-12.6) having at least 1 OpI (Candida sp., Toxoplasma gondi, Pneumocystis sp., Herpes sp., and Cryptococcus sp.). Four patients (3.6%) died from infections, but only 2 deaths (1.8%) were deemed to be related to everolimus. The multivariable analysis identified everolimus duration (every 6-month increase; OR = 1.28; 95% CI 1.02-1.60; p = 0.03) as an independent risk factor for serious infection. CONCLUSION: Infections are more frequent in NET patients using everolimus than previously reported in clinical trials. Patients on everolimus should be closely monitored for infections, especially those receiving it for several months.