Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer: Protocol for a hospital pharmacy-based real-world study.

OBJECTIVE: This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain. METHODS: This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis. CONCLUSIONS: We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.

Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial.

BACKGROUND: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology's use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting. METHODS: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia. DISCUSSION: The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this population. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.

Dietary Sugar and Anthropometrics among Young Children in the Guelph Family Health Study: Longitudinal Associations.

Purpose: Our understanding of the influence of sugar intake on anthropometrics among young children is limited. Most existing research is cross-sectional and has focused on sugar-sweetened beverages. The study objective was to investigate longitudinal associations between young children's total, free, and added sugar intake from all food sources at baseline with anthropometric measures at baseline and 18 months.Methods: The Guelph Family Health Study (GFHS) is an ongoing randomized controlled trial and a family-based health promotion study. Food records and anthropometric data were collected at baseline (n = 109, 55 males; 3.7 ± 1.1 y, mean ± SD) and 18 months (n = 109, 55 males; 5.1 ± 1.1 y) of the GFHS pilots. Associations between sugar intakes and anthropometrics were estimated using linear regression models with generalized estimating equations adjusted for age, sex, household income, and intervention status.Results: Total sugar intake was inversely associated with body weight at 18 months (P = 0.01). There was no effect of time on any other associations between total, free, and added sugar intakes and anthropometrics.Conclusions: Early life dietary sugar intakes may not relate to anthropometric measures in the short term. Further investigation into potential associations between dietary sugar intakes and anthropometric variables over longer time periods is warranted.

The use of FreeStyle libre improves glycaemic control along with reducing diabetes burden and hospital admissions in a socially deprived Northwest English population.

Aim: This retrospective study aimed to use mixed (qualitative and quantitative) methods to evaluate the role of FSL in reducing hospital admissions due to all causes, HbA1c, and reported hypoglycaemic episodes in people with diabetes living in a socially deprived region of Northwest England. Methods: Data were collected retrospectively from previous consultations, which coincided with the 6th -week, 6th -month and annual review including blood tests, hospital admissions due to any cause and reported hypoglycaemia. Also, FSL assessment and satisfaction semi-structured questionnaire was done to assess the impact of FSL on diabetes management and quality of life. Mixed-effects models were used to assess glycaemic control and reductions in hospital admissions and reported hypoglycaemic episodes. Results: Just 127 patients met the inclusion criteria. A multivariate linear mixed model method that analyses HbA1c data longitudinally revealed mean differences (mmol/mol) between baseline and post-FSL measurements, estimated by restricted maximum likelihood method (REML) of 9.64 (six weeks), 7.68 (six months) and 7.58 (annual review); all with a corresponding p-value of < 0.0001. For DKA patients, the bootstrap method revealed a significant reduction in mean HbA1c of 25.5, 95% confidence interval (CI) [8.8, 42.6] mmol/mol. It is demonstrated that FSL use for one year resulted in 59% reduction in hospital admissions and 46% reduction in reported hypoglycaemic episodes. Conclusion: The use of FSL resulted in statistically significant reductions in hospital admissions, HbA1c and reported hypoglycaemic episodes among diabetics in a socially deprived Northwest region of England. These outcomes show a direct association with a higher questionnaire score. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01424-4.

Reduced Rate of Hospitalizations for Acute Diabetes Events Before and After FreeStyle Libre® System Initiation in Some People With Type 2 Diabetes on Insulin-Secretagogue Oral Drug Therapy Without Insulin in France.

Objective: Glycemic management in people with type 2 diabetes mellitus (T2DM) on insulin-secretagogue regimens without insulin is of importance, as this group still represents a significant proportion of patients. Risks for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) or hypoglycemia, using insulin-secretagogue drugs are well established. Few studies have suggested that continuous glucose monitoring (CGM) could be useful for monitoring glucose dynamics associated with the use of such therapies. To document this point an exploratory analysis was conducted in a group of individuals with noninsulin treated T2DM in France who are managed with oral insulin-secretagogues and initiating the FreeStyle Libre® system (FSL). Methods: A retrospective study of the French national SNDS reimbursement claims database (≈66 million French people) was conducted to identify people with T2DM on oral insulin-secretagogues and receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. The analysis included data for the 12 months before and up to 24 months after FSL initiation. Hospitalizations for diabetes-related acute events were identified using ICD-10 codes as main or related diagnosis, for: hypoglycemic events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 1272 people with T2DM on insulin-secretagogues without insulin initiated FSL during the selection period. Of these, 7.15% had at least one hospitalization for any ADE in the year before FSL initiation, compared with 2.52% at 12 months and 2.83% at 24 months following FSL initiation. Reductions in ADEs were driven by -73% fewer admissions for ADEs related to diabetic ketoacidosis (DKA) or other hyperglycemia-related events. These patterns of reduced ADEs persisted after 2 years. Conclusions: This study suggests the value of the FSL system in reducing ADEs in some people with T2DM in France being treated with insulin-secretagogues without insulin. Characteristics of these patients remain to be documented.

A dose titration protocol for once-daily insulin glargine 300 U/mL for the treatment of diabetes mellitus in dogs.

BACKGROUND: In purpose-bred dogs, insulin glargine 300 U/mL (IGla300) has long duration of action, peakless time-action profile, and low potency, making it suitable for use as a basal insulin. HYPOTHESIS: To evaluate IGla300 in client-owned diabetic dogs monitored using a flash glucose monitoring system (FGMS). ANIMALS: Ninety-five client-owned diabetic dogs, newly diagnosed or previously treated with other insulin formulations, with or without concurrent diseases. METHODS: Prospective multi-institutional study. Clinical signs and standardized assessment of FGMS data, using treatment and monitoring guidelines established a priori, guided dose adjustments and categorization into levels of glycemic control. RESULTS: The initial IGla300 dose was 0.5 U/Kg q24h for newly diagnosed dogs and (median dose [range]) 0.8 U/Kg (0.2-2.5) q24h for all dogs. Glycemic control was classified as good or excellent in 87/95 (92%) dogs. The IGla300 was administered q24h (1.9 U/kg [0.2-5.2]) and q12h (1.9 U/kg/day [0.6-5.0]) in 56/95 (59%) and 39/95 (41%) dogs, respectively. Meal-time bolus injections were added in 5 dogs (0.5 U/kg/injection [0.3-1.0]). Clinical hypoglycemia occurred in 6/95 (6%) dogs. Dogs without concurrent diseases were more likely to receive IGla300 q24h than dogs with concurrent diseases (72% vs 50%, respectively; P = .04). CONCLUSIONS AND CLINICAL IMPORTANCE: Insulin glargine 300 U/mL can be considered a suitable therapeutic option for once-daily administration in diabetic dogs. Clinicians should be aware of the low potency and wide dose range of IGla300. In some dogs, twice-daily administration with or without meal-time bolus injections may be necessary to achieve glycemic control. Monitoring with FGMS is essential for dose titration of IGla300.

Continuous glucose monitoring with FreeStyle Libre PRO sensor in patients with type 2 diabetes and end-stage renal failure on haemoDIALysis (FSLPRO-DIAL pilot study).

AIMS: For end-stage renal disease (ESRD) patients with diabetes on haemodialysis, diabetes control is difficult to achieve. Hypoglycaemia is a major problem in these frailty subjects. Continuous glucose monitoring (CGM) devices appear therefore to be a good tool to help patients monitor their glycaemic control and to help practitioners optimize treatment. We aimed to compare the laboratory value of Hba1c with the sensor-estimated value of Hba1c (= glucose management indicator, GMI) in ESRD patients with type 2 diabetes (T2D) (with or without insulin treatment) on haemodialysis. Secondly, we aimed to identify CGM-derived monitoring parameters [time in range, time in hypo/hyperglycaemia, glycaemic variability (coefficient of variation, CV)] to identify patients at risk of frequent hypo- or hyperglycaemia. METHODS: The FSLPRO-DIAL pilot study (NCT04641650) was a prospective monocentric cohort study including 29 subjects with T2D who achieve the protocol. Inclusion criteria were: age ≥ 18 years, haemodialysis duration for at least 3 months, type 2 diabetes with no change in treatment for at least 3 months. Demographic data and blood sample were collected at the day of inclusion. Freestyle Libre pro IQ sensor (blinded CGM) was inserted for 14 days. After this period, all CGMs data were collected and analysed. RESULTS: Data were available for 27 patients. Mean age was 73 ± 10, mean BMI 27.2 kg/m2, mean duration of diabetes 16.9 years and mean dialysis duration 2.9 years. Twenty-four subjects were treated with insulin. Mean HbA1c was 6.6% (SD 1.2), and mean GMI was 6.7% (SD 0.9) (no significant difference, p = 0.3). Twelve subjects (44.4%) had a discordance between HbA1c and GMI of < 0.5%, 11 (40.8%) had a discordance between 0.5 and 1%, and only 4 (14.8%) had a discordance of > 1%. Mean time in range (70-180 mg/dl) was 71.9%, mean time below range (< 70 mg/dl) was 5.6%, and mean time above range (> 180 mg/dl) was 22.1%. Mean CV was 31.8%. For 13 out of 27 patients, we reduced antidiabetic treatment by stopping treatments or reducing insulin doses. CONCLUSION: In this pilot study, there was no global significant difference between HbA1c and GMI in this particular cohort with very well-controlled diabetes. However, the use of the sensor enabled us to identify an excessive time in hypoglycemia in this fragile population and to adapt their treatment.

Cross-sectional association of continuous glucose monitoring-derived metrics with cerebral small vessel disease in older adults with type 2 diabetes.

AIM: To examine cross-sectional associations between continuous glucose monitoring (CGM)-derived metrics and cerebral small vessel disease (SVD) in older adults with type 2 diabetes. MATERIALS AND METHODS: In total, 80 patients with type 2 diabetes aged ≥70 years were analysed. Participants underwent CGM for 14 days. From the CGM data, we derived mean sensor glucose, percentage glucose coefficient of variation, mean amplitude of glucose excursion, time in range (TIR, 70-180 mg/dl), time above range (TAR) and time below range metrics, glycaemia risk index and high/low blood glucose index. The presence of cerebral SVD, including lacunes, microbleeds, enlarged perivascular spaces and white matter hyperintensities, was assessed, and the total number of these findings comprised the total cerebral SVD score (0-4). Ordinal logistic regression analyses were performed to examine the association of CGM-derived metrics with the total SVD score. RESULTS: The median SVD score was 1 (interquartile range 0-2). Higher hyperglycaemic metrics, including mean sensor glucose, TAR >180 mg/dl, TAR >250 mg/dl, and high blood glucose index and glycaemia risk index, were associated with a higher total SVD score. In contrast, a higher TIR (per 10% increase) was associated with a lower total SVD score (odds ratio 0.73, 95% confidence interval 0.56-0.95). Glycated haemoglobin, percentage glucose coefficient of variation, mean amplitude of glucose excursions, time below range and low blood glucose index were not associated with total cerebral SVD scores. CONCLUSIONS: The hyperglycaemia metrics and TIR, derived from CGM, were associated with cerebral SVD in older adults with type 2 diabetes.

Impacto del uso de la vaina de acceso ureteral durante la ureteroscopia flexible: estudio comparativo de eficacia y seguridad / Impact of ureteric access sheath use during flexible ureteroscopy: A comparative study on efficacy and safety

Objetivos Este estudio evalúa el impacto del uso de una vaina de acceso ureteral (VAU) durante la ureteroscopia flexible (URSf) para el tratamiento de la litiasis urinaria, centrándose en resultados como la tasa libre de litiasis, el tiempo quirúrgico y las complicaciones. Métodos Este estudio prospectivo y aleatorizado se llevó a cabo en el Hospital de Badr en la Universidad de Helwan y en los hospitales de la Universidad de Ain Shams, desde agosto de 2021 hasta agosto de 2022. Los pacientes se aleatorizaron sistemáticamente a 2 grupos (URSf con VAU: 33 pacientes y URSf sin VAU: 31 pacientes), y se sometieron a evaluaciones preoperatorias y postoperatorias, incluyendo pruebas de laboratorio y de imagen. Se controlaron los posibles riesgos asociados al procedimiento, como el fracaso en el acceso al cálculo, el dolor, el sangrado y la sepsis. Resultados Se observó que los 2 grupos eran comparables en cuanto a características demográficas o hallazgos preoperatorios de la litiasis (p>0,05 para todos). Sin embargo, el tiempo quirúrgico fue menor en el grupo tratado sin VAU (79,4±15,3 vs. 90,4±16,7min en el grupo tratado con VAU; p=0,008). Las tasas de complicaciones intraoperatorias, incluidos el fracaso del acceso, la interrupción de la operación, las lesiones ureterales y el sangrado, fueron comparables en ambos grupos (p>0,05). No se observaron diferencias significativas en cuanto a la tasa libre de litiasis postoperatoria (78,8 vs. 71,0%; p=0,305) y el tamaño litiásico residual medio (2,7±3,5 vs. 3,1±3,1mm; p=0,687). Conclusiones El presente estudio sugiere que URSf sin VAU puede ofrecer una opción eficiente e igualmente efectiva para el tratamiento de los cálculos renales y de uréter superior. Sin embargo, se necesitan más estudios con muestras de mayor tamaño y periodos de seguimiento más largos para validar estos resultados y establecer indicaciones más precisas para este procedimiento. (AU)

Objectives This study evaluates the impact of using an access sheath (AS) during flexible ureteroscopy (fURS) for urolithiasis treatment, focusing on outcomes such as stone-free rate, operation time, and complications. Methods This prospective, randomized study was carried out at Badr Hospital, Helwan University, and Ain Shams University hospitals from August 2021 to August 2022. Patients were systematically randomized into two groups (fURS with AS: 33 patients and without AS: 31 patients) and underwent preoperative and postoperative assessments, including lab tests and imaging. Possible procedure-associated risks, such as failed stone access, pain, bleeding, and sepsis, were monitored. Results The two groups were found to be comparable in terms of demographic characteristics or preoperative stone findings (P>.05 for all). However, operation duration was shorter in the No Sheath group (79.4±15.3minutes vs. 90.4±16.7minutes in the Sheath group, P=.008). Intraoperative complication rates, including failed access, operation termination, ureteric injury, and bleeding, were comparable in both groups (P>.05). Postoperative stone-free rates (78.8% vs. 71.0%, P=.305) and mean residual stone size (2.7±3.5mm vs. 3.1±3.1mm, P=.687) showed no significant differences. Conclusions The present study suggests that fURS without an access sheath may offer an efficient and equally effective option for managing upper ureteric and renal stones. However, more studies with larger sample sizes and longer follow-up periods are required to validate these findings and to establish more precise indications for this approach. (AU)

Evaluación del valor predictivo negativo de la resonancia magnética multiparamétrica de próstata al combinar su puntuación con parámetros del antígeno prostático específico en pacientes con PSA en zona gris / The effect of the combination of prostate-specific antigen derivatives with multiparametric prostate magnetic resonance imaging scores on the negative predictive value of it in grey zone patients

Objetivo Calcular el valor predictivo negativo (VPN) de la resonancia magnética multiparamétrica (RMmp) de próstata negativa, definida como la ausencia de lesiones en las imágenes, cuando se combina con la densidad del PSA (DPSA) y el índice PSA libre/total (PSA l/t) en pacientes cuyo PSA se encuentra en la zona gris (4-10mg/ml). Métodos Se analizaron 191 pacientes con niveles de PSA entre 4 y 10mg/ml y RMmp negativa. El VPN de la RMmp negativa se calculó de acuerdo con un nivel de DPSA<0,15ng/ml/ml, un índice PSA l/t>0,15 y una combinación de ambos. Los pacientes se dividieron en 3 grupos de riesgo según estos dos parámetros, de la siguiente manera: • DPSA 0,01-0,07ng/ml/ml e índice PSA l/t≥25 en el grupo de bajo riesgo. • DPSA 0,08-0,15ng/ml/ml e índice PSA l/t 0,15-0,24 en el grupo de riesgo intermedio. • DPSA>0,15ng/ml/ml e índice PSA l/t<15 en el grupo de riesgo alto. Resultados El VPN de la RMmp negativa fue del 92,6% para el carcinoma de próstata clínicamente significativo (CPCS). El VPN aumentó al 97,5% en el grupo de riesgo bajo, y disminuyó al 33,3% en el de riesgo alto. El resultado al combinar la RMmp negativa con la DPSA<0,15ng/ml/ml fue muy similar al de su combinación con el PSA l/t>15. Conclusión el índice PSA l/t también podría utilizarse para aumentar el VPN de la RMmp, al igual que la DPSA. No recomendamos evitar la biopsia de próstata con una DPSA>0,15ng/ml/ml y un índice PSA l/t<0,15. Sin embargo, se requieren estudios controlados aleatorizados con más pacientes para confirmar los hallazgos de nuestro estudio. (AU)

Objective To calculate the negative predictive value (NPV) of negative multiparametric prostate magnetic resonance imaging (mpMRI), accepted as no lesions on images, when combined with prostate-specific antigen density (PSAD) and free/total prostate-specific antigen ratio (f/t PSA) in grey zone patients. Methods One hundred ninety-one patients with PSA levels between 4-10mg/ml and negative mpMRI were analyzed. The NPV of negative mpMRI was calculated according to a PSAD level of <0.15 ng/ml/ml, f/t PSA ratio of >0.15, and a combination of both. Patients were divided into three risk groups according to these two parameters: • PSAD 0.01-0.07 ng/ml/ml and f/t PSA ratio ≥25 in a low-risk group. • PSAD 0.08-0.15 ng/ml/ml, and f/t PSA ratio 0.15-0.24 in an intermediate-risk group and high-risk group. • PSAD>0.15 ng/ml/ml and f/t PSA ratio <15 in high-risk group, Results NPV of negative mpMRI was 92.6% for clinically significant prostate carcinoma (CSPCa). It increased to 97.5% in a low-risk group and decreased to 33.3% for CSPCa in a high-risk group. NPV of negative mpMRI results were so close when combined with PSAD <0.15 ng/ml/ml and f/t PSA>15. Conclusion f/t PSA ratio might also be used to increase the NPV of mpMRI, like PSAD. We advise not to avoid prostate biopsy when PSAD is >0.15 ng/ml/ml and the f/t PSA ratio is <0.15. However, we need randomized controlled studies with more patients to confirm our study. (AU)

[First isolation of Acanthamoeba spp. in seawater from the southeast of Buenos Aires (SE, Argentina)]. / Primer aislamiento de Acanthamoeba spp. en agua de mar del sudeste bonaerense, Argentina.

Free-living amoebae (FLA) of the genus Acanthamoeba are ubiquitous and amphizoic protozoa that colonize aquatic and terrestrial habitats and can serve as reservoirs for other microorganisms. They are considered econoses that can cause severe and rare pathologies. Due to limited epidemiological data available, the objective of this study was to investigate the presence of Acanthamoeba in coastal wetlands of the southeast of Buenos Aires province and evaluate their association with bacteriological and environmental variables. From February 2021 to July 2022, 22 seawater samples were collected at different points along the coast of the city of Mar del Plata (Buenos Aires, Argentina). Environmental parameters were determined and physicochemical and bacteriological studies, morphological identification, cultures and molecular typification were conducted. Regardless of the environmental and bacteriological variables, the presence of Acanthamoeba spp. was molecularly confirmed in 54.54% of the samples, being the first report of these protozoa in seawater in Argentina.

Procedimiento de evaluación de la fase inicial del tiro libre del baloncesto

El procedimiento que se presenta se elaboró con el objetivo de determinar indicadores para la evaluación de la fase inicial del tiro libre del baloncesto, en la categoría 9-10 años. En la confección del mismo, se tuvieron en cuenta los bajos porcientos de efectividad tanto en intentados y anotados, como las deficiencias en la ejecución obtenidas en el estudio preliminar, realizado a 120 niños de la zona occidental, con un dominio de solo el 25 % de los aspectos biomecánicos a alcanzar, en el proceso de enseñanza; ello constituyó una de las principales motivaciones para la confección del procedimiento evaluativo. El análisis documental, la observación a través de guías estructuradas y las técnicas de videografía, así como la entrevista, permitieron detectar las insuficiencias en la evaluación de la ejecución del tiro libre en la iniciación deportiva. En el trabajo, se realizó la valoración, mediante criterio de especialistas y criterio de usuarios, y deja abierto un espacio para ampliar acciones de orden metodológico y de carácter científico, técnico, fisiológico, teórico y psicológico que sirvan al desarrollo de los profesores y entrenadores de base.

O procedimento apresentado foi elaborado com o objetivo de determinar indicadores para a avaliação da fase inicial do lance livre no basquetebol, na categoria de 9 a 10 anos de idade. Em sua elaboração, foram levados em conta os baixos percentuais de eficácia tanto nos arremessos tentados como nos arremessos marcados, bem como as deficiências na execução obtidas no estudo preliminar, realizado em 120 crianças da zona oeste, com um domínio de apenas 25% dos aspectos biomecânicos a serem alcançados no processo de ensino; isso constituiu uma das principais motivações para a elaboração do procedimento de avaliação. A análise documental, a observação por meio de guias estruturados e técnicas de videografia, bem como a entrevista, permitiram detectar as insuficiências na avaliação da execução do lance livre na iniciação esportiva. No trabalho, a avaliação foi realizada por meio de critérios de especialistas e critérios de usuários, e deixa um espaço aberto para ampliar ações de ordem metodológica e de natureza científica, técnica, fisiológica, teórica e psicológica que sirvam ao desenvolvimento de professores e treinadores de base.

The procedure presented was developed with the objective of determining indicators for the evaluation of the initial phase of the basketball free throw, in the 9-10-year-old category. In its preparation, the low percentages of effectiveness in both attempted and scored were taken into account, as well as the deficiencies in execution obtained in the preliminary study, carried out on 120 children from the western zone, with a mastery of only 25% of the biomechanical aspects to be achieved in the teaching process; this constituted one of the main motivations for the preparation of the evaluation procedure. The documentary analysis, observation through structured guides and videography techniques, as well as the interview, made it possible to detect insufficiencies in the evaluation of the execution of the free throw in sports initiation. In the work, the assessment was carried out, through the criteria of specialists and the criteria of users, and leaves open a space to expand actions of a methodological order and of a scientific, technical, physiological, theoretical and psychological nature that serve the development of teachers and coaches. base.

Dietas populares y su impacto en la piel. Una revisión narrativa / Popular Diets and Skin Effects: A Narrative Review

Se han popularizado diversas dietas para perder peso, incrementar la capacidad física y para el manejo de múltiples enfermedades crónicas: cardiovasculares, neurológicas o cutáneas. Destacan la dieta cetogénica y el ayuno intermitente, con resultados prometedores en la medicina tradicional y deportiva. Además, la dieta mediterránea se ha consolidado como una forma de alimentación de impacto positivo muy significativo en la salud. Otras dietas populares son la dieta «paleo», la dieta vegana y la libre de gluten. La dieta cetogénica, el ayuno intermitente y la dieta mediterránea aportan resultados favorables en dermatosis inflamatorias como la psoriasis, dermatitis atópica, hidradenitis supurativa o acné. La dieta mediterránea podría actuar también como factor protector para el desarrollo de algunas neoplasias cutáneas. En este artículo presentamos una revisión del papel de diversas dietas populares en el manejo de dermatosis. (AU)

Numerous diets for losing weight, building strength, and managing a range of cardiovascular, neurologic, and skin diseases have become popular in recent years. The ketogenic diet and intermittent fasting in particular have shown promising results in clinical and sports medicine. The Mediterranean diet, in turn, is widely recognized for its numerous health benefits. Also popular are the paleo diet and vegan and gluten-free diets. Positive effects on inflammatory conditions, such as psoriasis, atopic dermatitis, hidradenitis suppurativa, and acne, have been observed in patients who practice intermittent fasting or follow ketogenic or Mediterranean diets. This last choice may also protect against certain skin cancers. We review the role of several popular diets in the management of skin disorders. (AU)

Abemaciclib as adjuvant treatment for high-risk early breast cancer / Abemaciclib en adyuvancia para el tratamiento del cáncer de mama precoz de alto riesgo

Objective: To adapt the GHEMA report of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6. European Medicines Agency authorization (April 2022) includes, in combination with endocrine therapy, the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive, early breast cancer at high risk of recurrence. Method: The efficacy and safety of abemaciclib were evaluated in a randomized, open-label, and multicenter phase III study. A total of 5637 patients diagnosed with early breast cancer with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive, and high risk of recurrence were included. High risk was defined as patients with 4 or more positive axillary lymph nodes, or 1–3 positive axillary lymph nodes and at least one of the following: tumor size ≥5 cm, histologic grade 3, or Ki-67≥20%. Patients were randomized (1:1) to receive adjuvant abemaciclib+endocrine therapy (n = 2808) or endocrine therapy alone (n = 2829) for 2 years, with endocrine therapy prescribed for at least 5 years. Results: With a median follow-up of 15.5 months, abemaciclib+endocrine therapy demonstrated a statistically significant improvement in invasive disease-free survival versus endocrine therapy alone [HR = 0.747 (95% CI 0.598–0.932), P = 0.0096]; achieving an absolute improvement of 3.5% invasive disease-free survival rate at 2-years. These results were maintained, with a median follow-up of 27.7 months: absolute improvement of 2.7% and 5.4% in invasive disease-free survival rate at 2 and 3 years, respectively. All-causality grade 3 or 4 adverse events were 45.9% for abemaciclib and 12.9% for endocrine therapy, and included neutropenia (19.6% vs. 0.8%), leukopenia (11.4% vs. 0.4%), and diarrhea (7.8% vs. 0.2%). Conclusions: The results of the pivotal trial are sufficient to consider abemaciclib as adjuvant treatment for...(AU)

Objetivo: Adaptar el informe GHEMA de abemaciclib, un inhibidor de quinasas dependientes de ciclinas 4 y 6, con autorización de la Agencia Europea del Medicamento en abril de 2022 para el tratamiento adyuvante de pacientes adultos con cáncer de mama precoz, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo, con afectación ganglionar y riesgo elevado de recaída; en combinación con hormonoterapia. Método: La eficacia y seguridad de abemaciclib se evaluó en un estudio fase III multicéntrico, aleatorizado y abierto. Se incluyeron 5.637 pacientes diagnosticados de cáncer de mama precoz con ganglios positivos, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo y alto riesgo de recaída. El criterio de alto riesgo se definió como la presencia de ≥ 4 ganglios positivos, o de 1–3 ganglios y al menos una de las siguientes características: tamaño del tumor ≥5 cm, grado histológico 3 o Ki-67 ≥ 20%. Los pacientes fueron aleatorizados (1:1) a recibir durante 2 años abemaciclib + hormonoterapia (n = 2.808) u hormonoterapia sola (n = 2.829). En ambos brazos el tratamiento con hormonoterapia se mantuvo mínimo 5 años. Resultados: Con una mediana de seguimiento de 15,5 meses, abemaciclib + hormonoterapia mostró beneficio significativo frente a la hormonoterapia sola [HR = 0,747 (IC95% 0,598-0,932), p = 0,0096], con una mejora absoluta del 3,5% en la tasa de supervivencia libre de enfermedad invasiva a 2 los años. Este beneficio se mantuvo con una mediana de seguimiento de 27,7 meses, logrando una mejora en la tasa de supervivencia libre de enfermedad invasiva del 2,7% y del 5,4% a los 2 y 3 años, respectivamente. La incidencia de efectos adversos grado 3–4 fue superior en el brazo de abemaciclib (45,9% vs. 12,9%); e incluía neutropenia (19,6% vs. 0,8%), leucopenia (11,4% vs. 0,4%) y diarrea (7,8% vs. 0,2%). Conclusiones: Los resultados del ensayo pivotal son suficientes para considerar abemaciclib como...(AU)

Abemaciclib en adyuvancia para el tratamiento del cáncer de mama precoz de alto riesgo / Abemaciclib as adjuvant treatment for high-risk early breast cancer

Objective: To adapt the GHEMA report of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6. European Medicines Agency authorization (April 2022) includes, in combination with endocrine therapy, the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive, early breast cancer at high risk of recurrence. Method: The efficacy and safety of abemaciclib were evaluated in a randomized, open-label, and multicenter phase III study. A total of 5637 patients diagnosed with early breast cancer with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive, and high risk of recurrence were included. High risk was defined as patients with 4 or more positive axillary lymph nodes, or 1–3 positive axillary lymph nodes and at least one of the following: tumor size ≥5 cm, histologic grade 3, or Ki-67≥20%. Patients were randomized (1:1) to receive adjuvant abemaciclib+endocrine therapy (n = 2808) or endocrine therapy alone (n = 2829) for 2 years, with endocrine therapy prescribed for at least 5 years. Results: With a median follow-up of 15.5 months, abemaciclib+endocrine therapy demonstrated a statistically significant improvement in invasive disease-free survival versus endocrine therapy alone [HR = 0.747 (95% CI 0.598–0.932), P = 0.0096]; achieving an absolute improvement of 3.5% invasive disease-free survival rate at 2-years. These results were maintained, with a median follow-up of 27.7 months: absolute improvement of 2.7% and 5.4% in invasive disease-free survival rate at 2 and 3 years, respectively. All-causality grade 3 or 4 adverse events were 45.9% for abemaciclib and 12.9% for endocrine therapy, and included neutropenia (19.6% vs. 0.8%), leukopenia (11.4% vs. 0.4%), and diarrhea (7.8% vs. 0.2%). Conclusions: The results of the pivotal trial are sufficient to consider abemaciclib as adjuvant treatment for...(AU)

Objetivo: Adaptar el informe GHEMA de abemaciclib, un inhibidor de quinasas dependientes de ciclinas 4 y 6, con autorización de la Agencia Europea del Medicamento en abril de 2022 para el tratamiento adyuvante de pacientes adultos con cáncer de mama precoz, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo, con afectación ganglionar y riesgo elevado de recaída; en combinación con hormonoterapia. Método: La eficacia y seguridad de abemaciclib se evaluó en un estudio fase III multicéntrico, aleatorizado y abierto. Se incluyeron 5.637 pacientes diagnosticados de cáncer de mama precoz con ganglios positivos, receptor hormonal positivo, receptor del factor de crecimiento epidérmico negativo y alto riesgo de recaída. El criterio de alto riesgo se definió como la presencia de ≥ 4 ganglios positivos, o de 1–3 ganglios y al menos una de las siguientes características: tamaño del tumor ≥5 cm, grado histológico 3 o Ki-67 ≥ 20%. Los pacientes fueron aleatorizados (1:1) a recibir durante 2 años abemaciclib + hormonoterapia (n = 2.808) u hormonoterapia sola (n = 2.829). En ambos brazos el tratamiento con hormonoterapia se mantuvo mínimo 5 años. Resultados: Con una mediana de seguimiento de 15,5 meses, abemaciclib + hormonoterapia mostró beneficio significativo frente a la hormonoterapia sola [HR = 0,747 (IC95% 0,598-0,932), p = 0,0096], con una mejora absoluta del 3,5% en la tasa de supervivencia libre de enfermedad invasiva a 2 los años. Este beneficio se mantuvo con una mediana de seguimiento de 27,7 meses, logrando una mejora en la tasa de supervivencia libre de enfermedad invasiva del 2,7% y del 5,4% a los 2 y 3 años, respectivamente. La incidencia de efectos adversos grado 3–4 fue superior en el brazo de abemaciclib (45,9% vs. 12,9%); e incluía neutropenia (19,6% vs. 0,8%), leucopenia (11,4% vs. 0,4%) y diarrea (7,8% vs. 0,2%). Conclusiones: Los resultados del ensayo pivotal son suficientes para considerar abemaciclib como...(AU)

Characteristics of gastrointestinal stromal tumors associated to other tumors / Características de los tumores del estroma gastrointestinal asociados a otras neoplasias

Introduction: Our aim is to analyze the differences between sporadic gastrointestinal stromal tumors and those associated with other tumors. Methods: Retrospective cohort study including patients with diagnosis of gastrointestinal stromal tumors operated at our center. Patients were divided into two groups, according to whether or not they had associated other tumors, both synchronously and metachronously. Disease free survival and overall survival were calculated for both groups. Results: 96 patients were included, 60 (62.5%) were male, with a median age of 66.8 years (35–84). An association with other tumors was found in 33 cases (34.3%); 12 were synchronous (36.3%) and 21 metachronous (63.7%). The presence of mutations in associated tumors was 70% and in non-associated tumors 75%. Associated tumors were classified as low risk tumors based on Fletcher's stratification scale (p=0.001) as they usually were smaller in size and had less than ≤5 mitosis per 50 HPF compared to non-associated tumors. When analyzing overall survival, there were statistically significant differences (p=0.035) between both groups. Conclusion: The relatively high proportion of gastrointestinal stromal tumors cases with associated tumors suggests the need to carry out a study to rule out presence of a second neoplasm and a long-term follow-up should be carried out in order to diagnose a possible second neoplasm. Gastrointestinal stromal tumors associated with other tumors have usually low risk of recurrence with a good long-term prognosis.(AU)

Introducción: El objetivo de este estudio es analizar si existen diferencias entre los GIST esporádicos y los que se presentan asociados a otros tumores. Métodos: Estudio de cohorte retrospectivo de pacientes operados de tumores del estroma gastrointestinal (GIST) en nuestro centro. Se dividió a los pacientes en función de si presentaban otros tumores asociados o no, de forma sincrónica o metacrónica. La supervivencia libre de enfermedad y la supervivencia global se calcularon en ambos grupos. Resultados: Se incluyeron un total de 96 pacientes, 60 (62,5%) eran hombres con una media de edad de 66,8 años (35-84). Se encontró una asociación con otros tumores en 33 casos (34,3%); 12 de manera sincrónica (36,3%) y 21 metacrónica (63,7%). La presencia de mutaciones en el grupo de tumores asociados fue de 70% y en el de no asociados de 75%. Los tumores asociados se clasificaron como tumores de bajo riesgo según la escala de Fletcher (p = 0,001), ya que fueron de menor tamaño y presentaron menos de ≤ 5 mitosis por 50 HPF en comparación con los no asociados. Al analizar la supervivencia global, hubo diferencias estadísticamente significativas entre ambos grupos (p = 0,035). Conclusión: La proporción relativamente alta de casos de GIST con tumores asociados sugiere la necesidad de realizar un estudio para descartar la presencia de una segunda neoplasia y, tras el tratamiento de GIST, elaborar un seguimiento a largo plazo para diagnosticar una posible segunda neoplasia. Los GIST asociados a otros tumores suelen tener un riesgo bajo de recurrencia con un buen pronóstico a largo plazo.(AU)

Glycemic Control in Patients with Type 1 Diabetes: Comparison of Holidays versus Schooldays.

BACKGROUND AND AIMS: To examine the influence of school life in children and adolescents with type 1 diabetes (T1D) by comparing the glycemic control and Ambulatory Glucose Profile (AGP) between the holidays and schooldays. METHODS: This is a retrospective study conducted on 147 patients with T1D (14-19 years) who used an intermittently scanned Continuous Glucose Monitoring (isCGM) system to self-test their glucose levels during the periods of school time and holiday time. A record was maintained of the Continuous Glucose Monitoring (CGM) metrics i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time above Range (TAR), Time below Range (TBR), and average time period of the hypoglycemic events during schooldays and the holidays. RESULTS: The study revealed differences between the recorded values during the holidays and schooldays, in % in target 70-180 mg/dL (38.2 vs 49.5; p = 0.039), mean glucose (194 vs 185; p = 0.048), frequency of low glucose events (9.2 vs 5.1; p = 0.036), mean duration of low glucose levels (117 vs 65; p = 0.021), % TBR below 70 mg/dL (2.9 vs 1.45; p = 0.023), % TBR below 54 mg/dL (1.1 vs 0.51; p = 0.031), TAR 181-250 mg/dL (21.1 vs 16.5; p = 0.037) and TAR >250 mg/dL (8.9 vs 6.5; p=0.043). On comparing the HbA1c levels of the study population recorded during the holidays (8.34%) with those recorded during the schooldays (8.13%), the HbA1c values during the school days were observed to be lower; however, no significant changes were noted in the HbA1c level between the holidays and schooldays. Concerning the FreeStyle Libre (FSL) scanning, the frequency during the holidays (n=6.2) was significantly lower than during the schooldays (n=9.5) (p=0.042). CONCLUSION: From the findings, it appears that children with T1D have good diabetes control during schooldays rather than during the holidays. To improve their glucose control during the holidays, these patients may also benefit from receiving greater attention and guidance.

Proposed treatment strategy for reactive hypoglycaemia.

Background/aim: Managing reactive hypoglycaemia (RH) poses challenges due to limited and often ineffective treatment options. We report a case series and draw on this to propose a stepwise treatment approach consisting of lifestyle modifications, metformin, GLP-1 analogues, and the use of flash glucose monitoring technology. Method: A retrospective review was conducted to analyse the management of 11 cases presenting with recurrent RH symptoms. Result: Two patients experienced successful resolution of symptoms through lifestyle modifications. Metformin alone was effective in treating seven out of nine patients who received pharmacological treatment. Two patients with previous upper gastrointestinal surgery showed a partial response to metformin and benefited further from additional long-acting GLP-1 analogue. Pharmacological intervention led to significant reductions in insulin and C-peptide levels in repeat mixed meal tolerance tests (P-values 0.043 for insulin and 0.006 for C-peptide). Finally, flash glucose monitoring technology was useful in early detection and preventing episodes of hypoglycaemia in one of these patients with persistent symptoms. Conclusion: These findings highlight the potential efficacy of escalated treatment strategies for RH, including the use of metformin, GLP-1 analogues, and flash glucose monitoring technology.

Encefalitis amebiana granulomatosa por Balamuthia mandrillaris en Chile confirmada con secuenciación de ADN / Granulomatous amoebic encephalitis due to Balamuthia mandrillaris in Chile confirmed with DNA sequencing

Las enfermedades causadas por amebas de vida libre son infecciones oportunistas que pueden tener un curso fatal. Pueden producir afecciones diseminadas graves con compromiso del sistema nervioso central, como la encefalitis amebiana granulomatosa. Esta infección es cada vez más frecuente en América Latina, aunque se reconocen tardíamente debido a la similitud con otras patologías o porque es inusual incluirla en el diagnóstico diferencial. Comunicamos un caso fatal de una encefalitis amebiana granulomatosa por Balamuthia mandrillaris en una niña de 10 años. Destacamos la gravedad de la afectación cerebral y la falta de esquemas antimicrobianos validados para su tratamiento. Hoy en el mundo esta infección es considerada una enfermedad emergente, influenciada por el cambio climático, lo que llama a estar atentos a su presencia.

Diseases caused by free-living amoebae are opportunistic infections that can have a fatal course. They can cause very serious disseminated conditions with involvement of the central nervous system such as granulomatous amoebic encephalitis. This infection has become more common in Latin America, although its recognition is late due to the similarity with other pathological conditions or because it is unusual to include it in the differential diagnosis. We report a fatal case of granulomatous amoebic encephalitis due to Balamuthia mandrillaris in a 10-year-old girl. We highlight the severity of the brain involvement and the lack of validated schemes for its treatment. Today in the world this infection is considered an emerging disease, influenced by climate change, which calls for being attentive to its presence.