Development of ISB 1442, a CD38 and CD47 bispecific biparatopic antibody innate cell modulator for the treatment of multiple myeloma.

Antibody engineering can tailor the design and activities of therapeutic antibodies for better efficiency or other advantageous clinical properties. Here we report the development of ISB 1442, a fully human bispecific antibody designed to re-establish synthetic immunity in CD38+ hematological malignancies. ISB 1442 consists of two anti-CD38 arms targeting two distinct epitopes that preferentially drive binding to tumor cells and enable avidity-induced blocking of proximal CD47 receptors on the same cell while preventing on-target off-tumor binding on healthy cells. The Fc portion of ISB 1442 is engineered to enhance complement dependent cytotoxicity, antibody dependent cell cytotoxicity and antibody dependent cell phagocytosis. ISB 1442 thus represents a CD47-BsAb combining biparatopic targeting of a tumor associated antigen with engineered enhancement of antibody effector function to overcome potential resistance mechanisms that hamper treatment of myeloma with monospecific anti-CD38 antibodies. ISB 1442 is currently in a Phase I clinical trial in relapsed refractory multiple myeloma.

Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial.

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. METHODS/DESIGN: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-ß), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. DISCUSSION: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. TRIAL REGISTRATION: ISRCTN27483786. Registered on August 2, 2023.

Virus de la leucemia e inmunodeficiencia felina: un estudio retrospectivo en clínicas veterinarias particulares en Bogotá y Chía (Colombia), 2015-2019 / Leukemia viruses and feline immunodeficiency: a retrospective study in private veterinary clinics in Bogotá and Chía (Colombia), 2015-2019

Resumen Los virus de inmunodeficiencia y leucemia felina representan un problema de gran envergadura para los felinos domésticos debido a la multiplicidad de sintomatologías que manifiestan. El objetivo del presente estudio fue establecer, retrospectivamente, la prevalencia en la presentación de ViLeF y VIF en pacientes de seis clínicas de pequeños animales en Bogotá y Chía, en relación con factores como su edad, raza y género. Se realizó un estudio transversal y retrospectivo, mediante la recopilación de datos de 1.014 historias clínicas de pacientes felinos que ingresaron a seis clínicas de la ciudad de Bogotá y Chía, para determinar la prevalencia de VIF y ViLeF y la asociación de estas con factores como edad, género y raza, entre 2015 y 2019, a través de la prueba OR. La detección de los virus se realizó mediante una prueba rápida basada en inmunocromatografía. La mayor prevalencia para cada enfermedad por año fue: 12,3% para VIF en 2012 y 18% para ViLeF en 2019. Los machos presentaron mayores seroprevalencias para ambas enfermedades durante la mayoría los años evaluados. Factores como raza (criolla: VIF: 1,85; ViLeF: 2,01), género (macho: VIF: 1,53 OR; ViLeF: 1,64) y edad (> 7 años: VIF: 3,82; ViLeF: 3,21) se relacionaron positivamente con la presentación de ambas enfermedades en la población felina evaluada.

Abstract Immunodeficiency virus and feline leukemia virus represent major problems for domestic felines due to the multiplicity of symptoms they manifest. The objective of the present study was to establish, retrospectively, the prevalence in the presentation of FeLV and FIV in patients from six small animal clinics in Bogota and Chia, related to factors such as age, race, and gender. A cross-sectional and retrospective study was carried out, collecting data from 1.014 clinical records of feline patients who were admitted to six clinics in the city of Bogota and Chia, to determine the prevalence of FIV and FeLV and their association with factors such as age, gender, and race, between 2015 and 2019 through the OR test. The detection of the viruses was carried out through a rapid test based on immunochromatography. The highest prevalence for each disease per year was 12,3% for FIV in 2012 and 18% for FeLV in 2019. Males presented higher seroprevalences for both diseases during most of the years evaluated. Factors such as race (Creole: FIV: 1,85; FeLV: 2,01), gender (male: FIV: 1.53 OR, FeLV: 1,64), and age (> 7 years: FIV: 3.82; FeLV: 3.21) were positively related to the presentation of both diseases in the feline population evaluated.

El buceo recreativo y la otorrinolaringología: ¿qué sabemos y deberíamos saber? / Recreational diving and otolaryngology: what do we know and should we know?

El buceo recreativo es una práctica cada vez más popular en la población mundial, sin embargo, no está exenta de riesgos. A medida que transcurre una inmersión, el buzo es susceptible a una serie de cambios de presión que afectan las distintas cavidades que contienen aire dentro del cuerpo humano, tales como el oído, cavidades paranasales y los pulmones. Existe un gran espectro de patologías asociadas al buceo, explicándose la mayoría de ellas por el barotrauma asociado, cuya gravedad depende de la magnitud del daño asociado, pudiendo presentar desde manifestaciones a nivel local, así como también a nivel sistémico. Las patologías otológicas suelen ser las más frecuentes y el principal motivo de consulta en este tipo de pacientes. Sin embargo, las afecciones otoneurológicas, rinosinusales, de vía aérea y sistémicas pueden ser comunes dependiendo de cada perfil de buceo. Actualmente no existen recomendaciones locales sobre esta práctica, por lo que el conocimiento de la fisiología, fisiopatología y el tratamiento de las patologías otorrinolaringológicas asociadas deben ser conocidas a medida que este deporte se vuelve cada vez más popular. Se realizó una revisión de la literatura sobre las distintas afecciones otorrinolaringológicas con el fin de sistematizarlas y elaborar recomendaciones para establecer una práctica segura.

Recreational diving is an increasingly popular practice in the world; however, it is not without risks. As a dive progresses, the diver is susceptible to a series of pressure changes that affect the air-containing cavities, such as the ear, paranasal cavities, and lungs. There is a large spectrum of pathologies associated with diving, most of them being explained by associated barotrauma, the severity of which depends on the magnitude of the associated damage, could present local manifestations, as well as at systemic level. Otological pathologies are usually the most frequent and the main reason for consultation in this type of patients, however, otoneurological, rhinosinusal, airway and systemic conditions can be common depending on each diving profile. Currently there are no local recommendations on this practice, therefore, knowledge of the physiology, pathophysiology and treatment of associated otorhinolaryngological pathologies should be known as this sport becomes increasingly popular. A review of the literature on the different ear, nose and throat conditions was carried out in order to systematize them and develop recommendations to establish a safe practice.

The challenge of quantifying screening colonoscopy quality: Development and psychometric properties of the Colonoscopy Quality Score instrument.

INTRODUCTION AND AIMS: Colonoscopy quality is measured by the degree in which the examination increases the likelihood of obtaining adequate results on health. Our aim was to develop an instrument for evaluating the quality of screening colonoscopies, taking into account the performance of endoscopists and endoscopy units. MATERIALS AND METHODS: Mixed methodology was employed. The first stage (qualitative) consisted of a Medline search, from which a group of experts developed the quality score items. The second stage (quantitative) utilized a modified Delphi technique to reach consensus (3 rounds). We evaluated the psychometric properties of the instrument (reliability and construct validity) in elective screening colonoscopies (in patients ≥ 50 years of age), performed within the January-April 2017 time frame. RESULTS: A final instrument with 8 items was produced: (1) the Boston Bowel Preparation Scale score; (2) cecal intubation rate; (3) colonoscopy withdrawal time; (4) image documentation; (5) adenoma detection rate; (6) endoscopic surveillance planning; (7) perforation rate, and (8) continuous improvement programs. The instrument was evaluated in 323 colonoscopies performed by 31 endoscopists and found to be one-dimensional and reliable (Cronbach's alpha 0.76). Performance was compared between endoscopists (center 1) and an expert endoscopist from another center (center 2): Boston Bowel Preparation Scale score 8.3 vs. 7.36 (P < .001), cecal intubation rate 93.5 vs. 96%, colonoscopy withdrawal time 14.8 vs. 8.4 min (P < .001), and adenoma detection rate 34 vs. 52.2% (P < .001), respectively. CONCLUSION: The Colonoscopy Quality Score is a reliable and valid instrument for evaluating screening colonoscopy quality. Its results could be adapted to the usual endoscopic report to adjust monitorization frequency post-colonoscopy.

The challenge of quantifying screening colonoscopy quality: Development and psychometric properties of the Colonoscopy Quality Score instrument. / El desafío de cuantificar la calidad de la colonoscopia de tamizaje: el desarrollo y las propiedades psicométricas de la Escala de Calidad en Colonoscopia.

INTRODUCTION AND AIMS: Colonoscopy quality is measured by the degree in which the examination increases the likelihood of obtaining adequate results on health. Our aim was to develop an instrument for evaluating the quality of screening colonoscopies, taking into account the performance of endoscopists and endoscopy units. MATERIALS AND METHODS: Mixed methodology was employed. The first stage (qualitative) consisted of a Medline search, from which a group of experts developed the quality score items. The second stage (quantitative) utilized a modified Delphi technique to reach consensus (3 rounds). We evaluated the psychometric properties of the instrument (reliability and construct validity) in elective screening colonoscopies (in patients≥50 years of age), performed within the January-April 2017 time frame. RESULTS: A final instrument with 8 items was produced: 1) the Boston Bowel Preparation Scale score; 2) cecal intubation rate; 3) colonoscopy withdrawal time; 4) image documentation; 5) adenoma detection rate; 6) endoscopic surveillance planning; 7) perforation rate, and 8) continuous improvement programs. The instrument was evaluated in 323 colonoscopies performed by 31 endoscopists and found to be one-dimensional and reliable (Cronbach's alpha 0.76). Performance was compared between endoscopists (center 1) and an expert endoscopist from another center (center 2): Boston Bowel Preparation Scale score 8.3 vs. 7.36 (P<.001), cecal intubation rate 93.5 vs. 96%, colonoscopy withdrawal time 14.8 vs. 8.4min (P<.001), and adenoma detection rate 34 vs. 52.2% (P<.001), respectively. CONCLUSION: The Colonoscopy Quality Score is a reliable and valid instrument for evaluating screening colonoscopy quality. Its results could be adapted to the usual endoscopic report to adjust monitorization frequency post-colonoscopy.

The effect of salinity on enterocytozoon hepatopenaei infection in Penaeus vannamei under experimental conditions.

BACKGROUND: Enterocytozoon hepatopenaei (EHP) is an enteric pathogen that affects Penaeus vannamei and Penaeus monodon shrimp in many SE Asian countries. In the western hemisphere, EHP was reported for the first time in 2016 in farmed P. vannamei in Venezuela. Anecdotal evidence suggests that EHP is more prevalent in grow-out ponds where the salinity is high (> 15 parts per thousand (ppt)) compared to grow-out ponds with low salinities (< 5 ppt). Considering that P. vannamei is an euryhaline species, we were interested in knowing if EHP can propagate in P. vannamei in low salinities. RESULTS: In this study, we described an experimental infection using fecal strings as a source inoculum. Specific Pathogen Free (SPF) P. vannamei were maintained at three different salinities (2 ppt, 15 ppt, and 30 ppt) while continuously challenged using feces from known EHP-infected P. vannamei over a period of 3 weeks. The fecal strings, used as a source of EHP inocula in the challenges, was sufficient to elicit an infection in shrimp maintained at the three salinities. The infectivity of EHP in shrimp reared at 2 ppt, 15 ppt, and 30 ppt salinities was confirmed by PCR and histopathology. The prevalence and the severity of the EHP infection was higher at 30 ppt than at 2 ppt and 15 ppt. CONCLUSION: The data suggests that fecal strings are a reliable source of EHP inoculum to conduct experimental challenges via the fecal-oral route. An EHP infection can occur at a salinity as low as 2 ppt, however, the prevalence and the severity of the EHP infection is higher at a salinity of 30 ppt.

First record of clinical coccidiosis (Eimeria ovinoidalis) in adult sheep from northwestern Argentina.

Coccidiosis of sheep is an intestinal infection caused by protozoa of the genus Eimeria. An outbreak of the disease in adult sheep from Salta province, northwestern Argentina, was studied to establish its clinical, epidemiological, pathological and etiological aspects. The affected animals were part of a flock of 20 sheep brought from Formosa province about 10 days before. Most sheep (80% incidence) showed hemorrhagic diarrhea, dehydration and loss of body condition; six of them died and two that became permanently recumbent were euthanized. Three necropsied sheep showed mild mesenteric lymphadenomegaly, diffuse proliferative enteritis in the small and large intestines, and mucosal thickening. Histopathological studies exhibited diffuse proliferative enteritis and presence of structures compatible with intracellular coccidia at different stages of development. Parasitological studies (n = 12) resulted in an average of 16,636.6 (± 15,266.8) Eimeria oocysts per gram of feces (range 1680-46,400). Taxonomy of Eimeria species based on analysis of sporulated oocysts derived from 4 fecal samples (n = 100 oocyst per sample) showed, on average, a high prevalence of E. ovinoidalis (61.5%), followed by E. parva (27.2%), and lower proportions of E. crandallis (5.3%), E. ahsata (3.2%) and E. intricata (2.8%). Clinical and pathological findings confirmed the diagnosis of coccidiosis in the affected sheep; parasitological results showed that E. ovinoidalis was the main species responsible for the clinical signs. Clinical coccidiosis is considered unusual in adult sheep, but the present case shows that under favorable environmental and/or management conditions, this infection may be highly deleterious for adult sheep.

Resultados auditivos del tratamiento quirúrgico de la otoesclerosis en el departamento de otorrinolaringología de la Pontificia Universidad Católica de Chile / Auditory results of surgical treatment of otosclerosis in the department of otolaryngology of the Pontificia Universidad Católica de Chile

RESUMEN Introducción: La otoesclerosis representa la causa de hipoacusia de conducción más común en adultos jóvenes. Las opciones de tratamiento incluyen amplificación mediante audífonos o resolución quirúrgica a través de cirugías como estapedectomía total o parcial, estapedostomía o implante coclear. Objetivo: Describir los resultados del tratamiento quirúrgico de la otoesclerosis en el Departamento de Otorrinolaringología del Hospital Clínico de la Pontificia Universidad Católica de Chile entre los años 1999 y 2018. Material y método: Se realizó un estudio de cohorte no concurrente con revisión de fichas clínicas y protocolos operatorios de pacientes atendidos en nuestro centro. Se registraron y analizaron las características biodemográficas de los pacientes, técnicas quirúrgicas, resultados auditivos, complicaciones, necesidad de reintervención y uso de audífono. Resultados: De un total de 78 pacientes sometidos a estapedectomía parcial (platinectomía parcial) o estapedostomía se incluyeron finalmente 37 quienes tenían datos clínicos completos, lo que corresponde al 47,4% del total. En ambos tipos de cirugía el promedio de gap óseo-aéreo varió de 30,8 dB en el preoperatorio a 13,9 dB en el posoperatorio lo cual es estadísticamente significativo. El promedio de variación de la vía aérea, éste fue mayor en el grupo de pacientes operados de estapedostomía, sin existir diferencias estadísticamente significativas al realizar test no paramétricos. Conclusión: Las características demográficas y los resultados auditivos obtenidos en nuestro centro son comparables con los descritos en la literatura. No existen diferencias significativas en cuanto al tipo de cirugía y la frecuencia y tipo de complicaciones, aunque se observan mejores resultados auditivos en los pacientes operados de estapedostomía.

ABSTRACT Introduction: Otosclerosis represents the most common cause of hearing loss in young adults. Treatment options include amplification with hearing aids or surgical resolution with surgeries such as total and partial stapedectomy, stapedostomy or cochlear implant. Aim: To describe the results of the surgical treatment of otosclerosis in the Otorhinolaryngology Department of the Clinical Hospital of the Pontificia Universidad Católica de Chile between the years 1999 and 2018 Material and method: A non-concurrent cohort study was performed with review of clinical files and operative protocols of patients seen in our center. The biodemographic characteristics of the patients, surgical techniques, auditory results, complications, need for reoperation and use of hearing aid were recorded and analyzed. Results: Of a total of 78 patients undergoing partial stapedectomy or stapedostomy, 37 were finally included, who had complete clinical data, which corresponds to 47.4% of the total. In both types of surgery, the average bone-air gap varied from 30.8 dB in the preoperative to 13.9 dB in the postoperative period, which is statistically significant. Regarding the average of variation of the airway, this was higher in the group of patients operated by stapedostomy without statistically significant differences when performing nonparametric tests. Conclusion: The demographic characteristics and the auditory results obtained in our center are comparable with those described in the literature. There are no significant differences in the type of surgery and the frequency and type of complications, although better hearing results are observed in patients operated by stapedostomy.

Effects of processing on structural, mechanical and biological properties of collagen-based substrates for regenerative medicine.

The aim of this work was to investigate the structural features of type I collagen isoforms and collagen-based films at atomic and molecular scales, in order to evaluate whether and to what extent different protocols of slurry synthesis may change the protein structure and the final properties of the developed scaffolds. Wide Angle X-ray Scattering data on raw materials demonstrated the preferential orientation of collagen molecules in equine tendon-derived collagens, while randomly oriented molecules were found in bovine skin collagens, together with a lower crystalline degree, analyzed by the assessment of FWHM (Full Width at Half Maximum), and a certain degree of salt contamination. WAXS and FT-IR (Fourier Transform Infrared) analyses on bovine collagen-based films, showed that mechanical homogenization of slurry in acidic solution was the treatment ensuring a high content of super-organization of collagen into triple helices and a high crystalline domain into the material. In vitro tests on rat Schwannoma cells showed that Schwann cell differentiation into myelinating cells was dependent on the specific collagen film being used, and was found to be stimulated in case of homogenization-treated samples. Finally DHT/EDC crosslinking treatment was shown to affect mechanical stiffness of films depending on collagen source and processing conditions.

Clinico-pathological findings in natural cases of "mascadera" in goats.

"Mascadera" is a chronic emaciating neuropathy affecting goats; it produces significant economic losses in many regions and its cause is unknown. Here, the histological lesions found in 15 animals naturally affected by the disease are described. Complete necropsy was performed and tissue samples were collected for histopathological study. Severe atrophy of the masseter and buccinator muscles and tongue was observed, as well as vacuolar degeneration of neurons in the nuclei of the trigeminal, facial, and glossopharyngeal nerves. No relevant lesions were observed in other tissues. These findings and the clinical signs are consistent with those observed by other authors in animals spontaneously and experimentally intoxicated with Prosopis juliflora. The disease may be due to consumption of a similar species present in our country that is still unknown. Further research on the etiology and pathogenesis of this disease is needed to establish appropriate prevention guidelines.

Single-Dose and Multiple-Dose Pharmacokinetics of Vaniprevir in Healthy Men.

Vaniprevir is an inhibitor of the hepatitis C virus (HCV) NS3/4A protease. The aim of these double-blind, placebo-controlled phase I studies was to evaluate the safety and pharmacokinetics of vaniprevir in healthy male volunteers. The primary objective for both studies was the safety and tolerability of vaniprevir. Single-dose and steady-state pharmacokinetics were also assessed. In both studies, there was no apparent relationship between the frequency or intensity of adverse events and vaniprevir dose. At single doses >20 mg, the plasma area under the curve (AUC)0-∞ and maximum concentration (Cmax ) increased in a greater-than-dose-proportional manner. The geometric mean ratios (GMRs; fed/fasted) were 1.22 and 0.79 for AUC0-∞ and Cmax , respectively. Following multiple doses, GMR accumulations for AUC0-12h and Cmax (day 14/day 1) ranged from 1.53 to 1.90 and from 1.41 to 1.92, respectively. These data support the use of vaniprevir with peginterferon and ribavirin in patients with HCV infection.

Spontaneous photosensitization by Heterophyllaea pustulata Hook. f. (Rubiaceae), in sheep from Northwestern Argentina.

Heterophyllaea pustulata Hook. f. (Rubiaceae) is a phototoxic plant. It grows in the Andean area of northwest of Argentina, and it causes significant economic losses in the livestock. This plant induces dermal lesions by photosensitization probably due to its content of photosensitizing anthraquinones. This paper describes an outbreak of poisoning in Corriedale sheepfold, which had an incidence of 49%. Ear skin biopsies and blood samples were collected of six affected animals. Liver enzymes remained within the reference limits. Histopathologically, a deep necrotizing dermatitis was identified in all samples. H. pustulata was identified in the areas of grazing. Anthraquinone concentration in leaves was 0.84% p/p, expressed as rubiadin. All findings allow us to conclude that the diagnosis is a primary photosensitization. Huge regional economic losses could be attributed to H. pustulata poisoning, although its toxicity has been little studied.

No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole.

Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open-label, three-period, fixed-sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed-dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single-dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole. Geometric mean ratios (GMRs) of grazoprevir AUC(0,∞), Cmax , and C24 (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 0.89-1.17. Similarly, GMRs of elbasvir AUC(0,∞), Cmax , and C24 (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 1.02-1.11. These results indicate that gastric acid-reducing agents do not modify the pharmacokinetics of elbasvir or grazoprevir in a clinically relevant manner and may be coadministered with elbasvir/grazoprevir in HCV-infected patients without restriction.

Interfibrillar packing of bovine cornea by table-top and synchrotron scanning SAXS microscopy.

Bovine cornea was studied with scanning small-angle X-ray scattering (SAXS) microscopy, by using both synchrotron radiation and a microfocus laboratory source. A combination of statistical (adaptive binning and canonical correlation analysis) and crystallographic (pair distribution function analysis) approaches allowed inspection of the collagen lateral packing of the supramolecular structure. Results reveal (i) a decrease of the interfibrillar distance and of the shell thickness around the fibrils from the periphery to the center of the cornea, (ii) a uniform fibril diameter across the explored area, and (iii) a distorted quasi-hexagonal arrangement of the collagen fibrils. The results are in agreement with existing literature. The overlap between laboratory and synchrotron-radiation data opens new perspectives for further studies on collagen-based/engineered tissues by the SAXS microscopy technique at laboratory-scale facilities.

Development of an E-learning System for the Endoscopic Diagnosis of Early Gastric Cancer: An International Multicenter Randomized Controlled Trial.

BACKGROUND: In many countries, gastric cancer is not diagnosed until an advanced stage. An Internet-based e-learning system to improve the ability of endoscopists to diagnose gastric cancer at an early stage was developed and was evaluated for its effectiveness. METHODS: The study was designed as a randomized controlled trial. After receiving a pre-test, participants were randomly allocated to either an e-learning or non-e-learning group. Only those in the e-learning group gained access to the e-learning system. Two months after the pre-test, both groups received a post-test. The primary endpoint was the difference between the two groups regarding the rate of improvement of their test results. FINDINGS: 515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to each group. Of these, 151 participants in the e-learning group and 144 in the non-e-learning group were included in the analysis. The mean improvement rate (standard deviation) in the e-learning and non-e-learning groups was 1·24 (0·26) and 1·00 (0·16), respectively (P<0·001). INTERPRETATION: This global study clearly demonstrated the efficacy of an e-learning system to expand knowledge and provide invaluable experience regarding the endoscopic detection of early gastric cancer (R000012039).

Informed consent in colonoscopy: A comparative analysis of 2 methods.

BACKGROUND: The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. MATERIALS AND METHODS: A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. RESULTS: The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). CONCLUSIONS: The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure.

Taponamiento cardiaco atípico por reservorio venoso central. ¿Podemos prevenirlo? / Atypical cardiac tamponade due to central venous catheter. Can we prevent it?

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Evidencia y uso actual de toxina botulínica en patología otorrinolaringológica / Evidence and actual use of botulinum toxin in otolaryngology

A partir de los primeros usos terapéuticos de la toxina botulínica su utilización se ha extendido a variadas ramas de la medicina incluyendo la otorrinolaringología. Se considera un medicamento seguro en manos de profesionales capacitados y su utilización se realiza a través de un procedimiento mínimamente invasivo con efectos adversos leves y transitorios. Se usa en un amplio número de patologías otorrinolaringológicas y de cabeza y cuello. Actualmente la toxina botulínica A representa la primera línea de tratamiento en pacientes con disfonía espasmódica y distonía cervical. Existe evidencia de buen nivel que recomienda su uso para el manejo de sialorrea, temblor laríngeo, trastornos de la ATM, bruxismo y rinitis en casos seleccionados. Presenta buenos resultados en otras patologías como espasmo faringoesofágico, síndrome de Frey y tinnitus, sin embargo, todavía son necesarios más estudios.

Since the first therapeutic uses of botulinum toxin its role has extended to a wide range of medicine áreas including otolaryngology. It is considered a safe medication in the hands of trained professionals and its application represents a minimally invasive procedure with mild and transient adverse effects. It has been used in a wide range of otolaryngology and head and neck pathologies. Today botulinum toxin a represents the first choice of treatment for patients with spasmodic dysphonia and cervical dystonia. There is good evidence that supports its use for shialorrea, laryngeal tremor, temporomandibular joint disorders, bruxism and selected cases of rhinitis. For pharyngo-oesophageal spasm, Frey's syndrome and tinnitus there have been studies that show a beneficial effect however more studies are required for routine recommendation.