Diseño de una metodología de planeación y monitoreo de los procesos clave del organismo nacional de acreditación para una proyección internacional de la acreditación

El siguiente trabajo se hizo con el objetivo de proporcionar a ONAC una metodología que apoye sus procesos internos y sea de utilidad para lograr el reconocimiento internacional por parte de los organismos pares. Mediante este reconocimiento no sólo estará beneficiada la imagen de ONAC como organismo de acreditación nacional, sino también facilitará el comercio colombiano, ya que las empresas que hayan demostrado que tienen la competencia técnica y obtengan un certificado de acreditación proveniente de ONAC, podrán comercializar sus productos (entiéndase tanto bienes como servicios) en otros países, pues se les brindará a éstos el cumplimiento de los requisitos mínimos de calidad necesarios para tener un intercambio comercial ideal con la garantía del respaldo de una entidad reconocida internacionalmente. Para la ejecución de este proyecto se realizó un análisis de la documentación de los procesos clave de la empresa determinando sus falencias y estableciendo planes de mejora y sistema de medición periódica de los mismos mediante el diseño de un cuadro de mando integral con indicadores de gestión, que permitió obtener una visión global de la empresa. Por último se realizó el diseño de un sistema de administración del riesgo tomando como base la NTC-ISO 31000, 2011, para integrarlo en el BSC y hacerlo parte de un proceso de mejora continua en la gestión interna de ONAC.This document was developed with the purpose to give to the national accreditation organism of Colombia (ONAC) a methodology that support all the intern process of the company and take it as a value for being recognized in the world as one of the countries with the international accreditation for pairs entities. Through this work will benefit not only the image of ONAC but also will get easy to Colombian companies have expanded to different parts of the world if they had the technical competencies and have a certification of ONAC. In other words; Colombian companies could import their products (goods and services) with the advantage of pass the minimum qualification requirements for the import process easier, since it has the support of an internationally recognized entity. For the development of the project an analysis of the documentation of key business processes was realized in order to determining their shortcomings and establishing improvement plans and periodic measurement system thereof by designing a scorecard with management indicators was conducted; that provided a comprehensive overview of the company. Finally the design of a risk management system is made based on the NTC- ISO 31000,2011, to integrate the BSC and make it part of a process of continuous improvement in the internal management of ONAC.Ingeniero (a) IndustrialPregrad

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study

Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn’s disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. Results A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Conclusions Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice

Using Interpretable Machine Learning to Identify Baseline Predictive Factors of Remission and Drug Durability in Crohn’s Disease Patients on Ustekinumab

Ustekinumab has shown efficacy in Crohn's Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients' data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index <= 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission