Objetivo. Este estudio evalúa la relación estadística entre la exposición a la publicidad de tabaco y el tabaquismo en los adolescentes de América del Sur. Material y métodos. Usando datos de la Encuesta Mundial de Tabaquismo en Jóvenes (GYTS) se estudiaron los niveles de exposición a nivel de escuela, ante distintos tipos de publicidad, además se evaluaron los comportamientos asociados al tabaquismo durante la experimentación y consumo. La muestra total fue de 134 073 jóvenes de Argentina, Bolivia, Chile, Perú, Brasil, Uruguay, Surinam, Colombia, Guyana, Ecuador, Paraguay y Venezuela que se combinaron en el análisis. Resultados. La exposición a la publicidad está positiva y significativamente asociada a un incremento en las probabilidades de que los jóvenes experimenten con el cigarrillo al menos una vez en sus vidas. Para los fumadores activos, la exposición a la publicidad está positiva y significativamente asociada con el número de cigarrillos fumados. Conclusiones. La publicidad de productos de tabaco debe ser controlada fuertemente o eliminada totalmente en varios países de Sudamérica.
IntroductionReal-world evidence (RWE) can be of value to support comparative effectiveness of drugs and technologies by providing additional information about their use for a variety of patients in real contexts of care. However, the integration of RWE in appraisals can be challenging, and INESSS felt the need to reinforce and explicit the underlying methodological and theoretical foundations.MethodsA comprehensive literature review was carried out, followed by collaborative development work by members of the methodological and assessment teams.ResultsThe literature review led to a common understanding of RWE underlying principles and fed the subsequent phases of the project. Three factors were identified as driving the integration of RWE in reimbursement appraisals at INESSS. Specifically, (i) the design and conduct of the real-world studies are done in accordance with best practices, (ii) the results are presented transparently and include all relevant information to assess the quality of the study and the data, and (iii) the RWE submitted is appropriate and relevant for decision-making. This third component is further ascertained by considering the decisional context (what are the circumstances motivating the submission of RWE and how does it correlate or not with existing evidence?), the data (is the dataset fit for decision needs?) and the study methods (are study design and analytical methods robust enough?). Globally, INESSS considers the integration of RWE in appraisals and its weighting, in relation with the (more traditional) available evidence, to be a case-by-case exercise.ConclusionsThe characterization of the main factors driving the integration of RWE in reimbursement appraisals at INESSS serves as a basis for communicating the requirements for evaluation submissions by sponsors. It further reinforces INESSS capabilities in assessing innovations, which can imply an appraisal of value at various moments along the lifecycle and with a diversity of evidence types. Considering the rapidly evolving literature and international experience, this work is expected to evolve too, and will be updated as needed.
INTRODUCTION:Decision makers worldwide face the challenge of offering the best health care within a context of scarce resources. Technological developments have multiplied in the past decades, with the lifecycle of technologies becoming shorter. As a result, the traditional Health Technology Assessment (HTA) model is often caught in a too early, too late syndrome. In the province of Québec (Canada), there is no standardized process for assessing non-pharmaceutical technologies for reimbursement purposes, and technologies are therefore introduced via multiple sources. There are concerns that the introduction of some of the most promising technologies is delayed, and on the contrary, that others are introduced without providing a real added value to patients and the health system.METHODS:INESSS (Institut national d'excellence en santé et services sociaux), collectively with stakeholders of the Québec innovation field, has developed a dynamic process for assessing the added value of innovative technologies. POETIS (Processus optimisé d'évaluation des technologies innovantes en santé) aims to identify the technologies with the highest potential for positive impact on patients and the health system, in order to accelerate their implementation and promote their optimal use.RESULTS:POETIS comprises four phases aligned with the lifecycle of technologies: research and development, pre-implementation, limited implementation, and diffusion. It allows a continuum of assessment, from the promise of a technology to its real-world benefit. It differs from other approaches because of the sustained involvement of key stakeholders, including patients, and because it assesses technologies iteratively, therefore fostering their adaptation to better suit patients needs. It is hoped for the first technologies to be assessed in 2017.CONCLUSIONS:HTA has to adapt to the challenges of innovation, and this could be done with a lifecycle approach and an enhanced collaboration with end-users. Developed in Canada, the goals behind POETIS are common to many countries and the process could be adapted by other HTA agencies.
Introduction:Stakeholders from the innovation field in Québec (Canada) have collectively stressed the need to formalize the process for evaluating innovative technologies in the province. In the context of innovation, and more so for non-pharmaceutical technologies where the pace of development is rapid and the lifecycle short, evidence supporting the added value can be limited and uncertainties are common. Therefore, pragmatic approaches are needed to guide recommendations and to assure that the process is rigorous, transparent and fair.Methods:Inspired by international experiences, the Institut national d'excellence en santé et services sociaux (INESSS) has developed a novel framework, where four types of recommendations are possible (introduction, refusal, limited or conditional introduction). The starting point is an evaluation of the technology's added value, for the patient, the population and the healthcare system, and the identification of uncertainties. The value of addressing uncertainty with further research is assessed, based on the value-of-information theory, and the distinct characteristics of medical devices are taken into account (e.g. learning curve effect, irrecoverable costs and incremental innovation). Those elements interact to support the formulation of recommendations by INESSS’ advisory committee.Results:The development of the framework was an iterative process supported by the use of the preliminary framework for the assessment of several innovative technologies. Challenges with its use were identified, and led to methodological and operational improvements. So far, the experience with the framework is positive and stakeholders confirm its relevance to support fair and reasonable recommendations for innovations.Conclusions:In the rapidly changing landscape of innovation, HTA has to adapt to the challenges of assessing technologies in a context of promise and uncertainties. The framework developed by INESSS is a tool for supporting timely and fair value-based decision-making, which will benefit the healthcare system, and the patients and population it serves.
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