ABSTRACT
BACKGROUND: Case-control studies involving test-negative (TN) and syndrome-negative (SN) controls are reliable for evaluating influenza and rotavirus vaccine effectiveness (VE) during a random vaccination process. However, there is no empirical evidence regarding the impact in real-world mass vaccination campaigns against SARS-CoV-2 using TN and SN controls. OBJECTIVE: To compare in the same population the effectiveness of SARS-CoV-2 vaccination on COVID-19-related hospitalization rates across a cohort design, TN and SN designs. METHOD: We conducted an unmatched population-based cohort, TN and SN case-control designs linking data from four data sources (public primary healthcare system, hospitalization registers, epidemiological surveillance systems and the national immunization program) in a Chilean municipality (Rancagua) between March 1, 2021 and August 31, 2021. The outcome was COVID-19-related hospitalization. To ensure sufficient sample size in the unexposed group, completion of follow-up in the cohort design, and sufficient time between vaccination and hospitalization in the case-control design, VE was estimated comparing 8-week periods for each individual. RESULTS: Among the 191,505 individuals registered in the primary healthcare system of Rancagua in Chile on March 1, 2021; 116,453 met the cohort study's inclusion criteria. Of the 9,471 hospitalizations registered during the study period in the same place, 526 were COVID-19 cases, 108 were TN controls, and 1,628 were SN controls. For any vaccine product, the age- and sex-adjusted vaccine effectiveness comparing fully and nonvaccinated individuals was 67.2 (55.7-76.3) in the cohort design, whereas it was 67.8 (44.1-81.4) and 77.9 (70.2-83.8) in the TN and SN control designs, respectively. CONCLUSION: The VE of a COVID-19 vaccination program based on age and risk groups tended to differ across the three observational study designs. The SN case-control design may be an efficient option for evaluating COVID-19 VE in real-world settings.
Subject(s)
COVID-19 Vaccines , COVID-19 , Hospitalization , Mass Vaccination , SARS-CoV-2 , Vaccine Efficacy , Humans , COVID-19/prevention & control , COVID-19/epidemiology , Chile/epidemiology , Middle Aged , Hospitalization/statistics & numerical data , Male , Female , Adult , Aged , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , Case-Control Studies , Adolescent , SARS-CoV-2/immunology , Mass Vaccination/methods , Mass Vaccination/statistics & numerical data , Young Adult , Child , Child, Preschool , Infant , Cohort Studies , Immunization Programs , Aged, 80 and overABSTRACT
La prevención Cuaternaria consiste en desarrollar cuidados de salud y de ejercer la medicina, priorizando los cuidados centrados en la persona. Su marco conceptual se sustenta en aspectos éticos y filosóficos centrales en el ejercicio de la medicina, en aspectos epistemológicos y de carácter social. Su objeto es proteger fundamentalmente a los pacientes, pero también a los integrantes del equipo de salud, de los excesos de la medicalización y de los excesos o prácticas innecesarias o dañinas. El presente artículo es el resultado de la síntesis de los documentos de trabajo, discusión y propuestas llevadas adelante por un amplio grupo de comprometidos profesionales de CIMF, con interés particular sobre la Prevención Cuaternaria. Los materiales se produjeron en forma colaborativa por medio de un largo y complejo proceso de trabajo a distancia, realizado durante los foros preparatorios de la VI Cumbre Iberoamericana de Medicina Familiar y Comunitaria. A estos materiales se sumaron los documentos de trabajo elaborados durante la misma cumbre en San José de Costa Rica, en el mes de abril de 2016. El cometido de este artículo es difundir el estado de desarrollo y de compromiso actual con este enfoque y el destacado impulso que ha tenido en Iberoamérica en los últimos cinco años. Por su relevancia, se pretende estimular una mayor difusión del concepto: la implementación de contenidos relacionados con él en la formación y en el nivel académico. A nivel político promover su consideración en la toma de decisión, en políticas de salud pública. Difundir a nivel poblacional y promover la elaboración de contenidos de calidad. Ofrecer pistas de reflexión y herramientas concretas para su aplicación.
Quaternary Prevention as main focus and practice, promotes changes in developing health care and practicing medicine, prioritizing the person centred care.Their conceptual framework is sustained on ethical and philosophical aspects essential to medicine practice, in epistemological aspects of social and others related to political nature. Its objective is to protect fundamentally the patients, but also the members of the health group from excessive medicalization and unnecessary and hurtful practices. The present article is the result of the synthesis of the work documents, discussion and proposals carried forward by a large group of committed professionals from CIMF, with particular interest in Quaternary Prevention. The materials were produced in collaboration through a complex long distance work process, done during preparatory forums of the VI Ibero-American Summit of Family And Community Medicine. The work documents made during the same summit in San JoseÌ of Costa Rica, in April 2016 were added to this material. The purpose of this document is to spread the state of development and current commitment to this approach and the outstanding initiative that it has had in Ibero America in the last five years. Due to its relevance, the intention is to stimulate greater dissemination of the concept; the implementation of content related to at in the training and academic levels. At a political level, to promote its consideration on decision making and public health issues so as to broadcast to demographic levels and promote the making of quality content. Finally to offer reflection clues to consider and concrete application tools.
A PrevençaÌo QuaternaÌria consiste em desenvolver cuidados de sauÌde e exercer a medicina priorizando o cuidado centrado na pessoa. Seu arcabouço conceitual se sustenta em aspectos eÌticos e filosoÌficos fundamentais ao exerciÌcio da praÌtica meÌdica, tambeÌm em aspectos epistemoloÌgicos e de caraÌter social. O seu objetivo eÌ proteger os pacientes, mas tambeÌm os membros da equipe de sauÌde, dos excessos da medicalizaçaÌo e das praÌticas excessivas ou desnecessaÌrias ou prejudiciais. Este artigo eÌ o resultado da siÌntese dos documentos de trabalho, discussaÌo e propostas levada a cabo por um numeroso grupo de profissionais comprometidos com a CIMF, com particular interesse na PrevençaÌo QuaternaÌria. Os materiais foram produzidos de forma colaborativa atraveÌs de um extenso e complexo processo de trabalho a distancia, realizado durante as reunioÌes preparatoÌrias da VI CuÌpula Ibero-Americana de Medicina de FamiÌlia e Comunidade. A estes materiais se somaram os documentos de trabalho preparados durante a mesma cuÌpula em San Jose, Costa Rica, em abril de 2016. O objetivo deste artigo eÌ o de difundir o estado de desenvolvimento e de compromisso atual com esta abordagem e o impulso notaÌvel que tem havido na Iberoamerica nos uÌltimos cinco anos. Por sua relevaÌncia, pretende-se estimular uma maior difusaÌo do conceito, bem como a implementaçaÌo de conteuÌdos relacionados a ele na formaçaÌo e em niÌvel acadeÌmico; a niÌvel poliÌtico, promover sua consideraçaÌo na tomada de decisoÌes de poliÌticas puÌblicas de sauÌde; difundir a niÌvel da populaçaÌo e promover o desenvolvimento de conteuÌdo de qualidade; oferecer pistas de reflexaÌo e ferramentas praÌticas para sua implementaçaÌo.
