Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol

Autor: Ángel Alberquilla, Río Aguilar-Torres, Ricardo Sánchez de Madariaga, Maurice Batlle-Pérez, Luis García-Olmos, Montserrat Carmona, Luis María Sánchez-Gómez, María Isabel Bernal-Gómez, Sergio Ruiz-Alonso, Carlos Porro-Fernández, Francisco Rodríguez-Salvanés, Alfredo García-Cabello, Sofía Garrido-Elustondo, Nicolás Baños-Pérez, Elena Monge-Navarrete, Luis Benito-Ortiz, Amaya Simón-Puerta, María Ángeles Velilla-Celma, Miguel Ángel Martínez-Álvarez, Ana Belén López Rodríguez
Přispěvatelé: Instituto de Salud Carlos III, European Regional Development Fund
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
Repisalud
Instituto de Salud Carlos III (ISCIII)
BMJ Open
Popis: BACKGROUND: Chronic heart failure (CHF) reduces quality of life and causes hospitalisation and death. Identifying predictive factors of such events may help change the natural history of this condition. AIM: To develop and validate a stratification system for classifying patients with CHF, according to their degree of disability and need for hospitalisation due to any unscheduled cause, over a period of 1 year. METHODS AND ANALYSIS: Prospective, concurrent, cohort-type study in two towns in the Madrid autonomous region having a combined population of 1 32 851. The study will include patients aged over 18 years who meet the following diagnostic criteria: symptoms and typical signs of CHF (Framingham criteria) and left ventricular ejection fraction (EF)50%).Outcome variables will be(a) Disability, as measured by the WHO Disability Assessment Schedule V.2.0 Questionnaire, and (b) unscheduled hospitalisations. The estimated sample size is 557 patients, 371 for predictive model development (development cohort) and 186 for validation purposes (validation cohort). Predictive models of disability or hospitalisation will be constructed using logistic regression techniques. The resulting model(s) will be validated by estimating the probability of outcomes of interest for each individual included in the validation cohort. ETHICS AND DISSEMINATION: The study protocol has been approved by the Clinical Research Ethics Committee of La Princesa University Teaching Hospital (PI-705). All results will be published in a peer-reviewed journal and shared with the medical community at conferences and scientific meetings. This study was funded by Health Research Fund (Fondo de InvestigacionesSanitarias/FIS) grant no. PI 14/01677 and co-financed with European Regional Development Fund (ERDF) funds (Carlos III Institute of Health-Research Network for Chronic Diseases/ISCIII–REDISSEC Project). Sí
Databáze: OpenAIRE