Please use this identifier to cite or link to this item:http://hdl.handle.net/20.500.12105/7160
Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol
García-Olmos, Luis | Rodríguez-Salvanés, Francisco | Batlle-Pérez, Maurice | Aguilar-Torres, Río | Porro-Fernández, Carlos | García-Cabello, Alfredo | Carmona, Montserrat ISCIII | Ruiz-Alonso, Sergio | Garrido-Elustondo, Sofía | Alberquilla, Angel | Sanchez-Gomez, Luis Maria ISCIII | Sanchez Madariaga, Ricardo ISCIII | Monge-Navarrete, Elena | Benito-Ortiz, Luis | Baños-Pérez, Nicolás | Simón-Puerta, Amaya | López Rodríguez, Ana Belén | Martínez-Álvarez, Miguel Ángel | Velilla-Celma, María Ángeles | Bernal-Gómez, María Isabel
BMJ Open. 2017 Jun 8;7(6):e014840
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% or structural cardiac lesion and/or diastolic dysfunction in the presence of preserved EF (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.
Aged | Aged, 80 and over | Chronic Disease | Female | Heart Failure | Hospitalization | Humans | Male | Middle Aged | Predictive Value of Tests | Prospective Studies | Risk Assessment | Risk Factors | Spain | Disability Evaluation
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