Adherence to oral anticoagulants in patients with atrial fibrillation-a population-based retrospective cohort study linking health information systems in the Valencia region, Spain: a study protocol.
BACKGROUND
Adherence to oral anticoagulation (OAC) treatment, vitamin K antagonists or new oral anticoagulants, is an essential element for effectiveness. Information on adherence to OAC in atrial fibrillation (AF) and the impact of adherence on clinical outcomes using real-world data barely exists. We aim to describe the patterns of adherence to OAC over time in patients with AF, estimate the associated factors and their impact on clinical events, and assess the same issues with conventional measures of primary and secondary adherence-proportion of days covered (PDC) and persistence-in routine clinical practice.


METHODS
This is a population-based retrospective cohort study including all patients with AF treated with OAC from 2010 to date in Valencia, Spain; data will be obtained from diverse electronic records of the Valencia Health Agency.


METHODS
adherence trajectories.


RESULTS
(1) primary non-adherence; (2) secondary adherence: (a) PDC, (b) persistence. Clinical outcomes: hospitalisation for haemorrhagic or thromboembolic events and death during follow-up.


METHODS
(1) description of baseline characteristics, adherence patterns (trajectory models or latent class growth analysis models) and conventional adherence measures; (2) logistic or Cox multivariate regression models, to assess the associations between adherence measures and the covariates, and logistic multinomial regression models, to identify characteristics associated with each trajectory; (3) Cox proportional hazard models, to assess the relationship between adherence and clinical outcomes, with propensity score adjustment applied to further control for potential confounders; (4) to estimate the importance of different healthcare levels in the variations of adherence, logistic or Cox multilevel regression models.


BACKGROUND
This study has been approved by the corresponding Clinical Research Ethics Committee. We plan to disseminate the project's findings through peer-reviewed publications and presentations at relevant health conferences. Policy reports will also be prepared in order to promote the translation of our findings into policy and clinical practice.
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Sanfélix-Gimeno
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Rodríguez-Bernal
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Hurtado
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Baixáuli-Pérez
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Librero
Health Services Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Peiró
D000284:Administration, Oral; D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D016208:Databases, Factual; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D063005:Health Information Systems; D006470:Hemorrhage; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D016015:Logistic Models; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012107:Research Design; D012189:Retrospective Studies; D013030:Spain; D013923:Thromboembolism; D016903:Drug Monitoring
D000925:Anticoagulants; D005343:Fibrinolytic Agents