[Morbidity and mortality in patients treated with oral anticoagulants]. / Morbilidad y mortalidad en pacientes con tratamiento anticoagulante oral.

INTRODUCTION AND OBJECTIVES: The number of patients receiving oral anticoagulant therapy has increased markedly in recent years, with the consequence that monitoring must be decentralized. The aim of this study was to provide reference values for the quality of care in patients receiving oral anticoagulants at large specialized Spanish centers for use in future comparative analyses. METHODS: The records of 20,347 outpatients who were receiving oral anticoagulants between January and December 2003 at four large Spanish centers were assessed. Databases at the four hospitals were searched for severe adverse events. RESULTS: In total, 211,987 regular check-ups were carried out, 72.7% of which gave international normalized ratios (INRs) within the range 2-4. Overall, 2369 hemorrhagic events were observed, 190 (8%) of which were severe, with 20 deaths (0.1 per 100 patient-years). In addition, there were 299 thromboembolic events, with 11 deaths (0.05 per 100 patient-years). The frequency of these events was greater in patients with a cardiac prosthesis, who required more intense anticoagulation. The incidence of death with different diagnoses was also greater in anticoagulated patients with a cardiac prosthesis, and the highest probability of death (1 in 3) was associated with episodes of cerebral hemorrhage. The incidence of hemorrhage increased as the INR increased. In contrast, thrombotic events occurred principally when the INR was below 2, and were not observed with INRs over 6. CONCLUSIONS: The incidence of adverse events in patients receiving oral anticoagulant therapy at large Spanish centers was similar to that observed in other European countries.

Morbilidad y mortalidad en pacientes con tratamiento anticoagulante oral / Morbidity and mortality in patients treated with oral anticoagulants

Introducción y objetivos. El número de pacientes en tratamiento anticoagulante oral (TAO) ha crecido notablemente en los últimos años y ha demandado un proceso de descentralización de los controles. El objetivo de este estudio es tener una referencia de los índices de calidad de la población en TAO seguida en grandes unidades especializadas de España que permita un análisis comparativo futuro. Métodos. Se valoraron desde enero a diciembre de 2003 las fichas de los 20.347 pacientes en TAO controlados en 4 grandes unidades del país. Se buscó efectos adversos severos en los ficheros informatizados de los 4 hospitales. Resultados. Se realizaron 211.987 controles, y el 72,7% está dentro de un rango de 2-4. Se detectaron en total 2.369 eventos hemorrágicos, 190 (8%) graves, con 20 fallecimientos (0,1/100 pacientes/año). Hubo 299 episodios tromboembólicos con 11 fallecimientos (0,05/100 pacientes/año). La frecuencia de estos eventos fue mayor en aquellos enfermos con prótesis cardiacas, que precisaban una mayor intensidad de anticoagulación. La incidencia de fallecimientos por diagnósticos fue también mayor en pacientes anticoagulados por prótesis cardiacas y la mayor probabilidad de muerte (1 de cada 3 pacientes) se asoció a episodios de hemorragia cerebral. La incidencia de hemorragia se incrementó en función de la prolongación del INR, mientras que los eventos trombóticos aparecieron especialmente con INR < 2, y no se detectaron con INR > 6. Conclusiones. La incidencia de efectos adversos que afectan a los pacientes en TAO controlados en grandes unidades del país es similar a las reconocidas en otros países occidentales (AU)

Introduction and objectives. The number of patients receiving oral anticoagulant therapy has increased markedly in recent years, with the consequence that monitoring must be decentralized. The aim of this study was to provide reference values for the quality of care in patients receiving oral anticoagulants at large specialized Spanish centers for use in future comparative analyses. Methods. The records of 20,347 outpatients who were receiving oral anticoagulants between January and December 2003 at four large Spanish centers were assessed. Databases at the four hospitals were searched for severe adverse events. Results. In total, 211,987 regular check-ups were carried out, 72.7% of which gave international normalized ratios (INRs) within the range 2­4. Overall, 2369 hemorrhagic events were observed, 190 (8%) of which were severe, with 20 deaths (0.1 per 100 patient­years). In addition, there were 299 thromboembolic events, with 11 deaths (0.05 per 100 patient­years). The frequency of these events was greater in patients with a cardiac prosthesis, who required more intense anticoagulation. The incidence of death with different diagnoses was also greater in anticoagulated patients with a cardiac prosthesis, and the highest probability of death (1 in 3) was associated with episodes of cerebral hemorrhage. The incidence of hemorrhage increased as the INR increased. In contrast, thrombotic events occurred principally when the INR was below 2, and were not observed with INRs over 6. Conclusions. The incidence of adverse events in patients receiving oral anticoagulant therapy at large Spanish centers was similar to that observed in other European countries (AU)

Características de 107 registros sanitarios españoles y valoración de su utilización / Characteristics of 107 Spanish Healthcare Registries and Evaluation of the Utilization Thereof

Fundamento: La información sobre los registros sanitarios existentesen nuestro país es poco accesible y escasa y algunos son pococonocidos, pudiendo estar infrautilizados en relación con sus múltiplesusos potenciales. El objetivo de este trabajo es evaluar las característicasde los Registros Sanitarios españoles y su utilización, especialmenteen Evaluación de Tecnologías Sanitarias.Métodos: Estudio descriptivo transversal de los Registros Sanitariosespañoles entre 1997 y 2002. La identificación de los registros serealizó a través de búsqueda bibliográfica y mediante encuesta a SociedadesCientíficas y Administración sanitaria central y autonómica. Seha realizado una búsqueda bibliográfica específica de las publicacionesque utilizan datos de los registros sanitarios incluidos y se han evaluadoaplicando los criterios de calidad de la evidencia científica.Resultados: Se han identificado 107 registros sanitarios, preferentementede cobertura local o regional (71%) y dependientes en sumayoría de la Administración autonómica (64,5%). Las áreas conmayor número de registros identificados corresponden a la mortalidad(16,8%) y al cáncer (15,9%). Se han recuperado 298 publicacionesque analizan datos producidos por los registros identificados, delas que la mayoría se dedican al estudio de la frecuencia y distribuciónde los eventos registrados (58,1%) y con menor frecuencia a la realizaciónde estudios de evaluación de tecnologías sanitarias (24,4%).Conclusiones: La evaluación crítica de las publicaciones ha permitidoidentificar algunos elementos relacionados con el diseño y lametodología de análisis que incrementarían la calidad de los estudiosde evaluación de tecnologías sanitarias.Los registros sanitarios enEspaña han tenido un desarrollo desigual y reciente. Se han detectadoáreas relevantes sin registros y elementos de mejora relacionadoscon la utilización de los registros sanitarios para estudios de evaluaciónde tecnologías sanitarias. Sería recomendable contar con unregistro de registros que proporcionara información relevante yactualizada sobre los mismos

Background: The information concerning the currently- existinghealthcare registries in our country is not readily accessible, is scarceand some are not well-known, possibly being underused in comparisonto their many potential uses. This study is aimed at evaluating thecharacteristics of the Spanish Healthcare registries and the utilizationthereof, especially in Healthcare technology assessment.Methods: Descriptive, cross-sectional study of the SpanishHealthcare registries within the 1997-2002 period. These registrieswere identified by means of a bibliographic databases search and byway of a survey of Scientific Societies and Central and AutonomicHealthcare Administration. Another bibliographic databases searchwas conducted of the publications which use data from the healthcareregistries included and have been evaluated by applying the scientificevidence quality criteria.Results: A total of 107 healthcare registries were identified,most of which of local or regional coverage (71%), preferably wereunder Autonomic government authority (64.5%). The areas showingthe largest number of registries identified were those related to deathstatistics (16.8%) and cancer (15.9%). A total of 298 publicationswere retrieved which analyze data produced by the registries identified,most of which are devoted to the study of the frequency and distributionof the events recorded (58.1%) and less frequently to theconducting of healthcare technology assessment studies (24.4%).Conclusions: The critical evaluation of the publications made itpossible to identify some elements related to the analysis methodologyand design which would heighten the quality of the healthcaretechnology assessment. Healthcare registries in Spain have developedrecently and to differing degrees. Important areas without anyrecords and improvement elements related to the use of healthcareregistries for healthcare technology assessment were detected. Itwould be advisable to avail of a register of registries which wouldprovide relevant, up-dated information thereon