Background Knowing the frequency and characteristics of adverse events is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of adverse events. Research on adverse events in primary care setting have been limited and primarily focuses on specific types of events (medication errors…) or patients. Large studies that search for any kind of adverse event in all patients are scarce. This study aimed to estimate the prevalence of adverse events in the primary care setting and their characteristics. Methods Setting: all 262 primary healthcare centres in the Madrid region (Spain) during the last quarter of 2018. Design: cross-sectional descriptive study. Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N=2,743,719). Randomised sample stratified by age. Main outcomes: age, sex, occurrence of an adverse event, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety. The SPSS software package (version 26) was used for the statistical analyses. Results The evaluators reviewed 1,797 clinical records. The prevalence of adverse events over the study period was 5.0%[confidence interval (CI) 95%:4.0%‒6.0%], with higher values in women (5.7%;CI95%:4.6%‒6.8%;P=0.10) and patients over 75 years of age (10.3%;CI95%:8.9%‒11.7%;P<0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (CI95%:1.28%‒1.94%). Of the detected adverse events, 71.3%(CI95%:62.1%‒80.5%) were avoidable. Additionally, 60.6%(CI95%:50.7%‒70.5%) were categorised as mild, 31.9%(CI95%:22.4%‒41.4%) as moderate, and 7.4%(CI95%:2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6%(CI95%:68.0%‒85.2%) of cases. The overall incidence of adverse events related to medication was 53.2%(CI95%:50.9%‒55.5%). The most frequent types of AE were prescription errors (28.7%;CI95%:19.5%‒37.9%), followed by drug administration errors by patients (17.0%;CI95%:9.4%‒24.6%), and clinical assessment errors (11.7%;CI95%:5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%;CI95%:71.1%‒90.1%) and tasks (59.7%;CI95%:48.0%‒71.4%). Conclusion A high prevalence of adverse events (1 in 66 consultations) was observed, which was slightly higher than those reported in similar studies. About three out of four such events were considered to be avoidable and one out of 13 were severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of adverse events.
Objetivo: evaluar el impacto del control de la tensión arterial (TA) sobre la morbimortalidad en > 65 años, sin patología cardiovascular previa, en el ámbito comunitario. Métodos: estudio de cohortes retrospectivas. Se incluyeron todos los pacientes (≥ 65 años) con diagnóstico de hipertensión arterial (HTA) (01/01/2007-31/12/2008), sin eventos cardiovasculares previos de los centros de salud de la Comunidad de Madrid, con al menos dos registros de TA el primer año de seguimiento (n = 17.150). Se evaluaron la aparición de eventos cardiovasculares (incluida mortalidad cardiovascular) y la mortalidad total, mediante regresión de Cox. Resultados: la mediana de seguimiento para mortalidad fue de 90,48 meses (rango intercuartil [RIC]: 53,19-130,30 meses). Se produjeron 8.641 eventos cardiovasculares y 1.026 muertes por cualquier causa. Ajustado por género, grado de hipertensión, tabaquismo, diabetes e hipercolesterolemia, el buen control (TA < 140/90 mmHg) no se asociaba con una disminución de eventos cardiovasculares, pero sí con una disminución de mortalidad del 14,41% (hazard ratio [HR] 0,8559; intervalo de confianza [IC] 95%: 0,7776-0,9421%) entre 75 y 84 años. Cuando se utilizan las cifras de 130/80 mmHg para definir el buen control, este se asociaba con un exceso de mortalidad del 43,58% (IC 95%: 19,60-72,36%) entre 65 y 74 años y del 61,22% (IC 95%: 22,99-111,35%) en sujetos de 85 y más años. Conclusión: el control de la TA en sujetos >65 años se asocia con una disminución ligera de la mortalidad entre 75 y 84 años. Cifras de control más estrictas se relacionan con mayor ocurrencia de evento cardiovascular y de mortalidad, especialmente en el grupo de mayor edad. Palabras clave: hipertensión, indicadores de morbimortalidad, Atención Primaria de Salud, salud de la persona anciana.
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