Impact and preventability of adverse events in Spanish public hospitals: results of the Spanish National Study of Adverse Events (ENEAS).

OBJECTIVE: To determine the impact and preventability of adverse events (AEs) associated with health care in Spanish hospitals. DESIGN: Retrospective cohort study. SETTING: Twenty-four Spanish hospitals. PARTICIPANTS: Patients of any age with a clinical record indicating an inpatient stay of >24 h and a discharge between 4 and 10 June 2005 (n = 5908). INTERVENTION: None. MAIN OUTCOME MEASURES: Percentage of AEs considered preventable. RESULTS: We were able to identify 525 patients suffering AEs associated directly with medical care, who accumulated 655 AEs with 43% of these AEs considered preventable. Overall, 45% (295 AEs) were considered minor, 39% (255 AEs) moderate and 16% (105 AEs) severe. There were no significant differences in AE severity by hospital size, but AEs associated with surgical services were more likely to be severe than those associated with medical services. Some 31.4% of AEs resulted in a longer stay and 23.4% led to hospital admission. AEs associated with medical care caused 6.1 additional days per patient. Of the patients, 66.3% required additional procedures and 69.9% required additional treatments. Incidence of death in patients with AEs was 4.4% (CI 95%: 2.8-6.5). Age over 65 was associated with a higher incidence of preventable AEs. The highest percentages of preventable AEs were related to diagnosis (84.2%), to nosocomial infections (56.6%) and to care (56%). CONCLUSIONS: In Spanish hospitals, AEs associated with health care cause distress, disability, death, lengthen hospital stay and cause increased consumption of health-care resources. A relatively high percentage of AEs in Spain may be preventable with improvements in medical care.

[Critically ill patient isolation: risk or protection?] / Aislamiento del paciente crítico: ¿riesgo o protección?

INTRODUCTION: Isolation precautions are an effective measure to prevent the spread of multi-resistant microorganisms (MMR). However, its implementation is complex and can increase some risks to the patient. The aim of this study is to determine whether the implementation of isolation precautions increase the risk of patient safety incidents (PSI) in critically ill patients. MATERIAL AND METHODS: A retrospective observational study was conducted involving patients admitted to the ICU of a University Hospital, and that required isolation for more than 48h. Period of study: two years (from 2013/03/01 to 2015/03/31). Data source was the electronic medical record. The tools for evaluation were the Modular Review Form questionnaires (MRF1 and MRF2). An analysis was made of PSI and adverse events (AEs) during periods with and without isolation precautions, including the PSI type, severity, and preventability. RESULTS: The study included a total of 76 patients, 74 of whom had at least one PSI. A total of 798 PSI were detected (511 during isolation period), 599 were a No harm incident (NHI) and 199 were adverse AEs. The most frequent PSIs were associated with medication (316) and patient health care (279). Most of them were moderately or highly preventable. The incidence of PSI during periods with and without isolation was 27.3 (SD 33.8) and 29 (39.6) per 100 patient-days, respectively. CONCLUSIONS: PSIs in ICU are frequent, and the most of them are preventable. The adoption of isolation precautions does not constitute a risk factor for PSI. Improving patient safety culture is essential for an adequate prevention strategy.

[Identification of adverse events in hospitalised influenza patients]. / Identificación de eventos adversos en pacientes hospitalizados por gripe.

OBJECTIVE: To test the inter-observer agreement in identifying adverse events (AE) in patients hospitalized by flu and undergoing precautionary isolation measures. METHODS: Historical cohort study, 50 patients undergoing isolation measures due to flu, and 50 patients without any isolation measures. RESULTS: The AE incidence ranges from 10 to 26% depending on the observer (26% [95%CI: 17.4%-34.60%], 10% [95%CI: 4.12%-15.88%], and 23% [95%CI: 14.75%-31.25%]). It was always lower in the cohort undergoing the isolation measures. This difference is statistically significant when the accurate definition of a case is applied. The agreement as regards the screening was good (higher than 76%; Kappa index between 0.29 and 0.81). The agreement as regards the accurate identification of AE related to care was lower (from 50 to 93.3%, Kappa index from 0.20 to 0.70). CONCLUSIONS: Before performing an epidemiological study on AE, interobserver concordance must be analyzed to improve the accuracy of the results and the validity of the study. Studies have different levels of reliability. Kappa index shows high levels for the screening guide, but not for the identification of AE. Without a good methodology the results achieved, and thus the decisions made from them, cannot be guaranteed. Researchers have to be sure of the method used, which should be as close as possible to the optimal achievable.

[Clinical safety plan in a university hospital complex. Initial diagnosis: study of adverse events]. / Plan de seguridad clínica del Complejo Hospitalario Universitario de Albacete (CHUA). Diagnóstico inicial: estudio de eventos adversos.

OBJECTIVES: To establish the incidence of adverse events (AEs) and incidence of patients with AEs in the University Hospital Complex of Albacete (CHUA); to identify and define the AEs which are linked to health care; to analyse avoidable AE and determine their impact; to plan improvement actions. METHOD: . DESIGN: Retrospective cohort study. SAMPLE: Patients registered from 5 November to 19 November, 2007. CASE DEFINITION: Any accident or incident reported in the medical record which injured or may have injured the patient. MATERIAL: Adverse Events Screening Guide, adapted from the Harvard study. Spanish version of the Modular Review Form (MRF2) for retrospective case record review. STATISTICAL ANALYSIS: Univariate and bivariate analysis and logistic regression model. RESULTS: The incidence of patients with AEs linked to hospital care was 6.8%. The incidence was significantly different depending on: age, presence of intrinsic or extrinsic risk factors (excluding peripheral venous catheter); 8.2% of AE was linked to care; 14.3% to medication; 26.5% to nosocomial infections; 35.7% to technical problems in procedures; 11.2% to diagnosis, and the remaining 4.1% to other types of AEs. In these incidences, 12.2% were considered mild, 78.6% moderate and 8.2% serious. Half (50%) of AEs caused an increase in hospital stay, and in 34.7% cases determined hospitalisation. A total of 63.3% of AEs were considered avoidable. CONCLUSIONS: The study of AEs in the CHUA represents an improvement within the hospital quality program. Incidences of patients with AEs and those related to health care fall within the range of those found in the studies where the objective was quality improvement.

[Factors that contribute to health care associated infections: how to prevent them]. / Factores que contribuyen a la infección relacionada con la asistencia sanitaria: cómo evitarlos.

OBJECTIVE: To determine the patient and medical care characteristics of Health Care-Associated Infections (HCAI) and to determine whether or not there are any differences between those that may be avoidable. METHOD: A retrospective cohort study, based on three Spanish cohort studies of Adverse Events associated with hospitalization. The medical records were reviewed to assess whether or not the health care was the causing factor of the HCAI. We carried out the analyses using the same methodology as the National Study on the Adverse Effects associated with hospitalization (ENEAS). After reviewing the patient medical records to identify the HCAI associated factors, the reviewers gave a valued judgment on how likely the health care was the cause of the infection (HCAI) and whether there was evidence that they could have been avoided. RESULTS: A total of 2.3% the patients in the study had one or more HCAI, with 60.2% of them being avoidable. The patients who had an HCAI were older and had a greater number of intrinsic and extrinsic risk factors. There was a significant difference in the presence of some intrinsic risk factor between patients who had an HCAI and those with an avoidable HCAI, but there were no differences as regards medical care extrinsic risk factors. The factors that best explained the HCAI were different for each one of the most common infection locations. Generally, the factors which best explained the HCAI were: urinary catheter (OR=2.4), nasogastric tube (OR=1.9) or central venous catheter (OR=1.8). Similarly, hospital admissions through a surgery department or a hospital stay longer than a week were identified as main factors, (OR=1.6), (OR=7.5), respectively. The best strategies to avoid an HCAI were: proper management of any aseptic technique and use of catheter (25.5%), a proper follow-up of the bladder catheterisation protocols (20%) and a proper health care follow-up of vulnerable patients (16.5%). CONCLUSION: Patients with an HCAI showed significant different characteristics from those who did not have an HCAI. The preventability is an independent valued judgment from the causality, and is associated to whether the proper protocol has been implemented or not. To identify these weaknesses enables us to establish strategies to improve the quality of medical care.