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.

[Research on patient safety: needs and perspectives]. / La investigación sobre seguridad del paciente: necesidades y perspectivas.

A safe health care system requires applying procedures and practices that have demonstrated effectiveness in reducing errors, faults and adverse events in health care, but it also needs to update its knowledge on the factors that contribute to improve patient safety. Adverse events and patient safety are two sides of the same coin, clinical risk. We must ensure that the priority of health managers and providers is aimed at patient safety more than adverse events. They are some fundamental areas of research in patient safety: to estimate the magnitude and features of the clinical risk, to understand the factors contributing to the appearance of adverse events, to evaluate the impact of adverse events on health care system and to identify effective, feasible and sustainable solutions to achieve a safe health care. Key points of patient safety research projects are: aims of research, priority, data and information quality, available resources and methodology. The study of the patient safety and adverse events needs two complementary perspectives: a collective one, based on epidemiological methods and aimed at quantifying the risks in healthcare, and an individual one, based on qualitative methods, to analyze causes and factors contributing to adverse events. Several things are required to improve the patient safety research: better data and information systems, greater collaboration in training between developed and transitional countries, and wider dissemination of experiences and results of the projects. Key points of patient safety research projects are: aims of research, priority, data and information quality, available resources and methodology. The study of the patient safety and adverse events needs two complementary perspectives: a collective, based on epidemiological method and guided to quantifying the risks of healthcare, and another individual, based on qualitative methods, to analyze causes and contributing factors of adverse events. To improve the patient safety research are necessary: better data and information systems, bigger collaboration between developed and transitional countries training and wide dissemination of experiences and results of the projects.

[Perceptions of clinical safety after hospital discharge]. / Percepción de seguridad clínica tras el alta hospitalaria.

OBJECTIVE: Patient perception of clinical safety has been scantly studied. This study describes the frequency of clinical errors from a patient point of view, their perception of safety and its relationship with the information received. MATERIAL AND METHODS: Descriptive study based on a postal survey to 336 surgical patients, 20 days after the discharge from the hospital (the corrected rate of response is 75.58%, the error is 5.7% for a confidence level of 95%). RESULTS: In the responses, 13.05% (95% CI, 9.16-16.95%) reported suffering a clinical error. Of these, 10.5% had severe complications. This experience decreases the perception of safety in future treatments (p = 0.0001). The risk of being a victim of a medical error with serious consequences is high was considered by 11.9% (95% CI, 7.2-16.6%) of the patients, although less than suffering from a traffic accident, a robbery or a serious illness. A higher frequency in the media related to medical mistakes, decreases the perception of safety (p < .001). The patients who positively value the information received regarding the treatment and who can formulate questions to ask the doctor are those who report less errors (p < .001). CONCLUSIONS: A total of 1.37% of surgical patients report mistakes with severe consequences, whereas 12% believe that the risk of a mistake with serious consequences is high. Distrust increases after an error. Improving communication with the patient helps to reduce mistakes, which strengthens the role of programs to increase safety that encourage more active patient involvement.

[Unique patient identification in hospitals in the National Health Service]. / Identificación inequívoca de pacientes ingresados en hospitales del Sistema Nacional de Salud.

Currently, patient misidentification in healthcare organizations is a risk that can lead to diagnostic errors, performing of surgical procedures, and administration of medicines or hemoderivates to wrong patients. The organizations that deal with patient safety promote methods that guarantee unique identifications within the strategies for improving safety in healthcare. Identification policies are obligatory to ensure the accuracy of the identification in all patients using universally implemented unique methods, and healthcare workers have the responsibility of verifying patient identification with appropriate documents when a diagnostic or therapeutic procedure is planned. In this paper we review the bases for an unmistakable unique identification and present the experiences of five regional health services that develop the policies promoted in Spain by the Quality Agency of the Ministry of Health and Consumer Affairs.

[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.

[Absenteeism and associated factors in scheduled visits to a Preventive Medicine outpatient clinic]. / Absentismo, y factores asociados, en las citas programadas de una consulta externa de Medicina Preventiva.

BACKGROUND: Patient absenteeism in outpatient clinics represents a significant obstacle to the cost-effectiveness of healthcare. The aim of this study was to assess the frequency of absence of patients and its associated factors in scheduled visits to a Preventive Medicine department. PATIENTS AND METHODS: The cross-sectional study was carried out in the Service of Preventive Medicine of the Lozano Blesa University Clinical Hospital of Zaragoza. It included all the visits scheduled from 3 January to 31 March 2017. For each visit, the date and time were registered, together with the type (first or consecutive appointments), age, gender, town of residence, country of birth, and underlying disease. The Chi-squared test was used to determine the association between the variables and making the visit, with a multiple logistic regression analysis being performed on the variables in which a significant association was found. RESULTS: Of the total of 582 appointments studied, the absenteeism rate was 12.5% (73 out of 582; 13.7% for first appointments and 11.7% for consecutive appointments). Variables that revealed a significant association with patients not attending were: time (9.00-11:15 a. m.; OR=1.84; 95%CI: 1.10-3.08), day of the week (Mondays-Thursdays; OR=3.19; 95%CI: 1.12-9.07), country of birth (outside of Spain; OR=2.09; 95%CI:1.09-3.99), vaccination group (chronic kidney disease during pre-dialysis or dialysis; OR=3.59; 95%CI: 1.57-8.18), and age group (under 52 years old; OR=1.85; 95%CI: 1.08-3.19). CONCLUSIONS: The rate of absenteeism is at an intermediate position compared to the outpatient visits for other departments. The detection of associated factors makes it possible to plan specific measures for improvements that may reduce absences.

[Trends in the prevalence of pressure ulcers in an acute care tertiary hospital (2006-2013)]. / Evolución de la prevalencia de úlceras por presión en un hospital de agudos de tercer nivel (2006-2013).

OBJECTIVES: To analyse the trends in pressure ulcer prevalence from 2006 to 2013. To determine the main risk factors associated with pressure ulcers. METHOD: A descriptive study analysing the prevalence in a series of pressure ulcers collected in the study on the prevalence of nosocomial infections in Spain from 2006 to 2013 in the Clinical University Hospital of Zaragoza. RESULTS: The mean prevalence among the 5,354 patients included over the period of study was 4.5% (95% CI=3.9-5.0%). No significant difference in its trend or distribution of pressure ulcers was observed over the several years of the study. Prevalence increased up to 5.0% (95% CI=4.4-5.6%) when short-stay patients (less than 24 hours) and those admitted into low risk units (Paediatrics, Psychiatry and Obstetrics) were removed from the study, but there was still no significant differences in its yearly trend or distribution (p>0.05). Age, length of stay, presence of coma, in-dwelling urethral catheters, malnutrition, infection, and admission unit were risk factors associated with pressure ulcer prevalence in the logistic regression. CONCLUSIONS: Age, length of stay, coma, in-dwelling urethral catheters, malnutrition, infection, and admission unit were independent risk markers for patients with pressure ulcers. No particular trend of pressure ulcer prevalence could be determined to demonstrate any effects from the different strategies of improvement implemented during the period of study, although this fact could be due to the limitations of data used in the study.

[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.

[The hospital costs for patients with human immunodeficiency virus infection]. / Costes hospitalarios en pacientes con infección por el virus de la inmunodeficiencia humana.

BACKGROUND: The economic issues derived from the care of HIV patients are increasingly more important and they affect to different levels of sanitary assistance. In Spain these costs are not always evaluated and there is no information about the efficiency of inverted resources. METHODS: The cost of mean hospital stay due to HIV (+) patients has been estimated and compared with two infectious diseases: respiratory tuberculosis (TBC) and viral hepatitis (VH), and we have analyzed their evolution in the period studied. The study was conducted between July 1st 1987 and December 31st 1989 at the Infectious Unit for the three mentioned diseases. RESULTS: The 227 included patients originated 292 hospitalizations. The total cost derived from hospital stays was 169,466,323 ptas. The mean cost for HIV(+) patients was 576,184 ptas, for TBC patients 1,111,115 ptas, and for VH 443,219 ptas. The number of HIV(+) stays has increased each year. CONCLUSIONS: The observed results suggest that it could be interesting to think about new systems of inpatient care.

[Drug-induced parkinsonism. Clinical aspects compared with Parkinson disease]. / Parkinsonismo inducido por fármacos. Aspectos clínicos comparativos con la enfermedad de Parkinson.

INTRODUCTION: Drug-induced Parkinsonism (DIP) is the second commonest cause of Parkinson syndrome, after Parkinson disease (PD) and represents between 10% and 30% of all patients with Parkinsonism. OBJECTIVES: To study the frequency and drugs responsible for DIP and to compare some of the clinical characteristics of these patients and those with PD. PATIENTS AND METHODS: A retrospective community based study in Bajo Aragon district to determine the frequency of PD and other Parkinsonism, including DIP. PD was diagnosed on the criteria proposed by the United Kingdom Parkinson's Disease Society Brain Bank and DIP on the criteria of Jiménez et al. RESULTS: Calcium antagonists were the cause of 73% of the DIP, followed by neuroleptic drugs (11.5%). There were 73% women (19/26). The patients with DIP were older than those with PD when their symptoms started (p = 0.02). In patients with DIP, 48% presented with bilateral symptoms as compared with 7% in PD (p < 0.0001). CONCLUSIONS: 1. Cinarizine is the main drug responsible for DIP (58%) 2. As compared with patients with PD, patients with DIP are mainly women, older, more frequently have bilateral onset of symptoms and consult the doctor sooner.

[Nosocomial infections in surgical patients. Problems of measuring and comparing results]. / Infección nosocomial en pacientes quirúrgicos. Problemas de medición y de comparación de resultados.

BACKGROUND: What is striking when studying the frequency of nosocomial infection (NI) is the variability of the study data. Different frequency indicators and infection criteria are used for estimates and these make it difficult to compare works. The aim of this work is to estimate the frequency of hospital infection by using different indicators to compare the results. METHODS: A market study was carried out including patients admitted to four surgical units over the period of one year. The following indicators were used: proportion of patients infected, cumulative number of cases of infection and density of number of cases. The infections were detected through active search and included those acquired in Intensive Care Units and those diagnosed after patients had been discharged from hospital. RESULTS: A total of 14.5% of the patients suffered NI and 5% of the infections were diagnosed after discharge from hospital. In 38.5% of the cases of infection a microbiological study was not requested. The General Surgery Unit had the highest figures for the three indicators. Nevertheless, the magnitude of the differences between services was modified in line with the indicator used. CONCLUSIONS: The real percentage of patients with NI is higher than the values given by the usual monitoring systems. Given the trend witnessed over recent years whereby the length of hospital stays is being reduced and early discharge programmes promoted with the aim of increasing efficiency, densities for the number of cases should be estimated and these should include the NI cases diagnosed after hospital discharge in order to make valid comparisons between different institutions and periods of time.

[Evolution of epidemiological methods in clinical research in Spain (1975-1994)]. / Evolución de los diseños epidemiológicos de la investigación clínica en España (1975-1994).

BACKGROUND: Previous studies have shown a sparing utilization of analytical and experimental designs in Spanish clinical research journals. The study aims are to compare among countries, the use of epidemiologic method in articles published in scientific journals, and to determine the extent to which this research has direct funding. METHODS: Cross-sectional study including all original papers published during 1994 in Medicina Clinica [(Med Clin (Barc)], Revista Clinica Española (Rev Clin Esp), The Lancet (Lancet) and New England Journal of Medicine (N Engl J Med). They were classified according to epidemiological design and we verified the financial support mention. RESULTS: 594 papers were included. Epidemiological studies without control group prevailed in Spanish journals. The most common designs were descriptive studies in Med Clin (Barc), with 45.5%, and clinical series in Rev Clin Esp, with 41.7%. The 33.6% of original papers published in Lancet and 28.4% of N England J Med were randomized trials. We found information about financial support in 73.7% of papers published in Lancet, in 77.4% of N Engl J Med, in 23.1% of Med Clin (Barc) papers and not one in the Rev Clin Esp studies. CONCLUSIONS: In Spanish clinical journals the use of epidemiological methods with control group is limited and direct financial support unusual. Wherefore these studies have a limited applicability.

[Use of ineffective practices in Primary Health Care: professional opinions]. / Utilización de prácticas inefectivas en atención primaria: opinión de los profesionales.

OBJECTIVE: To estimate the frequency of ineffective practices in Primary Health Care (PHC) based on the opinions of clinical professionals from the sector, and to assess the significance, implications and factors that may be contributing to their continuance. MATERIAL AND METHODS: An on line survey of opinion from a convenience sample of 575 professionals who had published articles over the last years in Atención Primaria and Semergen medical journals. RESULTS: A total of 212 professionals replied (37%). For 70.6% (95% confidence interval [CI] 64.5 to 73.3) the problem of ineffective practices is frequent or very frequent in PHC, and rate their importance with an average score of 7.3 (standard deviation [SD]=1.8) out of 10. The main consequences would be endangering the sustainability of the system (48.1%; 95% CI, 41.2 to 54.9) and harming patients (32.1%; 95% CI, 25.7 to 38.5). These ineffective practices are the result of the behaviour of the patients themselves (28%; 95% CI, 22.6 to 35.0) workload (26.4%; 95% CI, 20.3 to 32.5), and the lack of the continuous education (19.3%; 95% CI, 13.9 to 24.7). Clinical procedures of greatest misuse are the prescribing of antibiotics for certain infections, the frequency of cervical cancer screening, rigorous pharmacological monitoring of type 2 diabetes in patients over 65 years, the use of psychotropic drugs in the elderly, or the use of analgesics in patients with hypertension or renal failure. CONCLUSIONS: The use of ineffective procedures in PHC is considered a very important issue that negatively affects many patients and their treatment, and possibly endangering the sustainability of the system and causing harm to patients.

Prevalence of adverse events in the hospitals of five Latin American countries: results of the 'Iberoamerican Study of Adverse Events' (IBEAS).

BACKGROUND: Interest in patient safety (PS) is growing exponentially, fuelled by epidemiological research unveiling the extent of unsafe care. However, there is little information about the frequency of harm in developing and transitional countries. To address this issue, the authors performed a study known as the Iberoamerican Adverse Event Study, through a collaborative between the governments of Argentina, Colombia, Costa Rica, Mexico and Peru, the Spanish Ministry of Health, Social Policy and Equality, the Pan American Health Organization and the WHO Patient Safety. METHODS: The study used a cross-sectional design, involving 58 hospitals in the five Latin American countries, to measure the point prevalence of patients presenting an adverse event (AE) on the day of observation. All inpatients at the time of the study were included. RESULTS: A total of 11 379 inpatients were surveyed. Of these, 1191 had at least one AE that the reviewer judged to be related to the care received rather than to the underlying conditions. The estimated point prevalence rate was 10.5% (95% CI 9.91 to 11.04), with more than 28% of AE causing disability and another 6% associated with the death of the patient. Almost 60% of AE were considered preventable. CONCLUSIONS: The high rate of prevalent AE found suggests that PS may represent an important public-health issue in the participating hospitals. While new studies may be needed to confirm these results, these may already be useful to inspire new PS-improvement policies in those settings.

[IBEAS design: adverse events prevalence in Latin American hospitals]. / Diseño del estudio IBEAS: prevalencia de efectos adversos en hospitales de Latinoamérica.

OBJECTIVES: To describe the methodological characteristics of the IBEAS study: adverse events prevalence in Latin American hospitals, with the aim of analysing the magnitude, significance and impact of adverse events (AE); to identify the main problems associated with patient safety AE; to increase the capacity of professionals involved in patient safety; and the setting up of patient safety agendas in the participating countries. METHODS: A patient safety study launched in 35 Latin American hospitals through the analysis of AE in 5 countries: Argentina, Colombia, Costa Rica, Mexico and Peru, using a cross-sectional study using a review of clinical records as the main method. RESULTS: The implications of using a cross-sectional design when studying AE are described, in terms of resources required, internal validity and usefulness related to risk management. CONCLUSIONS: The cross-sectional design seems an efficient methodology in terms of time and resources spent, as well as being easy to carry out. Although the cross-sectional design does not review the all hospital episodes, it is able to provide a reliable estimate of prevalence and to support a surveillance system. Because of a possible survival bias, it is likely that the AE which led to hospital admissions will be overestimated, as well as the health related infections or those adverse events which are difficult to identify if the patient is not examined (e.g. contusions). Communication with the ward staff (if the patient is still hospitalised) help in finding the causality and their prevention.

Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events.

OBJECTIVE: To determine the incidence and incidence density of adverse events (AEs) in Spanish hospitals (including the pre-hospitalisation period). METHOD: Retrospective cohort study. RESULTS: The incidence of patients with AEs relating directly to hospital care was 8.4% (95% CI 7.7% to 9.1%) and rose 9.3% (95% CI 8.6% to 10.1%), including those from the pre-hospitalisation period. The incidence density was 1.2 AEs per 100 patient-days (95% CI 1.1 to 1.3). The incidence of moderate and serious AEs was 5.6 AEs per 1000 patient-days (95% CI 4.9% to 6.3%). In 66.3% of AEs, additional procedures were required and in 69.9% additional treatments were required. In total 42.8% of AEs were considered as avoidable. Of the subjects with some intrinsic risk factors, 13.2% developed AEs compared with 5.2% of the subjects who had no risk factors (p<0.001), and 9.5% of the subjects who had some extrinsic risk factors developed AEs compared with 3.4% of the subjects who had not (p<0.001). Patients older than 65 years of age showed a higher frequency of AEs than those under this age (12.4% vs 5.4%, p<0.001, RR 2.5). The most frequent AEs were those associated with medication (37.4%), hospital infections of any type (25.3%) and those relating to technical problems during a procedure (25.0%). A total of 31.4% of the AEs involved an increase in the length of stay. The AEs associated with medical assistance caused 6.1 additional hospital stays by patient. CONCLUSIONS: The incidence of patients with AE related to medical assistance in Spanish hospitals was relevant and similar to those found in the studies from Canada and New Zealand that had been conducted with comparable methodology. Patient vulnerability has been identified therein as playing a major role in generating healthcare-related AEs. These and other recent results indicate the need for AEs to be considered a public health priority in Europe.

[A near-miss event. A new approach in the study of adverse events]. / Análisis de los <>. Un nuevo enfoque en el estudio de los acontecimientos adversos.

A near-miss event is defined as an event that could have resulted in an injury, fatality, or property damage if it had not been prevented. Analysis of near-miss events could be an efficient method in the study of adverse events. Reporting of near-misses has many benefits in the study of adverse events since near-misses occur more frequently than adverse events. In addition, as they have no consequences, fear that the professionals involved would have to report them is less. However, up to now, this method has been slow to develop. We present two clinical cases that help to understand the usefulness of the near-miss reporting system.

[Hepatitis B virus vaccination in the province of Saragossa]. / Vacunación de hepatitis B en la provincia de Zaragoza.

We have studied 3001 hepatitis B vaccination protocols, during the period 1982-89, in three hospitals of Zaragoza. 87.24% of the vaccinations have been conducted on health staff, meanwhile other epidemiological important groups (drug users) don't have been attended. The seroprevalence of HBsAg was 0.96% at the prevaccination study. The cleaning staff and the hemodialyzed patients had the greatest ones (5.69% and 3.33%). The administration of the vaccine failed due to rejection in 25.50% and to withdrawal in 8.09%. Only 8.65% don't have developed antibodies after vaccination.