Comparison of two methods to estimate adverse events in the IBEAS Study (Ibero-American study of adverse events): cross-sectional versus retrospective cohort design.

BACKGROUND: Adverse events (AEs) epidemiology is the first step to improve practice in the healthcare system. Usually, the preferred method used to estimate the magnitude of the problem is the retrospective cohort study design, with retrospective reviews of the medical records. However this data collection involves a sophisticated sampling plan, and a process of intensive review of sometimes very heavy and complex medical records. Cross-sectional survey is also a valid and feasible methodology to study AEs. OBJECTIVES: The aim of this study is to compare AEs detection using two different methodologies: cross-sectional versus retrospective cohort design. SETTING: Secondary and tertiary hospitals in five countries: Argentina, Colombia, Costa Rica, Mexico and Peru. PARTICIPANTS: The IBEAS Study is a cross-sectional survey with a sample size of 11 379 patients. The retrospective cohort study was obtained from a 10% random sample proportional to hospital size from the entire IBEAS Study population. METHODS: This study compares the 1-day prevalence of the AEs obtained in the IBEAS Study with the incidence obtained through the retrospective cohort study. RESULTS: The prevalence of patients with AEs was 10.47% (95% CI 9.90 to 11.03) (1191/11 379), while the cumulative incidence of the retrospective cohort study was 19.76% (95% CI 17.35% to 22.17%) (215/1088). In both studies the highest risk of suffering AEs was seen in Intensive Care Unit (ICU) patients. Comorbid patients and patients with medical devices showed higher risk. CONCLUSION: The retrospective cohort design, although requires more resources, allows to detect more AEs than the cross-sectional design.

[Lights and shadows in patient safety: study and development of strategies. 2008 SESPAS Report]. / Luces y sombras en la seguridad de los pacientes: estudio y desarrollo de estrategias. Informe SESPAS 2008.

Study of the frequency of healthcare-related adverse events (AE) and of their effect on patients and impact on healthcare systems has markedly increased in recent years. Indepth individual analysis of the factors contributing to these events has allowed strategies to prevent or minimize the impact of AE to be developed. However, an epidemiologic perspective is needed to explore possible associations and generalize the recommendations that can be drawn from this type of analysis. Some aspects that should been considered while developing future strategies are discussed. These aspects include the importance of patient age and comorbidities on producing AE and the use of highly technological medicine, which is sometimes unnecessary. A culture of trust and confidentiality and a spirit of collaboration among organizations are indispensable to share and learn about the initiatives prompted by the study of AE and thereby improve patient safety in the national health service.

Luces y sombras en la seguridad de los pacientes: estudio y desarrollo de estrategias. Informe SESPAS 2008 / Lights and shadows in patient safety: study and development of strategies. 2008 SESPAS Report

El estudio sobre la frecuencia de los efectos adversos (EA) ligadosa la asistencia, su efecto en los pacientes y el impactoen los sistemas de salud ha experimentado un intenso impulsoen los últimos años. El análisis individual profundo de susfactores contribuyentes ha permitido el desarrollo de múltiplesestrategias para prevenirlos o minimizar su impacto, pero es necesariauna perspectiva epidemiológica para explorar estas posiblesasociaciones y generalizar las recomendaciones que sederiven de este análisis.Se comentan algunos de los aspectos que se deberían teneren cuenta para el desarrollo de estrategias futuras, como la importanciade la edad o las comorbilidades del paciente en la génesisde los EA y el alto grado de la instrumentalización de laasistencia (a veces innecesaria). Son imprescindibles una culturade confianza y confidencialidad y un espíritu de colaboraciónentre las organizaciones para poder compartir y aprenderde las iniciativas derivadas del estudio de los EA, y así mejorarla seguridad de los pacientes en el Sistema Nacional de Salud(AU)

Study of the frequency of healthcare-related adverseevents (AE) and of their effect on patients and impact on healthcaresystems has markedly increased in recent years. Indepthindividual analysis of the factors contributing to theseevents has allowed strategies to prevent or minimize the impactof AE to be developed. However, an epidemiologic perspectiveis needed to explore possible associations and generalizethe recommendations that can be drawn from thistype of analysis.Some aspects that should been considered while developingfuture strategies are discussed. These aspects include the importanceof patient age and comorbidities on producing AEand the use of highly technological medicine, which is sometimesunnecessary. A culture of trust and confidentiality anda spirit of collaboration among organizations are indispensableto share and learn about the initiatives prompted by thestudy of AE and thereby improve patient safety in the nationalhealth service(AU)