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

Abstract

BackgroundAdverse 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.ObjectivesThe aim of this study is to compare AEs detection using two different methodologies: cross-sectional versus retrospective cohort design.SettingSecondary and tertiary hospitals in five countries: Argentina, Colombia, Costa Rica, Mexico and Peru.ParticipantsThe 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.MethodsThis study compares the 1-day prevalence of the AEs obtained in the IBEAS Study with the incidence obtained through the retrospective cohort study.ResultsThe 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.ConclusionThe retrospective cohort design, although requires more resources, allows to detect more AEs than the cross-sectional design.

Prevalence, characteristics, and impact of adverse events in 34 Madrid hospitals. The ESHMAD study

“…Moderate severity AE were the most frequent (42%), followed by mild and severe AE. This is consistent with that obtained in other cross‐sectional studies, 25,35 but differs from that found in longitudinal studies, in which mild AE are usually more frequent (50%) 40,42 …”

Risk Analysis for Patient Safety in Surgical Departments: Cross-Sectional Design Usefulness

“…On the other hand, the fact that the prevalence design proportionally detects more serious AEs is not an inconvenience, as it is precisely these events that we should prioritise when analysing and establishing preventive and control strategies to reduce recurrence [28].…”

“…The methodology that ideally should be used for these types of epidemiological studies has been widely analysed, with a general consensus that it should be based on the objectives of the study and the need to combine the minimisation of bias and validity to identify AEs with reproducibility of value judgments in their iatrogenic or avoidable nature [21,28].…”

Factors Associated with In-Hospital Mortality in Acute Care Hospital Settings: A Prospective Observational Study

“…The prevalence of in-hospital AEs in the European Union ranges from 8% to 12%, where 1 in every 100,000 inhabitants dies from this cause, i.e., about 5000 deaths per year [2,3]. The latest report by the Ibero-American Study of Adverse Events (IBEAS) established a prevalence of AEs of 10.5% and a cumulative incidence close to 20% [4]. AEs increase hospital stays by a mean of 8.7 days and double inpatient mortality (relative risk (RR) = 2.10) [5,6].…”