Article Text
Abstract
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.
- patient safety
- adverse events
- quality in health care
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributor JMAA is the principal publication author, he has coordinated the IBEAS project and he is the team leader. RLR has participated in data collection, data analysis and interpretation of the results, and composition of the manuscript. CAR has been coordinator of the IBEAS project, and he has evaluated the manuscript and contributed to improving the presentation; has has also participated in the data collection. MTG-VdC has participated in data collection, data analysis, evaluation of the results, and she has improved the manuscript; she has coordinated the project with JMAA. FB has participated in the evaluation and improvement of the manuscript and data analysis. IH-A has participated in the design of the study and analysis planning. NLF has participated in the evaluation of the manuscript and she has been the responsible for sending the manuscript to the reviewer and the editorials. CDA has collaborated for manuscript composition and she has contributed to the critical review. ETG has been coordinator of the IBEAS project and he has contributed to the critical review of this paper. PS has collaborated in the data analysis and critical review of this paper. ILJ has contributed in the improvement of the paper composition and she has participated in data analysis. She has also been an IBEAS project coordinator. All the members have contributed towards the data collection.
Competing interests None declared.
Patient consent Detail has been removed from these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval The IBEAS Study maintained ethical conduct of research, and was approved by the PAHO Ethics Review Committee and by the National Ethics Review Committees of each participating country.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Additional data can be available by emailing: jesusmaria.aranaz@salud.madrid.org.
Collaborators Grupode Trabajo IBEAS: Agra-Varela Y (Ministerio de Sanidad, ServiciosSociales e Igualdad, España), Aibar-Villán L (Hospital San Juan de Dios de Úbeda. España), Casal-Gómez JM (Ministerio deSanidad, Servicios Sociales e Igualdad, España), Fernández-Maíllo M (Ministerio de Sanidad, Servicios Sociales e Igualdad, España), Aranaz-Ostáriz V (Hospital Universitario San Juan de Alicante, España), López Rodríguez-Arias F (Hospital Universitario de Elda, España), Valencia-Martín JL (Hospital Universitario Ramón y Cajal.España), Rincón-Carlavilla A (Hospital Universitario Ramón y Cajal, España), Gonseth-García J (Gerencia Hospital de Especialidades Guayaquil "Dr. Abel Gilbert Pontón", Ecuador), Amarilla AC (Dirección de Calidad de los Servicios deSalud, Ministerio de Salud, Argentina), Restrepo-Parra FR (Dirección general de Calidad, Ministerio de la Protección Social, Colombia), Sarabia-González O (Subsecretaría de Innovación y Calidad, Ministerio de Salud, México), Inga R (Seguro Social de Salud, Perú), Santivañez A (Seguro Social de Salud, Perú), Urroz-Torres O (Dirección Nacional, Caja Costarricense de Seguro Social, Costa Rica), García-Corcuera LV (Ministerio de Salud, Perú).