The Study on Safety in Hospitals in the Region of Madrid (ESHMAD) design: Screening and analysis of incidents and adverse events.

Background: A Study related to Safety in Hospitals in the Region of Madrid (ESHMAD) was carried out in order to determine the prevalence, magnitude and characteristics of adverse events in public hospitals. This work aims to define a useful methodology for the multicenter study of adverse events in the Region of Madrid, to set out the preliminary results of the hospital enrollment and to establish a model of a strategy of training of trainers for its implementation.

Methods: ESHMAD was a multicenter, double phase study for the estimation of adverse events and incidents prevalence across the Region of Madrid. First phase comprehended a 1-day cross-sectional prevalence study, in which it was collected, through a screening guide, information about admission, patient characteristics, intrinsic and extrinsic risk factors, and the possibility of an adverse event or incident had happened during the hospitalization. Second phase was a retrospective nested cohort study, in which it was used a Modular Review Form for reviewing the positive screenings of the first phase, identifying in each possible adverse event or incident the classification of the patient safety event, clinical onset, root, and associated causes and factors, impact, and preventability. A pilot study was performed in an Internal Medicine Unit of a tertiary hospital.

Results: 34 public hospitals participated, belonging to 6 healthcare categories and with more than 10,000 hospitalisations aggregate capacity. 72 coordinators were enrolled in the strategy of training of trainers, which was performed through five on-site training workshops. In the pilot study, 45.2% patients were identified with at least one positive event of the screening. Of them, 48.1% (25 positive events) were identified as truly AE, with a result of 0.29 EA per analyzed patient.

Conclusions: The ESHMAD protocol allows to estimate the prevalence of adverse events, and the strategy of training of trainers facilitated the spread of the research methodology among the participants.