Identification and Description of Randomized Controlled Trials and Systematic Reviews on Patient Safety Published in Medical Journals Leticia Andrea Barajas-Nava, MD, PhD,* Jose ´ Andre ´s Calvache, MD, MSc,Þ Jesu ´s Lo ´pez-Alcalde, MD, MSc,þ Ivan Sola `, BSc,* and Xavier Bonfill Cosp, MD, MPH, PhD§ Objective: To identify and describe randomized controlled trials (RCTs) and systematic reviews (SRs) on patient safety published from 1973 onward. Materials and Methods: We handsearched a total of 12 medical journals published in English with contents related to patient safety to identify RCTs and SRs published between 1973 and the end of 2010. The results obtained from this search were complemented with an ad- ditional search in MEDLINE. The documents were classified by area of specialty or service in which the intervention was applied, level of preventive action, and type of patient safety incident, the latter in accor- dance with the International Classification for Patient Safety proposed by the World Health Organization (WHO). The main features of the identi- fied studies are also described. Results: A total of 787 issues of 12 journals published between 1973 and 2010 were handsearched. This procedure yielded 10,162 refer- ences, of which, 131 corresponded to RCTs and 127 to SRs. A parallel MEDLINE search identified only about two-thirds of these articles. Of all the studies identified, 83 RCTs and 64 SRs addressed interven- tions related to patient safety. The types of incident related to patient safety that were included most often in RCTs involved the clinical pro- cess, and for SRs, those related to resources/organizational management. On average, only 3.5 RCTs and 3.4 SRs were published per year, many of which had significant deficiencies in the reported information, such as, for instance, a lack of details on the methodology used. Conclusions: The number of RCTs and SRs on patient safety pub- lished in specialized journals is scarce. No studies on interventions to improve the safety of the handling of blood and derivatives, infec- tions related to health care, nutrition, or infrastructure were identified as a result of our search. Handsearching plays a key role in the identi- fication of all the clinical trials that could be included in SRs on patient safety interventions. Knowing the content of RCTs and SRs published on patient safety can better target future research. Key Words: patient safety, randomized controlled trials, systematic reviews, meta-analysis (J Patient Saf 2013;9: 00Y00) Patient Safety Patient safety is the reduction of risk of unnecessary harm associated with health care to an acceptable minimum. An ac- ceptable minimum refers to the collective notions of given current knowledge, resources available, and the context in which care was delivered weighed against the risk of nontreatment or other treatment. Health careYassociated harm is a significant source of morbidity and mortality worldwide. 1,2 Studies suggest that between 4% and 17% of hospitalized patients experience an adverse event (AE). 3Y13 An AE is defined as an untoward in- cident, injury, or unnecessary harm that is caused by health-care delivery rather than by the underlying disease process and that can result in complications, prolonged hospitalization, disability on discharge, or death. 1,2,6,7 Moreover, it is estimated that ap- proximately 50% of the AEs are preventable. 3 Given the world- wide necessity to improve health-care safety, the World Health Organization (WHO) announced in 2004 the launch of the World Alliance for Patient Safety, 14 which aims to make health-care safety a top priority in the health agendas of all countries. Research in patient safety plays a key role in improving the quality of health care. However, despite the effort invested in this field during the last 20 years, the more effective inter- ventions to prevent or minimize the damage associated with AEs, and the most appropriate strategy to implement them, remain relatively unknown. To address this issue, the World Alliance for Patient Safety created a working group to identify priorities for research in patient safety, which took into con- sideration the frequency of adverse events, the severity of dam- age generated on the patient, and their impact on the health system. Thanks to this work, 50 topics were identified for re- search, including adverse events related to medications, inju- ries caused by health products, health careYassociated infections, and injuries from falls in hospitals. 2,15,16 Evidence on the Effects of Interventions to Improve Patient Safety Research on patient safety is a relatively recent practice. Scientific output in this field has increased dramatically in re- cent years and, as a result, evidence on practices to improve patient safety is increasing. 17 However, research on the efficacy of the interventions to decrease unnecessary risks associated with health care presents peculiarities. For instance, they are often ‘‘complex interventions’’ that target on groups of subjects in an equally complex environment, such as health organizations. 18,19 In general, the best available research design to evaluate the efficacy of health interventions is the randomized con- trolled trial (RCT), which is the study design that provides the most robust evidence. 20Y24 The term controlled clinical trial (CCT) was incorporated into the electronic bibliographic databases during the 1990s; thus, CCTs that had been published previously were classified in other categories, hindering their identification. Additionally, in many cases, the study authors do not clearly describe the methodology used, which makes the ORIGINAL ARTICLE J Patient Saf & Volume 9, Number 2, June 2013 www.journalpatientsafety.com 1 From the *Iberoamerican Cochrane Center, Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain; †Department of Anesthesiology, Universidad del Cauca, Colombia, Anaesthesiology/Biostatistics Department - Erasmus MC Hospital, Rotterdam, The Netherlands; ‡Health Technology Assessment Unit, UCICEC de Atencio ´n Primaria, Agencia Laı ´n Entralgo (Cochrane Collabo- rating Center), Madrid; and §Iberoamerican Cochrane Center - Institute of Biomedical Research (IIB Sant Pau), CIBER Epidemiologı ´a y Salud Pu ´blica (CIBERESP), Spain. Universitat Auto `noma de Barcelona, Barcelona, Spain. Correspondence: Leticia Andrea Barajas-Nava, MD, PhD, Iberoamerican Cochrane Center, Institute of Biomedical Research, Hospital de la Santa Creu i Sant Pau, Sant Antoni M a Claret 171, 4 a planta, 08041 Barcelona, Spain (email: leticia.barajas@cochrane.es). The authors disclose no conflict of interest. Funding: This project did not receive funding from any source. Leticia A. Barajas-Nava is a doctoral candidate at the Paediatrics, Obstetrics and Gynecology and Preventive Medicine Department, Universitat Auto `noma de Barcelona, Barcelona, Spain. Copyright * 2013 by Lippincott Williams & Wilkins Copyright © 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.