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Systematic reviews of non-randomized controlled trials (RCTs) suggest that using a checklist results in fewer medical errors and adverse events, but these evaluations are at risk of bias.To conduct a systematic review of RCTs of checklists to determine their effectiveness in improving patient safety outcomes in hospitalized patients.Ovid EMBASE, Ovid MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials were searched from inception until December 8, 2016. The search was restricted to RCTs. Included studies reported patient safety outcomes of a checklist intervention. Data extracted included the study characteristics, setting, population, intervention, outcomes measures, and sample size.11,225 citations were identified, of which 9 (16,987 patients) satisfied the inclusion criteria. Citations reported evaluations of checklists designed to improve surgical safety, prescription of medications, heart failure management, pain control, infection control precautions, and physician handover. Studies reported significant reductions in postoperative complications and medication-related problems and improved compliance with evidence-based prescribing of medications, infection control precautions, and patient handover procedures. 30-day mortality was reported in 3 studies and was significantly lower among patients allocated to the checklist group (odds ratio 0.60, 95% confidence interval, 0.41–0.89, P = 0.01, I2 = 0.0%, P = 0.573). Methodological quality of the studies was moderate.A small number of citations report RCT evaluations of the impact of checklists on patient safety. There is an urgent need for high-quality evaluations of the effectiveness of patient safety checklists in inpatient healthcare settings to substantiate their perceived benefits.