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Background: Substantial expenditures on health care safety programs have been justified by their goal of reducing health care associated–harm (adverse events), but adverse event rates have not changed over the past 4 decades. The objective of this study is to describe hospital-level factors that are relevant to safety in Canadian hospitals and the impact of these factors on hospital adverse events. Methods: This is a protocol for a national cohort study to describe the association between hospital-level factors and adverse events. We will survey at least 90 (35%) Canadian hospitals to describe 4 safety-relevant domains, chosen based on the literature and expert consultation, namely patient safety culture, safety strategies, staffing, and volume and capacity. We will retrospectively identify hospital adverse events from a national data source. We will evaluate organization-level factors using established scales and a survey, codesigned by the study team and hospital leaders. Hospital leaders, clinical unit leaders and front-line staff will complete the surveys once a year for 3 years, with an anticipated start date of winter 2022. We will use national health administrative data to estimate the rate and type of hospital adverse events corresponding to each 1-year survey period. Interpretation: Analysis of data from this project will describe hospital organizational factors that are relevant to safety and help identify organizational initiatives that improve hospital patient safety. In addition to biyearly reports to the leaders of the participating hospitals, we have a multifaceted and tailored dissemination strategy that includes integrating the knowledge users into the study team to increase the likelihood that our study will lead to improved hospital patient safety. [ABSTRACT FROM AUTHOR]

Background: Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being. However, increases in continuity-related errors may counteract the purported benefits of reducing fatigue. We evaluated the effects of 3 resident schedules in the intensive care unit (ICU) on patient safety, resident well-being and continuity of care. Methods: Residents in 2 university-affiliated ICUs were randomly assigned (in 2-month rotation-blocks from January to June 2009) to in-house overnight schedules of 24, 16 or 12 hours. The primary patient outcome was adverse events. The primary resident outcome was sleepiness, measured by the 7-point Stanford Sleepiness Scale. Secondary outcomes were patient deaths, preventable adverse events, and residents' physical symptoms and burnout. Continuity of care and perceptions of ICU staff were also assessed. Results: We evaluated 47 (96%) of 49 residents, all 971 admissions, 5894 patient-days and 452 staff surveys. We found no effect of schedule (24-, 16- or 12-h shifts) on adverse events (81.3, 76.3 and 78.2 events per 1000 patient-days, respectively; p = 0.7) or on residents' sleepiness in the daytime (mean rating 2.33, 2.61 and 2.30, respectively; p = 0.3) or at night (mean rating 3.06, 2.73 and 2.42, respectively; p = 0.2). Seven of 8 preventable adverse events occurred with the 12-hour schedule (p = 0.1). Mortality rates were similar for the 3 schedules. Residents' somatic symptoms were more severe and more frequent with the 24-hour schedule (p = 0.04); however, burnout was similar across the groups. ICU staff rated residents' knowledge and decision-making worst with the 16-hour schedule. Interpretation: Our findings do not support the purported advantages of shorter duty schedules. They also highlight the trade-offs between residents' symptoms and multiple secondary measures of patient safety. Further delineation of this emerging signal is required before widespread system change. Trial registration: ClinicalTrials.gov, no. NCT00679809. [ABSTRACT FROM AUTHOR]

Background: Research into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We esti-mated the incidence of AEs among patients in Canadian acute care hospitals. Methods: We randomly selected 1 teaching, 1 large community and 2 small community hospitals in each of 5 provinces (British Columbia, Alberta, Ontario, Quebec and Nova Sco-tia) and reviewed a random sample of charts for nonpsychi-atric, nonobstetric adult patients in each hospital for the fiscal year 2000. Trained reviewers screened all eligible charts, and physicians reviewed the positively screened charts to identify AEs and determine their preventability. Results: At least 1 screening criterion was identified in 1527 (40.8%) of 3745 charts. The physician reviewers identified AEs in 255 of the charts. After adjustment for the sampling strategy, the AE rate was 7.5 per 100 hospital admissions (95% confi-dence interval [CI] 5.7--9.3). Among the patients with AEs, events judged to be preventable occurred in 36.9% (95% CI 32.0%--41.8%) and death in 20.8% (95% CI 7.8%--33.8%). Physician reviewers estimated that 1521 additional hospital days were associated with AEs. Although men and women ex-perienced equal rates of AEs, patients who had AEs were sig-nificantly older than those who did not (mean age [and stan-dard deviation] 64.9 [16.7] v. 62.0 [18.4] years; p= 0.016). Interpretation: The overall incidence rate of AEs of 7.5% in our study suggests that, of the almost 2.5 million annual hospital admissions in Canada similar to the type studied, about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable. [ABSTRACT FROM AUTHOR]

Presents a response by G. Ross Baker, Peter G. Norton and Virginia Flintoft to a letter to the editor about their article "The Canadian Adverse Events Study: The Incidence of Adverse Events Among Hospital Patients in Canada."