Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019.

Importance: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade. Objective: To determine the change in the rate of adverse events in hospitalized patients. Design, Setting, and Participants: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%). Exposures: Adults aged 18 years or older hospitalized during each included calendar year. Main Outcomes and Measures: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations. Results: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly. Conclusions and Relevance: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety.

Development and Usability Testing of the Agency for Healthcare Research and Quality Common Formats to Capture Diagnostic Safety Events.

OBJECTIVES: A lack of consensus around definitions and reporting standards for diagnostic errors limits the extent to which healthcare organizations can aggregate, analyze, share, and learn from these events. In response to this problem, the Agency for Healthcare Research and Quality (AHRQ) began the development of the Common Formats for Event Reporting for Diagnostic Safety Events (CFER-DS). We conducted a usability assessment of the draft CFER-DS to inform future revision and implementation. METHODS: We recruited a purposive sample of quality and safety personnel working in 8 U.S. healthcare organizations. Participants were invited to use the CFER-DS to simulate reporting for a minimum of 5 cases of diagnostic safety events and then provide written and verbal qualitative feedback. Analysis focused on participants' perceptions of content validity, ease of use, and potential for implementation. RESULTS: Estimated completion time was 30 to 90 minutes per event. Participants shared generally positive feedback about content coverage and item clarity but identified reporter burden as a potential concern. Participants also identified opportunities to clarify several conceptual definitions, ensure applicability across different care settings, and develop guidance to operationalize use of CFER-DS. Findings led to refinement of content and supplementary materials to facilitate implementation. CONCLUSIONS: Standardized definitions of diagnostic safety events and reporting standards for contextual information and contributing factors can help capture and analyze diagnostic safety events. In addition to usability testing, additional feedback from the field will ensure that AHRQ's CFER-DS is useful to a broad range of users for learning and safety improvement.

Measuring Patient Safety: The Medicare Patient Safety Monitoring System (Past, Present, and Future).

ABSTRACT: The explicit declaration in the landmark 1999 Institute of Medicine report "To Err Is Human" that, in the United States, 44,000 to 98,000 patients die each year as a consequence of "medical errors" gave widespread validation to the magnitude of the patient safety problem and catalyzed a number of U.S. federal government programs to measure and improve the safety of the national healthcare system. After more than 10 years, one of those federal programs, the Medicare Patient Safety Monitoring System (MPSMS), has reached a level of maturity and stability that has made it useful for the consistent measurement of the safety of inpatient care. The MPSMS is a chart review-based national patient safety surveillance system that provides rates of 21 specific hospital inpatient adverse event measures, which have been divided into 4 clinical domains (general, hospital-acquired infections, postprocedure adverse events, and adverse drug events) for analysis. The 2014 MPSMS national sample was drawn from 1109 hospitals and includes approximately 20,000 medical records of patients admitted to the hospital (all payors) for at least 1 of the 4 conditions of congestive heart failure, acute myocardial infarction, pneumonia, and major surgical procedures as defined by the Centers for Medicare and Medicaid Services Surgical Care Improvement Project. The MPSMS is now going through a major transformation to capture additional types of adverse events and is being redeveloped as the Quality and Safety Review System (QSRS). As an example of this transformation, QSRS will electronically import electronic data, which are standardized according to the Centers for Medicare and Medicaid Services billing definitions and will be updated and evolve over time to incorporate expanded standardized data available from electronic health records. This article reviews the development of MPSMS, the strengths and limitations of MPSMS, and expected future directions in patient safety measurement, focusing on those issues that are informing the development and implementation of QSRS.

Challenges in Health Care Simulation: Are We Learning Anything New?

The growth of health care simulation in schools of medicine and nursing is noteworthy, as is the increasingly sophisticated simulation technology, support from funding agencies and foundations for research, well-attended annual conferences, and continued interest of accreditation and certification groups. Yet there are concerns preventing the full value of health care simulation to be realized when examined from a patient safety perspective. Basic questions are asked by funders of patient safety research when assessing past simulation projects undertaken to advance patient safety: Are the safety and quality of care to patients actually improved, and is something new being learned regarding the optimal use of simulation? Concerns focus on pursuing the right research questions to learn something new about the most effective use of simulation; doing more with simulation than simply providing an interesting, stand-alone educational experience; attending more seriously to how skill acquisition, maintenance, and progression get managed; and encouraging investigators, funders, and reviewers to expand their vision regarding what constitutes important inquiry and evidence in health care simulation. Patient safety remains a multifaceted challenge in the United States, requiring multifaceted approaches. Simulation training is considered a promising approach for improving the safety and quality of health services delivery. While it takes time for any new approach to gain momentum and learn from past efforts, it also will require addressing a systematic range of essential questions to improve existing knowledge on the optimal use of simulation, and to realize similar gains in safety that other high-risk industries have made.

Challenges and opportunities from the Agency for Healthcare Research and Quality (AHRQ) research summit on improving diagnosis: a proceedings review.

BACKGROUND: The Improving Diagnosis in Health Care report from the National Academies of Sciences, Engineering and Medicine (NASEM) provided an opportunity for many groups to reflect on the role they could play in taking actions to improve diagnostic safety. As part of its own process, AHRQ held a research summit in the fall of 2016, inviting members from a diverse collection of organizations, both inside and outside of Government, to share their suggestions regarding what is known about diagnosis and the challenges that need to be addressed. CONTENT: The goals of the summit were to learn from the insights of participants; examine issues associated with definitions of diagnostic error and gaps in the evidence base; explore clinician and patient perspectives; gain a better understanding of data and measurement, health information technology, and organizational factors that impact the diagnostic process; and identify potential future directions for research. Summary and outlook: Plenary sessions focused on the state of the new diagnostic safety discipline followed by breakout sessions on the use of data and measurement, health information technology, and the role of organizational factors. The proceedings review captures many of the key challenges and areas deserving further research, revealing stimulating yet complex issues.