Applying Human Factors and Systems Simulation Methods to Inform a Multimillion-Dollar Healthcare Decision.

PURPOSE: This article describes a case study of a collaborative human factors (HF) and systems-focused simulation (SFS) project to evaluate potential patient and staff safety risks associated with a multimillion-dollar design and construction decision. BACKGROUND: The combined integration of HF and SFS methods in healthcare related to testing and informing the design of new environments and processes is underutilized. Few realize the effectiveness of this integration in healthcare to reduce risk and improve decision-making, safety, design, efficiency, patient experience, and outcomes. This project showcases how the combined use of HF and SFS methods can provide objective evidence to help inform decisions. METHODS: The project was initiated by a healthcare executive team looking for an objective, user informed analysis of a current connector passageway between two existing buildings. The goal was to understand the implications of keeping the current route for simultaneous use for public and patients service flow versus building and financing a new passageway for separate flow and transport. An interprofessional team of intensive care unit professionals participated in two simulations designed to test the current connector. A failure mode and effects analysis and qualitative debrief feedback was used to evaluate risks and potential failures. RESULTS: The evaluation resulted in data that enabled informed executive decision making for the most effective, efficient, and safest option for public, staff, and patient transport between two buildings. This evaluation resulted in the decision to go forward with building a multimillion-dollar new connector passageway to improve integrated care and transport.

Real-world persistence of erenumab for preventive treatment of chronic and episodic migraine: Retrospective real-world study.

OBJECTIVE: To describe the real-world treatment persistence (defined as the continuation of medication for the prescribed treatment duration), demographics and clinical characteristics, and treatment patterns for patients prescribed erenumab for migraine prevention in Canada. BACKGROUND: The effectiveness of prophylactic migraine treatments is often undermined by poor treatment persistence. In clinical trials, erenumab has demonstrated efficacy and tolerability as a preventive treatment, but less is known about the longer term treatment persistence with erenumab. METHODS: This is a real-world retrospective cohort study where a descriptive analysis of secondary patient data was conducted. Enrollment and prescription data were extracted from a patient support program for a cohort of patients prescribed erenumab in Canada between September 2018 and December 2019 and analyzed for persistence, baseline demographics, clinical characteristics, and treatment patterns. Descriptive analyses and unadjusted Kaplan-Meier (KM) curves were used to summarize the persistence and dose escalation/de-escalation at different timepoints. RESULTS: Data were analyzed for 14,282 patients. Median patient age was 47 years, 11,852 (83.0%) of patients were female, and 9443 (66.1%) had chronic migraine at treatment initiation. Based on KM methods, 71.0% of patients overall were persistent to erenumab 360 days after treatment initiation. Within 360 days of treatment initiation, it is estimated that 59.3% (KM-derived) of patients who initiated erenumab at 70 mg escalated to 140 mg, and 4.4% (KM-derived) of patients who initiated at 140 mg de-escalated to 70 mg. CONCLUSIONS: The majority of patients prescribed erenumab remained persistent for at least a year after treatment initiation, and most patients initiated or escalated to a 140 mg dose. These results suggest that erenumab is well tolerated, and its uptake as a new class of prophylactic treatment for migraine in real-world clinical practice is not likely to be undermined by poor persistence when coverage for erenumab is easily available.

Prevalence and Characteristics of Interruptions and Distractions During Surgical Counts.

BACKGROUND: Surgical counting is a complex and safety-critical task that requires sustained attention by multiple members of the surgical team in order to prevent the occurrence of an unintentionally retained foreign object. Interruptions and distractions in the operating room are common and can negatively affect task performance. However, the prevalence and sources of interruptions and distractions during safety-critical tasks, such as surgical counting, have not previously been quantified. An understanding of the characteristics of these events could be used to inform targeted improvements to patient safety. METHODS: Observations were conducted of surgical procedures in order to quantify and describe interruptions and distractions during surgical counting activities. Analysis was separated into phases: the initial count, additions to the surgical field, removals from the surgical field, and closure counts. RESULTS: Thirty-six surgical procedures were observed. Interruptions occurred in 10.0% of initial counts, 15.4% of additions, 23.5% of removals, and 33.3% of closure counts observed. The source of 80.4% of interruptions was a surgeon, usually asking the scrub nurse for an item. Distractions were present in 46.7% of initial counts, 38.5% of additions, 41.2% of removals, and 40.9% of closure counts observed. Common sources of distraction included music, conversations, people entering and exiting the theater, and ringing phones. CONCLUSION: Interruptions and distractions are common during surgical counts and can significantly affect patient safety by jeopardizing the accuracy of the count. A number of suggestions are provided that could reduce interruptions and distractions and their consequences.

The evaluation of an ambulance rear compartment using patient simulation: Issues of safety and efficiency during the delivery of patient care.

The purpose of this study was to evaluate the safety and efficiency of a specific ambulance while providers delivered basic and advanced life support. Forty-eight, Emergency Medical Service (EMS) teams were observed delivering care to a simulated patient during an anaphylaxis scenario in a moving ambulance that contained a complete compliment of medical supplies and equipment. A detailed coding system was developed and applied to the audio and video behavioural data. Patterns of interaction among EMS personnel, the patient, equipment and the ambulance interior during the patient simulation scenario were analyzed. The results revealed a number of issues associated with the patient compartment including: potentially unsafe seated and standing positions; hazardous barriers to movement around the patient; difficulties accessing equipment and supplies; and the adequacy of work surfaces and waste disposal. A number of design recommendations are made to guide provider and patient comfort, efficiency and safety.

Melanophilin, a novel aldosterone-induced gene in mouse cortical collecting duct cells.

The molecular mechanisms of aldosterone-regulated Na+ transport are not entirely clear. The goal of this study was to identify aldosterone-induced genes potentially involved in the trafficking of the epithelial Na+ channel (ENaC). We report that the transcript levels of melanophilin (MLPH), a protein involved in vesicular trafficking in melanocytes, are rapidly increased by aldosterone in cortical collecting duct (CCD) cells. This effect was near maximal at physiological aldosterone concentrations, indicating that it is mediated by the mineralocorticoid receptor. De novo protein synthesis is not required for the induction of MLPH mRNA by aldosterone. To determine whether this induction has functional consequences on transepithelial Na+ current, we generated clonal CCD cell lines that express a tetracycline-inducible MLPH. Induction of MLPH in these cells led to a relatively modest, but statistically significant, increase in amiloride-sensitive Na+ current, suggesting the MLPH may be involved in ENaC trafficking. MyosinVc, the epithelial-specific class V myosin that is highly homologous to MyosinVa, another component of the melanosome trafficking complex, has putative consensus sites for serum and glucocorticoid-induced kinase 1 (SGK1), an early aldosterone-induced kinase that mediates some of aldosterone's effects on Na+ transport. Our results indicate that MyosinVc is phosphorylated by endogenous SGK1, suggesting that this complex may be involved in the aldosterone-regulated trafficking of ENaC in the CCD. These results suggest potential mechanisms by which aldosterone may regulate Na+ transport both directly, by increasing the abundance of MLPH, and indirectly by increasing the transcription of SGK1, which in turn regulates the activity of MyosinVc.