Kristen Miller

Effect of montelukast on single-dose theophylline pharmacokinetics.

The effect of montelukast (MK-0476), a cysteinyl leukotriene receptor antagonist in development for treatment of asthma, on single-dose theophylline plasma concentrations was studied in three separate clinical trials. Montelukast was evaluated at 10 mg once daily (the clinical dosage), 200 mg once daily, and 600 mg (200 mg three times daily). At the clinical dosage, montelukast did not change single-dose theophylline plasma concentration in a clinically important manner. The geometric mean ratios for theophylline area under the plasma concentration versus time curve (AUC0) (0.92) and maximal plasma concentration (Cmax) (1.04) were well within the predefined and generally accepted bioequivalence range of 0.80 and 1.25. Montelukast decreased theophylline Cmax by 12% and 10%, AUC0 by 43% and 44%, and elimination half-time by 44% and 39% at 200 mg/d (oral and intravenous, respectively), and at 600 mg/d, montelukast decreased theophylline Cmax by 25%, AUC0 by 66%, and elimination half-time by 63%. These results show that montelukast at the clinical dosage did not change theophylline pharmacokinetics in a clinically important manner, but at 20− to 60-fold higher dosages, montelukast significantly reduced the theophylline pharmacokinetics parameters; an apparent dosage dependence is suggested.

Interface, information, interaction: a narrative review of design and functional requirements for clinical decision support

ObjectivenProvider acceptance and associated patient outcomes are widely discussed in the evaluation of clinical decision support systems (CDSSs), but critical design criteria for tools have generally been overlooked. The objective of this work is to inform electronic health record alert optimization and clinical practice workflow by identifying, compiling, and reporting design recommendations for CDSS to support the efficient, effective, and timely delivery of high-quality care.nnnMaterial and MethodsnA narrative review was conducted from 2000 to 2016 in PubMed and The Journal of Human Factors and Ergonomics Society to identify papers that discussed/recommended design features of CDSSs that are associated with the success of these systems.nnnResultsnFourteen papers were included as meeting the criteria and were found to have a total of 42 unique recommendations; 11 were classified as interface features, 10 as information features, and 21 as interaction features.nnnDiscussionnFeatures are defined and described, providing actionable guidance that can be applied to CDSS development and policy. To our knowledge, no reviews have been completed that discuss/recommend design features of CDSS at this scale, and thus we found that this was important for the body of literature. The recommendations identified in this narrative review will help to optimize design, organization, management, presentation, and utilization of information through presentation, content, and function. The designation of 3 categories (interface, information, and interaction) should be further evaluated to determine the critical importance of the categories. Future work will determine how to prioritize them with limited resources for designers and developers in order to maximize the clinical utility of CDSS.nnnConclusionnThis review will expand the field of knowledge and provide a novel organization structure to identify key recommendations for CDSS.

Commentary on “Naturalistic Decision Making and the Practice of Health Care”

Falzer (2018) effectively describes the application of naturalistic decision making (NDM) to the best practices regimen. We agree on the increasing challenges posed in health care regarding clinical decision making under uncertain conditions, as magnified by the burden of exponentially expanding clinical knowledge, the timeliness and comprehensiveness of available data, as well as care and choice complexity. However, we see no inherent conflict between engineering for complex systems and the “best practices regimen.” As human factors practitioners and clinicians working to tackle diagnostic error, as well as many other clinical decision-making challenges, we fully recognize the criticality of a systems approach. If human factors engineering has taught us anything, it is that we do not redesign humans; we redesign the systems within which humans work. Human factors engineering focuses on industrial engineering, cognitive psychology, information processing, and perception to maximize the use of human strengths and accommodate human limitations. Falzer’s call to identify and address limitations in the design of complex interactive systems with a focus on how systems operate in actual practice is important and aligned with the human factors and systems safety approach. The gradual shift toward evidence-based medicine can and should be designed to take a systems approach with a better understanding of the decision-making practices of health care providers and the resulting impact on service delivery. It is why current efforts to produce value-based care encompass multifarious initiatives and programs that run the gamut of health care improvement, ranging from training and education to performance improvement and research. As noted by Falzer, the impact of case-specific factors (arguably in addition to environmental, resource, and nontechnical challenges) does not exclude suboptimal decision making and resistance to change. Providers face challenging clinical cases in resource-constrained and complex environments. As the complexity of a system increases, the ability of the human to fully understand the intricacies of a system diminishes without a countervailing force. The case study presented by Falzer highlights the challenge of effectively implementing evidence-based guidelines. Despite advances in evidence-based medicine, there remains a gap between the evidence-based knowledge developed through research and the systematic application of that research in the clinical setting. Given an insufficient focus on the effective translation of evidence-based knowledge to frontline clinical practice and the sheer number of clinical practice guidelines promulgated by many diverse authoritative bodies, it is not surprising that uptake by frontline clinicians is low. Our ability to produce clinical care guidelines is currently far more advanced than our ability to translate and implement them into clinical care, even acknowledging that guideline making is prone to the overstatement of the evidence base. For example, take evidence-based guidelines integrated as clinical decision support (CDS). 777942 EDMXXX10.1177/1555343418777942Journal of Cognitive Engineering and Decision MakingCommentary on “Naturalistic Decision Making” 2018

Development of Virtual Simulations for Medical Team Training: An Evaluation of Key Features

Medical team training (MTT) conducted in a virtual environment fosters growth in cognitive, technical, and clinical aptitudes while offering advantages of flexibility, cost, and ease of scheduling over traditional high- fidelity simulations. Growing technology facilitates innovations to improve the ability to emulate roles, rules, resources, and fidelity. Our objective was to evaluate elements of key features that inform technical specifications for virtual simulations. A narrative review included 27 articles as relevant to elaborate on five key features identified as critical to development of virtual environments for MTT: automated assessment, task fidelity, interface modality, virtual teammates, and adaptability. Designers continue to improve the technology of virtual reality to create better and more enhanced training modules. We must better understand how variances in simulation features impacts performance outcomes and learned behavior. Future research can more deeply examine features beyond the five reviewed here to guide development of effective, cost-efficient virtual simulations for MTT.

These Aren’t the Triads You’re Looking For: Updating Clinical Mental Models of Acute Spinal Cord Compression

Acute spinal cord compression (SCC) is rare, difficult to diagnose, and likely to result in devastating, irreversible neurological outcomes if not treated in a timely manner. This project aimed to 1) identify clinician perceptions and impressions of SCC diagnostic indicators and risk factors; 2) coalesce SCC diagnostic indicators and risk factors described in the literature; and 3) compare the above elements. The goal of this project is to optimize the SCC alert within the electronic health record system and to update the emergency department’s protocol.

Signaling Sepsis Scenario Development & Validation

Patient-based scenario-driven usability tests are routinely created for health information technology and clinical decision support evaluations. Due to low clinician awareness of sepsis, a study was undertaken to understand clinician performance and preference of different display types for sepsis clinical decision support through multi-centered usability testing. Patient-based clinical scenarios were created to mimic the environment in which providers would interact with clinical decision support. The data provided in the scenarios were drawn from real patient cases from two sepsis databases, including: demographics, visit/operational details, medical history (comorbidities, assessments, vital signs, laboratory values, clinician documentation), and patient disposition/outcomes. The purpose of this work is to inform electronic health record alert optimization and clinical practice workflow to support the effective and timely delivery of high quality sepsis care. This paper discusses the methodology, selection, and validation of patient-based cases used as the clinical scenarios in usability testing.

Oncology Related Patient Safety Events

Care for cancer patients is very complex with many treatments involving drugs that can be toxic outside of the therapeutic range. As such, cancer patients are a particularly vulnerable population within the healthcare system, with any error potentially being harmful to a population whose health is already compromised. Self-reported patient safety events can provide a window into healthcare, revealing areas of care that require improvement. We identified events occurring in oncology units that both caused harm and were involved cancer patients for both out-patients and in-patients. Across all events, adverse drug reactions and intravenous-related events were the most common. Other relatively frequent events included those related to poor care coordination and falling. These results illustrate the safety risks patients’ face when being treated with cytotoxic drugs and offer insight to areas in which patient care can be improved.

A usability and safety analysis of electronic health records: a multi-center study

To characterize the variability in usability and safety of EHRs from two vendors across four healthcare systems (2 Epic and 2 Cerner). Twelve to 15 emergency medicine physicians participated from each site and completed six clinical scenarios. Keystroke, mouse click, and video data were collected. From the six scenarios, two diagnostic imaging, laboratory, and medication tasks were analyzed. There was wide variability in task completion time, clicks, and error rates. For certain tasks, there were an average of a nine-fold difference in time and eight-fold difference in clicks. Error rates varied by task (X-ray 16.7% to 25%, MRI: 0 to 10%, Lactate: 0% to 14.3%, Tylenol: 0 to 30%; Taper: 16.7% to 50%). The variability in time, clicks, and error rates highlights the need for improved implementation optimization. EHR implementation, in addition to vendor design and development, is critical to usable and safe products.

The design of decisions: Matching clinical decision support recommendations to Nielsen’s design heuristics

OBJECTIVEnWhile general design heuristics exist for graphic user interfaces, it remains a challenge to facilitate the implementation of these heuristics for the design of clinical decision support. Our goals were to map a set of recommendations for clinical decision support design found in current literature to Jakob Nielsens traditional usability heuristics and to suggest usability areas that need more investigation.nnnMATERIALS AND METHODSnUsing a modified nominal group process, the research team discussed, classified, and mapped recommendations, organized as interface, information, and interaction, to design heuristics. A previous narrative review identified 42 recommendations from the literature to define the design and functional characteristics that impact the performance of CDS in terms of provider preference, process of care, and patient outcomes.nnnMAIN FINDINGSnWe matched 20 out of 42 recommendations to heuristics. The mapping reveals gaps in both heuristics and recommendations, identifying a set of Nielsens heuristics that are underrepresented in the literature and subsets of recommendations important to design not covered in Nielsens heuristics. We attributed this, in part, to the evolution of technology since the inception of Nielsens heuristics. The team created a new interaction heuristic: Integration into real-time workflow to consider the needs of the end-user in the clinical space.nnnDISCUSSIONnClinical decision support has enabled clinicians to better address arising information needs; however there remains a lack of evidence-based guidelines in terms of functional and design requirements.nnnCONCLUSIONnResults from this review suggest that interaction design principles were not fully satisfied by the current literature of clinical decision support.

Matt’s story: learning from heartbreak

The victims of medical error reach far beyond the patient. The aftermath forever changes the lives of the patients family and physician alike. We explore the life and death of nineteen-year-old Matt, a stellar athlete and better son, and the cognitive bias that led to an unfortunate and consequential medical misdiagnosis. This story is one of family heartbreak, the harsh reality of second victim phenomenon, and ultimately lessons learned in compassion, vigilance, and candidness for the health care industry. We share this tragedy with the medical community in hopes that we improve the use of post-mortems, transparency and disclosure to heal the wounds of our patients families.