Development and Validation of an Algorithm for Thrombosis with Thrombocytopenia Syndrome (TTS) at Unusual Sites.

Introduction: Thrombosis with thrombocytopenia syndrome (TTS) has been reported following receipt of adenoviral vector-based COVID-19 vaccines. However, no validation studies evaluating the accuracy of International Classification of Diseases-10-Clinical Modification (ICD-10-CM)-based algorithm for unusual site TTS are available in the published literature. Methods: The purpose of this study was to assess the performance of clinical coding to 1) leverage literature review and clinical input to develop an ICD-10-CM-based algorithm to identify unusual site TTS as a composite outcome and 2) validate the algorithm against the Brighton Collaboration's interim case definition using laboratory, pathology, and imaging reports in an academic health network electronic health record (EHR) within the US Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative. Validation of up to 50 cases per thrombosis site was conducted, with positive predictive values (PPV) and 95% confidence intervals (95% CI) calculated using pathology or imaging results as the gold standard. Results: The algorithm identified 278 unusual site TTS cases, of which 117 (42.1%) were selected for validation. In both the algorithm-identified and validation cohorts, over 60% of patients were 56 years or older. The positive predictive value (PPV) for unusual site TTS was 76.1% (95% CI 67.2-83.2%) and at least 80% for all but one individual thrombosis diagnosis code. PPV for thrombocytopenia was 98.3% (95% CI 92.1-99.5%). Discussion: This study represents the first report of a validated ICD-10-CM-based algorithm for unusual site TTS. A validation effort found that the algorithm performed at an intermediate-to-high PPV, suggesting that the algorithm can be used in observational studies including active surveillance of COVID-19 vaccines and other medical products.

A Systematic Review of Quantitative Methods for Evaluating Electronic Medication Administration Record and Bar-Coded Medication Administration Usability.

BACKGROUND: Although electronic medication administration records (eMARs) and bar-coded medication administration (BCMA) have improved medication safety, poor usability of these technologies can increase patient safety risks. OBJECTIVES: The objective of our systematic review was to identify the impact of eMAR and BCMA design on usability, operationalized as efficiency, effectiveness, and satisfaction. METHODS: We retrieved peer-reviewed journal articles on BCMA and eMAR quantitative usability measures from PsycInfo and MEDLINE (1946-August 20, 2019), and EMBASE (1976-October 23, 2019). Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we screened articles, extracted and categorized data into the usability categories of effectiveness, efficiency, and satisfaction, and evaluated article quality. RESULTS: We identified 1,922 articles and extracted data from 41 articles. Twenty-four articles (58.5%) investigated BCMA only, 10 (24.4%) eMAR only, and seven (17.1%) both BCMA and eMAR. Twenty-four articles (58.5%) measured effectiveness, 8 (19.5%) efficiency, and 17 (41.5%) satisfaction. Study designs included randomized controlled trial (n = 1; 2.4%), interrupted time series (n = 1; 2.4%), pretest/posttest (n = 21; 51.2%), posttest only (n = 14; 34.1%), and pretest/posttest and posttest only for different dependent variables (n = 4; 9.8%). Data collection occurred through observations (n = 19, 46.3%), surveys (n = 17, 41.5%), patient safety event reports (n = 9, 22.0%), surveillance (n = 6, 14.6%), and audits (n = 3, 7.3%). CONCLUSION: Of the 100 measures across the 41 articles, implementing BCMA and/or eMAR broadly resulted in an increase in measures of effectiveness (n = 23, 52.3%) and satisfaction (n = 28, 62.2%) compared to measures of efficiency (n = 3, 27.3%). Future research should focus on eMAR efficiency measures, utilize rigorous study designs, and generate specific design requirements.

Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases.

COVID-19 infections have contributed to substantial increases in hospitalizations. This study describes demographics, baseline clinical characteristics and treatments, and clinical outcomes among U.S. patients admitted to hospitals with COVID-19 during the prevaccine phase of the pandemic. A total of 20,446 hospitalized patients with a positive COVID-19 nucleic acid amplification test were identified from three large electronic health record databases during 5 February-30 November 2020 (Academic Health System: n = 4504; Explorys; n = 7492; OneFlorida: n = 8450). Over 90% of patients were ≥30 years of age, with an even distribution between sexes. At least one comorbidity was recorded in 84.6-96.1% of patients; cardiovascular and respiratory conditions (28.8-50.3%) and diabetes (25.6-44.4%) were most common. Anticoagulants were the most frequently reported medications on or up to 28 days after admission (44.5-81.7%). Remdesivir was administered to 14.1-24.6% of patients and increased over time. Patients exhibited higher COVID-19 severity 14 days following admission than the 14 days prior to and on admission. The length of in-patient hospital stay ranged from a median of 4 to 6 days, and over 85% of patients were discharged alive. These results promote understanding of the clinical characteristics and hospital-resource utilization associated with hospitalized COVID-19 over time.

"Are we there yet?" Ten persistent hazards and inefficiencies with the use of medication administration technology from the perspective of practicing nurses.

OBJECTIVES: (1) Characterize persistent hazards and inefficiencies in inpatient medication administration; (2) Explore cognitive attributes of medication administration tasks; and (3) Discuss strategies to reduce medication administration technology-related hazards. MATERIALS AND METHODS: Interviews were conducted with 32 nurses practicing at 2 urban, eastern and western US health systems. Qualitative analysis using inductive and deductive coding included consensus discussion, iterative review, and coding structure revision. We abstracted hazards and inefficiencies through the lens of risks to patient safety and the cognitive perception-action cycle (PAC). RESULTS: Persistent safety hazards and inefficiencies related to MAT organized around the PAC cycle included: (1) Compatibility constraints create information silos; (2) Missing action cues; (3) Intermittent communication flow between safety monitoring systems and nurses; (4) Occlusion of important alerts by other, less helpful alerts; (5) Dispersed information: Information required for tasks is not collocated; (6) Inconsistent data organization: Mismatch of the display and the user's mental model; (7) Hidden medication administration technologies (MAT) limitations: Inaccurate beliefs about MAT functionality contribute to overreliance on the technology; (8) Software rigidity causes workarounds; (9) Cumbersome dependencies between technology and the physical environment; and (10) Technology breakdowns require adaptive actions. DISCUSSION: Errors might persist in medication administration despite successful Bar Code Medication Administration and Electronic Medication Administration Record deployment for reducing errors. Opportunities to improve MAT require a deeper understanding of high-level reasoning in medication administration, including control over the information space, collaboration tools, and decision support. CONCLUSION: Future medication administration technology should consider a deeper understanding of nursing knowledge work for medication administration.

Electronic Health Record Legal Settlements in the US Since the 2009 Health Information Technology for Economic and Clinical Health Act.

This cross-sectional study describes allegations of misconduct by electronic health record vendors.

Free-Text Computerized Provider Order Entry Orders Used as Workaround for Communicating Medication Information.

OBJECTIVES: Medication information is frequently communicated via free-text computerized provider order entry (CPOE) orders in electronic health records. When such information is transmitted separately from a structured CPOE medication order, there is a significant risk of medication error. Although prior studies have described the frequency of using free-text CPOE orders for communicating medication information, there is a gap in understanding the nature of the medication information contained in the free-text CPOE orders. The aims of this study are to (1) identify the most common medication names communicated in free-text CPOE orders and their risk levels and (2) identify what actions physicians expect that nurses will complete when they place free-text CPOE orders, and (3) describe differences in these patterns across hospitals. METHODS: This study was a retrospective analysis of a sample of 26,524 free-text CPOE orders from 6 hospitals in the mid-Atlantic U.S. region. RESULTS: Free-text CPOE orders contained in the sample mentioned 193 medication names. Free-text CPOE orders were used frequently to communicate information about naloxone, heparin, flumazenil, and dextrose. Twenty-two percent of the free-text CPOE orders related to discontinuing medication(s), whereas 7% of the free-text CPOE orders relate to giving medication(s). There was high variation across hospitals both in the percentage of free-text CPOE orders mentioning medication information and in the proportion of those that referred to high-risk medications. CONCLUSIONS: The prevalence of medication information in free-text CPOE orders may suggest specific communication challenges in respect to urgency, uncertainty, planning, and other aspects of communication and clinical needs. Understanding and addressing communication challenges around commonly mentioned medication names and actions, especially those that are high risk, can help reduce the risk of medication errors.

Detection of allergic transfusion-related adverse events from electronic medical records.

BACKGROUND: Transfusion-related adverse events can be unrecognized and unreported. As part of the US Food and Drug Administration's Center for Biologics Evaluation and Research Biologics Effectiveness and Safety initiative, we explored whether machine learning methods, such as natural language processing (NLP), can identify and report transfusion allergic reactions (ARs) from electronic health records (EHRs). STUDY DESIGN AND METHODS: In a 4-year period, all 146 reported transfusion ARs were pulled from a database of 86,764 transfusions in an academic health system, along with a random sample of 605 transfusions without reported ARs. Structured and unstructured EHR data were retrieved, including demographics, new symptoms, medications, and lab results. In unstructured data, evidence from clinicians' notes, test results, and prescriptions fields identified transfusion ARs, which were used to extract NLP features. Clinician reviews of selected validation cases assessed and confirmed model performance. RESULTS: Clinician reviews of selected validation cases yielded a sensitivity of 67.9% and a specificity of 97.5% at a threshold of 0.9, with a positive predictive value (PPV) of 84%, estimated to 4.5% when extrapolated to match transfusion AR incidence in the full transfusion dataset. A higher threshold achieved sensitivity of 43% with specificity/PPV of 100% in our validation set. Essential features predicting ARs were recognized transfusion reactions, administration of antihistamines or glucocorticoids, and skin symptoms (e.g., hives and itching). Removal of NLP features decreased model performance. DISCUSSION: NLP algorithms can identify transfusion reactions from the EHR with a reasonable level of precision for subsequent clinician review and confirmation.

Clinician Perceptions on the Use of Free-Text Communication Orders.

OBJECTIVE: The aim of this study was to investigate (1) why ordering clinicians use free-text orders to communicate medication information; (2) what risks physicians and nurses perceive when free-text orders are used for communicating medication information; and (3) how electronic health records (EHRs) could be improved to encourage the safe communication of medication information. METHODS: We performed semi-structured, scenario-based interviews with eight physicians and eight nurses. Interview responses were analyzed and grouped into common themes. RESULTS: Participants described eight reasons why clinicians use free-text medication orders, five risks relating to the use of free-text medication orders, and five recommendations for improving EHR medication-related communication. Poor usability, including reduced efficiency and limited functionality associated with structured order entry, was the primary reason clinicians used free-text orders to communicate medication information. Common risks to using free-text orders for medication communication included the increased likelihood of missing orders and the increased workload on nurses responsible for executing orders. DISCUSSION: Clinicians' use of free-text orders is primarily due to limitations in the current structured order entry design. To encourage the safe communication of medication information between clinicians, the EHR's structured order entry must be redesigned to support clinicians' cognitive and workflow needs that are currently being addressed via the use of free-text orders. CONCLUSION: Clinicians' use of free-text orders as a workaround to insufficient structured order entry can create unintended patient safety risks. Thoughtful solutions designed to address these workarounds can improve the medication ordering process and the subsequent medication administration process.

Identifying Health Information Technology Usability Issues Contributing to Medication Errors Across Medication Process Stages.

OBJECTIVE: Different health information technology (health IT) systems are intended to support medication ordering, reviewing, and administration. We sought to identify the types of medication errors associated with health IT use, whether they reached the patient, where in the medication process those errors occurred, and the specific usability issues contributing to those errors. METHODS: Patient safety event reports from more than 595 healthcare facilities entered between January 2013 and September 2018 were analyzed. We computationally identified reports associated with health IT intended to support the medication process, including computerized provider order entry, electronic medication administration record, and barcode medication administration. From these, 2700 reports were manually reviewed to determine the type of medication error, medication process stage, and health IT usability issue. RESULTS: Of the 2700 manually reviewed reports, 1508 (55.9%) described a medication error that was associated with health IT use and 750 (49.7%) reached the patient. Improper dose errors were frequent (1214 of 1508, 80.5%) with most errors during ordering (673 of 1508, 44.6%) and reviewing medications (639 of 1508, 42.4%). Most health IT-associated medication error reports described usability issues (n = 1468 of 1508, 97.3%) including data entry, workflow support, and alerting. Data entry usability issues impacted few medication process stages, whereas workflow support and alerting impacted several stages. CONCLUSIONS: Health IT usability issues are a prevalent contributing factor to medication errors, many of which reach the patient. Data entry, workflow support, and alerting should be prioritized during usability and safety optimization efforts.

Emergency Physician Perceptions of Electronic Health Record Usability and Safety.

OBJECTIVES: Despite requirements for electronic health record (EHR) vendor usability testing, usability challenges persist, contributing to patient safety concerns. We sought to identify emergency physicians' perceived EHR usability and safety strengths and shortcomings across major EHR vendor products. METHODS: Fifty-five emergency physicians from 4 different hospitals were interviewed. The interviews were qualitatively analyzed, and physician comments were aligned with a usability taxonomy to identify emerging themes by vendor and hospital. RESULTS: Of the 194 comments about usability, the 3 most commonly discussed usability topics were Workflow Support (33.5% of comments), Visual Display (20.1%), and Data Entry (14.4%). Electronic health record usability strengths were centered on Visual Display, and the most common shortcoming was the lack of Workflow Support. Fourteen cross-hospital/cross-vendor themes, 6 vendor-specific themes, and 4 hospital-specific themes were identified. CONCLUSIONS: Usability shortcomings that spanned across hospitals and vendors may suggest a need for more applied research and improved design to resolve these issues. Shortcomings that are localized to a specific product or hospital may be due to customization and may be addressable by learning from other organizations.

Advancing electronic health record vendor usability maturity: Progress and next steps.

Despite basic federal requirements promoting a user-centered design approach to electronic health record (EHR) development and usability testing there have been usability and safety risks with EHR technology. Four EHR vendors were asked to provide written descriptions of their usability practices, and we reviewed these descriptions to identify areas where there has been advancement and areas for improvement. All 4 vendors described user-centered design processes and usability testing methods that demonstrate advancement from previous studies of vendor practices. Importantly, vendors are also beginning to address aspects of EHR implementation that play a critical role in shaping EHR usability. There are important areas for improvement in vendor practices including a greater focus on safety and on measurement and benchmarking. Vendors sharing their current usability practices demonstrates a step toward greater transparency which has typically been lacking.

Early mortality benefit with COVID-19 convalescent plasma: a matched control study.

Convalescent plasma can provide passive immunity during viral outbreaks, but the benefit is uncertain for the treatment of novel coronavirus disease 2019 (COVID-19). Our goal is to assess the efficacy of COVID-19 convalescent plasma (CCP). In all, 526 hospitalized patients with laboratory-confirmed SARS-CoV-2 at an academic health system were analyzed. Among them, 263 patients received CCP and were compared to 263 matched controls with standard treatment. The primary outcome was 28-day mortality with a subanalysis at 7 and 14 days. No statistical difference in 28-day mortality was seen in CCP cases (25·5%) compared to controls (27%, P = 0·06). Seven-day mortality was statistically better for CCP cases (9·1%) than controls (19·8%, P < 0·001) and continued at 14 days (14·8% vs. 23·6%, P = 0·01). After 72 h, CCP transfusion resulted in transitioning from nasal cannula to room air (median 4 days vs. 1 day, P = 0·02). The length of stay was longer in CCP cases than controls (14·3 days vs. 11·4 days, P < 0·001). Patients with COVID-19 who received CCP had a decreased risk of death at 7 and 14 days, but not 28 days after transfusion. To date, this is the largest study demonstrating a mortality benefit for the use of CCP in patients with COVID-19 compared to matched controls.

Communication through the electronic health record: frequency and implications of free text orders.

Communication for non-medication order (CNMO) is a type of free text communication order providers use for asynchronous communication about patient care. The objective of this study was to understand the extent to which non-medication orders are being used for medication-related communication. We analyzed a sample of 26 524 CNMOs placed in 6 hospitals. A total of 42% of non-medication orders contained medication information. There was large variation in the usage of CNMOs across hospitals, provider settings, and provider types. The use of CNMOs for communicating medication-related information may result in delayed or missed medications, receiving medications that should have been discontinued, or important clinical decision being made based on inaccurate information. Future studies should quantify the implications of these data entry patterns on actual medication error rates and resultant safety issues.

Qualitative findings from a pilot stage implementation of a novel organizational learning tool toward operationalizing the Safety-II paradigm in health care.

'Safety-II' is a new approach to safety, which emphasizes learning proactively about how safety and efficacy are achieved in everyday frontline work. Previous research developed a new lesson-sharing tool designed based on the Safety-II approach: Resilience Engineering Tool to Improve Patient Safety (RETIPS). The tool comprises questions designed to elicit narratives of adaptations that have contributed to effectiveness in care delivery. The purpose of this study is to revise and validate the design of RETIPS. The tool was revised based on feedback of clinicians at a large multi-specialty hospital, resulting in a version customized for anesthesia residents, RETIPS-AnRes. RETIPS-AnRes was administered on a pilot-basis to anesthesia resident groups for a limited period of time. A review of the reports obtained shows a strong alignment of responses with the conceptual basis of the tool, i.e. learning about how things go well in everyday work. The exemplars include both, specific instances of successful patient care, as well as generic routines that contribute to safe and/or effective care delivery. These findings support RETIPS as a tool to operationalize the Safety-II paradigm in healthcare. Lessons and implications for implementation on a wider scale are discussed.

Emergency Physician Use of Cognitive Strategies to Manage Interruptions.

STUDY OBJECTIVE: The purpose of this study is to examine whether emergency physicians use strategies to manage interruptions during clinical work. Interruption management strategies include immediately engaging the interruption by discontinuing the current task and starting the interruption, continuing the current task while engaging the interruption, rejecting the interruption, or delaying the interruption. METHODS: An observational time and motion study was conducted in 3 different urban, academic emergency departments with 18 attending emergency physicians. Each physician was observed for 2 hours, and the number of interruptions, source of interruptions, type of task being interrupted, and use of interruption management strategies were documented. RESULTS: Participants were interrupted on average of 12.5 times per hour. The majority of interruptions were in person from other staff, including nurses, residents, and other attending physicians. When participants were interrupted, they were often working on their computer. Participants almost always immediately engaged the interruption task (75.4% of the time), followed by multitasking, in which the primary task was continued while the interrupting task was performed (22.2%). Physicians rejected or delayed interruptions less than 2% of the time. CONCLUSION: Our results suggest there is an opportunity to introduce emergency physicians to the use of interruption management strategies as a method of handling the frequent interruptions they are exposed to. Use of these strategies when high-risk primary tasks are performed may reduce the disruptiveness of some interruptions and improve patient safety.

Effect of intensive physician oversight on a prehospital rapid-sequence intubation program.

OBJECTIVE: To examine the effects of adding close concurrent and retrospective physician oversight, consistent with National Association of EMS Physicians (NAEMSP) recommendations, to an existing regional prehospital rapid-sequence intubation (RSI) program. METHODS: This study involved a retrospective cohort of patients receiving RSI between January 1, 2004, and July 31, 2008. On January 1, 2007, an updated program including additional concurrent and retrospective physician oversight, increased RSI-specific continuing medical education, and cadaver laboratory training was implemented. Study patients were divided into a preintervention group (group 1) and a postintervention group (group 2) based on date of medical care. Data regarding baseline characteristics, airway management, medication usage, and performance factors were compared between the groups. A retrospective review by two emergency medical services (EMS) physicians assessed whether the RSI was "clearly indicated" based on a predetermined set of criteria. RESULTS: There were 109 RSIs performed in group 1 and 54 in group 2. Absolute increases in the use of both basic life support (BLS) (5%, p = 0.2) and advanced life support (ALS) (41%, p = 0.001) airway techniques were observed. Increases in postintubation administration of midazolam (30%, p = 0.001) and morphine (24%, p = 0.001) and a decrease for vecuronium (-28%, p = 0.001) were observed. There was no statistically significant difference in the intubation success rates (92% vs. 94%) and the frequencies of recognized esophageal endotracheal tube (ETT) placement (5% vs. 6%). The number of unrecognized esophageal ETT placements remained zero. Physician chart review demonstrated an absolute increase in "clearly indicated" RSIs (17%, p = 0.01). CONCLUSIONS: Close concurrent and retrospective physician oversight consistent with recommendations from the NAEMSP is associated with improved cognitive skills in paramedics, including appropriate patient selection for RSI. Further research is warranted to validate this model and optimize where resources are best used to enhance patient safety and improve clinical management for this controversial paramedic skill.

Emergency medical service attitudes toward geriatric prehospital care and continuing medical education in geriatrics.

OBJECTIVES: To understand the opinions of emergency medical service (EMS) providers regarding their ability to care for older adults, the domains of geriatric medicine in which they need more training, and the modality through which continuing education could be best delivered. DESIGN: Qualitative study using key informant interviews. SETTING: Prehospital EMS system in Rochester, New York. PARTICIPANTS: EMS providers, EMS instructors and administrators, emergency physicians, and geriatricians. MEASUREMENTS: Semistructured interviews were conducted using an interview guide that addressed knowledge and skill deficiencies, recommendations for improvement of geriatrics continuing education, and delivery methods of education. RESULTS: Participant responses were generally congruous despite the diverse backgrounds, and redundancy was achieved rapidly. All participants perceived a deficit in EMS education on the care of older adults, particularly related to communications with patients and skilled nursing facility staff. All desired more geriatric continuing education for EMS providers, especially in communications and psychosocial issues. Education was desired in various modalities. CONCLUSION: Further geriatric continuing education for EMS providers is needed. Some specific topics relate to medical issues, but a large proportion involve communications and psychosocial issues. Education should be delivered in a variety of modalities to meet the needs of the EMS community. Emerging on-line video technologies may bridge the gap between learners preferring classroom-based modailities and those preferring self-study modules.