The critical need for nursing education to address the diagnostic process.

Diagnostic errors are among the most common medical errors and the deadliest. The National Academy of Medicine recently concluded that diagnostic errors represent an urgent national concern. Their first recommendation to address this issue called for promoting the key role of the nurse in the diagnostic process. Registered nurses across clinical settings significantly contribute to the medical diagnostic process, though their role in diagnosis has historically gone unacknowledged. In this paper, we review the history and current state of diagnostic education in pre-licensure registered nurse preparation, introduce interprofessional individual- and team-based competencies to improve diagnostic safety, and discuss the next steps for nursing education. Nurses educated and empowered to fully participate in the diagnostic process are essential for achieving better, safer patient outcomes.

Closing the loop on test results to reduce communication failures: a rapid review of evidence, practice and patient perspectives.

BACKGROUND: Communication failures involving test results contribute to issues of patient harm and sentinel events. This article aims to synthesise review evidence, practice insights and patient perspectives addressing problems encountered in the communication of diagnostic test results. METHODS: The rapid review identified ten systematic reviews and four narrative reviews. Five practitioner interviews identified insights into interventions and implementation, and a citizen panel with 15 participants explored the patient viewpoint. RESULTS: The rapid review provided support for the role of technology to ensure effective communication; behavioural interventions such as audit and feedback could be effective in changing clinician behaviour; and point-of-care tests (bedside testing) eliminate the communication breakdown problem altogether. The practice interviews highlighted transparency, and clarifying the lines of responsibility as central to improving test result communication. Enabling better information sharing, implementing adequate planning and utilising technology were also identified in the practice interviews as viable strategies to improve test result communication. The citizen panel highlighted technology as critical to improving communication of test results to both health professionals and patients. Patients also highlighted the importance of having different ways of accessing test results, which is particularly pertinent when ensuring suitability for vulnerable populations. CONCLUSIONS: This paper draws together multiple perspectives on the problem of failures in diagnostic test results communication to inform appropriate interventions. Across the three studies, technology was identified as the most feasible option for closing the loop on test result communication. However, the importance of clear, consistent communication and more streamlined processes were also key elements that emerged. REVIEW REGISTRATION: The protocol for the rapid review was registered with PROSPERO CRD42018093316 .

Interventions to prevent iatrogenic anemia: a Laboratory Medicine Best Practices systematic review.

BACKGROUND: As many as 90% of patients develop anemia by their third day in an intensive care unit (ICU). We evaluated the efficacy of interventions to reduce phlebotomy-related blood loss on the volume of blood lost, hemoglobin levels, transfusions, and incidence of anemia. METHODS: We conducted a systematic review and meta-analysis using the Laboratory Medicine Best Practices (LMBP) systematic review methods for rating study quality and assessing the body of evidence. Searches of PubMed, Embase, Cochrane, Web of Science, PsychINFO, and CINAHL identified 2564 published references. We included studies of the impact of interventions to reduce phlebotomy-related blood loss on blood loss, hemoglobin levels, transfusions, or anemia among hospital inpatients. We excluded studies not published in English and studies that did not have a comparison group, did not report an outcome of interest, or were rated as poor quality. Twenty-one studies met these criteria. We conducted a meta-analysis if > 2 homogenous studies reported sufficient information for analysis. RESULTS: We found moderate, consistent evidence that devices that return blood from flushing venous or arterial lines to the patient reduced blood loss by approximately 25% in both neonatal ICU (NICU) and adult ICU patients [pooled estimate in adults, 24.7 (95% CI = 12.1-37.3)]. Bundled interventions that included blood conservation devices appeared to reduce blood loss by at least 25% (suggestive evidence). The evidence was insufficient to determine if these devices reduced hemoglobin decline or risk of anemia. The evidence suggested that small volume tubes reduced the risk of anemia, but was insufficient to determine if they affected the volume of blood loss or the rate of hemoglobin decline. CONCLUSIONS: Moderate, consistent evidence indicated that devices that return blood from testing or flushing lines to the patient reduce the volume of blood loss by approximately 25% among ICU patients. The results of this systematic review support the use of blood conservation systems with arterial or venous catheters to eliminate blood waste when drawing blood for testing. The evidence was insufficient to conclude the devices impacted hemoglobin levels or transfusion rates. The use of small volume tubes may reduce the risk of anemia.

Tracking Progress in Improving Diagnosis: A Framework for Defining Undesirable Diagnostic Events.

Diagnostic error is a prevalent, harmful, and costly phenomenon. Multiple national health care and governmental organizations have recently identified the need to improve diagnostic safety as a high priority. A major barrier, however, is the lack of standardized, reliable methods for measuring diagnostic safety. Given the absence of reliable and valid measures for diagnostic errors, we need methods to help establish some type of baseline diagnostic performance across health systems, as well as to enable researchers and health systems to determine the impact of interventions for improving the diagnostic process. Multiple approaches have been suggested but none widely adopted. We propose a new framework for identifying "undesirable diagnostic events" (UDEs) that health systems, professional organizations, and researchers could further define and develop to enable standardized measurement and reporting related to diagnostic safety. We propose an outline for UDEs that identifies both conditions prone to diagnostic error and the contexts of care in which these errors are likely to occur. Refinement and adoption of this framework across health systems can facilitate standardized measurement and reporting of diagnostic safety.

Pharma Websites and "Professionals-Only" Information: The Implications for Patient Trust and Autonomy.

BACKGROUND: Access to information is critical to a patient's valid exercise of autonomy. One increasingly important source of medical information is the Internet. Individuals often turn to drug company ("pharma") websites to look for drug information. OBJECTIVE: The objective of this study was to determine whether there is information on pharma websites that is embargoed: Is there information that is hidden from the patient unless she attests to being a health care provider? We discuss the implications of our findings for health care ethics. METHODS: We reviewed a convenience sample of 40 pharma websites for "professionals-only" areas and determined whether access to those areas was restricted, requiring attestation that the user is a health care professional in the United States. RESULTS: Of the 40 websites reviewed, 38 had information that was labeled for health care professionals-only. Of these, 24 required the user to certify their status as a health care provider before they were able to access this "hidden" information. CONCLUSIONS: Many pharma websites include information in a "professionals-only" section. Of these, the majority require attestation that the user is a health care professional before they can access the information. This leaves patients with two bad choices: (1) not accessing the information or (2) lying about being a health care professional. Both of these outcomes are unacceptable. In the first instance, the patient's access to information is limited, potentially impairing their health and their ability to make reasonable and well-informed decisions. In the second instance, they may be induced to lie in a medical setting. "Teaching" patients to lie may have adverse consequences for the provider-patient relationship.

The next organizational challenge: finding and addressing diagnostic error.

BACKGROUND: Although health care organizations (HCOs) are intensely focused on improving the safety of health care, efforts to date have almost exclusively targeted treatment-related issues. The literature confirms that the approaches HCOs use to identify adverse medical events are not effective in finding diagnostic errors, so the initial challenge is to identify cases of diagnostic error. WHY HEALTH CARE ORGANIZATIONS NEED TO GET INVOLVED: HCOs are preoccupied with many quality- and safety-related operational and clinical issues, including performance measures. The case for paying attention to diagnostic errors, however, is based on the following four points: (1) diagnostic errors are common and harmful, (2) high-quality health care requires high-quality diagnosis, (3) diagnostic errors are costly, and (4) HCOs are well positioned to lead the way in reducing diagnostic error. FINDING DIAGNOSTIC ERRORS: Current approaches to identifying diagnostic errors, such as occurrence screens, incident reports, autopsy, and peer review, were not designed to detect diagnostic issues (or problems of omission in general) and/or rely on voluntary reporting. The realization that the existing tools are inadequate has spurred efforts to identify novel tools that could be used to discover diagnostic errors or breakdowns in the diagnostic process that are associated with errors. New approaches--Maine Medical Center's case-finding of diagnostic errors by facilitating direct reports from physicians and Kaiser Permanente's electronic health record--based reports that detect process breakdowns in the followup of abnormal findings--are described in case studies. CONCLUSION: By raising awareness and implementing targeted programs that address diagnostic error, HCOs may begin to play an important role in addressing the problem of diagnostic error.

Internet-based crowdsourcing and research ethics: the case for IRB review.

The recent success of Foldit in determining the structure of the Mason-Pfizer monkey virus (M-PMV) retroviral protease is suggestive of the power-solving potential of internet-facilitated game-like crowdsourcing. This research model is highly novel, however, and thus, deserves careful consideration of potential ethical issues. In this paper, we will demonstrate that the crowdsourcing model of research has the potential to cause harm to participants, manipulates the participant into continued participation, and uses participants as experimental subjects. We conclude that protocols relying on this model require institutional review board (IRB) scrutiny.

Influence of comorbid depression and diagnostic workup on diagnosis of physical illness: a randomized experiment.

OBJECTIVES: Patients with mental illness are less likely to receive the same physical healthcare as those without mental illness and are less likely to be treated in accordance with established guidelines. This study employed a randomized experiment to investigate the influence of comorbid depression on diagnostic accuracy. METHODS: Physicians were presented with an interactive vignette describing a patient with a complex presentation of pernicious anemia. They were randomized to diagnose either a patient with or without (control) comorbid depression and related behaviors. All other clinical information was identical. Physicians recorded a differential diagnosis, ordered tests, and rated patient likeability. RESULTS: Fifty-nine physicians completed the study. The patient with comorbid depression was less likeable than the control patient (p=0.03, 95 % CI [0.09, 1.53]). Diagnostic accuracy was lower in the depression compared to control condition (59.4 % vs. 40.7 %), however this difference was not statistically significant χ2(1)=2.035, p=0.15. Exploratory analyses revealed that patient condition (depression vs. control) interacted with the number of diagnostic tests ordered to predict diagnostic accuracy (OR=2.401, p=0.038). Accuracy was lower in the depression condition (vs. control) when physicians ordered fewer tests (1 SD below mean; OR=0.103, p=0.028), but there was no difference for physicians who ordered more tests (1 SD above mean; OR=2.042, p=0.396). CONCLUSIONS: Comorbid depression and related behaviors lowered diagnostic accuracy when physicians ordered fewer tests - a time when more possibilities should have been considered. These findings underscore the critical need to develop interventions to reduce diagnostic error when treating vulnerable populations such as those with depression.

Impact of clinical note format on diagnostic accuracy and efficiency.

BACKGROUND: Clinician notes are structured in a variety of ways. This research pilot tested an innovative study design and explored the impact of note formats on diagnostic accuracy and documentation review time. OBJECTIVE: To compare two formats for clinical documentation (narrative format vs. list of findings) on clinician diagnostic accuracy and documentation review time. METHOD: Participants diagnosed written clinical cases, half in narrative format, and half in list format. Diagnostic accuracy (defined as including correct case diagnosis among top three diagnoses) and time spent processing the case scenario were measured for each format. Generalised linear mixed regression models and bias-corrected bootstrap percentile confidence intervals for mean paired differences were used to analyse the primary research questions. RESULTS: Odds of correctly diagnosing list format notes were 26% greater than with narrative notes. However, there is insufficient evidence that this difference is significant (75% CI 0.8-1.99). On average the list format notes required 85.6 more seconds to process and arrive at a diagnosis compared to narrative notes (95% CI -162.3, -2.77). Of cases where participants included the correct diagnosis, on average the list format notes required 94.17 more seconds compared to narrative notes (75% CI -195.9, -8.83). CONCLUSION: This study offers note format considerations for those interested in improving clinical documentation and suggests directions for future research. Balancing the priority of clinician preference with value of structured data may be necessary. IMPLICATIONS: This study provides a method and suggestive results for further investigation in usability of electronic documentation formats.

The next phase in patient safety education: Towards a standardized, tools-based pathology patient safety curriculum: A call to action from the Association of Pathology Chairs' Residency Program Directors Section Training Residents in Patient Safety Workgroup.

Patient safety education is a mandated Common Program Requirement of the Accreditation Council for Graduate Medical Education and for the Royal College of Physicians and Surgeons of Canada in all medical residency and fellowship programs. Although many hospitals and healthcare environments have general patient safety education tools for trainees, few to none focus on the unique training milieu of pathologists, including a mix of highly automated and manual error-prone processes, frequent multiplicity of events, and lack of direct patient relationships for error disclosure. We established a national Association of Pathology Chairs-Program Directors Section Workgroup focused on patient safety education for pathology trainees entitled Training Residents in Patient Safety (TRIPS). TRIPS included diverse representatives from across the United States, as well as representatives from pathology organizations including the American Board of Pathology, the American Society for Clinical Pathology, the United States and Canadian Academy of Pathology, the College of American Pathologists, and the Society to Improve Diagnosis in Medicine. Objectives of the workgroup included developing a standardized patient safety curriculum, designing teaching and assessment tools, and refining them with pilot sites. Here we report the establishment of TRIPS as well as data from national needs assessment of Program Directors across the country, who confirmed the need for a standardized patient safety curriculum.

Differential diagnosis generators: an evaluation of currently available computer programs.

BACKGROUND: Differential diagnosis (DDX) generators are computer programs that generate a DDX based on various clinical data. OBJECTIVE: We identified evaluation criteria through consensus, applied these criteria to describe the features of DDX generators, and tested performance using cases from the New England Journal of Medicine (NEJM©) and the Medical Knowledge Self Assessment Program (MKSAP©). METHODS: We first identified evaluation criteria by consensus. Then we performed Google® and Pubmed searches to identify DDX generators. To be included, DDX generators had to do the following: generate a list of potential diagnoses rather than text or article references; rank or indicate critical diagnoses that need to be considered or eliminated; accept at least two signs, symptoms or disease characteristics; provide the ability to compare the clinical presentations of diagnoses; and provide diagnoses in general medicine. The evaluation criteria were then applied to the included DDX generators. Lastly, the performance of the DDX generators was tested with findings from 20 test cases. Each case performance was scored one through five, with a score of five indicating presence of the exact diagnosis. Mean scores and confidence intervals were calculated. KEY RESULTS: Twenty three programs were initially identified and four met the inclusion criteria. These four programs were evaluated using the consensus criteria, which included the following: input method; mobile access; filtering and refinement; lab values, medications, and geography as diagnostic factors; evidence based medicine (EBM) content; references; and drug information content source. The mean scores (95% Confidence Interval) from performance testing on a five-point scale were Isabel© 3.45 (2.53, 4.37), DxPlain® 3.45 (2.63-4.27), Diagnosis Pro® 2.65 (1.75-3.55) and PEPID™ 1.70 (0.71-2.69). The number of exact matches paralleled the mean score finding. CONCLUSIONS: Consensus criteria for DDX generator evaluation were developed. Application of these criteria as well as performance testing supports the use of DxPlain® and Isabel© over the other currently available DDX generators.

Rivaroxaban vs. warfarin for stroke prevention in patients with nonvalvular atrial fibrillation.

Patients with nonvalvular atrial fibrillation and a CHADS2 score of 2 points or more should be placed on warfarin anticoagulation. If they do not meet the CHADS2 criteria for warfarin, then they should receive therapy with aspirin. If a patient's condition is well-controlled on warfarin, this study does not support transitioning him or her to rivaroxaban, the more expensive alternative. Home monitoring of INR should be considered for patients who are capable and motivated to perform self-monitoring. Rivaroxaban has no reversal agent and has significant drug interactions (P-glycoprotein inducers and CYP3A4 inhibitors increase the risk of bleeding; P-glycoprotein inducers reduce effectiveness).

How insight contributes to diagnostic excellence.

In the quest to improve diagnosis, a great deal of attention has already been focused on how to optimize clinical reasoning, and the importance of System 1 and System 2 processing. In this essay we consider the role of 'insight', a relatively overlooked pathway for arriving at the correct diagnosis. Insight refers to spontaneous emergence of the correct answer at some later point in time. We discuss factors that might facilitate insight, and how these could be incorporated into the diagnostic process.

Artificial intelligence and machine learning in emergency medicine: a narrative review.

AIM: The emergence and evolution of artificial intelligence (AI) has generated increasing interest in machine learning applications for health care. Specifically, researchers are grasping the potential of machine learning solutions to enhance the quality of care in emergency medicine. METHODS: We undertook a narrative review of published works on machine learning applications in emergency medicine and provide a synopsis of recent developments. RESULTS: This review describes fundamental concepts of machine learning and presents clinical applications for triage, risk stratification specific to disease, medical imaging, and emergency department operations. Additionally, we consider how machine learning models could contribute to the improvement of causal inference in medicine, and to conclude, we discuss barriers to safe implementation of AI. CONCLUSION: We intend that this review serves as an introduction to AI and machine learning in emergency medicine.

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.