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Background Clinical medicine has long recognized the potential for cognitive bias in the development of new treatments, and in response developed a tradition of blinding both clinicians and patients to address this specific concern. Although cognitive biases have been shown to exist which impact the accuracy of clinical diagnosis, blinding the diagnostician to potentially misleading information has received little attention as a possible solution. Recently, within the forensic sciences, the control of contextual information (i.e. information apart from the objective test results) has been studied as a technique to reduce errors. We consider the applicability of this technique to clinical medicine. Content This article briefly describes the empirical research examining cognitive biases arising from context which impact clinical diagnosis. We then review the recent awakening of forensic sciences to the serious effects of misleading information. Comparing the approaches, we discuss whether blinding to contextual information might (and in what circumstances) reduce clinical errors. Summary and outlook Substantial research indicates contextual information plays a significant role in diagnostic error and conclusions across several medical specialties. The forensic sciences may provide a useful model for the control of potentially misleading information in diagnosis. A conceptual analog of the forensic blinding process (the “agnostic” first reading) may be applicable to diagnostic investigations such as imaging, microscopic tissue examinations and waveform recognition. An “agnostic” approach, where the first reading occurs with minimal clinical referral information, but is followed by incorporation of the clinical history and reinterpretation, has the potential to reduce errors.

Current efforts focusing on better defining the prevalence of diagnostic errors, their causes and remediation strategies should address the role of laboratory testing and its contribution to high-quality care as well as a possible source of diagnostic errors. Data collected in the last few years highlight the vulnerability of extra-analytical phases of the testing cycle and the need for programs aiming to improve all steps of the process. Further studies have clarified the nature of laboratory-related errors, namely the evidence that both system-related and cognitive factors account for most errors in laboratory medicine. Technology developments are effective in decreasing the rates of system-related errors but organizational issues play a fundamental role in assuring a real improvement in quality and safety in laboratory processes. Educational interventions as well as technology-based interventions have been proposed to reduce the risk of cognitive errors. However, to reduce diagnostic errors and improve patient safety, clinical laboratories have to embark on a paradigmatic shift restoring the nature of laboratory services as an integral part of the diagnostic and therapy process.

Background Excellence in clinical reasoning is one of the most important outcomes of medical education programs, but assessing learners’ reasoning to inform corrective feedback is challenging and unstandardized. Methods The Society to Improve Diagnosis in Medicine formed a multi-specialty team of medical educators to develop the Assessment of Reasoning Tool (ART). This paper describes the tool development process. The tool was designed to facilitate clinical teachers’ assessment of learners’ oral presentation for competence in clinical reasoning and facilitate formative feedback. Reasoning frameworks (e.g. script theory), contemporary practice goals (e.g. high-value care [HVC]) and proposed error reduction strategies (e.g. metacognition) were used to guide the development of the tool. Results The ART is a behaviorally anchored, three-point scale assessing five domains of reasoning: (1) hypothesis-directed data gathering, (2) articulation of a problem representation, (3) formulation of a prioritized differential diagnosis, (4) diagnostic testing aligned with HVC principles and (5) metacognition. Instructional videos were created for faculty development for each domain, guided by principles of multimedia learning. Conclusions The ART is a theory-informed assessment tool that allows teachers to assess clinical reasoning and structure feedback conversations.

Background Diagnostic test accuracy (DTA) systematic reviews (SRs) characterize a test’s potential for diagnostic quality and safety. However, interpreting DTA measures in the context of SRs is challenging. Further, some evidence grading methods (e.g. Centers for Disease Control and Prevention, Division of Laboratory Systems Laboratory Medicine Best Practices method) require determination of qualitative effect size ratings as a contributor to practice recommendations. This paper describes a recently developed effect size rating approach for assessing a DTA evidence base. Methods A likelihood ratio scatter matrix will plot positive and negative likelihood ratio pairings for DTA studies. Pairings are graphed as single point estimates with confidence intervals, positioned in one of four quadrants derived from established thresholds for test clinical validity. These quadrants support defensible judgments on “substantial”, “moderate”, or “minimal” effect size ratings for each plotted study. The approach is flexible in relation to a priori determinations of the relative clinical importance of false positive and false negative test results. Results and conclusions This qualitative effect size rating approach was operationalized in a recent SR that assessed effectiveness of test practices for the diagnosis of Clostridium difficile . Relevance of this approach to other methods of grading evidence, and efforts to measure diagnostic quality and safety are described. Limitations of the approach arise from understanding that a diagnostic test is not an isolated element in the diagnostic process, but provides information in clinical context towards diagnostic quality and safety.

Background Diagnostic testing provides integral information for the prevention, diagnosis, treatment and management of disease. Inadequate test result reporting and follow-up is a major risk to patient safety. Factors contributing to failure to follow-up test results include unclear delineation of responsibility about who is meant to act on a test result; poor coordination across different levels of care; and the absence of integrated health information systems for the efficient information communication. Methods A 2016 Australian Stakeholder Forum brought together over 30 representatives from 14 different consumer, clinical and management stakeholder organisations to discuss safe and effective test result communication, management and follow-up. Thematic analysis was conducted drawing on multimodal data collected in the form of observational fieldnotes and document artefacts produced by participants. Results The forum identified major challenges which pose immediate risks to patient safety. Participants recommended priorities for addressing issues relating to: (i) the governance of test result management processes; (ii) integration of health care processes through the utilisation of effective digital health solutions; and (iii) involving patients as key partners in the decision-making and care process. Conclusions Stakeholder groups diverged slightly in their priorities. Consumers highlighted the lack of patient involvement in the test result management process but were less concerned about standardisation of reports and critical result thresholds than pathologists. The forum foregrounded the need for a systems approach, capable of identifying and addressing interconnections and multiple factors that contribute to poor test result follow-up, with a strong emphasis on enhancing the contribution of patients.

Background: Diagnostic error is a major problem in health care, yet there are few medical school curricula focused on improving the diagnostic process and decreasing diagnostic errors. Effective strategies to teach medical students about diagnostic error and diagnostic safety have not been established. Methods: We designed, implemented and evaluated a virtual patient module featuring two linked cases involving diagnostic errors. Learning objectives developed by a consensus process among medical educators in the Society to Improve Diagnosis in Medicine (SIDM) were utilized. The module was piloted with internal medicine clerkship students at three institutions and with clerkship faculty members recruited from listservs. Participants completed surveys on their experience using the case and a qualitative analysis was performed. Results: Thirty-five medical students and 25 faculty members completed the survey. Most students found the module to be relevant and instructive. Faculty also found the module valuable for students but identified insufficient curricular time as a barrier to implementation. Conclusions: Medical students and faculty found a prototype virtual patient module about the diagnostic process and diagnostic error to be educational.

Background Diagnostic errors are a significant cause of patient harm. Cognitive processes often contribute to diagnostic errors but studying and mitigating the effects of these errors is challenging. Computerized virtual patients may provide insight into the diagnostic process without the potential for patient harm, but the feasibility and utility of using such cases in practicing physicians has not been well described. Methods We developed a series of computerized virtual cases depicting common presentations of disease that included contextual factors that could result in diagnostic error. Cases were piloted by practicing physicians in two phases and participant impressions of the case platform and cases were recorded, as was outcome data on physician performance. Results Participants noted significant challenges in using the case platform. Participants specifically struggled with becoming familiar with the platform and adjusting to the non-adaptive and constraining processes of the model. Although participants found the cases to be typical presentations of problems commonly encountered in practice, the correct diagnosis was identified in less than 33% of cases. Conclusions The development of virtual patient cases for use by practicing physicians requires substantial resources and platforms that account for the non-linear and adaptive nature of reasoning in experienced clinicians. Platforms that are without such characteristics may negatively affect diagnostic performance. The novelty of such platforms may also have the potential to increase cognitive load. Nonetheless, virtual cases may have the potential to be a safe and robust means of studying clinical reasoning performance.

Background Learning patient outcomes is recognized as crucial for ongoing refinement of clinical decision-making, but is often difficult in fragmented care with frequent handoffs. Data on resident habits of seeking outcome feedback after handoffs are lacking. Methods We performed a mixed-methods study including (1) an analysis of chart re-access rates after handoffs performed using access logs of the electronic health record (EHR); and (2) a web-based survey sent to internal medicine (IM) and emergency medicine (EM) residents about their habits of and barriers to learning the outcomes of patients after they have handed them off to other teams. Results Residents on ward rotations were often able to re-access charts of patients after handoffs, but those on EM or night admitting rotations did so <5% of the time. Among residents surveyed, only a minority stated that they frequently find out the outcomes of patients they have handed off, although learning outcomes was important to both their education and job satisfaction. Most were not satisfied with current systems of learning outcomes of patients after handoffs, citing too little time and lack of reliable patient tracking systems as the main barriers. Conclusions Despite perceived importance of learning outcomes after handoffs, residents cite difficulty with obtaining such information. Systematically providing feedback on patient outcomes would meet a recognized need among physicians in training.

Background Uncertainty is ubiquitous in medical practice. The Pediatrics Milestones from the Accreditation Council on Graduate Medical Education state that advanced learners should acknowledge and communicate about clinical uncertainty. If uncertainty is not acknowledged, patient care may suffer. There are no described curricula specifically aimed to improve learners’ ability to acknowledge and discuss clinical uncertainty. We describe an educational intervention designed to fill this gap. Methods Second-year pediatric residents engaged in a two-phase simulation-based educational intervention designed to improve their ability to communicate about diagnostic uncertainty with patients and caregivers. In each phase, residents engaged in two simulated cases and debriefs. Performance was assessed after each simulated patient encounter using standardized metrics, along with learner perceptions of the experience. Results Residents’ skills in communicating with patients and families about diagnostic uncertainty improved after this intervention (mean score post 3.84 vs. 3.28 pre on a five-point Likert scale, p<0.001). Residents rated the experience as relevant, challenging and positive. Conclusions This prospective study suggests that a simulation-based intervention was effective in improving resident physicians’ skills in communicating about diagnostic uncertainty with patients and families. Further study is needed to determine how learners perform in real clinical environments.

This is a case report involving diagnostic errors that resulted in the death of a 15-year-old girl, and commentaries on the case from her parents and involved providers. Julia Berg presented with fatigue, fevers, sore throat and right sided flank pain. Based on a computed tomography (CT) scan that identified an abnormal-appearing gall bladder, and markedly elevated bilirubin and “liver function tests”, she was hospitalized and ultimately underwent surgery for suspected cholecystitis and/or cholangitis. Julia died of unexplained post-operative complications. Her autopsy, and additional testing, suggested that the correct diagnosis was Epstein-Barr virus infection with acalculous cholecystitis. The correct diagnosis might have been considered had more attention been paid to her presenting symptoms, and a striking degree of lymphocytosis that was repeatedly demonstrated. The case illustrates how cognitive “biases” can contribute to harm from diagnostic error. The case has profoundly impacted the involved healthcare organization, and Julia’s parents have become leaders in helping advance awareness and education about diagnostic error and its prevention.